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Ligand Reports Third Quarter 2018 Financial Results

On November 8, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three and nine months ended September 30, 2018, and provided an operating forecast and program updates (Press release, Ligand, NOV 8, 2018, View Source [SID1234530958]). Ligand management will host a conference call today beginning at 9:00 a.m. Eastern time to discuss this announcement and answer questions.

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"This quarter was marked by several events that demonstrate the strength of Ligand’s business model. First, our partners continued to deliver solid commercial and clinical development results. Specifically, sales of Promacta hit an all-time quarterly high and our partner Viking Therapeutics announced positive topline results for its Phase 2 trial of VK2809, with the potential for efficacy in patients with liver diseases such as non-alcoholic fatty liver disease and NASH. Additionally, we closed the acquisition of Vernalis in October, which provides several high-value shots on goal, as well as a top-notch R&D team, all for a modest cash outlay," said John Higgins, Chief Executive Officer of Ligand. "Despite the recent turbulence in the financial markets, Ligand continues to execute on its business model, and we will remain focused and will work to capitalize on opportunities the economic cycle brings us."

Third Quarter 2018 Financial Results

Total revenues for the third quarter of 2018 were $45.7 million, compared with $33.4 million for the same period in 2017. Royalties were $36.1 million, compared with $21.9 million for the third quarter of 2017 and $28.3 million for the fourth quarter of 2017. Under the new accounting standard ASC 606, adopted as of the start of 2018, third quarter 2018 royalties should be compared with fourth quarter 2017 royalties due to the timing of revenue recognition. Third quarter 2018 royalties primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Material sales were $7.0 million, compared with $7.7 million for the same period in 2017 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $2.5 million, compared with $3.8 million for the same period in 2017.

Cost of goods sold was $1.5 million for the third quarter of 2018, compared with $2.4 million for the same period in 2017. Amortization of intangibles was $5.7 million, compared with $2.7 million for the same period in 2017, due to recent acquisitions and amortization of R&D assets that were out-licensed or impaired. Research and development expense was $5.5 million, compared with $4.8 million for the same period of 2017. General and administrative expense was $9.6 million, compared with $7.0 million for the same period in 2017.

GAAP net income for the third quarter of 2018 was $67.4 million, or $2.80 per diluted share, compared with $8.4 million, or $0.36 per diluted share, for the same period in 2017. Net income for the third quarter of 2018 was impacted by a non-cash gain due to the marking of Ligand’s investment in Viking Therapeutics to market. Adjusted net income for the third quarter of 2018 was $31.7 million, or $1.32 per diluted share, compared with $15.3 million, or $0.69 per diluted share, for the same period in 2017.

As of September 30, 2018, Ligand had cash, cash equivalents, restricted cash and short-term investments of approximately $1 billion. Cash generated from operations during the third quarter of 2018 was $27.1 million.

Year-to-Date Financial Results

Total revenues for the nine months ended September 30, 2018 were $191.9 million, compared with $90.6 million for the same period in 2017. Royalties were $88.3 million, compared with $60.4 million for the nine months ended September 30, 2017 and $64.5 million for the nine months ended December 31, 2017. Under ASC 606, royalties for the nine months ended September 30, 2018 should be compared with royalties for the nine months ended December 31, 2017 due to the timing of revenue recognition. Royalties for the nine months ended September 30, 2018 primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Material sales were $19.0 million, compared with $14.3 million for the same period in 2017 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $84.5 million, compared with $15.9 million for the same period in 2017, primarily due to the receipt of a $47 million payment from WuXi Biologics to amend its OmniAb platform license agreement and a $20 million upfront payment upon the licensing of Ligand’s GRA program.

Cost of goods sold was $3.4 million for the nine months ended September 30, 2018, compared with $3.6 million for the same period in 2017 due to the timing and mix of Captisol sales. Amortization of intangibles was $12.3 million, compared with $8.1 million for the same period in 2017, due to recent acquisitions and amortization of R&D assets that were out-licensed or impaired. Research and development expense was $19.0, compared with $18.3 million for the same period in 2017. General and administrative expense was $26.6 million, compared with $20.9 million for the same period in 2017.

GAAP net income for the nine months ended September 30, 2018 was $185.8 million, or $7.61 per diluted share, compared with $19.6 million, or $0.84 per diluted share, for the same period in 2017. Net income for the nine months ended September 30, 2018 was impacted by a non-cash gain due to the marking of Ligand’s investment in Viking Therapeutics to market. Adjusted net income for the nine months ended September 30, 2018 was $127.9 million, or $5.44 per diluted share, compared with $42.9 million, or $1.94 per diluted share, for the same period in 2017.

2018 Financial Guidance

Ligand is raising its previous guidance for 2018 and now expects revenue to be approximately $240 million, including royalties of approximately $122 million, material sales of approximately $25 million and license fees and milestones of approximately $93 million, with the potential for up to an additional $5 million in license fees and milestones. Ligand notes that with revenue of $240 million, adjusted earnings per diluted share would be approximately $6.52.

This compares with previous guidance for 2018 revenue to be approximately $232 million, including royalties of approximately $120 million, material sales of approximately $23 million and license fees and milestones of approximately $89 million, with the potential for up to an additional $8 million in license fees and milestones, and adjusted earnings per diluted share of approximately $6.30.

Third Quarter 2018 and Recent Business Highlights

Promacta/Revolade

Novartis reported third quarter 2018 net sales of Promacta/Revolade (eltrombopag) of $295 million, a $68 million or 30% increase over the same period in 2017.
Novartis presented data from a Phase 4 open-label study of Promacta in the treatment of Chronic Immune Thrombocytopenia at the European Congress on Thrombosis and Haemostasis 2018.
Novartis announced that Promacta would be highlighted at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2018.
Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On October 30, 2018, Amgen reported third quarter net sales of Kyprolis of $232 million, a $25 million or 12% increase over the same period in 2017. On October 31, 2018, Ono Pharmaceutical reported Kyprolis sales in Japan of approximately $11 million for the most recent quarter.
On October 1, 2018, Amgen announced that the FDA approved the supplemental New Drug Application (sNDA) to expand the prescribing information for Kyprolis to include a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma.
On November 1, 2018, Amgen announced that new clinical data will be presented at the 60th ASH (Free ASH Whitepaper) annual meeting in December 2018 for Kyprolis and AMG-330.
Recent Acquisitions

Ligand announced the acquisition of Vernalis plc, a structure-based drug discovery biotechnology company with a broad pipeline of partnered programs and ongoing collaborations, for $43 million in cash, which was mostly offset by approximately $32 million of cash on hand at Vernalis after deal fees. The acquisition of Vernalis provides Ligand with more than eight fully-funded shots on goal, a 70-person R&D team based in Cambridge, England with a portfolio of ongoing collaboration agreements that have the potential to create additional shots on goal, a compound library of unpartnered programs for potential business development out-licensing and England-based operations that provide a platform to help efficiently pursue investment and acquisition activities in Europe and the United Kingdom.
Additional Pipeline and Partner Developments

Viking Therapeutics announced positive topline results from a 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease, which demonstrated statistically significant reductions in low-density lipoprotein cholesterol and statistically significant reductions in liver fat content, and that the study results would be presented in an oral late-breaker presentation at The Liver Meeting 2018.
Viking Therapeutics announced that results from its Phase 2 study of VK5211 in patients recovering from hip fracture were presented at the American Society for Bone and Mineral Research 2018 annual meeting.
Sage Therapeutics announced that the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted that data support the favorable benefit-risk profile of Zulresso injection for the treatment of postpartum depression (PPD).
Sage Therapeutics announced The Lancet published an integrated analysis across three double-blind, randomized, placebo-controlled studies of Zulresso injection in women with PPD, demonstrating significant and clinically meaningful reductions in HAM-D total score.
Melinta Therapeutics announced positive topline results from its Phase 3 trial of Baxdela for the treatment of adult patients with community-acquired bacterial pneumonia.
Retrophin announced presentation of new data examining the long-term effects of sparsentan in focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology Kidney Week 2018, and that the Journal of the American Society of Nephrology published online the positive results from Retrophin’s Phase 2 DUET study of sparsentan for the treatment of FSGS.
Retrophin announced two presentations related to sparsentan in the treatment of IgA Nephropathy during the 15th International Symposium on IgA Nephropathy.
Verona Pharma announced that it had enrolled the last patient in its Phase 2 clinical trial evaluating the effect of nebulized RPL554 as an add-on to dual therapy using long-acting anti-muscarinic / long-acting beta2-agonists and triple therapy in the maintenance treatment of patients with moderate to severe chronic obstructive pulmonary disease.
Aldeyra Therapeutics announced positive results from its Phase 2b clinical trial of topical ocular reproxalap in patients with dry eye disease demonstrating statistically significant reductions in the Four-Symptom Ocular Dryness Score and the Overall Ocular Discomfort Symptom Score.
Sermonix Pharmaceuticals announced the initiation of a 100-patient Phase 2 trial of oral lasofoxifene for the treatment of metastatic breast cancer.
Opthea Limited announced that its Phase 1b trial of OPT-302 in diabetic macular edema (DME) met its primary objective and that the company had dosed the first patient in a Phase 2a randomized, controlled clinical trial evaluating OPT-302 in patients with persistent center-involved DME.
Opthea Limited presented Phase 1/2a data of OPT-302 in wet age-related macular degeneration (AMD) at the Retina Society 2018 annual meeting.
Corvus Pharmaceuticals announced the publication of results of preclinical studies of CPI-444 demonstrating that it induces dose-dependent antitumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Corvus Pharmaceuticals announced new data on a biomarker associated with patient response to therapy with CPI-444, an adenosine receptor antagonist at the European Society for Medical Oncology 2018 Congress.
OmniAb partner Arcus Biosciences announced that abstracts relating to its portfolio have been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
Seelos Therapeutics announced a merger agreement with Apricus Biosciences, to form a combined publicly-traded company focused on developing a portfolio that includes Ligand-partnered CNS programs.
Roivant announced that OmniAb-derived RVT-1401 (previously HL161) will form the foundation of a new company called Immunovant.
Business Development

Ligand announced an OmniAb platform license agreement with the Fred Hutchinson Cancer Research Center (Fred Hutch) to use the OmniAb rodent platform technologies to discover fully human antibodies. Ligand is eligible to receive a defined share of revenue received by Fred Hutch from companies that commercialize products incorporating any such OmniAb-derived antibody.
Ligand entered into a Captisol use agreement with Sunshine Lake Pharma.
Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to our equity investments in Viking and Retrophin, unissued shares relating to the Senior Convertible Notes and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of our investments in Viking and Retrophin, share-based compensation expense and effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 591-4752 from the U.S. or (720) 405-1612 from outside the U.S., using the conference ID 5777841. To participate via live or replay webcast, a link is available at www.ligand.com.

Palleon Pharmaceuticals Announces Preclinical Data from EAGLE Platform to be Presented at the Society for Immunotherapy of Cancer Annual Meeting

On November 8, 2018 Palleon Pharmaceuticals, a leading biotech company focused on developing drugs that target Glyco-Immune Checkpoints to treat cancer, reported that the company will present preclinical data from its EAGLE platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting, in Washington, D.C (Press release, Palleon Pharmaceuticals, NOV 8, 2018, View Source [SID1234530957]).

Palleon’s EAGLE platform enables the development of drugs that inhibit Glyco-Immune Checkpoints by disabling the immunosuppressive function of tumor cell surface glycans. The critical challenge in this area arises from the complexity, heterogeneity and rapidly evolving nature of the tumor glycans. Palleon’s EAGLE platform employs an enzyme/antibody bi-specific construct, which removes terminal sialic acids, the molecules that are responsible for suppressing the immune system, from cancer cell surface glycans in the tumor micro-environment. This enzymatic approach uniquely overcomes tumor glycan heterogeneity and makes tumors vulnerable to both innate and adaptive immune responses.

"Palleon’s EAGLE platform has allowed us to develop a first-in-class therapeutic modality that enhances both the innate and adaptive responses to cancer, which is critical for targeting patients who are resistant to current therapies," said Jim Broderick, M.D., chief executive officer and founder of Palleon. "In addition, the EAGLE platform is robust and adaptable, and it can turn any existing targeted antibody therapy into a potent immuno-oncology agent."

Poster #037, titled "A New Immunomodulatory Strategy of Inhibiting Glyco-Immune Checkpoints Using EAGLE Technology" will be on display in Hall E. Presentation hours are Friday, November 9 from 12:45 – 2:15 p.m. and 6:30 – 8:00 p.m. ET. Li Peng, Ph.D., vice president, biotherapeutics discovery at Palleon, will make an oral presentation on Sunday, November 11 at 9:25 a.m. ET during SITC (Free SITC Whitepaper)’s Next Generation Bispecifics and Antibody-Like Molecules session.

Additionally, Poster #676, from Palleon’s Scientific Advisory Board member, Heinz Läubli, titled, "Targeting the Sialoglycan/Siglec Pathway in Combination with Checkpoint Inhibitors for Cancer Immunotherapy" will be on display in Hall E. Presentation hours are Saturday, November 10 from 12:20 – 1:50 p.m. and 7:00 – 8:30 p.m.

About Glyco-Immune Checkpoints
Cancer uses multiple pathways to evade the immune system, and Glyco-Immune Checkpoints are a significant and under-appreciated axis of immunosuppression in cancer. Tumors exploit Glyco-Immune Checkpoints through the alteration of glycans on the surface of their cells, impairing both innate and adaptive immune cells and resulting in a broad, comprehensive suppression of the anti-tumor immune response. Glyco-Immune Checkpoints had been overlooked relative to other anti-cancer strategies due to the complexity of glycoscience, and, until recently, the lack of scientific tools to demonstrate its relevance to immuno-oncology. Palleon has assembled the technologies needed to overcome these barriers and make drug development in this field possible.

Bicycle Therapeutics to Present at Jefferies 2018 London Healthcare Conference

On November 8, 2018 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that management will present a company update at the Jefferies 2018 London Healthcare Conference (Press release, Bicycle Therapeutics, NOV 8, 2018, View Source [SID1234530956]). The presentation will take place at 5:20 p.m. GMT on Thursday, November 15, 2018.

Seres Therapeutics Reports Third Quarter Financial Results and Provides Operational Updates

On November 8, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) reported third quarter 2018 financial results and provided an operational update (Press release, Seres Therapeutics, NOV 8, 2018, View Source [SID1234530954]).

"Based on a growing body of promising clinical data and preclinical data from our laboratories and others, Seres has increased its strategic focus toward immunology and immuno-oncology, and we are very pleased to have hired Kevin Horgan, M.D., an expert in these key areas, as our new Chief Medical Officer. Kevin has led the development and approval of numerous important drugs, and he has an ideal background to drive the Company’s clinical programs forward," said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. "Seres has also been working to expedite data read outs from the ongoing SER-109 clinical study for recurrent C. difficile infection, and the soon-to-be initiated SER-287 Phase 2b study for ulcerative colitis. In addition, Seres and our collaborators at MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy have taken significant steps to advance our SER-401 immuno-oncology program toward the clinic."

Recent Highlights and Events

SER-109 ECOSPOR III Phase 3 Study: Enrollment for ECOSPOR III remains ongoing with approximately 100 clinical sites open across the U.S. and Canada. Study enrollment has been impacted by the widespread availability of unapproved fecal microbiota transplantation. The Company is considering alternatives, including study design modification, to expedite the availability of clinical results. Based on ECOSPOR III screening to date, 38% of subjects screened have had a negative C. difficile toxin test, despite having a positive C. difficile PCR test. In agreement with recent clinical guidelines, these subjects were deemed to not have an active C. difficile infection and were not eligible for study inclusion. These data provide additional support for our important requirement of a positive toxin test implemented in ECOSPOR III, and suggest that C. difficile clinical studies relying on PCR-based testing alone may include a significant proportion of subjects without active disease.
New data supporting SER-109 activity presented at ID Week 2018 conference: SER-109 data from the completed Phase 2 study provided insights into the potential mechanism of action of microbiome therapeutics for C. difficile infection. Presented results showed that SER-109 administration led to changes in the metabolic products created by the microbiome, including higher concentrations of secondary bile acids thought to be inhibitory to C. difficile growth.
SER-287 development activity: The Company has made operational progress towards initiating a SER-287 Phase 2b clinical study in patients with active mild-to-moderate ulcerative colitis (UC). To expedite the time and resources required to obtain top-line results from this study, the Company has modified the previously planned four-arm placebo-controlled study design into a smaller, three-arm study in approximately 200 patients that will include two different doses of SER-287, both following pretreatment with oral vancomycin, and a placebo arm. Seres has designed this study as a potentially pivotal trial, and the Company is awaiting feedback from the FDA on this final study design.

Based on modification to the Nestlé Health Science collaboration agreement, Seres now expects to receive $40 million in milestone payments from Nestlé Health Science following initiation of the SER-287 Phase 2b study. Because the SER-287 Phase 2b study could serve as a pivotal trial, the parties agreed that at initiation of the SER-287 Phase 2b study Seres would receive $40 million in contractual payments corresponding to both the Phase 2 milestone and a payment of the Phase 3 milestone.
SER-401 immuno-oncology development activity: In collaboration with the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center, Seres is continuing activities to prepare the evaluation of the potential for SER-401 to augment checkpoint inhibitor response in patients with metastatic melanoma.
New Chief Medical Officer: Seres appointed Kevin Horgan, M.D., as Executive Vice President and Chief Medical Officer. Dr. Horgan will lead Seres’ clinical development, clinical operations, regulatory affairs, and medical affairs functions, and report directly to Dr. Pomerantz. He succeeds Seres’ outgoing Chief Medical Officer, Michele Trucksis, Ph.D., M.D., who will continue to provide clinical consulting services to the Company. Over a three-decade academic and industry career, Dr. Horgan has contributed to the development and approval of multiple therapeutics across immunology and oncology indications. Most recently, Dr. Horgan was Vice President of Clinical Development at AstraZeneca where he led the development of combination immuno-oncology programs. Dr. Horgan earned his medical degree from University College Cork in Ireland and did his medical residency at The Johns Hopkins Hospital in Baltimore, Maryland.
Financial Results

Seres reported a net loss of $21.9 million for the third quarter of 2018, as compared to a net loss of $6.9 million for the same period in 2017. The third quarter net loss was driven primarily by clinical and development expenses, personnel expenses, and ongoing development of the Company’s microbiome therapeutics platform. The third quarter net loss figure was inclusive of $9.1 million in recognized revenue primarily associated with the Company’s collaboration with Nestlé Health Science.

Research and development expenses for the third quarter were $23.7 million, as compared to $22.2 million for the same period in 2017. The research and development expenses were primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109, SER-262 and SER-287, as well as the Company’s SER-301, SER-155 and immuno-oncology preclinical programs.

General and administrative expenses for the third quarter were $7.6 million, as compared to $8.1 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and facility costs.

The decrease in cash, cash equivalents and investments balance during the quarter was $23.2 million. Seres ended the third quarter with approximately $72.9 million in cash, cash equivalents and investments. Current resources, that do not include $40 million of milestone payments that the Company expects to receive following the initiation of the SER-287 Phase 2b study, are expected to fund the Company into the second quarter of 2019.

Conference Call Information

Seres’ management will host a conference call today, November 8, 2018, at 8:30 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 9877087. Accompanying slides will be made available on the Seres website prior to the call. To join the live webcast, please visit the "Investors and Media" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

Deciphera Pharmaceuticals, Inc. Announces Third Quarter 2018 Financial Results

On November 8, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the third quarter ended September 30, 2018 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, NOV 8, 2018, View Source [SID1234530953]).

"Recent clinical and corporate achievements support Deciphera’s transition to a late-stage, pre-commercial company," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "Data presented at ESMO (Free ESMO Whitepaper) have bolstered our confidence in DCC-2618’s potential to transform the current treatment paradigm for GIST patients. As we approach the completion of enrollment for our pivotal Phase 3 INVICTUS study in the coming weeks, we look forward to the data readout from that study expected next year. In addition, we remain on track to initiate our Phase 3 INTRIGUE study later this year. We are building our commercial capabilities for DCC-2618 in the United States and are continuing to invest in our clinical-stage pipeline, with the recent initiation of our Phase 1b/2 clinical study of our investigational agent rebastinib in combination with paclitaxel."

Clinical Programs

DCC-2618
At the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October 2018, Deciphera presented updated preliminary Phase 1 clinical study results of DCC-2618 in patients with gastrointestinal stromal tumors (GIST). Highlights from the presentation included:
Preliminary median progression free survival (mPFS) in second- and third-line GIST patients of 42 weeks and 40 weeks, respectively, that the Company believes demonstrates the potential for improved and durable clinical outcomes in patients with less advanced disease.
Updated objective response rates (ORR) and disease control rates (DCR) in second- and third-line GIST patients continue to exceed previously published results of registrational trials for currently approved therapies.
In fourth-line and fourth-line-plus GIST patients, for whom there are currently no approved therapies, the Company believes that the observed mPFS of 24 weeks demonstrates the potential for durable clinical outcomes in patients with advanced disease. Published studies have reported a mPFS of 4 to 6 weeks for similarly heavily pre-treated patients who did not receive an active therapy.
Deciphera expanded the ongoing Phase 1 study to include additional cohorts for patients with: various solid tumors, including melanoma; non-small cell lung cancer; germ cell cancer; penile cancer; soft tissue sarcoma; GIST or other solid tumor patients with renal impairment.
Deciphera will present preclinical data on the effects of the combination of DCC-2618 and MAPK pathway inhibitors on cell death and apoptosis in cellular assays of GIST and mastocytosis in a poster session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on November 13, 2018.
Data in GIST patients from the ongoing Phase 1 study that were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in October 2018 will also be presented at the Annual Meeting of the Connective Tissue Oncology Society (CTOS) on November 15, 2018.
Deciphera previously announced that, following discussions with regulatory authorities in the United States and Europe, it is planning to initiate later this year a randomized, multicenter, open-label, pivotal Phase 3 INTRIGUE study evaluating DCC-2618 compared to sunitinib in second-line GIST patients.
Rebastinib
Deciphera initiated a Phase 1b/2 clinical study of rebastinib, the Company’s small molecule kinase switch control inhibitor of TIE2. In this two-part clinical study, rebastinib will be evaluated for the treatment of patients with advanced or metastatic solid tumors in combination with paclitaxel.
DCC-3014
Deciphera continues to enroll patients in the Phase 1 dose escalation study of DCC-3014, a selective small molecule kinase switch control inhibitor of CSF1R and expects to provide an update on this study later this year.
Corporate Updates

In September 2018, Deciphera appointed Daniel C. Martin as Chief Commercial Officer. Mr. Martin has more than 20 years of commercial experience within the biopharmaceutical industry with extensive background in oncology, including immuno-oncology.
In November 2018, Oliver Rosen, M.D., informed Deciphera that effective November 30, 2018, he would leave his position as the Company’s Chief Medical Officer to pursue another opportunity at an early-stage, private biotechnology company. The Company has commenced a search for his replacement.
"On behalf of the management team and board of directors, I want to thank Oliver for his many contributions to Deciphera over the past four and a half years," said Dr. Taylor. "During his tenure, Oliver was instrumental in developing DCC-2618 from a promising preclinical asset into a robust late-stage clinical program with a pivotal Phase 3 study expected to read out in 2019, a second Phase 3 study that is planned to initiate soon and a series of expansion studies in multiple indications. We wish Oliver all the best in his future endeavors."

"It has been a privilege to be a part of Deciphera’s successful growth since 2014 led by the rapid development of DCC-2618," said Dr. Rosen. "I am proud of the progress the Company has made in translating the promise of its kinase switch control platform into an exciting pipeline of clinical-stage drug candidates designed to provide cancer patients with novel therapies that address unmet medical needs."

Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, cash and cash equivalents were $320.9 million, compared to cash and cash equivalents of $196.8 million as of December 31, 2017. This increase was primarily related to proceeds obtained through the Company’s June 2018 underwritten public offering, offset by cash used in operating activities. We expect our current cash and cash equivalents will enable us to fund our operating and capital expenditures and debt service payments into the second half of 2020.
R&D Expenses: Research and development expenses for the third quarter of 2018 were $20.6 million, compared to $9.8 million for the same period in 2017. The increase was primarily due to an increase in spending on the DCC-2618 program of $6.1 million as a result of clinical trial costs related to the pivotal Phase 3 INVICTUS study that began enrollment in January 2018. Clinical trial costs also increased due to start-up activities related to a second Phase 3 INTRIGUE study in second-line GIST, which is expected to be initiated by the end of 2018. In addition, chemistry, manufacturing and controls development and manufacturing costs for the DCC-2618 program increased as a result of process development activities to support anticipated drug requirements for commercialization and the manufacture of registration lots to support the submission of a new drug application. Expenses related to the rebastinib program increased $1.5 million, primarily due to start-up activities related to the Phase 1b/2 study of rebastinib in combination with paclitaxel, which initiated in October 2018. Personnel-related costs increased $2.7 million due to increased headcount in our research and development functions. Personnel-related costs for the third quarters of 2018 and 2017 included non-cash share-based compensation expense of $1.1 million and $0.5 million, respectively.
G&A Expenses: General and administrative expenses for the third quarter of 2018 were $5.3 million, compared to $2.4 million for the same period in 2017. The increase was primarily due to an increase in non-cash share-based compensation expense related to additional employee stock options and a higher value of our common stock and to an increase in legal and professional fees as a result of various advisory fees related to ongoing operations as a public company. Facility-related and other costs increased due to director and officer insurance costs and higher rent expense related to our new lease. Non-cash share-based compensation was $1.5 million and $0.6 million for the third quarters of 2018 and 2017, respectively.
Net Loss: For the third quarter of 2018, Deciphera reported a net loss of $24.4 million, or $0.65 per share, compared with a net loss of $12.0 million, or $1.04 per share, for the same period in 2017.