On March 9, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the fourth quarter and 12 months ended December 31, 2019 (Press release, Quanterix, MAR 9, 2020, View Source [SID1234555319]).

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"We’re pleased to close out another year of compelling growth, product launches, productive capital raises, key hires and technology adoption, marking our ninth consecutive quarter of strong performance since going public two years ago," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman Quanterix. "2019 validated the vast utility for our Simoa technology to measure novel biomarkers with rich clinical potential such as neurofilament light chain (Nf-L), as well as other neuro biomarkers used in the fight against neurodegenerative diseases, such as Alzheimer’s Disease, Multiple Sclerosis (MS), Parkinson’s Disease, ALS and traumatic brain injury. Our mid-year acquisition of UmanDiagnostics also secured our long-term supply integrity of the fast growing and highly differentiated Uman Nf-L antibodies, which provide unmatched sensitivity and specificity for Nf-L neuro-degeneration measurements in blood. Now that we have harnessed most of the value chain of this highly attractive Nf-L franchise, we are working to fully realize its value creation potential through investments and strategic collaborations with marquee partners. This has catalyzed many growth vectors with wide-ranging potential across the research, drug development and clinical spectrum for neuro, oncology and inflammation biomarkers. We enter 2020 with a solid lineup of new differentiated instruments, serum-based biomarker assays, specialty pharma services and compelling validation stemming from over 650 Simoa-specific inclusions in publications. These advances, plus adoption momentum in drug development, are increasing the longer-term promise for our technologies in the larger, potentially more attractive, clinical landscape."

Fourth Quarter 2019 Financial Highlights

Key financial results for the fourth quarter of 2019 are shown below:

·Q4 revenue was $15.9M versus prior year Q4 of $10.9M, an increase of 46%;
·Q4 product revenue was $11.4M versus prior year Q4 of $7.5M, an increase of 53%;
·Q4 service revenue was $4.3M versus prior year Q4 of $3.4M, an increase of 26%;
·Q4 GAAP gross margin was 43.1% versus prior year Q4 of 47.9%; Q4 non-GAAP gross margin was 47.3%, versus prior year Q4 of 47.9%. Q4 2019 gross margins include 410 bps of adverse impact from our successful HD-X trade-in program.

Full Year 2019 Financial Highlights

Key financial results for FY 2019 are shown below:

·FY revenue was $56.7M versus prior year FY of $37.6M, an increase of 51%; excluding $1.3M in revenue recognized in Q3 2018 in connection with the termination of a license agreement, non-GAAP year-over-year revenue growth was 56%;
·FY product revenue was $40.5M versus prior year FY of $23.4M, an increase of 73%;
·FY service revenue was $16.1M versus prior year FY of $12.1M, an increase of 33%; and,
·FY gross margin was 47.3% versus prior year FY of 47.7%, FY non-GAAP gross margin was 49.7% versus prior year FY of 45.9%, an increase of 380 bps.

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

Fourth Quarter and Full Year 2019 Business Highlights

·Our Simoa technology was highlighted in a record-breaking 246 publications in 2019, bringing total Simoa-specific inclusions to over 650 publications.

·Launched Simoa HD-X Analyzer, Quanterix’ new, fully automated Simoa bead-based immunoassay instrument model; and extended our technology bench with the launch of the Simoa SP-X Imaging and Detection System, 10-Plex Simoa CorPlex Cytokine Panel, and broad menu of additional multiplex panels to further revolutionize research, disease monitoring and drug development across core therapeutic applications.

·Acquired UmanDiagnostics AB, the world’s leading Nf-L antibody supplier, solidifying Quanterix’ position as the world leader in Nf-L assays as the Nf-L biomarker continues to draw global attention as a promising neurodegenerative disease indicator. A follow-on licensing and supply agreement with Siemens Healthineers for access to the proprietary Nf-L antibodies signed in November marks a critical step toward a clinically viable Nf-L test.

·Reinforced growing utility of Simoa in neurology research, with increased citations demonstrating its critical role in identifying, monitoring and supporting treatment validation for neurodegenerative diseases through ultra-sensitive detection of serum Nf-L. Major research highlights include:

oNf-L as an indicator of Alzheimer’s disease 16 years before symptoms, supporting its potential utility as a clinically useful biomarker. (Nature)

oPowering more than 85 percent of the Nf-L abstracts presented at the American Academy of Neurology (AAN)’s Annual Meeting, supporting the biomarker’s utility as an indicator of neurodegenerative disease onset and progression.

oThe Simoa Nf-L assay being utilized in a record 50 publications presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Notable Nf-L papers included an application of Simoa to validate treatments for relapsing-remitting or primary progressive MS and use of Simoa to demonstrate the efficacy of treatments in patients with relapsing MS, which received FDA and EMA filing acceptance on Feb. 26, 2020.

oAdvanced critical infectious disease research valuable to the acceleration of a rapid triage test for adults with persistent cough suspected to have active pulmonary tuberculosis (TB).

·Successfully raised nearly $120 million through at-the-market equity (ATM) facility and follow-on offering, attracting marquee investors, and further enhancing Quanterix’ liquidity and potential for value creation.

·Expanded our leadership team with the addition of Amol Chaubal as Chief Financial Officer (CFO) following his tenure in the position at Smith & Nephew and Novartis; 18-year Biogen veteran Tatiana Plavina as Vice President of Clinical Biomarkers; seasoned Thermo Fisher commercial leader Hether Ide as Vice President, Commercial, North America; and the election of 25-year business growth veteran Sarah Hlavinka to its Board of Directors.

·Received EY’s Entrepreneur Of The Year 2019 Award in New England recognizing Hrusovsky’s achievements in healthcare technology innovation, Quanterix’ outstanding financial performance, his commitment to advancing precision health through the founding of the Powering Precision Health (PPH) foundation.

·Invited to present its disruptive approach to leadership and company growth at several high-profile executive venues, including the SVB Leerink Healthcare CEO Summit, the Laguna Biotech CEO Forum and the Healthcare CEO Summit in partnership with the Cleveland Clinic.

·Completed the move to our expanded 92,000 square-foot state-of-the-art headquarters in Billerica, Mass., which includes a CLIA-certified laboratory to support the needs of our growing pharmaceutical customer base.

·Sponsored the 2019 PPH Summit in Barcelona, Spain, attended by more than 250 opinion leaders and researchers from around the world. The event featured more than 40 speakers who presented research across two full concurrent neurology and oncology tracks. Key takeaways and the precision health mission were echoed in the inaugural "At the Edge of Biotech" leadership series created by Nasdaq, which reinforced the importance of biomarkers in accelerating disease detection, measurement of treatment efficacy and disease progression.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 9 at 4:30 p.m., EDT. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 8171579. A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

On March 9, 2020 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Aduro Biotech, MAR 9, 2020, View Source [SID1234555318]).

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"2019 was a critical year for Aduro as we narrowed the focus of our STING program to squamous cell carcinoma of the head and neck and non-muscle invasive bladder cancer, and shifted the focus of our APRIL program to IgA nephropathy. In an effort to ensure we have the appropriate resources in place to advance these programs, we scaled down the company with the strategic reset in January 2019 and corporate restructuring in January 2020," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Our strong cash position, which now takes us into 2023, enables us to execute on several key milestones in 2020 across our STING and APRIL programs."

Key Accomplishments in Fiscal Year 2019

STING

First patient dosed in Phase 2 clinical trial of ADU-S100 (MIW815) in combination with Keytruda (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma

Presented findings from the Phase 1b study of ADU-S100 (MIW815) in combination with spartalizumab (PDR001) in patients with advanced, metastatic treatment-refractory solid tumors or lymphomas in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Presented nonclinical data on the role of TNF-alpha in suppressing the immunogenicity of STING agonists at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting

Presented three abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, including updated preclinical data on ADU-S100

APRIL

Completed treatment of all healthy volunteer dose cohorts in the single ascending dose and multiple ascending dose portions of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy

Presented findings from the dose escalation portion of the Phase 1/2 study of BION-1301 in patients with relapsed or refractory multiple myeloma in two poster presentations at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting

Anti-CD27 Agonist Antibody

License partner, Merck & Co., Inc. (known as MSD outside the United States and Canada), presented findings from an ongoing Phase 1 clinical trial of MK-5890, the anti-CD27 agonist antibody licensed to Merck in 2014, in an oral presentation during the late breaking abstract session at the SITC (Free SITC Whitepaper) 34th Annual Meeting

Corporate

Appointed immuno-oncology drug development expert, Dimitry Nuyten, M.D., Ph.D., as chief medical officer

Appointed life sciences industry veterans, David H. Mack, Ph.D. and Frank Karbe, to the board of directors

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $213.6 million at December 31, 2019, compared to $277.9 million at December 31, 2018.

Revenue – Revenue was $3.6 million for the fourth quarter of 2019 and $17.3 million for the year ended December 31, 2019, compared to $2.8 million and $15.1 million, respectively, for the same periods in 2018. For the fourth quarter and year ended December 31, 2019, the increase in revenue was primarily due to ratable recognition of the upfront milestone payment received under our Lilly collaboration in 2019. The increase was offset by a reduction in the revenue recognized for our Novartis collaboration in 2019 and by the milestone payment received under our license and collaboration agreement with Merck upon its initiation of a phase 1 trial in 2018.

Expenses –

Research and development expenses were $15.1 million for the fourth quarter of 2019 and $67.0 million for the year ended December 31, 2019, compared to $17.6 million and $75.8 million, respectively, for the same periods in 2018. For the fourth quarter and year ended December 31, 2019, costs decreased primarily due to reduced headcount and reduced stock-based compensation expense resulting from our strategic reset in January 2019. The reset also resulted in reduced spending towards deprioritized programs partially offset by higher spending towards our STING and APRIL programs.

General and administrative expenses were $9.0 million for the fourth quarter of 2019 and $34.8 million for the year ended December 31, 2019, compared to $9.0 million and $36.0 million, respectively, for the same periods in 2018. For the year ended December 31, 2019, costs decreased primarily due to reduced headcount and stock-based compensation expense resulting from our strategic reset in January 2019. The decrease in costs for the year was partially offset by higher professional services costs due to consulting services. The higher professional services costs also resulted in general and administrative expenses for the fourth quarter of 2019 remaining consistent with the 2018 period.

Loss on impairment of intangible assets was $5.0 million for the year ended December 31, 2019. This expense was recorded due to the discontinuation of one of our acquired early research programs.

Net Loss – Net loss for the fourth quarter of 2019 was $19.4 million or $0.24 per share and $82.4 million or $1.03 per share for the year ended December 31, 2019, compared to net loss of $26.3 million or $0.33 per share and $95.4 million or $1.21 per share, respectively, for the same periods in 2018.

On March 9, 2020 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update (Press release, Crinetics Pharmaceuticals, MAR 9, 2020, View Source [SID1234555317]).

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"Crinetics made significant progress in 2019 advancing our development programs, as highlighted by the initiation of the ACROBAT Phase 2 clinical trials for acromegaly with our lead product candidate paltusotine," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Paltusotine is a first-in-class nonpeptide small molecule, which demonstrates our ability to develop novel drugs for diseases and patients that have not seen truly innovative therapies in a long time. We anticipate that 2020 will be a year of additional important milestones as our pipeline continues to advance. Importantly, we plan to provide guidance on timing of our acromegaly and neuroendocrine tumor programs early in the second quarter. In addition, we are advancing our ACTH antagonist development candidate for Cushing’s disease and congenital adrenal hyperplasia as well as our sst5 agonist development candidate for congenital hyperinsulinemia towards the clinic as IND enabling activities for both programs are underway."

Full Year 2019 Highlights

Dosed first patients in Phase 2 clinical trials of paltusotine (formerly CRN00808) for acromegaly. In March 2019, Crinetics dosed the first patients in the ACROBAT EDGE and EVOLVE trials for paltusotine in patients with acromegaly. EDGE is an open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine, an oral selective nonpeptide somatostatin receptor type 2 (sst2) biased agonist, in patients with acromegaly whose disease is not biochemically controlled by octreotide LAR or lanreotide depot alone. EVOLVE is a double-blind, placebo-controlled, randomized withdrawal study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine in patients with acromegaly whose disease is biochemically controlled by octreotide LAR or lanreotide depot monotherapy.

Initiated Phase 1 trial of CRN01941. In May 2019, Crinetics initiated a Phase 1, double blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers. Like paltusotine, CRN01941 is an oral nonpeptide sst2 biased agonist. CRN01941 is initially in development as a potential treatment for neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas. Upon analysis of the cumulative data from the paltusotine and CRN01941 preclinical, nonclinical and clinical programs, Crinetics intends to decide whether to advance CRN01941 or paltusotine into a later stage trial in NETs.

Expanded management team and board of directors. In March 2019, Crinetics appointed Gina Ford, R.Ph., MBA, as Vice President, Corporate Strategy and Commercial Planning. Ms. Ford joined Crinetics from One Joule, LLC a commercial and corporate strategy consulting company she founded, where she provided biopharmaceutical clients with strategic advice on corporate, commercial, marketing and global market access strategy. Among her prior roles, Ms. Ford served as Head of Endocrinology with Ipsen Pharmaceuticals, where she led the endocrine franchise, which included the commercial leadership of a drug to treat acromegaly and neuroendocrine tumors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme.

Fourth Quarter and Full Year 2019 Financial Results

Research and development expenses were $12.1 million and $41.5 million for the three months and full year ended December 31, 2019, respectively, compared to $7.7 million and $24.5 million for the same periods in 2018. The increases were primarily attributable to clinical development and manufacturing activities for paltusotine and CRN01941 as well as the company’s preclinical programs.

General and administrative expenses were $3.4 million and $13.5 million for the three months and full year ended December 31, 2019, compared to $2.6 million and $6.7 million for the same periods in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth.

Net loss for the three months ended December 31, 2019 was $14.5 million, compared to a net loss of $8.5 million for the same period in 2018. For the year ended December 31, 2019, the company’s net loss was $50.4 million compared to a net loss of $27.1 million for the year ended December 31, 2018.

Unrestricted cash, cash equivalents and investments totaled $118.4 million as of December 31, 2019, compared to $131.7 million as of September 30, 2019 and $163.9 million as of December 31, 2018. Crinetics expects that its cash, cash equivalents and investments will fund its current operating plan into the second half of 2021.

As of February 28, 2020, the company had 24,566,896 common shares outstanding.

On March 9, 2020 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2019 and provided a corporate update (Press release, Cellectar Biosciences, MAR 9, 2020, View Source [SID1234555315]).

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Fourth Quarter and Recent Corporate Highlights

·Announced CLR 131 achieved primary efficacy endpoints from its Phase 2 CLOVER-1 study in relapsed/refractory B-cell lymphomas and completion of the Phase 1 relapsed/refractory multiple myeloma Dose Escalation study. The data showed:

o42.8% overall response rate (ORR) in median 6th line treatment of multiple myeloma at the 75mCi total body dose

o81.8% of the multiple myeloma patients across all therapeutic doses tested experienced tumor reduction with a strong dose response

o100% ORR and 25% complete response (CR) seen in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM) patients

o42.0% ORR and 11% CR in all non-Hodgkin’s lymphoma (NHL) patients

·Received Orphan Drug Designation for CLR 131 in lymphoplasmacytic lymphoma (LPL) from the U.S. Food and Drug Administration

·Oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference entitled "Fractionated Dosing of CLR 131 in Patients with Relapsed or Refractory Multiple Myeloma"

·Oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress entitled "Interim Evaluation of a Targeted Radiotherapeutic, CLR 131, in Relapsed/Refractory Diffuse Large B-cell Lymphoma Patients"

·Scientific conference poster presentations during the quarter included:

oAmerican Association for Cancer Research (AACR) (Free AACR Whitepaper) San Antonio Breast Cancer Symposium entitled "Phospholipid ether delivery vehicle shows specificity for a broad range of tumor cells and provides a novel and improved approach for targeted therapy"

oAACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference entitled "CLR 180099, a lipid raft targeted phospholipid-drug conjugate, shows potent improved safety and efficacy against colorectal tumors"

oUK-AACR Joint Conference on Engineering and Physical Sciences in Oncology entitled "Preclinical evaluation of a novel phospholipid drug conjugate, CLR 2000045 with a combretastatin A-4 analogue for improved breast cancer therapy"

·Strengthened the management team with the appointment of Dr. Igor Grachev, Chief Medical Officer

"Data from our CLR 131 Phase 1 dose escalation study and the Phase 2 CLOVER-1 study demonstrated a unique safety profile and an encouraging response rate of nearly 43% as a sixth-line treatment for relapsed/refractory multiple myeloma," said James Caruso, President and CEO of Cellectar. "Importantly, the 75mCi dose demonstrated excellent activity in very challenging to treat subpopulations, high-risk, triple class refractory and penta-refractory. We plan to enroll additional patients at 100mCi of CLR 131 in the two-cycle dosing optimization regimen, which we believe will further increase response rates, the durability of responses and will likely be used in our pivotal study planned for initiation in Q4 of this year."

2019 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2019, the company had cash, cash equivalents and restricted cash of $10.6 million compared to $13.3 million at December 31, 2018. Cash provided by financing activities was $9.0 million, offset by cash used in operating activities of $11.7 million. Consistent with prior guidance, the company believes its cash on hand is adequate to fund operations into the first quarter of 2021.

Research and Development Expense: Research and development expense for the year ended December 31, 2019 was $9.0 million, compared to $6.8 million for the year ended December 31, 2018. The overall increase in research and development expense of approximately 32% was primarily attributable to an increase in clinical project costs largely related to the startup of the pediatric study, as well as an increase in patient recruitment for the ongoing clinical studies.

General and Administrative Expense: General and administrative expense for the year ended December 31, 2019 was $5.2 million, compared to $4.8 million for the year ended December 31, 2018. The increase of 8% in general and administrative costs was primarily related to an increase in personnel and consulting costs and an increase related to public company expenses, rent and depreciation. These costs were offset by a decrease in accounting fees and restructuring charges.

Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2019 was ($14.1) million, or ($1.84) per share, compared to ($15.5) million, or ($5.23) per share, in 2018.

On March 9, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAR 9, 2020, View Source [SID1234555314]).

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"2019 was a year of outstanding execution for Deciphera," said Steve Hoerter, President and Chief Executive Officer. "In 2020, our top priority is preparing for the potential approval and launch of ripretinib now that the NDA has been accepted by the FDA for Priority Review. Patients with GIST are in need of a new treatment option, and we believe ripretinib has the potential to transform the treatment of this disease."

Mr. Hoerter continued, "Our broad development program for ripretinib is on track, and we look forward to the completion of enrollment in INTRIGUE, our pivotal Phase 3 study of ripretinib in second-line GIST, in the second half of this year. Beyond ripretinib, we remain focused on the balance of our wholly-owned, clinical-stage pipeline, with updated clinical data for both DCC-3014 and rebastinib, as well as an IND submission for DCC-3116, expected later this year."

Recent Program Highlights

Ripretinib
Announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) seeking approval for ripretinib for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2020.

The NDA is being reviewed by the FDA under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program. This pilot program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality. Additional information about RTOR can be found at: View Source

Received Priority Review, under the Project Orbis initiative, for the marketing authorization applications in Canada and Australia. Project Orbis, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for concurrent submission and review of oncology products among international partners. Additional information about the Project Orbis initiative can be found at: View Source
DCC-3014
Presented preliminary data from the ongoing Phase 1 study of DCC-3014, including anti-tumor activity in three initial patients with diffuse-type tenosynovial giant cell tumor (TGCT). These data, which provide clinical proof-of-concept for DCC-3014’s potential in diffuse-type TGCT, were presented at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting. DCC-3014 was also shown to be generally well tolerated with no reported grade 3 or higher treatment-emergent adverse events in initial diffuse-type TGCT patients.
Rebastinib
Announced the selection of the Phase 2 dose for rebastinib in the Phase 1b/2 study in combination with carboplatin and activation of Part 2 of the study in patients with breast cancer, ovarian cancer, and mesothelioma.
Recent Corporate Updates

Announced the closing of an underwritten public offering of 3,659,090 shares of common stock at a public offering price of $55.00 per share in February 2020. Total net proceeds to Deciphera were approximately $188.4 million, after deducting underwriting discounts and commissions and other offering expenses.
Announced the appointment of Ron Squarer to its Board of Directors. Mr. Squarer served as Chief Executive Officer and a member of the Board of Directors of Array BioPharma, Inc. from 2012 until its acquisition by Pfizer Inc. in August 2019 following the successful commercial launches of both Braftovi and Mektovi and brings over two decades of experience in the biopharmaceutical industry.
Announced the appointment of Frank S. Friedman to its Board of Directors. Mr. Friedman recently served as the global Chief Operating Officer of Deloitte Touche Tohmatsu Limited, culminating a 40-year career at the organization.
Fourth Quarter 2019 Financial Results

Cash Position: As of December 31, 2019, cash, cash equivalents, and marketable securities were $579.6 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. The increase was primarily due to the follow-on public offering in the third quarter of 2019 and did not include the proceeds from the Company’s follow-on public offering completed in February 2020. We expect our current cash, cash equivalents, and marketable securities, together with the proceeds from our recent follow-on public offering in February 2020, will enable us to fund our operating and capital expenditures into the second half of 2022.
R&D Expenses: Research and development expenses for the fourth quarter of 2019 were $46.6 million, compared to $27.4 million for the same period in 2018. The increase was primarily due to personnel costs as well as clinical trial costs related to ripretinib, DCC-3014, and rebastinib. Non-cash stock-based compensation was $2.5 million and $1.0 million for the fourth quarters of 2019 and 2018, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the fourth quarter of 2019 were $23.7 million, compared to $6.5 million for the same period in 2018. The increase was primarily due to personnel costs as well as external spend associated with commercial readiness and moving to our new headquarters. Non-cash stock-based compensation was $2.9 million and $1.8 million for the fourth quarters of 2019 and 2018, respectively.
Net Loss: For the fourth quarter of 2019, Deciphera reported a net loss of $67.2 million, or $1.31 per share, compared with a net loss of $32.3 million, or $0.86 per share, for the same period in 2018. The increase in the net loss is primarily due to the increase in R&D expenses and G&A expenses discussed above.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, March 9, 2020 at 4:30 PM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 1669368. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.