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7	7	Mirati Therapeutics, Inc. (MRTX) is a clinical-stage oncology company developing product candidates to address the genetic, epigenetic and immunological promoters of cancer. The company's precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who are most likely to benefit from targeted drug treatment. In immuno-oncology, Mirati Therapeutics is advancing clinical programs where the ability of its product candidates to improve the immune environment of tumor cells may enhance and expand the efficacy of existing cancer immunotherapy medicines when given in combination. The company's preclinical programs include potentially first-in-class and best-in-class product candidates specifically designed to address mutations and tumors where few treatment options exist. The company approach each of its discovery and development programs with a singular focus: to translate its deep understanding of the molecular drivers of cancer into better therapies and better outcomes for patients.{{footnote}}https://fintel.io/doc/sec-mrtx-mirati-therapeutics-10k-2019-february-28-17956{{/footnote}}
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9		-The company's clinical pipeline consists of two clinical-stage product candidates: sitravatinib and mocetinostat. The company also have a KRAS inhibitor program in preclinical development. The company's clinical and preclinical programs are summarized in the chart below:
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11		-[[image:https://www.sec.gov/Archives/edgar/data/1576263/000162828018002942/miratipipelinea01.jpg]]
	10	+[[image:mrtx0.png||height="190" width="985"]]
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	12	+
	13	+== Product and Pipeline ==
	14	+
	15	+The company's clinical programs consist of two product candidates: MRTX849, a KRAS G12C inhibitor, and sitravatinib, a multi-kinase inhibitor.. The company also have a KRAS inhibitor program in preclinical development. The company's clinical and preclinical programs are summarized in the chart below:
	16	+
	17	+
	18	+[[image:mrtxp1.png]]
	19	+
13	13	== Sitravatinib ==
14	14
15	15	//Sitravatinib in Combination with Immune Checkpoint Inhibitors//
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65	65	In November 2017, the company announced that, in light of superior investment opportunities in its pipeline, the company suspended further investment in glesatinib and will pursue opportunities to partner the program.
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	74	+
	75	+[[image:mrtx1.png]]
	76	+
	77	+
67	67	= Market and Competition =
68	68
69		-**Market**
	80	+== Market ==
70	70
71	71	**Non-Small Cell Lung Cancer**
72	72
73		-The National Cancer Institute estimates that in 2017, approximately 223,000 patients in the United States ("U.S.") were diagnosed with lung cancer and 156,000 died due to the disease. Lung cancer represents over 13% of all new cancer cases in the U.S., and 26% of all cancer deaths. Approximately 85% of lung cancers are NSCLC. The five-year survival rate for lung cancer patients is 18%, indicating a significant need for novel therapies to extend overall survival in this patient population.
	84	+The National Cancer Institute estimates that in 2019, approximately 228,000 patients in the United States ("U.S. ") were diagnosed with lung cancer and 143,000 died due to the disease. Lung cancer represents almost 13% of all new cancer cases in the U.S., and 25% of all cancer deaths. Approximately 85% of lung cancers are NSCLC. The five-year survival rate for lung cancer patients is 19%, indicating a significant need for novel therapies to extend overall survival in this patient population.
74	74
75	75	**Immuno-oncology Combinations**
76	76
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93	93	|Tagrisso|423
94	94	|Alecensa|186
95	95
96		-= Competition =
	107	+== Competition ==
97	97
98	98	**Sitravatinib in Combination with Immune Checkpoint Inhibitors**
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138	138	Manufacturers of its products are required to comply with applicable FDA manufacturing requirements contained in the FDA's Current Good Manufacturing Practices (“cGMP”) regulations. cGMP regulations require, among other things, quality control and quality assurance as well as corresponding maintenance of records and documentation. Pharmaceutical product manufacturers and other entities involved in the manufacture and distribution of approved pharmaceutical products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer or holder of an approved new drug applications ("NDA"), including withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented.
139	139
140		-= Liquidity Overview =
141	141
142		-At March 31, 2018, the company had $148.7 million of cash, cash equivalents and short-term investments compared to $150.8 million at December 31, 2017. In January 2018 the company received an upfront fee of $10.0 million in connection with the BeiGene Agreement. Mirati Therapeutics has not generated any revenue from product sales. To date, Mirati Therapeutics has funded its operations primarily through the sale of its common stock and pre-funded warrants to purchase its common stock and through up-front payments, research funding and milestone payments under collaborative arrangements. To fund future operations, the company will likely need to raise additional capital.
	152	+= Financial Highlights =
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	154	+**Third Quarter 2020 Financial Results and Recent Business Highlights **{{footnote}}https://ir.mirati.com/news-releases/news-details/2020/Mirati-Therapeutics-Reports-Third-Quarter-2020-Financial-Results-And-Recent-Business-Highlights/default.aspx{{/footnote}}
	155	+
	156	+11/04/2020; Mirati Therapeutics, Inc. Reported financial results for the third quarter ended September 30, 2020 and recent business highlights.
	157	+"The third quarter was notable for significant progress and we have begun the fourth quarter with positive momentum. At the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Therapeutics last week, we presented preliminary adagrasib (MRTX849) data across multiple tumors, which highlighted the potential for this exciting and differentiated program. We have completed enrollment in our Phase 2 potentially registration-enabling monotherapy trial in 2nd or 3rd line non-small cell lung cancer patients, which will enable our anticipated NDA filing to the FDA for accelerated approval in the second half of 2021." said Dr. Charles M. Baum, President and Chief Executive Officer at Mirati Therapeutics, Inc. "We presented the first preclinical data for MRTX1133, a potentially first in class, potent, selective and reversible inhibitor of KRAS G12D in both its active and inactive states. MRTX1133 demonstrated significant tumor regression in several preclinical tumor models, and we anticipate filing an IND in the first half of 2021. Our recent public offering provides the resources to accelerate and expand development across our pipeline, including sitravatinib, adagrasib, MRTX1133 and discovery programs, as we continue to build our organization, prepare for commercialization and strive to bring novel therapies to cancer patients and their families."
	158	+Recent Corporate Updates:
	159	+
	160	+
	161	+**Adagrasib (MRTX849, KRAS G12C Selective Inhibitor)**
	162	+
	163	+* Presented preliminary updated data in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumors at the EORTC-NCI-AACR virtual conference
	164	+* Completed enrollment in the single-agent Phase 2 registrational arm in 2nd or 3rd line therapy in NSCLC
	165	+* Announced clinical collaboration with Boehringer Ingelheim to study BI 1701963, a SOS1::pan-KRAS inhibitor, in combination with adagrasib
	166	+
	167	+**MRTX1133 (KRAS G12D Selective Inhibitor)**
	168	+
	169	+* Reported initial preclinical data demonstrating significant tumor regression in several tumor models
	170	+
	171	+**Sitravatinib**
	172	+
	173	+* Presented updated clinical results from Phase 2 clinical trial evaluating sitravatinib in combination with nivolumab (OPDIVO®) in patients with advanced or metastatic urothelial carcinoma at the ESMO Virtual Congress
	174	+* Enrollment is on-going in the Phase 3 SAPPHIRE clinical trial in combination with nivolumab (OPDIVO®) in 2nd or 3rd line NSCLC patients
	175	+
	176	+**Operational Update**
	177	+
	178	+* Ended the third quarter with $579.1 million in cash, cash equivalents, and short-term investments and, in addition, strengthened our balance sheet by completing a public offering of common stock on October 30, 2020 that provided estimated net proceeds of $879.7 million
	179	+
	180	+**Financial Results for the Third Quarter 2020**
	181	+
	182	+License and collaboration revenues for the three months ended September 30, 2020, were $11.4 million, and relate to a license agreement with ORIC Pharmaceuticals, Inc. ("ORIC") pursuant to which the Company granted to ORIC an exclusive, worldwide license to develop and commercialize the Company's allosteric polycomb repressive complex 2 (PRC2) inhibitors for all indications. License and collaboration revenues for the nine months ended September 30, 2020 were $11.7 million and related primarily to the ORIC license transfer described above, as well as $0.3 million related to the manufacturing supply services agreement with BeiGene. License and collaboration revenues for the three and nine months ended September 30, 2019 were $1.0 million and $2.8 million, respectively, and relate to the manufacturing supply services agreement with BeiGene.
	183	+
	184	+Research and development expenses for the third quarter of 2020 were $79.9 million, compared to $47.4 million for the same period in 2019. Research and development expenses for the nine months ended September 30, 2020 were $216.6 million, compared to $119.9 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of adagrasib (MRTX849), MRTX1133, and other preclinical and early discovery activities, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $12.6 million during the third quarter of 2020, compared to $8.6 million for the same period in 2019, and $35.9 million during the nine months ended September 30, 2020, compared to $20.4 million for the same period in 2019.
	185	+
	186	+General and administrative expenses for the third quarter of 2020 were $20.2 million, compared to $10.7 million for the same period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $58.1 million, compared to $30.3 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and an increase in employee-related expenses and professional service expense. The Company recognized general and administrative-related share-based compensation expenses of $9.2 million during the third quarter of 2020, compared to $6.5 million for the same period in 2019, and $28.2 million during the nine months ended September 30, 2020, compared to $18.4 million for the same period in 2019.
	187	+
	188	+Net loss for the third quarter of 2020 was $87.3 million, or $1.96 per share basic and diluted, compared to net loss of $54.3 million, or $1.38 per share basic and diluted for the same period in 2019. Net loss for the nine months ended September 30, 2020 was $256.9 million, or $5.87 per share basic and diluted, compared to net loss of $140.9 million, or $3.83 per share basic and diluted for the same period in 2019.
	189	+Cash, cash equivalents, and short-term investments were $579.1 million at September 30, 2020.
	190	+
	191	+
144	144	= References =
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146	146	{{putFootnotes/}}