On May 4, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, Prime Market of TSE) reported that the companies have entered into an exclusive licensing agreement under which Jazz has acquired development and commercialization rights in the United States, Europe and other territories for Sumitomo Pharma’s investigational DSP-0187, a potent, highly selective oral orexin-2 receptor agonist with potential application for the treatment of narcolepsy, idiopathic hypersomnia and other sleep disorders. Jazz has designated this molecule JZP441 (Press release, Jazz Pharmaceuticals, MAY 4, 2022, View Source [SID1234613524]).

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Sumitomo Pharma initiated a Phase 1 trial in Japan of DSP-0187 in November 2021 to evaluate safety, tolerability and pharmacokinetics in healthy volunteers. Jazz expects to rapidly advance development of DSP-0187 based on these clinical findings.

"Orexin agonism is an exciting area of sleep disorder research and an approach that may be complementary to oxybate therapy. We believe that DSP-0187 has the potential to advance the treatment of narcolepsy and other sleep disorders based on its profile," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "As a leader in sleep medicine, we are committed to delivering innovative therapies to people who are living with debilitating sleep disorders. We look forward to leveraging our expertise in sleep disorders to rapidly advance this promising therapy into clinical trials in the U.S. and Europe. This agreement exemplifies both our ability to identify promising compounds that have the potential to improve patient care and our corporate objective of making strategic, value-creating investments in our pipeline."

"DSP-0187 is a potent, highly selective oral orexin-2 receptor agonist, which is a novel small molecule compound originally created by Sumitomo Pharma by utilizing our advanced expertise in drug discovery for central nervous system disorders. We are pleased to partner with Jazz on DSP-0187 given their strong track record of development success and commercial execution in sleep disorders and long-term commitment to advancing therapies to improve the lives of people with sleep disorders," said Toru Kimura, Representative Director, Executive Vice President of Sumitomo Pharma. "Jazz’s accomplishments in sleep medicine make the company an ideal partner for us as DSP-0187 enters its next phase of development."

Orexins are neuropeptides that play an important role in the regulation of sleep and wakefulness. DSP-0187 is a potent, highly selective orexin-2 receptor agonist designed to activate orexin signaling. DSP-0187 is initially planned to be evaluated in patients with narcolepsy, a debilitating sleep disorder which can manifest clinically with cataplexy, excessive daytime sleepiness (EDS), disrupted nighttime sleep (DNS), sleep paralysis and other symptoms. There is also potential for DSP-0187 to treat other sleep disorders.

Transaction Terms

Under the terms of the agreement, Jazz will receive an exclusive license to develop and commercialize DSP-0187 throughout the world except for Japan, China and certain other Asia/Pacific countries and regions, where Sumitomo Pharma will retain all development and commercialization rights. Sumitomo Pharma will receive an upfront payment of $50 million, and is eligible to receive development, regulatory and commercial milestone payments of up to $1.09 billion. Pending approval, Sumitomo Pharma is eligible to receive a tiered, low double-digit royalty on Jazz’s net sales of DSP-0187.

On May 4, 2022 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended March 31, 2022 and provided a corporate update (Press release, DURECT, MAY 4, 2022, View Source [SID1234613523]).

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"Progress continues in the larsucosterol (DUR-928) AHFIRM trial, with more patients dosed in the first quarter of 2022 than in any prior quarter, reflecting the opening of additional clinical trial sites and our ongoing efforts to work with existing sites to recruit more patients with severe alcohol-associated hepatitis (AH) that meet our enrollment criteria," stated James E. Brown, D.V.M., President and CEO of DURECT.

First Quarter and Recent Business Highlights:

Continued progress in AHFIRM enrollment – DURECT has now dosed the first patients in Australia, France and Belgium, with 57 AHFIRM study sites now open at leading hospitals in the U.S., Australia, E.U. and U.K., a net increase of 6 sites in the two months since our last earnings call. At the pace of enrollment achieved in the first quarter of 2022, we would complete dosing the last patient in the AHFIRM trial in mid-2023; we expect the pace of enrollment should improve through our clinical site expansion, clinical trial engagement activities and the potential lessening of the impact of COVID on the hospitals participating in AHFIRM.
Engaging thought leaders and increasing awareness of AH – DURECT’s medical affairs team has been substantially increasing our AH market outreach and education efforts to amplify larsucosterol awareness and facilitate AHFIRM enrollment efforts. We have recently hosted the first of multiple regional AHFIRM study update meetings with our investigators and study site coordinators, sponsored and exhibited at three liver-focused congresses in person, and retained a medical communications agency to broaden awareness of AH, the AHFIRM trial and larsucosterol.
Approaching U.S. launch of POSIMIR by our licensee – DURECT signed an exclusive U.S. licensing agreement for POSIMIR with Innocoll Pharmaceuticals in December 2021. Under the agreement, DURECT will earn low to mid double-digit royalties from net sales of POSIMIR and is eligible to receive up to $136 million in upfront and milestone payments, including the $4 million upfront license fee received in January 2022, and a $2 million milestone payment upon the first commercial sale of POSIMIR, which is anticipated in Q2 2022.
Financial highlights for Q1 2022:

Total revenues were $1.9 million and net loss was $10.8 million for the three months ended March 31, 2022 compared to total revenues of $2.2 million and net loss of $10.1 million for the three months ended March 31, 2021.
At March 31, 2022, cash and investments were $64.4 million, compared to cash and investments of $70.0 million at December 31, 2021. Debt at March 31, 2022 was $20.8 million, compared to $20.6 million at December 31, 2021.
Earnings Conference Call
We will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss first quarter 2022 results and provide a corporate update:

A live audio webcast of the presentation will be also available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.

About the AHFIRM Trial
Enrollment is ongoing in our Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study in subjects with severe acute alcohol-associated hepatitis (AH) to evaluate saFety and effIcacy of laRsucosterol (DUR-928) treatMent (AHFIRM). The study is comprised of three arms targeting enrollment of 300 total patients, with approximately 100 patients in each arm: (1) Placebo plus standard of care (SOC) which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). All patients in the trial receive supportive care. The primary outcome measure is 90-Day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. The Company is targeting more than 60 clinical trial sites across the U.S., EU, U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation for the treatment of AH. We believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026.

About Alcohol-associated Hepatitis (AH)
AH is a life-threatening acute alcohol-associated liver disease (ALD) often caused by chronic heavy alcohol use and a recent period of increased alcohol consumption (i.e., a binge). It is characterized by severe inflammation and destruction of liver tissue (i.e., necrosis), potentially leading to life-threatening complications including liver failure, acute renal injury and multi-organ failure. There are no FDA approved therapies for AH and an analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median MELD score of 23.5, reported mortality at 28 and 90 days of 20% and 31% respectively. Stopping alcohol consumption is not sufficient for recovery in many moderate and severe patients and the use of treatments to reduce liver inflammation, such as corticosteroids, are limited by contraindications and have been shown to provide no survival benefit at 90 days or 1 year. While liver transplantation is becoming more common for alcoholic liver disease patients, including AH patients, the procedure involves a long waiting period, a burdensome selection process, and costs more than $875,000 on average.

About Larsucosterol (DUR-928)
Larsucosterol is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.

On May 4, 2022 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended March 31, 2022 (Press release, Adaptive Biotechnologies, MAY 4, 2022, View Source [SID1234613522]).

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"We started the year strong and completed a strategic reorganization of our company around two key business areas: MRD and Immune Medicine," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "I am encouraged by the solid momentum across both business areas as we optimize our resource allocation to capitalize on the multiple opportunities ahead."

Recent Highlights

Revenue of $38.6 million for the first quarter 2022, representing a 0.5% increase from the first quarter 2021.

clonoSEQ test volume in the first quarter 2022 grew 45% versus the first quarter of prior year and 12% over the fourth quarter of 2021.

Signed expanded MRD pan-portfolio agreement with major partner in MM and CLL for the use of MRD status as a clinical endpoint.

Recognized $3.0 million in MRD regulatory milestone revenue resulting from a biopharmaceutical partner who used data from our MRD assay to support its drug approval.

Completed analysis from immuneSense Lyme blinded data from 990 participants, confirming T-Detect Lyme is nearly twice as sensitive as the current standard of care (54% T-Detect Lyme vs 30% STTT sensitivity, both at 99% specificity). T-Detect Lyme offering to be made available during 2022 Lyme season.

Entered a new T-MAP collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson to map T cell responses to RSV to support Janssen’s RSV vaccine program.

Announced the appointment of Tycho Peterson as chief financial officer, who brings several decades of financial leadership and experience within the life science and diagnostic industries.

First Quarter 2022 Financial Results

Revenue was $38.6 million for the quarter ended March 31, 2022, representing a 0.5% increase from the first quarter in the prior year. Immune Medicine revenue was $20.8 million for the quarter, representing a 4% increase from the first quarter in the prior year. MRD revenue was $17.8 million for the quarter, representing a 3% decrease from the first quarter in the prior year.

Operating expenses were $101.7 million for the first quarter of 2022, compared to $79.7 million in the first quarter of the prior year, representing an increase of 28%.

Net loss was $62.8 million for the first quarter of 2022, compared to $40.6 million for the same period in 2021.

Cash, cash equivalents and marketable securities was $500.7 million as of March 31, 2022.

2022 Financial Guidance

Adaptive Biotechnologies reiterates full year 2022 revenue to be in the range of $185 million to $195 million.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its first quarter 2022 financial results after market close on Wednesday, May 4, 2022 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On May 4, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the first quarter ended March 31, 2022, and highlighted recent Company progress (Press release, Omega Therapeutics, MAY 4, 2022, View Source [SID1234613521]).

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"We are delighted with the preclinical data emerging from our OMEGA platform, for example, from our OTX-2002 program where we demonstrated the ability to downregulate the overexpression of the c-Myc (MYC) oncogene in models of hepatocellular carcinoma (HCC) as shared at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We also recently announced additional preclinical data that will be presented at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, in which a different Omega Epigenomic ControllerTM (OEC) candidate showed the ability to regulate MYC expression resulting in decreased viability of cancer cells in both in vitro and in vivo models of non-small cell lung cancer (NSCLC). We are pleased to see this further validation of our targeted mRNA therapeutics and their potential to control gene expression through epigenomic programming. We look forward to advancing a broad portfolio of OECs and are keenly focused on advancing into the clinic this year, starting with our expected Investigational New Drug (IND) Application for OTX-2002 in the first half of 2022."

Recent Business Highlights

Development Pipeline and Platform

OTX-2002: OTX-2002 is a novel, engineered, and programmable mRNA therapeutic targeting MYC in patients with HCC. In preclinical studies, OTX-2002 demonstrated its ability to potently downregulate MYC oncogene expression by epigenetically targeting the MYC insulated genomic domain (IGD). The Company is pleased to announce that it remains on track to file an IND for OTX-2002 in the first half of 2022.
Presented New OTX-2002 Preclinical Data in Hepatocellular Carcinoma at AACR (Free AACR Whitepaper) 2022 that Highlighted the Potential of OTX-2002 to Downregulate Overexpression of the MYC Oncogene in Models of HCC: Results showed that OTX-2002 suppresses MYC gene expression resulting in a loss of cancer cell viability in vitro and reduces tumor growth in in vivo HCC xenograft models. The data also demonstrated the potential of the OMEGA platform to engineer programmable epigenetic mRNA therapeutics that successfully regulate gene expression by targeting IGDs. The poster presentation can be accessed on our website at View Source
Abstract on OEC for Non-Small Cell Lung Cancer Selected for Presentation at the Upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting: New data highlight the potential of an OEC to downregulate overexpression of the MYC oncogene in models of NSCLC. The results showed on-target changes to the epigenetic profile of the MYC IGD. Treatment also resulted in dose-dependent downregulation of MYC mRNA expression, leading to significant reduction of cell viability in NSCLC cell lines as well as decreased tumor growth in murine xenograft NSCLC models. Results will be further discussed during a poster presentation on May 18, 2022, from 5:30 p.m. through 6:30 p.m. EDT.
Additional OEC Development: Beyond HCC and NSCLC, the Company is working on multiple programs in preclinical studies, including acute respiratory distress syndrome (ARDS) with CXCL1-3/IL8, alopecia with SFRP1, liver disease with HNF4a, and additional undisclosed targets. Omega continues to anticipate nominating two OEC development candidates in the middle of 2022.
OMEGA Epigenomic Programming Platform: Omega is creating a new generation of programmable epigenetic mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to homeostasis without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple preclinical development programs in oncology, immunology, regenerative medicine, and select monogenic diseases.
Corporate

Joshua Reed to join as Chief Financial Officer, employment expected to commence on May 23, 2022: Mr. Reed has experience in finance, capital raising, business development, investor relations, and managing all aspects of the financial close process.
Roger Sawhney, M.D., to serve as Chief Business Officer effective on the date of the commencement of Mr. Reed’s employment: In this new role, Mr. Sawhney, currently Omega’s Chief Financial Officer, will focus on the Company’s business development efforts as Omega looks to accelerate the potential of its epigenomic programing platform.
Ling Zeng, Esq., appointed Chief Legal and Administrative Officer: Ms. Zeng has extensive management experience working with companies in the healthcare industry at various stages of their lifecycle, with responsibilities around legal, operations, reputation, intellectual property, corporate governance, and compliance.
Kevin McManus appointed Chief Human Resources Officer: Mr. McManus has extensive experience in developing and implementing strategies to enhance growth and attract and retain talent while strengthening company culture.
First Quarter 2022 Financial Results

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $200.8 million.

Research and development (R&D) expenses for the first quarter of 2022 were $14.2 million, compared to $9.7 million for the first quarter of 2021. The $4.5 million increase in R&D expense was primarily related to discovery and preclinical development costs and personnel-related expenses as the Company continues to support research and development growth and advance its pipeline and discovery portfolio.

General and administrative (G&A) expenses for the first quarter of 2022 were $5.4 million, compared to $2.7 million for the first quarter of 2021. The $2.7 million increase in G&A expense was primarily related to personnel-related expenses and increased costs to operate as a public company, and higher professional fees to support business growth.

Net loss for the first quarter of 2022 was $20.2 million, compared to $13.5 million for the first quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company’s growth and operations as a public company.

On May 4, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the first quarter of 2022 and recent corporate updates (Press release, Mirati, MAY 4, 2022, View Source [SID1234613520]).

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"Mirati continues to make significant progress across our pipeline, as we focus on executing our ambitious goals," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "This includes working toward our first potential commercial launch in the U.S. this year with adagrasib for the treatment of patients with previously-treated KRASG12C-mutated lung cancer and advancing the adagrasib program in earlier lines of therapy and across additional tumors. In addition, we completed enrollment of our Phase 3 trial evaluating sitravatinib in advanced lung cancer, continue to enroll patients in an ongoing Phase 1 study with our MTA cooperative PRMT5 inhibitor, MRTX1719, and continue to advance our novel preclinical programs. These milestones, combined with our strong financial position enable us to continue to invest in the advancement of our broad targeted oncology portfolio and prepare to become a successful commercial stage company."

Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•Announced two oral presentations at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Presentations to include full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation and late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases.
•Presented preclinical data describing the mechanism of adagrasib CNS penetration at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data were simultaneously published in the journal of Clinical Cancer Research, which also included preliminary clinical experience in patients with active, untreated CNS metastases.
Sitravatinib (Potent TAM receptor inhibitor)
•Completed enrollment in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC. The Company expects to reach the number of events needed to trigger an interim analysis of overall survival in Q4 2022.
MRTX1719 (MTA Cooperative PRMT5 inhibitor)
•Enrolling patients in an ongoing Phase 1 dose escalation cohort of the Company’s investigational MTA-cooperative PRMT5 inhibitor, MRTX1719, with initial clinical data expected in 2023.
1

MRTX1133 (Potent and selective KRASG12D inhibitor)
•Presented preclinical results on the pharmacogenomics of the Company’s investigational KRASG12D inhibitor, MRTX1133, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company plans to file an IND application for this program in the second half of 2022.
MRTX0902 (Potent SOS-1 inhibitor)
•Presented preclinical results on the design and discovery of the Company’s investigational SOS1 inhibitor, MRTX0902, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company expects to file an IND application for this program in the second half of 2022.
First Quarter 2022 Financial Results
•Ended the first quarter with approximately $1.3 billion in cash, cash equivalents, and short-term investments.
•Research and development expenses for the first quarter of 2022 were $131.0 million, compared to $104.1 million for the same period in 2021. The increase in research and development expenses is primarily due to an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense, an increase in expense associated with the development of adagrasib, sitravatinib and MRTX1719, an increase in preclinical and early discovery activities, as well as an increase in other research and development costs, offset by a decrease in expense for MRTX1133. The Company recognized research and development-related share-based compensation expenses of $26.3 million during the first quarter of 2022, compared to $14.5 million for the same period in 2021.
•General and administrative expenses for the first quarter of 2022 were $54.0 million, compared to $28.4 million for the same period in 2021. The increase is due to an increase in salaries and other employee-related expenses, which includes an increase in share-based compensation expense, an increase in professional services expense primarily associated with commercial scale up, an increase in insurance, rent and other facilities-related costs. The Company recognized general and administrative-related share-based compensation expenses of $16.6 million in the first quarter of 2022, compared to $10.2 million for the same period in 2021.
•Net loss for the first quarter of 2022 was $188.4 million, or $3.40 per share basic and diluted, compared to a net loss of $135.7 million, or $2.67 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on May 4, 2022 at 4:30 p.m. ET/ 1:30 p.m. PT during which company executives will review financial information for the first quarter of 2022 and provide a corporate update.
Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 800-406-5356, confirmation code: 6391007.
A replay of the call will be available approximately 2 hours after the event has ended at the same website.