On March 2, 2021 Agilent Technologies Inc. (NYSE: A), reported it has entered into a definitive agreement to acquire Resolution Bioscience Inc., a leader in the development and commercialization of next-generation sequencing (NGS)-based precision oncology solutions (Press release, Agilent, MAR 2, 2021, View Source [SID1234575966]). The acquisition complements and expands Agilent’s capabilities in NGS-based cancer diagnostics and provides the company with innovative technology to further serve the needs of the fast-growing precision medicine market. Under the terms of the agreement, Agilent will pay $550 million in cash at closing and up to an additional $145 million based on achieving future performance milestones.

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Resolution Bioscience’s noninvasive liquid biopsy assay platform supports both the biopharma services market and the clinical oncology diagnostic testing market and is enabled by its Clinical Laboratory Improvement Amendments (CLIA)-certified lab. The platform has been designed for both a centralized CLIA test service and a distributable kit format. In addition, the Resolution Bioscience homologous recombination deficiency (HRD) assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration. The assay is performed on a standard blood sample and detects actionable mutations in genes for identifying cancer. Last year, Resolution Bioscience announced a commercial partnership with LabCorp to enable broad access to the Resolution ctDx Lung test that detects actionable mutations in genes associated with non-small cell lung cancer.

"We are extremely pleased to add Resolution Bioscience’s outstanding team and powerful technology to Agilent’s growing business in precision oncology solutions," said Mike McMullen, Agilent president and CEO. "By adding Resolution Bioscience’s liquid biopsy-based diagnostic technologies to our portfolio, we are strengthening Agilent’s offering to our biopharma customers and boosting the growth of our diagnostics and genomics business. This also accelerates our strategy to broaden access to precision oncology testing for patients worldwide through distributed NGS-based diagnostic kits. We look forward to Resolution Bioscience joining with us to expand our work in the fight against cancer."

"Agilent’s broad expertise, global regulatory and commercial infrastructure, extensive partnerships with biopharma companies, and decades-long leadership in precision medicine will enhance and accelerate our groundbreaking work," said Mark Li, Resolution Bioscience president and CEO. "We are excited to further expand the use of NGS in precision oncology for clinical diagnostics as part of the Agilent team."

Resolution Bioscience is based in Kirkland, Washington. The company had revenues of approximately $35 million in calendar year 2020 and is expected to generate $50 million to $55 million in revenue this year. The acquisition is expected to be slightly dilutive to Agilent’s non-GAAP earnings per share in fiscal 2021 and 2022, and improving in the following years.

The transaction is expected to close in April, subject to regulatory approvals and customary closing conditions.

On March 2, 2021 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and twelve months ended December 31, 2020, and reviewed key pipeline programs (Press release, Eagle Pharmaceuticals, MAR 2, 2021, View Source [SID1234575919]).

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Business and Recent Highlights:

Posted strong year-over-year adjusted non-GAAP earnings growth of 36%;
Received a complete response letter ("CRL") from U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for vasopressin. Eagle had a post-CRL meeting with FDA late last week and believes it has clear agreement on how to proceed. As previously disclosed, FDA restated that it has prioritized Eagle’s ANDA, and it is also flagged as a COVID priority. Eagle plans to re-submit its ANDA by mid-year. The patent trial against Endo Par Innovation Company, LLC was postponed and is now scheduled to begin on July 7, 2021; the Company believes it will have 180 days of exclusivity.
Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith ("Judi") Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development, and
Continued productive engagement with FDA for EA-114, the Company’s fulvestrant product candidate. The Company now has agreement for the clinical design and study endpoints, and following additional formulation work, intends to begin a clinical trial in patients.
Financial Highlights

Fourth Quarter 2020

Total revenue for Q4 2020 was $49.9 million, compared to $48.3 million in Q4 2019, primarily reflecting increased product sales of Ryanodex and Belrapzo.
Q4 2020 net income was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share in Q4 2019.
Q4 2020 adjusted non-GAAP net income was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in Q4 2019.
Cash and cash equivalents were $103.2 million, net accounts receivable was $51.1 million, and debt was $34 million as of December 31, 2020.
Full Year 2020

Total revenue for the 12 months ended December 31, 2020 was $187.8 million, compared to $195.9 million in 2019. 2020 included a $5.0 million milestone from SymBio for regulatory approval of Treakisym ready-to-dilute (250 ml) liquid bendamustine formulation.
2020 net income was $12.0 million, or $0.89 per basic and $0.87 per diluted share, compared to net income of $14.3 million, or $1.04 per basic and $1.01 per diluted share in 2019.
2020 adjusted non-GAAP net income was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019.
From August 2016 through December 31, 2020, Eagle has repurchased $206.9 million of its common stock.
"2020 proved to be a strong earnings year for Eagle, with 36% year-over-year growth, despite the significant challenges brought about by the COVID-19 pandemic. Our balance sheet remains healthy and provides a solid basis to support our development programs and future growth prospects. Our key pipeline products – vasopressin, fulvestrant and Ryanodex for nerve agent exposure – represent significant opportunities, and we are pleased to have a path forward. We remain committed to completing the additional work to advance them through the regulatory process," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"Looking ahead, we have our exclusive Pemfexy launch in February 2022 and SymBio sales ramping in Japan. At the same time, we will continue pursuing both organic and inorganic opportunities that will deliver growth for many years to come," concluded Tarriff.

Fourth Quarter 2020 Financial Results

Total revenue for the three months ended December 31, 2020 was $49.9 million, as compared to $48.3 million for the three months ended December 31, 2019.

Q4 2020 BELRAPZO product sales were $10.2 million, compared to $7.6 million in Q4 2019.

Q4 2020 RYANODEX product sales were $7.9 million, compared to $3.5 million in Q4 2019.

Royalty revenue was $27.0 million in the fourth quarter of 2020, compared to $32.8 million in the fourth quarter of 2019. BENDEKA royalties were $27.0 million in the fourth quarter of 2020, compared to $32.4 million in the fourth quarter of 2019. A summary of total revenue is outlined below:

Gross Margin was 75% during the fourth quarter of 2020, as compared to 76% in the fourth quarter of 2019. The compression in gross margin for the fourth quarter of 2020 was primarily driven by the launch of Treakisym product sales to our partner, on which Eagle earns no profit.

R&D expense was $9.4 million for the fourth quarter of 2020, compared to $11.3 million in the fourth quarter of 2019. The decrease is largely attributable to lower spend on fulvestrant and Ryanodex for EHS programs, partially offset by higher spend on vasopressin. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the fourth quarter of 2020 was $8.7 million.

SG&A expense in the fourth quarter of 2020 decreased to $18.2 million compared to $22.5 million in the fourth quarter of 2019. External legal spend associated with litigation on pemetrexed, a decrease of travel and entertainment and other expenses due to COVID-19, as well as differences in incentive pay, account for the year-over-year decrease. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2020 SG&A expense was $11.2 million.

Net income for the fourth quarter of 2020 was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share, in the fourth quarter of 2019, due to the factors discussed above.

Adjusted non-GAAP net income for the fourth quarter of 2020 was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million or $0.49 per basic and $0.48 per diluted share in the fourth quarter of 2019. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Full Year 2020 Financial Results

Total revenue for the year ended December 31, 2020 was $187.8 million, as compared to $195.9 million for the year ended December 31, 2019. A summary of total revenue is outlined below:

Product sales decreased by $1.7 million in the year ended December 31, 2020, primarily driven by decreases in product sales of Bendeka of $15.7 million, coupled with decreases in Belrapzo’s product sales of $2.1 million, primarily due to volume decreases. In addition, the COVID-19 pandemic and associated lockdowns have resulted in a decrease in healthcare utilization broadly and specifically have led to a reduction in the utilization of physician-administered oncology products including Belrapzo and Bendeka. The decreased sales were partially offset by increases in product sales of Ryanodex of $15.2 million due to higher volume coupled with product sales of $0.9 million from the 2020 product launch of Treakisym.

Gross margin was 76% in 2020, as compared to 69% in 2019. The increase in gross margin in 2020 was primarily related to an increase in product sales of Ryanodex and a decrease in product sales of Bendeka.

R&D expense decreased to $30.8 million in 2020, compared to $36.8 million in 2019, primarily reflecting a decrease in project spending for Ryanodex for the EHS indication. This decrease was partially offset by increased spend related to the Company’s fulvestrant formulation initiative. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2020 was $27.8 million.

SG&A expenses increased by $2.2 million to $78.6 million in 2020, compared to $76.4 million in 2019. The increase primarily reflects costs related to the collaboration with Tyme and increases in stock compensation, partially offset by travel and entertainment expense which decreased due to COVID-19 restrictions on travel coupled with lower external legal fees. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense in 2020 was $50.9 million.

Net income for the year ended December 31, 2020 was $12.0 million or $0.89 per basic and $0.87 per diluted share as compared to net income of $14.3 million or $1.04 per basic and $1.01 per diluted share for the year ended December 31, 2019, as a result of the factors discussed above.

Adjusted non-GAAP net income for 2020 was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019.

2021 Expense Guidance

R&D spend in 2021, on a non-GAAP basis, is expected to be $26-$30 million, as compared to $27.8 million in 2020.
SG&A spend in 2021, on a non-GAAP basis, is expected to be $56-$60 million, as compared to $50.9 million in 2020.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of December 31, 2020, the Company had $103.2 million in cash and cash equivalents plus $51.1 million in net accounts receivable, $29.9 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $34 million in outstanding debt. Therefore, as of December 31, 2020, the Company had net cash plus receivables of $120.3 million.

In the fourth quarter of 2020, the Company purchased $4.0 million of Eagle’s common stock as part of its $160.0 million Share Repurchase Program. From August 2016 through December 31, 2020, the Company has repurchased $206.9 million of its common stock.

Conference Call

As previously announced, Eagle management will host its fourth quarter 2020 conference call as follows:

A replay of the conference call will be available for one week after the call’s completion by dialing 800-934-7612 (US) or 402-220-6980 (International) and entering conference call ID EGRXQ420. The webcast will be archived for 30 days at the aforementioned URL.

On March 2, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical 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, 2020 and provided a corporate update (Press release, Cellectar Biosciences, MAR 2, 2021, View Source [SID1234575935]).

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Fourth Quarter and Recent Corporate Highlights

Received Orphan Drug Designation from the European Commission for CLR 131 in Waldenstrom’s macroglobulinemia (WM) which provides certain benefits including protocol assistance, reduced EU regulatory filing fees and 10 years of European market exclusivity

Initiated pivotal study of CLR 131 in Waldenstrom’s macroglobulinemia (CLOVER-WaM)

Pivotal study is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131 and is in alignment with feedback received from the U.S. Food and Drug Administration from the September 2020 guidance meeting
The study will enroll 50 WM patients who have failed first-line therapy, have failed to respond to a BTK inhibitor (i.e., ibrutinib) or had a suboptimal response
The primary endpoint of the study is response rate defined as a partial response or better (a minimum of a 50% reduction in the biological marker IgM)
Announced Closing of $45.0 Million Underwritten Public Offering and Concurrent Private Placement

Announced CLR 131 demonstrated preliminary activity in inoperable brain tumors in an international open label, dose escalation Phase 1 safety study of children and adolescents with relapsed or refractory cancers, specifically high-grade gliomas, high risk neuroblastomas and select soft tissue sarcomas

CLR 131 was measured in brain tumors, confirming that systemic administration of CLR 131 crosses the blood brain barrier and is delivered into tumors
Initial activity was expected to occur at doses of 60 mCi/m2 and higher; disease control has been noted at lower dose levels in heavily pretreated patients with ependymomas
"2020 was an important year for Cellectar, having announced key data from our Phase 2a CLOVER-1 study; having gained clarity on our Waldenstrom’s macroglobulinemia regulatory strategy after a positive meeting with the FDA in the Fall; and having completed a successful capital raise to support our WM pivotal study to our anticipated marketing approval date," said James Caruso, president and CEO of Cellectar. "We are fully engaged in the execution our CLR 131 clinical programs, prioritizing the WM pivotal study, enriching our refractory multiple myeloma data sets, and advancing our pediatric study. In parallel, we continue our research to better understand the unique potential of our delivery platform and look forward to sharing additional data."

2020 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2020, the company had cash and cash equivalents of $57.2 million compared to $10.6 million at December 31, 2019. Cash provided by financing activities was $60.5 million, offset by cash used in operating activities of $13.9 million. The company believes its cash on hand is adequate to fund basic budgeted operations for at least 12 months from the filing of these financial statements.

Research and Development Expense: Research and development expense for the year ended December 31, 2020 was $10.1 million, compared to $9.0 million for the year ended December 31, 2019. The overall increase in research and development expense of approximately 13% was primarily attributable to an increase in general research and development costs resulting from increased personnel-related costs. Manufacturing and related costs decreased due to a reduction in materials production processes and related costs. Clinical and pre-clinical project costs were relatively consistent.

General and Administrative Expense: General and administrative expense for the year ended December 31, 2020 was $5.1 million, compared to $5.2 million for the year ended December 31, 2019. The decrease of approximately 1% in general and administrative costs was primarily related to a decrease in personnel and public company expenses offset by an increase in legal fees and business insurance.

Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2020 was ($15.1) million, or ($0.76) per share, compared to ($14.1) million, or ($1.84) per share, in 2019.

On March 2, 2021Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results and operational updates for the fourth quarter and year ended Dec. 31, 2020 (Press release, Turning Point Therapeutics, MAR 2, 2021, View Source [SID1234575951]).

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"The progress we made during the fourth quarter and in 2020 has set us up for another potentially pivotal year in 2021, with multiple anticipated milestones across our portfolio," said Athena Countouriotis, M.D., president and CEO. "Our growing team continues to execute well as we advance our pipeline of precision oncology drug candidates."

Fourth quarter 2020 and recent highlights include:

REPOTRECTINIB, ROS1/TRK Inhibitor

Progress in the Phase 2 TRIDENT-1 registrational study of lead drug candidate repotrectinib, where the company in January reported updated interim findings in patients with ROS1-positive TKI-naïve non-small cell lung cancer (NSCLC). As of the Dec. 31, 2020 data cutoff date in 15 patients enrolled in the Phase 2 portion of the TRIDENT-1 study, the preliminary efficacy analysis showed a confirmed objective response rate (ORR) by physician assessment of 93% (95% CI: 68-100), and in 22 patients pooled from the Phase 1 (dosed at or above the Phase 2 dose) and Phase 2 portions, the confirmed ORR was 91% (95% CI: 71-99). As of an Oct. 30, 2020 data cutoff date, the interim safety update in a total of 185 patients from the Phase 1 and Phase 2 portions of the study showed repotrectinib was generally well tolerated.

Strong enrollment in the TRIDENT-1 study during the fourth quarter and into 2021, with Turning Point now anticipating enrollment in cohort 1 (EXP-1) to reach 50 patients pooled from the Phase 1 and Phase 2 portions of the study in the second quarter of 2021. The company plans to discuss next steps towards registration of repotrectinib in this patient population at a Type B meeting with the Food and Drug Administration (FDA), also anticipated in the second quarter. In addition, enrollment in the other cohorts within TRIDENT-1 continues to progress, and it is the company’s goal to provide an enrollment and clinical data update for other cohorts in the study in the second half.

Breakthrough Therapy Designation (BTD) granted by the FDA for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 tyrosine kinase inhibitor. BTD is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.

Plans to present additional preclinical data highlighting repotrectinib’s combination potential in KRAS-mutant disease at a medical conference in the second quarter of 2021.

Progress toward initiating the first cohort in the multi-arm Phase 1b/2 TRIDENT-2 repotrectinib combination study in KRAS-mutant solid tumors in mid-2021.
TPX-0022, MET/ SRC/CSF1R Inhibitor

Progress in the Phase 1 SHIELD-1 study of TPX-0022, Turning Point’s MET, SRC and CSF1R inhibitor, where initial data reported in October 2020 highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally well-tolerated safety profile.

The company continues to enroll patients in the Phase 1 study and is currently evaluating multiple doses and schedules to further characterize the pharmacokinetics, safety and efficacy profile before ultimately determining a recommended Phase 2 dose (RP2D), anticipated in the second quarter. Turning Point plans to proceed directly into Phase 1 dose expansion in multiple patient cohorts after determining RP2D.
Additional clinical data update from the Phase 1 dose finding portion of SHIELD-1 planned in the second half of 2021. The company also plans to discuss the ongoing study with the FDA with the goal to modify the study into a registrational Phase 1/2 design and initiate the Phase 2 portion in the second half, pending FDA feedback.

Execution of an agreement with Zai Lab in January 2021 to develop and commercialize TPX-0022 in Greater China.
TPX-0046, RET Inhibitor

Progress in the Phase 1 dose finding study of TPX-0046, a novel RET inhibitor, where the company continues to evaluate multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile. Turning Point plans to provide preliminary data in the second quarter of 2021, which will focus primarily on safety and any early signals of efficacy from initial patients.
TPX-0131, ALK Inhibitor

Approval by the Australian Ethics Committee of the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients. Study initiation is anticipated in the second quarter of 2021.

IND submission to the FDA on track for March for TPX-0131, Turning Point’s fourth drug candidate, which has a compact macrocyclic structure that has been shown in preclinical studies to potently inhibit wildtype ALK and numerous ALK mutations, and in in-vivo studies has shown significant brain tissue penetration after repeat oral dosing supporting the potential to cross the blood-brain barrier.

Presentation of additional preclinical data highlighting the profile of TPX-0131 at a medical conference in the second quarter of 2021.
Fourth Quarter and Full-Year 2020 Financial Results

Revenue: Revenue of $25 million for the year was recognized during the third quarter in connection with the upfront payment from Zai Lab under the company’s license agreement for repotrectinib in Greater China.

R&D Expenses: Research and development expenses were $34.3 million for the fourth quarter compared to $17.1 million for the fourth quarter of 2019, and $113.4 million for the year compared to $57.9 million for the year ended Dec. 31, 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, TPX-0022, TPX-0046, TPX-0131, discovery efforts and personnel expenses.

G&A Expenses: General and administrative expenses were $13.7 million for the fourth quarter compared to $5.9 million for the fourth quarter of 2019, and excluding a one-time non-cash stock-based compensation charge from the first quarter, non-GAAP G&A expenses were $42 million for the year compared to $19.8 million for the year ended Dec. 31, 2019. The increase was primarily attributable to higher personnel expenses as a result of increased employee head count and professional fees for legal and accounting services.

Net Income/Loss: Net loss was $47.4 million for the fourth quarter compared to net loss of $21 million for the fourth quarter of 2019, and excluding a one-time non-cash stock-based compensation charge from the first quarter, non-GAAP net loss was $125.9 million for the year compared to a loss of $72.1 million for the year ended Dec. 31, 2019.

Cash position: Cash, cash equivalents and marketable securities at Dec. 31 totaled $1.1 billion, compared to $409.2 million as of Dec. 31, 2019, driven primarily by net proceeds from follow-on public stock offerings in May and October of $351.6 and $433.9 million, respectively, partially offset by cash used in operating activities. Net cash used in operating activities during 2020 was $82.8 million. Turning Point projects its cash position funds current operations into 2024.
Upcoming Milestones
Key milestones anticipated in 2021 include:

Repotrectinib

Reach enrollment of 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study in the ROS1-positive TKI-naïve NSCLC patient cohort (EXP-1) in second quarter

Discuss next steps towards registration of repotrectinib in patients with ROS1-positive TKI-naïve NSCLC at a Type B meeting with the FDA in the second quarter

Initiate the first cohort of a multi-arm Phase 1b/2 TRIDENT-2 combination study in patients with KRAS-mutant solid tumors mid-year

Provide an enrollment and clinical data update in other cohorts of the Phase 2 TRIDENT-1 study in the second half
TPX-0046

Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the second quarter
TPX-0022

Provide a clinical data update from the Phase 1 dose finding portion of the SHIELD-1 study in the second half

Initiate the Phase 2 portion of the SHIELD-1 study of TPX-0022, pending FDA feedback, in the second half

Initiate the Phase 1b/2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) targeted therapy in the second half
TPX-0131

Submit the IND for TPX-0131 in the first quarter

Initiate the Phase 1/2 clinical study of TPX-0131 focused on ALK-positive TKI-pretreated advanced NSCLC patients in the second quarter
Preclinical/Research

Present multiple preclinical data presentations in the second quarter

Outline research strategy in the second half, including focus and anticipated timeline to development candidates.
Webcast and Conference Call
Turning Point will webcast its Quarterly Update Conference Call today, March 1 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Countouriotis will host the call, which will be accessible through the "Investors" section of tptherapeutics.com or by dialing (877) 388-2118 (in the United States) or (470) 495-9489 (outside the U.S.) using conference ID 5683087. A replay will be available through the "Investors" section of www.tptherapeutics.com.

On March 2, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that it has CE-marked Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor) (Press release, Guardant Health, MAR 2, 2021, View Source [SID1234575967]). The test is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).

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The Guardant360 CDx test offers patients and clinicians a simple, faster blood test to help inform personalized treatment options. The Guardant360 CDx received U.S. FDA approval in August 2020.

"Gaining the CE-mark for our Guardant360 CDx test is an important step to making our test more widely accessible to patients around the world. We are committed to helping cancer patients be comprehensively tested to see if they are appropriate for potentially life-changing personalized treatments," said Helmy Eltoukhy, Guardant Health CEO.

The World Health Organization estimates over 10 million cancer deaths in 2020,1 many of whom may have benefitted from CGP to guide a more personalized treatment plan based on a growing list of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.2-8 Clinical adoption of targeted therapies lags behind medical guidelines due to several factors, including insufficient tissue for biopsy, which is the case for as many as 30 percent of solid cancer patients.9-11

Since the company’s inception, Guardant Health has been dedicated to unlocking the potential of liquid biopsy to transform cancer by enabling precision oncology at all stages of the disease. The FDA approval and CE-marking of Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib) represents a critical milestone in the company’s mission to conquer cancer with data. The Guardant360 CDx is also being developed as a companion diagnostic for investigational products in development by other collaborators, including Amgen, Janssen Biotech, Inc., and Radius Health, Inc.