On February 28, 2022, Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the fourth quarter and full year 2021 and recent corporate updates (Press release, Mirati, FEB 28, 2022, https://www.prnewswire.com/news-releases/mirati-therapeutics-reports-fourth-quarter-and-full-year-2021-financial-results-and-recent-corporate-updates-301491923.html [SID1234609184]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Mirati is aggressively advancing its mission for patients with cancer. 2021 was a pivotal year for the company as we achieved important regulatory and clinical milestones across our programs," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "I am confident in our ability to execute against our bold goals in 2022, including potentially launching adagrasib in previously-treated KRASG12C-mutated lung cancer in the U.S., and advancing the adagrasib development program, including moving into earlier lines of therapy and into additional tumor types. We are also rapidly progressing our broader portfolio, which includes sitravatinib, MRTX1719, an MTA cooperative PRTM5 inhibitor for which we recently initiated a Phase 1/2 clinical study, and potentially advancing two additional programs into the clinic in the next year – MRTX1133, our KRASG12D inhibitor and MRTX0902, our SOS1 inhibitor. Our financial strength and dedicated team will enable us to continue to advance our pipeline, invest in innovation and position the company for sustained growth."

Pipeline Updates

Adagrasib

Announced the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy. The Prescription Drug User Fee Action (PDUFA) goal date is December 14, 2022. (View Release)

Announced positive results from a Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pretreated pancreatic ductal adenocarcinoma and other gastrointestinal (GI) tumors harboring a KRASG12C mutation at the 2022 ASCO (Free ASCO Whitepaper) GI Cancers Symposium. (View Release)

Announced a non-exclusive clinical collaboration agreement with Verastem Oncology to evaluate the combination of adagrasib with Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766 in KRASG12C-mutant NSCLC. (View Release)
Sitravatinib

The Company remains on track to provide an update in the second half of 2022 from the actively enrolling global registrational Phase 3 study, SAPPHIRE, evaluating sitravatinib plus nivolumab1 in second or third line non-squamous NSCLC based on an interim analysis of overall survival.
MRTX1719

Announced submission of an Investigational New Drug (IND) application to the U.S. FDA to evaluate MRTX1719, a synthetic lethal MTA cooperative PRMT5 inhibitor, for the treatment of methylthioadenosine phosphoylase (MTAP)-deleted cancers, and initiated a Phase 1/2 clinical study. (View Release)
Recent Corporate Updates

Completed a public offering of common stock on November 10, 2021 that provided net proceeds of $475.0 million.

Published the 2021 Corporate Sustainability Report, the Company’s first report, which provided relevant information describing investments and resources based on the biotechnology and pharmaceuticals framework of the Sustainability Accounting Standards Board. (View Report)
Fourth Quarter and Full-Year 2021 Financial Results

Ended the fourth quarter with approximately $1.5 billion in cash, cash equivalents, and short-term investments.

Research and development expenses for the fourth quarter of 2021 were $153.8 million, compared to $82.7 million for the same period in 2020. Research and development expenses for the twelve months ended December 31, 2021 were $508.6 million, compared to $299.3 million for the same period in 2020. The increase in research and development expenses is primarily due to an increase in expense associated with the development of adagrasib and sitravatinib, an increase in preclinical and early discovery activities, an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense, as well as an increase in other research and development costs. The Company recognized research and development-related share-based compensation expenses of $21.8 million during the fourth quarter of 2021, compared to $12.2 million for the same period in 2020, and $68.5 million during the twelve months ended December 31, 2021, compared to $48.0 million for the same period in 2020.

General and administrative expenses for the fourth quarter of 2021 were $43.5 million, compared to $25.3 million for the same period in 2020. General and administrative expenses for the twelve months ended December 31, 2021 were $136.7 million, compared to $83.4 million for the same period in 2020. 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, and an increase in sponsorship agreements expense. The Company recognized general and administrative-related share-based compensation expenses of $12.1 million in the fourth quarter of 2021, compared to $9.6 million for the same period in 2020, and $45.0 million during the twelve months ended December 31, 2021, compared to $37.8 million for the same period in 2020.

Net loss for the fourth quarter of 2021 was $199.6 million, or $3.72 per share basic and diluted, compared to a net loss of $101.1 million, or $2.08 per share basic and diluted for the same period in 2020. Net loss for the twelve months ended December 31, 2021 was $581.8 million, or $11.21 per share basic and diluted, compared to a net loss of $357.9 million, or $7.96 per share basic and diluted for the same period in 2020.
Conference Call Information

There will be a conference call on February 28, 2022 at 4:30 p.m. ET 1:30 p.m. PT during which company executives will review financial information and address inquiries from investors and analysts.

Investors and the general public are invited 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 +1 877-502-9276, confirmation code: 6820152.

A replay of the call will be available approximately 2 hours after the event has ended at the same website or by dialing in the U.S. toll free +1 719-457-0820 or international +1 888-203-1112, confirmation code: 6820152.

On February 28, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported financial results for the fourth quarter and year ended December 31, 2021 and provided clinical development and operational highlights (Press release, ALX Oncology, FEB 28, 2022, View Source [SID1234609090]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"ALX Oncology achieved key milestones in 2021 to advance our lead program, evorpacept, a next-generation CD47 blocker, through multiple clinical trials," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Notable accomplishments included initiating two Phase 2 trials in head and neck squamous cell carcinoma ("HNSCC") and presenting encouraging Phase 1b data from the ASPEN-01 trial in gastric/gastroesophageal junction ("GEJ") cancer and HNSCC, along with early Phase 1a data from the ASPEN-02 trial in myelodysplastic syndromes ("MDS"). Data from these trials also showed evorpacept to be well tolerated when combined with anti-cancer antibodies and multi-agent chemotherapy regimens in solid tumors and with azacitidine in MDS."

Dr. Pons added: "2022 is expected to be another productive year with the anticipated initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer and the expected completion of enrollment and dose optimization data readout from our Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS. The design of evorpacept, with an inactive Fc, continues to set us apart from competing CD47 blockers to date. Our data suggest that evorpacept’s inactive Fc approach shows greater tolerability than CD47 blocking approaches using an active Fc domain, several of which have shown significant cytopenias in the clinic. Additionally, our initial clinical data show anti-tumor activity on par or better than other such agents."

Anticipated Key Clinical Milestones for 2022

Initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with Herceptin (trastuzumab), Cyramza (ramucirumab) and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer (ASPEN-06).
Dose optimization readout of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS (ASPEN-02).
Initiate and provide updates on investigator sponsored clinical trials with evorpacept.
Provide updates on ongoing collaboration with Zymeworks in HER2-expressing breast cancer and other solid tumors.
Select development candidate(s) from preclinical pipeline.
Recent Clinical Developments for Evorpacept (ALX148)

U.S. Food and Drug Administration ("FDA") Granted Orphan Drug Designation ("ODD") for Evorpacept for the Treatment of Patients with Gastric/GEJ Cancer
In January 2022, ALX announced that the U.S. FDA granted ODD to evorpacept, a next-generation CD47 blocker, for the treatment of patients with gastric/GEJ cancer.
Presented Initial Phase 1a Clinical Data in Combination with Azacitidine in Patients with MDS (ASPEN-02) at ASH (Free ASH Whitepaper)
In December 2021, the Company presented initial clinical data from its ongoing trial evaluating evorpacept in combination with azacitidine for the treatment of patients with previously untreated higher-risk or relapsed or refractory MDS. The new data, shared in a poster at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting [Abstract #2601], show that the combination of evorpacept and azacitidine is active and well-tolerated. Patient accrual is ongoing in the Phase 1b dose optimization part of the study.
Presented Updated Phase 1b Clinical Trial Data in Combination with Pembrolizumab with and without Chemotherapy in Patients with HNSCC and in Combination with Trastuzumab, Ramucirumab, and Paclitaxel in Patients with Gastric/GEJ Cancer (ASPEN-01) at SITC (Free SITC Whitepaper)
In November 2021, updated results from Phase 1b study (ASPEN-01) evaluating patients with solid tumor malignancies were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Anniversary Annual Meeting [Abstract #498]. ALX Oncology reported updated results from the gastric/GEJ cancer patient cohort receiving evorpacept plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma patient cohort receiving evorpacept plus pembrolizumab with and without chemotherapy. Data showed robust and durable responses with emerging signs of clinical benefit in survival-based endpoints in patients with advanced solid tumors. All data reflected response evaluable patients as of September 1, 2021.
Initiation of a Phase 1a Clinical Trial in Combination with Venetoclax and Azacitidine in Acute Myeloid Leukemia (ASPEN-05)
In October 2021, the first patient was dosed in the Phase 1/2 ASPEN-05 study evaluating the combination of evorpacept with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia ("AML"). The Phase 1 portion will characterize the safety of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy.
Initiation of a Phase 1b/2 Clinical Trial in Combination with Zanidatamab in Patients with Advanced HER2-Expressing Breast Cancer and Other Solid Tumors
In October 2021, Zymeworks and ALX Oncology dosed the first patient in an open-label, multi-center Phase 1b/2 clinical trial to evaluate the safety and efficacy of zanidatamab, Zymeworks’ lead HER2-targeted bispecific antibody, in combination with evorpacept in patients with advanced HER2-positive breast cancer, HER2-low breast cancer and additional non-breast HER2-expressing solid tumors.
Recent Corporate Updates

Acquired Privately Held ScalmiBio Inc.: In October 2021, ALX Oncology acquired ScalmiBio which further expanded its pipeline with plans to develop novel antibody-drug conjugates ("ADCs") based on ScalmiBio’s SHIELD platform.
Full Year and Fourth Quarter 2021 Financial Results:

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2021 were $363.7 million. ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through mid-2024.
Related-party Revenue: There was no related-party revenue for the three months ended December 31, 2021 and 2020. There was no related-party revenue for the year ended December 31, 2021, compared to $1.2 million for the prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac Therapeutics, Inc. in July 2020.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended December 31, 2021, were $20.9 million, compared to $12.1 million for the prior-year period. Expenses for the three months ended December 31, 2021 included $4.7 million of acquired in-process research and development expenses related to the acquisition of ScalmiBio. R&D expenses for the year ended December 31, 2021, were $60.2 million, compared to $29.0 million for the prior-year period.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended December 31, 2021, were $7.6 million, compared to $5.7 million for the prior-year period. G&A expenses for the year ended December 31, 2021, were $23.4 million, compared to $14.8 million for the prior-year period.
Net loss: GAAP net loss attributable to common stockholders was $28.4 million for the fourth quarter ended December 31, 2021, or $0.70 per basic and diluted share, as compared to a net loss of $18.8 million for the fourth quarter ended December 31, 2020, or $0.50 per basic and diluted share. GAAP net loss for the year ended December 31, 2021 was $83.5 million, or $2.07 per basic and diluted share, as compared to $50.9 million, or $2.76 per basic and diluted share, for the year ended December 31, 2020. Non-GAAP net loss was $22.8 million for the fourth quarter ended December 31, 2021, as compared to a net loss of $16.3 million for the fourth quarter ended December 31, 2020. Non-GAAP net loss for the year ended December 31, 2021 was $69.5 million, as compared to $43.8 million for the year ended December 31, 2020. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On February 28, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Jounce management will participate in a novel immuno-oncology panel discussion at the Cowen & Co. 42nd Annual Health Care Conference on Monday, March 7, 2022 at 10:30 a.m. ET (Press release, Jounce Therapeutics, FEB 28, 2022, View Source [SID1234609132]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A webcast of the panel will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcasts will be archived for 30 days following the presentation.

On February 28, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported preliminary financial results for the fourth quarter and full year of 2021, and associated Company developments (Press release, Supernus, FEB 28, 2022, View Source [SID1234609149]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Net Product Sales

For full year 2021, preliminary net product sales were $567.5 million, an 11% increase over $509.3 million for the full year 2020. The increase was primarily due to the acquisition of the CNS portfolio of US WorldMeds in June 2020, growth in net product sales of Oxtellar XR, the launch of Qelbree in the second quarter of 2021, and net product sales of GOCOVRI (amantadine) from the acquisition of Adamas Pharmaceuticals, Inc. (Adamas) in November 2021.

Preliminary fourth quarter 2021 net product sales were $155.0 million, a 10% increase over $140.7 million in the same period in 2020. The increase was primarily due to net product sales of GOCOVRI from the acquisition of Adamas in November 2021, the launch of Qelbree in the second quarter of 2021, and growth in net product sales of Oxtellar XR.

___________________________________________
(1) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.

The fourth quarter and full year 2021 revenue results included herein are preliminary and are therefore subject to change.

Qelbree Launch Update

Total IQVIA prescriptions were 34,328 in the fourth quarter of 2021, an increase of 122% compared to total prescriptions of 15,453 in the third quarter of 2021. In January 2022, the most recent month available, total prescriptions reached 14,177.
Total prescriptions are showing a quarter-to-date (first seven weeks) sequential growth rate of 42% in the first quarter 2022 versus the corresponding same seven-week period in the fourth quarter of 2021.
Qelbree continues to expand its base of prescribers, with over 5,600 prescribers in the fourth quarter of 2021, up from 3,470 prescribers from the third quarter of 2021.
Continued progress in securing and improving managed care coverage.
Preparations for the potential launch in the adult market are well underway, assuming timely approval by the U.S. Food and Drug Administration (FDA) of the supplemental New Drug Application (sNDA) for the adult indication.
Acquisition of Adamas Pharmaceuticals, Inc.

The Company completed the acquisition of Adamas in late November 2021, strengthening its Parkinson’s disease portfolio with two marketed products, including GOCOVRI extended release capsules, the first and only FDA-approved medicine indicated for the treatment of both "off" episodes and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy. In addition, the acquisition diversifies and increases the Company’s revenue base and cash flow.
Total prescriptions for GOCOVRI in January 2022 grew by 30% compared to January 2021.
Product Pipeline Update

Qelbree (viloxazine, extended-release capsules) – Novel non-stimulant for the treatment of ADHD in adults

In September 2021, the FDA acknowledged it received the sNDA for Qelbree for the treatment of ADHD in adult patients. The sNDA has a user fee target action date (PDUFA date) in late April 2022.
SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson’s disease (PD)

The Company received notice from the FDA that its New Drug Application (NDA) resubmission for SPN-830 for the continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease is considered a Standard Review, thereby assigning a timeline of 10 months for review by the FDA and establishing a PDUFA target action date in early October 2022.
The Company will work closely with the FDA as it reviews the SPN-830 NDA. The Company is preparing for the commercial launch of SPN-830 in the first quarter of 2023, assuming timely approval by the FDA.
SPN-820 – Novel first-in-class activator of mTORC1

The Company has initiated a Phase II multicenter, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 400 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

A randomized Phase II clinical study of SPN-817 for the treatment of focal seizures is expected to start in the second half of 2022.
Financial Highlights

Fourth Quarter

For the three months ended December 31, 2021, preliminary combined research and development (R&D) and selling, general and administrative (SG&A) expenses are expected to range between $105.0 million and $110.0 million, as compared to $74.4 million for the same period in 2020. The expected increase is primarily due to activities to support the launch of Qelbree and transactions costs associated with the Adamas acquisition.

For the three months ended December 31, 2021, preliminary amortization of intangible assets expense are expected to range between $11.0 million and $12.0 million, as compared to $5.9 million for the same period in 2020. The expected increase is primarily due to amortization for the acquired intangible assets associated with the Adamas acquisition.

For the three months ended December 31, 2021, preliminary operating earnings are expected to range between $20.0 million and $25.0 million, as compared to $43.0 million for the same period in 2020. The expected decrease is primarily attributable to higher expenses to support the launch of Qelbree and transaction and other costs associated with the Adamas acquisition.

Full Year

For the full year ended December 31, 2021, preliminary combined R&D and SG&A expenses are expected to range between $377.0 million and $382.0 million, as compared to $276.6 million for full year 2020. The expected increase is primarily due to activities to support the launch of Qelbree and timing of both the Adamas and US WorldMeds acquisitions.

For the full year ended December 31, 2021, preliminary amortization of intangible assets expense is expected to range between $29.0 million and $30.0 million, compared to $15.7 million, for the same period in 2020. The expected increase is primarily due to amortization for the acquired intangible assets associated with the Adamas acquisition and the timing of the US WorldMeds acquisition.

For the full year ended December 31, 2021, preliminary operating earnings are expected to range between $100.0 million and $105.0 million, as compared to $173.7 million for full year 2020. The expected decrease is primarily due to increased costs and expenses to support the launch of Qelbree and the timing of the US WorldMeds acquisition.

Cash, cash equivalents and marketable securities

At December 31, 2021, the Company’s cash, cash equivalents, current and long-term marketable securities are approximately $458.8 million, compared to $772.9 million as of December 31, 2020. This decrease is primarily due to funding of the acquisition of Adamas, partially offset by cash flow from operations.

The financial information for the fourth quarter and full year 2021 included herein are preliminary and are therefore subject to change.

Full Year 2021 Financial Information

The Company currently anticipates it will require additional time to finalize its financial statements for the year ended December 31, 2021. Accordingly, the Company currently anticipates it will be unable to file timely its Annual Report on Form 10-K for the year ended December 31, 2021 and that it will file a Form 12b-25 on March 1, 2022.

Full Year 2022 Financial Guidance (GAAP)

The Company expects to achieve the following financial objectives in 2022:

Amount ($ in millions)
Total revenues (1) $640 – $680
Combined R&D and SG&A expenses $460 – $490
Operating earnings (2) $20 – $40
Effective tax rate 25% – 28%
___________________________________________
(1) Includes net product sales and royalty revenue.
(2) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2022 Financial Guidance — GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating earnings on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows:

Non-GAAP Outlook

In providing an outlook for non-GAAP operating earnings, we exclude certain items which are otherwise included in determining the comparable GAAP financial measures. In order to inform our outlook measures of non-GAAP operating earnings, a description of the 2022 adjustments which have been applicable in determining non-GAAP operating earnings for the period are reflected in the tables above. In providing an outlook for non-GAAP operating earnings, we adjust for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration. We are providing such outlook on a non-GAAP basis because we believe it is useful supplemental information to investors and others in understanding and evaluating operating results and trends in our business that could otherwise be masked by the effect of the expenses that we exclude.

We use the outlook measure of non-GAAP operating earnings to understand and compare operating results across accounting periods, for internal budgeting and forecasting purposes and to evaluate our financial performance and the ability to generate cash from operations. We believe the outlook measure of non-GAAP operating earnings allows for meaningful period-to-period comparisons and analysis of trends in our business, as they exclude expenses that are not reflective of ongoing operating results.

There are limitations associated with the use of the non-GAAP financial measure. The Company’s method for calculating the non-GAAP financial measure may differ from those used by other companies, and therefore comparability may be limited. We mitigate the limitations by reconciling the non-GAAP financial measures to the most comparable GAAP financial measures. The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Investors are encouraged to review the reconciliation.

Conference Call Details

Supernus will host a conference call and webcast today, February 28, 2022, at 4:30 p.m. Eastern Time to discuss these results.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

On February 28, 2022 Thermo Fisher Scientific reported that it is calling for new proposals for its Oncomine Clinical Research Grant (Press release, Thermo Fisher Scientific, FEB 28, 2022, View Source [SID1234609168]). The latest request for submissions from the global scientific community will award funding for molecular profiling research that helps accelerate the use of genomic sequencing in oncology .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Next-generation sequencing is vital to match eligible patients with lung carcinomas with targeted therapies, but often this testing takes too long to inform their care"

The recipients of the grants will each be awarded up to $200,000 in reagents and general funding for independent clinical research proposals that demonstrate excellence in cancer molecular profiling. Project proposals harnessing the value of next generation sequencing (NGS) in either the context of solid or hematological cancers will be reviewed by independent and internationally recognized experts for scientific rigor and merit. Grant proposals are now being accepted through April 7, 2022.

"The Oncomine Clinical Research Grant program aims to fund research furthering our understanding of cancer at the genomic level. The identification of specific cancer biomarkers associated with response or resistance to treatment can inform clinical care and potentially help predict patient outcomes," said José Luis Costa, Ph.D., director of medical affairs for clinical next-generation sequencing and oncology, Thermo Fisher Scientific. "Thermo Fisher is committed to supporting scientists and researchers globally as we look to advance cutting-edge genetic research."

Since launching the program in 2020, Thermo Fisher has awarded Oncomine Clinical Research Grants to 16 projects worldwide in support of research in hematology-oncology, immuno-oncology, liquid biopsy, and fusion gene detection. Recipients of the last funding round, which supported clinical research programs using NGS technology in solid tumors and hematology-oncology applications, included: Myung-shin Kim, The Catholic University of Korea Seoul St. Mary’s Hospital, South Korea; Wolfram Jochum, Kantonsspital St. Gallen, Switzerland; Fernando Lopez-Rios, Hospital Universitario 12 de Octubre, Spain; Tarek Bismar, University of Calgary, Canada.

"Next-generation sequencing is vital to match eligible patients with lung carcinomas with targeted therapies, but often this testing takes too long to inform their care," said grant recipient Fernando Lopez-Rios, Hospital Universitario 12 de Octubre. "With the support from the Oncomine Clinical Research Grant, we hope to demonstrate that comprehensive genomic sequencing with very rapid turnaround times can increase patient access and advance the idea of universal testing of all patients with lung carcinomas, including those with early-stage disease."