On February 13, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies with biomarker patient enrichment selection, reported updated results from its Phase 1b/2 clinical trial of ciforadenant, an adenosine A2A receptor antagonist, in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Corvus Pharmaceuticals, FEB 13, 2020, View Source [SID1234554287]). The data were presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco by Lawrence Fong, M.D., study investigator and leader of the Cancer Immunotherapy Program at the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

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"We are pleased to see activity in mCRPC both with ciforadenant monotherapy and in combination with atezolizumab," said Richard Miller M.D., chief executive officer of Corvus. "The results from this study and prior results reported with CPI-006, our anti-CD73 antibody, indicate that prostate cancer is another potential disease that is amenable to therapy with adenosine blockade. Many prostate cancers express CD73 and contain adenosine that is produced by multiple biochemical sources. Our recently published adenosine signature allows us to identify tumors where adenosine is playing an immunosuppressive role and where adenosine blockade may be clinically useful. We plan to pursue the mCRPC indication further and we anticipate additional data to be presented at the ASCO (Free ASCO Whitepaper) annual meeting in late May/June. Overall, these results continue to demonstrate our leading position in the development of agents targeting the adenosine pathway."

Ciforadenant, Corvus’ lead product candidate, is a selective and potent inhibitor of the adenosine A2A receptor. The ciforadenant Phase 1b/2 study is currently enrolling patients with renal cell cancer (RCC) and mCRPC. The mCRPC arm of the study, which began enrolling patients in October 2019, is evaluating ciforadenant monotherapy and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The study is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy and form the basis for future biomarker driven studies.

Ciforadenant Phase 1b/2 Clinical Trial Results at ASCO (Free ASCO Whitepaper) GU
The clinical data from the Phase 1b/2 trial of ciforadenant were presented by Dr. Fong in a poster presentation titled "Adenosine Receptor Blockade with Ciforadenant ± Atezolizumab in Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)" at the ASCO (Free ASCO Whitepaper) GU 2020 conference. The presentation included data from 35 patients with advanced mCRPC, including 11 that received ciforadenant as a monotherapy (100 mg twice daily) and 24 that received ciforadenant (100 mg twice daily) in combination with atezolizumab (840 mg delivered intravenously every two weeks). These patients had failed a median of three prior therapies and 43% had visceral metastases, which is a negative prognostic factor for patients with mCRPC. The key updates from Dr. Fong’s presentation included:

With median follow up of 3.2+ months, there was one partial response (PR, RECIST); this patient had a prostate-specific antigen (PSA) level drop from 98 to less than 1. Ten additional patients had tumor regression not meeting the criteria for PR. Seven patients have confirmed stable disease exceeding 6 months; one of these patients remains on therapy. Five patients have unconfirmed stable disease and continue on therapy. A total of 9 patients continue on therapy.
Gene expression profiling of tumor biopsies demonstrate a significant correlation of tumor CD73 expression with the adenosine signature (p=0.02). This correlation supports the relevance of adenosine in prostate cancer, its production by CD73 and the expression of adenosine induced immunosuppressive genes. Prior work in renal cell cancer, recently published in Cancer Discovery in January 2020, showed that the adenosine signature is associated with resistance to anti-PD(L)1 therapy, and predicted response to ciforadenant.
Treatment was well tolerated with 1 Grade 3 adverse event of fatigue in monotherapy and 1 Grade 3 adverse event of anemia in the combination arm.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and blockade of adenosine production. These product candidates are being studied in ongoing Phase 1 and 2 clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant, and in combination with pembrolizumab. The Company’s third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.

About Ciforadenant
Ciforadenant (CPI-444) is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.

Adenosine Gene Signature
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor. These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated macrophages, which are thought to mediate resistance to anti-PD(L)1 treatment. In renal cell cancer this biomarker is associated with response to ciforadenant.

On February 13, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report its audited 2019 fourth quarter and full-year financial results and provide a corporate update on February 20, 2020 (Press release, Corcept Therapeutics, FEB 13, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-audited-financial-results-0 [SID1234554286]). The company will host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information

To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call. The passcode will be 7085899.

A replay will be available through March 5, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 7085899.

On February 13, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its fourth quarter and full year 2019 financial results on Monday, February 24, 2020, after the close of the U.S. financial markets (Press release, Clovis Oncology, FEB 13, 2020, View Source [SID1234554285]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss fourth quarter and full year 2019 results on Monday, February 24 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (866) 393-4306, International participants (734) 385-2616, conference ID: 1255036.

On February 13, 2020 Bonnie J Addario Lung Cancer Foundation reported that Patients with lung cancer face the challenge of drug resistance, while researchers focus on extending treatment duration (Press release, Bonnie J Adodario Lung Cancer Fundation, FEB 13, 2020, View Source [SID1234554284]). In collaboration with the patient group ALK Positive, we have awarded a new research collaboration grant dedicated to overcoming ALK+ treatment resistance.

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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

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ALK mutations occur in nearly 5% of patients with non-small cell lung cancer (NSCLC). Currently, five ALK-specific inhibitors (alectinib, brigatinib, ceritinib, crizotinib, and lorlatinib) have greatly extended the lives of patients. The downside is that drug resistance kicks in far too often. The search for innovative approaches to prevent drug resistance and extend treatment duration is imperative to ALK+ patients and to all individuals living with lung cancer.

This grant was awarded to Dr. Trever Bivona, associate professor of medicine at the University of California – San Francisco, and Dr. Christine Lovly, associate professor of medicine at Vanderbilt University Medical Center. The research will focus on understanding why ALK specific drugs stop working and will test the use of drug combinations to delay or prevent resistance. The project is entitled "Transforming ALK+ lung cancer into a chronic or curable condition by combating drug resistance."

This collaboration seeks to fill key knowledge gaps in our understanding of ALK inhibitor response and resistance, with an overarching goal of identifying new targets that improve responses to ALK inhibitor therapy and, ultimately, improve the quantity and quality of life for patients. The project was selected after a rigorous internal and external review process by a committee consisting of patients living with ALK+ NSCLC and some of the world’s foremost ALK experts.

In this era of precision medicine, patients are disrupting the research paradigm by funding and selecting projects that deliver maximum benefit to their community. All of us at GO2 Foundation are pleased to partner with ALK Positive on this research collaboration grant. We look forward to continuing to fuel life-saving research.

Please help save, extend, and improve the lives of those vulnerable, at risk, and living with lung cancer and make a contribution today.

On February 13, 2020 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2019 and provided financial expectations for 2020 (Press release, Alkermes, FEB 13, 2020, View Source [SID1234554281]).

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"2019 was an important year for Alkermes as we took active steps to shape the future of our business and continued to make a real-world impact in the treatment of serious diseases. We made significant progress on three fronts: driving growth in our proprietary product portfolio, advancing and expanding our diversified neuroscience and oncology pipeline, and positioning the business for long-term growth and future profitability," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, our priorities for 2020 are clear as we focus on commercial execution for VIVITROL and ARISTADA, prepare for potential approval and launch of ALKS 3831, advance the development of ALKS 4230, and continue to develop our pipeline of preclinical assets. We remain steadfast in our commitment to be a positive force for change through our science, our medicines, and our advocacy, as we advance patient-centered care."

Quarter Ended Dec. 31, 2019 Financial Highlights

Total revenues for the quarter were $412.7 million. This compared to $315.8 million for the same period in the prior year.

Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $5.4 million for the quarter, or a basic and diluted GAAP loss per share of $0.03. This compared to GAAP net loss of $9.7 million, or a basic and diluted GAAP loss per share of $0.06, for the same period in the prior year.

Non-GAAP net income was $131.4 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.83. This compared to non-GAAP net income of $54.8 million, or a non-GAAP basic earnings per share of $0.35 and non-GAAP diluted earnings per share of $0.34, for the same period in the prior year.

In October 2019, Alkermes implemented a strategic restructuring plan, which included the elimination of approximately 160 current positions across the organization, a decrease in the company’s expected near-term hiring plans and the implementation of cost-saving measures related to external spend. These efforts are expected to result in cost savings of approximately $150 million in 2020.

In November 2019, Alkermes completed the acquisition of Rodin Therapeutics, Inc. (Rodin), a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies. At the closing of the transaction, Alkermes made a cash payment of $98.1 million to Rodin’s former security holders. This upfront cash payment was funded by Alkermes’ available cash and was accounted for as an asset acquisition, with $86.6 million of this upfront payment recorded as research and development (R&D) expense in the quarter.

Quarter Ended Dec. 31, 2019 Financial Results

Revenues

Net sales of proprietary products were $149.6 million, compared to $132.7 million for the same period in the prior year.

Net sales of VIVITROL were $92.8 million, compared to $83.8 million for the same period in the prior year, representing an increase of approximately 11%.

Net sales of ARISTADA1 were $56.8 million, compared to $48.8 million for the same period in the prior year, representing an increase of approximately 16%.

Manufacturing and royalty revenues were $107.3 million, compared to $167.4 million for the same period in the prior year.

Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $79.1 million, compared to $81.4 million for the same period in the prior year.

Manufacturing and royalty revenues from AMPYRA/FAMPYRA2 were $7.5 million, compared to $38.8 million for the same period in the prior year, due to generic competition to AMPYRA entering the U.S. market in 2018.

Manufacturing and royalty revenues in the fourth quarter of 2018 included $26.7 million related to Alkermes’ share of proceeds from the sale of certain royalty streams by Zealand Pharma A/S related to products using Alkermes technology.

Total revenues also included a $150.0 million milestone payment from Biogen related to the U.S. Food and Drug Administration (FDA) approval of VUMERITY, of which $144.8 million was recorded as license revenue and $5.2 million was recorded as R&D revenue.

R&D revenues were $11.1 million, primarily related to R&D reimbursement from the company’s collaboration with Biogen for VUMERITY and a portion of the milestone payment noted above.

Costs and Expenses

Total operating expenses were $422.7 million, compared to $315.7 million for the same period in the prior year.

R&D expenses were $198.2 million, which included $86.6 million related to the acquisition of Rodin during the fourth quarter. Excluding this R&D charge related to Rodin, R&D expenses were $111.6 million compared to $109.0 million for the same period in the prior year.

Selling, General and Administrative (SG&A) expenses were $154.5 million, compared to $141.2 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of ARISTADA and VIVITROL.

As a result of the restructuring implemented in October 2019, the company recorded a restructuring expense charge of $13.4 million in the fourth quarter of 2019, consisting of one-time termination benefits for employee severance, benefits and related costs.

"Our 2019 results reflect volume growth of VIVITROL and ARISTADA, continued strength of our royalty and manufacturing portfolio and investment in the commercialization of our products and our research and development pipeline," commented James Frates, Chief Financial Officer of Alkermes. "We enter 2020 well positioned to drive growth of our proprietary product portfolio and advance our pipeline of novel oncology and neuroscience candidates. Our financial expectations for 2020 reflect anticipated net

sales growth of our proprietary products and operating expenses in line with the predicted impact of the strategic restructuring that we implemented in the fourth quarter of 2019, reflecting our commitment to non-GAAP profitability while investing in the long-term growth of the company."

Calendar Year 2019 Financial Highlights

Total revenues increased 7% to $1.17 billion in 2019, which included VIVITROL net sales of $335.4 million, ARISTADA net sales of $189.1 million, and the $150.0 million milestone payment from Biogen related to the approval of VUMERITY. This compared to total revenues of $1.09 billion in 2018, which included VIVITROL net sales of $302.6 million, ARISTADA net sales of $147.7 million and license revenues of $48.4 million from Biogen. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products.

GAAP net loss was $196.6 million, or a basic and diluted GAAP loss per share of $1.25, for 2019. This compared to a GAAP net loss of $139.3 million, or a basic and diluted GAAP loss per share of $0.90, for 2018.

Non-GAAP net income was $112.2 million, or a non-GAAP basic and diluted earnings per share of $0.71, for 2019, and excludes the impact of the acquisition of Rodin and the restructuring. This compared to non-GAAP net income of $97.8 million, or a non-GAAP basic earnings per share of $0.63 and non-GAAP diluted earnings per share of $0.61, for 2018.

At Dec. 31, 2019, Alkermes recorded cash, cash equivalents and total investments of $614.4 million, compared to $620.0 million at Dec. 31, 2018. At Dec. 31, 2019, the company’s total debt outstanding was $277.1 million, compared to $279.3 million at Dec. 31, 2018.

Recent Events:

ALKS 3831

In January 2020, the FDA accepted for review the company’s New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder, and assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.

VUMERITY

In October 2019, the FDA approved VUMERITY, a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Biogen holds the exclusive worldwide license to commercialize VUMERITY. In November 2019, Alkermes received a $150 million milestone payment from Biogen related to the approval of VUMERITY.

ALKS 4230

In November 2019, Alkermes presented preliminary clinical data from the ARTISTRY-1 phase 1/2 study investigating intravenous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab in adults with advanced solid tumors, and study design details and preliminary safety data from the ARTISTRY-2 phase 1/2 study evaluating subcutaneous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

HDAC-Inhibitor Platform

In November 2019, Alkermes announced the acquisition of Rodin, a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics

for synaptopathies, which expanded Alkermes’ neuroscience development efforts into a wide range of neurodegenerative disorders.

Financial Expectations for 2020

The following outlines the company’s financial expectations for 2020, which reflect the expected impact of the strategic restructuring implemented in 2019. All line items are according to GAAP, except as otherwise noted.

Revenues: The company expects total revenues to range from $1.03 billion to $1.08 billion. Excluding license and R&D revenues from Biogen of approximately $195 million related to the development and approval of VUMERITY recorded in 2019, this represents revenue growth of approximately 8%. Included in this total revenue expectation, Alkermes expects VIVITROL net sales to range from $340 million to $355 million, and ARISTADA net sales to range from $220 million to $235 million.

Cost of Goods Manufactured and Sold: The company expects cost of goods manufactured and sold to range from $185 million to $195 million.

Research and Development (R&D) Expenses: The company expects R&D expenses to range from $405 million to $430 million.

Selling, General and Administrative (SG&A) Expenses: The company expects SG&A expenses to range from $535 million to $560 million.

Amortization of Intangible Assets: The company expects amortization of intangibles to be approximately $40 million.

Net Interest Expense: The company expects interest expense and interest income to offset one another.

Income Tax Expense: The company expects income tax expense of up to $10 million.

GAAP Net Loss: The company expects GAAP net loss to range from $130 million to $160 million, or a basic and diluted loss per share of $0.82 to $1.01, based on a weighted average share count of approximately 159 million shares outstanding.

Non-GAAP Net Income: The company expects non-GAAP net income to range from $40 million to $70 million, or a non-GAAP basic earnings per share of $0.25 to $0.44, based on a weighted average basic share count of approximately 159 million shares outstanding and a non-GAAP diluted earnings per share of $0.25 to $0.43, based on a weighted average diluted share count of approximately 161 million shares outstanding.

Share-Based Compensation: The company expects share-based compensation of approximately $110 million.

Capital Expenditures: The company expects capital expenditures to range from $45 million to $55 million.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 13, 2020, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 13, 2020, through Thursday, Feb. 20, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13698323.