On May 9, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its third quarter ended March 31, 2019 (Press release, MEI Pharma, MAY 9, 2019, View Source [SID1234536137]).

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"As progress continues across our pipeline of four clinical-stage oncology candidates, including two in clinical studies that may support future submissions for FDA marketing approval, we are particularly excited with the expanding data set from the ME-401 intermittent dosing schedule as it continues to mature and we look forward to presenting the data at upcoming medical meetings, including next month at ASCO (Free ASCO Whitepaper)," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Our immediate focus for MEI-401 is twofold: executing the ME-401 follicular lymphoma global Phase 2 study, data from which we intend to submit as an accelerated approval marketing application with the FDA, and the expansion of our investigation of ME-401 in combination with Rituxan or zanubrutinib, a BTK inhibitor being investigated pursuant to our BeiGene collaboration, to earlier stages of follicular lymphoma as well as other B-cell malignancies."

Upcoming Program Milestones

Advancement of ME-401 Program for B-Cell Malignancies
Phase 1b study initiation of new arm to evaluate the combination of ME-401 with zanubrutinib under a clinical collaboration with BeiGene.
Updates and presentations of clinical data from the ME-401 clinical development program, including at 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper).
Final Clinical Results: ME-344 for Breast Cancer
Present complete results from the investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with breast cancer at ASCO (Free ASCO Whitepaper) 2019.
Phase 1b Study Progress: Voruciclib for B-Cell Malignancies and AML
Report initial clinical results from ongoing Phase 1 study, including single agent dose ranging data and results from the combination with venetoclax in patients with B-cell malignancies and relapsed and refractory acute myeloid leukemia around year end 2019.
Phase 2 Results: Pracinostat for Myelodysplastic Syndrome
Results from the Phase 2 clinical trial, including response and 1-year survival, expected to be available around year end 2019.
Financial Highlights

As of March 31, 2019, MEI had $82.3 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the three months ending March 31, 2019, cash expenditures for operating activities were $11.3 million, compared to $6.2 million for 2018. For the nine months ending March 31, 2019, cash expenditures for operating activities were $31.4 million, compared to $17.6 million for 2018. The increase in cash used for the nine months ended March 31, 2019 primarily relates to costs associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 study.
Research and development expenses were $9.1 million for the quarter ended March 31, 2019, compared to $3.1 million for the same period in 2018. Research and development expenses primarily reflect increased costs associated with the development of ME-401.
General and administrative expenses were $3.6 million for the quarter ended March 31, 2019, compared to $2.5 million for the same period in 2018. The increase primarily relates to increased salary and share-based compensation associated with increased headcount, and increased professional services expenses.
The Company recognized revenue of $1.2 million for the quarter ended March 31, 2019, compared to $0.4 million for the same period in 2018. The increase is related to revenues from our agreement with KHK, and to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net loss for the quarter ended March 31, 2019, was $17.4 million, or $0.24 per share compared to a net loss of $5.9 million, or $0.16 per share for the same period in 2018. The Company had 71,280,660 shares of common stock outstanding as of March 31, 2019, compared with 37,323,441 shares as of March 31, 2018.
The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended March 31, 2019, was $12.2 million.

On May 9, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2019 (Press release, G1 Therapeutics, MAY 9, 2019, View Source [SID1234536038]).

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"Following meetings with regulatory authorities, we have clarity on a path to submitting marketing applications in the U.S. and Europe for trilaciclib based on existing data from our three trials in small cell lung cancer patients," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "Our goal is to make trilaciclib available to patients across the globe as quickly as possible and we are encouraged with regulators’ understanding of this new approach to protecting patients from the damaging effects of chemotherapy."

Raj Malik, M.D., Chief Medical Officer added, "Trilaciclib is the first in a deep pipeline of clinical-stage programs with near-term data readouts expected. We anticipate presenting new data on our next two programs – lerociclib and G1T48 – later this year. Based on promising early results in our Phase 1 clinical trial of G1T48 in ER+ breast cancer, we plan to present proof-of-concept data in the third quarter."

Clinical, Operational and Executive Team Updates

Plan to submit U.S. and European regulatory filings for trilaciclib: The company announced plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer (SCLC) based on written feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and discussions with European regulatory authorities. G1 intends to file a New Drug Application (NDA) with the FDA in 2020 and submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) subsequent to an NDA filing. Full press release available here.

Executive team change: Jennifer Moses, who has been with the company for four years and most recently served as Vice President, Finance, has been appointed Chief Financial Officer. Barclay "Buck" Phillips, who had served as CFO and Senior Vice President, Corporate Development since 2017, departed the company to pursue other interests and opportunities.

First investor day presentation: The G1 management team provided a comprehensive overview of the company’s three clinical development programs and outlined the commercialization strategy for trilaciclib. External experts Jeffrey Crawford, M.D., Co-director, Solid Tumor Therapeutics Program, Duke Cancer Institute and Lowell Hart, M.D., Scientific Director of Research, Florida Cancer Specialists and trilaciclib clinical trial investigator,

discussed chemotherapy-induced myelosuppression and trilaciclib’s potential to protect the bone marrow from damage by chemotherapy and improve patient outcomes. The webcast is available on the G1 website here.

First Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $347.8 million as of March 31, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $25.9 million for the first quarter of 2019, compared to $20.7 million for the first quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.8 million for the first quarter of 2019, compared to $1.6 million for the first quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2019 were $18.1 million, compared to $17.3 million for the first quarter of 2018. The increase in expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2019 were $7.8 million, compared to $3.4 million for the first quarter of 2018. The increase in expense was largely due to an increase in compensation due to headcount increase, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $24.0 million for the first quarter of 2019, compared to $20.4 million for the first quarter of 2018.

Anticipated Milestones for 2019

Expect to complete pre-NDA meeting with the FDA.

Report additional data from all four randomized Phase 2 trilaciclib clinical trials.

Present proof-of-concept data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in 3Q19.

Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso (osimertinib) in non-small cell lung cancer in 3Q19.

Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2019 ended March 31, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code:7988598. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On May 9, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its first quarter ended March 31, 2019 (Press release, NantHealth, MAY 9, 2019, View Source;p=RssLanding&cat=news&id=2398133 [SID1234536055]).

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"We had an excellent start to fiscal 2019," said Bob Petrou, Chief Financial Officer of NantHealth. "Our solid 2019 first quarter results were driven by higher total revenue combined with an improved gross margin. Our SaaS business, which comprises the largest portion of our operations, continued its sequential quarterly topline growth, and with the recent signing of a multi-year contract for our Eviti clinical decision support solution, we expect to continue to see further revenue growth."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In Q2, signed a three-year partnership with a leading nonprofit multi-state health plan, expanding Eviti Connect’s total covered lives to over 25 million
In Q1, released versions 7.6 and 7.7, with the following enhancements:
Added features that alert payers when a patient begins treatment before eligibility is determined
Clinical content teams can now publish regimens more efficiently and effectively to meet client needs
Payer medical management groups can now customize warnings and deviations for their clinically equivalent programs
Payers are now provided with superior insights into member eligibility and treatment timeframes
Payer Engagement (NaviNet):
In Q1, implemented refreshed pricing for NaviNet AllPayer services, which is expected to drive enhanced SaaS financial performance in 2019
In Q1, enhanced new workflow capabilities within the Authorizations applications to support functionality in submission workflow, and updated the Authorization Appeals application to better support users
In Q1, upgraded the Claim Status Inquiry tool to allow for better visibility of actions taken within NaviNet for non-NaviNet Claims, increasing utility of the NaviNet solution beyond current payer partners
In Q1, provided health plans/payers greater efficiency by allowing enhanced customization to Open Claim attachment metadata, improving automated file retrieval and processing on their backend
Connected Care (DeviceConX):
In Q1, participated in Healthcare Information and Management Systems Society (HIMSS) Conference in Orlando, FL, showcasing the DeviceConX solution’s ability to successfully deliver GE Healthcare device data and the company’s collaborations with Dell Boomi, Baxter and other kidney dialysis treatment solutions
In Q1, significantly increased connectivity license sales, driving improved recurring maintenance revenue on a go forward basis, as previously announced
In Q1, as previously announced, deployed DeviceConX Version 5.15 upgrade, with the ability to push OS security patches directly to HBox Connected Care hardware devices
In April, the company presented its VitalsConX technology at the American Nursing Informatics Association (ANIA) Annual Conference, demonstrating the ease of collecting, inputting and integrating patient data into electronic health records (EHRs)
Sequencing and Molecular Analysis – Highlights
In Q1, total GPS orders were 820, comprised of GPS Cancer of 428 and Liquid GPS of 392
In Q1, scientific teams from NantHealth and NantOmics presented five posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium and two posters at the ASCO (Free ASCO Whitepaper)’s Genitourinary Cancers Symposium. The research presented focused on the significance of RNA expression, in tissue and blood, and individual biomarkers in determining why some patients do not respond to targeted cancer therapies based on DNA genomic profiling alone
Business and Financial Highlights

For the 2019 first quarter, total net revenue was $23.7 million, compared with $22.3 million in 2018 first quarter. Gross profit was $12.4 million, or 52% of total net revenue, compared with $11.2 million, or 50% of total net revenue, for the prior year period. Selling, general and administrative expenses declined to $16.8 million, from $20.7 million in 2018 first quarter. Research and development expenses decreased to $5.1 million from $5.2 million.

Financial results for the first quarter of 2019 included non-cash charges for loss from related party equity method investment and Allscripts liability of $4.7 million. Net loss from continuing operations, net of tax, was $19.8 million, or $0.18 per share, compared with $22.0 million, or $0.20 per share, for the 2018 first quarter. Net loss was $19.9 million, or $0.18 per share, compared with $22.2 million, or $0.20 per share, for 2018 first quarter.

For the 2019 first quarter, on a non-GAAP basis, adjusted net loss from continuing operations was $10.7 million, or $0.10 per share, compared with $13.5 million, or $0.12 per share, for the 2018 first quarter.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the first quarter ended March 31, 2019. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 6159197. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On May 9, 2019 Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported financial results for the first quarter ended March 31, 2019 (Press release, Acceleron Pharma, MAY 9, 2019, View Source [SID1234536072]).

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"With the submission of marketing applications for luspatercept in the U.S. and E.U. last month, we and our global collaboration partner, Celgene, are excited about the potential to bring a new therapy to patients with myelodysplastic syndromes and beta-thalassemia within the next year," said Habib Dable, President and Chief Executive Officer of Acceleron. "At the same time, our pulmonary program remains on track, with enrollment ongoing in two Phase 2 trials of sotatercept in PAH, and we are anticipating topline results from the placebo-controlled part of the Phase 2 trial of our locally-acting muscle agent, ACE-083, in FSHD during the second half of this year."

Development Program Highlights

Hematology

Luspatercept: Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)
Luspatercept is an investigational first-in-class erythroid maturation agent (EMA) designed to address a late-stage erythroid maturation defect that results in chronic anemia and the need for regular red blood cell transfusions in adults with serious hematologic diseases. Luspatercept is part of the global collaboration between Acceleron and Celgene.

Celgene recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept in patients with MDS- and beta-thalassemia-associated anemia based on the safety and efficacy results of the pivotal Phase 3 studies MEDALIST and BELIEVE.

The Companies expect to announce preliminary topline results from the Phase 2 trial of luspatercept in patients with MF in the second half of 2019.

Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with first-line lower-risk MDS and the BEYOND Phase 2 trial in patients with non-transfusion-dependent beta-thalassemia, with preliminary results expected from the BEYOND trial in 2020.

Neuromuscular Disease

ACE-083: Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie-Tooth Disease (CMT)
ACE-083 is an investigational locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause focal muscle weakness. ACE-083 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta superfamily ligands involved in muscle formation.

Previously presented results from Part 1 of the Phase 2 trial evaluating ACE-083 in patients with FSHD were highlighted in an encore presentation at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in April 2019.

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Preliminary results from Part 2 of the Phase 2 trial in patients with FSHD are expected in the second half of 2019.

Previously presented results from Part 1 of the Phase 2 trial evaluating ACE-083 in patients with CMT will be highlighted in a platform presentation at the American Academy of Neurology (AAN) 71st Annual Meeting on May 10, 2019.

Enrollment is ongoing in Part 2 of the Phase 2 trial in patients with CMT, with preliminary results expected in the first quarter of 2020.

Pulmonary Disease

Sotatercept: Pulmonary Arterial Hypertension (PAH)
Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH. In preclinical studies of PAH, sotatercept reversed pulmonary vessel muscularization and improved indicators of right heart failure.

Enrollment is ongoing in the PULSAR Phase 2 trial in patients with PAH, with topline results expected in the first half of 2020.

Enrollment is ongoing in the exploratory SPECTRA trial in patients with PAH, with preliminary results expected in 2020.

A preclinical abstract of sotatercept in PAH has been accepted for presentation at the American Thoracic Society (ATS) 2019 International Conference on May 21, 2019.

Financial Results

Cash Position – Cash, cash equivalents and investments as of March 31, 2019 were $513.1 million. As of December 31, 2018, the Company had cash, cash equivalents and investments of $291.3 million. Based on the Company’s current operating plan and projections, it believes that current cash, cash equivalents and investments will be sufficient to fund projected operating requirements until such time as it expects to receive significant royalty revenue from luspatercept sales.

Revenue – Collaboration revenue for the first quarter was $2.8 million. The revenue is all from the Company’s partnership with Celgene and is primarily related to expenses incurred by the Company in support of luspatercept.

Costs and Expenses – Total costs and expenses for the first quarter were $43.6 million. This includes R&D expenses of $32.8 million and G&A expenses of $10.8 million.

Net loss – The Company’s net loss for the first quarter ended March 31, 2019 was $38.1 million.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its first quarter 2019 financial results and provide an update on recent corporate activities on May 9, 2019, at 5:00 p.m. EDT.

The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at www.acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron First Quarter 2019 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On May 9, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended March 31, 2019 (Press release, Spectrum Pharmaceuticals, MAY 9, 2019, View Source [SID1234536089]).

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"We are well on our way to fully executing our strategy for Spectrum," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "The Q1 sale of our portfolio of legacy oncology products provided cash and allowed us to focus on our late-stage assets as well as new growth opportunities. Earlier today, we announced the acquisition of two new assets and a novel antibody-interferon fusion technology platform that could have broad application in oncology. With key near-term catalysts for poziotinib and ROLONTIS and two newly acquired assets, we are building a robust oncology pipeline."

Pipeline Overview

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Topline results from the EGFR previously treated non-small cell lung cancer cohort (cohort 1) in the ZENITH20 trial are expected in Q4 2019; data from cohort 1 are intended to support a New Drug Application (NDA) filing with the FDA.
Enrollment for the HER2 previously treated non-small cell lung cancer cohort (cohort 2) is progressing ahead of previous expectations that enrollment would be complete in Q4. This cohort also has the potential to support an NDA filing with the FDA in the future.
ROLONTIS (eflapegrastim), a novel long-acting GCSF

Integrated data from the two Phase 3 ROLONTIS clinical trials (n = 643) will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 annual meeting.
Spectrum is working on filing the ROLONTIS BLA as soon as possible.
Business Development

Spectrum completed an asset purchase and license agreement for a novel immuno-oncology platform and two early stage assets. Originally developed by scientists at UCLA and licensed to Spectrum by UCLA Technology Development Group, the FIT platform fuses interferon with various monoclonal antibodies targeting various tumor antigens and potentially has broad application in oncology. The license also includes two novel assets derived from this platform.
The first asset is an antibody-interferon fusion molecule directed against CD20 (Anti-CD20-IFNá). This drug candidate is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients where a considerable unmet medical need exists. Research for this program received financial support through the Therapy Acceleration Program of The Leukemia & Lymphoma Society, Inc. (LLS), and an LLS research grant to UCLA.
The second asset is an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies. It has the potential for treating both solid and hematologic malignancies.
Three-Month Period Ended March 31, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $39.8 million, or a loss of $0.36 per basic and diluted share, in the three-month period ended March 31, 2019, compared to a loss of $19.2 million, or a loss of $0.19 per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $21.9 million in the quarter, as compared to $13.4 million in the same period in 2018. Selling, general and administrative expenses were $16.0 million in the quarter, compared to $16.6 million in the same period in 2018.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $29.2 million, or a non-GAAP loss of $0.27 per basic and diluted share, in the three-month period ended March 31, 2019, compared to a non-GAAP net loss of $26.8 million, or a non-GAAP loss of $0.27 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $20.4 million, as compared to $12.7 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $10.7 million, as compared to $14.3 million in the same period in 2018.

Conference Call

Thursday, May 9, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 4290388
International: (973) 796-5077, Conference ID# 4290388
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on May 9, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.