On August 9, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported its financial results for the second quarter ended June 30, 2018 (Press release, Puma Biotechnology, AUG 9, 2018, View Source [SID1234528600]). Unless otherwise stated, all comparisons are for the second quarter 2018 compared to the second quarter 2017.

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On July 17, 2017, Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and the Company began shipment to wholesalers at the end of July 2017. Prior to the launch of NERLYNX the Company had no product revenue. Net product revenue from sales of NERLYNX in the second quarter of 2018 amounted to $50.8 million, compared to net product revenue of $36.0 million and $20.1 million in the first quarter of 2018 and fourth quarter of 2017, respectively.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $44.3 million, or $1.17 per share, for the second quarter of 2018, compared to a net loss applicable to common stock of $77.8 million, or $2.10 per share, for the second quarter of 2017. Net loss applicable to common stock for the first six months of 2018 was $68.7 million, or $1.82 per share, compared to $150.7 million, or $4.08 per share, for the first six months of 2017.

Non-GAAP adjusted net loss was $22.2 million, or $0.59 per share, for the second quarter of 2018, compared to non-GAAP adjusted net loss of $50.9 million, or $1.38 per share, for the second quarter of 2017. Non-GAAP adjusted net loss for the first six months of 2018 was $21.2 million, or $0.56 per share, compared to non-GAAP adjusted net loss of $94.0 million, or $2.54 per share, for the first six months of 2017. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the second quarter of 2018 was $17.6 million. Net cash used in operating activities for the first six months of 2018 was $23.9 million. At June 30, 2018, Puma had cash and cash equivalents of $95.9 million and marketable securities of $38.6 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"In the second quarter of 2018, we saw strong commercial progress for Puma," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We continued to grow NERLYNX sales in the United States, with net sales of NERLYNX rising approximately 41% from the 2018 first quarter. We were also pleased that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for NERLYNX for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU)."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) in the third quarter of 2018, a decision by the European Commission (EC) regarding the Marketing Authorisation Application for neratinib; (ii) in the second half of 2018 or first half of 2019, reporting data from the Phase III NALA trial in third-line metastatic breast cancer patients; (iii) in the second half of 2018 and first half of 2019, submitting for regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries; (iv) in the fourth quarter of 2018, reporting additional data from the Phase II CONTROL trial; and (v) in the fourth quarter of 2018 and first half of 2019, reporting additional data from the Phase II SUMMIT trial."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and Puma commenced shipment to wholesalers in late July. For the second quarter of 2018, total revenue was $50.8 million, all of which was net product revenue. For the first six months of 2018, total revenue was $117.3 million, of which $86.8 million was net product revenue and $30.5 million was license revenue received from Puma’s sub-licensees.

Operating Costs and Expenses

Operating costs and expenses were $92.2 million for the second quarter of 2018, compared to $78.2 million for the second quarter of 2017. Operating costs and expenses for the first six months of 2018 were $182.1 million, compared to $151.4 million for the first six months of 2017.

Cost of Sales:

Cost of sales was $8.8 million for the second quarter of 2018 and $15.2 million for the first six months of 2018. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $40.1 million for the second quarter of 2018, compared to $24.9 million for the second quarter of 2017. SG&A expenses for the first six months of 2018 were $76.7 million, compared to $43.3 million for the first six months of 2017. This approximately $33.4 million increase was attributable to an increase of approximately $8.5 million in external expenses, such as marketing, commercialization support and commercial strategy. Additionally, internal expenses increased approximately $22.0 million, primarily due to the hiring of a salesforce for the commercialization of NERLYNX in the United States. Finally, employee stock-based compensation increased approximately $2.9 million due to the hiring of the salesforce in conjunction with the NERLYNX commercial launch. Puma expects SG&A expenses in 2018 and into 2019 to remain higher than in 2017 as it launches NERLYNX commercially in the United States and other territories.

Research and Development Expenses:

Research and development (R&D) expenses were $43.3 million for the second quarter of 2018, compared to $53.3 million for the second quarter of 2017. R&D expenses for the first six months of 2018 were $90.2 million, compared to $108.1 million for the first six months of 2017. The $17.9 million year-to-date decrease resulted primarily from a decrease of approximately $12.1 million for stock-based compensation and a decrease of approximately $9.0 million for clinical trial expenses. This was partially offset by an increase of approximately $3.2 million in other expenses, such as additional personnel needed to support medical affairs and quality assurance. We expect R&D expenses in 2018 to continue to decline slightly when compared with R&D expenses in 2017 based on a decline in clinical trial activities as existing trials continue to wind down.

On August 9, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported its financial results for the three-month period ended June 30, 2018 (Press release, Spectrum Pharmaceuticals, AUG 9, 2018, View Source [SID1234528599]).

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"The second quarter marked significant progress and data milestones for our two lead programs poziotinib and ROLONTIS, moving us closer to our ultimate goal of delivering targeted and novel therapies to cancer patients," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We have strong momentum going into the second half of the year as we aggressively broaden our poziotinib clinical program and continue to gain additional regulatory clarity."

Clinical Program Overview:

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

Updated data from the MD Anderson Phase 2 trial in non-small cell lung cancer with exon 20 mutations will be presented at the World Conference on Lung Cancer in Toronto on September 24. Updated data will include EGFR and HER2 patients with exon 20 mutations. The abstract will be released online on September 5.
Spectrum recently had a meeting with the FDA regarding poziotinib to gain clarity on the regulatory pathway. Based on that conversation, Spectrum views the current poziotinib phase 2 study as the pivotal registrational trial needed for the Agency’s review.
Data published in Nature Medicine from the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial demonstrated a confirmed objective response rate of 64 percent. The median progression-free survival had not been reached, with a median follow up of 6.6 months. The safety profile was consistent with what has been previously described for poziotinib and other TKIs with the two most common adverse events being known EGFR inhibitor-related toxicities: skin rash and diarrhea.
Data presented at AACR (Free AACR Whitepaper) demonstrated that HER2 exon 20 mutations were prevalent across multiple solid tumors.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

Spectrum plans to conduct a pre-BLA meeting in the third quarter to ensure alignment with the FDA in preparation for a planned BLA filing in the fourth quarter of 2018.
Top line data from RECOVER, the second Phase 3 ROLONTIS study, demonstrated that the study met the primary efficacy endpoint of non-inferiority in the duration of severe neutropenia (DSN) between ROLONTIS and pegfilgrastim. Both Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER which studied more than 600 patients combined, have met the primary efficacy endpoint. Additional RECOVER data will be released at a future medical meeting.
ADVANCE data released as part of ASCO (Free ASCO Whitepaper) 2018 demonstrated that ROLONTIS was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of the study. Mean DSN±SD was 0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. There were no statistically significant differences in all secondary endpoints in Cycle 1. The adverse event profiles were similar across groups. The most common treatment emergent adverse events in both treatment arms were fatigue, nausea, neutropenia, and lymphopenia.
In an oral presentation at MASCC 2018, data from the ADVANCE Phase 3 study demonstrated an absolute risk reduction of severe neutropenia of 8.5 percent (95% CI: 0.2%, 16.2%) versus pegfilgrastim in Cycle 1. Absolute risk reduction was defined as the difference in percentage of patients experiencing no severe neutropenia (ROLONTIS 84.2 percent; pegfilgrastim 75.7 percent).
Financial Guidance

Spectrum’s 2018 revenue guidance remains between $95 to $115 million. Additionally, Spectrum anticipates current cash and marketable securities will be sufficient to fund operations into 2020.

Three-Month Period Ended June 30, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $23.8 million in the second quarter of 2018. Product sales in the second quarter included: FOLOTYN (pralatrexate injection) net sales of $11.7 million, EVOMELA (melphalan) for injection net sales of $5.8 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $1.6 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.1 million, and FUSILEV (levoleucovorin) net sales of $0.8 million.

Spectrum recorded net income of $13.7 million, or $0.13 income per basic share and $0.13 per diluted share in the three-month period ended June 30, 2018, compared to net loss of $(20.9) million, or $(0.27) loss per basic and diluted share in the comparable period in 2017. Total research and development expenses were $21.5 million in the quarter, as compared to $15.2 million in the same period in 2017. Selling, general and administrative expenses were $23.5 million in the quarter, compared to $17.4 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $(21.6) million, or $(0.21) loss per basic and diluted share in the three-month period ended June 30, 2018, compared to non-GAAP net loss of $(8.6) million, or $(0.11) loss per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $20.1 million, as compared to $14.6 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $19.6 million, as compared to $14.5 million in the same period in 2017.

Conference Call

Thursday, August 9, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic:
(877) 837-3910

Conference ID# 9084737

International:
(973) 796-5077

Conference ID# 9084737
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 August 9, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On August 9, 2018 Turnstone Biologics, a clinical-stage immuno-oncology company developing the next generation of oncolytic viral therapies, reported its presentation at the upcoming investor conference (Press release, Turnstone Biologics, AUG 9, 2018, View Source [SID1234528598]):

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2018 Wedbush PacGrow Healthcare Conference
Date: Tuesday, August 14, 2018
Time: 3:05 p.m. ET
Presenter: Sammy Farah, Ph.D., President and Chief Executive Officer

On August 9, 2018 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the "Company")reported that it has released its financial results for the second quarter ended June 30, 2018 (Press release, Aurinia Pharmaceuticals, AUG 9, 2018, View Source [SID1234528597]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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"We are excited to announce that the AURORA Phase III trial in lupus nephritis is running ahead of schedule and we now anticipate completing enrollment in early Q4 2018. We are extremely pleased with the trial’s progress thus far and having patients roll over into the AURORA 2 extension study reinforces our confidence in the program", said Richard Glickman, Aurinia’s CEO and Chairman of the Board. "Our clinical team continues to deliver on our important milestones with the Phase II trials in FSGS and Dry Eye now initiated. We are well-capitalized into 2020 and look forward to an eventful second half of the year."

Highlights

Our Phase III clinical trial ("AURORA") to evaluate voclosporin for the treatment of lupus nephritis ("LN"), which we initiated in May of 2017, is now expected to complete enrollment in early Q4 2018. We have over 225 clinical trial sites activated and able to enroll patients in 29 countries around the globe.
The first patients have rolled over into the AURORA 2 blinded extension study from the AURORA Phase III clinical trial. The purpose of AURORA 2 is to assess the long-term safety and tolerability of voclosporin in patients with LN; however, this study is not a requirement for potential regulatory approval for voclosporin.
We initiated a Phase II proof-of-concept study in focal segmental glomerulosclerosis ("FSGS") in June 2018. This is an open-label study of 20 treatment naïve patients. We submitted our Investigational New Drug application ("IND") to the FDA in Q1 2018 and received agreement from the FDA with regards to the guidance we provided on this study.
We also initiated a Phase II head-to-head tolerability study of voclosporin ophthalmic solution ("VOS") versus Restasis (cyclosporine ophthalmic emulsion) 0.05% for the treatment of Dry Eye Syndrome ("DES") in July 2018. Depending on the pace of recruitment, data could be available as early as the end of this year or early 2019. This four-week study of approximately 90 patients is expected to be completed by the end of 2018. We believe calcineurin inhibitors ("CNIs") are a mainstay of treatment for DES, and the goal of this program is to develop a best-in-class treatment option, and upon completion, we will look to evaluate strategic alternatives for this asset.
Financial Liquidity at June 30, 2018

At June 30, 2018, we had cash, cash equivalents and short term investments of $150.2 million compared to $159.1 million at March 31, 2018 and $173.5 million at December 31, 2017. Net cash used in operating activities was $12.3 million for the second quarter ended June 30, 2018 compared to $14.0 million for the second quarter ended June 30, 2017.

We believe, based on our current plans, that we have sufficient financial resources to fund our existing LN program, including the AURORA trial and the NDA submission to the FDA, conduct the Phase II trials for FSGS and DES, and fund operations into 2020.

Financial Results for the Three and Six Months Ended June 30, 2018

We reported a consolidated net loss of $15.7 million or $0.19 per common share for the three months ended June 30, 2018, as compared to a consolidated net loss of $2.4 million or $0.03 per common share for the three months ended June 30, 2017.

The increase in the loss for the three months ended June 30, 2018 compared to the same period in 2017 was primarily due to the non-cash change in the estimated fair value of derivative warrant liabilities of $9.4 million. The three months ended June 30, 2018 reflected a $1.9 million increase in the estimated fair value of derivative warrant liabilities compared to a reduction of $7.5 million in the estimated fair value of derivative warrant liabilities for the three months ended June 30, 2017. The change in the revaluation of the derivative warrant liabilities is primarily driven by the change in our share price at each period end. An increase in our share price results in an increase in the estimated fair value of derivative warrant liabilities and vice versa. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company.

The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was $13.8 million for the three months ended June 30, 2018 compared to $9.9 million for the same period in 2017 with the increased loss amount primarily reflecting higher research and development expenses.

For the six months ended June 30, 2018, the consolidated net loss was $31.2 million or $0.37 per common share compared to a consolidated net loss of $54.3 million or $0.78 per common share for the comparable period in 2017. For the six months ended June 30, 2018 we recorded an increase of $4.6 million in the estimated fair value of derivative warrant liabilities compared to $33.3 million for the comparable period in 2017.

The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was $26.6 million for the six months ended June 30, 2018 compared to $21.1 million for the same period in 2017. The increased loss reflected higher research and development expenses.

Research and development expenses increased to $10.5 million for the three months ended June 30, 2018, compared to $7.1 million for the three months ended June 30, 2017. We incurred research and development expenses of $19.4 million for the six months ended June 30, 2018, as compared to $14.4 million for the same period in 2017. The increased research and development expenses reflected higher AURORA clinical and drug supply costs as well as startup costs for the AURORA 2 extension study, and the FSGS and DES studies.

Corporate, administration and business development expenses increased to $3.5 million for the three months ended June 30, 2018, compared to $2.9 million for the same period in 2017. We incurred corporate, administration and business development expenses of $7.3 million for the six months ended June 30, 2018 compared to $6.3 million for the comparable period in 2017. The increase was primarily due to higher non-cash stock compensation expense in 2018 compared to the same periods in 2017.

On August 9, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its second quarter ended June 30, 2018 (Press release, NantHealth, AUG 9, 2018, View Source [SID1234528596]).

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Molecular Analysis – Highlights

In Q2 2018, at AHIP, the company’s Chief Medical Officer, Sandeep Reddy, M.D., and Vice President of Sales, Kristin Lee, presented "Demystifying the Convergence of Precision Medicine and Value-Based Care," which highlights the challenges and opportunities posed by precision medicine and value-based care and how health plans can navigate their convergence
In Q2 2018, at ASCO (Free ASCO Whitepaper):
Launched Liquid GPS, a powerful next-generation tool for blood-based tumor profiling and quantitative monitoring
Co-presented, with Shumei Kato, M.D., and Razelle Kurzrock, M.D., both at the University of California San Diego, data on next-generation sequencing of paired DNA and RNA analysis in patients with rare cancers
Co-presented data on three-fold overestimation of tumor mutation burden (TMB) using a 248 gene list as a panel to impute TMB
Co-presented, with Sumanta Pal, M.D., at City of Hope, findings on how targeting immune checkpoints can improve clinical trial design across a variety of tumor types
Co-presented findings on how 17 percent of DNA next generation sequencing (NGS) 50 gene panel variants are not expressed in RNA sequencing
Commercially Launched the Precision Insights Portal: GPS and Eviti
Precision Insights Portal is a web-based application for molecular test ordering and results and the only solution available to blend guidelines-based regimen information powered by Eviti with personalized insights from GPS Cancer
"The newest generation of clinical trials in immune oncology focus on novel checkpoint targets, T cells, and NK cells and NantHealth’s liquid tumor profiling service provides unparalleled data on quantitative expression of these and other related targets," said Dr. Reddy. "Circulating cell-free RNA is the newest frontier in the liquid biopsy field and NantHealth is proud to lead the way in these clinical trials."

Software and Services Highlights:

Payer Engagement (NaviNet):
In Q2 2018, closed a SaaS contract with major east coast-based health plan — expected to be a significant revenue contributor to the Payer Engagement business
In June 2018, launched Provider Initiated Document Exchange, which streamlines and automates the delivery of information between providers and payers; and, Authorizations Appeals, a product for automating the authorizations appeals process
Clinical Decision Support (Eviti):
Developed and deployed the Precision Insights Portal, the only solution available to blend guidelines-based regimen information powered by Eviti, with personalized insights from GPS Cancer, as mentioned above
Software release 7.0 successfully launched in May, with expanded policy guidance information for radiation oncology and drug management of high cost/abuse drugs, differentiating Eviti from the competition on standard of care policy guidance
Connected Care:
In Q2 2018, showcased medical device integration (MDI) product portfolio (including DeviceConX, VitalsConX and HBox) at Vitalis, the largest e-health event in Scandinavia
"Our Software as a Service business continued to generate solid year over year revenue growth," said Paul Holt, Chief Financial Officer of NantHealth. "Looking ahead, we are optimistic about several significant opportunities in our SaaS and software sales pipelines and the potential of our recently launched products."

Business and Financial Highlights

The company adopted a new revenue recognition standard on January 1, 2018. Please note that the financial results presented below include both amounts "as presented," which reflect implementation of the new revenue recognition standard, as well as amounts prior to the impact of the new revenue recognition standard to allow for comparability against historical results. Starting in fiscal year 2019, the company will no longer present its GAAP and Non-GAAP financial results under the previous revenue recognition standard. For additional information and reconciliations of our financial results between the new and previous revenue recognition standard, see the additional tables included in this press release and in the company’s Form 10-Q to be filed with the Securities and Exchange Commission.

For the 2018 second quarter, total net revenue as presented was $22.0 million. Total 2018 second quarter net revenue prior to the impact of the new revenue recognition standard decreased 10% to $21.2 million from $23.5 million in 2017 second quarter. The prior year quarter included approximately $4.0 million in revenue recognized from the completion of a large implementation. Gross profit as presented was $11.5 million, or 52% of total net revenue. Gross profit prior to the impact of the new revenue recognition standard was $10.7 million, or 50% of total net revenue, compared with $13.9 million, or 59% of total net revenue, for the prior-year second quarter. Selling, general and administrative (SG&A) expenses as presented were $18.4 million. SG&A prior to the impact of the new revenue recognition standard was $18.4 million compared with $19.2 million in 2017 second quarter. Research and development (R&D) expenses as presented decreased to $5.9 million from $8.4 million; the new revenue recognition standard did not impact R&D expenses.

Net loss from continuing operations, net of tax, as presented was $21.8 million, or $0.20 per share. Net loss from continuing operations, net of tax, prior to the impact of the new revenue recognition standard narrowed to $22.5 million, or $0.21 per share, from $57.7 million, or $0.48 per share for the 2017 second quarter. Loss from discontinued operations, net of tax, as presented was $1.6 million, or $0.01 per share, compared with $12.4 million, or $0.10 per share; the new revenue recognition standard did not impact loss from discontinued operations. Net loss as presented was $23.4 million, or $0.21 per share. Net loss prior to the impact of the new revenue recognition standard was $24.1 million, or $0.22 per share, compared with $70.1 million, or $0.58 per share, for 2017 second quarter.

For the 2018 second quarter, on a non-GAAP basis, adjusted net loss from continuing operations as presented was $11.1 million, or $0.10 per share, for the 2018 second quarter. On a non-GAAP basis, adjusted net loss from continuing operations prior to the impact of the new revenue recognition standard was $11.8 million, or $0.11 per share, compared with $13.1 million, or $0.11 per share, for the 2017 second quarter.

In August 2017, NantHealth sold its provider/patient engagement assets to Allscripts to focus on core competencies and accelerate the plan to achieve profitability. As a result, the company has classified the current and prior period operating results of its provider/patient engagement business as discontinued operations. All results presented below represent the company’s continuing operations.

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 second quarter ended June 30, 2018. 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 3132409. 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.