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.

On August 9, 2018 CymaBay Therapeutics, Inc. (NASDAQ: CBAY) a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported financial results and a corporate update for the quarter and six months ended June 30, 2018 (Press release, CymaBay Therapeutics, AUG 9, 2018, View Source [SID1234528710]).

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"Having completed a significant capital raise to start the year, we are now laser focused on high quality execution as we continue to advance novel treatment alternatives to patients suffering from liver diseases with significant unmet needs," said Sujal Shah, President and Chief Executive Officer of CymaBay. "We have collected feedback from regulatory agencies and finalized our design for our planned Phase 3 study of seladelpar in primary biliary cholangitis (PBC) and we are on track to initiate this study in the second half of the year. Data from the ongoing Phase 2 study of seladelpar in patients with PBC were presented in a late-breaking presentation at The International Liver CongressTM in April, and we believe these data support the potential of seladelpar to provide improved efficacy and better tolerability over existing second-line therapy. We are also excited to expand development of seladelpar into non-alcoholic steatohepatitis (NASH) with the recent initiation of a Phase 2b proof-of-concept study. We believe seladelpar’s PPAR-delta mechanism of action may be particularly well suited to treat NASH given its beneficial impacts on lipid, glucose, and sterol metabolism, as well as its effects on inflammation and fibrogenesis."

Second Quarter 2018 Business Highlights

Announced plans to proceed with a double-blind, placebo-controlled Phase 3 pivotal study of seladelpar in PBC. The study intends to enroll approximately 240 patients randomized to receive either 5 mg or 10 mg seladelpar, or placebo. Patients who have an inadequate response on the 5 mg dose will have the potential to increase to 10 mg after 6 months.
Presented new 12-week and 26-week results from the ongoing Phase 2 study of seladelpar in primary biliary cholangitis (PBC) at The International Liver CongressTM in April.
• The results showed potent anti-cholestatic and anti-inflammatory activities, with no drug-induced pruritus, through 26 weeks of treatment.
• 52-week data from this study are expected to be announced in the fourth quarter of 2018.
Initiated a Phase 2b proof-of-concept study of seladelpar for the treatment of NASH. This randomized, placebo-controlled, parallel, dose-ranging study is intended to enroll approximately 175 patients with liver biopsy proven NASH. The primary efficacy outcome is change in liver fat content from baseline to 12 weeks as measured by magnetic resonance imaging. The secondary analysis includes evaluation of histological improvement in NASH and fibrosis as assessed by comparing liver biopsy samples taken at baseline and 52 weeks.
Added CBAY to the Russell 3000 and the Russell 2000 Indexes at the conclusion of the Russell US Indexes annual reconstitution.
Expanded workforce with clinical, regulatory, scientific and administrative personnel necessary to support expansion of clinical programs, notably the Phase 3 PBC registration study, and business operations.
Amended the existing corporate office lease to extend it for an additional 5-year term and relocate to a larger facility within current corporate campus location.
Second Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities totaled $212.1 million at June 30, 2018. Based on current projections, existing cash is expected to fund the current operating plan into 2021.
Term loan facility repaid in full resulting in a debt-free balance sheet at June 30, 2018.
No collaboration revenue was recognized in the second quarter of 2018.
Research and development expenses were $14.4 million in the second quarter of 2018 as compared to $4.0 million in the same period of 2017 and consisted primarily of higher clinical trial expenses related to ongoing PBC Phase 2 and extension studies, start-up activities for the planned PBC Phase 3 study, and enrollment activities associated with the recently initiated NASH Phase 2b study. Additionally, higher seladelpar drug manufacturing expenses were incurred to provide clinical supplies to these studies.
General and administrative expenses were unchanged at $3.6 million in the second quarter of 2018 and 2017.
Net loss was $17.5 million, or ($0.30) per share in the second quarter of 2018, as compared to $8.9 million, or ($0.31) per share in the second quarter of 2017. Net loss was higher primarily due to increased research and development expenses incurred to support expanding clinical studies.
First Half 2018 Financial Results

No collaboration revenue was recognized in the first half of 2018 as compared to $4.8 million in the same period of 2017. Revenue associated with the collaboration arrangement with Kowa Pharmaceuticals America was recognized in 2017 upon transfer of a license and know how to Kowa.
Research and development expenses were $23.9 million in the first half of 2018 as compared to $8.1 million in the same period of 2017 and consisted primarily of higher clinical trial expenses related to ongoing PBC Phase 2 and extension studies, start-up activities for the planned PBC Phase 3 study, and enrollment activities associated with the recently initiated NASH Phase 2b study. Additionally, higher seladelpar drug manufacturing expenses were incurred to provide clinical supplies to these studies.
General and administrative expenses were $6.9 million in the first half of 2018, as compared to $7.3 million in the first half of 2017. Expenses were higher in 2017 primarily due to severance expenses associated with the retirement of CymaBay’s former CEO.
Net loss was $34.5 million, or ($0.61) per share in the first half of 2018, as compared to $14.3 million, or ($0.52) per share in the second quarter of 2017. Net loss was higher primarily due to increased research and development expenses incurred to support the expanding clinical studies and lower collaboration revenue.
Conference Call Details
CymaBay management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2018 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13680965. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On August 9, 2018 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended June 30, 2018 (Press release, Corcept Therapeutics, AUG 9, 2018, View Source [SID1234528784]).

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Financial Highlights

Revenue of $62.3 million, a 75 percent increase from second quarter 2017 GAAP net income of $0.14 per share, compared to $0.10 per share in second quarter 2017 Non-GAAP net income of $0.20 per share, compared to $0.13 per share in second quarter 2017 Cash and investments of $159.9 million, a $19.6 million increase from first quarter 2018 2018 revenue guidance revised to $250 – 270 million, from $275 – 300 million Company announces $100 million stock repurchase program Relacorilant Data

The final 18 patients enrolled in the trial (the "High-Dose" cohort) receive 250 mg/day of relacorilant for four weeks, with dose being increased, as tolerability permits, to 300 mg/day for four weeks, then 350 mg/day for four weeks, then 400 mg/day for four weeks; data are available for the 250 mg/day and 300 mg/day dose levels.

Based on FDA feedback, Corcept has developed response criteria for relacorilant’s Phase 3 trial. Applying these endpoints to the High-Dose cohort at eight weeks of treatment (conclusion of the 300 mg dose level) produces the following results:

Fifty-eight percent of patients with hyperglycemia achieved improved glucose control, as shown by a
(i) 0.5 percent or greater reduction in HbA1c or (ii) 50 mg/dl or greater reduction (or normalization) in 2-hour glucose as measured in the oral glucose tolerance test or (iii) 25 percent or greater decrease in antidiabetic medications

Fifty-five percent of patients with uncontrolled hypertension achieved a five millimeter or greater drop in either systolic or diastolic blood pressure, as measured by 24-hour ambulatory monitoring No evidence of progesterone receptor affinity; no instances of hypokalemia Testing of higher doses is ongoing; Phase 3 trial planned to start this year Oncologic and Metabolic Disorders

Placebo-controlled, Phase 2 trial of relacorilant plus Abraxane (nab-paclitaxel) in metastatic ovarian cancer planned to start by year-end Results expected by year-end in study of relacorilant plus Abraxane in patients with metastatic pancreatic cancer Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer Planning underway for placebo-controlled, Phase 2 trials of CORT118335 in patients with antipsychotic-induced weight gain and non-alcoholic steatohepatitis ("NASH"); both trials planned to start by year-end Financial Results

Corcept reported quarterly revenue of $62.3 million, compared to $35.6 million in the second quarter of 2017. Second quarter GAAP net income was $18.2 million, compared to $12.6 million in the same period last year. Excluding non-cash expenses related to stock-based compensation, utilization of deferred tax assets, accreted interest on the company’s retired royalty financing obligation and related income tax effects, non-GAAP net income in the second quarter was $25.4 million, compared to $16.0 million in the second quarter of 2017. (A reconciliation of GAAP to non-GAAP net income is set forth below.) The company reduced its 2018 guidance to $250 – 270 million.

Second quarter operating expenses were $41.7 million, compared to $22.8 million in the second quarter of 2017, primarily due to increased spending to advance relacorilant, CORT118335 and CORT125281 and costs from increased sales volume.

Cash and investments were $159.9 million at June 30, 2018, an increase of $19.6 million from first quarter 2018.

The company announced a program to repurchase up to $100 million of its common stock, which it intends to fund using cash and investments. Details of the program are provided below.

"Our Cushing’s syndrome franchise continues its significant growth, driven by physicians’ increasing realization that hypercortisolism is a serious disorder and that cortisol modulation is the best medical therapy for many patients," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "We are confident this shift in medical practice will continue."

Relacorilant’s Phase 2 Trial

"Interim data from our Phase 2 trial’s High-Dose cohort showed that relacorilant provided clinically meaningful benefit without the two off-target effects – progesterone receptor affinity and increased cortisol levels – that cause Korlym’s most common and serious adverse events – termination of pregnancy, endometrial thickening, vaginal bleeding and low potassium (hypokalemia)," said Robert S. Fishman, MD, Corcept’s Chief Medical Officer.

"That relacorilant did not cause hypokalemia in these patients is surprising – and important," he added. "Forty-four percent of the patients in Korlym’s pivotal trial experienced hypokalemia, which can be life-threatening. It is one of the most common adverse events in patients taking Korlym today.

"Interim efficacy data have also been impressive. Based on our planned Phase 3 endpoints, 58 percent of the patients with hyperglycemia achieved improved glucose control. Applying the same endpoints, this figure was 48 percent at the comparable time in Korlym’s pivotal trial ("SEISMIC") and 23 percent at the conclusion of treatment in the Low-Dose cohort. (See Figure 1) For patients with hypertension, 55 percent responded in the High-Dose cohort, compared to 44 percent in SEISMIC and 45 percent of the Low-Dose cohort. (See Figure 2)

"Relacorilant was well-tolerated," he concluded. "We observed one serious adverse event, a pilonidal abscess, which resolved without discontinuing relacorilant. One patient discontinued due to musculoskeletal pain and fatigue – a relatively common adverse event seen as cortisol modulation decreases cortisol activity."

Oncology

"At ASCO (Free ASCO Whitepaper)’s annual meeting this May, we reported positive data from the dose-finding portion of our Phase 1/2 study of relacorilant plus Abraxane to treat patients with solid tumors," added Dr. Fishman. "At the minimum therapeutic dose, four of nine patients with metastatic pancreatic cancer and four of seven patients with metastatic ovarian cancer demonstrated durable disease control. These results are especially notable in patients with such dire disease, all of whom had progressed on one or more prior taxane-based treatments. Recently, another patient with pancreatic cancer has achieved a partial response.

"These results justify significantly expanding our oncology program. By year-end, we plan to open a placebo-controlled, Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer. We also expect to have enough data by year-end in patients with metastatic pancreatic cancer to determine if a definitive trial is warranted."

Conference Call

Corcept will hold a conference call August 9, 2018, at 5:00 pm Eastern Time (2:00 pm Pacific Time). To participate, dial 1-888-394-8218 from the United States or 1-323-794-2588 internationally ten minutes before the start of the call (passcode: 6703650). A replay will be available through August 23, 2018 at 888-203-1112 from the United States and 719-457-0820 internationally (passcode: 6703650).

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 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported financial results for the second quarter of 2018 (Press release, Agenus, AUG 9, 2018, View Source [SID1234528647]).

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"Innovation and speed are core to our strategy. We have delivered eight new discoveries over the past 2 years. This year alone, 3 INDs from our discovery engines have been filed and 3 additional INDs will be filed by year end; they include our NexGen CTLA-4 and our first-in-class bispecifics. We have delivered on our partnership commitments with Merck and Incyte with 2 programs in the clinic this year and a third expected before the end of the year, each triggering a cash milestone," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In addition, our proprietary CTLA-4 and PD-1 programs are advancing in three trials designed to take advantage of accelerated pathways for a BLA filing as early as 2020. Our partnership discussions have advanced towards potential closure. With these developments, we expect to deliver value to our shareholders and partners."

Key clinical and business updates

Operational Achievements:
New discoveries advance to clinic
Three INDs filed and 3 more to be filed by the end of 2018, including Next-Gen CTLA-4 and two first-in-class bispecifics
Lead CTLA-4 (AGEN1884) & PD-1 (AGEN2034) trials advance towards BLA as early as 2020
ASCO reported data show 31-42% benefit
New data in 2018 anticipated to show expanded benefit
Three trials ongoing designed to leverage accelerated pathways
Payment milestones triggered in partnerships with Incyte, Merck
LAG-3 (INCAGN02385) in the clinic
TIM-3 (INCAGN02390) expected to enter clinic in 2018
Undisclosed target with Merck entered clinic
Sales of GSK’s Shingrix, containing QS-21 Stimulon, have exceeded projections
Manufacturing Speed and Innovation:
Completed clinical & pivotal grade material for AGEN1884 & AGEN2034 3-5x faster than industry standards
First-in-class bispecific, AGEN1223, manufactured at scale in <2 months; setting industry records
AgenTus Cell Therapy Business:
Lead identified for IND filing; private financing and plans for IPO underway
Second Quarter 2018 Financial Results

Cash and cash equivalents were $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively.

For the second quarter ended June 30, 2018, we reported a net loss of $25.2 million, or $0.24 per share, compared to a net loss for same period in 2017 of $31.7 million, or $0.32 per share. We recognized revenue during the current quarter of $16 million which includes milestone achievements and non-cash royalties earned.

For the six months ended June 30, 2018, we reported a net loss of $79.5 million or $0.76 per share compared to a net loss for the same period in 2017 of $48.8 million or $0.51 per share. The increased net loss reflects reduced revenue due to an accelerated milestone received during 2017 from Incyte and the loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Agenus executives will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. Eastern Time. To access the live call, dial (844) 492-3727 (domestic) and (412) 317-5118 (international). Ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or via the following link: View Source A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.