On August 7, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported its financial results and business highlights for the second quarter of 2019 (Press release, Athenex, AUG 7, 2019, View Source [SID1234538305]).

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"Athenex has continued to execute successfully across all of our strategic objectives in our development programs as well as our commercial operations and readiness," stated Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex. "We are particularly excited about today’s announcement of success in our Phase III study of oral paclitaxel and encequidar in metastatic breast cancer. We believe the success of this program serves to derisk our technology platform and provides further validation as we continue advancing our other Orascovery candidates (including docetaxel, cabazitaxel, irinotecan, topotecan and eribulin) and combination therapies."

Mr. Jeffrey Yordon, Chief Operating Officer of Athenex, commented, "We have been building the commercial infrastructure in manufacturing (active pharmaceutical ingredient and dosage-form), logistics and marketing to support the potential launch of oral paclitaxel and encequidar, which, based on the Phase III results announced, we believe has significant potential. Athenex is in the process of transforming from a clinical stage company to a fully integrated, commercial organization focused on delivering innovative cancer treatments that can improve patient outcomes."

Second Quarter 2019 and Recent Business Highlights:

Clinical Programs:

Phase III study of oral paclitaxel and encequidar for metastatic breast cancer

Primary efficacy endpoint met in Phase III clinical trial of oral paclitaxel and encequidar (Oral Paclitaxel) versus IV paclitaxel in patients with metastatic breast cancer. Oral Paclitaxel showed a statistically significant improvement compared to IV paclitaxel with an ORR of 36% compared to 24% based on intention-to-treat analysis (p = 0.01). Oral Paclitaxel also showed statistically significant improvement compared to IV paclitaxel based on other analyses on populations excluding non-evaluable patients (which would give higher response rates), with p £ 0.01 in all analyses.

Results also showed that the proportion of confirmed responders with a duration of response more than 150 days was 2.5 times higher in Oral Paclitaxel versus IV paclitaxel.

There were strong trends in progression-free survival (p = 0.077) and overall survival (p = 0.11) favoring Oral Paclitaxel over IV paclitaxel.

Neuropathy was less frequent with Oral Paclitaxel compared to IV paclitaxel.

Plan to request a pre-NDA meeting as soon as possible and present data at a major upcoming scientific meeting.

Other

Reported promising clinical results from a clinical study of oral paclitaxel and encequidar in cutaneous angiosarcoma. Preliminary data show rapid, visible response to oral paclitaxel and encequidar monotherapy in the first seven subjects, including three complete responses.

Four posters featuring the Company’s products/technologies were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Preliminary positive clinical activity signals observed in a cohort of patients with psoriasis treated with tirbanibulin ointment (formerly known as KX2-391) in a Phase I clinical trial.

The U.S. Food and Drug Administration (FDA) allowed the Company’s Investigational New Drug (IND) application for the clinical investigation of PT01 (Pegtomarginase) for the treatment of patients with advanced malignancies.

Corporate Announcements:

Launched new brand, Athenex Oncology, and corresponding website, AthenexOncology.com, during the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.

Strategically expanded presence in Europe and Latin America to grow the Company’s global clinical research and development capacity and maximize the global potential of its pipeline.

Formed a subsidiary in the U.K. and established offices in Manchester.

Entered into a definitive agreement to acquire certain assets of CIDAL Limited, a contract research organization (CRO) with headquarters in Guatemala and operations in various countries in Latin America.

Voluntarily suspended production activities at its active pharmaceutical ingredient (API) plant in Chongqing (Taihao API plant). This decision was made based on discussions with the Department of Emergency Management of Chongqing (DEMC) related to concerns raised about the location of our plant. The DEMC has been evaluating the safety of all chemical and other plants in the region after recent accidents at other plants. In the meantime, the Company has been working on the build-out of the new API plant in Chongqing, and the plant is expected to commence operations in the first half of 2020.

Commercial Business:

Athenex Pharmaceutical Division (APD) currently markets a total of 30 products with 58 SKUs.

Athenex Pharma Solutions (APS) currently markets 5 products in total with 13 SKUs.

Goal is to launch 9-12 products in 2019.

Financial Results for the Quarter Ended June 30, 2019

Product sales for the three months ended June 30, 2019 were $22.0 million, compared with $11.5 million for the three months ended June 30, 2018, an increase of $10.6 million or 92%. This increase was primarily attributable to an increase in 503B revenue of $6.0 million, an increase in specialty product revenue of $4.6 million, and an increase in API sales of $0.6 million.

Cost of sales for the three months ended June 30, 2019 totaled $16.9 million, an increase of $7.5 million, or 79%, as compared to $9.4 million for the three months ended June 30, 2018. This was primarily due to an increase of $5.8 million in cost of sales from the sale of specialty products and $1.7 million from 503B and API products. Gross margin attributable to product sales increased from 17.7% in the three months ended June 30, 2018 to 23.1% in the three months ended June 30, 2019, primarily as a result of change in product mix.

Research and development expenses for the three months ended June 30, 2019 were $18.5 million as compared to $26.6 million for the three months ended June 30, 2018. This was primarily due to a decrease in licensing fees, as well as expenses in relation to clinical operations and product development. The decrease in these R&D expenses was offset primarily by an increase of $1.1 million of preclinical development costs related to the arginase and TCR-T platforms.

Selling, general and administrative expenses for the three months ended June 30, 2019 were $17.2 million as compared to $12.8 million for the three months ended June 30, 2018. This was primarily due to an increase of $3.7 million related to the costs of preparing to commercialize our proprietary drugs, if approved, and an increase of $1.3 million in general administrative expenses including legal fees and other professional service fees, offset by a decrease of $0.6 million in administrative related compensation expense.

Net loss attributable to Athenex for the three months ended June 30, 2019 was $32.0 million, or $0.44 per diluted share, compared to a net loss of $36.9 million, or $0.58 per diluted share, in the same period last year.

On May 7, 2019, the Company closed a private placement transaction in which it issued 10 million shares of common stock to three institutional investors (Perceptive Advisors, Avoro Capital Advisors (formerly known as venBio Select Advisor) and OrbiMed) at a purchase price of $10.00 per share, for net proceeds of approximately $99.9 million to Athenex.

The Company received a $20 million milestone payment from Almirall S.A. during the second quarter of 2019 in connection with the partnership on tirbanibulin and expects this payment to be recorded as revenue in the second half of 2019.

At June 30, 2019, the Company had cash, cash equivalents, restricted cash and short-term investments of $165.9 million, compared to $107.4 million at December 31, 2018. Based on the current operating plan, we expect that our cash, cash equivalents, restricted cash and short-term investments as of June 30, 2019, together with cash to be generated from our operating activities, will enable us to fund our operations into the third quarter in 2020.

Financial Results for the Six Months Ended June 30, 2019

Product sales reached $47.2 million for the six months ended June 30, 2019, compared with $24.1 million for the six months ended June 30, 2018, an increase of $23.1 million or 96%.

Total revenue for the six months ended June 30, 2019 was $47.5 million, a decrease of $1.9 million, or 4%, as compared to $49.4 million for the six months ended June 30, 2018. The decrease was primarily due to $25.0 million related to license milestone revenue earned in the

first quarter of 2018, and $1.1 million decrease in medical device product sales and contract manufacturing revenue, offset by a $24.3 million the increase in product sales, of which $10.9 million was from the sales of 503B products, $10.5 million was from sales of specialty products, and $2.8 million was from API.

Cost of sales for the six months ended June 30, 2019 totaled $36.8 million, an increase of $16.1 million, or 77%, as compared to $20.8 million for the six months ended June 30, 2018. This was primarily due to the increase of $12.0 million in cost of sales from the sale of specialty products and $4.1 million in cost of sales from 503B and API products. Gross margin attributable to product sales increased from 13.7% in the six months ended June 30, 2018 to 21.9% in the six months ended June 30, 2019, primarily as a result of change in product mix.

Research and development expenses for the six months ended June 30, 2019 were $43.0 million as compared to $47.9 million for the six months ended June 30, 2018. This was primarily due to a decrease in licensing fees, as well as expenses in relation to clinical operations and product development. The decrease in these R&D expenses was offset by an increase of $2.8 million of preclinical development costs related to the arginase and TCR-T platforms, and a $1.7 million increase of R&D related compensation.

Selling, general and administrative expenses for the six months ended June 30, 2019 were $32.4 million as compared to $25.9 million for the six months ended June 30, 2018. This was primarily due to an increase of $6.2 million related to the costs of preparing to commercialize our proprietary drugs, if approved, and an increase of $1.3 million of general administrative expenses including legal fees and other professional service fees, offset by a decrease of $1.3 million in administrative related compensation expense.

Net loss attributable to Athenex for the six months ended June 30, 2019 was $67.3 million, or $0.96 per diluted share, compared to a net loss of $44.2 million, or $0.71 per diluted share, in the same period last year.

Outlook and Upcoming Milestones:

Intend to submit results from Phase III clinical trial of oral paclitaxel and encequidar in metastatic breast cancer for presentation at a major upcoming scientific meeting and for peer review publication (Q4 2019 / H1 2020)

Expect to request a pre-NDA meeting as soon as possible for oral paclitaxel and encequidar in metastatic breast cancer (Q4 2019)

Expect to file an NDA for tirbanibulin ointment in actinic keratosis (Q1 2020)

Financial Guidance:

Athenex provides revenue guidance for product sales only. The Company is raising its product sales guidance for 2019 and is now forecasting that product sales this year will increase by between 30% and 35% year-over-year from $56.4 million in 2018 (versus previous guidance of 25% – 30% annual growth). This new revenue guidance has taken into account the court’s latest decision in the Vasopressin proceeding and the suspension of operations at our Taihao API plant. The revenue guidance excludes license and collaboration fees.

Conference Call and Webcast Information:

The Company will host a conference call and live audio webcast today, Wednesday, August 7, 2019, at 8:00am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13691069. The live conference call and replay can be accessed via audio webcast at View Source and also on the Investor Relations section of the Company’s website, located at View Source

On August 7, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, Jounce Therapeutics, AUG 7, 2019, View Source [SID1234538304]).

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"2019 has been a time of clinical progress and important strategic business development activity for Jounce, with the initiation of our Phase 2 EMERGE trial for vopratelimab, the completion of enrollment in our Phase 1 clinical trial of JTX-4014 and the recently announced renegotiation of our Celgene collaboration. These important developments demonstrate the value and utilization of our novel scientific platform and reverse translational analyses to further advance our immuno-oncology pipeline with an aim to match the right therapies to the right patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our translational science platform has been further validated by the establishment of our new licensing agreement with Celgene for the worldwide rights to JTX-8064. Now that we have retained full worldwide rights to vopratelimab, JTX-4014 and all of our discovery programs, we look forward to advancing our broad pipeline of potential next-generation immuno-oncology therapies."

Wholly-owned Programs:
Vopratelimab (JTX-2011)

Initiated Phase 2 EMERGE trial: In June 2019, Jounce announced the initiation of dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies.

The primary endpoint of EMERGE is overall response rate and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of ICOS hi CD4 T cell emergence, and a range of other biomarkers, including exploratory assessment of potential predictive biomarkers. Jounce expects to report preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.

Key data presented at AACR (Free AACR Whitepaper) 2019: In April 2019, Jounce presented two posters on vopratelimab at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Highlights from the poster presentations include:

Patients in the ICONIC trial with the emergence of ICOS hi CD4 T cells demonstrated improved PFS and OS compared to patients with ICOS lo CD4 T cells, based on an analysis of a subgroup of patients with multiple solid tumor types including PD-1 inhibitor naive and PD-1 inhibitor experienced patients.

The characteristics of ICOS hi CD4 T cells associated with vopratelimab treatment via translational analyses demonstrated that vopratelimab stimulates only primed CD4 T cells with high levels of ICOS. The translational data shows that vopratelimab, unlike PD-1 inhibitors, leads to expansion and activation of peripheral CD4 T effector cells, and that these are observed in patients with clinical benefit.
JTX-4014

Completed enrollment of Phase 1 trial: Jounce is pleased to announce the completion of enrollment in the Phase 1 clinical trial of JTX-4014, its PD-1 inhibitor, and determination of the recommended Phase 2 dose. Jounce plans to report data from the trial in the second half of this year.
Discovery Pipeline

On track to announce next discovery candidate: Jounce continues to advance and develop its broad discovery pipeline, which includes multiple programs targeting T-regulatory cells, macrophages and stromal cells. Jounce expects to move its next novel program into IND-enabling studies later this year.
Licensed Program:

JTX-8064

Licensed JTX-8064: In July 2019, Jounce announced a new agreement in which Celgene exclusively licensed the worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Under this license agreement, Jounce received a $50.0 million non-refundable license fee and is eligible to receive up to $480.0 million in development, regulatory and commercial milestone payments, as well as potential royalties on worldwide sales. Celgene will be responsible for all development and commercialization of JTX-8064.

Jounce and Celgene also entered into a mutual agreement to terminate the original strategic collaboration agreement, established in July 2016. Jounce now retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs.
Second Quarter 2019 Financial Results:

Cash Position: As of June 30, 2019, cash, cash equivalents and investments were $152.0 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period. In July 2019, Jounce received a $50.0 million license fee pursuant to its new license agreement with Celgene.

Collaboration Revenue: Collaboration revenue was $17.4 million for the second quarter of 2019, compared to $19.4 million for the same period in 2018. Collaboration revenue during both periods represents non-cash revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s original strategic collaboration with Celgene. In connection with the termination of the original strategic collaboration, Jounce expects that the remaining deferred revenue relating to the Celgene agreement will be fully recognized in the third quarter of 2019.

Research and Development Expenses: Research and development (R&D) expenses were $18.1 million for the second quarter of 2019, compared to $18.5 million for the same period in 2018. The decrease in R&D expenses was primarily due to $0.5 million of decreased external research and development costs attributable to vopratelimab manufacturing expenses incurred during the second quarter of 2018, $0.4 million of decreased external clinical and regulatory costs and $0.3 million of decreased lab consumables expenses. These decreases were partially offset by $0.7 million of increased employee compensation costs.

General and Administrative Expenses: General and administrative (G&A) expenses were $7.3 million for the second quarter of 2019, compared to $6.5 million for the same period in 2018. The increase in G&A expenses was primarily due to $0.5 million of increased employee compensation costs, including $0.3 million of increased stock-based compensation expense, and $0.3 million of increased other G&A costs to support Jounce’s operations.

Net Loss: Net loss was $7.0 million for the second quarter of 2019, or a basic and diluted net loss per share of $0.21. Net loss was $4.7 million for the same period in 2018, or a basic and diluted net loss per share of $0.14. The increase in net loss and net loss per share was primarily attributable to the decrease in non-cash collaboration revenue from the second quarter of 2018 to the second quarter of 2019.
Financial Guidance:

Jounce reiterates its updated revenue guidance and expects to record $50.0 million in cash revenue in 2019 related to the license of JTX-8064 and approximately $98.0 million in non-cash revenue in 2019 representing the remaining recognition of the Celgene upfront payment received in July 2016.

Based on its operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $80.0 million to $95.0 million.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4484315. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

On August 7, 2019 INmune Bio, Inc. (NASDAQ: INMB), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported positive preliminary data today during a presentation at Cambridge Healthtech Institute’s 7th Annual Immuno-Oncology Summit in Boston (Press release, INmune Bio, AUG 7, 2019, View Source [SID1234538303]). INB03 is being developed as part of combination immunotherapy to potentially reverse resistance to treatment.

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The Phase I trial is an open-label, dose-escalation trial in patients with advanced solid tumors. Patients received INB03, a novel, second-generation soluble TNF (tumor necrosis factor) inhibitor that works by a dominant-negative technology. Today, positive preliminary data from the first two cohorts were released. These data will be followed by a final report later this year as the company advances the program into a Phase II study.

"The goal of the Phase I study is to determine, in order of priority, the safety of INB03 in cancer patients, the dose of INB03 to take into the Phase II trials in cancer, and evidence of a biologic effect of INB03," said RJ Tesi, MD, Chief Executive Officer and Chief Medical Officer of INmune Bio. "All of these goals have been met. Using data from this trial, we have begun planning a Phase II trial using INB03 as part of combination immunotherapy in patients with cancer."

To date, 11 of 12 patients have been enrolled in one of three dosing cohorts of INB03 (0.3, 1.0 and 3.0 mg/kg). Participants were a mix of patients with advanced solid tumors that have progressed after multiple previous lines of therapy. INB03 was given once a week by subcutaneous injection. Safety, INB03 pharmacokinetics and inflammatory biomarkers were followed in all patients.

Preliminary data from patients treated in the first two cohorts are available. Patients included two males and four females, and the average age was 63-years-old. Patients in the study had prostate cancer, ovarian cancer, colon cancer (two), cholangiocarcinoma and lung cancer, with an average of three previous lines of therapy (range: two to four). INB03 was given for a median of 74 days (range: 12 to 119 days). No drug-related serious adverse events have been reported, and INB03 was well tolerated. Discontinuation of INB03 was due to tumor progression in all patients. INB03 trough drug levels were obtained before each INB03 dose. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03.

About INB03

INB03, a novel dominant-negative TNF inhibitor, is a selective second-generation TNF inhibitor that neutralizes soluble TNF (sTNF) without blocking the function of trans-membrane TNF or TNF receptors. In animal studies, INB03 neutralization of sTNF alters the immunobiology of the tumor microenvironment (TME) to improve tumor killing by decreasing populations of cells in the TME that protect the tumor from the patient’s immune system and immunotherapy – myeloid derived suppressor cells, T regulatory cells and tumor activated macrophages. The unique mechanism of action suggests INB03 may have safety and efficacy advantages over currently approved non-selective TNF inhibitors in the treatment of cancer and other diseases.

On August 7, 2019 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 ended June 30, 2019 (Press release, CymaBay Therapeutics, AUG 7, 2019, View Source [SID1234538302]).

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"In the second quarter of 2019, we made significant progress advancing the development of seladelpar for PBC and NASH and began activities to further diversify development into PSC," said Sujal Shah, President and CEO of CymaBay. "Enrollment in our ENHANCE Phase 3 registration study in PBC, expected to be completed by year-end, continued on track during the quarter. Topline 12-week results from our 52-week, dose-ranging Phase 2b study in NASH showed clinically meaningful reductions in multiple biomarkers of inflammation and liver injury despite minimal reductions in total liver fat. At two of the three doses being tested, mean reductions in alanine aminotransferase exceed thresholds that have been correlated to histologic improvement in NASH. In this ongoing study, the effects of seladelpar on the two key histologic endpoints, NASH resolution and fibrosis, will be assessed from a liver biopsy taken at 52 weeks. We expect to share these data in the second quarter of 2020. In June, we announced plans to initiate a Phase 2, dose-ranging study of seladelpar in patients with PSC in the third quarter of 2019."

Second Quarter and Recent Business Highlights

Janet Dorling joined the CymaBay executive team as Chief Commercial Officer
Ms. Dorling is a seasoned commercial leader with over 15 years of experience in pharmaceutical sales and marketing at Achaogen, Roche and Genentech.
Continued enrollment of ENHANCE, a global, Phase 3 registration study of seladelpar for the treatment of primary biliary cholangitis (PBC).
ENHANCE is intended to establish the efficacy and safety of seladelpar for the treatment of PBC to support the submission of a global registration dossier with health authorities to obtain approval.
The study is expected to be fully enrolled by the end of 2019 with the 52-week treatment period targeted for completion by the end of 2020 and topline data in 2021.
Topline data from our Phase 2b dose-ranging, paired liver biopsy study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH) was released in June 2019.
Treatment with seladelpar resulted in robust and clinically meaningful reductions in markers associated with liver injury.
Treatment with seladelpar resulted in minimal reductions in liver fat that were not significant when compared to placebo.
Seladelpar demonstrated a favorable safety and tolerability profile at all doses evaluated in this study.
Announced FDA acceptance of an IND to initiate a Phase 2 clinical study of seladelpar in primary sclerosing cholangitis (PSC).
PSC is a rare, chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts for which there are no FDA-approved treatments.
The Phase 2 study is expected to be initiated in the third quarter of 2019 and will be a randomized, placebo-controlled, dose-ranging study that will enroll approximately 100 patients at 60 sites globally.
Second Quarter Financial Highlights & Results

Held $241.2 million in cash, cash equivalents and marketable securities at June 30, 2019. Existing cash is expected to fund the current operating plan into 2021.
Research and development expenses were $21.1 million in the second quarter of 2019 as compared to $14.4 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including:
start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study
continued treatment of patients in our PBC Phase 2 clinical study
start-up activities related to our PSC Phase 2 clinical study
execution of other NDA-enabling studies
General and administrative expenses were $4.5 million in the second quarter of 2019 as compared to $3.6 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $24.0 million, or ($0.35) per diluted share in the second quarter of 2019, as compared to $17.5 million, or ($0.30) per diluted share, in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
First Half Financial Highlights & Results

Raised $107.7 million in net proceeds through our March public offering of common stock.
Research and development expenses were $39.7 million in the first half of 2019 as compared to $23.9 million in the same period of 2018. The increase was primarily driven by increases in seladelpar-related clinical trial expenses including:
start-up and enrollment activities related to our ENHANCE PBC Phase 3 clinical study
final enrollment activities and ongoing treatment of patients in our NASH Phase 2b clinical study
continued treatment of patients in our PBC Phase 2 clinical study
start-up activities related to our PSC Phase 2 clinical study
execution of other NDA-enabling studies
General and administrative expenses were $10.2 million in the first half of 2019 as compared to $6.9 million in the same period of 2018. The increase was driven primarily by higher employee compensation and other administrative expenses as we hired additional personnel to support our expanding operations.
Net loss was $47.1 million, or ($0.72) per diluted share in the first quarter of 2019, as compared to $34.5 million, or ($0.61) per diluted share, in the same period of 2018. Net loss was higher primarily due to increased research and development expenses.
Conference Call Details

CymaBay management will host a conference call today at 4:30 p.m. ET to discuss second quarter 2019 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# 13692706. 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 7, 2019 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported second quarter 2019 financial results (Press release, CytomX Therapeutics, AUG 7, 2019, View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2019-financial" target="_blank" title="View Source/news-releases/news-release-details/cytomx-therapeutics-announces-second-quarter-2019-financial" rel="nofollow">View Source [SID1234538301]).

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As of June 30, 2019, CytomX had cash, cash equivalents and short-term investments of $349.1 million.

"CytomX continues to make progress across its pipeline. Highlights of the second quarter included additional presentations of clinical data for our lead, wholly owned assets, CX-072 and CX-2009, which further demonstrated the potential of these two novel anti-cancer agents," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our clinical work to date with our lead programs provides validation for our unique approach to targeting antibody therapies to the tumor microenvironment and, accordingly, the discovery and development of new and differentiated treatments for cancer patients."

Business Highlights and Recent Developments

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

CX-072 is a wholly owned Probody therapeutic targeting PD-L1, a clinically and commercially validated anti-cancer target.
CytomX presented updated clinical data from monotherapy expansion cohorts (Part D) of the PROCLAIM-CX-072 Phase 1/2 study, evaluating the safety and efficacy of CX-072 in multiple tumor types at 10 mg/kg at the 2019 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated a favorable safety profile and evidence of anti-cancer activity in certain patients with triple negative breast cancer, anal squamous cell carcinoma, cutaneous squamous cell carcinoma and undifferentiated pleomorphic sarcoma.
David Page, M.D., Medical Oncologist, Providence Cancer Center presented clinical data from PROCLAIM-CX-072 monotherapy and in combination with ipilimumab (YERVOY) as part of a Poster Discussion Session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a wholly owned, first in class Probody drug conjugate (PDC) targeting CD166, a novel antigen that is broadly and highly expressed in many types of cancer.
CytomX reported preliminary data from the dose-escalation phase (Part A and A2) of the ongoing PROCLAIM-CX-2009 Phase 1/2 study, evaluating the safety and antitumor activity of CX-2009 in seven selected tumor types, at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CX-2009 was generally well tolerated. Single agent anti-cancer activity was observed in certain patients with breast cancer, ovarian cancer and head and neck cancer.
CX-2029 (CD71 Probody Drug Conjugate) Clinical Program

CX-2029 is a first in class PDC targeting CD71, the Transferrin Receptor, a highly efficient cellular mechanism for the internalization of antibody drug conjugates in preclinical models.
CD71 is widely expressed on normal tissues and therefore is considered to be an undruggable clinical target for conventional antibody drug conjugate technology.
CytomX discovered and is developing CX-2029 in collaboration with AbbVie to potentially turn CD71 into a druggable target.
CytomX continues to enroll patients in the PROCLAIM-CX-2029 Phase 1/2 study evaluating CX-2029 as monotherapy in patients with solid tumors or lymphomas.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical Program

Bristol-Myers Squibb (BMS) continues enrollment in a Phase 1/2 dose escalation clinical study evaluating BMS-986249 alone and in combination with OPDIVO (nivolumab) in solid tumors that are advanced and have spread.
BMS is preparing to initiate the Phase 2 portion of this clinical trial, upon which CytomX is entitled to a $10 million milestone payment.
AbbVie Second Target Selection Under Strategic Oncology Collaboration

In July 2019, CytomX announced its partner AbbVie selected a second target under the companies’ 2016 Discovery Collaboration and Licensing Agreement to discover and develop Probody drug conjugates. The target selection triggered a $10 million payment to CytomX.
Second Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $349.1 million as of June 30, 2019, compared to $436.1 million as of December 31, 2018. The decrease of $87.0 million for the six months ended June 30, 2019 included certain infrequent payments such as $5.0 million for the acquisition from an Astellas subsidiary of technical know-how related to drug conjugate linker-toxin and CD3-based bispecific antibody technology in the first quarter, a $13.7 million federal tax payment for the 2018 tax return filing in the second quarter and approximately $4.7 million related to the UCSB license agreement, also in the second quarter.

Revenue was $9.0 million for the three months ended June 30, 2019, compared to $21.3 million for the three months ended June 30, 2018. The decrease in revenue of $12.3 million for the three months ended June 30, 2019 compared to the corresponding period in 2018 was primarily due to the $21.0 million milestone payment (net of the associated sublicense fee of $4.0 million) earned in May 2018 under the CD71 Agreement with AbbVie, of which $9.9 million was recognized in the second quarter of 2018 reflecting the percentage completed-to-date of the project related to this milestone.

Research and development expenses increased $5.3 million during the three months ended June 30, 2019 compared to the corresponding period in 2018. The increase was attributable to $3.4 million in license fees and maintenance fees related to an amendment to the UCSB Licensing Agreement (which included the issuance of 150,000 shares of Company common stock valued at $1.6 million, an upfront payment of $1.0 million and an additional annual maintenance fee of $0.8 million), an increase of $0.8 million sublicense expense pertaining to the $10.0 million milestone payment earned upon the AbbVie selection of the second target in the second quarter of 2019 under the Amended and Restated Discovery Collaboration and License Agreement, an increase of $2.4 million in personnel-related expenses due to an increase in headcount, an increase of $0.5 million in clinical related expenses resulting from increased clinical trial activities and an increase of $0.7 million in the allocation of information technology and facilities related expenses resulting from an increase in headcount, partially offset by a decrease of $2.3 million in laboratory contracts and services as a result of timing of manufacturing activities.

General and administrative expenses increased by $0.4 million during the three months ended June 30, 2019 compared to the corresponding period in 2018. The increase was attributable to an increase of $1.0 million in personnel-related expenses due to an increase in headcount, an increase of $0.3 million for dues and subscriptions primarily related to software and other IT services and an increase of $0.2 million in professional service expenses, partially offset by a decrease of $0.5 million in consulting and contract services and a decrease of $0.7 million through increased expense allocation of information technology and facilities-related expenses to research and development due to an increase in research and development headcount.

Teleconference Scheduled Today at 5:00 p.m. ET
Conference Call/Webcast Information

CytomX management will host a conference call today at 5:00 p.m. ET. Interested parties may access the live audio webcast of the teleconference through the "Investor & News" section of CytomX’s website at View Source or by dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International) and using the passcode 7785617. An archive of the webcast will be available on the CytomX website from August 7, 2019, until August 21, 2019.