1stOncology™: Cancer Intelligence Service – Page 14383 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BeiGene Reports First Quarter 2019 Financial Results

On May 9, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights, anticipated upcoming milestones and financial results for the first quarter of 2019 (Press release, BeiGene, MAY 9, 2019, View Source [SID1234536052]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We made good progress in each of our business areas, including strong commercial performance in the first quarter of 2019, as we prepare for our planned launches in China and first new drug application in the United States. Our team is continuing to expand across the globe, with new trials, new indications, and importantly, new hope for patients with cancer who may not have had access or options for treating their disease," said John V. Oyler, Co-Founder, Chief Executive Officer, and Chairman of BeiGene.
Recent Business Highlights and Upcoming Milestones
Clinical Programs
Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects
Expected Milestones in 2019

Receive approvals in China for the treatment of patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL);

Submit an initial New Drug Application (NDA) for zanubrutinib in the U.S. in 2019 or early 2020;

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with Waldenström macroglobulinemia (WM) and submit an NDA in China for WM;

Achieve first patient dosing in a Phase 1b trial conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;

Complete enrollment of the Phase 3 trial of zanubrutinib compared to bendamustine plus rituximab in patients with previously untreated CLL or SLL;

Present data from the non-randomized MYD88WT cohort of the Phase 3 trial in WM;

Announce top-line results from the randomized cohort of the Phase 3 trial comparing zanubrutinib to ibrutinib in patients with WM; and

Present updated data from the global Phase 1 trial in WM and MCL; pivotal data from the China Phase 2 trials in R/R MCL and R/R CLL/SLL; data from Phase 1 obinutuzumab combination data in CLL/SLL; updated data from the Phase 1 obinutuzumab combination trial in non-Hodgkin’s lymphoma (NHL); and updated data from the global Phase 1 trial in CLL/SLL.
Tislelizumab (BGB-A317), an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Announced Phase 1 long-term exposure data and results from the structural and mechanistic analyses at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2019; and

Initiated a Phase 3 front-line trial in China of tislelizumab combined with chemotherapy compared to placebo with chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.
Expected Milestones in 2019

Receive NDA approval in China for treatment of patients with R/R classical Hodgkin’s lymphoma (cHL);

Present preliminary results of tislelizumab in Chinese patients with nasopharyngeal cancer at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago May 31 – June 4;

Announce top-line results from the pivotal Phase 2 trial in Asian patients with urothelial carcinoma (UC) and file an NDA for UC in China;

Announce top-line results from the global Phase 2 trial in second- or third-line patients with hepatocellular carcinoma (HCC) and have regulatory discussions;

Present updated China pivotal Phase 2 data in R/R cHL; updated Phase 2 chemotherapy combination data; and Phase 1 data from China trials; and

Complete or nearly complete enrollment in all four ongoing Phase 3 trials in lung and liver cancers.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor
Expected Milestones in 2019

Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in late 2019 or early 2020; and

Present data from the global Phase 1 trial in patients with ovarian cancer and Phase 1 combination data in patients with solid tumors or glioblastoma multiforme.
Lifirafenib (BGB-283), an investigational RAF dimer inhibitor

In collaboration with SpringWorks Therapeutics, Inc., initiated a Phase 1b combination trial of lifirafenib in combination with PD-0325901, an investigational MEK inhibitor in patients with advanced or refractory solid tumors that harbor RAS mutations, RAF mutations, and other MAPK pathway aberrations.
Manufacturing Facilities

Substantially completed equipment installation and validation of GE Healthcare’s KUBioTM technology-based biologics manufacturing facility in Guangzhou, China.
Commercial Operations

Generated $57.42 million in product revenue in the three months ended March 31, 2019, from sales in China of ABRAXANE, REVLIMID and VIDAZA, which represents a 147% increase compared to the same period in 2018 and a 52% sequential growth compared to the previous quarter; and

Received supplementary medical insurance coverage for REVLIMID from Zhuhai, Guangdong province, China.
Corporate Developments

Announced a global collaboration agreement with BioAtla, LLC, for the development, manufacturing, and commercialization of BioAtla’s investigational Conditionally Active Biologic (CAB) CTLA-4 antibody (BA3071). BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors. Subject to regulatory clearance of the Investigational New Drug (IND) application, a Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3071 alone and in combination with tislelizumab is anticipated to start in the second half of 2019; and

Announced a global research and development collaboration with Ambrx, Inc. to develop next-generation biologics utilizing Ambrx’s proprietary Expanded Genetic Code technology platforms designed to allow the efficient incorporation of non-natural amino acids into proteins in both E. Coli (ReCODETM) and CHO cells (EuCODETM) for precision protein engineering.
First Quarter 2019 Financial Results
Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $1.64 billion as of March 31, 2019, compared to $1.81 billion as of December 31, 2018.

The decrease of $171.67 million in the first quarter of 2019 was primarily due to $171.98 million of cash used in operating activities, $29.00 million of upfront payments made under collaboration agreements, and $21.83 million for investments in property, plant and equipment primarily attributable to the build-out of the Guangzhou biologic

manufacturing facility. The decrease was partially offset by $36.70 million in proceeds from an additional drawdown under our Guangzhou factory loan.
Revenue for the first quarter ended March 31, 2019 was $77.83 million, compared to $32.54 million in the same period in 2018. The increase is attributable to increased product revenue in China and collaboration revenue under our license and collaboration agreements with Celgene.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $57.42 million for the first quarter ended March 31, 2019, compared to $23.25 million for the same period in 2018.

Collaboration revenue totaled $20.41 million for the first quarter ended March 31, 2019, compared to $9.29 million for the same period in 2018.
Expenses for the first quarter ended March 31, 2019 were $251.59 million, compared to $143.35 million in the same period in 2018.

Cost of Sales for the first quarter ended March 31, 2019 were $15.26 million, compared to $4.55 million in the same period in 2018. Cost of sales related to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the first quarter ended March 31, 2019 were $178.35 million, compared to $109.70 million in the same period in 2018. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, and manufacturing costs related to pre-commercial activities and supply. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was $15.77 million for the first quarter ended March 31, 2019, compared to $12.05 million for the same period in 2018, due to increased headcount.

SG&A Expenses for the first quarter ended March 31, 2019 were $57.65 million, compared to $28.92 million in the same period in 2018. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was $10.62 million for the first quarter ended March 31, 2019, compared to $5.34 million for the same period in 2018, due to increased headcount.

Net Loss for the first quarter ended March 31, 2019 was $167.64 million, or $0.22 per share, or $2.81 per American Depositary Share (ADS), compared to $104.60 million, or $0.16 per share, or $2.03 per ADS in the same period in 2018.

Surface Oncology Reports Financial Results and Corporate Highlights for First Quarter 2019

On May 9, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the first quarter of 2019 (Press release, Surface Oncology, MAY 9, 2019, View Source [SID1234536051]).

"2019 is an important execution year for Surface and we are off to a fantastic start. During the first quarter, we continued to make strong progress on a number of fronts, including the expansion of both our executive team and scientific advisory board, as well as the advancement of our next wave of product programs, SRF617 and SRF388, towards initial clinical trials," said Jeff Goater, chief executive officer.

Recent Corporate Highlights:

Addition of F. Steven Hodi, M.D., Dana Farber Cancer Institute, to our Scientific Advisory Board. Dr. Hodi is a clinical pioneer in the field of cancer immunotherapy and his groundbreaking work in melanoma with checkpoint inhibitors led to the first wave of cancer immunotherapy drug approvals.

Appointment of Wendy Dwyer as chief business officer. Ms. Dwyer brings over 20 years of transactional experience, including prior business development leadership roles at AstraZeneca, Ipsen Biosciences and Endo Pharmaceuticals.

The Novartis-sponsored phase 1 trial of NZV930 (CD73) continues to progress, now enrolling patients in seven countries.

IND filings for both SRF617 (CD39) and SRF388 (IL-27) remain on track for Q4 of 2019.

Surface Oncology scientists co-authored the paper, "IL-27 and TCR Stimulation Promote T Cell Expression of Multiple Inhibitory Receptors," which was published in ImmunoHorizons.
Financial Results:

As of March 31, 2019, cash, cash equivalents and marketable securities were $140.2 million, compared to $158.8 million on December 31, 2018.

Research and development (R&D) expenses were $14.3 million for the first quarter ended March 31, 2019, compared to $11.1 million for the same period in 2018. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.6 million in stock-based compensation expense for the first quarter of 2019.

General and administrative (G&A) expenses were $5.1 million for the first quarter ended March 31, 2019, compared to $3.4 million for the same period in 2018. The increase in G&A expenses is primarily due to increased personnel costs and professional fees associated with the growth of the company and operating as a public company. G&A expenses included $0.8 million in stock-based compensation expense for the first quarter of 2019.

For the first quarter ended March 31, 2019, net loss was $4.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.15. Net income was $31.2 million for the same period in 2018 or diluted net income per share attributable to common stockholders of $1.05. Income from the first quarter of 2018 was driven by milestones from our partnership with Novartis.

Financial Outlook:

Based upon its current operating plan, Surface continues to have a projected cash runway through 2021.

Puma Biotechnology Reports First Quarter 2019 Financial Results

On May 9, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2019 (Press release, Puma Biotechnology, MAY 9, 2019, View Source [SID1234536050]). Unless otherwise stated, all comparisons are for the first quarter 2019 compared to the first quarter of 2018.

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the first quarter of 2019 was $45.6 million, compared to net NERLYNX revenue of $36.0 million in the first quarter of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $10.1 million, or $0.26 per share, for the first quarter of 2019, compared to a net loss of $24.3 million, or $0.65 per share, for the first quarter of 2018.

Non-GAAP adjusted net income was $8.1 million, or $0.21 per basic share and $0.20 per diluted share, for the first quarter of 2019, compared to non-GAAP adjusted net income of $1.1 million, or $0.03 per basic share and $0.02 per diluted share, for the first quarter of 2018. Non-GAAP adjusted net income excludes stock-based compensation expense, which represents a significant portion of overall expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income and GAAP net loss per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2019 was $16.1 million, compared to $6.3 million in the first quarter of 2018. At March 31, 2019, Puma had cash and cash equivalents of $48.8 million and marketable securities of $101.6 million, compared to cash and cash equivalents of $108.4 million and marketable securities of $57.0 million at December 31, 2018. Puma’s cash and cash equivalents at March 31, 2019 did not include a $60.0 million upfront license payment that was received in April 2019. At March 31, 2019, the $60.0 million upfront license payment was recorded in accounts receivable.

"Puma experienced lower than expected net product revenue in the first quarter of 2019," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "This reduction in net revenues was the result of an increase in expenses charged against gross revenue for the quarter. Additionally, net product revenue declined in the quarter as a result of an increase in patients discontinuing treatment with NERLYNX."

Mr. Auerbach added, "During 2019, we anticipate the following key milestones for Puma: (i) presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; (ii) filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; (iii) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; (iv) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019; (v) reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and (vi) reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and license revenue. For the first quarter ended March 31, 2019, total revenue was $99.1 million, of which $45.6 million was net NERLYNX revenue and $53.5 million was license revenue received from Puma’s sub-licensees. This compares to total revenue of $66.5 million in the first quarter of 2018, of which $36.0 million was net NERLYNX revenue and $30.5 million was license revenue.

Operating Costs and Expenses

Total operating costs and expenses were $89.2 million for the first quarter of 2019, compared to $89.9 million for the first quarter of 2018.

Cost of Sales:

Cost of sales was $8.0 million for the first quarter of 2019, compared to $6.4 million for the first quarter of 2018.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $45.5 million for the first quarter of 2019, compared to $36.6 million for the first quarter of 2018. The $8.9 million increase resulted primarily from increases of approximately $6.8 million for professional fees such as legal fees and marketing and commercial support, approximately $0.9 million related to employee stock-based compensation expense, approximately $0.7 million in payroll and payroll related expenses, and approximately $0.4 million in travel and meeting-related expenses.

Research and Development Expenses:

Research and development (R&D) expenses were $35.7 million for the first quarter of 2019, compared to $46.9 million for the first quarter of 2018. The $11.2 million decrease resulted primarily from decreases of approximately $8.1 million of stock-based compensation, $2.1 million in internal R&D primarily related to payroll and payroll related expenses, $1.5 million in clinical trial expenses primarily due to external clinical service, external manufacturing, testing and logistics, partially offset by increases in CRO-related expenses, grant expenditures and comparator drug expenses.

Total Other Income (Expenses)

Total other expenses were $20.0 million for the first quarter of 2019, compared to total other expenses of $0.9 million for the first quarter of 2018. Other expense recorded in the first quarter of 2019 includes $16.4 million related to a March 2019 jury verdict against Puma in a defamation lawsuit, Eshelman v. Puma Biotechnology, Inc., et al., and represents $22.4 million in damages awarded to the plaintiff, net of a $6.0 million anticipated insurance receivable. Puma intends to appeal the verdict and has filed a motion for a new trial or, in the alternative, a reduced damages award. The plaintiff has also filed motions seeking attorneys’ fees and pre-judgment interest. The total amount of damages to be paid by Puma remains subject to the exhaustion of post-trial motions and appeals.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 9, 2019. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

Heron Therapeutics Announces Financial Results for the Three Months Ended March 31, 2019 and Highlights Recent Corporate Progress

On May 9, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three months ended March 31, 2019 and highlighted recent corporate progress (Press release, Heron Therapeutics, MAY 9, 2019, View Source [SID1234536048]).

Recent Corporate Progress

Pain Management Franchise

Complete Response Letter Received from the FDA Regarding the NDA for HTX-011: A Complete Response Letter (CRL) was received from the U.S. Food and Drug Administration (FDA) on April 30, 2019 regarding the Company’s New Drug Application (NDA) for HTX-011 for postoperative pain management. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional Chemistry, Manufacturing and Controls (CMC) and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.

European Medicines Agency Validation of Marketing Authorisation Application for HTX-011 for Postoperative Pain Management: In April of 2019, Heron announced that the Marketing Authorisation Application (MAA) for its investigational agent, HTX-011, for postoperative pain management, was validated by the European Medicines Agency (EMA). The EMA granted eligibility to the Centralised Procedure for HTX-011 based on it meeting the criteria of a medicinal product constituting a significant scientific innovation. The Centralised Procedure allows applicants to receive a marketing authorisation that is valid throughout the European Union (EU). With the validation of the MAA, an opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) is anticipated in the first half of 2020.

77% of Patients Treated with HTX-011 Remain Opioid-Free 72 Hours Post-Surgery in Multi-center Clinical Study in Bunionectomy: In March of 2019, we reported positive topline results of a multi-center postoperative pain management study in which 31 patients undergoing bunionectomy surgery received HTX-011 together with a regimen of generic, over-the-counter, oral analgesics (acetaminophen and ibuprofen). Seventy-seven percent (77%) of patients were opioid-free 72 hours post-surgery, and 100% of these patients remained opioid-free 28 days post-surgery. Patients mean pain scores stayed in the mild range through 72 hours.

90% of Patients Treated with HTX-011 Remain Opioid-Free 72 Hours Post-Surgery in Multi-center Clinical Study in Hernia Repair: In January of 2019, we reported positive topline results of a multi-center postoperative pain management study in which 63 patients undergoing hernia repair surgery received HTX-011 together with a regimen of generic, over-the-counter, oral analgesics (acetaminophen and ibuprofen). Ninety percent (90%) of patients were opioid-free 72 hours post-surgery, and 81% were still opioid-free 28 days post-surgery.
CINV Franchise

FDA Approval of sNDA to Expand CINVANTI Label for IV Push: In February of 2019, the FDA approved Heron’s supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion, for intravenous (IV) use. The sNDA requested FDA approval to expand the administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.

First Quarter 2019 Net Product Sales: First-quarter 2019 net product sales for the chemotherapy-induced nausea and vomiting (CINV) franchise were $31.6 million, up 173% and 10% from the first and fourth quarters of 2018, respectively. This included net product sales of $28.0 million for CINVANTI injectable emulsion and $3.6 million for SUSTOL (granisetron) extended-release injection. Heron reaffirms full-year 2019 net product sales guidance for the CINV franchise of $115 million to $120 million.
"We are focused on resubmitting the NDA for HTX-011 as soon as possible to bring this important medicine to market to help patients manage their postoperative pain without the need for opioids," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "Our CINV franchise remains strong, highlighted by our strong net product sales in the first quarter and our label expansion for CINVANTI for IV push."

Financial Results

Net product sales for the three months ended March 31, 2019 were $31.6 million compared to $11.6 million for the same period in 2018.

Heron’s net loss for the three months ended March 31, 2019 was $63.0 million, or $0.80 per share, compared to $52.3 million, or $0.81 per share for the same period in 2018. Net loss for the three months ended March 31, 2019 included non-cash, stock-based compensation expense of $17.9 million compared to $7.7 million for the same period in 2018.

As of March 31, 2019, Heron had cash, cash equivalents and short-term investments of $289.2 million, compared to $332.4 million as of December 31, 2018. Net cash used for operating activities for the three months ended March 31, 2019 was $49.0 million compared to $61.7 million for the same period in 2018. Heron expects to end the year with more than $190 million in cash, cash equivalents and short-term investments.

About HTX-011 for Postoperative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. By delivering sustained levels of both a potent anesthetic and a local anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five diverse surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty and breast augmentation. HTX-011 was granted Fast Track designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted an NDA to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A CRL was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to CMC and non-clinical information. No issues related to clinical efficacy or safety were noted. An MAA for HTX-011 was validated by the EMA in March 2019 for review under the Centralised Procedure.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). CINVANTI is an IV formulation of aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist (RA). CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). CINVANTI is the only IV formulation of an NK1 RA indicated for the prevention of acute and delayed nausea and vomiting associated with HEC and nausea and vomiting associated with MEC that is free of polysorbate 80 or any other synthetic surfactant. The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute infusion or a 2-minute injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0 – 24 hours after chemotherapy) and delayed phase (24 – 120 hours after chemotherapy).

Intrexon Reports First Quarter 2019 Financial Results

On May 9, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its first quarter financial results for 2019 (Press release, Intrexon, MAY 9, 2019, View Source [SID1234536047]).

Recent Business Highlights:

Intrexon announced alignment of its operations into two units, Intrexon Health and Intrexon Bioengineering, to better deploy resources, realize inherent synergies and position the company for growth with a core focus on healthcare. Intrexon Health, will be led by Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon while Intrexon Bioengineering will be led by LTG (Ret.) Thomas Bostick, PhD, PE, Chief Operating Officer of Intrexon, who will also assume the title of President, Intrexon Bioengineering; and

As Intrexon announced previously, the Company believes it will end the year with approximately the same net cash and short-term investment position that it held on April 3, 2019. The Company is making progress toward this goal through a combination of partnering, asset sales and operating cost reductions. The Company has initiated plans to reduce its original 2019 operating budget by approximately $70 million and commenced actions toward achieving this goal.

Intrexon Health

Precigen, Inc., a wholly-owned subsidiary of Intrexon, opened its new nearly 5,000 square foot facility in Germantown, Maryland to support gene therapy manufacturing. The U.S. Food and Drug Administration (FDA) good manufacturing practices (GMP) compliant facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs;

Intrexon and its majority-owned subsidiary Triple-Gene LLC (formerly Xogenex LLC) completed enrollment in the first cohort of a Phase 1 clinical trial of INXN-4001, an investigational new drug which is the world’s first triple effector gene drug candidate being evaluated for the treatment of heart failure; and

Intrexon continues advancing its proprietary yeast-based platform for robust production of cannabinoids with consistent yield and purity and with production of CBGA at 700 mg/L in stirred tank fermenter. The platform is on track to realize a target cost of goods of <$1000 USD/kg.

Intrexon Bioengineering

Intrexon entered into a strategic licensing agreement with Surterra Wellness to utilize Intrexon’s Botticelli next generation plant propagation platform to enable rapid production of Surterra’s proprietary cannabis cultivars for the Florida market;

Oxitec, Ltd., a wholly-owned subsidiary of Intrexon, signed two, multi-year development agreements with a collaborator to apply its 2nd generation, self-limiting technology to develop solutions for the soybean looper and fall armyworm, two insect pests that cause significant damage to agricultural crops globally; and

AquaBounty Technologies, Inc. (NASDAQ: AQB), an investment of Intrexon, announced the FDA lifted the Import Alert on AquAdvantage Salmon (AAS) in March. Environment and Climate Change Canada has also approved the company’s Rollo Bay production facility for the commercial manufacture and grow-out of AAS.

First Quarter 2019 Financial Highlights:

Total revenues of $23.3 million;

Net loss of $60.7 million attributable to Intrexon, or $(0.40) per basic share, including non-cash charges of $17.8 million;

Adjusted EBITDA of $(39.2) million, or $(0.26) per basic share; and

Cash, cash equivalents, and short-term investments totaled $181.6 million and the value of common equity securities totaled $1.8 million at March 31, 2019.

"Our realignment into Intrexon Health and Intrexon Bioengineering is well underway," commented Mr. Kirk. "On the healthcare side it is satisfying and exciting for all of us that we currently are dosing in clinical trials several novel therapeutic candidates of our design that incorporate our unique technology. Moreover, as we prepare to get underway with patient dosing of two Ultra-CAR-T candidates, we see the potential realization of a set of aspirations that we have held — and declared — since before our IPO and believe that these should constitute major advances in immuno-oncology. We await data with great anticipation."

Mr. Kirk concluded, "Our share price carries implications as well, so we are determined to prosecute all that we have set ourselves to accomplish in healthcare while realizing maximum value for our shareholders from our non-healthcare assets, the portfolio of Intrexon Bioengineering. These realizations may be participating or transactional in nature, but we are determined to achieve them and indeed are currently advancing several such prospects. Combined with the cost-cutting program that we have implemented, we expect our company will be a leaner, more-focused enterprise but not one lacking ambition or impact."

"Intrexon Bioengineering’s highly skilled teams are contributing their breadth of expertise across diverse fields to advance programs in food, agriculture, environmental, and industrial fields. We believe these programs offer a unique opportunity to realize the potential of engineered solutions in generating more efficient and sustainable approaches than current industry practices. Intrexon Bioengineering is focused on delivering these technologies and products with the goal of increasing shareholder value," added Dr. Bostick.

First Quarter 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $16.3 million from the quarter ended March 31, 2018. Collaboration and licensing revenues decreased $13.9 million from the quarter ended March 31, 2018 primarily due to the reacquisition of rights previously licensed to certain significant collaborators, including ZIOPHARM Oncology, Inc., and ARES Trading S.A., the result of which eliminated or substantially reduced revenues generated from those collaborations. The decline was also attributable to the mutual termination of the Company’s ECC with OvaScience, Inc., in March 2018. Product revenues decreased $2.3 million, or 32%, primarily due to lower customer demand for pregnant cows and cloned products. Gross margin on products declined in the current period as a result of fewer products sold and increased costs associated with new product offerings. Service revenues decreased $0.9 million, or 7%. The decrease in service revenues and the gross margin thereon relates to fewer embryos produced per bovine in vitro fertilization cycle performed as a result of unfavorable production results.

Research and development expenses decreased $4.2 million, or 11%. Research and development depreciation and amortization expense decreased $2.0 million primarily due to intangible assets that were impaired or abandoned in 2018. Research and development salaries, benefits and other personnel costs decreased $1.3 million primarily due to the closing of one of the Company’s research

and development facilities in Brazil in 2018. Selling, general and administrative (SG&A) expenses decreased $6.1 million, or 16%. SG&A salaries, benefits and other personnel costs decreased $4.8 million primarily due to decreased compensation expenses related to performance and retention incentives for SG&A employees as well as decreased share-based compensation expense as a result of certain 2014 stock option grants becoming fully vested in March 2018.

The Company will not host a conference call associated with this financial results release.