On May 9, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the first quarter ended March 31, 2019 (Press release, Checkpoint Therapeutics, MAY 9, 2019, View Source [SID1234536065]).

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!

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to make substantial progress with our lead clinical programs, both of which have recently produced data demonstrating unequivocal activity in patients with multiple forms of cancer, including lung cancer and skin cancer. We presented data late last year in an oral presentation at the World Conference on Lung Cancer demonstrating that CK-101, our novel, oral, third-generation EGFR inhibitor, was active in patients with treatment-naïve and relapsed/refractory EGFR mutation-positive lung cancer. EGFR mutation-positive lung cancer represents approximately 20% of the 228,000 newly-diagnosed lung cancer patients in the US, and there is currently only one third-generation EGFR inhibitor approved for these patients. Our plan is to commence a phase 3 trial in first-line EGFR mutation-positive non-small cell lung cancer later this year."

Mr. Oliviero continued, "We are also excited by our progress with our anti-PD-L1 program. We announced earlier this year that we advanced cosibelimab ("cosi", formerly CK-301), our high affinity, fully-human anti-PD-L1 antibody, into potentially pivotal cohorts in several solid tumor indications. This was supported by the positive interim clinical results we announced earlier this month showing anti-tumor activity across multiple advanced cancers. We believe the early data for cosi are very exciting and may show differentiation from other drugs in this class as a result of cosi’s dual mechanism of action through the engagement of both T-cells and NK cells."

Financial Results:

Cash Position: As of March 31, 2019, Checkpoint’s cash and cash equivalents totaled $14.1 million. The Company believes its cash and cash equivalents and projected licensing revenue will be sufficient to fund its anticipated operating cash requirements for at least 12 months.
R&D Expenses: Research and development expenses for the first quarter of 2019 were $4.6 million, compared to $6.9 million for the first quarter of 2018, a decrease of $2.3 million. Research and development expenses for the first quarter of 2019 included $0.2 million of non-cash stock expenses, compared to $0.7 million for the first quarter of 2018. The Company expects research and development expenses throughout the rest of 2019 to continue to remain lower than the comparable periods in 2018.
G&A Expenses: General and administrative expenses for the first quarter of 2019 were $1.7 million, compared to $2.2 million for the first quarter of 2018, a decrease of $0.5 million. General and administrative expenses for the first quarter of 2019 included $0.6 million of non-cash stock expenses, compared to $1.1 million for the first quarter of 2018.
Net Loss: Net loss attributable to common stockholders for the first quarter of 2019 was $5.9 million, or $0.18 per share, compared to a net loss of $8.8 million, or $0.35 per share, for the first quarter of 2018. The net loss for the first quarter of 2019 included $0.8 million of non-cash stock expenses, compared to $1.8 million for the first quarter of 2018.
Recent Corporate Highlights:

In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody cosibelimab was expanded to enroll patients in three endometrial and colorectal cohorts intended to support potential requests for accelerated approval and Biologics License Application ("BLA") submissions to the U.S. Food and Drug Administration ("FDA"). The ongoing trial is also enrolling cohorts of patients with non-small cell lung cancer ("NSCLC") and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.
In May 2019, Checkpoint announced positive interim safety and efficacy data from its ongoing multicenter Phase 1 clinical trial of cosibelimab. Cosibelimab is a high affinity, fully-human IgG1 monoclonal antibody that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab is potentially differentiated from currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% tumor target occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types. Cosibelimab appeared to be safe and well-tolerated with no dose-limiting toxicities. Objective responses and target lesion reductions were observed across diverse tumor types, particularly in NSCLC and cutaneous squamous cell carcinoma.

On May 9, 2019 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2019, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, MAY 9, 2019, View Source [SID1234536081]).

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!

Product Development Updates

Phase 2/3 CARDINAL Trial of Bardoxolone in Alport Syndrome

Enrollment in the pivotal Phase 3 portion of the CARDINAL trial of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) caused by Alport syndrome is complete at 157 patients. Alport syndrome is a rare and serious hereditary disease that affects approximately 30,000 to 60,000 patients in the United States. There are no approved therapies for Alport syndrome anywhere in the world. We expect to have one-year top-line results available in the second half of 2019.

Phase 2 PHOENIX Trial of Bardoxolone in Rare Forms of Chronic Kidney Disease

In the first quarter of 2019, we announced final data from the cohort of patients with focal segmental glomerulosclerosis (FSGS) from the Phase 2 PHOENIX study of bardoxolone in rare forms of CKD, as well as aggregate data across all four cohorts of PHOENIX. PHOENIX was an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of bardoxolone in 103 patients, including 31 patients with autosomal dominant polycystic kidney disease (ADPKD), 26 with IgA nephropathy, 28 with CKD caused by type 1 diabetes, and 18 with FSGS. Patients were treated with bardoxolone for 12 weeks, and each cohort showed statistically significant increases in mean estimated glomerular filtration rate (eGFR) at Week 12. The mean change in eGFR from baseline across all four cohorts was 7.8 mL/min/1.73 m2 (n=103; p<0.00001). Of the patients that reached Week 12, 88% experienced increases in eGFR. Bardoxolone significantly reduced mean systolic blood pressure by 3.8 mmHg (n=103; p=0.002) and mean diastolic blood pressure by 2.8 mmHg (n=103; p=0.0009). Urinary albumin excretion was low upon study entry and remained unchanged by bardoxolone treatment (n=103; p=0.6). No severe adverse events were reported related to bardoxolone treatment.

Phase 3 FALCON Trial of Bardoxolone in Autosomal Dominant Polycystic Kidney Disease

Based on the results from the ADPKD cohort of PHOENIX, we announced in January of 2019 that we will initiate a registrational Phase 3 trial called FALCON in patients with ADPKD. ADPKD is the most common single-gene disorder of the kidneys, and there are an estimated 400,000 patients in the United States, with approximately 140,000 diagnosed. The only therapy currently approved for the treatment of ADPKD is tolvaptan, which was approved in the United States in 2018.

FALCON is an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone in approximately 300 patients with ADPKD randomized one-to-one to active drug or placebo. The primary efficacy endpoint is the retained eGFR benefit, defined as the change from baseline in eGFR compared to placebo after 48 weeks of treatment and a four-week drug withdrawal period. Based upon guidance from the FDA, the 52-week retained eGFR benefit data may support accelerated approval under subpart H. After Week 52, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year. The second-year retained eGFR benefit will be measured at Week 104 after withdrawal of drug for four weeks. Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval. We plan to enroll the first ADPKD patient in FALCON in May 2019.

Pivotal MOXIe Trial of Omaveloxolone in Friedreich’s Ataxia

We are conducting the pivotal part 2 of the MOXIe Phase 2 trial of omaveloxolone in Friedreich’s ataxia, an inherited, debilitating, and degenerative neuromuscular disorder. Enrollment in part 2 of the MOXIe trial is complete at 103 patients, and top-line data are expected in the second half of 2019.

Phase 3 CATALYST Trial of Bardoxolone in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension

We are conducting the pivotal Phase 3 CATALYST trial of bardoxolone in patients with pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH), an often fatal manifestation of many types of autoimmune disease, including systemic sclerosis (scleroderma) and systemic lupus erythematosus. The trial will enroll approximately 200 patients, with top-line data expected in the first half of 2020.

Selected Clinical Milestones in 2019

Initiation of pivotal FALCON trial in ADPKD in May 2019
Pivotal CARDINAL data in the second half of 2019
Pivotal MOXIe data in the second half of 2019
First Quarter Results

The Company incurred total expenses of $36.3 million for the quarter ended March 31, 2019, with research and development accounting for $26.1 million. This compares to total expenses of $28.1 million for the same period of the year prior, when research and development accounted for $21.4 million. We reported a net loss of $29.2 million or $0.98 per share for the quarter ended March 31, 2019. This compares to net income of $4.1 million or $0.16 per share in the same period of the year prior.

The net loss for the three-month period compared to the prior year is primarily driven by both an increase in expenses and a decrease in revenue. Higher expenses were driven by an increase in research and development expenses due to clinical and manufacturing activities and an increase in personnel expenses to support expanded development activities. Revenue to date has primarily been related to license and collaboration agreements entered into during 2009, 2010, and 2011. The decrease in revenue was primarily due to an increase in revenue in the first quarter of 2018 from the portion of a $30 million milestone from KHK that related to the period of time from execution of the KHK agreement until the three months ended March 31, 2018. There was no such catch-up revenue recognition in the first quarter of 2019.

Our cash-based operating expenses, a non-GAAP measure, were $31.9 million for the three months ended March 31, 2019. This compares to $25.6 million for the same period in 2018. We expect our cash-based operating expenses to continue to increase in the future as we advance bardoxolone and omaveloxolone through ongoing and future clinical trials, scale manufacturing for registrational and validation purposes, advance other product candidates into mid- and later-stage clinical trials, expand our product candidate portfolio, increase both our research and development and administrative personnel, and plan for commercialization of our product candidates.

At March 31, 2019, we had $313.1 million in cash and cash equivalents. We expect our current cash to fund our operations through data readouts for CARDINAL, MOXIe, and CATALYST.

Non-GAAP Financial Measures

In addition to the U.S. generally accepted accounting principles (GAAP) financial highlights, this earnings release includes cash-based operating expenses, a non-GAAP financial measure, which the Company defines as total expenses excluding stock-based compensation expense and depreciation expense. A reconciliation of this non-GAAP financial measure to its most directly comparable GAAP financial measure is presented in the table below in this earnings release.

We believe that this non-GAAP financial measure, in addition to GAAP financial measures, provides a meaningful measure of our ongoing business and operating performance by allowing investors to analyze our financial results similarly to how management analyzes our financial results by viewing period expense totals more indicative of effort directly expended to advance the business and our product candidates. Non-GAAP financial measures should be considered in addition to, not in isolation or as a substitute for, GAAP financial measures. In addition, our non-GAAP financial measure may differ from similarly named measures used by other companies.

CONFERENCE CALL INFORMATION

Date: Thursday, May 9, 2019
Time: 8:00 a.m. ET
Audience Dial-in (toll-free): 844-348-3946
Audience Dial-in (international): 213-358-0892
Conference ID: 5177169
Webcast Link: View Source

On May 9, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company, developing and commercializing novel antibiotics to treat serious bacterial infections, reported financial results and provided a business update for the first quarter ended March 31, 2019 (Press release, Cempra, MAY 9, 2019, View Source [SID1234536131]).

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!

"During the first quarter of 2019, we continued to execute against a number of strategic initiatives to help streamline operations and strengthen Melinta’s balance sheet, while continuing to advance our commercial plans and sales efforts," said John H. Johnson, chief executive officer of Melinta. "We also recently filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia (CABP). We believe that the potential market opportunity for CABP is substantial and that, if approved, Baxdela may play a significant role in the treatment of this life-threatening illness. We remain confident in the strength of our long-term strategy to position Melinta for future success as the largest branded antibiotics-focused company and are committed to meeting the growing global threat of antibiotic resistance."

"We are pleased with our swift execution of cost-cutting initiatives during the first quarter of 2019, which significantly drove down our operating expenses both on a year-over-year and quarter-over-quarter basis," said Peter Milligan, chief financial officer of Melinta. "We believe that we have the ability to sustain this disciplined approach to stewardship of financial resources, which is critical for long-term shareholder value."

First Quarter 2019 Financial Results
Melinta reported revenue of $14.1 million for the first quarter of 2019. Revenue from product sales was $11.8 million, flat with the first quarter of 2018. Strong performance by Vabomere (meropenem and vaborbactam) and Minocin (minocycline) for Injection were offset by softer sales of Baxdela and Orbactiv (oritavancin).

Cost of goods sold ("COGS") was $7.4 million and $7.7 million, respectively, for the first quarter of 2019 and the first quarter of 2018, of which $4.1 million and $4.7 million was comprised of non-cash amortization of intangible assets.
Research and development ("R&D") expenses were $5.4 million for the first quarter of 2019, compared to $16.1 million for the same period in 2018. R&D expenses decreased primarily as a result of the completion of the Company’s Phase III study for Baxdela in CABP as well as winding down its early research and discovery programs, which was completed at the end of March 2019. Selling, general and administrative ("SG&A") expenses were $25.9 million for the first quarter of 2019, compared to $34.6 million for the same period in 2018. SG&A expenses decreased primarily as a result of the cost-cutting measures the Company initiated in the fourth quarter of 2018.
Net loss was $26.5 million, or $2.34 per share, for the first quarter of 2019, compared to a net loss of $29.4 million, or $4.76 per share, for the first quarter of 2018. Net loss per share year-over-year reflects changes in share count as a result of the one-for-five reverse stock split effective on February 22, 2019.

The Company ended the quarter with $116.9 million of cash and cash equivalents, which included the $75 million disbursement under the convertible loan facility with Vatera in February 2019.

2019 Guidance
In light of the first quarter results, and to provide the Company with additional time to evaluate the impact of its new strategic commercial initiatives, the Company will update 2019 financial guidance as part of its second quarter 2019 earnings communications. Previous revenue guidance should no longer be relied upon.

Portfolio Updates

sNDA submission to FDA for Baxdela for treatment of CABP in adult patients in April 2019; awaiting official acceptance and PDUFA date from the FDA

Clinical study for a new formulation of Orbactiv scheduled to commence in the second half of 2019, targeted to reduce infusion time from three hours to one hour

Presentation of portfolio data, including results from real-world registry studies of Vabomere, Orbactiv and Minocin for Injection at the Making a Difference in Infectious Diseases (MAD-ID) 2019 Annual Meeting held from May 8-11, 2019 in Orlando, Florida

Business Highlights

Recent execution of several new strategic commercial initiatives, including the engagement of a contract sales organization to sell Baxdela in the retail setting

Implementation of operating cost-reduction initiatives, delivering significant cost savings in 2019

Upcoming Potential Catalysts

European Commission approval decision for delafloxacin (to be marketed under the brand name Quofenix) for acute bacterial skin and skin structure infections (ABSSSI)

Country approvals for Baxdela in South America and Central America

Latin America commercialization agreement execution for Vabomere, Orbactiv and Minocin for Injection

FDA approval for Baxdela for the treatment of CABP in adults

Conference Call and Webcast
Melinta’s earnings conference call for the first quarter of 2019 will be broadcast at 4:30 p.m. ET on May 9, 2019. Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151, using the conference ID# 5233509. A live webcast of the call will be available online from the Investor Relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 5233509.

On May 9, 2019 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the closure of an asset purchase and license agreement with ImmunGene, Inc., a privately held biotechnology company (Press release, Spectrum Pharmaceuticals, MAY 9, 2019, View Source [SID1234536008]). The deal includes an exclusive license for the intellectual property related to the FIT antibody-interferon fusion technology drug delivery platform originally developed by scientists at UCLA.

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!

The license also includes two novel assets derived from this platform. The first asset is an antibody-interferon fusion molecule directed against CD20 (Anti–CD20-IFNα). This drug candidate is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients where a considerable unmet medical need exists. Research for this program received financial support through the Therapy Acceleration Program of The Leukemia & Lymphoma Society, Inc. (LLS), and an LLS research grant to UCLA. The second asset is an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies. It has the potential for treating both solid and hematologic malignancies.

"The FIT platform that we’ve acquired today represents a new class of biotherapeutics which may have the potential to make the administration of an antibody-interferon fusion protein feasible and allows Spectrum to harness this powerful immune activating cytokine," said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. "In pre-clinical models, anti–CD20-IFNα has been shown to have significant proapoptotic activity. Anti–CD20-IFNα is essentially a 2-pronged attack whereby both CD20 and IFNAR signaling pathways can be activated to induce tumor cell apoptosis. Although IFNα has potent biologic activities against B-cell malignancies, its clinical utility has been curtailed by systemic toxicities. Preclinical results suggest that anti–CD20-IFNα fusion proteins have an improved therapeutic index, while still exhibiting the ability to eradicate tumor cells."

Originally developed by scientists at UCLA and licensed to Spectrum by UCLA Technology Development Group, the FIT platform fuses interferon with various monoclonal antibodies targeting various tumor antigens. Interferons are highly potent and well-established anticancer cytokines but have been associated with significant dose-related side effects. The FIT technology may be able to maintain the potency and efficacy of interferon while reducing toxicity traditionally associated with interferon therapy. FIT therapies have potential application as single agents or in combination with other therapies, such as checkpoint inhibitors.

"Adding a promising platform and two early stage assets is consistent with our commitment to serving the needs of cancer patients by developing innovative drugs for unmet need," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We are aggressively building a robust oncology pipeline anchored by our late-stage assets, poziotinib and ROLONTIS."

Under the terms of the agreement, Spectrum will pay an upfront cash payment of approximately $3 million, up to $156 million in development and sales milestones, and royalties on net sales in the high-single digits.

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]).

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!

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).