1stOncology™: Cancer Intelligence Service – Page 14292 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Theravance Biopharma, Inc. Reports Second Quarter 2019 Financial Results and Provides Business Update

On July 31, 2019 Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) reported financial results for the second quarter ended June 30, 2019 (Press release, Theravance, JUL 31, 2019, View Source [SID1234537974]). Revenue for the second quarter of 2019 was $26.2 million. Second quarter operating loss was $42.5 million or $31.2 million excluding share-based compensation expense. Cash, cash equivalents, and marketable securities totaled $396.1 million as of June 30, 2019.

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!

Rick E Winningham, Chief Executive Officer, commented: "2019 is a critical year of progress that sets the stage for what we believe will be an extraordinary year of data-driven, value-creating milestones in 2020.

"TD-1473, our gut-selective pan-JAK inhibitor, is moving forward in a Phase 2b/3 study in ulcerative colitis and a Phase 2 study in Crohn’s disease. Ampreloxetine, our norepinephrine reuptake inhibitor, is advancing in a Phase 3 registrational program in symptomatic nOH. New data from the Phase 2 study of ampreloxetine presented at recent scientific meetings demonstrated consistent and durable improvements in both symptom severity and daily activity performance in patients with nOH treated with ampreloxetine for 20 weeks. These data further support the potential of this therapy to provide patients with greater durability of effect. The Phase 1 study of TD-8236, our lung-selective inhaled pan-JAK inhibitor, in healthy volunteers and asthmatics is ongoing, and we anticipate results in September 2019.

"The YUPELRI U.S. launch is progressing well in partnership with Mylan and we are pleased by our progress against key performance metrics. Additionally, we were excited to announce the expansion of our development and commercialization agreement with Mylan for nebulized revefenacin to include China. Lastly, sales of GSK’s TRELEGY ELLIPTA for COPD continue to grow, supported by product approvals and launches in additional geographies. We expect GSK to submit regulatory submissions in support of an asthma indication in the second half of this year, following the completion of the Phase 3 CAPTAIN study of TRELEGY ELLIPTA in patients with asthma.

"We are well capitalized and enter the second half of the year in a strong position to continue to drive our key programs toward meaningful inflection points. We are proud of our ability to advance a rich pipeline of differentiated assets that can yield a broad line-up of important milestones and catalysts over the next 12 to 18 months as our later-stage trials mature, earlier-stage programs advance to the clinic, and our commercial efforts gain traction. We look forward to the near-term resolution of the dispute with Innoviva to ensure we retain our economics related to TRELEGY ELLIPTA," concluded Mr. Winningham.

Program Updates

TD-1473 (gut-selective pan-Janus kinase (JAK) inhibitor):

Supplemental data from the four-week exploratory Phase 1b study of TD-1473 in patients with ulcerative colitis shared in an oral presentation at Digestive Disease Week (DDW) in May 2019
Study designed to measure signals of localized biologic activity, and with little to no systemic exposure or immunosuppression
Data were positive across a variety of measures, including disease activity, including rectal bleeding and endoscopic improvement, as well as biomarker changes confirming target engagement
Registrational Phase 2b/3 induction and maintenance study in ulcerative colitis (RHEA) and Phase 2 induction study in Crohn’s disease (DIONE) progressing
Data from the Phase 2b portion of the ulcerative colitis and Phase 2 Crohn’s disease studies planned late-2020
Ampreloxetine (TD-9855, norepinephrine reuptake inhibitor (NRI)):

New 20-week data from the Phase 2 study in patients with neurogenic orthostatic hypotension (nOH) presented at the International Association of Parkinsonism and Related Disorders (IAPRD) in June 2019 and in an oral presentation at the 32nd European Neurology Congress (ENC) in July 2019
Consistent and durable improvements in both symptom severity and daily activity performance in patients with nOH were sustained through 20 weeks of ampreloxetine therapy
Following withdrawal of ampreloxetine treatment, patients’ symptom severity and daily activity scores returned to pre-treatment baseline levels
Ongoing registrational program in symptomatic nOH comprised of two studies:
Phase 3 4-week treatment study (SEQUOIA), with data expected in 2H 2020
Phase 3 4-month open label study followed by a 6-week randomized withdrawal phase (REDWOOD) to demonstrate durability of response
TD-8236 (novel, lung-selective inhaled pan-JAK inhibitor for serious respiratory diseases):

Phase 1 data expected in September 2019; study designed to evaluate safety and provide biomarker data of TD-8236 in healthy volunteers and asthmatic patients
Program goal in asthma is the prevention of exacerbations and the improvement of symptoms in patients uncontrolled by steroids despite compliance
TD-8236 shown to potently inhibit targeted mediators of Th2-high and Th2-low asthma in human cells in preclinical studies
YUPELRI (revefenacin) inhalation solution (lung-selective nebulized long-acting muscarinic antagonist (LAMA)):

First and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with COPD
Launch underway with partner Mylan; continued strong customer acceptance and brand performance across key market metrics; combined sales infrastructures covering the hospital, hospital discharge, and home health settings
Development and commercialization agreement with Mylan for nebulized revefenacin expanded to include China and certain adjacent geographies
TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD)1:

Q2 2019 net sales of $151.4 million; Theravance Biopharma entitled to approximately 5.5% to 8.5% (tiered) of worldwide net sales of the product
Supplemental NDA submitted to FDA supporting revised labelling for TRELEGY ELLIPTA on reduction in risk of all-cause mortality compared with ANORO ELLIPTA in patients with COPD
Phase 3 CAPTAIN study in asthma met primary endpoint demonstrating statistically significant improvement in lung function compared with RELVAR/BREO; regulatory submissions planned for 2H 2019
Product now launched in 36 countries, including Japan; approval in China expected in Q4 2019
Notes:
1 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY ELLIPTA (the combination of fluticasone furoate, aclidinium, and vilanterol, (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of TRC LLC expenses paid and the amount of cash, if any, expected to be used in TRC over the next four fiscal quarters). RELVAR/BREO ELLIPTA (FF/VI). ANORO ELLIPTA (UMEC/VI).

Second Quarter Financial Results

Revenue

Total revenue for the second quarter of 2019 was $26.2 million compared to $23.5 million in the same period in 2018. The increase was primarily due to licensing revenue of $18.5 million recognized in the second quarter of 2019 related to the upfront from Mylan for rights to nebulized revefenacin in China and adjacent geographies. The increase was partially offset by a decrease in product sales which resulted from the sale of VIBATIV to Cumberland Pharmaceuticals in late-2018 and a one-time opt-in received from Alfasigma for velusetrag (TD-5108) in the second quarter of 2018.

Research and Development (R&D) Expenses

R&D expenses for the second quarter of 2019 were $46.4 million, compared to $48.6 million in the same period in 2018. The decrease was primarily due to lower employee-related costs associated with the reduction in force announced in the first quarter of 2019 as well as a decrease in share-based compensation which was partially offset by an increase in external expenses related to the progression of our key programs. Second quarter R&D expenses included non-cash share-based compensation of $5.7 million.

Selling, General and Administrative (SG&A) Expenses

SG&A expenses for the second quarter of 2019 were $22.2 million, compared to $25.0 million in the same period in 2018. The decrease was primarily due to lower VIBATIV-related external expenses due to the sale of VIBATIV to Cumberland in late-2018 as well as a decrease in share-based compensation which was partially offset by higher collaboration expenses associated with the commercial launch of YUPELRI. Second quarter SG&A expenses included non-cash share-based compensation of $5.6 million.

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $396.1 million as of June 30, 2019. The quarter ending cash balance include proceeds from the upfront payment received from Mylan for rights to nebulized revefenacin in China and adjacent territories.

2019 Financial Guidance

The Company’s guidance on operating loss excluding non-cash share-based compensation for the full year of 2019 remains unchanged at $210.0 million to $230.0 million. Operating loss guidance does not include royalty income for TRELEGY ELLIPTA which the Company recognizes as non-operating income. The Company’s share of U.S. profits and losses related to the commercialization of YUPELRI, potential future business development collaborations as well as the timing and cost of clinical studies associated with its key programs, among other factors, could impact the Company’s financial guidance.

Arbitration Against Innoviva

In May 2019, the Company announced that it had initiated arbitration against Innoviva, Inc. ("Innoviva") in connection with Innoviva’s failure to disburse certain royalties to Theravance Biopharma. Innoviva had caused Theravance Respiratory Company, LLC ("TRC LLC") to not make any distributions to Theravance Biopharma with respect to Theravance Biopharma’s 85% economic interest in TRC LLC for the quarter ended December 31, 2018. Those distributions were due March 31, 2019. Additionally, Innoviva stated that it intended to cause TRC LLC to withhold making further cash distributions through calendar year 2019. The arbitration hearing commenced on July 23, 2019. Resolution of the arbitration should occur in the third quarter of 2019.

Conference Call and Live Webcast Today at 8:00 am ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 8:00 am ET. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, and use the confirmation code 2445969. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through August 30, 2019. An audio replay will also be available through 11:00 am ET on August 7, 2019 by dialing (855) 859-2056 from the U.S., or (404) 537-3406 for international callers, and then entering confirmation code 2445969.

Nuvo Pharmaceuticals™ Announces Second Quarter 2019 Results Release Date and Conference Call Details

On July 31, 2019 Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI;OTCQX:NRIFF), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, reported it intends to release its second quarter 2019 financial results before markets open on Wednesday, August 14, 2019 (Press release, Nuvo Pharmaceuticals, JUL 31, 2019, View Source [SID1234537973]).

The Company will subsequently hold a conference call that same day, Wednesday, August 14, 2019 at 8:30 a.m. ET, hosted by Jesse Ledger, Nuvo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.

CONFERENCE CALL DETAILS

DATE:

Wednesday, August 14, 2019

TIME:

8:30 a.m. ET

DIAL-IN NUMBER:

416 764 8688 or 888 390 0546

TAPED REPLAY:

416 764 8677 or 888 390 0541 / REPLAY PASSCODE: 509912 #

The audio webcast can be accessed at:

View Source

An archived replay of the webcast will be available by clicking the link above.

GEMoaB Announces First Patient Dosed With the Affinity-Tailored T-Cell-adaptor GEM3PSCA in a Phase I Study in PSCA-positive Late-Stage Solid Tumors

On July 31, 2019 GEMoaB GmbH, a biopharmaceutical company focused on the development of next generation immunotherapies for hard-to-treat cancers, reported the dosing of the first patient in a Phase I open-label, dose escalation study of GEM3PSCA, an Affinity-Tailored Adapter for T-Cells (ATAC) (Press release, GEMoaB Monoclonals, JUL 31, 2019, View Source [SID1234537972]). The bispecific antibody binds to the CD3-Receptor on T-cells and prostate stem cell antigen (PSCA), differentially and broadly expressed in a variety of late stage solid tumors, such as castrate-resistant prostate cancer, pancreatic and breast cancer, bladder and renal cancer as well as non-small cell lung cancer. The ongoing execution of its clinical development plan reflects GEMoaB’s strategy to position itself as a leading and fully integrated biotech company for long-term success, building on the strong science and R&D foundation of the company.

"In addition to moving forward with multiple pre-clinical assets of our earlier-stage portfolio this year, we are pleased to demonstrate the productivity of our proprietary next generation ATAC platform by advancing GEM3PSCA, our second internally discovered molecule, into the clinic. GEM3PSCA follows our ongoing Phase I study of our first ATAC asset GEM333 in CD33-positive relapsed/refractory AML," said Armin Ehninger, Ph.D., Chief Scientific Officer of GEMoaB. "Due to its unique molecular features, GEM3PSCA has the potential to balance efficacy and tolerability and benefit the large number of patients whose metastatic cancer is expressing PSCA. We look forward to conducting the early clinical work for GEM3PSCA in close cooperation with highly experienced academic clinical centers and are proud about our global GEM333 and GEM3PSCA partnerships with Celgene."

Purpose of the Phase I study is to evaluate safety, pharmacokinetics, pharmacodynamics and clinical activity of GEM3PSCA in patients with advanced solid tumors expressing PSCA. GEM3PSCA will be administered as a single agent dosed as a continuous infusion over 7-day cycles. Cohorts of patients will receive ascending doses of GEM3PSCA to determine the maximum tolerated dose (MTD) or optimal dose. Patients must have evidence of expression of the PSCA antigen from their tumor tissue, measured by immunohistochemistry, in order to be eligible for the study.

"We are excited to participate in the development of this novel approach to the immunologic treatment of solid tumors," said Prof. Dr. Ralf Bargou, Head of Comprehensive Cancer Center Mainfranken at the University Hospital Würzburg. "PSCA is a very promising target expressed in multiple late stage cancers that do not sufficiently benefit from currently existing targeted or immunotherapies. We are very motivated to provide our broad expertise in early clinical trial conduct and immuno-oncology and work closely with the GEMoaB team in order to rapidly obtain meaningful safety and efficacy results for GEM3PSCA."

About the Affinity-Tailored Adaptor for T-Cells (ATAC) platform
GEMoaB’s platform of Affinity-Tailored Adaptors for T-Cells (ATAC) is characterized by high binding affinity to tumor antigens and lower affinity to the CD3 antigen on T-effector cells, preventing T-cell auto-activation in pre-clinical models. Safety and tolerability of the treatment are also increased by the relatively short (60 min) serum half-life. The use of fully humanized antibodies reduces the potential risk of immunogenicity even in case of chronic dosing. The first two clinical stage ATAC assets are GEM333 and GEM3PSCA. GEM333 is an ATAC with binding specificities to CD3 and CD33, currently in early clinical development in CD33 positive relapsed/refractory acute myeloid leukemia (for further information see View Source). GEM3PSCA is an ATAC with binding specificities to CD3 and PSCA, currently in early clinical development in multiple PSCA positive advanced solid tumors (for further information see View Source). GEM333 and GEM3PSCA are globally partnered with Celgene.

Helsinn and Endo Announce Agreement for Paladin Labs Inc. to Commercialize Pracinostat in Canada

On July 31, 2019 Endo International plc (NASDAQ: ENDP) and Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, are reported that Endo International plc’s subsidiary Endo Ventures Limited has entered into definitive agreements with Helsinn to register, commercialize, and distribute Pracinostat on an exclusive basis in Canada upon receipt of the required regulatory approval (Press release, Endo Pharmaceuticals, JUL 31, 2019, View Source [SID1234537971]).

Under the terms of the agreement, Paladin Labs Inc., an operating company of Endo, will be responsible for the registration, distribution, sales, marketing, medical affairs, pricing and reimbursement activities in connection with Pracinostat in Canada. Helsinn will be responsible for supplying the drug to Paladin and will retain all international development rights, including clinical development activities.

Pracinostat is a novel oral histone deacetylase (HDAC) inhibitor that is in a pivotal Phase 3 study in combination with Azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. It is also being evaluated in a Phase II study in naïve patients with high or very high-risk myelodysplastic syndrome (MDS). The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Pracinostat in combination with Azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

AML is a cancer of the blood and bone marrow that is caused by the uncontrolled proliferation of a blood progenitor cell of myeloid lineage. It is the most common type of acute leukemia in adults. Pracinostat is thought to act as an epigenetic cell cycle regulator in cancerous cells. The clinical study combination of Pracinostat and Azacitidine is being evaluated for the effect in reverse gene silencing, leading to cell apoptosis and differentiation.

"Our collaboration with Paladin demonstrates our commitment to advancing the quality of cancer care for patients around the world. Paladin has a very successful 24-year track record of commercializing innovative pharmaceutical products in Canada and our partnership with them will be an invaluable component of our strategy to ensure global access to Pracinostat," said Riccardo Braglia, Helsinn Group Vice Chairman and CEO.

"Pracinostat has shown potential as a possible treatment for AML and MDS in an elderly population with otherwise limited therapeutic options," said Rahul Garella, Senior Vice President, International Pharmaceuticals of Endo. "We are excited to partner with Helsinn and add this important medicine to our leukemia cancer care product offering in Canada."

About Pracinostat:

Pracinostat is an oral HDAC that is in a pivotal Phase III study in combination with Azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia ("AML") who are unfit for intensive induction chemotherapy. It is also being evaluated in a Phase II study in patients with high risk myelodysplastic syndromes ("MDS"). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Pracinostat in combination with Azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.

In 2016 Helsinn obtained global rights to Pracinostat from MEI Pharma, Inc. under an exclusive license, development and commercialization agreement, the terms of which are not altered by the sublicense agreement, which also included the right for Helsinn to grant sublicenses to third parties.

Exclusive licensing rights for all territories excluding US, Canada, Japan and South America were granted to Menarini, the Italian biopharmaceutical group, in December 2018.

Pracinostat is an investigational agent and is not approved for commercial use in the U.S. and any other country worldwide.

About AML:

AML is a disorder of the blood and bone marrow caused by the uncontrolled proliferation of an abnormal hematopoietic cell of myeloid lineage. This results in a high circulating number of immature blood cells and replacement of normal bone marrow by malignant cells. AML has eight different subtypes, which are based on the type of cell from which the leukemia developed. It is typically a disease of older patients, with a median age at diagnosis of 67 years. Although the cure rate for AML patients 60 years and younger with intensive chemotherapy is 35 to 40%, it remains poor in older patients, typically not exceeding 15%.

About MDS:

Myelodysplastic Syndrome is a type of blood cancer in which the bone marrow does not make enough healthy blood. MDS is normally a disease of the elderly and sometimes may progress into AML, which is a more rapidly growing cancer.

ANI Pharmaceuticals Schedules Conference Call to Discuss Second Quarter and Year-to-Date 2019 Financial Results

On July 31, 2019 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its second quarter and year-to-date 2019 financial results on Wednesday, August 7, 2019, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, JUL 31, 2019, View Source [SID1234537970]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Wednesday, August 7, 2019. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 3823848.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 3823848.