On November 1, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2018 (Press release, Puma Biotechnology, NOV 1, 2018, View Source [SID1234530615]). Unless otherwise stated, all comparisons are for the third quarter 2018 compared to the third quarter 2017.

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!

Net product revenue in the third quarter of 2018 was $52.6 million, compared to net product revenue of $6.1 million in the third quarter of 2017. Puma Biotechnology received approval from the U.S. Food and Drug Administration (FDA) for NERLYNX (neratinib) for the treatment of early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy on July 17, 2017, and the Company began shipment to wholesalers at the end of July 2017.

Based on generally accepted accounting principles in the United States (GAAP), Puma reported a net loss applicable to common stock of $14.2 million, or $0.37 per share, for the third quarter of 2018, compared to a net loss applicable to common stock of $77.2 million, or $2.07 per share, for the third quarter of 2017. Net loss applicable to common stock for the first nine months of 2018 was $82.9 million, or $2.19 per share, compared to $227.9 million, or $6.15 per share, for the first nine months of 2017.

Non-GAAP adjusted net income was $6.6 million, or $0.17 per basic share and $0.16 per diluted share, for the third quarter of 2018, compared to non-GAAP adjusted net loss of $50.7 million, or $1.36 per share, for the third quarter of 2017. Non-GAAP adjusted net loss for the first nine months of 2018 was $14.5 million, or $0.38 per basic and diluted share, compared to non-GAAP adjusted net loss of $144.7 million, or $3.90 per share, for the first nine months of 2017. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the third quarter of 2018 was $7.3 million. Net cash used in operating activities for the first nine months of 2018 was $31.2 million. At September 30, 2018, Puma had cash and cash equivalents of $68.3 million and marketable securities of $59.7 million, compared to cash and cash equivalents of $81.7 million at December 31, 2017.

"The third quarter of 2018 marked the achievement of another important milestone for Puma with the European Commission granting marketing authorisation for NERLYNX for the extended adjuvant treatment of hormone receptor positive HER2-positive early stage breast cancer," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We expect this new medicine to be commercially available to patients in Europe in 2019, beginning with the expected launch in Germany during the first half of 2019 and followed by additional countries throughout Europe in the second half of 2019."

"We also continue to drive toward expanding availability of NERLYNX throughout the world," Mr. Auerbach added. "In the third quarter, our New Drug Submission was accepted in Canada, and our

licensing partner in China, CANbridge Pharmaceutical Inc., received confirmation that the country’s National Medical Products Administration accepted its New Drug Application for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, following adjuvant trastuzumab based-therapy."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting data from the Phase III NALA trial in third-line metastatic breast cancer patients in the fourth quarter of 2018 or first half of 2019; (ii) submitting for regulatory approval of NERLYNX for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries in the fourth quarter of 2018 and first half of 2019; (iii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2018; (iv) reporting additional data from the Phase II SUMMIT trial in the fourth quarter of 2018 or first half of 2019; and (v) meeting with the FDA in the first quarter of 2019 to discuss the clinical development and regulatory strategy for neratinib in HER2 mutated cancers based on the results of the ongoing SUMMIT Phase II trial."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first and only commercial product to date, and license revenue. For the third quarter of 2018, total revenue was $62.6 million, of which $52.6 million was net product revenue and $10.0 million was license revenue received from one of Puma’s sub-licensees. For the first nine months of 2018, total revenue was $179.9 million, of which $139.4 million was net product revenue and $40.5 million was license revenue. The FDA approved NERLYNX for commercial sale in the United States in July 2017 and Puma commenced shipment to wholesalers in late July.

Operating Costs and Expenses

Operating costs and expenses were $73.9 million for the third quarter of 2018, compared to $83.5 million for the third quarter of 2017. Operating costs and expenses for the first nine months of 2018 were $256.0 million, compared to $234.9 million for the first nine months of 2017.

Cost of Sales:

Cost of sales was $9.0 million for the third quarter of 2018 and $24.3 million for the first nine months of 2018, compared to $1.5 million for the third quarter and first nine months of 2017. The Company had no product sales prior to the third quarter of 2017.

Selling, General and Administrative Expenses:

Selling, general and administrative expenses were $28.5 million for the third quarter of 2018, compared to $32.5 million for the third quarter of 2017. SG&A expenses for the first nine months of 2018 were $105.2 million, compared to $75.8 million for the first nine months of 2017. The $29.4 million year-to-date increase was attributable to increases of approximately $26.9 million in internal expenses, such as payroll and payroll-related expenses attributable to the addition of a salesforce since the third quarter of 2017. External expenses declined approximately $1.5 million during the same time period and employee stock-based compensation increased approximately $4.0 million, primarily related to the addition of sales staff to support the commercial launch of NERLYNX in the United States. Puma expects SG&A expenses in 2018 and into 2019 to remain higher than in 2017 as it markets NERLYNX commercially in the United States and launches the product in other territories.

Research and Development Expenses:

Research and development (R&D) expenses were $36.4 million for the third quarter of 2018, compared to $49.5 million for the third quarter of 2017. R&D expenses for the first nine months of 2018 were $126.5 million, compared to $157.5 million for the first nine months of 2017. The $31.0 million year-to-date decrease resulted primarily from decreases of approximately $18.9 million in stock-based compensation and of approximately $15.4 million for external expenses related to clinical trials, manufacturing and logistics associated with clinical supply. Puma expects R&D expenses in 2018 to continue to decline slightly when compared with R&D expenses in 2017 based on a decline in clinical trial activities as existing trials continue to wind down.

On November 1, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will host a conference call at 4:30 p.m. ET on Thursday, November 8, 2018 to discuss third quarter financial results and provide a general corporate update (Press release, Tetraphase, NOV 1, 2018, View Source [SID1234530632]).

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 conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 3997765. A live audio webcast of the conference call, or the subsequent archived recording, will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, November 8, 2018, through 7:30 p.m. ET on Thursday, November 15, 2018 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 3997765. A replay of the webcast will be available for 90 days by visiting Tetraphase’s website.

On November 1, 2018 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel bispecific antibodies that target the immune system to fight cancer, reported that it will present preclinical data on two new proprietary bispecific antibodies at the SITC (Free SITC Whitepaper) Annual Meeting, PEGS Summit Europe and the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress (Press release, f-star, NOV 1, 2018, View Source [SID1234530648]).

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!

Checkpoint antagonists dominate the clinical landscape and yet despite encouraging progress, only a small patient population reaches a durable and clinically meaningful response. Current approaches have shown limited efficacy for poorly immunogenic tumours which harness different and often multiple escape or resistance mechanisms to attenuate the local immune response.

FS120 is a dual agonist mAb² simultaneously targeting OX40 (CD134, TNFRSF4) and CD137 (4-1BB). FS222 is an agonist/antagonist mAb² against CD137 and PD-L1 (Programmed Death-Ligand 1). Both OX40 and CD137 are co-stimulatory molecules, part of the Tumour Necrosis Factor Receptor Super Family (TNFRSF). Unlike checkpoint antagonists, engagement of OX40 or CD137 on activated T cells triggers a positive signal that enhances several cellular and effector functions, essential to the elimination of tumour cells.

Neil Brewis, CSO of F-star said "It is only recently that the full complexity of tumour heterogeneity and how this translates into the clinical setting has been appreciated. With the increase in tumour resistance to checkpoint therapies, there is an urgent need to generate new and efficacious treatment options for cancer patients. F-star’s new programmes have the potential to leverage a more targeted, potent and safer immune response, even in highly immune-suppressive tumour microenvironments."

The data to be presented will highlight the potent anti-tumour activity of F-star’s mAb² and how each of them outperforms combinations of monospecific agents in multiple syngeneic tumour models. Furthermore, the results will describe how F-star’s bispecific format can alleviate some of the inherent limitations of an antibody-mediated TNFRSF activation, such as low efficacy or dose-dependent liver toxicity observed in current clinical trials.

Eliot Forster, CEO of F-star said "I am very excited about the presentation of these wholly owned molecules to these conferences. The data on FS120 a dual agonist mAb² and FS222 an agonist/antagonist mAb² demonstrate the versatility and power of our Modular Antibody Technology and its ability to address the known heterogeneity of tumour types and, especially, their immune evasion mechanisms. With the potential to go beyond combination approaches, the two programmes are heading towards INDs in 2019, reinforcing F-star’s commitment to deliver life-changing treatments for cancer patients".

Details of the presentations are below:

SITC Annual Meeting – 7-11 Nov 2018 – Washington DC

Oral presentation information:

Title: FS120 mAb², a dual agonist bispecific antibody targeting OX40 and CD137, activates T cells in vitro and induces potent, FcγR-independent anti-tumour activity
Session: Next Generation Bispecifics and Antibody-Like Molecules
Session date and time: 11 Nov from 08:05-10:30

Poster presentations information:

Title: FS120 mAb², a dual agonist bispecific antibody targeting OX40 and CD137, activates T cells in vitro and induces potent, FcγR-independent anti-tumour activity
Abstract poster number: O44
Poster hall location: Hall E
Poster hall hours: 09 Nov from 08:00 – 20:00 and 10 Nov from 08:00 – 20:30
Poster presentation hours: 10 Nov from 12:20 – 13:50 and 19:00 – 20:30

Title: A novel CD137/PD-L1 bispecific antibody modulates the tumour microenvironment by activating CD8+ T cells and results in tumour growth inhibition
Abstract poster number: P631
Poster hall location: Hall E
Poster hall hours: 09 Nov from 08:00 – 20:00 and 10 Nov from 08:00 – 20:30
Poster presentation hours: 09 Nov from 12:45 – 14:15 and 18:30 – 20:00

PEGS Summit Europe 2018 – 12-16 Nov 2018 – Lisbon

Oral presentation information:

Title: Agonist bispecific antibodies delivering the next Immuno-Oncology breakthrough Session: Advancing Bispecifics and Combination Therapy to the Clinic
Presentation time: 15 Nov at 11:15

ESMO Immuno-Oncology Congress – 13-16 Dec 2018 – Geneva

Poster presentation information:

Title: Optimising TNFRSF Agonism and Checkpoint Blockade with a Novel CD137/PD-L1 Bispecific Antibody
Abstract: 444
Session date and time: 14-15 Dec, lunch time

On November 1, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T cell Receptor (ACTR) technology platform, reported that the Company will present preliminary results from the ongoing Phase 1 ATTCK-20-03 study, testing ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell lymphoma (r/r/ NHL), and the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA in patients with relapsed/refractory multiple myeloma (r/r MM), at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting taking place December 1-4, 2018, in San Diego, CA (Press release, Unum Therapeutics, NOV 1, 2018, View Source [SID1234530466]).

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!

"Preliminary data from these two trials demonstrate ACTR T cell activity and a well-tolerated safety profile of both ACTR707 and ACTR087 product candidates in their respective patient populations," said Michael Vasconcelles, Chief Medical Officer of Unum. "We remain encouraged by the emerging potential best-in-class profile of ACTR707 in combination with rituximab in patients with r/r NHL and the early safety data of ACTR087 in combination with the novel antibody, SEA-BCMA, in patients with r/r MM."

Data from the first dose level in the multicenter Phase 1 study, ATTCK-20-03, testing ACTR707 in combination with rituximab in patients with relapsed or refractory CD20+ B cell lymphoma, was presented in September 2018 at the Fourth Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper). Three of the six patients treated at the first dose level in the study achieved a complete response, two of which remained ongoing at the time of the September 4, 2018 data cut off. No dose-limiting toxicities (DLTs) were observed in any of the four DLT-evaluable patients, and no serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. Updated data from this cohort, along with data on the subsequent dose cohort will be presented at the ASH (Free ASH Whitepaper) meeting.

In addition, first-in-human dosing of single agent SEA-BCMA, and of ACTR087 in combination with SEA-BCMA, in the ATTCK-17-01 multi-center Phase 1 dose-escalation study was well tolerated, with no dose-limiting toxicities in the first two single-subject cohorts. Following infusion, ACTR+ T cells were detectable in these patients and demonstrated expansion post infusion. These data have supported the continued dose escalation of ACTR087 in combination with SEA-BCMA. Updated data from the first three dose cohorts of the trial will be presented at the ASH (Free ASH Whitepaper) meeting, with subsequent updates anticipated in 2019.

Details on the presentations are as follows:

Presentation Title: Preliminary Clinical Results of a Phase 1 Study Evaluating the Safety and Anti-tumor activity of ACTR707 in Combination with Rituximab in Subjects with Relapsed or Refractory CD20+ B-cell Lymphoma
Session Title: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster II
Date & Time: Sunday, 2 December, 2018 from 6:00 – 8:00pm
Location:San Diego Convention Center, Hall GH

Presentation Title: A Phase 1 Study of Two Investigational Agents, ACTR087, an Autologous T Cell Product Expressing an Antibody-Coupled T cell Receptor, in Combination With SEA-BCMA, a Novel Non-fucosylated Monoclonal Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
Session Title: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date & Time:Saturday, December 1, 2018 from 6:15 – 8:15pm
Location:San Diego Convention Center, Hall GH

On November 1, 2018 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for CPI-0610 in treatment of myelofibrosis (MF) based on preliminary results from the Company’s Phase 2 study, MANIFEST (Press release, Constellation Pharmaceuticals, NOV 1, 2018, View Source [SID1234530508]).

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!

Constellation is developing CPI-0610 with the goal of providing a new treatment option for patients with MF who have progressed after treatment with Jakafi (ruxolitinib), the only approved therapy for MF. Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial, which is exploring CPI-0610’s potential both as a monotherapy and as a combination therapy with Jakafi. As previously reported, preliminary data demonstrated clinical activity, such as spleen volume reduction, symptom improvement, increase in hemoglobin levels, and conversion to transfusion independent status in a patient who was transfusion dependent. Constellation recently expanded the MANIFEST study to include a third cohort, designed to evaluate CPI-0610 as a first-line therapy in combination with ruxolitinib in JAK 1/2-inhibitor-naïve MF patients.

"We believe there is an opportunity to improve the standard of care for MF patients with agents that modify the underlying disease," said Adrian Senderowicz, Senior Vice President and Chief Medical Officer of Constellation Pharmaceuticals. "This Fast Track designation highlights CPI-0610’s potential to address a significant unmet need. Based on promising early data and our progress with site initiation and patient enrollment, we continue to expect to determine proof of concept in mid-2019."

The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases and fill unmet medical needs. A drug that receives Fast Track designation is

eligible for more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication about the design of the proposed clinical trials and use of biomarkers, eligibility for accelerated approval and priority review, and rolling review.

About Myelofibrosis

MF is part of a collection of progressive blood cancers known as myeloproliferative neoplasms and is associated with significantly reduced quality of life and shortened survival. As the disease progresses, the bone marrow produces fewer red blood cells. Within one year of diagnosis, the incidence of thrombocytopenia (a condition characterized by low platelet counts in the blood) and severe anemia (a condition characterized by low red blood cell counts) and the need for red blood cell transfusion increase significantly. Among other complications, most patients with MF have enlarged spleens, as well as many other physical symptoms, including abdominal discomfort, bone pain, and extreme fatigue.

About CPI-0610

CPI-0610 is a potent and selective small molecule designed to promote anti-tumor activity by selectively inhibiting the function of BET proteins to decrease the expression of abnormally expressed genes in cancer. Constellation’s epigenetics platform includes a deep understanding of the biological contexts in which BET proteins operate, including cancer pathways that are highly sensitive to CPI-0610. The results from preclinical studies, as well as translational insights from the successful first-in-human study of CPI-0610, led to prioritizing the clinical development of CPI-0610 in myelofibrosis (MF). Enrollment is ongoing in the Phase 2 portion of the open-label Phase 1/2 MANIFEST clinical trial of CPI-0610, either as a monotherapy or in combination with ruxolitinib, in patients with MF who are refractory or intolerant or have relapsed or lost response to the standard of care. MANIFEST also includes a third cohort designed to evaluate treatment with CPI-0610 in combination with ruxolitinib as a first-line therapy in JAK 1/2-inhibitor-naïve MF patients. The company expects to determine proof of concept for CPI-0610 in MF in mid-2019.