1stOncology™: Cancer Intelligence Service – Page 14248 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Phase 3 Study Of Subcutaneous Pertuzumab And Trastuzumab Initiated Using Halozyme’s ENHANZEÂ® Technology

On July 26, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 3 study of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) for subcutaneous administration using Halozyme’s proprietary ENHANZE drug-delivery technology in combination with chemotherapy (Press release, Halozyme, JUL 26, 2018, View Source [SID1234527902]).

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 global Phase 3 study is investigating the combination as a single fixed-dose in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant and adjuvant settings. The estimated administration time for the initial loading dose of the combination is 7 to 8 minutes and subsequent maintenance doses are approximately 5 minutes.

"We are excited to support the initiation by Genentech of the first Phase 3 study exploring a fixed-dose combination of two therapeutics," said Dr. Helen Torley, president and CEO of Halozyme. "For breast cancer patients and healthcare professionals, the approach of administering pertuzumab and trastuzumab subcutaneously in a single injection with ENHANZE offers the potential for a new treatment administration option."

The Phase 3 study follows a Phase 1b clinical trial that assessed the safety, tolerability and pharmacokinetics of the same fixed-dose combination presented at the 2017 San Antonio Breast Cancer Symposium.

Perjeta (pertuzumab) and Herceptin (trastuzumab) are registered trademarks of Genentech, a member of the Roche Group.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE technology may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery method has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Five Prime Therapeutics to Announce Second Quarter 2018 Financial Results and Host Conference Call on August 8

On July 26, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported that it will report its second quarter 2018 financial results on Wednesday, August 8, 2018, after the U.S. financial markets close (Press release, Five Prime Therapeutics, JUL 26, 2018, View Source [SID1234527901]). Five Prime will host a conference call and live audio webcast on Wednesday, August 8, 2018, at 4:30 p.m. (ET)/1:30 p.m. (PT) to discuss the company’s financial results and provide a general business update.

The live audio webcast may be accessed through the "Events & Presentations" page in the "Investors" section of the company’s website at www.fiveprime.com. Alternatively, participants may dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 4194786.

The archived conference call will be available on Five Prime’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

Cytokinetics, Inc. Reports Second Quarter 2018 Financial Results

On July 26, 2018 Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results for the second quarter of 2018 (Press release, Cytokinetics, JUL 26, 2018, View Source [SID1234527900]). Net loss for the second quarter was $27.5 million, or $0.51 per share, compared to a net loss for the second quarter of 2017 of $29.1 million, or $0.60 per share. Cash, cash equivalents and investments totaled $232.0 million at June 30, 2018.

"We made substantial progress in the second quarter of 2018 advancing programs in both our cardiac and skeletal muscle verticals," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Following the recent presentation of positive data from our Phase 2 study of reldesemtiv in patients with SMA, we are now working with our partner, Astellas, as well as advocacy partners and clinical advisors, to consider a potential path forward in this indication, and potentially others, as we expect additional results this year. In the past quarter, we also received feedback from FDA regarding the planned second Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure, under our collaboration with Amgen; we are working toward the objective of initiating this trial before the end of the year. Finally, we continued the preclinical development of several new compounds, independently and within our collaborations, and we expect to move one or more potential drug candidates into Phase 1 clinical studies later this year."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil (cardiac myosin activator)

Continued patient enrollment in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil. Enrollment has surpassed 50 percent completion with over 4,000 patients randomized to date having a risk profile consistent with the trial design. We expect completion of patient enrollment into GALACTIC-HF to occur during the first half of 2019.

Conducted further interactions with FDA and finalized the protocol for a second Phase 3 clinical trial of omecamtiv mecarbil. This trial is intended to evaluate the potential effect of omecamtiv mecarbil on exercise performance in patients with heart failure and will be conducted by Cytokinetics in collaboration with Amgen. We continue to work toward the objective of beginning this clinical trial by the end of the year.
Skeletal Muscle Program

reldesemtiv (next-generation FSTA)

Announced that data from the Phase 2 clinical study of reldesemtiv in patients with spinal muscular atrophy (SMA) were presented by John W. Day, M.D., Ph.D., Professor of Neurology and Pediatrics (Genetics), Stanford University, at the 2018 Annual Cure SMA Conference in Dallas. The study showed dose- and concentration-dependent increases in time to muscle fatigue as measured by changes from baseline in Six Minute Walk Distance, a sub-maximal exercise test of aerobic capacity and endurance, and Maximal Expiratory Pressure, a measure of strength of respiratory muscles, after eight weeks of treatment with reldesemtiv.

Continued site activation and patient enrollment in FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv which is designed to assess the change from baseline in percent predicted slow vital capacity and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS. This trial has enrolled over 250 patients toward the objective of 445 patients in the trial and is being conducted by Cytokinetics in collaboration with Astellas. We expect to complete enrollment in FORTITUDE-ALS in Q4 2018 with results from this clinical trial now expected in the first half of 2019.

Completed patient enrollment in the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD) which is designed to assess its effect on physical function. This trial is being conducted by Astellas in collaboration with Cytokinetics. We expect results from this clinical trial in Q3 2018.

Continued patient enrollment in the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility which is designed to assess its effect on measures of physical function. This trial is being conducted by Astellas in collaboration with Cytokinetics. We expect Astellas will conduct an interim analysis of data from this clinical trial in Q3 2018.
Pre-Clinical Research and Development

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators; jointly advanced a potential drug candidate into IND-enabling studies.

Continued pre-clinical development of a next-generation cardiac muscle activator in collaboration with Amgen; we expect to submit an IND in 2018 and plan to initiate Phase 1 studies for this potential drug candidate by year-end or in early 2019.

Continued IND-enabling studies with an unpartnered cardiac sarcomere directed compound and engaged FDA in preparation for potential advancement to Phase 1 studies expected in Q4 2018.

Continued independent research activities directed to our other muscle biology research programs.
Corporate

Announced the continuation of our partnership with The ALS Association in the fight against ALS with renewal of Gold Level Sponsorship of the National Walks to Defeat ALS and Premier Level National ALS Advocacy Conference Sponsorship as well as Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter, including grant funding for care services for people living with ALS in the San Francisco Bay Area.

Announced an expanded partnership with Cure SMA to increase education, awareness and fundraising for SMA. As a National Platinum Partner for 2018, Cytokinetics will lend support to several of Cure SMA’s initiatives at both the local and national level to advance understanding of, and research toward potential treatments for SMA.
Financials

Revenues for the three and six months ended June 30, 2018 were $6.2 million and $11.5 million, respectively, compared to $3.1 million and $7.2 million for the corresponding periods in 2017. Revenues for the first six months of 2018 stemmed from our strategic alliance with Astellas.

Research and development expenses for the three months ended June 30, 2018 increased to $21.6 million and $43.7 million, respectively from $19.8 million and $39.1 million for the same periods in 2017, respectively, primarily due to increases in clinical trial expenses for reldesemtiv and preclinical expenses for our cardiac sarcomere directed program, offset in part by lower clinical trial and other development expenses for tirasemtiv.

General and administrative expenses for the three months ended June 30, 2018 decreased to $8.0 million from $8.4 million in 2017 primarily because of reduced precommercial and general outside services and increased to $17.3 million for the six months ended June 30, 2018 from $16.6 million for the same period in 2017, primarily due to increased general facilities-related costs.

Financial Guidance

The Company also updated financial guidance for 2018. The Company has reduced spending and revenue guidance by $5 million because of a delay in enrollment of FORTITUDE-ALS, with a corresponding reduction in cash revenues as the cost of that trial is being reimbursed by Astellas. The Company does not anticipate any change in net cash utilization. The Company estimates cash revenue will be in the range of $12 to $18 million, operating expenses will be in the range of $100 to $110 million, and net cash utilization will be approximately $100 million.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s second quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9599438.

An archived replay of the webcast will be available via Cytokinetics’ website until August 2, 2018. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9599438 from July 26, 2018 at 7:30 PM Eastern Time until August 2, 2018.

CTI BioPharma to Report Second Quarter 2018 Financial Results on August 2, 2018

On July 26, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management plans to report its second quarter 2018 financial results on Thursday, August 2, 2018, after the close of the U.S. financial markets (Press release, CTI BioPharma, JUL 26, 2018, View Source;p=RssLanding&cat=news&id=2360352 [SID1234527899]). Following the announcement, members of the management team will host a webcast conference call to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT). Access to the event can be obtained as follows:

Thursday, August 2, 2018
1:30 p.m. PT/4:30 p.m. ET/10:30 p.m. CET
877-260-1479 (domestic)
+1 334 323 0522 (international)

To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma’s website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 3255708. The telephone replay will be available until Thursday, August 9, 2018.

Champions Oncology Reports Record Annual Revenue Exceeding $20M for Fiscal Year Ended April 30, 2018

On July 26, 2018 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, reported its financial results for the fourth fiscal quarter and 12 months ended April 30, 2018 (Press release, Champions Oncology, JUL 26, 2018, View Source [SID1234527898]).

Fiscal Year 2018 Financial and Recent Business Highlights:

Record annual revenue of $20.2 million, an increase of 31.3% year-over-year

Record Translational Oncology Services ("TOS") revenue of $18.8 million, an increase of 37.2% year-over-year

Record annual TOS bookings

Successfully transitioned to our own new lab facility, doubling capacity, expanding revenue opportunities and realizing material cost savings

Forecast of at least 20% revenue growth in fiscal 2019 and sustained, quarterly operational profitability

Ronnie Morris, CEO of Champions, commented, "Exceeding $20 million in revenue is a significant milestone for our company, and our increasingly robust bookings and a growing pipeline of identified opportunities reinforce our optimism for the coming quarters and for revenue growth that will again exceed 20% this fiscal year. There is tremendous energy within our team about the opportunities in the market and the level of engagement from both new and existing customers."

"In addition, we made meaningful progress towards achieving our goal of sustained, long-term profitability by growing our business organically and leveraging the scale of our operations," added Mr. Morris. "Our core business is built on a highly leverageable, scalable business model that enabled us to grow our revenue by more than 30% in fiscal 2018, well ahead of our targeted 20% growth, and manage costs and operating expense to a modest increase of 4.2%. We anticipate delivering operational profitability during each quarter of fiscal 2019."

Fourth Fiscal Quarter Financial Results

Exhibit 99.1

For the fourth quarter of fiscal 2018, revenue increased 32.3% to $4.9 million compared to $3.7 million for the fourth quarter of fiscal 2017. Total operating expenses for the fourth quarter of fiscal 2018 were $5.5 million compared to $6.1 million for the fourth quarter of fiscal 2017, a decrease of $593,000 or (9.7%). For the fourth quarter of fiscal 2018, Champions reported a loss from operations of $594,000, which includes $172,000 in stock-based compensation and $110,000 in depreciation, an improvement of $1.8 million or (75.1%), compared to the loss from operations of $2.4 million, inclusive of $761,000 in stock-based compensation and $35,000 depreciation expense, in the fourth quarter of fiscal 2017. Excluding stock based compensation and depreciation, Champions reported a loss from operations for the quarter of $312,000; however, as forecasted for the full year, Champions reported income from operations of $40,000 and is positioned for sustained quarterly operational profitability going forward.

Cost of oncology solutions was $2.8 million for the three months ended April 30, 2018, an increase of $248,000, or 9.6% compared to $2.6 million for the three months ended April 30, 2017. The increase in cost of sales was due to an increase in TOS studies. For the three months ended April 30, 2018, gross margin was 42.7% compared to 30.9% for the three months ended April 30, 2017. Gross margin varies based on timing differences between expense and revenue recognition; however, the improvement can be attributed to leveraging cost of sales against a growing revenue base.

Research and development expense was $1.1 million for both the three months ended April 30, 2018 and 2017. Sales and marketing expense for the three months ended April 30, 2018 was $715,000, a decrease of $177,000, or (19.8%) compared to $892,000 for the three months ended April 30, 2017. The decrease is mainly due to a reduction of payroll and travel expenses. General and administrative expense was $888,000 for the three months ended April 30, 2018 compared to $1.6 million for the three months ended April 30, 2017, a decrease of $682,000 or (43.4%). The decrease is mainly due to a reduction in stock-based compensation expense.

Year-to-Date Financial Results

For the twelve months of fiscal 2018, revenue increased 31.3% to $20.2 million, as compared to $15.4 million for the twelve months of fiscal 2017. For the twelve months of fiscal 2018, total operating expenses decreased (2.8%) to $21.6 million, as compared to $22.2 million for the twelve months of fiscal 2017. The decrease is mainly due to a decrease in stock-based compensation.

For the twelve months ended April 30, 2018, Champions reported a loss from operations of $1.4 million, which includes $1.0 million in stock-based compensation and $360,000 in depreciation, an improvement of $5.5 million or (80.1%), compared to the loss from operations of $6.8 million, inclusive of $2.7 million in stock-based compensation and $141,000 depreciation, for the twelve months ended April 30, 2017. Excluding stock-based compensation and depreciation, Champions reported operating income of $40,000 for the twelve months ended April 30, 2018.

Net cash used in operations was $1.2 million and $2.8 million for the twelve months ended April 30, 2018 and 2017, respectively, a decrease of $1.6 million or (56.9%). The reduction in cash burn is the result of our revenue growth and expense management.

Cost of oncology solutions was $10.6 million for the twelve months ended April 30, 2018 compared to $9.7 million for the twelve months ended April 30, 2017, an increase of $850,000 or 8.8%. The increase in cost of sales was due to an increase in TOS studies. Gross margin was 47.9% for the twelve months ended April 30, 2018 compared to 37.0% for the twelve months ended April 30, 2017.The increase in cost of sales was due to an increase in TOS studies. The improvement in gross

Exhibit 99.1

margin was due to higher TOS revenue leveraged off the fixed cost component of the lab and effective management of the variable lab costs. Gross margin varies based on timing differences between expense and revenue recognition. While the gross margin improved, there are expenses incurred and recognized in advance of future revenue.

Research and development expense was $4.4 million for the twelve months ended April 30, 2018 an increase of $108,000, or 2.5% compared to $4.3 million for the twelve months ended April 30, 2017. Sales and marketing expense for the twelve months ended April 30, 2018 was $2.6 million, a decrease of $691,000, or (21.2%) compared to $3.3 million for the twelve months ended April 2017. The decrease is mainly due to reduction in salary and travel expenses. General and administrative expense was $4.1 million for the twelve months ended April 30, 2018, a decrease of 892,000 or (18.0%) compared to $5.0 million for the twelve months ended April 30, 2017. The decrease is primarily due to a reduction in stock-based compensation expense.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its fourth quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available Monday July 30, 2018 in the Company’s Form 10-K at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net loss to non-GAAP net loss for an explanation of the amounts excluded to arrive at non-GAAP net loss and related non-GAAP net loss per share amounts for the three and twelve months ended April 30, 2018 and 2017. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net loss and non-GAAP loss per share are not, and should not be viewed as a substitute for similar GAAP items. Champions’ defines non-GAAP dilutive loss per share amounts as non-GAAP net loss divided by the weighted average number of diluted shares outstanding. Champions’ definition of non-GAAP net loss and non-GAAP diluted loss per share may differ from similarly named measures used by others.