On October 29, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") reported that it will release financial results for the period ended September 30, 2019 and provide a business update after market close on Tuesday, November 5, 2019 (Press release, Theravance, OCT 29, 2019, View Source [SID1234549996]).

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!

An accompanying conference call will be held at 5:00 pm ET on November 5, 2019. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, using the confirmation code 6281636. 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 December 5, 2019. An audio replay will also be available through 8:00 PM ET on November 12, 2019 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 6281636.

On October 29, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its third quarter financial results on Tuesday, November 5, 2019, after the close of US markets (Press release, Curis, OCT 29, 2019, View Source [SID1234549965]). Management will host a conference call on the same day at 4:30 p.m. ET.

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!

To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On October 29, 2019 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biopharmaceutical company focused on Alzheimer’s disease, reported recent clinical highlights and reported financial results for the third quarter ended September 30, 2019 (Press release, Pain Therapeutics, OCT 29, 2019, View Source [SID1234549981]).

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 loss for the third quarter 2019 was $0.7 million, or $0.04 per share, as compared to a net loss of $1.3 million, or $0.11 per share, for the same period in 2018. Net cash used was $0.7 million during the third quarter of 2019. Cassava Sciences ended the third quarter 2019 with $17.8 million of cash and equivalents, and no debt.

"Cassava Sciences had a productive quarter with our clinical research program in Alzheimer’s," said Remi Barbier, President & CEO. "We are encouraged by the robust biomarker data from a Phase 2a study in Alzheimer’s with lead drug candidate, PTI-125. PTI-125 is a twice-daily oral drug that targets both the neurodegeneration and the inflammatory components of Alzheimer’s. We’re seeing the research community shift from an amyloid-centric view, with all its noise and confusion, to one that targets neurodegeneration and neuroinflammation. PTI-125’s mechanism of action supports this evolution in Alzheimer’s drug development. That gets us excited."

Clinical Highlights

In September, Cassava Sciences reported positive clinical results in Alzheimer’s disease with its lead drug candidate, PTI-125. In a first-in-patient, Phase 2a study funded by the National Institutes of Health (NIH), treatment with PTI-125 for 28 days significantly reduced biomarkers of disease pathology, neuroinflammation and neurodegeneration, consistent with years of basic research and pre-clinical data.

Key results of the Phase 2a study include: total tau (T-tau) decreased 20% (p<0.001); phosphorylated tau (P-tau) decreased 34% (p<0.0001); neurofilament light chain (NfL), a marker for neurodegeneration, decreased 22% (p<0.0001); neurogranin, a marker for cognitive decline, decreased 32% (p<0.0001); and neuroinflammatory marker YKL-40, an indicator of microglial activation, decreased 9% (p<0.0001). We believe these and other data provide evidence of target engagement in patients with Alzheimer’s disease.

All evaluable patients showed a biomarker response to PTI-125. The drug was well tolerated, with no observable drug-related adverse events.

As a result of positive clinical results from its Phase 2a study of PTI-125, Cassava Sciences recently initiated a Phase 2b study. This Phase 2b is designed to evaluate safety, tolerability and drug effects of PTI-125 in Alzheimer’s disease. This blinded, randomized, placebo-controlled, oral dose study will enroll approximately 60 patients with mild-to-moderate Alzheimer’s disease. Patients will be dosed with PTI-125 100 mg, 50 mg or matching placebo, twice daily for 28 continuous days. The primary endpoint is improvement in biomarkers of neurodegeneration and neuroinflammation from baseline to Day 28. The study is supported by a clinical research grant award from NIH.

In October, Cassava Sciences announced that results of its Phase 2a study of PTI-125 were selected for a late-breaking oral presentation by the 12th International Conference on Clinical Trials on Alzheimer’s Disease (CTAD), which takes place December 4-7th, 2019.
Financial Highlights

At September 30, 2019, cash and cash equivalents were $17.8 million, compared to $19.8 million at December 31, 2018, with no debt.
Cash used was $0.7 million during the third quarter of 2019, net of reimbursements received from NIH.

Net cash use for full year 2019 is expected to be $3.0 – $5.0 million, consistent with previous financial guidance.

Net loss for the third quarter 2019 was $0.7 million, or $0.04 per share, as compared to a net loss of $1.3 million, or $0.11 per share, for the same period in 2018.
Research grant funding reimbursements of $1.5 million from NIH were recorded as a reduction in research and development expenses (R&D). This compared to $1.1 million of NIH grant receipts received for the same period in the prior year.
R&D expenses, after deducting the grant reimbursement, were negative $0.1 million. This compared to $0.4 million for the same period in the prior year, representing a 112% decrease. The decrease was due primarily to an increase in NIH grant funding in 2019 compared to the prior year, combined with a decrease in non-cash stock-based compensation expense.
General and administrative expenses were $0.8 million, consistent with the same period in 2018.
About PTI-125 and Cassava Sciences’ Scientific Approach
The target of PTI-125 is an altered form of filamin A (FLNA), a scaffolding protein. Published studies have shown that altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. Cassava Sciences’ lead drug candidate, PTI-125, is a small molecule that restores the normal shape and function of FLNA in the brain. This action improves the function of certain receptors in the brain and exerts powerful anti-neuroinflammatory effects.

Cassava Sciences is also developing an investigational diagnostic to detect Alzheimer’s disease with a simple blood test. This program, called PTI-125Dx, also receives significant scientific and financial support from NIH.

The underlying science for Cassava Sciences’ programs in neurodegeneration is published in several prestigious peer-reviewed technical journals, including Journal of Neuroscience, Neurobiology of Aging, and Journal of Biological Chemistry. As previously announced, NIH has awarded Cassava Sciences two research grants following an in-depth, confidential review of its science and technology. These two grant awards represent up to $6.7 million of non-dilutive financing.

About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys memory and thinking skills. Currently, there are no drug therapies to halt Alzheimer’s disease, much less reverse its course. In the U.S. alone, approximately 5.8 million people are currently living with Alzheimer’s disease, and approximately 487,000 people age 65 or older will develop Alzheimer’s in 2019.1 The number of people living with Alzheimer’s disease is expected to grow dramatically in the years ahead, which may also result in a growing social and economic burden.2

1, 2 Source: Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and Figures. Available online at: View Source

On October 29, 2019 Accuray Incorporated (NASDAQ: ARAY) reported its financial results for the first quarter of fiscal 2020 ended September 30, 2019 (Press release, Accuray, OCT 29, 2019, View Source [SID1234549997]).

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 Company Highlights

Gross orders increased 28 percent year over year to $78.5 million
11 orders received from China, including 2 orders sourced from the China joint venture
Accuray systems named in 50 out of 58 Class A licenses awarded by the China Ministry of Health
"Our first quarter performance represented a solid start to our fiscal year with double digit gross order growth," said Joshua H. Levine, president and chief executive officer. "We are also very excited about Accuray systems named in 50 out of 58 Class A licenses recently awarded by the China National Health Commission which were announced on October 9, 2019. We need to remember that the process identified by the Ministry of Health requires a tender process following the license awards for all participating end user hospitals prior to being able to take receipt of a Type A device. This tender process has been put in place to define the transactional terms and conditions related to each hospital’s equipment order and is not a competitive bidding situation that would result in changes in the specific device that the hospital has received the Type A license for. We expect that based on the timelines required for this tendering process, we would not begin to see revenue impact related to the China Type A awards until sometime in our fiscal 4th quarter, and we remain excited about the China market opportunity as a significant growth catalyst for our business."

Fiscal First Quarter Results

Gross orders totaled $78.5 million, an increase of 28 percent compared to $61.4 million for the prior year period. Backlog as of September 30, 2019 was $495.0 million, an increase of 7 percent compared to $461.9 million for the prior year period.

Total revenue was $89.6 million compared to $95.8 million for the prior year period. Product revenue totaled $37.6 million compared to $41.5 million, while service revenue totaled $52.0 million compared to $54.3 million.

Total gross profit for the fiscal 2020 first quarter was $32.9 million, or 36.8 percent of sales, comprised of product gross margin of 42.6 percent and service gross margin of 32.5 percent. This compares to total gross profit of $37.9 million, or 39.5 percent of sales, comprised of product gross margin of 40.9 percent and service gross margin of 38.5 percent for the prior fiscal year first quarter.

Operating expenses were $37.2 million, a decrease of 13 percent compared to $42.6 million in the prior fiscal year first quarter.

Net loss was $9.4 million, or $0.11 per share, compared to a net loss of $9.2 million, or $0.11 per share, for the prior fiscal year period.

Adjusted EBITDA for the first quarter of fiscal 2020 was a loss of $1.0 million, compared to $4.0 million in the prior fiscal period.

Cash, cash equivalents and short-term restricted cash were $86.7 million as of September 30, 2019 compared with $87.0 million as of June 30, 2019.

2020 Financial Guidance

The Company is reiterating its revenue and adjusted EBITDA guidance provided on August 15, 2019. Total revenue for fiscal year 2020 is expected to range between $410.0 and $420.0 million with revenue during the first half of the fiscal year expected to be approximately five to six percent below the first half of the prior fiscal year. The Company expects to generate revenue growth during the second half of fiscal year 2020 compared to the second half of the prior fiscal year. Adjusted EBITDA for fiscal year 2020 is expected to range between $19.0 to $24.0 million and include approximately $2.0 million of the Company’s share of expected loss from the joint venture operations in China.

Conference Call Information

Accuray will host a conference call beginning at 1:30 p.m. PT/4:30 p.m. ET today to discuss results for the first fiscal quarter as well as recent corporate developments. Conference call dial-in information is as follows:

U.S. callers: (855) 867-4103
International callers: (262) 912-4764
Conference ID Number (U.S. and international): 4191278
Individuals interested in listening to the live conference call via the Internet may do so by logging on to Accuray’s website, www.accuray.com. In addition, a taped replay of the conference call will be available beginning approximately two hours after the call’s conclusion and available for seven days. The replay telephone number is (855) 859-2056 (USA) or (404) 537-3406 (International), Conference ID: 4191278. An archived webcast will also be available at Accuray’s website until Accuray announces its results for the second quarter of fiscal 2020.

Use of Non-GAAP Financial Measures

Accuray has supplemented its GAAP net loss with a non-GAAP measure of adjusted earnings before interest, taxes, depreciation, amortization and stock-based compensation ("adjusted EBITDA"). Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the company and facilitates a meaningful comparison of results for current periods with previous operating results. A reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA is provided in the schedule below.

There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the company’s consolidated financial statements prepared in accordance with GAAP.

On October 29, 2019 Inivata, a leader in liquid biopsy, and the European Organisation for Research and Treatment of Cancer (EORTC) have reported a collaboration in which Inivata’s InVisionFirst-Lung liquid biopsy test will be used in a Phase II trial to screen and monitor ALK positive non-small cell lung cancer (NSCLC) patients initiating treatment with third generation ALK inhibitor therapy lorlatinib (Press release, EORTC, OCT 29, 2019, View Source [SID1234549947]).

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!

Although ALK positive NSCLC cancer patients are known to respond well to ALK inhibition therapies, such as lorlatinib, this has been limited in time by the emergence of drug resistance. Furthermore, the impact of acquired resistance on response to sequential therapies is unknown. The study has been designed to better understand resistance mechanisms and to analyze the correlation between ALK resistance mutational profile and response to lorlatinib.

Inivata’s InVisionFirst-Lung ctDNA test will be used initially to provide ‘real-time’ data for the pre-trial selection of patients through the detection of molecular resistance. The liquid biopsy test will also be used to provide data on ALK mutational profile in relation to each patient’s response to lorlatinib treatment at the point of disease progression and throughout the course of the study for those patients in whom new ALK mutations are detected.

Eighty-four patients will be involved in this Phase II study across 30 participating EORTC sites in Belgium, France, Italy, The Netherlands, Norway, Spain and the United Kingdom. EORTC, an independent, non-profit research organization in cancer, is the trial sponsor. The trial is being funded by Pfizer Inc., the marketing authorization holder of lorlatinib.

Clive Morris, Chief Executive Officer at Inivata, said: "This pharmaceutical company-backed collaboration highlights the value of our InVision platform in providing rapid and repeatable genomic profiling to enable new analyses of disease and benefit patient treatment. EORTC is a highly regarded leader in translation research and we look forward to working with them on this important study."

Dr Denis Lacombe, EORTC Director General, said: "Understanding the patterns of resistance and relapse is one of the most burning challenges in oncology. EORTC’s scientific strategy, being primarily patient centered, has developed, over the years, a specific focus on programs which address the entire course of the disease taking forward the challenges that patients face at recurrence. We are, therefore, particularly excited with this partnership which brings together the capacity of our organization and new technologies to address the applicability of liquid biopsy for longitudinal studies on this critical question. Better understanding of resistance will not only provide insight on how to design the next generation of treatment, but could also potentially suggest combination treatment to prevent the development of resistance."

"I would also like to add that this trial protocol was developed in the Methods in Clinical Research workshop (MCCR). This is a workshop to educate early career investigators on how to develop good clinical trial designs and we are delighted that we have been able to implement this protocol."

InVisionFirst-Lung is a ctDNA next generation sequencing liquid biopsy capable of testing 36 genes, including ALK, relevant to the care of patients with advanced NSCLC. The test is available world-wide for both commercial and research use. In the US, InVisionFirst-Lung is covered for Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.