On November 1, 2018 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2018 (Press release, Cerus, NOV 1, 2018, View Source [SID1234530505]).

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!

Third Quarter Highlights and Recent Events

Third quarter product revenue of $15.4 million, a 43% increase compared to the third quarter of 2017
Year-over-year worldwide disposable kit volumes increased 85% in the third quarter of 2018
2018 product revenue guidance revised upwards to a range of $58 million to $60 million, representing an increase of 33% to 38% compared to 2017 product revenue
Notified TÜV SÜD in October of the Company’s request to file its planned CE Mark submission in 60 days for INTERCEPT red blood cells
Received FDA Breakthrough Device Designation for pathogen-reduced cryoprecipitate
"The market adoption of the INTERCEPT Blood System continues to be strong with third quarter product revenue totaling $15.4 million," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Year-over-year product revenue growth was driven by sales of INTERCEPT platelet kits and was broad based with all major geographic regions delivering gains. Given our strong year-to-date results and increasing visibility into our commercial pipeline, we recently revised our 2018 product revenue guidance to a range of $58 million to $60 million."

"In addition to our strong third quarter results, we recently notified TÜV SÜD, our Notified Body, of our request to file our CE Mark submission in 60 days for INTERCEPT red blood cells. Our red cell team is working diligently in preparation for the planned submission and is on track to deliver on this important milestone," continued Greenman.

A Notified Body is an organization accredited by a member country of the European Union to determine if a product conforms to predetermined standards.

Revenue

Product revenue during the third quarter of 2018 was $15.4 million, compared to $10.8 million during the same period in 2017. The increase in third quarter product revenue was led by gains in platelet kit sales, which were partially offset by a year-over-year decline in illuminator sales. Third quarter 2017 illuminator sales benefited from the initial instrument shipments pursuant to the Company’s expanded supply agreement with EFS, the French National Blood Service. Year-to-date product revenue totaled $44.4 million, an increase of 62% compared to the same period of the prior year.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $3.9 million during the third quarter of 2018, compared to $2.3 million during the same period in 2017, as a result of increasing INTERCEPT red cell clinical and development activities. Year-to-date government contract revenue totaled $11.4 million compared to $5.4 million in the first nine months of 2017.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the third quarter of 2018 were 47%, compared to 50% for the third quarter of 2017. The change in gross margin was primarily attributable to lower selling prices associated with high volume customers, and to a lesser extent, the unfavorable impact of foreign exchange rates. Gross margins through the first nine months of 2018 were 48% compared to 51% in the same period of the prior year.

Operating Expenses

Total operating expenses were $24.8 million for the quarter ended September 30, 2018, compared to $20.1 million for the quarter ended September 30, 2017. Year-to-date, operating expenses totaled $72.2 million compared to $66.0 million in the same period of the prior year.

Selling, general, and administrative (SG&A) expenses for the third quarter of 2018 totaled $14.0 million, compared to $12.2 million for the third quarter of 2017. The year-over-year increase was primarily tied to higher commercial activity in the U.S. Year-to-date SG&A expenses totaled $42.0 million, compared to $40.1 million during the first nine months of 2017.

Research and development (R&D) expenses for the third quarter of 2018 were $10.8 million, compared to $7.9 million for the third quarter of 2017. The increase in year-over-year R&D expenses was primarily due to additional activities and costs tied to the development of INTERCEPT red blood cells, including preparation for the planned CE Mark submission, trials and activities in pursuit of FDA approval of INTERCEPT red blood cells and activities aimed at expanded label claims for INTERCEPT platelets and plasma. Year-to-date R&D expenses through the third quarter of 2018 totaled $30.1 million, compared to $25.9 million during the first nine months of 2017.

Net Loss

Net loss for the third quarter of 2018 was $14.2 million, or $0.11 per diluted share, compared to a net loss of $13.4 million, or $0.12 per diluted share, for the third quarter of 2017. Year-to-date net loss was $41.4 million, or $0.32 per diluted share, compared to a net loss of $49.1 million, or $0.46 per diluted share, in the first nine months of 2017.

Cash, Cash Equivalents and Investments

At September 30, 2018, the Company had cash, cash equivalents and short-term investments of $119.0 million, compared to $60.7 million at December 31, 2017.

At September 30, 2018, the Company had approximately $29.9 million in outstanding debt under its loan agreement with Oxford Finance compared to $29.8 million at December 31, 2017.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 7095077. The replay will be available approximately three hours after the call through November 15, 2018.

On November 1, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company pioneering the use of DARPin therapeutics* to treat serious diseases, reported its Interim Management Statement for the period ending September 30, 2018 (Press release, Molecular Partners, NOV 1, 2018, View Source [SID1234530521]).

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!

"In July 2018, our partner Allergan presented positive results on the primary endpoints in the phase 3 trial of abicipar, our long-acting anti-VEGF in ophthalmology. Allergan has now presented on the secondary endpoints reinforcing the potential of abicipar to be the first fixed 12-week anti-VEGF therapeutic, constituting a major milestone for our company," said Dr. Patrick Amstutz, Chief Executive Officer of Molecular Partners. "In parallel, we have been advancing our clinical trials of MP0250 in oncology as well as our research and development programs in immuno-oncology, specifically for our promising asset MP0310 which is scheduled to move into the clinic in 2019."

Update on phase 2 study of MP0250 in multiple myeloma at ASH (Free ASH Whitepaper) in December 2018
MP0250, Molecular Partners’ lead oncology asset, is a multi-DARPin candidate that binds hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF), two prominent pathways involved in tumor progression. HGF is known to confer resistance to several targeted therapies and MP0250 has the potential to overcome this adaptive resistance mechanism. An ongoing phase 2 study is evaluating MP0250 in combination with bortezomib (Velcade) and dexamethasone in patients with multiple myeloma who have failed standard therapies. The dose level for the expansion part of the trial has been set at 8 mg/kg, administered every 3 weeks.

Durable responses have been observed in several patients with immediately previous proteasome inhibitor (PI) based treatment, suggesting the potential of MP0250 to reverse HGF-mediated adaptive resistance to the PI. The company will present an update on the trial at the ASH (Free ASH Whitepaper) conference in San Diego on December 1, 2018. Molecular Partners anticipates further safety data and initial efficacy data before year-end 2018 and will discuss the drug candidate and potential development strategies in more detail at the company’s R&D Day in New York on December 6, 2018.

Patient recruiting for second phase 2 study of MP0250 in Non-Small Cell Lung Cancer (NSCLC) ongoing in first patient cohort
Molecular Partners is continuing patient recruitment for its phase 1b/2 clinical study of MP0250 in combination with osimertinib (Tagrisso) in patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) who were pre-treated with osimertinib. The study is being conducted in the United States and initial safety data are expected by the end of 2018 with initial efficacy data in 2019.

Immuno-oncology: Pre-clinical data on the company’s DARPin "toolbox" and on MP0310 to be presented at multiple scientific conferences in Q4 2018
At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference in Washington, the company will present additional data on MP0310, its most advanced multi-specific (FAP x 4-1BB) DARPin immuno-oncology compound. MP0310 will also be presented and discussed at the scientific conferences in Bari, San Diego, London and Berlin.

At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference in Washington and the ENA in Dublin, Molecular Partners will highlight preclinical data on FAP x CD40, a second multi-specific DARPin immuno-oncology compound.

"We are very pleased with the progress of our immuno-oncology portfolio. The DARPin platform provides the ability to design and develop novel multi-specific I/O molecules," commented Dr. Pamela A. Trail, Chief Scientific Officer of Molecular Partners. "Our lead I/O construct, MP0310, has the potential to be combined with existing therapies and provide substantial clinical benefit, and we have additional I/O molecules advancing towards clinical development."

Abicipar: Positive topline data for ongoing phase 3 trials has been complemented with reinforcing data on secondary endpoints presented at AAO in Chicago
In July 2018, Allergan and Molecular Partners announced positive phase 3 topline data from two clinical trials of abicipar. Those trials, SEQUOIA and CEDAR, demonstrated that both the 8-week and 12-week treatment regimens of abicipar met the pre-specified primary endpoint of non-inferiority to ranibizumab (Lucentis). SEQUOIA and CEDAR are ongoing identical global phase 3 studies designed to assess the efficacy and safety of abicipar compared with ranibizumab in treatment-naive patients with neovascular age-related macular degeneration (nAMD).

On October 26, 2018, additional phase 3 safety and efficacy data of abicipar were presented at the American Academy of Ophthalmology (AAO) conference in Chicago. The data show that the initial vision gains for both abicipar treatment regimens of either 2 mg abicipar every 12 weeks (2q12) or every 8 weeks (2q8) were maintained throughout week 52. The anatomical data (OCT) on abicipar-treated patients showed reductions of central retinal thickness (CRT) in all arms in both studies in the same range as for ranibizumab. Overall, the efficacy endpoints at week 52 showed comparable efficacy with 6 to 8 injections of abicipar vs. 13 injections of ranibizumab.

The overall incidence of treatment emergent adverse events was comparable among all three treatment groups. Abicipar-treated patients had a higher risk of developing intraocular inflammation (IOI) compared to ranibizumab-treated patients. The majority of IOI were mild to moderate and were treated with topical corticosteroids.

The data presented underline that abicipar has the potential to become the first fixed 12-week anti-VEGF therapeutic.

Allergan reiterated its plan to file abicipar with the Food and Drug Administration (FDA) in H1 2019 pending a pre-BLA (biologics license application) meeting with the FDA. Additionally, Allergan expects to share results from the MAPLE trial, using a further optimized formulation of abicipar, in H1 2019 and plans the market launch of abicipar for 2020.

Balance Sheet: Strong cash and equity positions as of September 2018
Molecular Partners’ financial performance for the first nine months of 2018 was in line with management’s expectations and reflects investments in the ongoing clinical trials as well as in the expansion of the company’s proprietary pipeline, specifically in immuno-oncology. Cash and short-term deposits decreased by CHF 30.4 million over the course of the first three quarters of 2018 to CHF 110.8 million as of September 30, 2018.

As of September 30, 2018, the company employed 113 FTEs (+6% year-over-year), with approximately 90% of employees serving in R&D functions.

Business outlook and priorities
Molecular Partners will present additional oncology data from its ongoing phase 2 study of MP0250 in patients with multiple myeloma (MM) at the ASH (Free ASH Whitepaper) conference in San Diego on December 1, 2018, as well as at its R&D Day in New York on December 6, 2018. The company also expects initial safety data from its ongoing phase 1b/2 study of MP0250 in NSCLC at the end of 2018. For MP0274, the proprietary, single-pathway DARPin drug candidate for the treatment of HER2-positive cancer, Molecular Partners expects additional safety and first efficacy data in 2019.

The company will continue to advance its immuno-oncology pipeline and will present further research and preclinical data for its DARPin candidate MP0310 as well as for additional therapeutic candidates resulting from the company’s immuno-oncology toolbox. The focus in this field remains clearly on activating agonists in a tumor-restricted way. Molecular Partners will highlight its preclinical data at multiple international scientific conferences over the course of Q4 2018.

In ophthalmology, following the positive phase 3 primary and secondary endpoint data of abicipar, Molecular Partners will continue to support Allergan in advancing abicipar through phase 3 studies in patients with neovascular AMD and in further optimizing the abicipar formulation in order to minimize inflammation. Molecular Partners will also continue to support Allergan in the preparation of the launch of the phase 3 study for abicipar in DME, expected for 2019, using the further optimized formulation of abicipar, as well as in advancing the three preclinical ophthalmology assets optioned-in from the existing research collaboration.

Allergan plans to file abicipar with the FDA in H1 2019 pending a pre-BLA (biologics license application) meeting with the FDA. Allergan also continues to expect results in H1 2019 from the MAPLE trial using the further optimized formulation of abicipar.

Financial outlook 2018
For the full year 2018, at constant exchange rates, the company expects total expenses of around CHF 50million, of which around CHF 6 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation. This guidance is subject to the progress of the pipeline, mainly driven by manufacturing costs, the speed of enrollment of patients in clinical studies and data from research and development projects. No guidance can be provided with respect to net cash flow projections. Timelines and potential milestone payments from existing and potentially new partnerships are not disclosed.

R&D Day in New York on December 6, 2018
Molecular Partners is hosting its 2nd R&D update on "Building Tomorrow’s Breakthroughs" in New York City on December 6, 2018. This event is intended for institutional investors, sell-side analysts, investment bankers and business development professionals.

Discussion topics will include the development strategy for MP0250 in multiple myeloma and an update on the clinical trials in NSCLC and multiple myeloma. Moreover, the company will highlight the advancement of its immuno-oncology pipeline. Dr. Pamela Trail, the company’s CSO, will present the research strategy and new research data of the company. Finally, a representative of the company’s strategic partner Allergan will present the latest clinical data on Allergan-licensed abicipar.

A detailed agenda, including speakers and presentation titles as they are confirmed, can be found on the Molecular Partners’ R&D Day 2018 website ahead of the event. Please RSVP by emailing Susan A. Noonan at [email protected].

Conference call and audio webcast
Molecular Partners will conduct a conference call and audio webcast related to its Q3 Interim Management Statement on November 01, 2018, at 2:00pm CET (1:00pm GMT, 9:00am EST).
In order to register for the conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Switzerland / Europe +41 (0) 58 310 5000
UK +44 (0) 207 107 0613
USA +1 (1) 631 570 5613
Participants will have the opportunity to ask questions after the presentation.

The corresponding audio webcast will be accessible, both live and as a replay, on the investors section of the company’s website, along with the accompanying presentation slides.

Financial Calendar
November 1, 2018 – Q3 2018 Management Statement
December 6, 2018 – R&D Day in New York
February 7, 2019 – Publication of Full-year Results 2018 (unaudited)
March 15, 2019 – Expected Publication of Annual Report 2018
April 16, 2019 – Annual General Meeting
May 9, 2019 – Interim Management Statement Q1 2019
August 27, 2019 – Publication of Half-year Results 2019 (unaudited)
October 31, 2019 – Interim Management Statement Q3 2019
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics.
The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid tumors and hematological tumors. MP0274, the second-most advanced DARPin drug candidate owned by Molecular Partners, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 is currently in phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On November 1, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the first patient has been dosed in a Phase 2 study evaluating its novel, targeted cancer immunotherapy, BN-Brachyury, and radiation in patients with advanced chordoma (Press release, Bavarian Nordic, NOV 1, 2018, View Source [SID1234530537]).

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!

Chordoma is a rare cancer that occurs in the bones of the skull base and spine, resulting in approximately 1,000 new cases being diagnosed in the United States and Europe annually. The brachyury protein has been shown to be universally overexpressed in chordoma tumors, while not being found in most normal tissue. The presence of brachyury in epithelial solid tumors has been highly correlated with metastatic disease, multi-drug resistance and decreased survival rates. BN-Brachyury’s prime-boost vaccination regimen has been optimized to include the gene for brachyury, as well as costimulatory molecules (TRICOM) known to increase immune activation. Prior data suggests that BN-Brachyury can safely target brachyury and induce brachyury-specific T-cell immune responses.

"While upfront surgical resection or definitive radiation can result in cure for some patients, we know that the majority of patients with this disease are not cured. Those who are not cured will almost all go on to have advanced disease, for which there are no therapeutic options known to result in defined clinical benefit," said Chris Heery, M.D., the Chief Medical Officer of Bavarian Nordic and member of the Medical Advisory Board of the Chordoma Foundation. "The almost universal expression of brachyury in chordoma makes it a prime candidate for our targeted immunotherapy. The initiation of the Phase 2 study serves as a significant step in the evaluation of BN-Brachyury as an effective treatment for patients with this rare disease."

The Phase 2, multiple-site trial will assess the effectiveness of BN-Brachyury and radiation therapy in patients with advanced chordoma. The study is expected to enroll up to 29 patients, in a two-stage design. If the threshold of activity is reached in stage 1, the study will proceed to stage 2 and full enrollment. Patients will be administered a primer of the highly attenuated, non-replicating vaccinia virus MVA-BN-Brachyury, followed by a booster of the recombinant fowlpox virus FPV-Brachyury and radiation therapy. The study aims to determine if the combination therapy results in a clinically meaningful objective response rate (ORR) within 12 months of radiation therapy, a timeframe during which historical controls show an ORR of less than 5% with radiation alone.

"For more than a decade, we have supported patients and research centers across the United States and Europe in their quest to find and develop better treatment options for this devastating cancer," said Josh Sommer, Founder and Executive Director of the Chordoma Foundation. "Although there has been a dramatic increase in chordoma research over the years, the rarity and complexity of the disease has left it relatively underserved. Bavarian Nordic’s cancer immunotherapy, BN-Brachyury, is a welcome, needed and promising advancement in the treatment of patients with advanced chordomas."

In May 2018, the FDA granted orphan drug designation to BN-Brachyury for the treatment of chordoma. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

For more information on trial, please visit: View Source

About BN-Brachyury
BN-Brachyury is a novel prime-boost cancer immunotherapy candidate, developed in collaboration with the National Cancer Institute (NCI). The product candidate consists of two different vaccine components; MVA-BN and fowlpox or FPV, which have been modified to express brachyury and to encode three costimulatory molecules, known as TRICOM. Brachyury is a tumor-associated antigen that is overexpressed in major solid tumor indications, as well as several rare, ultra-orphan cancer indications, and is reported to play a key role in the metastasis and progression of tumors. Tumors that overexpress brachyury are believed to be highly resistant to standard therapies, including radiation and chemotherapy, and are associated with decreased survival rates.

On November 1, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that preclinical data for its pan-FLT3/pan-BTK inhibitor CG-806 will be presented in two separate posters at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 1-4, 2018 in San Diego, CA (Press release, Aptose Biosciences, NOV 1, 2018, View Source [SID1234530564]).

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 abstracts accepted for presentation are listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website.

CG-806 Poster Presentation Details

CG-806, a First-in-Class Pan-FLT3/Pan-BTK Inhibitor, Exhibits Broader and Greater Potency Than Ibrutinib Against Primary and Cultured Malignant B Cells

Date & Time: Sunday December 2, 2018, 6:00-8:00 PM PT
Session Name: 802. Chemical Biology and Experimental Therapeutics: Poster II
Abstract Number: 3503
Location: San Diego Convention Center, Hall GH

Concomitant Targeting of FLT3 and BTK with CG-806 Overcomes FLT3-Inhibitor Resistance Through Inhibition of Autophagy

Date & Time: Sunday December 2, 2018, 6:00-8:00 PM PT
Session Name: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster II
Abstract Number: 2635
Location: San Diego Convention Center, Hall GH

About CG-806

CG-806 is a preclinical stage oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

On November 1, 2018 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2018. Net loss for the third quarter was $22.8 million, or $0.40 per share, compared to a net loss for the third quarter of 2017 of $32.4 million, or $0.60 per share. Cash, cash equivalents and investments totaled $210.3 million at September 30, 2018 (Press release, Cytokinetics, NOV 1, 2018, View Source [SID1234530581]).

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!

"With five programs advancing in development, we were pleased to report progress of our expanded pipeline of muscle biology directed potential medicines as recently outlined at our R&D Day," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "We look forward to beginning multiple trials across our cardiac muscle programs before year-end as well as soon completing enrollment in FORTITUDE-ALS, our Phase 2 clinical trial of reldesemtiv in patients with ALS, with results expected next year. I believe that the company has never been better positioned programmatically, operationally and financially to potentially deliver on the promise of our pioneering leadership in muscle biology."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Programs

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 70 percent completion with over 5,800 patients randomized to date having the high-risk profile intended by the trial design. We expect completion of patient enrollment in GALACTIC-HF to occur during the first half of 2019. We also expect that GALACTIC-HF will have accrued a sufficient number of events to enable the Data Monitoring Committee to conduct a first interim analysis for the trial, the design of which is tied to the potential for futility, in the first half of 2019.

Conducted readiness activities in advance of the initiation of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure). METEORIC-HF is a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment. Cytokinetics is working together with Amgen towards the objective of starting METEORIC-HF by the end of 2018.
AMG 594 (cardiac troponin activator)

Continued pre-clinical development of AMG 594 and filed an IND in collaboration with Amgen. AMG 594 is a novel, first-in-class, selective, oral, small molecule cardiac troponin activator, discovered under a joint research program with Amgen. In preclinical models, AMG 594 increases myocardial contractility by binding to cardiac troponin through an allosteric mechanism that sensitizes the cardiac sarcomere to calcium. Based on preclinical data, AMG 594 may offer differentiated efficacy and dose-related convenience relative to omecamtiv mecarbil.

We expect that Amgen will initiate a Phase 1 program for AMG 594 before the end of the year to assess its safety, tolerability, pharmacokinetics and its potential to increase cardiac function in healthy volunteers.
CK-3773274 (CK-274, cardiac myosin inhibitor)

Continued pre-clinical development and filed an IND for CK-274. CK-274 is a novel, oral, small molecule cardiac myosin inhibitor that company scientists discovered independent of its collaborations. CK-274 arose from an extensive next-generation chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into best-in-class potential in clinical development. In preclinical models, CK-274 reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site preventing myosin from entering a force producing state.

We expect to initiate a Phase 1 program for CK-274 before the end of the year to assess its safety, tolerability, pharmacokinetics and its effect on cardiac function in healthy volunteers.
Skeletal Muscle Program

reldesemtiv (next-generation FSTA)

Announced that additional results 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 Muscle Study Group Scientific Meeting in Oxford, UK, showing sustained increases in 6MWD and MEP four weeks after discontinuation of study drug.

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. FORTITUDE-ALS has enrolled over 400 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 expected in the first half of 2019.

With Astellas, announced the Phase 2 clinical trial of reldesemtiv in patients with chronic obstructive pulmonary disease (COPD), which was designed to assess its effect on physical function, did not meet the primary endpoint and did not demonstrate a statistically significant treatment difference in any of the secondary endpoints. Adverse events were similar between groups receiving reldesemtiv and placebo.

With Astellas, announced that an interim analysis of the Phase 1b clinical trial of reldesemtiv in elderly subjects with limited mobility, which was designed to assess its effect on measures of physical function, was recently conducted. The Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met; Astellas has proceeded to notify investigators to halt further enrollment in the trial.
Pre-Clinical Development and Ongoing Research

Continued pre-clinical development of CK-3762601 (CK-601), a next-generation fast skeletal muscle troponin activator (FSTA) into IND-enabling studies under our collaboration with Astellas.

Continued research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators. The companies are continuing their joint research program with Astellas providing sponsorship of Cytokinetics’ activities through 2019.

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

Announced that The ALS Association Golden West Chapter is the inaugural recipient of the Cytokinetics Communications Fellowship, an annual grant from the company intended to support increased capacity and community engagement for nonprofit organizations.
Financials

Revenues for the three and nine months ended September 30, 2018 were $10.6 million and $22.1 million, respectively, compared to $6.2 million and $13.4 million for the corresponding periods in 2017. Revenues for the first nine months of 2018 stemmed from our strategic alliance with Astellas.

Research and development expenses for the third quarter of 2018 decreased to $21.4 million from $24.9 million for the third quarter of 2017, primarily due to cessation of development of tirasemtiv in late 2017, offset in part by increased spending in clinical trials of reldesemtiv and preclinical activities for CK-274 and other potential drug candidates. Research and development expenses for the first nine months of 2018 increased to $65.9 million from $64.0 million for the first nine months of 2017, primarily due to increased spending in clinical trials of reldesemtiv and preclinical activities for CK-274 as well as other potential drug candidates, offset in part by suspension of development of tirasemtiv in late 2017.

General and administrative expenses for the three and nine months ended September 30, 2018 decreased to $7.2 million and $23.7 million, respectively, from $9.7 million and $26.2 million for the same periods in 2017, respectively, primarily due to reduced pre-commercial activities for tirasemtiv and reduced other corporate activities.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s third 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 9785146.

An archived replay of the webcast will be available via Cytokinetics’ website until November 8, 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 9785146 from November 1, 2018 at 7:30 PM Eastern Time until November 8, 2018.