On November 6, 2018 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the period ended September 30, 2018 (Press release, Athersys, NOV 6, 2018, View Source [SID1234530876]).

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Highlights of the third quarter of 2018 and recent events include:

Completed enrollment of our Phase 1/2 study evaluating MultiStem therapy in acute respiratory distress syndrome (ARDS) patients;

Commenced enrollment of patients in the MASTERS-2 Phase 3 registration study for ischemic stroke;

Continued to support Healios’ ongoing TREASURE study for ischemic stroke in Japan by providing clinical product;

Extended to December 6, 2018, Healios’ option and negotiation period for further expansion of the collaboration, including an exclusive option for a license to develop and commercialize MultiStem therapy in China for certain indications;

Recognized revenues of $2.3 million for the quarter ended September 30, 2018 and net loss of $9.7 million, or $0.07 net loss per share, for the quarter ended September 30, 2018; and

Cash and cash equivalents were $48.0 million at the end of the third quarter.

"We had another solid quarter in the third quarter of 2018 as we advanced key initiatives, reflected by the completion of enrollment in our exploratory clinical trial evaluating administration of MultiStem to patients suffering from ARDS and the initiation of enrollment in the Phase 3 MASTERS-2 study for treating ischemic stroke," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "We are working collaboratively with Healios in multiple areas, and we further strengthened our core capabilities.

"In addition, we have maintained a solid balance sheet as we continue to implement our strategic plan, working toward the achievement of our key goals on behalf of our shareholders and the patients we are committed to help," concluded Dr. Van Bokkelen.

Third Quarter Results

Revenues increased to $2.3 million for the three months ended September 30, 2018 compared to $0.4 million for the three months ended September 30, 2017. Our revenues are generally derived from license fees, manufacturing-related activities for Healios, royalty and related contract revenue from our collaborations, and grant revenue.

Research and development expenses increased to $9.5 million for the three months ended September 30, 2018 from $5.4 million for the comparable period in 2017. The $4.1 million increase is primarily associated with increased clinical development costs of $3.0 million, increased personnel costs of $0.6 million, increased license fees of $0.2 million and increased internal research supplies and other of $0.3 million. The $3.0 million increase in our clinical costs during the period is primarily a result of increased clinical product manufacturing costs, covered in part by Healios, technology transfer services associated with planned Japan manufacturing for Healios, process development activities to support large-scale manufacturing, and costs related to our MASTERS-2 clinical trial that began enrolling patients in the third quarter of 2018.

General and administrative expenses increased to $2.6 million for the three months ended September 30, 2018 from $2.1 million in the comparable period in 2017. The $0.5 million increase was due primarily to increases in professional fees, consulting services, personnel costs and other administrative costs compared to the same period last year.

Net loss for the third quarter was $9.7 million in 2018 compared to a net loss of $7.2 million in 2017. The difference of $2.5 million reflects the above variances, as well as an increase of $0.2 million in other income.

In the nine months ended September 30, 2018, net cash used in operating activities was $8.8 million compared to $17.9 million in the nine months ended September 30, 2017. The difference reflects in part $15.0 million in license fees paid by Healios in connection with the collaboration expansion and an increase in clinical development activity in 2018. Healios is obligated to make two more license fee payments of $2.5 million each in December 2018 and March 2019. At September 30, 2018, we had $48.0 million in cash and cash equivalents, compared to $29.3 million at December 31, 2017.

Conference Call

William (B.J.) Lehmann, President and Chief Operating Officer, and Laura Campbell, Senior Vice President of Finance, will host a conference call today to review the results as follows:

Date Tuesday, November 6th, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada 800-273-1254
Telephone access: International 973-638-3440
Access code 7396506
Live webcast

www.athersys.com, under the Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on November 20, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 7396506.

On November 6, 2018 Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, reported that it filed an Investigational New Drug Application (IND) with the FDA to move forward a radiotherapeutic drug, CTT1403, into human clinical trials for prostate cancer (Press release, Cancer Targeted Technology, NOV 6, 2018, View Source [SID1234530938]). CTT1403 is a peptidomimetic drug that targets Prostate Specific Membrane Antigen (PSMA). PSMA is over-expressed on prostate cancer and this expression increases as the cancer metastasizes and becomes hormone-resistant. Unlike other drugs, CTT’s molecules bind irreversibly to PSMA. This distinctive mode of binding enhances uptake and results in rapid and extensive internalization of these drugs by tumor cells, leading to increased uptake within the tumor. CTT1403 is labeled with the radionuclide 177-Lutetium and, unlike other PSMA-targeted drugs in clinical development, contains a unique albumin binding component. The albumin binding moiety on CTT1403 acts to increase the circulation of the drug in the body and further substantially increases the dose of drug that accumulates at the tumor sites. Once targeted to the tumor, the radionuclide on CTT1403 leads to tumor cell destruction. CTT1403 has shown excellent safety results to date in animal studies and CTT1403 treatment results in prolonged survival of animals with prostate cancer tumors

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"We are very excited with the potential for CTT1403 to make a difference in men with advanced stage prostate cancer. This is a highly innovative molecule that combines excellent PSMA-targeting characteristics, already proven effective in prostate cancer, with the ability to enhance circulation time allowing for greater anti-tumor effects," stated Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator for the clinical program. The unique chemical structure for CTT1403 was designed by Dr. Cliff Berkman, Professor of Chemistry at Washington State University (WSU) and consultant to CTT as its Chief Scientific Officer. The work to discover and progress CTT1403 through preclinical development to IND was funded by a $2.3M Small Business Innovation Research contract from the NIH.

CTT recently completed clinical trials of CTT1057, the companion PET diagnostic to CTT1403, with excellent safety and imaging results. CTT1057 is undergoing further development and commercialization by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 can act as a theranostic pair to both diagnose and treat prostate cancer. Phase I clinical trials for CTT1403 are expected to start January, 2019.

On November 6, 2018 South Korean pharma company Yuhan Corp (KS: 000100) reported it has licensed out its new clinical-stage lung cancer drug to Janssen Biotech, a unit of US healthcare giant Johnson & Johnson (NYSE: JNJ), in a deal potentially valued at up to $1.25 billion, according to the Korea Herald and other local media (Press release, Genosco, NOV 6, 2018, View Source [SID1234531533]).

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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

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11/16/2018 Yuhan signs $1.25 billion licensing deal with Janssen View Source 2/3 Yuhan said it had entered a licensing and cooperation agreement with Janssen to develop lazertinib, a novel clinical-stage therapeutic candidate for the treatment of patients with non-small cell lung cancer (NSCLC).

Following news of the agreement, shares of Yuhan spiked 29.78% to close at 231,000 won on Monday.
Deal includes $50 million upfront payment
Under the terms of the agreement, Yuhan will receive an upfront payment of $50 million and is eligible to receive up to $1.205 billion in potential
development and commercial milestone payments, along with tiered double-digit royalties on future net sales.
"Yuhan is committed to developing lazertinib as an effective treatment option for patients suffering from NSCLC. And Janssen, with strong
scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission," said Lee Jung-hee, president and chief
executive of Yuhan, adding: "We are excited to start this collaboration and dive into advancing this treatment regimen with a focus on improving
the lives of people who suffer from lung cancer."
The compound is currently in an ongoing Phase I/II clinical trials in Korea. Interim results showed that lazertinib exhibited robust disease activity
in patients with NSCLC with acquired resistance to EGFR-TKIs, with or without brain metastasis and was well tolerated with low rates of Grade 3
or higher adverse events.
In 2015, US firm Genosco partnered globally with Yuhan for development and commercialization of lazertinib, on which data from a Phase I/II
study in NSCLC were presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June this year.
Results from the open-label, multi-center dose-escalation, Phase I/II study of lazertinib (YH25448, GNS-1480) for patients with advanced EGFRTKI-resistant
NSCLC with or without CNS metastasis concluded that lazertinib was well-tolerated with low rates of Grade 3 or higher adverse
events (AE) and exhibited robust activity in patients with NSCLC with acquired resistance to EGFR-TKIs, with or without brain metastasis.

On November 6, 2018 Oncoceutics, Inc. reported that it will host an investigator meeting and that initial efficacy data of its lead compound ONC201 in patients with H3 K27M-mutant gliomas will be presented at the 2018 Annual Meeting of the Society for Neuro-Oncology in New Orleans, on November 15th to November 18th (Press release, Oncoceutics, NOV 6, 2018, View Source [SID1234558365]).

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The company, along with scientific and medical collaborators, will give 10 presentations that describe several aspects of ONC201, including clinical efficacy and safety, mediated via highly specific interaction with dopamine receptor 2 (DRD2), unique molecular characteristics, and novel insights on dopamine receptor dysregulation in glioma. Moreover, presentations will include the preclinical effectiveness and mechanism of action of ONC206, another molecule from this newly established class of compounds, called imipridones. One of the highlights of the event will be an oral presentation entitled, "Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients," which scored highly in the review process of the SNO conference and will be one of three selected abstracts to be presented by a discussant separate from the oral presentation. The data set that will be disclosed will focus on radiographic and clinical responses in H3 K27M-mutant glioma patients from several clinical programs with ONC201.

"The reported findings are very meaningful for the medical community, and we look forward to sharing our experience with ONC201 in this first group of patients," said Yazmin Odia, MD, Lead Physician of Medical Neuro-Oncology, Miami Cancer Institute. "Patients with H3 K27M-mutant gliomas have a dismal prognosis, and there is currently no known effective drug for these patients."

Additionally, Oncoceutics will hold an investigator meeting for physicians involved in ongoing and future clinical trials with ONC201.

"We are conducting a number of clinical trials to translate these compelling findings into robust clinical data sets," said Wolfgang Oster, MD, PhD, and CEO of Oncoceutics. "We are excited about the progress in our development programs and hope that our findings will make a difference for patients with unmet medical need. We are grateful to the Society for Neuro-Oncology and its members for their interest and collaboration."

More Information: Imipridone-related SNO 2018 Abstracts

ONC201 glioma clinical experience (3 abstracts)

ACTR-34 (Talk): Integrated clinical experience with ONC201 in previously-treated H3 K27M-mutant glioma patients, Chi et al, Sunday November 18th, 8:50-9:00am
ACTR-33 (Talk): Tumor Tissue Penetration and Pharmacodynamics of ONC201 in Adult Recurrent Glioblastoma Patients, Arrillaga-Romany et al, Friday November 16th, 2:40-2:45pm
PDCT-06 (Talk): Phase I clinical trial of ONC201 in pediatric H3 K27M-mutant glioma or newly diagnosed DIPG, Gardner et al, Friday November 16th, 8:22-8:26pm
DRD2 dysregulation in glioma and ONC201 preclinical efficacy (4 abstracts)

DRES-10 (Talk): DRD5 is a modulator of glioma susceptibility to DRD2 antagonism by ONC201, Prabhu et al, Sunday November 18th, 11:25-11:30am
EXTH-26 (Poster): Molecular determinant of clinical response to ONC201, an inhibitor of dopamine receptor 2 (DRD2) signaling, in glioblastoma patients, Li et al, Saturday November 17th
DDIS-12 (Poster): ONC201: The first selective, non-competitive DRD2/3 antagonist for clinical neuro-oncology, Prabhu et al, Saturday November 17th
DDIS-16 (Poster): ONC201 in combination with radiation exhibits synergistic efficacy in high grade gliomas and other advanced cancers, Tarapore et al, Saturday November 17th
Utility of imipridone scaffold in neuro-oncology (3 abstracts)

EXTH-64 (Talk): Imipridones Cause Metabolic Reprogramming and Elicit Unique Vulnerabilities in Glioblastoma, Ishida et al, Friday November 16th, 8:06-8:10pm
EXTH-17 (Talk): Selective, non-competitive DRD2/3 antagonism by imipridone ONC206 is effective in tumors with dopamine receptor dysregulation, Prabhu et al, Friday November 16th, 8:02-8:06pm
EXTH-58 (Poster): ONC206, an imipridone family member, suppresses glioblastoma cells via blocking cancer stemness pathways, Jung et al, Saturday November 17th

On November 6, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming investor conferences (Press release, Kura Oncology, NOV 6, 2018, View Source [SID1234530755]):

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A presentation at the Stifel Healthcare Conference in New York on November 13, 2018 at 8:45 a.m. ET / 5:45 a.m. PT; and

A fireside chat at the Evercore ISI HealthConX in Boston on November 27, 2018 at 4:15 p.m. ET / 1:15 p.m. PT.
A live audio webcast and replay of each presentation will be available in the Investors section of Kura Oncology’s website at www.kuraoncology.com.