Bristol-Myers Squibb has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On October 31, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has concluded an End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, OCT 31, 2019, View Source [SID1234550100]). The purpose of the meeting was to review the Phase II study data with the FDA and to present Can-Fite’s proposed Phase III study design to the regulatory agency.

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The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval. The Phase III study will enroll patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line therapy. This design leverages the previously announced Phase II trial data, which showed promising efficacy signals in this population. The FDA’s guidance will be incorporated into the Phase III study’s final protocol.

"Namodenoson is a novel approach to treating advanced liver cancer with an orally bioavailable drug specifically targeting the tumor cells, a unique mechanism that contributes to the favorable safety profile. We are very pleased with this outcome from our meeting with the FDA. With the FDA’s guidance, we plan to now finalize our Phase III study protocol for this unmet advanced liver cancer indication," stated Dr. Michael Silverman, Can-Fite’s Medical Director.

Can-Fite’s completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with CPB7 cirrhosis, the largest subpopulation of the study, even though the Phase II study did not achieve its primary endpoint of overall survival in the whole population.

DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries. According to the American Cancer Society, in the U.S. liver cancer incidence has tripled since 1980, with an estimated 42,000 cases diagnosed and 32,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being developed as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On October 31, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported a regulatory and clinical update on IDE196 following receipt of meeting minutes from an End‑of‑Phase 1 (EOP1) meeting with the FDA (Press release, Ideaya Biosciences, OCT 31, 2019, View Source [SID1234550157]). IDE196 is being evaluated for the treatment of MUM and other solid tumors harboring activating GNAQ or GNA11 (GNAQ/11) mutations in its ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385).

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"Following FDA feedback from the EOP1 meeting, we plan to initiate the Phase 2 single-arm, potentially registration-enabling clinical trial of IDE196 monotherapy. This arm of our clinical trial will target enrollment of 60 evaluable MUM patients with blinded independent central review (BICR)‑determined overall response rate (ORR) as the primary endpoint," said Bao Truong, Vice President, Head of Regulatory Affairs at IDEAYA Biosciences. "We look forward to the continued clinical advancement of IDE196 in MUM and in our broader tissue-type agnostic basket trial to treat other solid tumors that harbor activating GNAQ/11 mutations, including in cutaneous melanoma and colorectal cancer," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.

Regulatory and Clinical Program Highlights for IDE196:

FDA EOP1 meeting minutes indicate that the proposed single-arm Phase 2 IDE196 clinical trial may be adequate to support a new drug application (NDA) seeking Accelerated Approval of IDE196 monotherapy for the treatment of MUM
Phase 2 dose selection, and the single-arm, potentially registration‑enabling Phase 2 part of the Phase 1/2 clinical trial is anticipated to be initiated in Q4 2019
This Phase 2 clinical trial will target enrollment of 60 evaluable MUM patients with the primary endpoint of overall response rate (ORR) as determined by blinded independent central review (BICR), supported by BICR‑determined duration of response (DOR) as a secondary endpoint
The 13-week GLP-compliant toxicology studies in 2 species is scheduled to initiate in November 2019, in support of FDA requirement that results of these studies be submitted prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
An immediate release tablet formulation for IDE196 is on-track for introduction in the clinic in Q1 2020, as a potential registration and commercial formulation
Interim data for GNAQ/11 Phase 1/2 basket trial expected in Q2/Q3 2020
Confirmed Complete Response observed at month 31 in one patient previously reported with confirmed Partial Response in the ongoing IDE196 monotherapy clinical trial conducted by Novartis (ClinicalTrials.gov Identifier: NCT02601378)
"We are grateful for the regulatory feedback from the FDA on our single-arm trial design, providing an opportunity for a potential Accelerated Approval path for IDE196 monotherapy in MUM, a high unmet medical need and a solid tumor indication where there are no FDA approved therapies. We are also encouraged to see continued progress in our tissue-type agnostic GNAQ/11 Phase 1/2 basket trial to treat solid tumor patients beyond MUM," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

Celgene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On October 30, 2019 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three months ended July 31, 2019 (Press release, Cotinga, OCT 30, 2019, View Source [SID1234550034]). Recent highlights are outlined below. The Company also announces the reinstatement of Victor Hugo, of Marrelli Services Inc, as CFO, effective October 10, 2019; and the resignation of John Yoo, MD, from the Board of Directors, effective September 24, 2019. Dr. Yoo will remain as an advisor to the Company.

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Advanced the clinical development of COTI-2:

• Cotinga announced the initiation of dosing patients in the first three cohorts in the combination therapy trial at MD Anderson Cancer Center evaluating COTI-2 and cisplatin in a wide spectrum of cancers.

• The Company announced early interim data from cohorts 1 and 2, reporting signs of clinical activity in both cohorts determined by disease stabilization or regression. Additionally, the Company announced the closings of a two-tranche debenture in May and June, 2019, bringing $300,000 CDN into the company to fund the clinical trial and general operations. Upcoming Milestones COTI-2:

• Continue the dose escalation Phase 1b/2a combination therapy trial evaluating the effect of COTI2 plus cisplatin in patients with solid tumors;

• Contingent on the raising of necessary funds, initiate the TNBC trial with COTI-2 plus eribulin. Corporate:

• Strengthen the balance sheet;

• Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.

Financial Results

The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.

For the three-months ended July 31, 2019, the Company incurred a net loss of $0.527 million, or $0.02 per share, compared to a net loss of $0.982 million, or $0.04 per share, for the three-months ended July 31, 2018. The decrease in net loss during the three-month period is primarily due to decreases in Research and Development (R&D) expense and General and Administrative (G&A) expense. Press Release Page | 2

There was no revenue for the three months ended July 31, 2019 or in the comparative periods in the prior year.

R&D expense in the three-month period ended July 31, 2019 decreased by $0.218 million over the same period in the prior year. The decrease in R&D expense in the three-month period is primarily due to a decrease in clinical trial expenses and synthesis and miscellaneous R&D expenses.

S&M expense in the three-month period ended July 31, 2019 decreased by $0.028 million over the same period in the year prior. The decrease in S&M expense in the three-month period is primarily due to less travelling and conferences and in 2019, and professional fees on marketing.

G&A expense in the three-month period ended July 31, 2019 decreased by $0.158 million over the same period in the year prior. The decrease in G&A expense in the three-month period is primarily due to primarily due to lower professional fees and share-based compensation.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three months ended July 31, 2019, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.