AmpliPhi Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AmpliPhi Biosciences, 2017, NOV 14, 2017, View Source [SID1234522079]).

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On November 14, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported a corporate update and reported financial results for the three months ended September 30, 2017 (Press release, Mateon Therapeutics, NOV 14, 2017, View Source [SID1234522046]).

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Recent Corporate Highlights

Announced phase 1b data for OXi4503 in Study OX1222 for the treatment of relapsed/refractory acute myeloid leukemia/myelodysplastic syndromes, which show complete remissions and evidence of a dose response;
Elevated OXi4503 to lead program, representing the primary focus of Mateon’s drug development efforts; and
Terminated FOCUS Study in platinum-resistant ovarian cancer, terminated clinical development of CA4P, and restructured company down to six employees to reduce expenditures.
"OXi4503 destroys the protective environment that bone marrow tumors provide to AML stem cells while also simultaneously attacking the tumor cells themselves. Thus, if ultimately approved, our lead compound would be a completely new way to treat AML and should offer many advantages over other drugs currently on the market or in development for this indication," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "With patent protection in AML to 2033, we believe that OXi4503 represents an outstanding business development or financing proposition, and are working to secure an arrangement that will allow us to accrue clinical data in higher-dose cohorts in Study OX1222."

Financial Results for the Third Quarter of 2017

For the three months ended September 30, 2017, Mateon reported a net loss of $3.5 million, compared to a net loss of $3.2 million for the three months ended September 30, 2016. Research and development expenses increased to $2.8 million for the three months ended September 30, 2017, compared to $2.1 million for the three months ended September 30, 2016, primarily due to higher clinical costs associated with the recently terminated FOCUS study. General and administrative expenses decreased to $0.7 million for the three months ended September 30, 2017, compared to $1.2 million for the three months ended September 30, 2016.

At September 30, 2017, Mateon had cash and short-term investments of $1.9 million.

"We very rapidly closed out the FOCUS Study in October. Following the other cost reductions implemented in late September, we now project that our existing cash, when combined with expected refunds from certain vendors, should sustain our OXi4503-focused business development and financing efforts into approximately February 2018," concluded Dr. Schwieterman.

On November 14, 2017 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported financial results for the three months ended September 30, 2017 and reported on corporate developments. Unless specified otherwise, all amounts are in Canadian dollars (Press release, Aptose Biosciences, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316911 [SID1234522060]).

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The net loss for the quarter ended September 30, 2017 was $3.3 million ($0.14 per share) compared with $4.0 million ($0.31 per share) in the quarter ended September 30, 2016. Total cash and cash equivalents and investments as of September 30, 2017 were $13.6 million (or $10.9 million US dollars) which, based on current operations, provide the Company with sufficient resources to fund research and development and operations into Q4 2018.

"During the third quarter, we made important progress with both of our novel small molecule compounds for the treatment of certain hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We’ve completed manufacture of high quality drug substance and explored multiple formulations of CG’806, our oral first-in-class pan-FLT3/pan-BTK inhibitor. We triggered PK and dose range finding studies with CG’806 in order to prepare the agent for advancement into the clinic for patients with acute myeloid leukemia and certain B-cell malignancies. We also generated renewed excitement about the potential for APTO-253, a clinical-stage compound that effectively inhibits expression of the c-Myc oncogene, and we believe we have effectively addressed the formulation and manufacturing setbacks that led to a clinical hold for APTO-253. Our goal is to return APTO-253 to the clinic for the treatment of patients with AML or MDS."

Corporate Highlights
Successful completion of APTO-253 formal root cause studies – Aptose successfully completed Formal Root Cause Studies for the manufacturing setback related to the clinical batch supply that failed stability testing and established a Corrective and Prevention Action (CAPA) plan.

Manufacture of APTO-253 clinical supply has begun – The Company has initiated the process to manufacture a cGMP clinical supply that will be required for a potential return of APTO-253 to the clinic. Upon manufacture of the new clinical supply, Aptose plans to perform stability, sterility, mock infusion, animal bridging and blood compatibility studies. Following completion of those studies, we would plan to submit findings to the FDA to seek release of the clinical hold and allow return of APTO-253 to the open Phase 1b trial in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

CG’806 manufacturing and preclinical testing progress – Aptose produced a highly purified batch of drug substance (API) to support pharmacokinetic (PK), formulation evaluation and dose range finding studies of CG’806. The PK and formulation evaluation studies have been completed, and the dose range finding preclinical studies are expected to begin before or shortly after year-end. Separately, the Company has initiated the process to manufacture multi-kilogram batches of GLP-grade API for use in the formal GLP/IND-enabling animal toxicity studies.

Intellectual property protection for CG’806 – During the third quarter, Aptose continued to strengthen its patent portfolio. In September, Aptose and partner CrystalGenomics announced that the United States Patent and Trademark Office issued U.S. Patent No. 9,758,508 which claims numerous compounds, including the CG’806 compound, pharmaceutical compositions comprising the CG’806 compound, and methods of treating various diseases. The patent is expected to provide protection until the end of 2033. In August, Aptose received notice allowing U.S. Patent Application No. 14/655,954. The allowed ‘954 application claims numerous compounds, including the CG’806 compound, pharmaceutical compositions comprising the CG’806 compound, and methods of treating various diseases caused by abnormal or uncontrolled activation of protein kinase in a mammal by administering a compound, including the CG’806 compound.

Strengthened financial position – The Company recently announced that it entered into a Common Shares Purchase Agreement with Aspire Capital Fund, LLC ("Aspire Capital") to sell up to US$15.5 million of common shares to Aspire Capital. Under the terms of the agreement, Aspire Capital made an initial investment of US$500,000 to purchase APTO common shares at US $1.40 per share on October 31, 2017. In addition, Aspire Capital has committed to purchase up to an additional US$15.0 million of APTO common shares, at Aptose’s request from time to time during a 30 month period beginning on the effective date of a registration statement related to the transaction, and at prices based on the market price at the time of each sale. Under terms of the agreement, the Company also issued 321,429 common shares to Aspire Capital as consideration for Aspire Capital entering into the Purchase Agreement.

On November 14, 2017 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the third quarter ended September 30, 2017 (Press release, Cleveland BioLabs, NOV 14, 2017, View Source [SID1234522045]).

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Cleveland BioLabs reported a net loss of $(1.3) million, excluding minority interests, for the third quarter of 2017, or $(0.11) per share, compared to net income, excluding minority interests, of $1.1 million, or $0.10 per share, for the same period in 2016. The increase in net loss was primarily due to an increase in the downward non-cash adjustment to our warrant liabilities and decreased revenues and expenses due to the completion of our development contracts with the Russian Federation Ministry of Industry and Trade ("MPT"), which was partially offset by reduced operating costs aligned with our streamlined focus primarily on pursuing a pre- Emergency Use Authorization ("pre-EUA") with the U.S. Food and Drug Administration ("FDA") and a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure ("MRC").

As of September 30, 2017, the Company had $10.1 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of approval by the FDA and EMA and commercialization for entolimod as a medical radiation countermeasure are continuing to be the company’s most important priorities and goals. Per FDA’s request during the past quarter, we collated and submitted manufacturing information (Module 3) to the agency. We also initiated the in vivo biocomparability study in non-human primates that had been previously requested by the agency as part of its review of our pre-EUA application; this study is ongoing. Following completion of this study and discussion of the study results with the FDA, we expect the agency to resume review of our pre-EUA dossier."

"We are also pleased to announce submission in the European Union of a MAA for use of entolimod as a MRC. Our application was recently validated by the EMA and will now undergo agency review. Filing of the MAA represents a significant milestone for the company and another major step toward making entolimod available worldwide as a life-saving treatment of acute radiation syndrome ("ARS")," continued Dr. Kogan. "I am proud of the dedicated team at CBLI that prepared the MAA and shares the company’s commitment to developing an effective and practical ARS therapy for mass-casualty radiation and nuclear disaster scenarios."

Further Financial Results

Revenue for the third quarter of 2017 decreased to $0.3 million compared to $1.1 million for the third quarter of 2016. The net decrease was primarily attributable to reduced revenue from our development contracts with MPT which completed in 2016 and reduced revenue due to completion of manufacturing activities from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the third quarter of 2017 decreased to $0.9 million compared to $1.1 million for the third quarter of 2016. The reduction in research and development costs is due to completion

of a clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer and completion of associated preparatory research studies, offset by an increase in entolimod for biodefense applications for continued preclinical development along with drug manufacturing activities associated with our JWMRP contract and expenses associated with our regulatory activities in support of filing a MAA with EMA.

General and administrative costs for the third quarter of 2017 decreased to $0.6 million compared to $0.8 million for the third quarter of 2016. This decrease was primarily attributable to reductions in personnel and other operating costs in connection with cost savings efforts to streamline operations.

On November 14, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported financial results for the quarter ended September 30, 2017, and provided an update on the Clinical Validation Study of DetermaVu, the Company’s liquid biopsy lung cancer diagnostic test (Press release, Oncocyte, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316948 [SID1234522061]).

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"We continued to make important progress during the third quarter, including the successful completion of the Analytical Validation Study of DetermaVu and certification of our CLIA laboratory," said William Annett, President and Chief Executive Officer. "The consistent and significantly positive data that we have demonstrated and the numerous presentations highlighting the results are raising awareness of the potential benefits of DetermaVu in the early diagnosis of lung cancer."

Recent Developments

Successfully completed the Analytical Validation and CLIA Lab Validation studies of OncoCyte’s liquid biopsy lung cancer diagnostic test, confirming data that was reported in May at the American Thoracic Society 2017 International Conference (ATS), which demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92,

Received Clinical Laboratory Improvements Amendments (CLIA) certification of registration from the Centers for Medicare and Medicaid Services (CMS),

Dr. Anil Vachani, an Associate Professor of Medicine at the Hospital of the University of Pennsylvania and the Philadelphia Veteran’s Administration Medical Center, reported data on DetermaVu at the CHEST Annual Meeting 2017 in Toronto, Ontario, Canada, and

Data from the Company’s most recent breast cancer diagnostic study has been selected for presentation in a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS), being held from December 5-9, 2017.
Clinical Validation Study Update and Commercial Launch Plans

The Clinical Validation Study for DetermaVu is the final development step prior to commercial launch. This step involves assaying approximately 300 blinded prospectively collected samples to assess the performance of the full diagnostic system against clinically confirmed diagnoses.

During the process of running initial samples for the Clinical Validation Study, inconsistent analytic results were observed by OncoCyte’s technical team. OncoCyte believes this was caused by a variance in a recently received lot of consumables used in the processing system that analyzes blood samples for the genetic markers that indicate whether lung nodules found in patients are benign or suspicious. To address this issue, OncoCyte has ordered and is waiting to receive new lots of consumables from the supplier. Once the new consumables are received, OncoCyte will conduct internal quality control procedures to ensure that they meet OncoCyte’s requirements. Upon confirming that the new consumables will allow the analytic devices to generate data with the consistency and precision required for DetermaVu, OncoCyte will initiate the Clinical Validation Study. Due to the time required for these steps, OncoCyte now anticipates that completion of the Clinical Validation Study necessary for the commercial launch of DetermaVu will be delayed into 2018, depending on the successful rectification of the causes of the inconsistent analytic results.

OncoCyte has only observed this issue in the recent lot of consumables. Earlier studies were conducted using different lots of consumables where this issue was not observed. Consequently, the previous studies were not impacted by this issue and the positive results reported to date have not changed.

Mr. Annett commented, "We remain confident in the positive results reported to date and believe that the clinical use of DetermaVu can make an important contribution to the management of lung cancer nodules and help to improve therapeutic outcomes for lung cancer patients."

Breast Cancer Diagnostic Update

Data from the Company’s most recent breast cancer diagnostic study has been selected for presentation in a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS), which is being held from December 5-9, 2017. The data to be presented are from the Company’s NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer follow-on study.

Third Quarter 2017 Financial Results

For the quarter ended September 30, 2017, OncoCyte incurred a net loss of $6.9 million, or ($0.22) per share, compared to a net loss of $2.6 million, or ($0.10) per share, in the third quarter of 2016.

Operating expenses for the three months ended September 30, 2017, were $6.8 million, as reported, and were $3.2 million, on an as adjusted basis.

Research and development expenses for the quarter ended September 30, 2017, were $1.8 million compared to $1.4 million for the same period in 2016. The increase in research and development expenses for the three months ended September 30, 2017, of $0.4 million compared to the three months ended September 30, 2016, is primarily attributable to increases in salaries and compensation related expenses, development expenses primarily for our lung cancer test and stock-based compensation expenses.

General and administrative expenses for the three months ended September 30, 2017, increased by $3.2 million in comparison to the comparable period in 2016. The increase is mainly attributable to $3.0 million in shareholder noncash expense for the issuance of warrants to certain investors to exercise warrants, $0.1 million in recruiting and hiring expenses and $0.1 million in stock based compensation expenses.

At September 30, 2017, OncoCyte had cash and cash equivalents of $11.0 million and available-for-sale securities valued at $1.0 million.

Nine Month 2017 Financial Results

The net loss for the nine months ended September 30, 2017, was $15.4 million, or ($0.52) per share, compared to $8.1 million, or ($0.31) per share, in the first nine months of 2016.

Total operating expenses for the nine months ended September 30, 2017, were $15.0 million, as reported, and were $9.3 million on an as adjusted basis.

Research and development expenses for the nine months ended September 30, 2017, were $5.7 million compared with $4.2 million for the nine months ended September 30, 2016. The increase in research and development expenses of $1.4 million is primarily attributable to increases in salaries and payroll related expenses, clinical trial expenses for OncoCyte’s lung cancer test, DetermaVu, stock based compensation expenses, charges to OncoCyte by BioTime for shared services expenses, which includes facilities, insurance and other indirect expense, and services and development expenses primarily for DetermaVu. The increases were offset by a decrease in outside services expenses and consulting fees.

General and administrative expenses for the nine months ended September 30, 2017, increased by $4.3 million in comparison to the comparable period in 2016. The increase is mainly attributable to $4.1 million in noncash expense for the issuance of warrants to certain investors who exercised warrants, and $0.2 million in insurance expense.

Conference Call

OncoCyte will host a conference call today, November 14, 2017, at 4:30 p.m. ET / 1:30 p.m. PT to discuss financial results.

The dial-in number in the U.S./Canada is 888-542-1102; for international participants, the number is 719-325-2356. For all callers, please refer to Conference ID 1817036. To access the live webcast, go to the investor relations section on the Company’s website, View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial 719-457-0820. Use the Conference ID 1817036. Additionally, the archived webcast will be available at View Source