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

On November 14, 2017 Atossa Genetics Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported third quarter ended September 30, 2017 financial results and provided an update on recent company developments (Press release, Atossa Genetics, NOV 14, 2017, View Source [SID1234522044]).

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Steve Quay, President and CEO, commented, "We are very pleased with our recent clinical progress with our Endoxifen programs. Preliminary results from our Phase 1 study show that all objectives of both our proprietary topical and oral formulations of Endoxifen have been met. We recently raised capital to support advancement of our Endoxifen programs into Phase 2 trials."

Recent Corporate Developments

Atossa’s important recent developments include the following:

Completed a public offering of common stock with gross proceeds of $5.5 million.

Announced the preliminary results from the Phase 1 study of oral Endoxifen with all objectives successfully met: there were no clinically significant safety signals and no clinically significant adverse events; oral Endoxifen was well tolerated; and study participants exhibited dose-dependent Endoxifen levels consistent with the therapeutic ranges identified in published reports.

Announced a new program using Chimeric Antigen Receptor Therapy, or CAR-T. Atossa plans to use its proprietary intraductal microcatheter technology to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer.

Announced an upcoming Phase 2 Study of proprietary topical Endoxifen for the treatment of women with mammographic breast density, or MBD, which will be conducted by Stockholm South General Hospital in Sweden. The study will be led by principal investigator Dr. Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

Announced the preliminary results from the Phase 1 study of topical Endoxifen with all objectives successfully met: there were no clinically significant safety signals and no clinically significant adverse events; the topical Endoxifen was well tolerated; and there were low but measurable Endoxifen levels detected in the blood in a dose-dependent fashion.
Q3 2017 Financial Results

We are in the research and development phase and we did not generate revenue for the three and nine months ended September 30, 2017.

Total operating expenses were approximately $2.1 million and $5.6 million for the three and nine months ended September 30, 2017, respectively, consisting of general and administrative (G&A) expenses of approximately $1.3 million and $3.5 million, respectively, and research and development (R&D) expenses of approximately $0.7 million and $2.1 million, respectively. Total operating expenses were approximately $1.6 million and $5.4 million for the three and nine months ended September 30, 2016, respectively, consisting of G&A expense of approximately $1.5 million and $5.0 million, respectively, and R&D expenses of $0.1 million and $0.4 million, respectively.

On November 14, 2017 Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company pioneering the field of regenerative medicine, reported financial and operational results for the quarter ended September 30, 2017, as well as recent corporate progress (Press release, Asterias Biotherapeutics, NOV 14, 2017, View Source;p=RssLanding&cat=news&id=2316950 [SID1234522062]).

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"We have continued to advance our spinal cord injury clinical trial while improving our financial profile in advance of the next phase of our AST-OPC1 program," said Mike Mulroy, President and Chief Executive Officer of Asterias. "Recent 12-month data from our SCiStar study showed subjects administered 10 million cells of AST-OPC1 observed meaningful and durable recovery of arm, hand and finger function that was more than double the rates of recovery seen at 12 months in both matched historical controls and published data. Based on this early encouraging result in the clinic, combined with our extensive pre-clinical work, our safety study in thoracic spinal cord injury, and MRI data suggesting durable engraftment of our OPC1 cells, we look forward to investing in a larger randomized controlled trial in the future. Our next data readout is expected in early 2018, and that data should help provide further clarity surrounding the design of that trial. Separately, in our cancer immunotherapy program, we received regulatory clearance during the third quarter to initiate the first-in-human clinical trial of AST-VAC2 in non-small cell lung cancer in the United Kingdom."

"On the financial front, the company has strengthened its cash position and improved its cost structure," said Ryan Chavez, Chief Financial Officer. "These steps, which include both our recent capital raise and a more focused allocation of capital into investments that can deliver value in the short and medium term, have strengthened the company’s financial outlook so that it may continue to advance its programs in the clinic and achieve additional important clinical milestones in 2018."

Third Quarter 2017 and Recent Key Achievements

AST-OPC1:

Reported 12-month data from the AIS-A 10 million cell cohort (Cohort 2) in the SCiStar study that showed additional motor level improvement was seen at 12 months. Specifically, 67% (4/6) of subjects have recovered two or more motor levels over baseline on at least one side through 12 months, which compares favorably to the rates of recovery at 9 months (50%) and at 3 months and 6 months (33%). Furthermore, the rate of recovery at 12 months is more than double the rates of recovery seen in both matched historical controls (29%) and published data in a similar population (26%).
Reported new 12-month MRI data from the SCiStar study that indicated no sign of lesion cavities in any subject. The MRI results are consistent with formation of a tissue matrix at the injury site, which is supportive evidence showing that AST-OPC1 cells have durably engrafted to help prevent lesion cavity formation, possibly reducing spinal cord tissue deterioration after spinal cord injury.
Reported continued positive safety profile for AST-OPC1 based on trial results to date. In September, an independent Data Monitoring Committee (DMC) recommended the SCiStar study continue as planned after it completed a regularly scheduled review of the accumulated safety data to date from the study.
Obtained U.S. Food and Drug Administration (FDA) designation as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act. The RMAT designation is intended to facilitate expedited development, review and approval for important new regenerative medicine therapies for which preliminary clinical evidence indicates the potential to address a serious or life-threatening disease or condition. In addition to providing an avenue for increased and earlier interactions with the FDA, RMAT-designated products may be eligible for priority review and accelerated approval.
Published new efficacy and safety data from preclinical studies of AST-OPC1 in the peer-reviewed journal "Stem Cells Translational Medicine." The preclinical studies described in this paper were among those submitted in Asterias’ 2014 Investigational New Drug Amendment in support of the SCiStar trial.
AST-VAC2:

Received regulatory clearance in the United Kingdom to initiate the clinical trial of Asterias’ cancer immunotherapy product AST-VAC2 in subjects with early and late stage non-small cell lung cancer (NSCLC). This First-In-Human (FIH) trial, which is being sponsored and managed by Cancer Research UK, will examine the safety, tolerability, immunogenicity and activity of AST-VAC2 in subjects with NSCLC.
Corporate:

In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds.
Asterias expanded its operating expense reduction efforts and reduced staffing allocated to non-clinical activities as a part of a broader effort to more closely align operating expenses with the company’s primary goal of continuing to generate clinical data in its key clinical stage programs. The company anticipates a one-time severance-related pre-tax restructuring charge of approximately $0.6 million in the fourth quarter of 2017 associated with the operating expense reductions. As a result of the operating cost saving initiatives implemented year to date, the company expects to reduce its operating costs by approximately 40% to start 2018.
Financial Results

As of September 30, 2017, the combined total of cash, cash equivalents, and available-for-sale securities totaled $20.7 million. In October 2017, Asterias closed the sale of shares of its common stock in a registered direct offering which raised approximately $10.4 million in gross proceeds. As of October 31, 2017, Asterias had a combined total of cash, cash equivalents, and available-for-sale securities of approximately $27.3 million.

Total revenues were $1.7 million for the third quarter. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $6.6 million in the third quarter, with the primary driver being expenses associated with the company’s AST-OPC1 program. General and administrative expenses were $2.0 million in the third quarter.

Net loss was $6.8 million, or $0.14 per share, for the third quarter. For the quarter ended September 30, 2017, net cash used in operating activities was $4.5 million and net cash provided from financing activities was $1.1 million.

Conference Call and Webcast Details

Asterias will host a conference call and webcast today, November 14, 2017, at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss the results and corporate developments. For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 877-830-2645 (U.S./Canada) or 785-424-1791 (international) five minutes prior to the start of the call and providing the Conference ID 8579194. To access the live webcast, go to 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 dialing 888-203-1112 (U.S./Canada) or 719-457-0820 (international) and providing the Conference ID 8579194. Additionally, the archived webcast will be available at View Source

GTx has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, GTx, 2017, NOV 14, 2017, View Source [SID1234522055]).

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