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Atossa Genetics Announces Third Quarter 2017 Financial Results And Provides Company Update

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.

CLEVELAND BIOLABS REPORTS THIRD QUARTER 2017 FINANCIAL RESULTS AND DEVELOPMENT PROGRESS

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]).

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.

Mateon Provides Corporate Update and Reports Third Quarter 2017 Financial Results

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]).

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.

Moleculin Biotech, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2017

On November 14, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported its financial results for the third quarter ended September 30, 2017 (Press release, Moleculin, NOV 14, 2017, View Source [SID1234522027]). Additionally, the Company announced potential upcoming milestones and recent corporate developments.

Management Discussion
Walter Klemp, Chairman and CEO of Moleculin, commented, "We continue to make progress in advancing our drug candidates through their various regulatory approval pathways. We accomplished a number of important milestones on Annamycin, one of our lead cancer drug candidates. During the quarter, the Food and Drug Administration ("FDA") allowed our Investigational New Drug application ("IND") to proceed, meaning we could begin clinical trials of Annamycin for the treatment of relapsed or refractory Acute Myeloid Leukemia ("AML"). In preclinical tests, Annamycin has shown little to no cardiotoxicity and an ability to avoid the multidrug resistance mechanisms that often defeat the current first-line therapies for AML. For that reason, we believe Annamycin has the potential to become the first second-line therapy suitable for a majority of relapsed or refractory AML patients. Because first-line therapies fail in a significant majority of AML patients, we believe Annamycin may give new hope to those who have run out of treatment options.

We recently announced that 14 qualified cancer clinics have asked to participate in in the Phase I/II clinical trial that is the subject of our IND, and that will study Annamycin for the treatment of relapsed or refractory AML. Seven of the interested sites are in Poland which we anticipate will give us access to a higher percentage of patients who are ‘treatment naïve’ patients. Study subjects who have not received any experimental therapies before entering our trial are important because we believe such patients may be in a better condition to respond positively to the Annamycin therapy. We have requested permission from the Polish government and we expect to receive authorization before the end of the year, at which point we plan to immediately begin enrolling patients.
We have several other drug candidates that are making progress in their respective development programs. We recently announced that the MD Anderson Cancer Center ("MD Anderson") has submitted an IND request to conduct a physician-sponsored Phase I clinical trial of WP1066 in patients with glioblastoma and melanoma that has metastasized to the brain. Preclinical testing suggests that WP1066 may increase the natural immune response to tumors, suppressing of tumor cell proliferation and tumor cell survival. If that IND is approved, we will then have two "clinical stage" programs under way.

During the quarter, we also announced that we have begun efforts to seek a Clinical Trial Authorization ("CTA") in Poland for the study of WP1220 (part of our WP1066 Portfolio) in the treatment of Cutaneous T-Cell Lymphoma. Additionally, we announced several collaborations, including an agreement with Mayo Clinic to study WP1066 for the treatment of a rare form of childhood brain tumor and two projects with the University of Bergen in Norway, one to conduct research on the ability of WP1122 to inhibit glycolysis and limit tumor growth and the other to dig more deeply into the potential ability of WP1066 to stimulate anti-cancer immune response. In addition, we announced research findings suggesting that one of our WP1122 analogs could be well suited for the treatment of pancreatic cancer."

"We believe one of the key strengths of Moleculin is the breadth and diversity of our drug development portfolio. We now have active development programs with four drug candidates representing three substantially different approaches to treating cancer."

Jonathan Foster, Chief Financial Officer of Moleculin, stated, "I am pleased we have been able to raise $8.7 million during the nine-month period ended September 30, 2017. As a result, we finished the third quarter with $8.7 million in cash and cash equivalents and no debt, compared to $5.0 million at December 31, 2016. During the third quarter we had a cash burn rate of approximately $1.5 million, but anticipate the cash burn rate will increase as we move our cancer drugs into clinical trials. We are highly focused on running our business in an efficient manner, prudently managing our cash burn rate and maintaining a solid cash position."

Third Quarter Highlights and Recent Corporate Developments
Moleculin Appoints Dr. Sandra Silberman as Chief Medical Officer – New Products – November 8, 2017, the Company announced the appointment of Dr. Sandra Silberman as Chief Medical Officer ("CMO") in charge of New Products.
Moleculin Announces MD Anderson has Filed an IND with the FDA on its Drug WP1066 for the Treatment of Brain Tumors – November 1, 2017, the Company announced that responses have been submitted to FDA requests for additional information relating to the physician-sponsored IND application to study WP1066 as a potential treatment for brain tumors.

Moleculin Requests Authorization from the Polish Government to Advance Annamycin – October 24, 2017, the Company announced that it has submitted its request for CTA in Poland which, if allowed, will enable a clinical trial to study Annamycin for the treatment of relapsed or refractory AML in Poland. This will be in addition to the previously announced allowance of Moleculin’s IND filing with the FDA.

Moleculin Announces 14 Qualified Clinical Sites Requesting Participation in Annamycin Trial – October 18, 2017, the Company announced that 14 qualified cancer clinics have requested to participate in its clinical trial to study Annamycin for the treatment of relapsed or refractory AML.

Moleculin Announces Strategic Collaboration to Develop Immune Stimulation Drug – October 11, 2017, the Company announced that it has entered into an agreement to collaborate with the University of Bergen to expand research on WP1066 and early indications of a possible dual ability to increase immune system response to tumors while also suppressing tumor cell proliferation tumor cell and survival.

Moleculin Signs Agreement with First Hospital for Annamycin Trials – October 3, 2017, the Company announced it has entered into an agreement with the first of several hospitals desiring to become treatment sites for its clinical trial to study Annamycin for the treatment of relapsed or refractory AML.

Moleculin Announces FDA Approval of Annamycin IND – September 26, 2017, the Company announced that the FDA has allowed Moleculin’s IND for the study of Annamycin in relapsed or refractory AML to proceed. This allows Moleculin to begin clinical trials of Annamycin in the US.

Moleculin Engages CRO to Begin Clinical Trials of WP1220 for the Treatment of Cutaneous T-Cell Lymphoma – September 13, 2017, the Company announced it has engaged contract research organization ("CRO") Bioscience SA ("Bioscience") to prepare for a proof-of-concept clinical trial in Poland to study Moleculin’s drug candidate WP1220 for the treatment of cutaneous T-cell lymphoma.

Moleculin to Collaborate on Combining its WP1122 Brain Cancer Drug Candidate with Roche’s Drug Avastin – September 6, 2017, the Company announced it has entered into a collaborative agreement with the University of Bergen in Norway to study WP1122 in combination with the drug Avastin (bevacizumab) made by Roche Pharma. Roche Pharma is not a party to the collaborative agreement.

Moleculin Begins Clinical Testing Site Development Efforts in Poland; Selects Bioscience SA as Polish CRO – August 3, 2017, the Company announced it has selected Bioscience SA, a Polish CRO to begin identifying and preparing clinical testing sites in Poland for Annamycin, the Company’s drug candidate for the treatment of relapsed or refractory AML.
Moleculin Strengthens Board of Directors with Appointment of John M. Climaco – July 27, 2017, the Company announced the appointment of John M. Climaco as an independent member of the Company’s Board of Directors, effective July 24, 2017 to fill a board vacancy.

Moleculin Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin – July 18, 2017, the Company announced it has signed a new technology license agreement with MD Anderson based on new patent applications Moleculin intends to file relating to its drug Annamycin for the treatment of relapsed or refractory AML.
Moleculin Appoints Lead European Principal Investigator for Planned Annamycin Clinical Trial – July 6, 2017, the Company announced it has appointed Dr. Lidia Gil of Poznan University of Medical Sciences in Poznan, Poland to be the lead European Principal Investigator for its upcoming planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory AML, subject to receipt of Polish approval of the CTA.

Third Quarter Results
Research and Development Expense. Research and development (R&D) expense was $1.1 million and $0.5 million for the three months ended September 30, 2017 and 2016, respectively. The increase of approximately $0.6 million mainly represents an increase of approximately: $0.1 million related to an increase in R&D associated headcount costs, $0.1 million for sponsored research and related expenses; and, approximately $0.4 million associated with developing and testing drug product as we prepare our IND for Annamycin and for the related clinical trials.
General and Administrative Expense. General and administrative expense was $1.3 million and $0.9 million for the three months ended September 30, 2017 and 2016, respectively. The expense increase of approximately $0.4 million was mainly attributable to the increase in headcount and associated payroll costs of $0.2 million, $0.3 million of stock based compensation; and, approximately $0.1 million in legal, accounting, consulting, and other professional expenses. This was offset by a reduction in public listing expenses of $0.2 million.
Net Loss. The net loss for the three months ended September 30, 2017 was $2.9 million which included non-cash income of $0.5 million related to a gain recognized on the expiration of warrants. The net loss also included additional noncash charges for $0.5 million for stock based compensation and other stock based expenses.
Liquidity and Capital Resources

As of September 30, 2017, we had $8.7 million in cash and cash equivalents compared to $5.0 million at December 31, 2016. In February 2017, we completed a public offering of our common stock and warrants, pursuant to which we received approximately $4.5 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses. Additionally, through September 30, 2017, $3.3 million in cash was received from the exercise of warrants issued in our February public offering and $0.4 million from the sale of common stock in our ATM offering. Cash used in operations was $4.9 million for the nine months ended September 30, 2017. This increase over the prior year of $2.3 million was mainly due to to an increase in headcount and general company activity as it prepared its IND for Annamycin and readied for the related, upcoming trials. We believe that our existing cash and cash equivalents as of September 30, 2017 and cash generated already in the third quarter will be sufficient to fund our planned operations into the third quarter of 2018. Such plans are subject to change depending on clinical enrollment progress and use of drug product.

10-Q – Quarterly report [Sections 13 or 15(d)]

Angiogenex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Angiogenex, 2017, NOV 13, 2017, View Source [SID1234522031]).