On March 6, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported that financial results and development progress for the fourth quarter and year ended December 31, 2017 (Filing, 8-K, Cleveland BioLabs, MAR 6, 2018, View Source [SID1234524411]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Cleveland BioLabs reported a net loss, excluding minority interests, of $(1.2) million for the fourth quarter of 2017, or $(0.10) per share, compared to a net loss of $(1.2) million, or $(0.11) per share, for the fourth quarter of 2016. Net loss, excluding minority interests, for full year 2017 was $(9.7) million, or $(0.87) per share, compared to a net loss of $(2.7) million, or $(0.24) per share, for full year 2016.

As of December 31, 2017, the Company had $8.8 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is estimated to fund operations for at least one year beyond the filing date of our Form 10-K.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The past year was one of substantial progress for the company and our Entolimod and Mobilan programs. We continued our pursuit of a pre- Emergency Use Authorization ("pre-EUA") with the U.S. Food and Drug Administration ("FDA") and submitted a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure ("MRC"), and continued clinical exploration designed to further substantiate the potential of our Toll-like receptor 5 agonists, entolimod and Mobilan."

"The pursuit of approval by the FDA and EMA and commercialization of entolimod as a medical radiation countermeasure continue to be the company’s most important priorities and goals," continued Dr. Kogan. "Per FDA request and as part of its review of our pre-EUA application, we collated and submitted manufacturing information (Module 3) to the agency and initiated the in vivo biocomparability study in non-human primates, which is currently 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," added Dr. Kogan. "Our application was recently validated by the EMA and is currently undergoing 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 and practical treatment of acute radiation syndrome for mass-casualty radiation and nuclear disaster scenarios."

Further Financial Results

Revenue for the fourth quarter of 2017 was $0.9 million compared to $1.0 million for the fourth quarter of 2016. Revenue for full year 2017 was $1.9 million compared to $3.5 million for full year 2016. The revenue changes are primarily due to decreased revenue from our MPT contracts at BioLab 612 and Panacela which were completed in 2016 partially offset by a slight increase in revenue from our DoD JWMRP contract.

Research and development (R&D) costs for the fourth quarter of 2017 were $1.5 million compared to $2.2 million for the fourth quarter of 2016. R&D costs for the full year 2017 decreased to $5.0 million compared to $6.5 million for the full year 2016. The research and development changes were primarily attributable to significant reductions of funds spent on Entolimod for oncology indication due to the completion of a clinical

study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naive patients with primary colorectal cancer, reduction in spending related to CBLB612 due to the completion of a clinical study in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy, and the
reduction in Panacela product candidate spending due to the completion of the active recruitment stage of the ongoing clinical studies with Mobilan. These reductions were partially offset by increased expenses on Entolimod’s biodefense indication for continued preclinical development along with other drug manufacturing activities associated with our JWMRP contract and expenses associated with our regulatory efforts with the EMA to prepare a pediatric investigational plan and other activities in support of filing a MAA with EMA.

General and administrative costs (G&A) for the fourth quarter of 2017 were $0.6 million compared to $0.7 million for the fourth quarter of 2016. G&A costs for full year 2017 decreased to $2.5 million compared to $3.4 million for full year 2016. These decreases were primarily attributable to reductions in personnel and outside professional costs.

At December 31, 2017 the Company had 11,279,834 shares of common stock outstanding. In addition, the Company has 211,487 shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $36.94 and 710,174 shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $8.95.

On March 6, 2018 Cellular Biomedicine Group Inc. (NASDAQ:CBMG) ("CBMG" or the "Company"), a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported business highlights and financial results for the fiscal year ended December 31, 2017 (Press release, Cellular Biomedicine Group, MAR 6, 2018, View Source [SID1234524441]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2017 was a pivotal year for CBMG and for the cell therapy environment. The U.S. Food and Drug Administration (FDA) had approved the first two chimeric antigen receptor T cell (CAR-T) therapies that use a patient’s own T cells to fight cancer. The issuance in December 2017 of China’s CFDA Guiding Principles for the Research and Evaluation of Cell Therapy Products provides a clear path for CBMG to advance our pipeline from clinical development to commercialization. We have initiated our CAR-T clinical trials and have been recruiting patients. We opened our new state-of-the-art GMP manufacturing facility in Shanghai’s Pharma Valley and signed strategic partnerships with GE Healthcare Life Sciences China and Thermo Fisher Scientific China to focus on improving manufacturing processes for cell therapies," said Tony (Bizuo) Liu, CEO of the Company. "These recent advancements, complete with existing in-house integrated Chemistry Manufacturing Controls ("CMC"), further our global leadership in cell therapy manufacturing and advance our goal to carry out transformative cancer treatment for patients. We have $48.9 million on hand at end of February 2018 to support our on-going clinical trials into 2019."

Tony Liu added, "We have also further strengthened our advisory team with the appointments of Dr. Michael A. Caligiuri, 2017-2018 President of American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), and President of City of Hope National Medical Center, as Chair of the company’s External Advisory Board and Dr. Robert S. Langer, Professor of The Koch Institute for Integrative Cancer Research at MIT, as a member of the Company’s Scientific Advisory Board."

2017 & Early 2018 Clinical and Facility Highlights

Immuno-Oncology Platform

●Commenced CALL-1 ("CAR-T against Acute Lymphoblastic Leukemia") Phase I clinical trial in China with CBMG’s optimized proprietary C-CAR011 construct of CD19 CAR-T therapy for the treatment of adult patients with Acute Lymphoblastic Leukemia ("ALL");

●Expanded the Phase I clinical trial in China of the Company’s ongoing CARD-1 ("CAR-T Against DLBCL") study in patients with Diffuse Large B-cell Lymphoma ("DLBCL");

●Sought to expand our efforts to develop therapies targeting solid tumors by acquiring a three-year option to license T-cell Receptor ("TCR") technology in Hepatocellular Carcinoma ("HCC").

Stem Cell Platform

●Completed 48-week follow-up of all patients in Phase I clinical trial of an "Off-the-Shelf" Allogeneic adipose-derived haMPC AlloJoinTM therapy for the treatment of Knee Osteoarthritis (KOA) patients in China;

●Awarded $2.29 million by the California Institute for Regenerative Medicine (CIRM), to support pre-clinical studies of AlloJoinTM, CBMG’s "Off-the-Shelf" Allogeneic stem cell treatment for KOA in the United States.

GMP Expansion and Capabilities

●Expanded the Company’s cell therapy manufacturing capabilities with the opening of a new 100,000-square-foot, state-of-the-art GMP manufacturing facility located in Shanghai Zhangjiang High-Tech Park (Shanghai’s "Pharma Valley");

● Completed the expansion of a 30,000 square foot multipurpose facility in Wuxi, China, which will be dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;

● Established strategic partnership with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in CAR-T and stem cell manufacturing. A joint laboratory, named "CBMG-GE Joint Laboratory of Cell Therapy" using GE Healthcare’s FlexFactoryTM platform will be established within CBMG’s Shanghai GMP manufacturing facility and will be dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system;

●Established a strategic partnership with Thermo Fisher Scientific China Ltd. to build a "CBMG-Thermo Fisher Scientific Joint Innovation & Application Center" which will focus on the research and development of an automated cell therapy manufacturing system.

Recent Business Highlights

●Advanced the Company’s cash position with two private placement transactions for total aggregate gross proceeds of approximately $45 Million;

●Sailing Capital, an institutional-quality, returns-focused private equity firm initiated by Shanghai International Group – the financial holding group of the Shanghai Municipal Government – became a significant investor in the Company.

Full Year 2017 Financial Results

Cash Position: The Company had working capital of $20.9 million as of December 31, 2017 compared to $38.3 million as of December 31, 2016. Cash position decreased to $21.6 million at December 31, 2017 compared to $39.3 million at December 31, 2016. We had an increase in cash used in operating and investing activities, partially offset by cash inflow generated from financing activities due to a private placement financing in 2017 for aggregate net proceeds of approximately $14.5 million.

Net Cash Used in Operating Activities: Full-year 2017 net cash used in operating activities was $18.6 million compared to $15.9 million in 2016. The 2017 change in operating assets and liabilities was primarily due to an increase in accounts receivable, other receivables and long-term prepaid expenses as well as the decrease in accrued expenses and non-current liabilities, netting of by the increase in other current liabilities.

Revenue: Full-year 2017 revenue was $0.3 million compared to $0.6 million in 2016. The majority of the revenue was derived from cell therapy technology service for the year ended December 31, 2017. The decrease in revenue is the result of prioritizing cancer therapeutic technologies, and focusing our clinical efforts on developing CAR-T technologies, Vaccine, Tcm and TCR clonality technologies.

G&A Expenses: Full-year 2017 general and administrative expenses were $12.8 million compared to $11.7 million in 2016. There was an increase in rental expenses of $2.2 million, which mainly resulted from the new leased plant located in the "Pharma Valley" of Shanghai from January 1, 2017.

R&D Expenses: Full-year 2017 research and development expenses were $14.6 million compared to $11.5 million in 2016. The increase was primarily attributed to an increase in rental expenses of $1,514,000, which was mainly attributed to the launching of R&D activities at our Beijing facility in the 2nd quarter of 2016 and the lease of a GMP facility in the United States to commence the KOA preclinical and clinical studies in 2017.

Net Loss: Full-year 2017 net loss allocable to common stock holders was $25.5 million compared to $28.2 million in 2016.

On March 6, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that Pieris will present at the following upcoming investor conferences (Press release, Pieris Pharmaceuticals, MAR 6, 2018, View Source [SID1234524460]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Cowen & Company 38th Annual Health Care Conference, Tuesday, March 13, 2018 at 8:40 a.m. EDT at the Marriott Copley Place in Boston. A webcast of the presentation can be accessed by visiting this link.
The Oppenheimer & Co. 28th Annual Healthcare Conference, Tuesday, March 20, 2018 at 11:30 a.m. EDT at the Westin New York Grand Central in New York City. A webcast of the presentation can be accessed by visiting this link.

On March 6, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported financial results for the three-month period and year ended December 31, 2017 (Press release, Spectrum Pharmaceuticals, MAR 6, 2018, View Source [SID1234524425]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2017 was a landmark year for Spectrum driven by advancements in our pipeline," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Poziotinib has the potential to be a life-altering therapy for cancer patients with exon-20 insertion mutations. ROLONTIS gives Spectrum a near-term opportunity to compete in a blockbuster market. We expect several pipeline milestones in 2018 and we look forward to keeping you updated."

Pipeline Update:

Poziotinib, an irreversible tyrosine kinase inhibitor:

The Company has initiated a multi-center study which is currently enrolling Non-Small Cell Lung Cancer (NSCLC) patients. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations at several leading cancer centers. The study will evaluate objective response rate (ORR) as the primary endpoint, and disease control rate (DCR), duration of response (DOR), and safety as secondary endpoints.
An investigator sponsored trial is currently enrolling at the University of Texas MD Anderson Cancer Center in NSCLC patients with exon 20 insertion mutations in EGFR or HER2. The study yielded preliminary results demonstrating evidence of significant antitumor activity in NSCLC patients with EGFR exon 20 insertion mutations, with preliminary data in the first 11 patients showing an unconfirmed Objective Response Rate of 73%. Safety profile was consistent with those previously described for poziotinib and other TKIs. The Company expects additional data from this study in 2018.
An abstract on poziotinib was accepted at AACR (Free AACR Whitepaper). Primarily pre-clinical data will be available at AACR (Free AACR Whitepaper) on the anti-tumor activity of poziotinib in HER2 exon-20 insertion mutations in NSCLC.
Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S.

ROLONTIS(eflapegrastim), a novel long-acting GCSF:

A registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company announced the ADVANCE study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms.
The Company has completely enrolled RECOVER, an international Phase 3 trial that has a similar design.
The Company expects to file the BLA in Q4 2018.

2018 Guidance

The Company expects total revenue to be between $90 to $110 million in 2018. Gross margin is expected to improve primarily as a result of enhancements to Evomela manufacturing. R&D expense is expected increase driven by additional spend on pipeline.

Three-Month Period Ended December 31, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $27.9 million in the fourth quarter of 2017. Product sales in the fourth quarter included: FUSILEV (levoleucovorin) net sales of $0.9 million, FOLOTYN (pralatrexate injection) net sales of $11.0 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.9 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.2 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, and EVOMELA (melphalan) for injection net sales of $8.3 million.

Spectrum recorded net loss of $28.6 million, or $0.29 per basic and diluted share in the three-month period ended December 31, 2017, compared to net loss of $18.1 million, or $0.23 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $22.1 million in the quarter, as compared to $16.0 million in the same period in 2016. Selling, general and administrative expenses were $29.2 million in the quarter, compared to $18.9 million in the same period in 2016.

During the quarter the Company purchased $69.5 million face value of its convertible debentures for $27.3 million in cash and 5.4 million newly-issued shares of our common stock. The Company ended the quarter with cash, cash equivalents and marketable securities of $227.6 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $22.8 million, or $0.23 per basic and diluted share in the three-month period ended December 31, 2017, compared to non-GAAP net loss of $8.1 million, or $0.10 per basic and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $21.3 million, as compared to $15.4 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $19.1 million, as compared to $15.6 million in the same period in 2016.

Twelve-Month Period Ended December 31, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $116.2 million for the twelve months ended December 31, 2017. Total product sales decreased 9.7% from $128.6 million in the same period of 2016.

Product sales in 2017 included: FUSILEV (levoleucovorin) net sales of $7.3 million, FOLOTYN (pralatrexate injection) net sales of $43.0 million, ZEVALIN (ibritumomab tiuxetan) net sales of $11.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $6.6 million, BELEODAQ (belinostat) for injection net sales of $12.4 million, and EVOMELA (melphalan) for injection net sales of $35.2 million.

Spectrum recorded net loss of $91.2 million, or $1.07 per basic and diluted share in the twelve-month period ended December 31, 2017, compared to net loss of $69.8 million, or $0.96 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $65.9 million for the year, as compared to $59.1 million in the same period in 2016. Selling, general and administrative expenses were $84.3 million for the year, compared to $88.4 million in the same period in 2016.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $52.1 million, or $0.61 per basic and diluted share in the twelve-month period ended December 31, 2017, compared to non-GAAP net loss of $16.8 million, or $0.23 per basic and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $63.4 million, as compared to $54.1 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $65.4 million, as compared to $64.1 million in the same period in 2016.

On March 6, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported that the company will present at the Cowen and Company 38th Annual Health Care Conference 2018 in Boston, Massachusetts (Press release, Constellation Pharmaceuticals, MAR 6, 2018, View Source [SID1234524412]). The presentation is scheduled for Tuesday, March 13, at 11:20 a.m. Eastern Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A webcast of the presentation will be available live and 30 days following the event. The webcast may be accessed via the conference website and from the investor relations section of the Corvus website