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Fate Therapeutics Reports Fourth Quarter 2016 Financial Results

On March 16, 2017 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the fourth quarter and year ended December 31, 2016 (Filing, Q4/Annual, Fate Therapeutics, 2016, MAR 16, 2017, View Source [SID1234518176]).

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"The past twelve months has been a period of significant progress for Fate Therapeutics, including advancing two first-in-class product candidates to clinical development and launching our revolutionary induced pluripotent cell platform to enable our ‘one cell, many patients’ approach to cancer immunotherapy. We have recently treated the first subject in our PROTECT study with ProTmune, our next-generation mobilized peripheral blood graft with the potential to change the field of allogeneic hematopoietic cell transplantation, and FDA clearance was granted for clinical investigation of FATE-NK100, our first-in-class adaptive memory natural killer cell product candidate. Additionally, we established collaborations with Dr. Jeffrey S. Miller at the University of Minnesota and Dr. Michel Sadelain at Memorial Sloan Kettering Cancer Center to build our off-the-shelf cancer immunotherapy pipeline using master pluripotent cell lines," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Looking ahead to a data-rich 2017, having recently raised approximately $70 million from a leading investor syndicate, we are in a position of financial strength and are poised to be the first company to advance a cancer immunotherapy created from a master pluripotent cell line toward clinical development."

Recent Highlights & Program Updates

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First Subject Treated with ProTmune for GvHD Prevention. The Company’s Phase 1/2 PROTECT study of ProTmune for the prevention of acute graft-versus-host disease (GvHD) has treated its first subject and is open across ten U.S. centers. The Phase 1 stage of the clinical study is expected to enroll up to ten adult subjects with hematologic malignancies undergoing allogeneic mobilized peripheral blood hematopoietic cell transplantation. ProTmune has been granted Fast Track and Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency.

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IND Cleared by FDA for FATE-NK100 in AML. Enrollment of a first-in-human clinical trial of FATE-NK100 under an investigator-initiated clinical trial is poised to commence at the Masonic Cancer Center, University of Minnesota (UMN). In February 2017, the FDA cleared the Investigational New Drug (IND) application of FATE-NK100 for the treatment of refractory or relapsed acute myelogenous leukemia (AML). An oral presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2016 featured FATE-NK100 preclinical data. The natural killer (NK) cell product candidate demonstrated enhanced anti-tumor activity across a broad range of liquid and solid tumors, improved persistence and increased resistance to immune checkpoint pathways as compared to current conventional NK cell therapies.

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Expanded Collaboration with UMN to Advance hnCD16-iNK Cell Product Candidate. In February 2017, Fate Therapeutics and UMN expanded their collaboration, initiating the clinical translation of a first-of-kind product candidate, an off-the-shelf cellular immunotherapy created from an induced pluripotent stem cell (iPSC) line for the treatment of cancer. Similar to the manufacture of therapeutic antibodies using master cell lines, the Company’s targeted NK cell product candidate is created from a master iPSC line engineered to express a proprietary high-affinity, non-cleavable CD16 (hnCD16) receptor. Preclinical data, which the Company plans to present at the upcoming 2017 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), demonstrates the potential of its hnCD16-iNK cell product candidate to complement standard-of-care monoclonal antibody therapy for the treatment of breast, head and neck, colorectal and certain blood cancers by binding to and selectively killing antibody-coated tumor cells.

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Launched iPSC-derived NK Cell Research Collaboration with Oslo University Hospital. In February 2017, Fate Therapeutics formed a two-year research collaboration with Oslo University Hospital to develop NK cell product candidates expressing certain activating and targeting receptors using master pluripotent cell lines. The collaboration is being led by Karl-Johan Malmberg, M.D., Ph.D., Group Leader of Natural Killer Cell Biology and Cell Therapy, Department of Immunology, who has extensively studied the human NK cell repertoire, including the influence of killer cell immunoglobulin-like receptors, in regulating anti-tumor activity.

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Bolstered NK Cell Product and iPSC Platform Intellectual Property. In December 2016, the Company exclusively licensed intellectual property from UMN covering compositions of a modified CD16, as well as certain chimeric antigen, receptors and immune cells expressing such receptors. In addition, in March 2017, the U.S. Patent and Trademark Office issued U.S. Patent No. 9,593,311, which is owned by the Whitehead Institute for Biomedical Research and licensed exclusively to the Company for all therapeutic purposes, protecting cellular compositions comprising an iPSC and a WNT pathway activator. Publications in the pluripotent cell biology field have shown that WNT pathway activation is required to enable single cell isolation and clonal expansion of iPSCs, which are critical steps in generating, engineering and maintaining master pluripotent cell lines.

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Completed $56.7M Common and Preferred Stock Private Placement. In November 2016, Fate Therapeutics issued 2.82 million shares of non-voting Class A Preferred Stock at $13.30 per share, each of which is convertible into five shares of common stock upon certain conditions, and 7.24 million shares of common stock at $2.66 per share. The sale and issuance was pursuant to a securities purchase agreement with certain institutional and accredited investors including Redmile

Group LLC, BVF Partners L.P., EcoR1 Capital LLC, Franklin Advisers, Inc. and certain members of the Company’s Board of Directors and management.

Fourth Quarter 2016 Financial Results

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Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of December 31, 2016 were $92.1 million compared to $64.8 million as of December 31, 2015. The increase was primarily driven by net proceeds from the sale of the Company’s securities in two private issuances, a $56.7 million sale and issuance of preferred and common stock in November 2016 and a $10.2 million sale and issuance of common stock in August 2016. These proceeds were offset by the Company’s use of cash to fund operating activities and to service principal and interest obligations under its loan agreement with Silicon Valley Bank.

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Total Revenue: Revenue was $1.0 million for the fourth quarter of 2016 compared to $1.1 million for the comparable period in 2015. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.

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Total Operating Expenses: Total operating expenses were $8.7 million for the fourth quarter of 2016 compared to $8.0 million for the comparable period in 2015. Operating expenses for the fourth quarter of 2016 included $0.8 million of stock compensation expense, compared to $0.5 million for the comparable period in 2015.

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R&D Expenses: Research and development expenses were $6.2 million for the fourth quarter of 2016 compared to $5.4 million for the comparable period in 2015. The increase in R&D expenses was primarily related to an increase in third-party service provider fees to support the Company’s clinical development of ProTmune and the preclinical development of its NK cell programs.

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G&A Expenses: General and administrative expenses were $2.5 million for the fourth quarter of 2016 compared to $2.6 million for the comparable period in 2015. The decrease in G&A expenses was primarily related to a decrease in intellectual property-related expenses.

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Common Shares Outstanding: Common shares outstanding as of December 31, 2016 were 41.4 million compared to 28.7 million as of December 31, 2015. Common shares outstanding increased primarily as a result of the Company’s sale and issuance of its securities in two private issuances in November and August 2016, respectively.

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Preferred Shares Outstanding: Preferred shares outstanding as of December 31, 2016 were 2.82 million. Preferred shares outstanding increased as a result of the Company’s sale and issuance of 2.82 million shares of non-voting Class A convertible preferred stock to Redmile Group, LLC in November 2016.

Omeros Corporation Reports Fourth Quarter and Year-End 2016 Financial Results

On March 16, 2017 Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, reported recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2016 (Press release, Omeros, MAR 16, 2017, View Source [SID1234518173]).

4Q 2016 total and OMIDRIA revenues were $12.9 million. Revenues from OMIDRIA sales rose 94% from the prior year’s fourth quarter and 14% from 3Q 2016. OMIDRIA units sold in the fourth quarter increased by 22% over the third quarter.
Total year 2016 revenues were $41.6 million, a 208% increase over 2015, the year in which OMIDRIA was launched.
Net loss in 4Q 2016 was $19.6 million, or $0.45 per share, and, for the full year of 2016, was $66.7 million, or $1.65 per share. Both periods included a $5.6 million ($0.13 per share in 4Q) charge for early extinguishment of previously existing debt. Non-cash expenses for 4Q and the full year of 2016 were $5.2 million, or $0.12 per share, and $16.1 million, or $0.40 per share, respectively.
Successful outcome of post-marketing clinical trial of OMIDRIA in pediatric patients undergoing cataract surgery, which is expected to result in an additional six months of regulatory exclusivity.
Opened enrollment in Phase 3 clinical trial of OMS721 in patients with atypical hemolytic uremic syndrome (aHUS).
Positive data from Phase 2 clinical trials of OMS721 in both renal disorders and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
"2016 was a year of significant achievements across a wide range of our programs," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMIDRIA sales grew more than two hundred percent over the previous year and our pipeline made equally impressive progress. Our Phase 3 trial in aHUS with our MASP-2 inhibitor OMS721 is underway, and positive OMS721 Phase 2 data in both IgA nephropathy and HSCT-TMA have set the stage for additional Phase 3 registration trials this year. MASP-3, targeted by our OMS906 program, was shown to be the key activator of the alternative pathway. Both OMS906 and our PDE7 inhibitor OMS527 are advancing quickly toward the clinic, and our GPCR program continues to generate exciting data over broad therapeutic areas, including immuno-oncology. We are pleased with Omeros’ accomplishments in 2016, and we expect that 2017 will build on those successes."

Fourth Quarter and Recent Highlights and Developments

Omeros reported in November 2016 the successful outcome of its recently completed post-marketing clinical trial of the effect of OMIDRIA in pediatric patients undergoing cataract surgery. In the trial, OMIDRIA was well tolerated with adverse event rates consistent with those seen in pediatric cataract surgery and with the control group. The company plans to submit a supplemental NDA this year, requesting expanded label language to cover patients of any age. Omeros expects that this submission will result in an additional six months of regulatory exclusivity for OMIDRIA.
Highlights and developments regarding OMS721, Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including aHUS and HSCT-TMA, and for the treatment of complement-related renal diseases, include:
Enrollment has opened in Omeros’ Phase 3 clinical trial in patients with aHUS.
Omeros reported positive data (p = 0.017) from its Phase 2 clinical trial of OMS721 for the treatment of renal disorders, including IgA nephropathy and membranous nephropathy, in October 2016. In this trial, OMS721 significantly improved key endpoints of renal function, and patients achieved partial remission with only 12 weeks of dosing. Also in October 2016, Omeros announced positive results in patients with HSCT-TMA from the company’s Phase 2 clinical trial of OMS721 in TMAs, with clinically meaningful improvement in measures of red blood cell destruction, specifically lactate dehydrogenase (LDH) and haptoglobin levels (p < 0.01 and p < 0.06, respectively).
Following discussion with the FDA, the company plans to pursue breakthrough therapy designation for OMS721 in IgA nephropathy and in HSCT-TMA. Omeros also has been pursuing accelerated approval for OMS721 in both of these indications as well as in aHUS. The FDA has granted fast track designation for OMS721 in patients with aHUS and orphan designation for OMS721 in patients with TMAs, including aHUS and HSCT-TMA.
Highlights and developments regarding OMS906, Omeros’ lead antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), a protein essential for the activation of the alternative pathway of complement (APC), include:
In November 2016, the company announced data from the evaluation of OMS906 in non-human primates. Single-dose administration of OMS906 to cynomolgus monkeys resulted in sustained ablation of systemic APC activity for approximately 16 days. The APC is involved in a wide range of diseases, including paroxysmal nocturnal hemoglobinuria (PNH), aHUS, age-related macular degeneration, arthritis, asthma and traumatic brain injury. No safety concerns were identified.
Omeros is finalizing selection of lead and back-up molecules and preparing to initiate scale-up for clinical trials. The company is evaluating PNH as the first clinical indication for OMS906.
In October 2016, Omeros entered into a $125.0 million senior secured credit facility with CRG Servicing LLC, under which the company borrowed $80.0 million in November 2016. The credit facility has a six-year term with four years (through December 31, 2020) of interest-only payments after which quarterly principal and interest payments will be due through the September 30, 2022 maturity date; in addition, there is the potential to extend the interest-only period through maturity if certain milestones are satisfied. The company may borrow additional tranches of up to $25.0 million and $20.0 million, subject to the satisfaction of certain milestones on or before June 30, 2017 and December 31, 2017, respectively.
Financial Results

Fourth Quarter 2016

For the quarter ended December 31, 2016, total revenues were $12.9 million, all relating to sales of OMIDRIA. This compares to OMIDRIA revenues of $6.7 million for the same period in 2015. On a sequential quarter-over-quarter basis, OMIDRIA revenue grew $1.6 million, or 14%. The increase in units sold from 3Q to 4Q 2016 was 22%. The quarter-over-quarter increases in OMIDRIA revenue and units sold are due to continued acceptance of and increased demand for OMIDRIA in the ophthalmic surgery community.

Total operating costs and expenses for the three months ended December 31, 2016 were $24.8 million compared to $24.7 million for the same period in 2015. The change in the current year quarter was primarily due to increased legal costs associated with the company’s patent infringement lawsuit against Par Pharmaceutical and additional headcount-related costs, partially offset by a decrease in research and development costs due to the timing of clinical and manufacturing activities.

In November 2016, the company incurred a $5.6 million loss ($0.13 per share) on early extinguishment of debt associated with the initiation of a new secured credit facility and the prepayment of Omeros’ prior secured credit facility.

For the three months ended December 31, 2016, Omeros reported a net loss of $19.6 million, or $0.45 per share, which included noncash expenses of $5.2 million ($0.12 per share). This compares to the prior year’s fourth quarter when Omeros reported a net loss of $19.8 million, or $0.52 per share, which included non-cash expenses of $2.8 million ($0.07 per share).

At December 31, 2016, the company had cash, cash equivalents and short-term investments of $45.3 million. In addition, the company had $5.8 million of restricted cash on hand to satisfy its credit facility covenant and lease obligations.

Full Year 2016

Revenues for the full year 2016 were $41.6 million, compared to $13.5 million for the full year 2015.

Total operating costs and expenses for the year ended December 31, 2016 were $95.9 million, an increase of $11.1 million compared to 2015. The 2016 increase related primarily to the Par lawsuit and to increased employee costs, including stock compensation costs.

For the full year 2016, Omeros reported a net loss of $66.7 million, or $1.65 per share, including non-cash expenses of $16.1 million, or $0.40 per share. This compares to a net loss of $75.1 million, or $2.00 per share in 2015, including non-cash expenses of $11.0 million, or $0.29 per share.

Cellectar Biosciences Reports 2016 Company Performance and Continued Progress in First Quarter 2017

On March 15, 2017 Cellectar Biosciences, Inc. (Nasdaq: CLRB), (the "company"), an oncology-focused, clinical stage biotechnology company, reported financial results for the year ending December 31, 2016 (Filing, 8-K, Cellectar Biosciences, MAR 16, 2017, View Source [SID1234518164]). Management will host a teleconference and live webcast to review these financial results, followed by a review of corporate performance and 2017 objectives at 6:00 PM EDT today.

Summary of Q1 2017 Accomplishments:

· Positive safety, tolerability and activity data through Cohort 3 of Phase I study of CLR 131 in multiple myeloma

· Initiation of fourth cohort of Phase I study of CLR 131 in multiple myeloma

· Additional IP protection for CLR 131 in solid tumors

· Japanese Composition of Matter Patent for CLR 1501 and CLR 1502

· Consolidation of IP portfolio for CLR 131 in multiple myeloma following license agreement with Wisconsin Alumni Research Foundation

Summary of 2016 Financial Results:

Research and development expenses for 2016 were $4.8 million, a reduction of $0.4 million from 2015. This reflects the company’s continued focus on its therapeutic lead product candidate, CLR 131 and the implementation of operating improvements, which have reduced its cost structure.

General and administrative expenses for the year totaled $4.7 million, compared to $3.4 million in 2015. The increase was largely a result of increased consulting and personnel costs, of which approximately $0.5 million are not expected to recur.

The operating loss was $9.4 million for 2016, compared to $8.8 million in 2015. Other income was $3.3 million for fiscal 2016 and 2015, and is primarily due to changes in the valuation of certain warrants that are classified as liabilities on the company’s balance sheet. These amounts are almost exclusively non-cash in nature. As a result, the company’s net loss for the year ended December 31, 2016 was $6.2 million, or $1.36 per share, compared to a 2015 net loss of $5.5 million, or $7.03 per share.

As of December 31, 2016, the company had $11.4 million in cash and cash equivalents on hand, compared to $3.9 million in cash and cash equivalents at December 31, 2015. Management anticipates its available cash and cash equivalents will fund its planned operations into the first quarter of 2018, and believes additional capital will be required to complete its research and development plans.

"Over the last year Cellectar Biosciences, has made tremendous progress in the development of our lead product candidate, CLR 131, which is in the fourth cohort of a Phase I trial for multiple myeloma, and will enter an NCI-supported Phase II study in hematological malignancies in the first quarter of this year," said Jim Caruso, president and CEO of Cellectar Biosciences. "The numerous additions to our intellectual property portfolio provide further protection for our product assets and we are encouraged by the progress with our conjugate program and Pierre Fabre partnership. We look forward to reviewing our 2016 successes and 2017 plans on today’s conference call."

Celsion Corporation Reports Year End 2016 Financial Results and Provides Business Update

On March 16, 2017 Celsion Corporation (NASDAQ:CLSN), an oncology drug development company, reported financial results for the year ended December 31, 2016 and provided an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein (Press release, Celsion, MAR 16, 2017, View Source [SID1234518159]). The Company’s lead program is ThermoDox which is currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The Company’s immunotherapy program consists of GEN-1 and is currently in Phase I development for the localized treatment of ovarian cancer.

"Celsion had an exceedingly productive 2016 as our accomplishments, one after another, established meaningful progress with respect to our two leading-edge technology platforms designed to enhance clinically powerful therapies. With sound fundamentals, the superb execution of our ongoing global, pivotal Phase III OPTIMA Study in primary liver cancer, continues to attract interest and support from the medical community, international regulatory agencies, and research organizations like the National Institutes of Health for this ground-breaking study," said Michael H. Tardugno, Celsion’s chairman, president and CEO. "Our efforts in immuno-oncology are equally important. Over the past year, we have demonstrated the potential of our GEN-1 program to be an effective adjuvant, in both first and second-line ovarian cancer. Recruiting the immune system to work in combination with the standard of care in this patient population has been the goal of medical researchers worldwide. With GEN-1, we believe there is the potential for a break-through and we look forward to reporting comprehensive clinical findings and translational data from our nearly complete OVATION Study in the first half of 2017."

Recent Developments
ThermoDox
Announced the Independent NIH Analysis Showing Treatment with ThermoDox Plus RFA may Significantly Improve Overall Survival of Patients with Primary Liver Cancer. In November 2016, the Company announced the presentation of results from an independent retrospective analysis conducted by the National Institutes of Health (NIH) on the intent-to-treat population of the Company’s HEAT Study during The Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma at the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA). The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome, concluded that increased burn time per tumor volume significantly improved overall survival (OS) in patients with solitary lesions treated with RFA + ThermoDox compared to patients treated with RFA alone. More specifically, the analysis showed that a one unit increase in RFA duration per tumor volume improved OS by 20% in patients treated with optimized RFA + ThermoDox compared to RFA alone.These findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox resulted in a statistically significant improvement in overall survival of over two years when compared to standardized RFA alone.

Announced Support for the OPTIMA Study from the China FDA and Vietnam Ministry of Health. The Company discussed ThermoDox and the OPTIMA Study with regulatory agencies in two key markets, China and Vietnam. The Company met with the China Food and Drug Administration (CFDA) to review the ongoing Phase III OPTIMA Study and regulatory pathway for ThermoDox in China. CFDA was presented with the final overall survival data from the Chinese patient cohort of the HEAT study, which demonstrated a survival benefit in patients treated with ThermoDox plus optimized RFA versus optimized RFA alone. The CFDA informed the Company that if the ongoing Phase III OPTIMA Study is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the Company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected. In addition, the Company’s management team met with the Ministry of Health in Vietnam and based on that meeting, it will move forward with launching additional trial sites for the OPTIMA Study in that country. The Company expects to have approximately 5 additional clinical trial sites in Vietnam activated in early 2017. Vietnam represents a significant market for
ThermoDox where HCC incidence rates are among the highest in the world.

Announced the Issuance of Two New Patents for ThermoDox. In January 2017, the Company announced the issuance of two patents which are directly applicable to the method of treating cancer using our current ThermoDox formulation. These new patents further strengthen the Company’s global patent portfolio around novel heat-sensitive liposome engineered to address a broad range of difficult-to-treat cancers.

Announced Collaboration with the Children’s Research Institute to Evaluate the Use of ThermoDox and High Intensity Focused Ultrasound in the Treatment of Solid Tumors in Children and Young Adults. In October 2016, the Company announced a collaboration with the Children’s Research Institute to conduct a clinical study of ThermoDox in combination with magnetic resonance-guided high intensity focused ultrasound to treat relapsed or refractory solid tumors in children and young adults. This investigator-sponsored Phase I clinical study is being partially funded by the National Institutes of Health and commenced in the fourth quarter of 2016.
GEN-1 Immunotherapy

Announced Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients. In January 2017, the Company announced data from the first four cohorts of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1 with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. The efficacy data included highly encouraging tumor response rates – 100% disease control rate (DCR) and 75% objective response rate (ORR), successful surgical resections of the eligible patients’ tumors, impressive pathological responses and dramatic, clinically meaningful drops in CA-125 protein levels.

Announced the Issuance of Two New U.S. Patents for GEN-1 Immuno-Oncology Product. In November 2016, the Company announced the issuance of two patents which expand the use of GEN-1 into additional cancer treatment modalities in combination with other chemotherapeutics and extends previous patent claims on the making of and composition of formulations consisting of our PPC delivery polymer and nucleic acids. These new patents further strengthen coverage of GEN-1 for the localized treatment of ovarian cancer and glioblastoma multiforme (GBM), which is already covered by a composition of matter patent in the United States.

Corporate Development
Raised $6.8 Million Through Two Equity Offerings in December 2016 and February 2017. The Company completed two equity offerings of shares of common stock, or pre-funded warrants in lieu thereof, to purchase common stock with institutional healthcare and retail investors totaling $6.8 million in gross proceeds.

Financial Results
For the year ended December 31, 2016, Celsion reported a net loss of $22.1 million, or $0.85 per share, compared to a net loss of $22.5 million, or $1.03 per share, in 2015. Operating expenses were $21.1 million in 2016 compared to $21.3 million in 2015. This decrease was primarily due to lower general and administrative expenses and clinical supply costs offset by higher clinical development costs for the Phase III OPTIMA Study.

Research and development (R&D) costs were constant at $14.6 million in 2016 and 2015. Clinical development costs for the OPTIMA Study were $5.6 million in 2016 compared to $3.6 million in 2015 due to higher patient enrollment, investigator grants and site initiation expenses in the trial. R&D costs for other development programs were lower as a result of the Company’s tighter clinical development focus around the pivotal Phase III OPTIMA Study for the treatment of primary liver cancer and the clinical development program for GEN-1 IL-12 immunotherapy for the localized treatment of ovarian cancer coupled with lower costs in 2016 associated with the production of ThermoDox to support the OPTIMA Study. General and administrative expenses decreased $0.2 million, from $6.7 million in 2015 to $6.5 million in the current year. This decrease in general and administrative expenses in 2016 is primarily the result of reductions in personnel costs and professional fees offset by $0.6 million of non-cash amortization expense related to the covenant not to compete from the June 2014 EGEN acquisition.

Other expenses included a non-cash charge of $1.4 million related to the impairment of in process research and development for the Company’s RNA delivery system (TheraSilence) offset by a $0.7 million reduction in the earn-out liability related to potential milestone payments for the TheraSilence asset. Interest expense decreased by $0.7 million in 2016 due to lower principal balances outstanding under the Company’s current debt facility.

Net cash used in operations was $18.4 million in 2016 compared to $20.8 million in the prior year. The Company ended 2016 with $4.5 million of total cash, investments and accrued interest on these investments. In February 2017, the Company raised an additional $5 million in gross proceeds under a secondary public offering.

Calithera Biosciences Reports Fourth Quarter and Full Year 2016 Financial Results and Recent Highlights

On March 16, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the fourth quarter and year ended December 31, 2016 (Press release, Calithera Biosciences, MAR 16, 2017, View Source [SID1234518158]). As of December 31, 2016, cash, cash equivalents and investments totaled $51.8 million. Subsequent to the end of the year, Calithera received an upfront payment of $45.0 million from its global collaboration and license agreement with Incyte Corporation and gross proceeds of $46.0 million from the sale of common stock to Incyte and through its at-the-market program with Cowen and Company LLC.

"2016 was a transformative year for Calithera as our lead product candidate CB-839 entered into multiple novel combination trials and progressed towards Phase II, and CB-1158 advanced into clinical development leading to a partnership with Incyte Pharmaceuticals for a strategic development and commercialization collaboration in January 2017," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2017, we expect to highlight new clinical data from each of our clinical programs at scientific meetings, with clinical data expected from CB-1158 in the first half of the year, and multiple clinical updates on CB-839 combination trials in the second half of 2017. This includes the first clinical data presentation of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo."

Fourth Quarter 2016 and Recent Highlights

CB-1158: Global Research, Development and Commercialization Collaboration with Incyte. In January 2017, Incyte and Calithera announced the global collaboration and license agreement for the research, development and commercialization of the first in class, small molecule arginase inhibitor CB-1158. Under the terms of the collaboration and license agreement, Calithera has received an up-front payment of $45 million from Incyte in addition to an $8 million equity investment. CB-1158 entered clinical trials in September 2016, and pharmacodynamic data on the first three patients was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in November 2016.

CB-839: Phase I Triple Negative Breast Cancer Combination Data at the 2016 San Antonio Breast Cancer Symposium (SABCS). New data was presented at the 2016 SABCS in December 2016 on 28 triple negative breast cancer patients treated with CB-839 in combination with paclitaxel; 23 patients were evaluable for efficacy. Among evaluable patients treated with CB-839 doses of at least 600 mg bid (n=16), there were 5 partial responses (31%) and disease control (response or stable disease) in 11 patients (69%). In addition, the combination overcame resistance to paclitaxel in heavily pretreated TNBC patients. There was a 38% response rate and 50% disease control rate in patients who received prior taxanes in the metastatic setting. There was a 50% response rate among taxane-refractory African American patients.

CB-839: Phase I Renal Cell Carcinoma Combination Data at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics. In a plenary session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium in November 2016, new data was presented with CB-839 in combination with everolimus. Fifteen renal cell carcinoma patients were treated and evaluable for response, including 12 clear cell patients, and three papillary patients. Ninety-three percent (93%) had disease control; one patient had a partial response, one patient had progressive disease, and 13 patients had stable disease. The median progression free survival was 8.5 months and for the majority of patients, their time on therapy was longer than their time on treatment in their prior therapy. In the clear cell patient population the disease control rate was 100%.

At-the-Market Program. In 2017, Calithera received approximately $38.0 million in gross proceeds, $36.9 million in net proceeds, from the sale of common stock pursuant to its at-the-market offering program with Cowen.

Key Management Appointments. Curtis Hecht was named Senior Vice President of Business and Corporate Development, Frank Parlati was named Vice President of Research, and Jennifer McNealey was named Vice President of Investor Relations and Strategy.
Selected Fourth Quarter and Year-end 2016 Financial Results

Cash, cash equivalents and investments totaled $51.8 million at December 31, 2016, compared with $71.9 million at December 31, 2015. Subsequent to the end of the year, Calithera received a $45.0 million upfront payment from Incyte and an additional $44.8 million in net proceeds from sales of common stock in 2017.

Research and development expenses for the full year 2016 were $27.7 million, compared with $23.7 million in the prior year. The increase of $4.0 million was due to an increase of $2.3 million due to higher employment related expenses and an increase of $1.7 million primarily related to the advancement of CB-1158 to a phase 1 clinical trial. Research and development expenses for the fourth quarter of 2016 were $6.6 million, compared to $5.8 million for the same period last year.

General and administrative expenses for the full year 2016 were $10.6 million, compared with $9.1 million in the prior year. The increase of $1.5 million in 2016 was primarily due to higher employment related expenses, including stock based compensation expense. General and administrative expenses for the fourth quarter of 2016 were $3.0 million, compared to $2.3 million for the same period last year. Loss from operations for the three months and year ended December 31, 2016 was $9.5 million and $38.0 million, respectively.

Financial Guidance for 2017

Calithera expects that its cash, cash equivalents and investments will be between $95 and $105 million at the end of 2017, exclusive of any funds arising from new collaborations or partnerships, milestone payments, additional equity financings or other new sources.