On August 15, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the quarter ended June 30, 2018 (Press release, Sellas Life Sciences, AUG 15, 2018, View Source [SID1234528887]).

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!

"During the second quarter of 2018 we made significant progress in laying the foundation for executing on our clinical programs by closing the second tranche of our sale of Series A Preferred Stock and warrants and commencing the process for a follow-on equity offering. We are pleased to have closed that equity financing last month which, together with the proceeds from the sale of the preferred stock and warrants, provides us with funding to begin to advance our pipeline of novel cancer immunotherapies, focusing first on galinpepimut-S (GPS)," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We plan to initiate our Phase 1/2 basket trial of GPS in combination with Keytruda in a number of indications by the end of the third quarter with the first patient in during the fourth quarter and are actively finalizing our clinical plan for a Phase 3 study of GPS in patients with acute myeloid leukemia. Looking ahead, we are also excited to present our Phase 2b data of Herceptin +/- NeuVax in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in late October as well as optimizing our regulatory strategy for NeuVax with U.S. and European regulatory authorities and exploring strategic partnering alternatives around NeuVax," continued Dr. Stergiou.

Second Quarter 2018 and Recent Business Highlights

In July 2018, SELLAS completed an underwritten public offering of common stock and pre-funded warrants, together with accompanying common stock warrants, for aggregate net proceeds of approximately $21.6 million, after deducting underwriting discounts, commissions and offering expenses.
In July 2018, SELLAS announced that data on the adjuvant treatment of women with triple-negative breast cancer (TNBC) with the combination of trastuzumab (Herceptin) +/- NeuVax from a Phase 2b independent investigator-sponsored trial (IST) will be presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting October 19-23 in Munich, Germany.
In July 2018, SELLAS announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to GPS for the treatment of multiple myeloma (MM).
In June 2018, SELLAS presented interim data from an open-label Phase 1 IST of GPS in combination with nivolumab in patients with Wilms Tumor 1 (WT1)+ ovarian cancer in second or third remission after salvage chemotherapy at the 2018 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Exploratory efficacy interim data showed that GPS, when combined with a PD-1 inhibitor, demonstrated a progression-free survival rate of 64% at one year in an intent to treat group of 11 evaluable patients with WT1+ ovarian cancer in second or greater remission. Among patients who received at least three doses of GPS in combination with nivolumab, PFS at one year was 70% (7/10). The historical rates with best standard treatment do not exceed 50% in this disease setting.
In June 2018, SELLAS announced that the Phase 2b independent IST of Herceptin +/- NeuVax in HER2 1+/2+ breast cancer patients achieved its key clinical development objectives and was being discontinued, based in part on the recommendation of the independent Data Safety Monitoring Board to further develop the NeuVax + Herceptin combination for patients with TNBC.
In June 2018, the Company was issued U.S. Patent No. 9,993,538 which is a method of use patent that is part of the patent portfolio for the GALE-301 and GALE-302 folate binding protein derived peptides. The method claims cover a dosing regimen to induce an immune response against a tumor expressing folate receptor alpha (FR-alpha) using the GALE-301 peptide (peptide of FR-alpha epitope E39) and the GALE-302 peptide booster (peptide of FR-alpha epitope E39’). The patent will expire on May 31, 2036 and provides further patent protection on the initial GALE-302 patent family, which expires in 2022.
In May 2018, SELLAS announced that the FDA granted orphan drug designation to GPS for the treatment of MM.
In May 2018, SELLAS completed the second tranche of its $10.7 million private placement transaction.
In April 2018, SELLAS appointed Gene Mack as Chief Financial Officer and Treasurer.
Second Quarter 2018 Financial Results

For accounting purposes, SELLAS Life Sciences Group Ltd., a private Bermuda exempted company (SELLAS Ltd.), is considered to have acquired the Company (which was formerly known as Galena Biopharma, Inc. (Galena)) in the business combination between SELLAS Ltd. and Galena (the Merger); therefore, upon the Merger, the financial statements of Galena became those of SELLAS Ltd. and the results reported are those of SELLAS Ltd. reflecting the acquisition of Galena as of December 29, 2017.

Cash Position: As of June 30, 2018, cash and cash equivalents were $1.3 million, compared to $2.3 million as of December 31, 2017. Net cash used in operating activities was $11.7 million for the first half of 2018, partially offset by $8.9 million of net cash provided by financing activities. On July 16, 2018, SELLAS completed an underwritten public offering of common stock and pre-funded warrants, together with accompanying common stock warrants, for aggregate net proceeds of approximately $21.6 million, after deducting underwriting discounts, commissions and offering expenses.

R&D Expenses: Research and development expenses were $1.6 million for the second quarter of 2018, as compared to $1.8 million for the second quarter of 2017. The decrease was primarily attributable to a decrease in licensing fees, partially offset by a severance charge and an increase in clinical and regulatory consulting services. Research and development expenses for the six months ended June 30, 2018 were $3.4 million, as compared to $4.0 million for the same period in 2017. The decrease was primarily attributable to a decrease in licensing fees.

G&A Expenses: General and administrative expenses were $4.9 million for the second quarter of 2018, as compared to $3.8 million for the second quarter of 2017. The increase was primarily driven by an increase in legal fees related to ongoing litigation and other legal matters related to Galena’s business and operations, personnel related expenses and an increase in insurance premiums. These increases were partially offset by a decrease in stock-based compensation expense. General and administrative expenses for the first half of 2018 were $8.8 million, as compared to $6.1 for the six months ended June 30, 2017. The increase during the period was primarily related to legal and advisory fees associated with the Merger with Galena and ongoing litigation and other legal matters related to Galena’s business and operations.

Net Loss: Net loss attributable to common stockholders was $8.5 million for the second quarter of 2018, or a basic and diluted loss per share attributable to common stockholders of $1.26, as compared to a net loss attributable to common stockholders of $5.9 million for the second quarter of 2017, or a basic and diluted loss per share attributable to common stockholders of $4.50. Net loss attributable to common stockholders was $18.5 million for the six months ended June 30, 2018, or a basic and diluted loss per share attributable to common stockholders of $2.89, as compared to a net loss attributable to common stockholders of $10.5 million for the prior period, or a basic and diluted loss per share attributable to common stockholders of $8.14.

On August 15, 2018 Crescendo Biologics Ltd (Crescendo), the developer of targeted T-cell engagers, reported that it has achieved another technical milestone in its collaboration with Takeda Pharmaceutical Company Limited (Takeda) (Press release, Crescendo Biologics, AUG 15, 2018, View Source [SID1234528994]).

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!

Crescendo’s global, strategic, multi-target collaboration and license agreement with Takeda was announced in October 2016. Under this agreement, Crescendo’s proprietary transgenic platform and engineering expertise is used to identify and configure Humabody-based therapeutics against certain targets selected by Takeda.

This milestone, for an undisclosed amount, marks the successful delivery of another highly diverse panel of functional Humabody leads against the second of Takeda’s selected targets. The achievement of an equivalent milestone related to the first of Takeda’s selected targets was announced in April 2018.

Dr Peter Pack, CEO of Crescendo, commented:

"Crescendo has once again demonstrated its ability to deliver, ahead of schedule, a diverse selection of functional Humabody molecules meeting the stringent specifications outlined in the collaboration agreement.

"Our highly productive relationship draws together Takeda’s deep oncology experience with Crescendo’s expertise in developing optimally configured Humabodies. Together we are fast progressing towards our goal of developing next generation, highly modular and multi-functional biologics against cancer. This is another important step forward for Crescendo and further validates the power of our innovative technology."

On August 14, 2018 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for its second fiscal quarter, which ended June 30, 2018, and provided a business update (Press release, Galectin Therapeutics, AUG 14, 2018, View Source [SID1234528874]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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!

Key Highlights

Company has initiated Phase 3 preparation of GR-MD-02 for NASH cirrhosis

Reported a net operating loss of $4.1M and has sufficient cash resources to fund operations at least through June 2019

Has received notice of issuance of additional patents surrounding GR-MD-02

Board of Directors elected Richard E. Uihlein as Chairman and Kevin D. Freeman as Vice Chairman

Engaged Back Bay Life Science Advisors to pursue strategic alternatives

"The second quarter was another active quarter with significant progress advancing our proprietary compound GR-MD-02 to a pivotal Phase 3 trial and preparing for the opportunities it represents to our business," said Dr. Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics. "Most importantly, we announced that we are proceeding with plans for a Phase 3 clinical trial program with GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the US Food and Drug Administration (FDA), and based on the positive effects of GR-MD-02 on HVPG and the possible prevention or postponement of development of esophageal varices in the Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients."

Richard Uihlein, Chairman of the Board, added, "Galectin’s new leadership is focused on planning and conducting additional supportive work to prepare for a Phase 3 trial for GR-MD-02 in NASH cirrhosis based on the positive effects of GR-MD-02 on HVPG. However, we believe our galectin-3 inhibitor GR-MD-02 has widespread applicability for a range of diseases. Consequently, we are simultaneously pursuing other opportunities and, most immediately, anticipate results on our combination immunotherapy clinical trial. We also now have a potential pathway forward in pulmonary fibrosis, where GR-MD-02 was recently granted a patent. Finally, on behalf of the Board, we are extremely pleased that Dr. Harold Shlevin has agreed to take on the broader role of CEO, and we are all confident in his ability to drive Galectin Therapeutics forward across all our multiple programs."

Expected Upcoming Milestones Enrollment in cohort 3 (GR-MD-02 8 mg/kg) of the pembrolizumab combination immunotherapy Phase 1 clinical trial has completed and will likely include up to 10 evaluable patients with melanoma and head & neck cancer, to provide a larger group of and different type of cancer patients in this initial evaluation. It is hoped that these additional data can be reported in the near term when we anticipate a decision on progressing this program to the next phase.

Summary of Key Development Programs and Updates

Announced that we are proceeding with plans for a Phase 3 clinical trial program with our galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has submitted a final clinical trial protocol with the FDA.

At the Company’s Annual Meeting of Shareholders on May 22, 2018, it was announced that the Board of Directors had elected Richard E. Uihlein, who has been a member of the Board since 2017, as Chairman and Kevin D. Freeman, who has been a member of the Board since 2011, as Vice Chairman.

The Company received notice of issuance of U.S. Patent Number 9,968,631 titled "Method and Treatment of Pulmonary Fibrosis," covering method of use of GR-MD-02 as a means to treat pulmonary fibrosis. Pharmaceutical companies may have an interest in this molecule as there is a sizeable section of the population in need of treatment and well defined regulatory pathways for approval of agents to treat pulmonary fibrosis.

The Company received notice of issuance on May 22, 2018 of U.S. Patent Number 9,974,802 titled "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases" covering a composition comprising its galectin inhibitor, GR-MD-02, and an immunotherapeutic agent or a vaccine directed against CTLA4, OX40, PD-1, PD-L1 or combinations thereof (and the composition for use in cancer disorders). This patent complements USP 9,872,909 issued on January 23, 2018 which covers method of treating cancer by administering GR-MD-02 and an immunomodulatory agent wherein the cancer is one of gastrointestinal cancer, pancreatic cancer, bile duct cancer, sarcoma, myosarcoma, breast cancer, lung cancer, head and neck cancer, mouth cancer, skin cancer, melanoma, kidney cancer, urinary tract cancer, prostate cancer, testicular cancer, ovarian cancer, endometrial cancer, neurological cancer, endocrine gland cancer, bone cancer, hematological cancers, multiple myeloma, and myelofibrosis.

The Company has engaged Back Bay Life Science Advisors, a Boston-based, internationally focused integrated strategy and transaction advisory organization, to support the Company’s exploration of strategic alternatives.

Dr. Shlevin concluded, "Galectin Therapeutics has developed a novel compound, GR-MD-02, a galectin-3 inhibitor, which we believe has the potential to be effective in treating a wide range of
diseases wherein elevated levels of galectin protein and inflammation play key roles in the pathophysiology of the diseases. Most immediately, we are focused on advancing our Phase 3 trial in NASH Cirrhosis. However, we continue to investigate a variety of other preclinical applications where research shows that GR-MD-02’s antifibrotic capabilities may help provide more effective treatment in a variety of conditions. We believe this is the best path to build value in our overall galectin franchise."

Financial Results

For the three months ended June 30, 2018, the Company reported a net loss applicable to common stockholders of $4.1 million, or $0.11 per share, compared with a net loss applicable to common stockholders of $4.8 million, or $0.14 per share, for the three months ended June 30, 2017. The decrease is largely due to lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

Research and development expense for the three months ended June 30, 2018 was $1.5 million, compared with $3.4 million for the three months ended June 30, 2017. The decrease primarily reflects lower research and development expenses primarily related to the winding down of the Phase 2 NASH clinical program somewhat offset by higher non-cash stock compensation expenses.

General and administrative expense for quarter was $2.3 million, compared with $1.1 million for the prior year, with the increase being primarily related to higher investor relations, business development and non-cash stock compensation expenses.

As of June 30, 2018, the Company had $10.5 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash on hand in addition to its $10 million line of credit (untapped at June 30, 2018) to fund currently planned operations and research and development activities through at least June 30, 2019.

On August 14, 2018 AVEO Oncology (Nasdaq: AVEO) reported that the China National Drug Administration (CNDA) has accepted CANbridge Life Sciences’ Investigational New Drug (IND) Application for a Phase Ib/III clinical trial of CAN017 (AV-203), AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate, in esophageal squamous cell cancer (ESCC) (Press release, AVEO, AUG 14, 2018, View Source [SID1234528891]).

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!

Under the terms of a March 2016 agreement, the acceptance of this IND triggers a $2 million milestone payment to AVEO from CANbridge Life Sciences. CANbridge licensed worldwide rights, excluding the United States, Canada, and Mexico, to AV-203 from AVEO and AVEO is eligible to receive up to $40 million in potential additional development and regulatory milestone payments and up to $90 million in potential commercial milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives.

"CANbridge continues to make progress in advancing CAN017, and we look forward to the initiation of a Phase Ib/extension clinical trial in ESCC, a large unmet medical need globally with a particularly acute need in Asia," said Michael Bailey, president and chief executive officer of AVEO. "Together with ficlatuzumab, our partnered oncology programs allow us to retain meaningful rights to a promising pipeline and advance it at little or no cost to AVEO, allowing us to focus resources on our tivozanib strategy, including U.S. registration for kidney cancer as well as combinations with immunotherapy."

AVEO previously completed a Phase 1, open-label, dose-escalation study of AV-203 (CAN017) in patients with advanced solid tumors. In this study, AV-203 was found to be generally safe and well-tolerated, with an early signal of activity consistent with preclinical data showing the potential for heregulin or neuregulin, the only known ligand for ErbB3, to serve as a biomarker predictive of AV-203 anti-tumor activity.

AVEO will pay percentage of the milestone payment to Biogen Idec International GmbH as a sublicensing fee.

On August 14, 2018 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company"), reported that it will conduct a conference call on Wednesday, August 15, 2018 at 9:00 AM ET to provide an update on the Pivotal Phase 3 SIERRA Trial (Study of Iomab-B in Elderly Relapsed/Refractory AML) of Iomab-B (Press release, Actinium Pharmaceuticals, AUG 14, 2018, View Source [SID1234528958]). Actinium recently announced that the SIERRA trial had reached twenty-five percent patient enrollment and that the independent Data Monitoring Committee (DMC) would conduct a formal analysis, which has now occurred. Post this event, members of Actinium’s management team are hosting this call to provide an update on the SIERRA trial.

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!

Conference Call Details

Date: Wednesday, August 15, 2018
Time: 9:00 AM ET
Registration Link: View Source
Toll-Free Dial-in: (855) 427-0225
Dial-in: (718) 865-8336
Conference ID: 4831

"Based on the DMC’s unanimous recommendation, we are pleased that the ongoing SIERRA trial will continue as planned," said Dr. Mark Berger, Chief Medical Officer of Actinium. "This is an important milestone for Iomab-B since it is the first formal safety evaluation of the trial. We note that no Iomab-B safety concerns were raised. With new insights from the data available from the trial thus far as well as feedback from the trial sites, we will make certain protocol revisions to further expand salvage regimens in the control arm. We’ll also be making it easier for patients on the Conventional Care arm who have disease progression to access Iomab-B treatment. In addition, we will be simplifying certain data collection requirements. These improvements coupled with our deeper understanding of referral patterns and other outreach efforts, are anticipated to enable the recently strengthened SIERRA clinical team to complete the trial as quickly as possible with the goal of bringing Iomab-B to a patient population with a significant unmet need."

Sandesh Seth, Actinium’s Chairman and CEO added, "Iomab-B is a very compelling drug candidate that has been studied in over 500 patients in multiple hematologic malignancies including AML, myelodysplastic syndrome, lymphoma and multiple myeloma and is intended to facilitate a potentially curative bone marrow transplant. Iomab-B was developed by the Fred Hutchinson Cancer Research Center in collaboration with the National Cancer Institute and has been studied extensively by leading bone marrow transplant physicians. We are incredibly proud of the pedigree of Iomab-B and motivated by its potential to address unmet medical needs as a targeted conditioning agent in multiple hematologic diseases. We believe that Iomab-B via the SIERRA trial can be the linchpin for developing the leading franchise in targeted conditioning with an emphasis on improving bone marrow transplant access and outcomes."

About Iomab-B

Iomab-B, Actinium’s lead targeted conditioning product candidate, is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. This pivotal Phase 3 study is called the SIERRA Trial (Study of Iomab-B in Elderly Relapsed/Refractory AML). Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, an antigen widely expressed in the hematopoietic system on all leukemic and lymphomic (white blood cells), bone marrow cells and cancer stem cells with the monoclonal antibody, BC8 or apamistamab, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects that conventional treatments such as chemotherapy and radiation has on most healthy tissues while effectively killing the patient’s cancer and marrow cells potentially enabling more bone marrow transplants with better outcomes through targeted conditioning. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, who typically would not be transplant candidates, were able to receive a transplant after being conditioned with Iomab-B and the study resulted in significantly improved transplant success and survival. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 500 patients in a number of Phase 1 and Phase 2 clinical trials across a variety of blood cancer indications with promising results. The studies included patients with acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.