On August 8, 2017 Galena Biopharma, Inc. (NASDAQ: GALE) and SELLAS Life Sciences Group Ltd, a privately-held, oncology-focused, clinical stage biopharmaceutical company, reported they have entered into an all stock definitive merger agreement under which SELLAS will merge into and become an indirect, wholly-owned subsidiary of Galena (Press release, Galena Biopharma, AUG 8, 2017, View Source [SID1234520194]). The combined company will be renamed SELLAS Life Science Group, Inc. The merger will result in a combined company focused on the development of novel treatments for cancer.

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The combined company will feature a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in hematology and solid tumors. SELLAS licenses the rights to its lead asset, galinpepimut-S, (GPS), a novel WT1 antigen-targeting immunotherapy. GPS is initially being developed for the treatment of acute myeloid leukemia (AML) and is Phase 3-ready in this setting. SELLAS has also successfully completed a Phase 2 study of GPS in malignant pleural mesothelioma (MPM) and its end-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) for GPS in both indications. For both AML and MPM, SELLAS has been granted orphan drug designation from the FDA and the European Medicines Agency (EMA) and been given FDA fast track status. In addition, SELLAS is currently conducting two Phase 2 trials of GPS in multiple myeloma, as well as a combination trial in ovarian cancer with nivolumab (OPDIVO; Bristol-Myers Squibb), and is currently preparing for additional combination trials for GPS in combination with another checkpoint inhibitor. Galena’s lead immunotherapy program, NeuVax (nelipepimut-S), is currently in three, Phase 2, investigator-sponsored clinical trials in breast cancer, and these trials will remain ongoing. Galena’s other development programs, GALE-401, a controlled release version of anagrelide that is Phase 3-ready, and GALE-301/GALE-302, an earlier stage cancer immunotherapy program targeting folate binding protein, are currently being evaluated for potential internal development or strategic partnership.

"This transaction with Galena is an important step for SELLAS and the advancement of our lead product candidate, GPS, through important development milestones," said Dr. Angelos Stergiou, SELLAS’s Chief Executive Officer. "We believe GPS has the potential to benefit a wide range of cancer patients and
become an important piece of the cancer immunotherapy treatment landscape as both a monotherapy and in combination with other agents, particularly checkpoint inhibitors. NeuVax strengthens our platform and may provide important value inflections as the clinical trials progress. The combined pipeline, with significant near term milestones, creates multiple development and partnering opportunities to create value as these programs evolve."

Stephen F. Ghiglieri, Galena’s Interim Chief Executive Officer and Chief Financial Officer, added, "Following a thorough review of strategic alternatives and extensive search for a merger partner, we selected SELLAS due to the depth of their cancer immunotherapy pipeline which is clearly complimentary to Galena’s development programs. In evaluating many alternatives, SELLAS stood out in terms of its vision, strategic alignment with Galena’s cancer immunotherapy programs, and near term opportunity for value creation for our shareholders. We are encouraged by the GPS data generated to date and the potential advancement of that program into clinical trials in several indications. I, and our board of directors, believe that patients and our shareholders have the opportunity to benefit greatly from the clinical development efforts that the combined companies will undertake."

About the Proposed Transaction
On January 31, 2017, Galena announced the initiation of a process to explore a range of strategic alternatives focused on maximizing shareholder value. After a thorough review of available alternatives, and extensive diligence and negotiation with SELLAS, Galena’s board of directors unanimously approved to enter into a definitive merger agreement with SELLAS.

Under the terms of the merger agreement, existing SELLAS shareholders will receive newly issued shares of Galena common stock. On a pro forma basis, assuming completion of the proposed merger, Galena stock and warrant holders are expected to own approximately 32.5%, and SELLAS shareholders will own approximately 67.5% of the combined company.

The transaction has also been unanimously approved by the SELLAS board of directors and a majority of SELLAS shareholders have agreed to vote in favor of the transaction. The proposed merger is expected to close in the fourth quarter of 2017, subject to the approval of Galena stockholders and other customary closing conditions.

Galena’s financial advisor for the transaction is Canaccord Genuity Inc. and Galena’s legal counsel are Paul Hastings LLP and BeesMont Law Limited. SELLAS’ financial advisor for the transaction is Guggenheim Securities, and SELLAS’ legal counsels are Cooley LLP and Conyers Dill & Pearman.

Management and Organization
Angelos M. Stergiou, MD, SCD h.c., Chief Executive Officer of SELLAS will become the Chief Executive Officer of the combined company. Upon completion of the merger, Galena’s board of directors will resign, and a new board of directors will be constituted consisting of seven members that will include five representatives appointed by SELLAS, two of whom will be independent directors, and two representatives designated by Galena subject to SELLAS’ approval. SELLAS’ management team will manage the combined company.

Upon closing of the transaction, the name of the combined company will become SELLAS Life Sciences Group, Inc. and shares of the combined are expected to continue trading on the NASDAQ Capital Market under a new ticker symbol, SLS.

On August 8, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported financial results and business highlights for the second quarter and six months ended June 30, 2017 (Press release, Cellular Biomedicine Group, AUG 8, 2017, View Source [SID1234520150]).

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"In the first half of 2017, we made significant advancements in our dual technology platforms of immuno-oncology and stem cells," commented Tony (Bizuo) Liu, CBMG’s Chief Executive Officer. "In China we successfully launched two Phase I clinical trials for our anti-CD19 CAR-T product C-CAR011 and we expect to report topline clinical data from both trials by year-end. In the United States the development of AlloJoinTM, our "off-the-shelf" allogeneic adipose stem cell candidate, continues to progress with the recent $2.29 million award from California Institute for Regenerative Medicine (CIRM) to establish a cell line and IND filing in the treatment of Knee Osteoarthritis (KOA)." Mr. Liu further stated, "Upon completion of our new Shanghai GMP facility later this year, we believe we will have one of the largest cell therapy facilities in the world. The Shanghai facility will house our joint technology laboratory with GE Healthcare Life Sciences China to co-develop high-quality industrial control processes in CAR-T and stem cell manufacturing. With these recent advancements in our pipelines and validation of our GMP capabilities, we believe we will have the first mover advantage to deliver effective cell therapies in China. The recent unanimous U.S. FDA Advisory Committee approval of a large pharma’s Biological License Application (BLA) designated as Breakthrough Therapy on a CAR-T candidate for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), and the FDA acceptance of another company’s diffuse large B-cell lymphoma (DLBCL) BLA filing under Priority Review, have set a precedent for a substantially shortened review clock for such breakthrough therapies in the United States. With both ALL and DLBCL in our pipeline, we are hopeful to see an analogous accelerated BLA review treatment in China when we are ready for our submission."

Second Quarter and First Half 2017 Financial Performance

Cash Position: Cash and cash equivalents as of June 30, 2017 were $27.3 million compared to $39.3 million as of December 31, 2016.
Net Cash Used in Operating Activities: Net cash used in operating activities for the quarter and six months ended June 30, 2017 was $2.9 million and $7.8 million (offset by $1.2 million CIRM grant in Q2), respectively, compared to $5.2 million and $8.8 million for the same periods in 2016.
G&A Expenses:General and administrative expenses for the quarter and six months ended June 30, 2017 were $3.3 million and $6.5 million, respectively, compared to $3.1 million and $5.8 million for the same periods in 2016.
R&D Expenses:Research and development expenses for the quarter and six months ended June 30, 2017 were $3.3 million and $6.4 million respectively, compared to $3.0 million and $5.4 million for the same periods in 2016.
Net Loss: Net loss allocable to common stock holders for the quarter and six months ended June 30, 2017 was $6.2 million and $12.4 million respectively, compared to $7.2 million and $11.4 million for the same periods in 2016.
Recent Business Highlights First Half 2017

Appointment of Michael A. Caligiuri, MD, current President of American Association for Cancer Research (AACR) (Free AACR Whitepaper), as Chair of the External Advisory Board;
Signed a strategic research collaboration agreement with GE Healthcare Life Sciences China to establish a joint technology laboratory in CBMG’s new Shanghai Zhangjiang GMP facility in order to co-develop control processes for the manufacture of CAR-T and stem cell therapies;
Completed expansion of our 30,000 square foot facility in Huishan High Tech Park in Wuxi, China;
Signed a ten-year lease of a 113,038 square feet building located in the "Pharma Valley" in Shanghai Zhangjiang High-Tech Park. The new GMP facility that will be built on these premises will consist of 40,000 square feet dedicated to advanced cell manufacturing.
Clinical Developments First Half 2017

Immuno-Oncology Platform

Commenced Phase I Trial (CALL-1) for C-CAR011 in adult patients with r/r B-cell ALL in China;
Commenced patient enrollment in a new independent Phase I clinical trial of the Company’s ongoing CARD-1 study in patients with chemorefractory and aggressive DLBCL;
Publication of an abstract exploring the application of B-cell antigen, CD20, for targeted Chimeric Antigen Receptor T cells (CAR-T) therapy, in conjunction with the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Stem Cell Platform

Awarded $2.29 million by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s "off-the-shelf" allogeneic human adipose-derived mesenchymal stem cells (haMPC) for the treatment of KOA in the United States.

On August 8, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2017 (Press release, Nektar Therapeutics, AUG 8, 2017, View Source [SID1234520199]).

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Cash and investments in marketable securities at June 30, 2017 were $310.7 million as compared to $389.1 million at December 31, 2016. The cash balance does not include the $150 million upfront payment expected from Nektar’s recently announced collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

"Nektar has successfully achieved a number of important milestones in 2017," said Howard W. Robin, President and CEO of Nektar. "In July, we announced positive results from the human abuse potential study of NKTR-181, which followed the positive Phase 3 efficacy data earlier in the year. The body of data for NKTR-181 shows that it could be a transformational pain medicine for the treatment of chronic pain and be a key building block in the nation’s fight against the opioid abuse epidemic. Our new collaboration with Lilly for NKTR-358 enables the broad development of this first-in-class resolution therapeutic in multiple autoimmune conditions. Finally, in immuno-oncology, we are pleased to announce that we began dosing patients in the expansion stage of the PIVOT study of NKTR-214 with Bristol’s OPDIVO, which will enroll up to 260 patients in eight target cancer indications."

Revenue in the second quarter of 2017 was $34.6 million as compared to $32.8 million in the second quarter of 2016. Year-to-date revenue for 2017 was $59.3 million as compared to $91.6 million in the first half of 2016. Revenue in the first half of 2016 was higher primarily because of the recognition of $28.0 million received from AstraZeneca for the sublicense of MOVENTIG to Kirin in Europe.

Total operating costs and expenses in the second quarter of 2017 were $85.2 million as compared to $71.1 million in the second quarter of 2016. Total operating costs and expenses in the first half of 2017 were $164.4 million as compared to $139.5 million in the first half of 2016. Total operating costs and expenses increased primarily because of research and development (R&D) expense, which included the completion of Phase 3 clinical studies for NKTR-181.

R&D expense in the second quarter of 2017 was $60.3 million as compared to $52.4 million in the second quarter of 2016. For the first half of 2017, R&D expense was $121.3 million as compared to $101.6 million in the first half of 2016. R&D expense was higher in the second quarter and first half of 2017 as compared to the same periods in 2016 and includes increased expenses for our pipeline programs, including clinical development of NKTR-214 and NKTR-358 and preclinical activities for NKTR-262 and NKTR-255.

General and administrative (G&A) expense was $16.0 million in the second quarter of 2017 as compared to $11.0 million in the second quarter of 2016. Q2 2017 G&A expense includes a $3.3 million charge for a litigation settlement related to a cross-license agreement. G&A expense in the first half of 2017 was $28.0 million as compared to $21.3 million in the first half of 2016.

Net loss in the second quarter of 2017 was $59.9 million or $0.39 loss per share as compared to a net loss of $48.6 million or $0.36 loss per share in the second quarter of 2016. Net loss was higher in Q2 2017 versus Q2 2016 primarily as a result of the litigation settlement expense and the increased R&D expense described above. Net loss in the first half of 2017 was $123.7 million or $0.80 loss per share as compared to a net loss of $68.1 million or $0.50 loss per share in the first half of 2016.

The company also announced the following upcoming presentation:

ESMO 2017 Congress, Madrid, Spain:

Poster 1212TiP: "PIVOT-02: A Phase 1/2, Open-label Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies.", Diab, A., et al.
Date: September 9, 2017, 13:15 – 14:15 p.m. Central European Summer Time

On August 8, 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 second quarter ended June 30, 2017 (Press release, Calithera Biosciences, AUG 8, 2017, View Source [SID1234535256]). As of June 30, 2017, cash, cash equivalents and investments totaled $208.2 million.

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"Recent highlights included the presentation of clinical trial results of CB-1158, a first-in-class small molecule arginase inhibitor, in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and the advancement of CB-839 into Phase 2 clinical trials in renal cell carcinoma and triple negative breast cancer," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to the second half of 2017, we plan to present clinical updates on CB-839, including the initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo (nivolumab) in the fourth quarter."

Second Quarter 2017 and Recent Highlights

CB-839 Randomized Phase 2 Combination Trial in Renal Cell Carcinoma Initiated. In August 2017, Calithera announced the initiation of a randomized, double blind, placebo controlled trial to evaluate the safety and efficacy of CB-839 in combination with everolimus versus placebo in approximately 250 patients with metastatic, clear cell renal cell carcinoma who have been treated with at least two lines of prior systemic therapy including a VEGFR-targeting tyrosine kinase inhibitor and at least one of either CABOMETYX (cabozantinib) or an active PD-1/PD-L1 inhibitor. CB-839 has been granted Fast Track designation for this indication.

CB-839 Triple Negative Breast Cancer Phase 2 Trial Initiated. In July 2017, Calithera initiated a Phase 2 trial of CB-839 with paclitaxel in triple negative breast cancer patients. Four single arm, open label, cohorts of African American and non-African American patients will be treated in both the early stage setting, where patients have no prior treatment for metastatic disease, as well as the late stage setting, after at least two prior therapies for metastatic disease including prior taxane therapy. The primary endpoint of this trial is objective response rate. Additional data from the triple negative breast cancer development program are expected in the fourth quarter of 2017.

Collaboration with Bristol-Myers Squibb expanded. In May 2017, Calithera’s existing collaboration evaluating Opdivo (nivolumab) in combination with CB-839 was expanded to include additional renal cell carcinoma cohorts as well as non-small cell lung cancer and melanoma. Initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo are expected in the fourth quarter of 2017.

CB-1158 (INCB01158) Phase I Solid Tumor Data Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In June 2017, data was presented from the first 17 patients with advanced solid tumors dosed with CB-1158 as a single agent. Plasma levels of arginase were inhibited > 90% in all patients, and in 10 of 11 patients plasma arginine increased 1.5-fold or more.

CB-1158 was generally well tolerated with no drug-related serious adverse events. The trial is continuing to enroll patients in the dose escalation phase of the study, and expansion cohorts in pre-defined tumor types, to be followed by combination studies with an anti-PD-1 antibody.

Selected Second Quarter 2017 Financial Results Cash, cash equivalents and investments totaled $208.2 million at June 30, 2017, compared with $207.1 million at March 31, 2017. During the second quarter of 2017, Calithera received payment of a $12.0 million milestone under its global collaboration and license agreement with Incyte.

Revenue was $7.3 million for the three months ended June 30, 2017 and represents the portion of deferred revenue recognized in the second quarter from the Company’s collaboration and license agreement with Incyte.

Research and development expenses were $10.1 million for the three months ended June 30, 2017, compared with $7.8 million for the same period in the prior year. The increase of $2.3 million was primarily due to an increase in the CB-839 program, including for Phase 2 start-up activities, as well as investment in our early stage research programs, partially offset by decreases in the CB-1158 program including Incyte’s co-funding of development costs

General and administrative expenses were $2.8 million for the three months ended June 30, 2017, compared with $2.7 million for the same period in the prior year. The increase of $0.1 million was primarily due to increases in professional services and higher personnel-related costs. Net loss from operations for the three months ended June 30, 2017 was $5.2 million, or $0.15 per share.

Conference Call Information

Calithera will host an update conference call today, August 8th at 1:30 p.m. Pacific Time/ 4:30 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 63329558. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On August 8, 2017 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for difficult to treat cancers, reported financial results for the quarter ended June 30, 2017 (Filing, Q2, Stemline Therapeutics, 2017, AUG 8, 2017, View Source [SID1234520201]). The Company also reviewed recent clinical and regulatory events, and outlined key upcoming milestones:

SL-401 In Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

· The SL-401 pivotal Phase 2 trial enrolled 45 BPDCN patients in Stages 1, 2 and 3. Stage 3 was prospectively designed to support potential registration.

· During the quarter, we presented updated data from Stages 1 and 2 of the Phase 2 trial at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Madrid, Spain.

· Analysis of Phase 2 data, inclusive of Stage 3, is ongoing and we remain on track to announce top-line results in 2H17. We are also targeting a medical conference to present more detailed results later this year.

· To ensure ongoing patient access to SL-401, we are enrolling both first-line and relapsed/refractory BPDCN patients in an additional cohort.

· Depending on the data from the trial, we plan to use the results generated, along with other relevant data, to support the filing of a Biologics License Application (BLA) for approval in BPDCN. We continue to anticipate a possible BLA filing could begin in 4Q17 or 1Q18.

Additional Clinical Trials

· Clinical trials evaluating SL-401 are ongoing in additional indications including certain myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML), and multiple myeloma, as a single agent or in combination with other agents. We expect to provide updates on these studies later this year and into next year.

· SL-801, a novel XPO1 inhibitor, is being evaluated in a Phase 1 trial of patients with advanced solid tumors. SL-701 has completed dosing in a Phase 2 trial of patients with second-line glioblastoma. We are targeting medical conferences for updates on both of these studies later this year.

Second Quarter 2017 Financial Results Review

Stemline ended the second quarter of 2017 with $93.2 million in cash, cash equivalents and investments, as compared to $105.8 million as of March 31, 2017, which reflects a use of cash of $12.6 million for the quarter. The company ended the second quarter of 2017 with 25.2 million shares outstanding.

For the second quarter of 2017, Stemline had a net loss of $15.5 million, or $0.66 per share, compared with a net loss of $9.3 million, or $0.52 per share, for the same period in 2016.

Research and development expenses were $11.5 million for the second quarter of 2017, which reflects an increase of $4.6 million, or 67%, compared with $6.9 million for the second quarter of 2016. The higher costs are primarily driven by an increase of $2.1 million in manufacturing expenses to support our potential BLA filing for SL-401. We also incurred $1.2 million in higher costs for regulatory support of our potential BLA filing for SL-401. Additionally, we incurred higher compensation expense as a result of increased headcount.

General and administrative expenses were $4.5 million for the second quarter of 2017, which reflects an increase of $1.6 million, or 57%, compared with $2.9 million for the second quarter of 2016. The increase in expense was primarily attributable to $0.7 million in pre-launch expenses in support of a potential commercialization of SL-401 in BPDCN, if marketing approval from the FDA is granted. The increase in costs was also driven by $0.4 million in higher legal expense as a result of the class action lawsuit, as well as a $0.3 million increase in non-cash stock-based compensation expense.

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