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

Champions Oncology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

AC Immune has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, DURECT, 2018, MAR 17, 2017, View Source [SID1234526000]).

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, GlaxoSmithKline, 2016, MAR 17, 2017, View Source [SID1234518177])

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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

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Threshold Pharmaceuticals and Molecular Templates Agree to Combine

On March 17, 2017 Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, and Molecular Templates, Inc., a privately held biopharmaceutical company, today jointly announced that they have entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction (Press release, Threshold Pharmaceuticals, MAR 17, 2017, View Source [SID1234518202]). The transaction will result in a combined company focused on the development of novel treatments for cancer.

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Longitude Capital, a U.S. based venture capital firm, will invest $20 million at the close of the transaction, subject to certain conditions, including the receipt of additional equity financing commitments of $20 million.

Molecular Templates’ proprietary technology has been used to create a new class of biologic drug candidates known as Engineered Toxin Bodies or ETBs. ETBs have the affinity of an antibody, the ability to induce cellular internalization against non-internalizing receptors, and a novel mechanism of cell-kill (ribosome inhibition) in oncology. Molecular Templates is also using its technology to deliver foreign class I antigens into tumor cells to boost immune recognition of the tumor in a novel approach to immuno-oncology. The Molecular Templates technology has the advantage of being able to generate "off the shelf" therapeutics that do not require patient cell harvesting or transplantation.

Molecular Templates’ lead product candidate, MT-3724, is an ETB that targets the CD20 cell surface antigen present in a variety of lymphomas and leukemias. A Phase 1 trial with MT-3724 in relapsed and refractory non-Hodgkin’s lymphoma (NHL) has demonstrated good safety and efficacy in elderly, heavily pre-treated patients. In addition to MT-3724, Molecular Templates has preclinical programs targeting HER2 and PD-L1 and has received $15.2 million in new funding commitments from The Cancer Prevention and Research Institute of Texas for its program targeting CD38. Molecular Templates was previously awarded a CPRIT grant for $10.6M that has funded development of its MT-3724 program.

"The merger of our two companies provides Threshold shareholders with a significant equity stake in a biopharmaceutical company with a promising cancer therapy, MT-3724, as well as an innovative and unique technology platform that has generated preclinical drug candidates to treat multiple myeloma, breast cancer and melanoma," said Barry Selick, Ph.D. and Chief Executive Officer of Threshold. "Following an extensive and thorough review of strategic alternatives, we believe this transaction combines promising drug candidates, a solid management team and the resources to create significant value for shareholders and important new cancer therapies for patients."

Eric Poma, Ph.D., Chief Executive Officer of Molecular Templates, commented, "The combined company will have two exciting clinical-stage compounds in evofosfamide and MT-3724 and a unique biological platform with a differentiated mechanism of action in oncology. Longitude’s commitment to invest in the company is a strong testament to the promise inherent in the combined companies’ clinical assets and technology platform."

Threshold’s financial advisor for the transaction is Ladenburg Thalmann & Co. Inc., and Threshold’s legal counsel is Cooley LLP. Molecular Templates’ legal counsel are Mintz Levin Cohn Ferris Glovsky and Popeo PC and Pillsbury Winthrop Shaw Pittman LLP.

Stemline Therapeutics Reports Fourth Quarter 2016 Financial Results

On March 16, 2017 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology indications of unmet medical need, reported financial results for the quarter ended December 31, 2016 (Filing, Q4/Annual, Stemline Therapeutics, 2016, MAR 17, 2017, View Source [SID1234518191]). The company also reviewed clinical and regulatory events from the past quarter, and outlined key upcoming milestones:

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

· SL-401 Phase 2 clinical trial results in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) delivered as an oral presentation at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

· After receipt of breakthrough therapy designation in 3Q16, Stemline had a successful meeting with the U.S. Food and Drug Administration (FDA) resulting in a defined registration pathway for possible full approval in first-line BPDCN.

· Stemline is currently enrolling patients in a new cohort (Stage 3) that is expected to enroll approximately 8-12 first-line BPDCN patients.

· Completion of enrollment of the Stage 3 cohort expected this quarter. We plan to provide clinical results from this cohort in the second half of this year.

Additional Clinical Trials

· SL-401 is being clinically evaluated in several additional indications including certain high-risk myeloproliferative neoplasms (MPN), acute myeloid leukemia (AML) in complete remission with minimal residual disease, and with relapsed/refractory multiple myeloma. SL-801 is being evaluated in a Phase 1 dose escalation trial of advanced solid tumor patients. SL-701 has completed dosing in a Phase 2 trial in second-line glioblastoma. Updates from these studies are expected this year.

Fourth Quarter 2016 Financial Results Review

Stemline ended the fourth quarter of 2016 with $67.6 million in cash, cash equivalents and investments, as compared to $74.3 million as of September 30, 2016, which reflects a cash burn of $6.7 million for the quarter. Subsequent to year end 2016, Stemline completed a follow-on public offering during January 2017 raising $48.2 million in net cash proceeds bringing total cash, cash equivalents and investments to approximately $110.0 million as of March 16, 2017.

For the fourth quarter of 2016, Stemline had a net loss of $10.0 million, or $0.56 per share, compared with a net loss of $10.2 million, or $0.58 per share, for the same period in 2015.

Research and development expenses were $7.3 million for the fourth quarter of 2016, which reflects a decrease of $0.6 million, or 8%, compared with $7.9 million for the fourth quarter of 2015. The lower costs reflect a one-time payroll-related expense in 2015 partially offset by higher non-cash stock based compensation expense in 2016.

General and administrative expenses were $3.1 million for the fourth quarter of 2016, which reflects an increase of $0.5 million, or 19%, compared with $2.6 million for the fourth quarter of 2015. The increase in costs was primarily attributable to higher non-cash stock based compensation expense and the commencement of building infrastructure to support a potential commercial launch of SL-401 for BPDCN.