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.

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.

On March 17, 2017 Caladrius Biosciences, Inc. (NASDAQ: CLBS) ("Caladrius" or the "Company"), a cell therapy company with a select therapeutic development pipeline focused on immune modulation and a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, reported financial results for the three and twelve months ended December 31, 2016 (Filing, Q4/Annual, Caladrius Biosciences, 2016, MAR 17, 2017, View Source [SID1234518175]).

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2016 and 2017 Year to Date Highlights
PCT:

•Executed a global collaboration and license agreement between PCT and Hitachi Chemical Co., Ltd. in connection with the sale of 19.9% of PCT to Hitachi Chemical Co. America, Ltd. ("Hitachi America") for $19.4 million; and

•Entered into a definitive agreement with Hitachi America whereby Hitachi America agreed to purchase Caladrius’ remaining 80.1% membership interest in PCT for $75 million, subject to potential adjustments, including based on PCT’s cash and outstanding indebtedness as of the closing of the sale, and a potential future milestone payment.
CLBS03:

•Awarded a grant from the California Institute for Regenerative Medicine (CIRM) for the development of CLBS03 for an aggregate amount of up to $12.2 million, payable upon the achievement of certain milestones, for the Company’s investigational cell therapy currently being evaluated as a treatment for recent onset type 1 diabetes (T1D);

•Initiated a Phase 2 trial, the Sanford Project: T-Rex Study (T-Rex Study), for CLBS03;

•Completed enrollment of the initial cohort of 18 subjects of the T-Rex Study and, following a favorable safety recommendation from the Data Safety Monitoring Board, resumed enrollment of the second and final cohort of the study;

•Received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for CLBS03; and

•Expanded the strategic collaboration with Sanford Research beyond operational support for the CLBS03 clinical program.
CLBS12:

•Reached agreement with Japanese regulators on a development plan for CD34 cell therapy for critical limb ischemia (CLBS12) which would qualify the product for early conditional commercial approval upon successful execution.

Fourth Quarter Financial Highlights
Total revenues for the fourth quarter of 2016 increased 35% to $10.2 million compared with $7.6 million in the fourth quarter of 2015, primarily due to higher reported Clinical Services revenues at PCT.
Research and development (R&D) expenses for the fourth quarter of 2016 decreased 19% to $2.6 million compared with $3.2 million for the fourth quarter of 2015, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by costs related to the ongoing Phase 2 T-Rex Study.




Selling, general and administrative (SG&A) expenses were approximately $4.3 million for the fourth quarter of 2016 compared with $5.0 million for the same period in 2015, primarily due to lower operational and compensation-related costs during the 2016 fourth quarter.
The net loss attributable to Caladrius common stockholders for the three months ended December 31, 2016 was $6.0 million or $0.73 per share, compared to $33.2 million or $5.92 per share for same period in 2015.
Net loss for the fourth quarter of 2015 included the impairment of in-process R&D (IPR&D) valued at $34.3 million related to the Company’s decision to discontinue its Phase 3 study of CLBS20 in metastatic melanoma. This impairment was partially offset by the reversal of a related deferred tax liability and the reversal of a related contingent consideration milestone obligation. The net impact for these changes was a $24.7 million increase in net loss.

Full Year Financial Highlights
Total revenues for 2016 of $35.3 million represented an increase of 57% compared with $22.5 million for 2015. R&D expenses in 2016 were $15.1 million compared with $23.9 million in 2015. SG&A expenses for 2016 were $20.4 million compared with $30.0 million for 2015.
The net loss attributable to Caladrius common stockholders for 2016 was $32.7 million or $4.99 per share based on 6.5 million shares outstanding, compared to $80.9 million or $16.67 per share based on 4.9 million shares outstanding for 2015.
Net loss for 2015 included the impairments of IPR&D associated with our CLBS20 and CLBS10 clinical programs, valued at $43.7 million. These impairments were partially offset by reversals of related deferred tax liabilities, and the reversals of related contingent considerations obligations. The net impact for these changes was a $24.7 million increase in 2015 net loss.

Balance Sheet and Cash Flow Highlights
As of December 31, 2016, Caladrius had cash and cash equivalents of $14.7 million. The net cash used in operating activities for 2016 was $23.7 million. During 2016, the Company invested $2.8 million in capital expenditures primarily related to equipment and improvements for PCT’s Allendale, N.J. and Mountain View, CA manufacturing facilities.
Conference Call
Caladrius’ management will host a conference call for the investment community today, March 17, 2017, beginning at 8:30 a.m. Eastern time to review the financial results, provide a Company update and answer questions.
Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 95709222. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events.
The webcast will be archived on the Company’s website for 90 days.