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Tarveda Therapeutics to Present at Upcoming Investor Conferences

On March 6, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that Drew Fromkin, President and Chief Executive Officer, will present at Cowen’s 38th Annual Health Care Conference, occurring March 12-14, 2018 in Boston, MA and Needham & Company’s 17th Annual Healthcare Conference, occurring March 27-28, 2018 in New York City (Press release, Tarveda Therapeutics, JUN 6, 2018, View Source [SID1234524525]). Tarveda presentation details:

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Cowen and Company 38th Annual Health Care Conference
Date: Tuesday, March 13
Time: 5:00pm Eastern Time
Location: MIT Room, Boston Marriott Copley Place, Boston, MA

Needham & Company’s 17th Annual Healthcare Conference
Date: Tuesday, March 27
Time: 1:30pm Eastern Time
Location: Westin Grand Central Hotel, New York, NY

About Pentarins

Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell-killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell-killing payload inside the cancer cells for efficacy.

Ophthotech to Present at the Cowen and Company 38th Annual Health Care Conference

On March 6, 2018 Ophthotech Corporation (Nasdaq: OPHT) reported that Kourous A. Rezaei, M.D., Chief Medical Officer, will present an overview of the Company at the Cowen and Company 38th Annual Health Care Conference in Boston, MA on Tuesday, March 13, 2018 at 9:20 a.m. Eastern Time (Press release, Ophthotech, MAR 6, 2018, http://investors.ophthotech.com/news-releases/news-release-details/ophthotech-present-cowen-and-company-38th-annual-health-care [SID1234524485]).

Investors and the general public are invited to listen to a live webcast of the presentation on the Events & Presentations section on the Ophthotech website at www.ophthotech.com. An archived replay of the webcast will be available on the Company’s website for 14 days after the conference.

Spectrum Pharmaceuticals Reports Fourth Quarter 2017 and Full Year 2017 Financial Results and Pipeline Update

On March 6, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported financial results for the three-month period and year ended December 31, 2017 (Press release, Spectrum Pharmaceuticals, MAR 6, 2018, View Source [SID1234524425]).

"2017 was a landmark year for Spectrum driven by advancements in our pipeline," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "Poziotinib has the potential to be a life-altering therapy for cancer patients with exon-20 insertion mutations. ROLONTIS gives Spectrum a near-term opportunity to compete in a blockbuster market. We expect several pipeline milestones in 2018 and we look forward to keeping you updated."

Pipeline Update:

Poziotinib, an irreversible tyrosine kinase inhibitor:

The Company has initiated a multi-center study which is currently enrolling Non-Small Cell Lung Cancer (NSCLC) patients. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations at several leading cancer centers. The study will evaluate objective response rate (ORR) as the primary endpoint, and disease control rate (DCR), duration of response (DOR), and safety as secondary endpoints.
An investigator sponsored trial is currently enrolling at the University of Texas MD Anderson Cancer Center in NSCLC patients with exon 20 insertion mutations in EGFR or HER2. The study yielded preliminary results demonstrating evidence of significant antitumor activity in NSCLC patients with EGFR exon 20 insertion mutations, with preliminary data in the first 11 patients showing an unconfirmed Objective Response Rate of 73%. Safety profile was consistent with those previously described for poziotinib and other TKIs. The Company expects additional data from this study in 2018.
An abstract on poziotinib was accepted at AACR (Free AACR Whitepaper). Primarily pre-clinical data will be available at AACR (Free AACR Whitepaper) on the anti-tumor activity of poziotinib in HER2 exon-20 insertion mutations in NSCLC.
Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S.

ROLONTIS(eflapegrastim), a novel long-acting GCSF:

A registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company announced the ADVANCE study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms.
The Company has completely enrolled RECOVER, an international Phase 3 trial that has a similar design.
The Company expects to file the BLA in Q4 2018.

2018 Guidance

The Company expects total revenue to be between $90 to $110 million in 2018. Gross margin is expected to improve primarily as a result of enhancements to Evomela manufacturing. R&D expense is expected increase driven by additional spend on pipeline.

Three-Month Period Ended December 31, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $27.9 million in the fourth quarter of 2017. Product sales in the fourth quarter included: FUSILEV (levoleucovorin) net sales of $0.9 million, FOLOTYN (pralatrexate injection) net sales of $11.0 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.9 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.2 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, and EVOMELA (melphalan) for injection net sales of $8.3 million.

Spectrum recorded net loss of $28.6 million, or $0.29 per basic and diluted share in the three-month period ended December 31, 2017, compared to net loss of $18.1 million, or $0.23 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $22.1 million in the quarter, as compared to $16.0 million in the same period in 2016. Selling, general and administrative expenses were $29.2 million in the quarter, compared to $18.9 million in the same period in 2016.

During the quarter the Company purchased $69.5 million face value of its convertible debentures for $27.3 million in cash and 5.4 million newly-issued shares of our common stock. The Company ended the quarter with cash, cash equivalents and marketable securities of $227.6 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $22.8 million, or $0.23 per basic and diluted share in the three-month period ended December 31, 2017, compared to non-GAAP net loss of $8.1 million, or $0.10 per basic and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $21.3 million, as compared to $15.4 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $19.1 million, as compared to $15.6 million in the same period in 2016.

Twelve-Month Period Ended December 31, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $116.2 million for the twelve months ended December 31, 2017. Total product sales decreased 9.7% from $128.6 million in the same period of 2016.

Product sales in 2017 included: FUSILEV (levoleucovorin) net sales of $7.3 million, FOLOTYN (pralatrexate injection) net sales of $43.0 million, ZEVALIN (ibritumomab tiuxetan) net sales of $11.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $6.6 million, BELEODAQ (belinostat) for injection net sales of $12.4 million, and EVOMELA (melphalan) for injection net sales of $35.2 million.

Spectrum recorded net loss of $91.2 million, or $1.07 per basic and diluted share in the twelve-month period ended December 31, 2017, compared to net loss of $69.8 million, or $0.96 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $65.9 million for the year, as compared to $59.1 million in the same period in 2016. Selling, general and administrative expenses were $84.3 million for the year, compared to $88.4 million in the same period in 2016.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $52.1 million, or $0.61 per basic and diluted share in the twelve-month period ended December 31, 2017, compared to non-GAAP net loss of $16.8 million, or $0.23 per basic and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $63.4 million, as compared to $54.1 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $65.4 million, as compared to $64.1 million in the same period in 2016.

GlycoMimetics Reports Fourth Quarter and Year-End 2017 Results

on March 6, 2018 GlycoMimetics, Inc. (Nasdaq:GLYC) reported progress on its clinical development programs and its financial results for the fourth quarter and year ended December 31, 2017 (Press release, GlycoMimetics, MAR 6, 2018, View Source [SID1234524470]).

"Highlighting the fourth quarter of 2017, GlycoMimetics presented a robust data set for its Phase 1/2 study of GMI-1271 for the treatment of AML patients. This data provided the basis for discussions with the U.S. FDA focused on a Phase 3 trial design – the result of which we announced yesterday. The ongoing discussions were made possible via our Breakthrough Therapy designation for GMI-1271 for the treatment of relapsed/refractory AML patients, and we now plan to initiate our own Phase 3 trial in this patient population later this year," noted Rachel King, Chief Executive Officer.

Recent Operational Highlights:

In the Phase 1/2 clinical trial, acute myeloid leukemia (AML) patients treated with GMI-1271, a specific E-selectin inhibitor, together with standard chemotherapy, consistently performed better than would be expected based on historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, even with a population consisting of very high-risk patients based on age, disease status, and cytogenetic risk factors. The updated data announced at ASH (Free ASH Whitepaper) in December 2017 reinforced earlier findings that disrupting the relationship between leukemic cells and the protective bone marrow microenvironment, when combined with chemotherapy, could improve outcomes for patients with AML.
Investigators continue to evaluate GMI-1271 as a therapy for multiple myeloma in a European trial that has been expanded beyond its initial base in Ireland to include other European Union clinical centers. Preliminary results from this study are expected in the first quarter of 2019.
GlycoMimetics continues to evaluate its product candidate, GMI-1359, which simultaneously targets both E-selectin and the chemokine CXCR4, in a Phase 1 dose-escalation study in healthy volunteers.
Ongoing preclinical work is being focused on a new pipeline program targeted at the galectins, a biological target potentially important in treating certain cancers and fibrosis.
In the Phase 3 trial of rivipansel, being conducted by our collaborator Pfizer, investigators are evaluating patients hospitalized for vaso-occlusive crisis of sickle cell disease. Pfizer reports that the study remains on track for completion in the second half of 2018.
Fourth Quarter 2017 Financial Results:

Cash position: As of December 31, 2017, GlycoMimetics had cash and cash equivalents of $123.9 million as compared to $40.0 million as of December 31, 2016.
R&D Expenses: The Company’s research and development expenses increased to $6.7 million for the quarter ended December 31, 2017 as compared to $6.1 million for the fourth quarter of 2016. Research and development expenses increased by $0.8 million to $24.1 million for the year ended December 31, 2017, from $23.3 million in the year ended December 31, 2016. During the year ended December 31, 2017, there was an increase in the manufacturing costs related to the clinical supplies for GMI-1271 as we advance towards a planned Phase 3 clinical trial, which increase was offset in part by a decrease in clinical expenses as the GMI-1271 Phase 2 clinical enrollment was completed in May 2017.
G&A Expenses: The Company’s general and administrative expenses increased to $2.8 million for the quarter ended December 31, 2017 as compared to $2.3 million for the fourth quarter of 2016. General and administrative expenses for the year ended December 31, 2017 increased to $9.8 million as compared to $8.7 million in the prior year. These increases were primarily due to increased labor-related costs and stock-based compensation expense.
Shares Outstanding: Shares outstanding as of December 31, 2017 were 34,359,799.
The company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1453008. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1453008.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and MM or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteer

Tetraphase Pharmaceuticals Reports Fourth Quarter and Full-Year 2017 Financial Results, Highlights Achievements and Key 2018 Milestones

on march 6, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections,reported financial results for the fourth quarter and year ended December 31, 2017, provided an overview of recent achievements, and highlighted key milestones for 2018 (Press release, Tetraphase, MAR 6, 2018, View Source [SID1234524468]).

"2017 was a year of tremendous progress for Tetraphase, as we successfully completed IGNITE4, our second positive phase 3 clinical trial evaluating IV eravacycline in complicated intra-abdominal infections (cIAI), and filed regulatory approval applications in the U.S. and in Europe for cIAI," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "Although we were very disappointed with the recently announced topline results from our IGNITE3 trial in complicated urinary tract infections (cUTI), in which eravacycline did not achieve statistical non-inferiority to ertapenem, we are excited to move forward with bringing eravacycline to market for the treatment of cIAI. We recently announced that the FDA has accepted our NDA submission for review and our PDUFA date is August 28, 2018."

Key Milestones for 2018

Potential approval of eravacycline in cIAI in US – 2H 2018

Potential approval of eravacycline in cIAI in Europe – 2H2018

Potential commercial launch of eravacycline in cIAI in the US – Q4 2018

Complete phase 1 MAD studies for TP-271 and TP-6076 – 2H 2018

Fourth Quarter and Recent Highlights

Entered into an exclusive licensing agreement with Everest Medicines Limited, a biopharmaceutical company based in China, to develop and commercialize eravacycline for the treatment of cIAI and other indications in mainland China, Taiwan, Hong Kong, Macau, South Korea, and Singapore.

Submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for IV eravacycline for the treatment of cIAI. Notified of a Prescription User Fee Act (PDUFA) goal date of August 28, 2018 for the FDA’s completion of its review. The NDA submission includes data from the IGNITE1 and IGNITE4 phase 3 clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI. Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators – ertapenem in IGNITE1 and meropenem in IGNITE4 – for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.

Announced top-line results from IGNITE3, the Company’s phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem for the treatment of patients with cUTI, in which eravacycline did not achieve statistical non-inferiority to ertapenem. The Company is fully analyzing the data to understand the outcome and will provide an update when more information is available. Based on the results of the study, the Company does not plan to further evaluate eravacycline in cUTI and has ceased its development of an oral formulation of eravacycline for the treatment of cUTI.

Appointed Larry Tsai, M.D., Chief Medical Officer. Dr. Tsai joined Tetraphase in 2014 as senior medical director and became vice president, clinical development in 2015. He has nearly 20 years of experience in clinical practice and development. Dr. Tsai has provided significant expertise to the clinical team throughout the IGNITE phase 3 program for eravacycline, as well as in the early clinical development of the Company’s pipeline programs.

Appointed Larry Edwards, Chief Operating Officer. Mr. Edwards joined Tetraphase in July 2015 as vice president, marketing, served as vice president, commercial operations from January 2016 to December 2016 and as senior vice president, chief commercial officer from December 2016 to February 2017. He has over 20 years of experience in the infectious disease area. Mr. Edwards is responsible for all phases of the launch of eravacycline, assuming regulatory approval.
Fourth Quarter and Full-Year 2017 Financial Results
As of December 31, 2017, Tetraphase had cash and cash equivalents of $136.4 million and 51.4 million shares outstanding. The Company expects that its cash and cash equivalents, as well as expected revenue from its U.S. government awards, will be sufficient to fund operations through the first half of 2019.

For the fourth quarter of 2017, Tetraphase reported a net loss of $23.5 million, or $0.46 per share, compared to a net loss of $22.5 million, or $0.61 per share, for the same period in 2016. Revenues were $2.5 million compared to $1.1 million for the same period in 2016. Revenues for each period consisted of contract and grant revenue under the Company’s U.S. government awards for the development of Tetraphase compounds for the treatment of diseases caused by bacterial biothreat pathogens and for certain infections caused by life-threatening multidrug-resistant bacteria. The increase in revenue was mainly due to scope and timing of activities related to our Biomedical Advanced Research and Development Authority (BARDA) Contract conducted during the fourth quarter of 2017. Research and development (R&D) expenses for the fourth quarter of 2017 were $18.5 million compared to $19.3 million for the same period in 2016. The decrease in R&D expenses was primarily due to lower manufacturing costs in 2017 compared to the same period in 2016, offset, in part, by higher clinical costs related to our IGNITE3 clinical trial. General and administrative (G&A) expenses for the fourth quarter of 2017 were $7.9 million compared to $4.3 million for the same period in 2016. The increase in G&A was primarily due to pre-launch commercial investments, business development expenses and headcount related costs.

For the year ended December 31, 2017, Tetraphase reported a net loss of $114.8 million, or $2.63 per share, compared to a net loss of $77.5 million, or $2.11 per share, for the same period in 2016. Revenues were $9.7 million for the year ended December 31, 2017 compared to $5.1 million for the same period in 2016. As stated above, revenues for each period consisted of contract and grant revenue under the Company’s U.S. government awards for the development of Tetraphase compounds for the treatment of diseases caused by bacterial biothreat pathogens and for certain infections caused by life-threatening multidrug-resistant bacteria. This increase in 2017 was due to changes in the timing and scope of activities under the subcontract with respect to the BARDA and National Institute of Allergy and Infectious Diseases (NIAID) contracts and the addition of amounts received under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) award. R&D expenses were $101.7 million for the year ended December 31, 2017 compared to $63.8 million for the same period in 2016. The increase was mainly due to costs associated with conducting our IGNITE3 and IGNITE4 phase 3 clinical trials and an increase in regulatory costs associated with eravacycline related to our marketing authorization application (MAA) and NDA filing activities. G&A expenses were $23.7 million for the year ended December 31, 2017 compared to $19.2 million for the same period in 2016. This increase was primarily due to pre-launch commercial investments, business development and legal expenses and headcount related costs.

About Eravacycline
Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of cIAI and other serious infections, including those caused by MDR pathogens that have been highlighted as urgent public health threats by both the World Health Organization and the U.S. Centers for Disease Control & Prevention (CDC). In clinical trials, eravacycline has demonstrated potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.

Eravacycline was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) phase 3 programs. In IGNITE1, a pivotal phase 3 trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The IGNITE1 data is serving as the basis of the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of patients with cIAI now under review by the European Medicines Agency (EMA). In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well tolerated, and achieved high cure rates. The Company has used the results from IGNITE1 and IGNITE4 to support a New Drug Application (NDA) submission for IV eravacycline in cIAI. To date, eravacycline has been administered to over 2,700 patients.