On August 04, 2016 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported its financial results for the second quarter ended June 30, 2016 (Press release, Curis, AUG 4, 2016, View Source [SID:1234514237]).

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"We are pleased that dosing of patients has started in the Phase 1 trial of CA-170, the first oral, small molecule immune checkpoint inhibitor targeting PD-L1 and VISTA pathways from our collaboration with Aurigene," said Ali Fattaey, Ph.D., Curis’s President and CEO. "Additionally, the second immuno-oncology program in our Aurigene collaboration that is focused on oral small molecules that target PD-1 and TIM3 pathways continues to progress well, further supporting our strategy to address inhibitory immune checkpoints with oral small molecules."

Dr. Fattaey continued, "We continue to enroll patients in the Phase 2 trial of CUDC-907 in patients with relapsed/refractory diffuse large B cell lymphoma or DLBCL, to assess its efficacy specifically in patients with MYC—altered DLBCL and remain on track for data in 2017."

Second Quarter 2016 Financial Results

Curis reported a net loss of $11.3 million, or ($0.09) per share on both a basic and diluted basis for the second quarter of 2016, as compared to a net loss of $8.1 million, or ($0.06) per share on both a basic and diluted basis for the same period in 2015. Curis reported a net loss of $20.7 million or ($0.16) per share on both basic and diluted basis for the six months ended June 30, 2016, as compared to a net loss of $40.0 million, or ($0.34) per share on both basic and diluted basis for the same period in 2015. The net loss for the six months ended June 30, 2015 includes a non-cash in-process research and development charge of $24.3 million related to Curis’s license agreement with Aurigene.

Revenues for the second quarter of 2016 were $1.7 million, as compared to $2.1 million for the same period in 2015. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the six months ended June 30, 2016 were $3.4 million, as compared to $3.7 million for the same period in 2015.

Operating expenses were $12.4 million for the second quarter of 2016, as compared to $9.5 million for the same period in 2015.

Operating expenses for the six months ended June 30, 2016 were $22.9 million, as compared to $42.1 million for the same period in 2015, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the second quarter of 2016 and 2015. Cost of royalty revenues for the six months ended June 30, 2016 and 2015 were $0.2 million for both periods.

In-Process Research and Development Expense. No in-process research and development expenses were recorded for the six months ended June 30, 2016 as compared to $24.3 million recorded during the same period in 2015 associated with the issuance of 17,120,131 shares of Curis common stock to Aurigene as partial consideration for the rights granted under the terms of the January 2015 collaboration agreement.

Research and Development Expenses. Research and development expenses were $8.8 million for the second quarter of 2016, as compared to $5.9 million for the same period in 2015. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and programs under the Aurigene collaboration over the prior year period, including a $3.0 million milestone payment to Aurigene upon the U.S. Food and Drug Administration (FDA) acceptance of the CA-170 IND. Employee-related expenses increased over the prior year period primarily due to additional headcount to support the multiple programs. Research and development expenses were $15.7 million for the six months ended June 30, 2016 as compared to $10.7 million for the same period in 2015.

General and Administrative Expenses. General and administrative expenses remained unchanged at $3.4 million for the second quarter of 2016 as compared the second quarter of 2015. General and administrative expenses were $7.1 million for the six months ended June 30, 2016, as compared to $6.9 million for the same period in prior 2015.

Other expense, net was $0.6 million for the second quarter of 2016, as compared to $0.8 million for the same period in 2015. Other expense, net primarily consisted of $0.7 million and $0.8 million in interest expense for the quarters ended June 30, 2016 and 2015, respectively, related to the loan made by BioPharma-II (an investment fund managed by Pharmakon Advisors) to Curis Royalty (a wholly owned subsidiary of Curis). Other expense, net was $1.2 million and $1.6 million for the six months ended June 30, 2016 and 2015, respectively.

As of June 30, 2016, Curis’s cash, cash equivalents, marketable securities and investments totaled $61.7 million and there were approximately 129.5 million shares of common stock outstanding.

Second Quarter Operational Highlights

Precision oncology (CUDC-907: HDAC / PI3K inhibitor program):

In June 2016, updated data from the Phase 1 trial of CUDC-907 in 75 patients with relapsed/refractory lymphoma or multiple myeloma were presented at the European Hematology Association (EHA) (Free EHA Whitepaper)’s Annual Meeting. The updated assessment from a total of 31 of these patients with relapsed refractory DLBCL showed that among 21 response-evaluable patients with DLBCL, objective responses were reported in 9 patients, including 3 patients with complete responses. Additionally, a retrospective post-hoc analysis showed that among 6 response-evaluable DLBCL patients whose tumors were characterized with MYC alterations, 5 experienced objective responses, including 3 patients with complete responses. All 5 patients with MYC altered disease who experienced objective responses also had alterations in BCL-2, including 2 patients with BCL-2 gene translocations.

In June 2016, Curis presented the CUDC-907 Phase 2 trials-in-progress poster at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentation included the Phase 2 study’s design for investigating CUDC-907’s efficacy in patients with relapsed/refractory DLBCL with MYC alterations.
Immuno-oncology (CA-170: PD-L1 / VISTA antagonist program; Aurigene collaboration):

In June 2016, the Company filed an Investigational New Drug (IND) application with the U.S. FDA to initiate the Phase 1 trial of CA-170 for once-daily oral treatment of patients with advanced solid tumors or lymphoma. The FDA accepted the Company’s IND filing during the same month.

In June 2016, the Company initiated dosing of the first patient in the Phase 1 trial of CA-170.
Erivedge (partner: Roche/ Genentech):

In June 2016, Roche presented data from two trials of Erivedge at the ASCO (Free ASCO Whitepaper) Annual Meeting, highlighting that (1) the safety profile of Erivedge continues to be consistent with the previously reported safety profiles, and (2) intermittent dosing schedules may be an option for patients with multiple basal cell carcinomas to derive long term benefit from Erivedge treatment.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through September 2016:

Baird’s Global Healthcare Conference on Sept 8-9, 2016 in New York City

On August 4, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported its second quarter 2016 financial results and provided a summary of anticipated milestones (Press release, OncoGenex Pharmaceuticals, AUG 4, 2016, View Source [SID:1234514258]).

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Financial Results and Anticipated Near-term Milestones

As of June 30, 2016, the company’s cash, cash equivalents, and short-term investments were $39.7 million compared with $55.2 million as of December 31, 2015.

Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations into the third quarter of 2017. Depending on timing of enrollment or event-driven final analyses, the expected key milestones and activities are as follows:

Custirsen
Announcing results from the AFFINITY trial, the phase 3 trial evaluating a survival benefit for custirsen in combination with cabazitaxel as second-line chemotherapy in approximately 630 patients with castrate-resistant prostate cancer. The final analysis for the intent-to-treat population is expected in the third quarter of 2016.
Announcing results from the ENSPIRIT trial, the phase 3 trial evaluating a survival benefit for custirsen in combination with docetaxel as second-line chemotherapy in approximately 700 patients with non-small cell lung cancer. The final survival analysis is expected by the first half of 2017.
Apatorsen
Announcing results from the Borealis-2 trial, an investigator-sponsored, randomized phase 2 trial evaluating apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in patients with advanced or metastatic bladder cancer. Final results are expected in the fourth quarter of 2016.
Completing a submission-ready investigational new drug application regarding apatorsen via intravesical administration in combination with Bacillus Calmette-Guerin (BCG) treatment in patients with non-muscle invasive bladder cancer.
Revenue for the three and six months ended June 30, 2016 was $2.1 million and $5.1 million, respectively, compared to $4.0 million and $5.4 million for the three and six months ended June 30, 2015, respectively. Revenue consists of recognition of deferred collaboration revenue representing our efforts in the development of custirsen. As of June 30, 2016, the full amount of the deferred collaboration revenue has been fully recognized.

Total operating expenses for the three and six months ended June 30, 2016 were $8.5 million and $15.9 million, respectively, compared to $9.6 million and $16.0 million for the three and six months ended June 30, 2015, respectively. Net loss for the three and six months ended June 30, 2016 was $6.9 million and $10.6 million, respectively, compared to $6.0 million and $10.5 million for the three and six months ended June 30, 2015, respectively.

As of Aug. 4, 2016 OncoGenex had 30,009,730 shares outstanding.

On August 4, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for second-quarter 2016 and provided an update on the Company’s marketed product and development programs (Press release, TESARO, AUG 4, 2016, View Source [SID:1234514313]).

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"The second quarter of 2016 was an exciting time for TESARO, marked by the availability of positive clinical results from our NOVA trial of niraparib. These results are the first and only Phase 3 data for a PARP inhibitor in a population of patients with platinum-sensitive, recurrent ovarian cancer," said Lonnie Moulder, CEO of TESARO. "Looking ahead, we intend to leverage these landmark data to enhance our ongoing ovarian cancer trials and expand the overall development strategy for niraparib. We are globalizing our mission of delivering transformative cancer therapies to patients, and are now expanding our commercial footprint in Europe to support planned launches of oral rolapitant and niraparib next year. Finally, our immuno-oncology portfolio continues to rapidly advance, and our antibody candidates targeting TIM-3 and PD-1 are now in Phase 1 studies."

Recent Business Highlights

The U.S. launch of VARUBI continues, and unit volume increased by 30% for the second quarter compared to the first quarter. For the month of June, VARUBI achieved a 27% market share in the oral NK-1 market in the U.S.
The New Drug Application (NDA) for an intravenous (IV) formulation of rolapitant was accepted for review by the Food and Drug Administration (FDA), and a U.S. launch is planned for the first half of 2017.
The Marketing Authorisation Application (MAA) for oral rolapitant is under review by the European Medicines Agency (EMA). In order to support a launch of niraparib and oral rolapitant in 2017, TESARO is now expanding its commercial operations in key European countries.
In June, TESARO and the European Network for Gynaecological Oncological Trial groups (ENGOT) announced that the Phase 3 NOVA trial of niraparib successfully achieved its primary endpoint of progression-free survival (PFS). This trial demonstrated that niraparib significantly prolonged PFS compared to control for patients in both the germline BRCA mutation (gBRCAmut) cohort and the non-germline BRCA mutation (non-gBRCAmut) cohort. These data will support NDA and MAA submissions during the fourth quarter of 2016.
Ongoing trials of niraparib in combination with other agents include the TOPACIO trial (formerly KEYNOTE-162) with KEYTRUDA (pembrolizumab) in patients with ovarian cancer or with triple negative breast cancer, and the AVANOVA trial with bevacizumab in patients with ovarian cancer.
The Phase 1 dose escalation study of TSR-022, our anti-TIM-3 antibody candidate, has been initiated, and the Phase 1 study of TSR-042, our anti-PD-1 antibody candidate, continues to enroll patients.
TESARO completed a public offering of common stock in July 2016, resulting in approximately $409 million in net proceeds.
Second Quarter 2016 Financial Results

TESARO reported a net loss of $58.4 million, or ($1.28) per share, for the second quarter of 2016, compared to a net loss of $60.6 million, or ($1.51) per share, for the second quarter of 2015.

Revenue recognition for certain sales of VARUBI to specialty distributors continues to be deferred at this point in the commercial launch. Net product revenue for the second quarter of 2016 totaled $1.4 million and included sales of VARUBI from specialty pharmacy customers to patients that were made during the second quarter, as well as sales from specialty distributors to providers that occurred in the first quarter of 2016 and the fourth quarter of 2015. The specialty pharmacy sales made during the second quarter represented a small portion of total product shipments. License revenue for the second quarter of 2016 totaled $35.1 million and included an up-front payment of $35 million from Janssen related to initiation of the global niraparib prostate cancer collaboration.

Research and development expenses increased to $50.1 million for the second quarter of 2016, compared to $38.9 million for the second quarter of 2015, driven primarily by higher costs related to the ongoing registration trials of niraparib, manufacturing costs associated with IV rolapitant and niraparib, and the advancement of our immuno-oncology portfolio, in addition to increased headcount.

Selling, general and administrative expenses increased to $36.2 million for the second quarter of 2016, compared to $16.8 million for the second quarter of 2015, primarily due to increased commercial headcount, including the establishment of a U.S. field sales organization in the fall of 2015, commercial activities in support of the launch of VARUBI, and higher professional service fees.

Acquired in-process research and development expenses totaled $4.0 million for the second quarter of 2016 and included a milestone payment related to our immuno-oncology portfolio, compared to $1.0 million for the second quarter of 2015, which also related to a development milestone achieved within our immuno-oncology programs. Operating expenses, as described above, include total non-cash, stock-based compensation expense of $11.7 million for the second quarter of 2016, compared to $5.5 million for the second quarter of 2015.

As of June 30, 2016, TESARO had approximately $320 million in cash and cash equivalents. This cash and cash equivalents total excludes the $409 million in net proceeds resulting from a follow-on offering of 5.3 million shares of common stock that was completed in July 2016.

For the quarter ended June 30, 2016, TESARO had approximately 45.8 million shares outstanding on a weighted average basis. As of July 7, following completion of the follow-on offering on that date, TESARO had approximately 51.4 million outstanding shares of common stock.

In anticipation of four product launches in 2017, TESARO will invest in pre-launch inventory manufacturing, development of supply chain capabilities and capacity, and expansion of European and targeted U.S. commercial operations, in addition to making milestone payments for regulatory submissions. As a result of these investments, the Company expects its cash and cash equivalents balance to decline by approximately $100 million on average, per quarter, during the third and fourth quarters of 2016.

Corporate Objectives

The following is a summary of TESARO’s key objectives:

VARUBI / Rolapitant:

Achieve #1 market share position within the oral NK-1 receptor antagonist market by year-end 2016 in the U.S.;
Launch IV rolapitant into the U.S. market in 1H 2017, pending FDA approval;
Establish a European commercial organization; and
Launch oral rolapitant in Europe in 1H 2017, pending EMA approval.
Niraparib:

Present NOVA data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual congress in Copenhagen in October;
Submit the niraparib NDA and MAA in Q4 2016;
Launch niraparib in the U.S. in 1H 2017 and in Europe in 2H 2017, pending regulatory approval;
Submit sNDA and MAA based upon QUADRA data in mid-2017;
Report Phase 3 BRAVO data in 2H 2017;
Finalize a potential lung cancer registration strategy and initiate development program in 1H 2017; and
Determine the potential registration strategy for niraparib plus an anti-PD-1 antibody in ovarian cancer and triple-negative breast cancer in mid-2017.
Immuno-Oncology Portfolio:

Identify a dose and schedule for TSR-042 by the end of 2016;
Select at least one bispecific antibody clinical candidate by the end of 2016;
Identify the first clinical candidate within the MD Anderson collaboration in 1H 2017;
Initiate a Phase 1 study of TSR-033 (anti-LAG-3 antibody) in 1H 2017;
Finalize the TSR-042 registration strategy and initiate a registration program in 1H 2017; and
Initiate a Phase 1 clinical trial of TSR-022 in combination with an anti-PD-1 antibody in mid-2017.

AVEO has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AVEO, AUG 4, 2016, View Source [SID1234514232]).

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On August 4, 2016 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported financial results for the second quarter ended June 30, 2016, and provided an overview of certain corporate achievements and plans (Press release, Tetraphase, AUG 4, 2016, View Source [SID:1234514266]).

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"During the second quarter, we finalized the protocol for IGNITE4, our upcoming phase 3 clinical trial evaluating IV eravacycline in patients with complicated intra-abdominal infections (cIAI), and remain on track to initiate this trial early in the fourth quarter of 2016," said Guy Macdonald, Tetraphase’s President and Chief Executive Officer. "Based on discussions with the FDA, we have designed IGNITE4 using a 12.5% non-inferiority margin and a trial population of approximately 450 patients. We currently anticipate reporting top-line results from IGNITE4 as early as the fourth quarter of 2017. In parallel, we are also working to finalize the trial design for IGNITE3, our phase 3 clinical trial evaluating once-daily IV eravacycline in complicated urinary tract infections (cUTI), and we look forward to providing details regarding the design and timing of IGNITE3 once the protocol is completed."

Dr. Patrick Horn, Tetraphase’s Chief Medical Officer, commented, "Separately, we continue to advance development work on the oral formulation of eravacycline. Early data from this phase 1 program indicate that the oral dosing regimen used in IGNITE2 leads to lower systemic levels of eravacycline than expected. These data also suggest that administration of oral eravacycline in a fasted state results in increased drug exposure. With this information now in hand, we have commenced further clinical testing designed to evaluate several additional variables associated with optimizing the oral eravacycline dosing regimen."

"Along with the advancement of our clinical programs, we continue to build the profile of eravacycline by testing it against multidrug-resistant bacterial strains in vitro and, at ASM Microbe and ECCMID we presented data showing eravacycline’s potent activity against these difficult-to-treat pathogens, including carbapenem-resistant enterobacteriaceae and Acinetobacter baumannii," added Dr. Horn. "We also recently confirmed that in in vitro studies eravacycline retained its potent activity against colistin-resistant clinical isolates expressing the mcr-1 gene, which was just found in bacteria in the U.S. for the first time, and we look forward to presenting these data at an upcoming medical meeting."

Second Quarter 2016 Financial Results

As of June 30, 2016, Tetraphase had cash and cash equivalents of $178.3 million and 36.7 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 into the middle of 2018.

Revenues during the second quarter of 2016 were $1.2 million compared to $3.3 million for the same period in 2015. 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 decrease in revenues was primarily due to the scope and timing of activities related to our BARDA Contract conducted during the quarter ended June 30, 2016.

Research and development (R&D) expenses for the second quarter of 2016 were $13.7 million compared to $22.9 million for the same period in 2015. The decrease in R&D expenses was primarily due to lower costs related to our Phase 3 clinical program for eravacycline.

General and administrative (G&A) expenses for the second quarter of 2016 were $4.8 million compared to $6.5 million for the same period in 2015. The decrease in G&A expenses was primarily due to a decrease in stock-based compensation expense, as well as a decrease in pre-commercialization activities for eravacycline.

For the second quarter of 2016, Tetraphase reported a net loss of $17.2 million, or $0.47 per share, compared to a net loss of $26.0 million, or $0.72 per share, for the same period in 2015.

Second Quarter and Recent Corporate Highlights

Presented data at the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), including preclinical data for eravacycline and TP-6076.

Received guidance from the U.S. FDA confirming that one additional positive phase 3 clinical trial will be required to support a New Drug Application (NDA) submission for IV eravacycline. Based on the FDA’s guidance, Tetraphase plans to conduct two additional pivotal phase 3 clinical trials: one in cIAI (IGNITE4) to support the NDA filing and one in cUTI (IGNITE3) that will form the basis of a supplemental NDA for IV eravacycline.

Finalized the clinical trial design for IGNITE4 to support an NDA filing for IV eravacycline for cIAI. IGNITE4, the Company’s planned phase 3 clinical trial evaluating the efficacy and safety of twice-daily IV eravacycline compared to meropenem in patients with cIAI, is expected to enroll approximately 450 patients and the primary analysis will be conducted using a 12.5% non-inferiority margin. Tetraphase expects to initiate this clinical trial early in the fourth quarter of 2016, with top-line results expected as early as the fourth quarter of 2017.

Presented data at the American Society of Microbiology (ASM) Microbe 2016 Conference, including clinical and preclinical data for eravacycline and preclinical data for TP-271, a novel, broad-spectrum antibiotic candidate which is being developed to combat respiratory disease caused by bacterial biothreats and antibiotic-resistant public health pathogens, as well as bacterial pathogens associated with community-acquired bacterial pneumonia.

Commenced patient dosing in a phase 1 clinical trial for TP-6076, the lead candidate from the Company’s second-generation antibiotic program which has demonstrated potent preclinical activity against multidrug-resistant Gram-negative pathogens.
Continued clinical testing designed to advance the development of an oral dose formulation of eravacycline. During the second quarter, Tetraphase completed preliminary clinical testing which indicates that the overall efficacy results in IGNITE2 were likely driven by underperformance of the oral formulation due to a food effect. Preliminary clinical testing also suggests that administration of oral eravacycline in a fasted state results in increased drug exposure. Further clinical testing is now underway to evaluate several additional variables associated with increasing drug exposure and optimizing the oral eravacycline dosing regimen.
Added to the Russell Microcap Index when the Russell Investment Group reconstituted its family of U.S. indexes in late June 2016.