On August 8, 2017 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the second quarter ended June 30, 2017, and provided an update on recent developments (Press release, Bellicum Pharmaceuticals, AUG 8, 2017, View Source;p=RssLanding&cat=news&id=2292700 [SID1234520145]).

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"Since I joined the Company six months ago, we have conducted a thorough review of our strategy and operations, and are very optimistic about the opportunities before us," said Rick Fair, Bellicum’s President & Chief Executive Officer. "We continue to be encouraged by the results from our ongoing BPX-501 pediatric studies and our progress toward a filing in Europe. We have adjusted our plans for U.S. registrational trials to enable an efficient path to seeking approvals for the greatest areas of unmet need. Lastly, we continue to be excited about the clinical progress of our CAR T and TCR product candidates, and the application of our molecular switch platform for future pipeline expansion."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

BPX-501
Adjunct T-cell therapy incorporating the CaspaCIDe safety switch, administered after a haploidentical hematopoietic stem cell transplant (haplo-HSCT), to improve outcomes and reduce mortality

Data Update Suggests BPX-501 Improves Outcomes of Haploidentical Stem Cell Transplants
During the Presidential Symposium of the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June, Bellicum reported data from 98 pediatric patients within the BP-004 trial which showed rapid immune recovery, a low incidence of transplant-related mortality, a reduction in viral infections and a low rate of Graft versus Host Disease (GvHD) that was manageable with either standard treatments or rimiducid. The data suggest BPX-501 could improve outcomes of haploidentical stem cell transplants, providing an option for the many patients who could benefit from a life-saving transplant but lack a matched donor.

Positive Clinical Results of BPX-501 in Pediatric Leukemias
Also at EHA (Free EHA Whitepaper), Bellicum reported data from the BP-004 trial in a cohort of 47 pediatric patients with acute leukemias who lack a matched donor. The data showed rapid immune reconstitution and low rates of relapse and mortality, suggesting that BPX-501 may offer benefits in combination with HSCT in acute leukemia patients.

European BP-004 Pivotal Clinical Trial Progressing
Enrollment in the pivotal EU BP-004 trial remains on track for completion by the end of 2017. Bellicum expects to initiate an observational trial in pediatric patients receiving transplants from matched unrelated donors (MUD) without BPX-501 in the third quarter. Outcomes from these trials are expected to be the basis for filings of European Marketing Authorization Applications for BPX-501 and rimiducid. The Company expects to report top-line results of these studies in the second half of 2018, with MAA filings planned for 2019.

Company Clarifies U.S. Clinical Development Strategy
Bellicum is finalizing plans for the design of registrational trials of BPX-501 in the U.S. The Company’s current plans include conducting a controlled clinical trial in adult patients with acute myeloid leukemia (AML), which it expects to fund in part through its $16.9 million Product Development Award from the Cancer Prevention and Research Institute of Texas ("CPRIT"). In the pediatric non-malignant setting, Bellicum is designing a registrational trial to evaluate BPX-501 in a distinct subset of orphan inherited blood disorders.
BPX-601

Phase 1 BPX-601 Clinical Trial Continues
BPX-601 is Bellicum’s novel GoCAR-T product candidate, which is designed with its proprietary iMC activation switch to allow control over the level of stimulation and proliferation of the modified T cells. Enrollment and treatment is ongoing in Bellicum’s Phase 1 trial in patients with nonresectable pancreatic cancer who test positive for prostate stem cell antigen (PSCA).
BPX-701

Phase 1 BPX-701 Clinical Trial Continues
BPX-701 is a high affinity TCR product candidate designed with the CaspaCIDe safety switch, enabling the elimination or reduction of the engineered cells in the event of severe toxicities. Dosing has been initiated in the Company’s Phase 1 clinical trial in patients with refractory or relapsed AML and myelodysplastic syndromes (MDS) who test positive for preferentially-expressed antigen in melanoma (PRAME).
CORPORATE UPDATE

Addition of Chief Business Officer to Expand Partnership Opportunities
Greg Naeve, Ph.D., an accomplished product strategy and business development executive, is joining Bellicum’s leadership team in August 2017 from Pfizer, where he led efforts to identify and implement multiple strategic partnerships and translational science collaborations across Pfizer Worldwide R&D, including CAR T alliances with Cellectis and Servier.
PRECLINICAL RESEARCH

In April, Bellicum reported positive preclinical data at AACR (Free AACR Whitepaper) on its novel dual-switch technology incorporated into CAR T and TCR constructs, an approach offering the possibility of both activating cells to enhance efficacy and eliminating them to manage toxicity. Bellicum is working to incorporate its dual-switch technology into future CAR T and TCR product candidates.

The Company continues to work with academic collaborators to explore the applicability of CaspaCIDe in CD19 CARs, the first of which is expected to enter the clinic in the second half of this year in patients with B-cell malignancies.
SECOND QUARTER AND SIX MONTHS ENDED JUNE 30, 2017 FINANCIAL RESULTS

Bellicum reported a net loss of $24.5 million for the second quarter of 2017 and $46.4 million for the six months ended June 30, 2017, compared to a net loss of $16.5 million and $31.6 million for the comparable periods of 2016. The results included non-cash, share-based compensation charges of $3.2 million and $6.6 million for the second quarter and six months ended June 30, 2017 and $3.1 million and $6.2 million for the comparable periods in 2016.

As of June 30, 2017, cash, restricted cash and investments totaled $139.0 million. Based on current operating plans, Bellicum continues to expect to end 2017 with approximately $85 to $95 million in cash and investments, and that current cash resources will be sufficient to meet operating requirements through 2018.

Research and development expenses were $18.0 million and $33.3 million, for the three and six months ended June 30, 2017, respectively, compared to $12.0 million and $22.9 million during the comparable periods in 2016. The higher expenses in the 2017 periods were primarily due to an increase in clinical development and manufacturing costs due to increased enrollment in trials, principally BPX-501, and increased personnel expenses, overhead charges and manufacturing facility start-up costs.

General and administrative expenses were $5.5 million and $11.4 million for the three and six months ended June 30, 2017, respectively, compared to $4.2 million and $8.5 million during the comparable periods in 2016. The higher expenses in the 2017 periods were primarily due to the Company’s overall growth, including an increase in personnel related costs, principally due to hiring additional employees and severance costs, higher facility costs and increased legal, accounting and travel expenses.

At June 30, 2017, Bellicum had 33,193,229 shares of common stock outstanding.

On August 8, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the quarter ended June 30, 2017 (Press release, Loxo Oncology, AUG 8, 2017, View Source [SID1234520187]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

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"I am very proud of the Loxo Oncology team for delivering a great second quarter," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "The larotrectinib (LOXO-101) presentations at ASCO (Free ASCO Whitepaper) and the simultaneous LOXO-195 publication in Cancer Discovery illustrate what can be accomplished for patients when a focused management team brings together the disparate disciplines of medicinal chemistry, comprehensive tumor testing and clinical-regulatory execution. In addition, the LOXO-292 IND moves the company into an exciting second target and third clinical-stage program. We look forward to the second half of 2017, when we plan to prepare the larotrectinib NDA submission, advance our TRK fusion diagnostics strategy with third party collaborators, and advance LOXO-292 efficiently through a dose escalation. We hope to be able to share initial clinical data from the LOXO-292 program by the end of the year."

Recent Highlights

Larotrectinib Adult and Pediatric Interim Clinical Data Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: In June, interim clinical data from three ongoing larotrectinib trials were reported in two oral presentations at ASCO (Free ASCO Whitepaper). The data demonstrated a 76 percent confirmed objective response rate (ORR) in 50 patients for whom follow-up was sufficiently long to include a confirmatory scan. Responses were observed across 17 unique tumor types harboring TRK fusions. The ASCO (Free ASCO Whitepaper) presentation included adult and pediatric patients with Response Evaluation Criteria In Solid Tumors (RECIST)-evaluable TRK fusion cancers, with an April 14, 2017 data cut-off. See the presented data here.
Larotrectinib Regulatory Updates: In May, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to larotrectinib for the "treatment of solid tumors with NTRK-fusion proteins." Loxo Oncology remains on track to submit a New Drug Application (NDA) for larotrectinib to the FDA in late 2017 or early 2018. The primary analysis for the NDA will rely upon central, independent radiology review. The company plans to announce these data, which will also include additional patient follow-up from the data set presented at ASCO (Free ASCO Whitepaper), before the end of 2017.
LOXO-195: In May, the FDA cleared the IND application for LOXO-195, Loxo Oncology’s next-generation TRK inhibitor. On June 3, 2017, a research brief was published in Cancer Discovery outlining the preclinical rationale for LOXO-195 and clinical proof-of-concept data from the first two patients treated. The Phase 1 trial is currently open for enrollment.
LOXO-292: In May, the first patient was enrolled in the Phase 1 clinical trial of LOXO-292, a highly selective RET inhibitor. This first-in-human, global, multi-center Phase 1 trial is evaluating LOXO-292 as a single agent in patients with advanced solid tumors.
LOXO-305: In July, Loxo Oncology announced the acquisition of the Redx Pharma Plc BTK inhibitor program, including lead candidate LOXO-305 (formerly RXC005). Under the terms of the agreement, Loxo Oncology has made a $40 million payment to Redx Pharma Plc. Loxo Oncology is not subject to milestone or royalty obligations. Lead candidate LOXO-305 was designed to reversibly bind BTK and preserve activity in the presence of the C481S acquired resistance mutation. Additionally, it was designed to avoid off-target kinases that have complicated the development of both covalent and reversible BTK inhibitors. LOXO-305 is expected to enter clinical development in 2018.
Equity Financing: In June, Loxo Oncology announced the closing of an underwritten public offering of 3,622,500 shares of common stock at a public offering price of $72.00 per share, which included the exercise in full by the underwriters of their option to purchase 472,500 additional shares of common stock. Gross proceeds to Loxo Oncology from this offering were approximately $260.8 million.
Second Quarter 2017 Financial Results

As of June 30, 2017, Loxo Oncology had aggregate cash, cash equivalents and investments of $467.6 million, compared to $141.8 million as of December 31, 2016.

Research and development expenses were $24.4 million for the second quarter of 2017 compared to $12.3 million for the second quarter of 2016. This increase was primarily due to expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional development expenses related to LOXO-292 and increases in employment costs primarily due to increased headcount. Loxo Oncology also recognized research and development-related stock-based compensation expense of $3.5 million during the second quarter of 2017 compared to $0.2 million for the second quarter of 2016.

Research and development expenses were $44.6 million for the six months ended June 30, 2017, compared to $20.7 million for the six months ended June 30, 2016. This increase was primarily due to expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional development expenses related to LOXO-292 and LOXO-195 and increases in employment costs primarily due to increased headcount. Loxo Oncology also recognized research and development-related stock-based compensation expense of $5.9 million during the six months ended June 30, 2017, compared to $0.5 million for the six months ended June 30, 2016.

General and administrative expenses were $6.5 million for the second quarter of 2017 compared to $3.8 million for the second quarter of 2016. The increase was primarily due to increases in preparation activities for the potential commercialization of larotrectinib, headcount and employment costs and general and administrative professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $2.0 million during the second quarter 2017 compared to $1.1 million for the second quarter of 2016.

General and administrative expenses were $11.3 million for the six months ended June 30, 2017, compared to $7.2 million for the six months ended June 30, 2016. The increase was primarily due to increases in preparation activities for the potential commercialization of larotrectinib, headcount and employment costs and general and administrative professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $3.5 million during the six months ended June 30, 2017, compared to $2.1 million for the six months ended June 30, 2016.

Net loss was $30.4 million and $54.9 million for the three and six months ended June 30, 2017, respectively, compared to $15.9 million and $27.5 million for the three and six months ended June 30, 2016, respectively.

On August 8, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported financial results for the second quarter ended June 30, 2017, and provided an update on tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for HER2 and the Company’s lead product in development (Press release, Cascadian Therapeutics, AUG 8, 2017, View Source [SID1234520146]).

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"During the second quarter, we were pleased to receive confirmation from the European Medicines Agency (EMA) that HER2CLIMB, if positive, could serve as a single registrational trial for submission to the European regulators for potential marketing approval, and that tucatinib was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer patients with brain metastases," said Scott Myers, President and CEO of Cascadian Therapeutics. "We are now enrolling patients in HER2CLIMB on three continents. We are pleased with site activations and patient enrollment, which are currently ahead of our projections in North America."

Second Quarter and Recent Highlights

In July 2017, the Company announced that it received confirmation from the EMA that positive results from its ongoing pivotal trial of tucatinib, known as HER2CLIMB, could serve as a single registrational trial for submission of a Marketing Authorization Application to the EMA and potential marketing approval. The Company had received similar confirmation from the FDA in 2016.

In June 2017, the Company announced that tucatinib was granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.
Second Quarter Financial Results

Cash, cash equivalents and investments totaled $125.4 million as of June 30, 2017, compared to $62.8 million at December 31, 2016. The increase was primarily due to the result of net proceeds of $88.0 million from the Company’s January 2017 financing, less cash used in operations of $24.8 million.

Net loss attributable to common stockholders for the three months ended June 30, 2017 was $14.7 million, or $0.30 per share, compared with a net loss attributable to common stockholders of $25.1 million, or $1.57 per share, for the comparable period in 2016. The $10.4 million decrease in net loss attributable to common stockholders for the quarter was primarily due to the non-cash intangible asset impairment charge of $19.7 million offset by a $6.9 million tax benefit related to the reversal of the deferred tax liability. Both amounts were recorded in connection with the termination of the STC.UNM license agreement in 2016. The decrease was offset by an increase in research and development expenses of $5.1 million primarily due to greater activity related to the development of the Company’s product candidates.

Net loss attributable to common stockholders for the six months ended June 30, 2017 was $27.1 million, or $0.60 per share, compared to a net loss attributable to common stockholders of $38.0 million, or $2.39 per share, for the same period in 2016. The $10.9 million decrease in net loss attributable to common stockholders for the six months ended June 30, 2017 was primarily due to the non-cash intangible asset impairment charge of $19.7 million offset by a $6.9 million tax benefit related to the reversal of the deferred tax liability. Both of these amounts were recorded in connection with the termination of the STC.UNM license agreement in 2016. In addition, the decrease was due to lower general and administrative expenses of $4.5 million primarily due to compensation-related expenses in connection with management changes in the first quarter of 2016 and lower non-cash expense from the deemed dividend related to the beneficial conversion feature on convertible preferred stock. The decrease in net loss attributable to common stockholders were partially offset by increases in research and development expenses of $7.4 million due to greater activity related to the development of the Company’s product candidates.

2017 Financial Outlook

Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, primarily due to an increase in activities related to the ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations for 2017 is expected to be approximately $50.0 million to $54.0 million.

Cascadian Therapeutics believes the above financial guidance to be correct as of the date provided and is providing the guidance as a convenience to investors and assumes no obligation to update it.

On August 8, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal fourth-quarter 2017 and fiscal full-year 2017, provided an update on recent business highlights and issued its fiscal year 2018 and fiscal first-quarter 2018 financial guidance (Press release, Myriad Genetics, AUG 8, 2017, View Source [SID1234520189]).

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"This quarter we saw record demand for hereditary cancer tests and now have 86 percent of our hereditary cancer revenue under long-term contract, providing future stability upon which to build our growing portfolio of new products," said Mark C. Capone, president and CEO, Myriad Genetics. "Our diversification efforts showed continued success with new products representing greater than two-thirds of test volume and 28 percent of revenue in the fourth-quarter. Our strong progress on transforming the company leaves us well positioned to achieve our long-term strategic goals."

Financial Highlights

The following table summarizes the financial results and product revenue for our fiscal fourth-quarter 2017:

Revenue
Fiscal Fourth-Quarter Fiscal Year
($ in millions) 2017 2016 %
Change 2017 2016 %
Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 144.6 $ 152.8 (5%) $ 568.7 $ 632.3 (10%)

GeneSight testing revenue 25.5 NA NM 78.4 NA NM

Vectra DA testing revenue 10.3 * 12.7 (19%) 43.7 47.8 (9%)

Prolaris testing revenue 2.9 3.5 (17%) 12.1 11.3 7%

EndoPredict testing revenue 2.0 1.7 18% 7.6 4.5 69%

Other testing revenue 2.6 3.1 (13%) 11.6 9.8 18%

Total molecular diagnostic testing revenue 187.9 173.7 8% 722.1 705.7 2%

Pharmaceutical and clinical service revenue 12.6 12.7 (1%) 49.3 48.1 3%

Total Revenue $ 200.5 $ 186.5 8% $ 771.4 $ 753.8 2%

Income Statement
Fiscal Fourth-Quarter Fiscal Year
($ in millions) 2017 2016 %
Change 2017 2016 %
Change
Total Revenue $ 200.5 $ 186.5 8% $ 771.4 $ 753.8 2%

Gross Profit 158.0 146.5 8% 600.3 596.5 1%
Gross Margin 78.8 % 78.6 % 77.8 % 79.1 %

Operating Expenses 140.9 110.8 27% 550.8 429.7 28%

Operating Income 17.1 35.7 (52%) 49.4 166.8 (70%)
Operating Margin 8.5 % 19.1 % 6.4 % 22.1 %

Adjusted Operating Income 28.0 39.0 (28%) 97.2 179.5 (46%)
Adjusted Operating Margin 14.0 % 20.9 % 12.6 % 23.8 %

Net Income 12.9 23.4 (45%) 21.8 125.3 (83%)

Diluted EPS 0.19 0.32 (41%) 0.32 1.71 (81%)

Adjusted EPS $ 0.30 $ 0.36 (17%) $ 1.05 $ 1.63 (36%)
* Negatively impacted by delayed submission of $2 million in Medicare claims

Business Highlights

• Hereditary Cancer

Record hereditary cancer demand in the fourth quarter with 6 percent year-over-year volume growth.
Signed multiple payer contracts, increasing revenue under long-term contract to 86 percent.
Presented the results of a 2,000 patient study with myRisk Hereditary Cancer at ASCO (Free ASCO Whitepaper) demonstrating that 50 percent of patients with mutations would be missed with current testing criteria and that 34 percent of mutations were in genes not indicated by family history.
• New Products

GeneSight in fiscal 2017 grew revenue by 34 percent. Additionally, over 17,000 physicians ordered the test representing a 55 percent increase.
Prolaris received a final local coverage determination (LCD) from Palmetto GBA for favorable intermediate patients which will expand coverage to approximately 30,000 additional Medicare patients.
Prolaris clinical validity study with 767 patients presented at the American Urological Association annual meeting demonstrated the ability of the test to predict metastatic disease. The study found that patients with a low Prolaris score had a 10-year risk of metastases of less than 1 percent, while patients with a high Prolaris score had a 10-year risk of metastases of 25 percent.
Vectra DA clinical utility study presented at the European League Against Rheumatism (EULAR) demonstrated the ability of the test to predict radiographic progression in a meta-analysis of six cohorts incorporating over 800 patients. Vectra DA predicted radiographic progression in all six patient cohorts, and had greater than three times the predictive power of current standard of care disease activity measures such as DAS28-CRP and CRP.
Vectra DA clinical utility study presented at EULAR demonstrated the ability of the test to predict which patients could be considered for biologic tapering. In a study of 146 patients, relapse rates for patients who had undergone full or partial tapering on biologic therapy were 24 percent in patients with a low Vectra DA score and negative ACPA compared to 79 percent in patients with high Vectra DA scores and positive ACPA. The study found that patients with low Vectra DA scores and/or negative ACPA were at a low risk for relapse when tapered, and average biologic usage was reduced for the entire cohort by 20 percent.
Companion diagnostics advanced with planned submission of a premarket approval (PMA) supplement in the second half of calendar year 2017 to the U.S. Food and Drug Administration for BRACAnalysis CDx to identify HER2-negative, metastatic breast cancer patients for olaparib therapy.
EndoPredict received a draft LCD from Medicare for node negative and node positive, ER+ patients with breast cancer representing a U.S. market of approximately 140,000 patients per year. If approved, Myriad would have coverage for approximately 75 percent of breast cancer patients when combined with the contracted private lives in the United States.
• International

EndoPredict revenues increased 18 percent compared on a year-over-year basis.
Received provincial reimbursement in Quebec for EndoPredict. Expect additional Canadian provincial decisions in fiscal year 2018.
• Elevate 2020

Announced the launch of the Elevate 2020 program with a goal of delivering $50 million of incremental operating income by fiscal year 2020. Projects already have been identified that will generate $17 million in operating income in fiscal 2018 and an additional $24 million in operating income in fiscal 2019.
Fiscal Year 2018 and Fiscal First-Quarter 2018 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2018 and fiscal first-quarter 2018 financial guidance:

Revenue GAAP Diluted
Earnings Per
Share Adjusted
Earnings Per
Share
Fiscal Year 2018 $750-$770
million $0.37-$0.42 $1.00-$1.05

Fiscal First-Quarter 2018 $181-$183
million $0.05-$0.07 $0.19-$0.21
These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today to discuss the fiscal fourth-quarter financial results, fiscal 2017 financial results, fiscal year 2018 financial guidance, and fiscal first-quarter 2018 financial guidance.

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.