(Filing, 10-Q, CTI BioPharma, AUG 6, 2015, View Source [SID:1234507087])

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On August 6, 2015 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, reported its financial results for the second quarter ended June 30, 2015 (Press release, Curis, AUG 6, 2015, View Source [SID:1234507055]).

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"During the second quarter, we presented results of the Phase 1 trial of CUDC-907 at scientific conferences, where we reported clinical activity, including complete responses in heavily pre-treated patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL)," said Ali Fattaey, Ph.D., Curis’ President and Chief Executive Officer. "CUDC-907 appears to be well tolerated with a manageable side effect profile at the recommended dose and schedule. Enrollment of patients with relapsed or refractory DLBCL in the expansion arms of the ongoing Phase 1 study is continuing, where we are administering CUDC-907 either as monotherapy or in combination with rituximab. We are in the process of finalizing the Phase 2 study design for CUDC-907, and we expect to initiate the study later this year."

Dr. Fattaey continued, "Our partner Aurigene has made progress in advancing programs under our collaboration, and we remain on-track to file an IND application for the first immuno-oncology drug candidate later this year. We also expect to file an IND application for the lead IRAK4 inhibitor candidate and initiate its Phase 1 program during the first half of 2016."

Second Quarter and First Half 2015 Financial Results

Curis reported a net loss of $8.1 million, or ($0.06) per share on both a basic and fully diluted basis for the second quarter of 2015, as compared to a net loss of $1.9 million or ($0.02) per share on both a basic and fully diluted basis for the same period in 2014. Curis reported a net loss of $40 million, or ($0.34) per share on both a basic and fully diluted basis for the six months ended June 30, 2015, as compared to a net loss of $7.5 million or ($0.09) per share on both a basic and fully diluted basis for the same period in 2014. The net loss for the first half of 2015 includes an in-process research and development charge of $24.3 million related to Curis’ license agreement with Aurigene.

Revenues for the second quarter of 2015 were $2.1 million, as compared to $4.8 million for the same period in 2014. The decrease in revenues was primarily due to a decrease in license fee revenues due to a $3 million milestone payment that Curis earned from Genentech/Roche upon achievement by Genentech/Roche of certain development objectives during the second quarter of 2014. Offsetting these decreases, royalty revenues recorded on Genentech/Roche’s net sales of Erivedge increased to $2.0 million in the second quarter of 2015 as compared to $1.8 million during the same period in 2014.

Revenues for the six months ended June 30, 2015 were $3.7 million, as compared to $6.1 million for the same period in 2014.

Operating expenses for the second quarter of 2015 were $9.5 million, as compared to $6.3 million for the same period in 2014. Operating expenses for the six months ended June 30, 2015 were $42.1 million, as compared to $12.4 million for the same period in 2014 and were comprised of the following:

Costs of royalty revenues. Costs of royalty revenues, which are comprised of amounts due to third-party university patent licensors in connection with Genentech/Roche’s Erivedge net sales, were $103,000 and $92,000 during the second quarters of 2015 and 2014, respectively. Costs of royalty revenues for the six months ended June 30, 2015 were $187,000, as compared to $157,000 for the same period in 2014.

In-process research and development expenses. The Company recorded a one-time charge for in-process research and development expense of $24.3 million during the first half of 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 parties’ January 2015 collaboration agreement.

Research and development expenses. Research and development expenses were $5.9 million for the second quarter of 2015 as compared to $3.3 million for the same period in 2014. The increase in research and development expense was primarily due to increased spending on CUDC-907 and preclinical programs under the Company’s collaboration with Aurigene. The Company incurred expenses of $2.7 million and $1.4 million on CUDC-907 for the quarters ended June 30, 2015 and 2014, respectively, related to its ongoing Phase 1 studies. Spending of $2.5 million on the Company’s preclinical research programs for the three months ended June 30, 2015 includes a $2 million milestone payment to Aurigene for selection of a third program under that collaboration and also includes costs to support planned development activities, primarily consisting of personnel costs, compared to costs of $81,000 in the prior year quarter. Offsetting these increases, spending on CUDC-427 decreased by $900,000 during the three months ended June 30, 2015 as compared to the prior year period. Research and development expenses were $10.7 million for the six months ended June 30, 2015 as compared to $6.5 million for the same period in 2014.

General and administrative expenses. General and administrative expenses were $3.4 million for the second quarter of 2015 as compared to $2.9 million for the second quarter of 2014. Increased legal costs and stock-based compensation were partially offset by decreased professional and consulting costs. General and administrative expenses were $6.9 million for the six months ended June 30, 2015 as compared to $5.8 million for the same period in 2014.

Other expense was $759,000 for the second quarter of 2015, as compared to $351,000 for the same period in 2014. Other expense primarily consisted of $843,000 and $950,000 in interest expense for the quarters ended June 30, 2015 and 2014, respectively, related to the loan made by BioPharma-II to Curis Royalty, a wholly-owned subsidiary of Curis. The Company also recorded other income of $557,000 and $649,000 during the three and six month periods ended June 30 2014, respectively, associated with the change in fair value of a warrant liability. Other expense was $1.6 million and $1.2 million for the six month periods ended June 30, 2015 and 2014, respectively.

As of June 30, 2015, Curis’ cash, cash equivalents, marketable securities and investments totaled $99.2 million, and there were approximately 128.4 million shares of common stock outstanding.

2015 Financial Guidance

The Company has revised its 2015 financial guidance for research and development expenses for 2015. The Company currently expects that these expenses will be in the range of $30 to $35 million for 2015. The Company had previously estimated that these expenses would range from $37 to $42 million. As a result, the Company currently expects to end 2015 with cash, cash equivalents and investments of $72 to $77 million versus its previous estimate of $65 to $70 million.

The Company’s decrease in research and development expenses is primarily the result of a decrease in estimated expenses across its development programs, including a recent re-evaluation of its clinical development plans for CUDC-427, an orally-available, small molecule antagonist of IAP proteins, as well as for its HSP90 inhibitor CUDC-305. The Company’s management determined that it would preserve Curis’ current resources for the continued development of CUDC-907 and drug candidates under the Company’s collaboration with Aurigene.

Recent Operational Highlights

CUDC-907:

In May 2015, Curis reported data from the dose escalation (completed) and expansion (ongoing) stages of the Phase 1 study of CUDC-907 at the Annual Meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that was held in Chicago, IL. CUDC-907 demonstrated evidence of clinical activity with objective responses reported in patients with relapsed/refractory DLBCL and Hodgkin’s lymphoma. Among 10 response evaluable patients with DLBCL across various cohorts, two complete responses and four partial responses were reported. One patient with Hodgkin’s lymphoma experienced partial response out of a total of 12 response evaluable patients with Hodgkin’s lymphoma. In addition, stable disease was observed in 25 of 44 response evaluable patients across various lymphomas and multiple myeloma.
In June 2015, Curis presented data from the Phase 1 study of CUDC-907 at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), in Vienna, Austria, and the 13th International Congress on Malignant Lymphoma (ICML) in Lugano, Switzerland.
Aurigene Collaboration:

In April 2015, Aurigene presented a poster entitled "Novel IRAK4 inhibitors exhibit highly potent anti-proliferative activity in DLBCL cell lines with activating MYD88 L265P mutation" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2015 Annual Meeting. This poster included data from multiple orally bioavailable molecules that showed potent inhibition of IRAK4 kinase activity in biochemical assays and proliferation in DLBCL cancer cell lines with MYD88 mutation. Some of these compounds were further tested in in vivo models and demonstrated significant anti-tumor activity in a DLBCL xenograft model with MYD88 mutation as well as disease reduction in a rat collagen-induced arthritis model, which is a model for inflammatory conditions.
Upcoming Activities

Curis expects to present at the following investor conferences through October 2015:

Robert W. Baird & Co. 2015 Health Care Conference, September 9-10, 2015 in New York City
FBR 2nd Annual Healthcare Conference, September 9, 2015 in Boston, MA
14th Annual BIO Investor Forum, October 20-21, 2015 in San Francisco

On August 6, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, provided a corporate update and reported financial results for the second quarter ending June 30, 2015 (Press release, Five Prime Therapeutics, AUG 6, 2015, View Source [SID:1234507088]).

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"Five Prime is actively building a comprehensive and complementary portfolio of immuno-oncology candidates and programs that target macrophages, immune check points, T cell agonist pathways and regulatory T cells in the tumor microenvironment," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "Regarding our clinical programs, we recently received IND clearance for our Phase 1a/1b clinical trial to evaluate the combination of our CSF1 receptor antibody, FPA008, and Bristol-Myers Squibb’s nivolumab, and plan to initiate dosing this month. In July, we began dosing patients in our Phase 1/2 clinical trial of FPA008 in PVNS, a tumor driven by the CSF1 pathway. On the research side, we added a T cell agonist to our early pipeline with the in-licensing of Inhibrx’s antibodies to GITR, a pathway we identified in our protein library and proprietary in vivo screens as one of the most potent inhibitors of tumor growth. We also licensed to bluebird bio our novel human antibodies to an undisclosed target to develop CAR T cell therapies for hematologic malignancies and solid tumors."

"Looking ahead, we expect data from two of our clinical programs before year end. GSK intends to present initial data from the Phase 1b clinical trial of FP-1039 in squamous non-small cell lung cancer and mesothelioma patients at the World Conference on Lung Cancer in September, and we plan to report preliminary data from the open label portion of our Phase 1 study of FPA008 in rheumatoid arthritis patients by year end."

Business Highlights and Recent Developments

Pipeline:

FPA008: FPA008 targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. In joint diseases, such as PVNS and RA, synovial macrophages play a central role in the disease process.

Initiated Phase 1/2 Clinical Trial of FPA008 in PVNS. In July, Five Prime initiated patient dosing in its Phase 1/2 clinical trial of FPA008 in pigmented villonodular synovitis (PVNS), an orphan indication. During the Phase 1 dose escalation portion of the trial, Five Prime will assess safety and pharmacodynamics of multiple ascending doses of FPA008 to determine the dose for expansion. During the Phase 2 expansion, the company will evaluate tumor response rate and duration, as well as measures of pain and joint function, in approximately 30 patients. Five Prime plans to complete dose escalation and move into dose expansion by the end of 2015 or early 2016.
Prepared for Initiation of Phase 1a/1b FPA008/Nivolumab Combination Trial in Collaboration with Bristol-Myers Squibb (BMS). In July, Five Prime received IND clearance for the Phase 1a/1b clinical trial to explore the combination of FPA008 and nivolumab, BMS’s PD-1 immune checkpoint antibody, in multiple tumor types. The trial will evaluate the safety, tolerability and preliminary efficacy of the combination in patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. Five Prime plans to initiate patient dosing during August and to present the trial design at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. The company expects to complete Phase 1a dose escalation and expand into Phase 1b with the selected dose of FPA008 in late 2015 or early 2016.

Continued Dosing Rheumatoid Arthritis (RA) Patients in Open-Label Portion of Phase 1 Clinical Trial of FPA008. Five Prime continued to dose FPA008 in RA patients with active disease who are on methotrexate in its Phase 1 clinical trial. The company plans to report preliminary open-label data from RA patients by the end of 2015.

Continued Enrollment in the Phase 1 Clinical Trial of FPA144. Five Prime continued to enroll its Phase 1a/1b clinical trial of FPA144, an FGF receptor 2b-selective antibody. By the end of 2015, Five Prime expects to complete Phase 1a dose escalation in patients with solid tumors, including gastric cancer, and to begin the Phase 1b expansion at a selected dose in gastric cancer patients whose tumors have evidence of FGFR2b protein overexpression or FGFR2 gene amplification. The company anticipates preliminary Phase 1a data will be available by the end of 2015 or early 2016.

Continued Enrollment in the Phase 1b Clinical Trial of FP-1039/GSK3052230 in Squamous Non-Small Cell Lung Cancer (NSCLC) and Mesothelioma. GlaxoSmithKline (GSK) continued to enroll patients in the Phase 1b clinical trial of FP-1039, an FGF ligand trap, combined with standard doses of chemotherapy. Patients with newly-diagnosed or recurrent squamous non-small cell lung cancer whose tumors have amplification of the FGF receptor 1 gene are being studied in Arms A and B, respectively. In Arm C, GSK is studying patients with malignant pleural mesothelioma, a tumor in which the FGF2 ligand is overexpressed. GSK intends to present preliminary safety and efficacy data from the trial at the World Conference on Lung Cancer in September.

Research Programs:

Established Strategic Research and License Agreement With Inhibrx for Novel GITR Antibodies. In July, Five Prime established a research collaboration and license agreement for Inhibrx’s novel glucocorticoid-induced tumor necrosis factor receptor (GITR) antibodies. The program is currently at lead selection stage and could potentially reach IND in 2017. Using its comprehensive protein library and proprietary in vivo screening technologies, Five Prime identified the GITR pathway as one of the most potent inhibitors of tumor growth. Additionally, agonist antibodies have demonstrated the ability to induce tumor regressions in preclinical models, particularly when administered with other immuno-oncology therapies. The Inhibrx technology represents a potentially best-in-class approach for engineering a multivalent GITR agonistic antibody. Five Prime paid an upfront license fee of $10 million to Inhibrx in July 2015.

Entered into License Agreement with bluebird bio for Novel Antibodies to Develop CAR T Cell Therapy. In May, Five Prime granted an exclusive license to bluebird bio to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Five Prime’s proprietary human antibodies to an undisclosed target for hematologic malignancies and solid tumors. Five Prime received a $1.5 million upfront payment, and is eligible for development, regulatory, and commercial milestones payments of up to $131 million per licensed product as well as tiered royalties on future product sales.

Continued to Advance Immuno-Oncology Research Programs. Five Prime continues to progress its immuno-oncology product candidates toward preclinical development, with fully human antibody campaigns underway to multiple targets. The company provided background on its immuno-oncology discovery methods and preclinical data on novel immune checkpoint candidates during its Research and Development Day in May. Five Prime plans to present further updates at scientific conferences and remains on track for one new IND per year from its research programs beginning in 2017.

Summary of Financial Results and Guidance:

Cash Position. Cash, cash equivalents and marketable securities totaled $207.4 million on June 30, 2015 compared with $149.1 million on December 31, 2014. The increase was primarily attributable to Five Prime’s January 2015 public offering of common stock, offset by cash used in operations.

Revenue. Collaboration and license revenue for the second quarter of 2015 increased by $1.3 million, or 26%, to $6.3 million from $5.0 million in the second quarter of 2014, primarily due to the $1.5 million upfront license payment from bluebird bio.
R&D Expenses. Research and development expenses for the second quarter of 2015 increased by $1.4 million, or 12%, to $13.3 million from $11.9 million in the second quarter of 2014. This increase was primarily related to advancing the FPA008 development program into additional indications and expanding the company’s internal immuno-oncology research and preclinical activities.
G&A Expenses. General and administrative expenses for the second quarter of 2015 increased by $1.6 million, or 53%, to $4.6 million from $3.0 million in the second quarter of 2014. This increase was primarily due to increases in personnel related expenses, including stock-based compensation and facility costs.

Net Loss. Net loss for the second quarter of 2015 was $11.5 million, or $0.45 per basic and diluted share, compared with a net loss of $9.9 million, or $0.46 per basic and diluted share, for the second quarter of 2014. This increase in net loss was primarily related to advancing the FPA008 development program into additional indications and expanding internal immuno-oncology research and preclinical activities.

Updated 2015 Cash Guidance. Five Prime expects full-year 2015 net cash used in operating activities to be between $65 and $70 million and estimates ending 2015 with between $158 and $163 million in cash, cash equivalents and marketable securities. With the addition of the GITR program to the pipeline in July 2015, Five Prime expects to have cash to fund operations through 2017, without entering into any additional collaboration or license agreements or receiving any future milestone payments. This provides sufficient runway to move Five Prime’s three clinical programs beyond efficacy data readouts and to move one or more new immuno-oncology candidates into clinical trials.

(Filing, 10-Q, Galena Biopharma, AUG 6, 2015, View Source [SID:1234507089])

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On August 6, 2015 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and six months ended June 30, 2015 (Press release, Emergent BioSolutions, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076503 [SID:1234507057]).

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Financial highlights include:
Total revenues: Q2 2015 of $126.1 million, up 14% over prior year; six months 2015 of $189.7 million, up 16% over prior year;
GAAP net income/loss: Q2 2015 net income of $14.1 million, or $0.32 per diluted share; six months 2015 net loss of $7.4 million, or $0.19 per diluted share;

Adjusted net income/loss: Q2 2015 net income of $17.0 million, or $0.36 per diluted share; six months 2015 net loss of $1.8 million, or $0.05 per diluted share;

EBITDA: Q2 2015 of $29.6 million, or $0.62 per diluted share; six months 2015 of $9.6 million, or $0.25 per diluted share; and
Adjusted EBITDA: Q2 2015 of $31.0 million, or $0.65 per diluted share; six months 2015 of $12.2 million, or $0.32 per diluted share.

2015 business accomplishments:

FDA approval of Anthrasil (Anthrax Immune Globulin Intravenous (Human))
Awards to manufacture Ebola monoclonal antibodies under our CIADM arrangement with BARDA
Successful dosing of our first patient in the Phase I trial for MOR209/ES414, our immunotherapeutic treatment for prostate cancer
FDA approval and launch of IXINITY, a recombinant factor IX treatment for Hemophilia B
Continued steady progress on Building 55 sBLA approval

2015 outlook:

Reaffirmation of previous guidance – FY 2015 total revenues of $510-$540 million, net income of $50-$60 million (GAAP) and $60-$70 million (adjusted); and

New guidance – Q3 2015 total revenues of $140 to $155 million.

2015 FINANCIAL PERFORMANCE
(I) Quarter Ended June 30, 2015 (unaudited)

Revenues

Product Sales

For Q2 2015, product sales were $82.0 million, an increase of 5% as compared to 2014. The increase primarily reflects increased sales of BioThrax during the quarter.

Contract Manufacturing

For Q2 2015, revenue from our contract manufacturing operations was $8.9 million, a decrease of 3% as compared to 2014. The decrease was primarily due to the timing of fill/finish facility service to third parties.
Contracts, Grants and Collaborations
For Q2 2015, contracts, grants and collaborations revenue was $35.2 million, an increase of 54% as compared to 2014. The increase was primarily due to development funding for Anthrasil.

Operating Expenses

Cost of Product Sales and Contract Manufacturing

For Q2 2015, cost of product sales and contract manufacturing was $27.3 million, a decrease of 21% as compared to 2014. The decrease was primarily attributable to the decrease in the BioThrax cost per dose sold associated with increased production yield in the period in which the doses were produced.

Research and Development
For Q2 2015, gross research and development (R&D) expenses were $40.9 million, an increase of 9% as compared to 2014. The increase was primarily attributable to additional R&D expenditures associated with product development programs in the Biodefense segment. Net R&D expenses, which are more representative of the company’s actual out-of-pocket investment in product development, are calculated as gross research and development expenses less contracts, grants and collaboration revenues. For Q2 2015, net R&D expenses were $5.7 million, a decrease of 61% as compared to 2014.

Selling, General and Administrative
For Q2 2015, selling, general and administrative expenses were $36.5 million, an increase of 19% as compared to 2014. The increase was primarily attributable to selling, general and administrative costs associated with the launch of IXINITY and professional services to support the company’s strategic growth initiatives.

Net Income
For Q2 2015, GAAP net income per diluted share is computed using the if-converted method. This method requires GAAP net income to be adjusted in the amount of $1.0 million, from $14.1 million to $15.1 million, related to interest expense and amortization of debt issuance cost, both net of tax, associated with the company’s 2.875% Convertible Senior Notes due 2021.
(II) Six Months Ended June 30, 2015 (unaudited)

Revenues

Product Sales
For the six months of 2015, product sales were $100.3 million, a decrease of 12% as compared to 2014. The decrease was primarily attributable to the timing of deliveries of BioThrax to the SNS due to our decision to suspend shipments to the CDC in Q1 2015. Shipments were subsequently resumed in Q2 2015.

Contract Manufacturing
For six months of 2015, revenue from our contract manufacturing operations was $21.1 million, an increase of 77% as compared to 2014. The increase was primarily due to the impact of fill/finish services revenues for the entire six month period in 2015.

Contracts, Grants and Collaborations
For six months of 2015, contracts, grants and collaborations revenue was $68.3 million, an increase of 78% as compared to 2014. The increase was primarily due to development funding for Anthrasil.

Operating Expenses
Cost of Product Sales and Contract Manufacturing
For the six months of 2015, cost of product sales and contract manufacturing was $46.0 million, a decrease of 14% as compared 2014. The decrease was primarily attributable to a decrease in product sales and contract manufacturing revenues.

Research and Development
For the six months of 2015, gross R&D expenses were $79.6 million, an increase of 18% as compared to 2014. The increase was primarily attributable to additional R&D expenditures in the Biodefense segment.

Net R&D expenses for the six months of 2015 were $11.3 million, a decrease of 62% as compared to 2014.

Selling, General and Administrative

For the six months of 2015, selling, general and administrative expenses were $70.9 million, an increase of 17% as compared to 2014. The increase was primarily attributable to additional post-acquisition selling, general and administrative costs largely associated with the operations acquired in Q1 2014, including IXINITY launch costs, as well as professional services to support the company’s strategic growth initiatives.

(III) Reconciliation of GAAP Net Income to Adjusted Net Income/(Loss), EBITDA and Adjusted EBITDA

This press release contains three financial measures (Adjusted Net Income/(Loss), EBITDA or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA) that are considered "non-GAAP" financial measures under applicable Securities & Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The company’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. Adjusted EBITDA also excludes specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments. The company views these non-GAAP financial measures as a means to facilitate management’s financial and operational decision-making, including evaluation of the company’s historical operating results and comparison to competitors’ operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the company’s operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure, may provide a more complete understanding of factors and trends affecting the company’s business.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the company’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety.