On November 7, 2017 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported financial results for the quarter ended September 30, 2017 (Press release, Affimed, NOV 7, 2017, View Source [SID1234521625]).

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"We continue to make great strides in validating our NK cell engager programs, in particular through encouraging data from studies of our lead candidate AFM13, which is progressing through clinical development as a mono- and combination therapy," said Dr. Adi Hoess, CEO of Affimed. "Leveraging our unique NK cell-based platform for high-affinity CD16A-targeting, we are advancing our tetravalent bispecific antibodies with the potential to tailor immune-engaging therapy to different indications and settings."

Third Quarter Updates

Corporate Update

· In September 2017, Dr. Wolfgang Fischer, former Global Head of Program and Project Management of Sandoz Biopharmaceuticals (Novartis Group) joined Affimed as Chief Operating Officer. Dr. Fischer has over 20 years of R&D experience with a focus on oncology, immunology and pharmacology. With his proven track record in drug development, he will support the Company in advancing its unique immune cell engagers to address the existing medical need in hematologic and solid tumor indications. In addition to his role as COO, Dr. Fischer will assume responsibility as interim CMO, working closely with the Company’s clinical team.

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NK cell engager programs

· In Affimed’s Phase 1b combination study of its lead product candidate, the CD30/CD16A-targeting NK cell engager AFM13, with Merck’s Keytruda (pembrolizumab) in Hodgkin lymphoma (HL), the dose expansion cohort is open and recruiting. Data analysis of three-month response rates is ongoing for the escalation phase of the trial with analysis of 9 out of 12 patients completed to date. Of the 3 patients enrolled into cohort 1, two experienced partial metabolic responses, while one patient progressed. Of the 3 patients enrolled into cohort 2, one patient experienced a complete metabolic response, one patient experienced a partial metabolic response and one patient progressed. Out of the six patients in dose cohort 3, three were analyzed to date, all of which experienced partial metabolic responses at the first tumor response assessment. The Company intends to present detailed dose escalation data including response data of the three remaining patients in cohort 3 at the upcoming ASH (Free ASH Whitepaper) 2017 Annual Meeting in December.

· Affimed is supporting a translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. The study is designed to allow for serial biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment. The first cohort has been fully enrolled and recruitment into further cohorts is ongoing. The first patient, suffering from anaplastic large-cell lymphoma (ALCL) with cutaneous manifestation, experienced a complete response of cutaneous lesions after the first treatment cycle. Systemic evaluation is ongoing. This provides first evidence that NK cell engagers are able to induce tumor regression in this indication.

· The Company’s investigator-sponsored Phase 2a monotherapy study of AFM13 in HL led by the German Hodgkin Study Group (GHSG), is open to recruit under the new design, which includes patients pre-treated with both brentuximab vedotin (B.V.) and anti-PD1.

· In Affimed’s collaboration with The University of Texas MD Anderson Cancer Center (MDACC) evaluating the Company’s NK cell engager AFM13 in combination with MDACC’s NK cell product, preclinical research activities are progressing.

· The Company has developed multiple tetravalent, bispecific antibody formats in addition to its TandAbs. These molecules confer distinct biophysical properties aimed at tailoring PK profiles. Based on its platform, Affimed is advancing AFM24, an EGFR/CD16A-specific NK cell engager and AFM26, a BCMA/CD16A-specific NK cell engager, through IND-enabling studies. Final candidates have been selected for AFM24 and AFM26, respectively.

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· Candidates for AFM24, developed to treat solid tumors, are based on both TandAb format and on novel proprietary antibody formats. AFM24 molecules offer a differentiated mode of action as compared to cetuximab. Furthermore, binding to NK cells is largely unaffected by IgG competition, resulting in higher efficacy and elimination of cells with low target expression. Affimed is currently evaluating its novel format-based AFM24 molecules, which have significantly longer half-lives, in comparison to the Company’s TandAbs, which have already shown evidence of a beneficial safety profile.

· AFM26 is designed to eliminate malignant cells in multiple myeloma (MM) independent of BCMA expression levels. AFM26 offers a differentiated mode of action, targeting cells expressing very low levels of BCMA, conferring NK cell cytotoxicity and eliciting lower cytokine release compared to a BiTE molecule. Furthermore, binding to NK cells is largely unaffected by IgG competition. These unique features could position AFM26 in patients receiving autologous stem cell transplant (ASCT)-eligible at or shortly after transplant, a period in which no treatment is currently available.

T cell engager programs

· Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19-targeting tetravalent bispecific T cell engager in patients with relapsed and refractory (r/r) acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. Both studies are ongoing and recruiting.

· Recruitment is ongoing into a first-in-human Phase 1 dose escalation trial of AMV564 conducted by Amphivena Therapeutics, Inc. in patients with r/r acute myeloid leukemia (AML). AMV564 is a CD33/CD3-specific antibody based on Affimed’s technology platform. Affimed owns ~18.5% of Amphivena (fully diluted).

Financial Highlights
(Figures for the third quarter and first nine months of 2017 and 2016 represent unaudited figures)

Cash and cash equivalents and financial assets totaled €41.8 million as of September 30, 2017 compared to €44.9 million as of December 31, 2016. Affimed’s operational expenses for the nine months ended September 30, 2017 were primarily offset by net proceeds of €16.4 million from a public offering of common shares in the first quarter and of €2.5 million from the drawdown of the second tranche of the loan from Silicon Valley Bank.

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Net cash used in operating activities was €20.7 million for the nine months ended September 30, 2017 compared to €25.5 million for the nine months ended September 30, 2016. The decrease was primarily related to lower cash expenditure for research and development (R&D) in connection with Affimed’s development and collaboration programs and to the expiration of the Amphivena collaboration.

Revenue for the third quarter of 2017 was €0.5 million compared to €0.9 million for the third quarter of 2016. Revenue in the 2017 period was derived from AbCheck services while revenue in the 2016 period related predominantly to Affimed’s collaboration with Amphivena.

R&D expenses for the third quarter of 2017 were €6.0 million compared to €8.8 million for the third quarter of 2016. The decrease was primarily related to lower expenses for AFM13 and our discovery/early stage development activities.

G&A expenses for the third quarter of 2017 were €1.9 million compared to €2.2 million for the third quarter of 2016.

Net loss for the third quarter of 2017 was €8.1 million, or €0.18 per common share, compared to a net loss of €10.3 million, or €0.31 per common share, for the third quarter of 2016. The decrease of operating expenses was partially offset by lower revenue and higher finance costs.

Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

On November 7, 2017 Aptose Biosciences Inc. (Aptose) (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that it will release its financial results for the quarter ended September 30, 2017 on Tuesday, November 14, 2017 after the close of the market (Press release, Aptose Biosciences, NOV 7, 2017, View Source [SID1234521626]). The company intends to host a conference call the same day at 5:00 p.m. ET to discuss the financial results.

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Participants can access the conference call by dialing (844) 882-7834 (North American toll free number) and (574) 990-9707 (International) and using passcode 98696700. The conference call can also be accessed here and will be available through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. An archived version of the webcast along with a transcript will be available on the company’s website for 30 days. An audio replay of the webcast will be available approximately two hours after the conclusion of the call for 7 days by dialing (855) 859-2056, using the passcode 98696700.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2017 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On November 7, 2017 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the third quarter ended September 30, 2017 (Press release, BioCryst Pharmaceuticalsa, NOV 7, 2017, View Source [SID1234521627]).

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"Now that we have completed our end of Phase 2 regulatory interactions with the FDA and EMA and have agreement on the requirements for marketing authorization applications of BCX7353, we are focused on executing the Phase 3 program to support NDA and MAA filings in 2019," said Jon P. Stonehouse, President & Chief Executive Officer. "We expect to start the single required Phase 3 efficacy and the long-term safety trials in first quarter 2018."

Third Quarter Financial Results

For the three months ended September 30, 2017, revenues increased to $8.8 million from $7.8 million in the third quarter of 2016. The increase in revenue was primarily due to a $5.0 million milestone payment associated with the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for RAPIVAB (peramivir injection), extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older, and the recognition of $1.5 million of peramivir product sales to the Company’s commercial partner, Green Cross Corporation. These increases were offset by a $3.1 million decrease in RAPIACTA royalties primarily due to lower government stockpiling sales by the Company’s commercial partner in Japan, Shionogi & Co. Ltd. (Shionogi), and lower collaboration revenue under U.S. Government development contracts.

Research and Development (R&D) expenses for the third quarter of 2017 increased to $17.5 million from $14.1 million in the third quarter of 2016, primarily due to increased spending on the Company’s hereditary angioedema (HAE) portfolio, including the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial. These increases were offset by a decrease in the Company’s galidesivir expenses under U.S. Government development contracts.

General and administrative (G&A) expenses for the third quarter of 2017 increased to $3.3 million compared to $2.8 million of expense in the third quarter of 2016. The increase was primarily due to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial.

Interest expense was $2.1 million in the third quarter of 2017 as compared to $1.5 million in the third quarter of 2016, an increase related primarily to the September 2016 closing of a $23 million senior credit facility. Also, a $84,000 mark-to-market gain on the Company’s foreign currency hedge was recognized in the third quarter of 2017, as compared to a $931,000 mark-to-market loss in the third quarter of 2016. These changes result from periodic changes in the U.S. dollar/Japanese yen exchange rate. During the third quarter of 2017, the Company also realized a currency gain of $45,000 from the exercise of a U.S. Dollar/Japanese yen currency option within its foreign currency hedge.

The net loss for the third quarter of 2017 was $15.1 million, or $0.18 per share, compared to a net loss of $11 .5 million, or $0.16 per share, for the third quarter 2016.

Cash, cash equivalents and investments totaled $169.3 million at September 30, 2017, and reflect an increase from $65.1 million at December 31, 2016. Net operating cash use for the third quarter of 2017 was $10.6 million, and was $31.6 million for the first nine months of 2017, which excludes net proceeds from the March 2017 ($47.8 million) and September 2017 ($85.8 million) public offerings.

Year to Date Financial Results

For the nine months ended September 30, 2017, revenues increased to $21.3 million from $17.4 million in the first nine months of 2016. The increase in revenue was primarily due to $7.0 million of milestone payments associated with the Canadian regulatory and FDA sNDA approvals of RAPIVAB, and to a lesser extent a $1.2 million increase in royalty revenue from Shionogi & Co. Ltd., Green Cross Corporation and Seqirus. The increase in royalty revenue was largely the result of continued Japanese Government stockpiling of RAPIACTA. Future government stockpiling orders are difficult to predict, as they are subject to the relevant appropriation and stockpiling processes. These revenue increases were offset by a $5.5 million decrease in collaboration revenue under U.S. Government development contracts.

R&D expenses for the nine months of 2017 increased to $50.0 million from $48.9 million in the first nine months of 2016, primarily due to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial. These increases were offset by a decrease in galidesivir expenses under U.S. Government development contracts.

G&A expenses for the nine months of 2017 increased to $9.2 million compared to $8.7 million in the first nine months of 2016. The increase was due to the achievement of a performance-based stock option grant related to the successful completion of the APeX-1 clinical trial.

In the nine months of 2017 and 2016, interest expense was $6.3 million and $4.4 million, respectively. The increase in interest expense was related primarily to the September 2016 closing of a $23 million senior credit facility. A $1.9 million mark-to-market loss on the Company’s foreign currency hedge was recognized in the first nine months of 2017, as compared to a $7.4 million mark-to-market loss in the first nine months of 2016. These losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate. During 2017 and 2016, we also realized currency gains of $966,000 and $811,000, respectively, from the exercise of a U.S. Dollar/Japanese yen currency option within our foreign currency hedge.

The net loss for the nine months of 2017 was $46.2 million, or $0.58 per share, compared to a net loss of $50.6 million, or $0.69 per share for the same period last year.

Clinical Development Update & Outlook

In the fourth quarter, BioCryst completed end of Phase 2 regulatory interactions with the FDA and European Medicines Agency (EMA) resulting in finalizing the marketing authorization requirements, including agreement on the design of a single Phase 3 clinical trial and the details regarding a long-term safety trial.

On November 1, 2017, the FDA granted orphan drug designation to BCX7353 for the prevention and treatment of angioedema attacks in patients diagnosed with HAE.

On September 5, BioCryst announced positive final results from its Phase 2 APeX-1 clinical trial in HAE. APeX-1 was a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients.

On September 15, BioCryst announced the completion of an underwritten public offering of 17,864,078 shares of its common stock, including 2,330,097 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares. The gross proceeds from this offering, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were $92 million before deducting underwriting discounts and commissions and other estimated offering expenses.

On September 21, BioCryst announced that the U.S. FDA approved a sNDA for RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor, extending its availability for the treatment of acute uncomplicated influenza to pediatric patients two years and older who have been symptomatic for no more than two days.
Financial Outlook for 2017

Based upon development plans and our awarded government contracts, BioCryst expects its 2017 net operating cash use to be in the upper half of its previously disclosed range of $30 to $50 million, and its 2017 operating expenses to be in the upper half of its previously disclosed range of $53 to $73 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in reliably projecting this expense, as it is impacted by the volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast Tuesday, November 7, 2017 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.BioCryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

About BCX7353

Discovered by BioCryst, BCX7353 is a novel, oral, once-daily, selective inhibitor of plasma kallikrein currently in development for the prevention and treatment of angioedema attacks in patients diagnosed with HAE. BCX7353 was generally safe and well tolerated in the recently completed Phase 2 APeX-1 clinical trial for the prophylaxis of angioedema attacks in patients with HAE and in clinical pharmacology studies in healthy volunteers.

About RAPIVAB (peramivir injection)

Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous viral neuraminidase inhibitor approved for the treatment of acute uncomplicated influenza in patients two years and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit View Source to learn more.

On November 7, 2017 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the third quarter 2017 (Press release, Cambrex, NOV 7, 2017, View Source [SID1234521628]).

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Highlights

Net Revenue increased 13% to $112.6 million compared to $99.4 million in the same quarter last year. Excluding the impact of foreign exchange, net revenue increased 12%.
GAAP Diluted EPS from continuing operations increased 24% to $0.52 from $0.42 in the same quarter last year. Adjusted Diluted EPS increased 20% to $0.55 compared to $0.46 in the same quarter last year.
EBITDA increased 29% to $33.3 million compared to the same quarter last year (see table at the end of this press release).
Net cash was $118.4 million at the end of the quarter, an increase of $24.2 million during the quarter.
The Company continued to execute on its strategic growth plan, investing in new manufacturing capacity and analytical laboratory space at its facilities in Charles City, High Point, Karlskoga, and Milan.
The Company continues to expect full year 2017 Net Revenue, excluding the impact of foreign currency, to increase between 7% and 11% compared to 2016, Adjusted EBITDA to be between $171 and $177 million, an 11% to 15% increase compared to 2016 and Adjusted income from continuing operations to be between $3.00 – $3.12 per share.
The Company now expects 2017 free cash flow to be between $60 and $70 million, an increase of $5 million from the mid-point and capital expenditures to be between $65 and $70 million, a reduction of $5 million from the mid-point (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"We are pleased with our financial performance in the third quarter, and when combined with an expected strong fourth quarter, we are positioned to finish 2017 within our financial expectations. Continued strong performance at our manufacturing facilities resulted in higher profit margins in the quarter and year-to-date," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"We recently completed the installation of new, large scale manufacturing capacity at our Karlskoga and Charles City facilities. Construction of the new High Potency facility at our Charles City plant has begun, and the recently announced investment in R&D and manufacturing capabilities to support the development of generic APIs at our Milan facility should be completed by the end of this year. In addition, we are adding pilot plant capacity and new analytical laboratories at our High Point location. These investments will enable Cambrex to increase its capabilities and ensure our facilities continue to address favorable industry trends and the evolving demands of our customers."

Basis of Reporting

The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Third Quarter 2017 Operating Results – Continuing Operations

Net revenue was $112.6 million, an increase of $13.2 million, or 13%, compared to the third quarter of 2016. Excluding a 1% favorable impact of foreign exchange compared to the third quarter of 2016, net revenue increased 12%. The increase primarily reflects higher volumes partially offset by lower pricing. The increase in volumes was driven primarily by growth in all product categories, as well as the addition of Cambrex High Point.

Gross margin increased to 42% from 38% compared to the same quarter last year. The increase was primarily driven by high capacity utilization, manufacturing efficiency improvements and favorable product mix, partially offset by lower pricing.

Selling, general and administrative expenses were $17.6 million, compared to $15.0 million in the same quarter last year. The increase was mainly due to the addition of Cambrex High Point, higher personnel related expenses, and higher expenses related to the evaluation of acquisition opportunities.

Research and development expenses were $4.2 million, compared to $3.2 million in the same quarter last year. The increase was mainly driven by costs to develop new generic drug products.

Operating profit increased to $25.1 million from $19.5 million in the same quarter last year. The increase was primarily the result of higher gross profits in 2017 partially offset by higher operating expenses as described above. Adjusted EBITDA was $33.3 million compared to $25.9 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $7.5 million resulting in an effective tax rate of 30% compared to $5.4 million and an effective tax rate of 28% in the same quarter last year. Excluding the favorable impact of immediately recognizing certain effects of share-based compensation as required by a recently adopted accounting standard, the effective tax rate in the current period would have been 33%.

Income from continuing operations was $17.3 million or $0.52 per share compared to $13.7 million or $0.42 per share in the same quarter last year. Adjusted income from continuing operations was $18.5 million or $0.55 per share, compared to $15.1 million or $0.46 per share in the same quarter last year (see table at the end of this press release).

Capital expenditures and depreciation were $14.9 million and $7.7 million, respectively, compared to $11.7 million and $6.2 million, respectively, in the same quarter last year.

Net cash was $118.4 million at the end of the third quarter, an increase of $24.2 million during the quarter.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2017 financial performance versus its previous expectations:

Current Expectations Previous Expectations
Net revenue increase 7% – 11% 7% – 11%
Adjusted EBITDA $171 – $177 million $171 – $177 million
Adjusted income from continuing operations per share $3.00 – $3.12 $3.00 – $3.12
Free cash flow $60 – $70 million $55 – $65 million
Capital expenditures $65 – $70 million $70 – $75 million
Depreciation and amortization $32 – $34 million $32 – $34 million
Adjusted effective tax rate 31% – 33% 31% – 33%

Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities and outcomes of tax disputes. Net revenue expectations exclude the impact of foreign exchange. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2017 will be computed on a basis consistent with the reconciliation of the third quarter 2017 financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes certain effects of share-based payments that were possibly deferred under the previous guidance. The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax codes within the countries in which the Company operates and the effects of certain share-based payments.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s Form 10-Q for third quarter 2017 is filed with the SEC.Conference Call and Webcast

A conference call to discuss the Company’s third quarter 2017 results will begin at 8:30 a.m. Eastern Time on November 7, 2017 and can be accessed by calling 1-866-548-4713 for domestic and +1-323-794-2093 for international. Please use the passcode 1511082 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through November 14, 2017 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 1511082 to access the replay.

On November 7, 2017 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 third quarter ended September 30, 2017 (Press release, Curis, NOV 7, 2017, View Source [SID1234521629]).

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"We are pleased to announce the acceptance of our Investigational New Drug (IND) application for CA-4948, an inhibitor of IRAK4 kinase, which we expect to enter the clinic soon for the treatment of lymphomas with specific mutations," said Ali Fattaey, President and CEO. "In addition, we are continuing to enroll patients in the Phase 1 trial of CA-170, an oral, small molecule, dual immune checkpoint inhibitor, to determine the recommended dose and most promising areas of future development for this molecule. We look forward to presenting additional preliminary data from the ongoing Phase 1 trial at the upcoming 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting. In our CUDC-907 program, we expect to present data supporting its clinical benefit in patients with MYC-altered DLBCL at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December, and are planning for our discussions regarding these results with the FDA. And, on the financial front, our recently completed offering of common stock in September provides us operating capital to support these programs well into 2019."

Third Quarter 2017 Financial Results

Curis reported a net loss of $15.5 million, or $0.11 per share, on both a basic and diluted basis for the third quarter of 2017, as compared to a net loss of $28.3 million, or $0.21 per share, on both a basic and diluted basis for the same period in 2016. Curis reported a net loss of $45.3 million, or $0.31 per share, on both a basic and diluted basis for the nine months ended September 30, 2017, as compared to a net loss of $49.1 million, or $0.38 per share on both a basic and diluted basis for the same period in 2016. The net loss for the prior year period includes a non-cash in-process research and development charge of $18.0 million related to the amendment of Curis’s license agreement with Aurigene.

Revenues for the third quarter of 2017 were $2.4 million, as compared to $1.8 million for the same period in 2016. Revenues for the nine months ended September 30, 2017 were $6.6 million, as compared to $5.2 million for the same period in 2016. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $16.9 million for the third quarter of 2017, as compared to $29.5 million for the same period in 2016.

Operating expenses for the nine months ended September 30, 2017 were $49.3 million, as compared to $52.4 million for the same period in 2016, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily relates to 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 third quarter of 2017 and 2016. Cost of royalty revenues for the nine months ended September 30, 2017 and 2016 were $0.3 million for both periods.

In-Process Research and Development Expense. No in-process research and development expenses were recorded for the nine months ended September 30, 2017 as compared to $18.0 million recorded during the third quarter of 2016 associated with the issuance of 10,208,333 shares of Curis common stock to Aurigene as consideration for the rights granted under the terms of the September 2016 amendment to our collaboration agreement.

Research and Development Expenses. Research and development expenses were $13.4 million for the third quarter of 2017, as compared to $6.8 million for the same period in 2016. The increase was primarily due to a payment to Aurigene of $3.8 million for an exclusivity option in September 2017 and increased direct spending related to clinical activities of CA-170 and increased employee-related expenses primarily due to additional headcount. Research and development expenses were $38.2 million for the nine months ended September 30, 2017 as compared to $22.4 million for the same period in 2016.­

General and Administrative Expenses. General and administrative expenses were $3.4 million for the third quarter of 2017 as compared to $4.7 million for the same period in 2016. The decrease in general and administrative expenses was driven primarily by a one-time stock-based compensation modification expense incurred in 2016 and lower legal, professional, consulting and other administrative expenses. General and administrative expenses were $10.8 million for the nine months ended September 30, 2017, as compared to $11.7 million for the same period in prior 2016.

Other expense, net was $1.0 million for the third quarter of 2017, as compared to $0.6 million for the same period in 2016. Other expense, net primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations. Other expense, net was $2.7 million and $1.8 million for the nine months ended September 30, 2017 and 2016, respectively.

As of September 30, 2017, Curis’s cash, cash equivalents, marketable securities and investments totaled $69.2 million and there were approximately 164.0 million shares of common stock outstanding. On a fully-diluted basis, which includes 17.0 million options, there were 181.0 million shares outstanding.

Immuno-oncology (CA-170: PD-L1 / VISTA antagonist program; Aurigene collaboration):

In September 2017, Curis presented preliminary data from the dose escalation stage of the CA-170 Phase 1 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress.

Following evidence in Phase 1 of tumor shrinkage, multiple patients remaining on CA-170 treatment for extended periods, and compelling signals for biomarkers of immune modulation in patient blood and tumor samples, Curis’s partner Aurigene announced a decision to fund a jointly-designed Phase 2 study at sites in India.

Precision oncology (CA-4948, IRAK4 inhibitor program):

Curis announces U.S. FDA acceptance of the IND to test CA-4948 in a Phase 1 trial in patients with hematologic malignancies, and in particular those with MYD88 gene mutations. A Phase 1 trial is expected to begin in the fourth quarter of 2017.

Precision oncology (CUDC-907: MYC-altered DLBCL program):

In August 2017, Curis reported data from the interim analysis of the Phase 2 trial of CUDC-907 in patients with MYC-altered diffuse large B-cell lymphoma (DLBCL). The company is preparing for discussions with the FDA regarding these results.

CA-327 (an orally bioavailable inhibitor of PDL1 and TIM3 immune checkpoints):

Curis expects to file an IND in the first half of 2018.

Upcoming Activities

Curis expects that it will make presentations at the following conferences through December 2017:

An oral presentation on preliminary data from the ongoing Phase 1 trial of CA-170 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting (Nov. 8-12, 2017) in Oxon Hill, Maryland

Poster presentation on oral small molecule combination therapy targeting PD-L1, VISTA and Tim-3 checkpoints at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting (Nov. 8-12, 2017) in Oxon Hill, Maryland

Presentation as part of an analyst-moderated fireside chat at the Cowen IO NEXT Summit (Nov. 10, 2017) in Oxon Hill, Maryland

CUDC-907 poster presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Dec. 9-12, 2017) in Atlanta

Overview of Company’s pipeline at the Guggenheim Securities Healthcare Conference (Dec. 13, 2017) in Boston

Conference Call Information

Curis management will host a conference call today, Nov. 7, 2017, at 8:30 a.m. EST to discuss these financial results and provide a corporate update.

To access the live conference call, please dial (877) 868-1829 from the United States or (253) 237-1135 from other locations shortly before 8:30 a.m. EST. The conference ID number is 6198027. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.