On March 12, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its fourth quarter and year-end 2017 (Press release, Iovance Biotherapeutics, MAR 12, 2018, View Source;p=RssLanding&cat=news&id=2337617 [SID1234524677]).

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"We ended 2017 having completed significant accomplishments involving both manufacturing and clinical aspects of development of TIL as a viable commercial therapy. We developed a new manufacturing method, lasting 22 days and yielding a cryopreserved product, conducted a clinical study investigating the efficacy of this method, reported preliminary data showing responses from this generation 2 manufacturing method in late-line metastatic melanoma patients and subsequently selected this manufacturing method for all ongoing and future clinical trials for Iovance. We have also expanded our manufacturing capacity in the US, in commercial-ready suites, and built out our capacity in the EU. On the clinical front, we are currently running four studies to evaluate the potential breadth of utility of TIL therapy in multiple indications," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "In early 2018, we successfully completed a common stock public offering adding approximately $162 million in net proceeds to the cash reserves. The proceeds from this public offering, combined with the year-end cash balance, put us in a strong position to execute on our upcoming milestones."

2017 Achievements and 2018 Updates

Manufacturing

Completed development of the generation 2 manufacturing method and the associated technology transfer into multiple CMOs in the US and the EU.
Entered into a new three-year Manufacturing Services Agreement (MSA) with PharmaCell B.V., now a subsidiary of Lonza Group Ltd., in the Netherlands to support EU manufacturing. PharmaCell is now able to receive clinical samples and manufacture TIL therapy for patients.
Entered into a new two-year MSA with H. Lee Moffitt Cancer Center and Research Institute (Moffitt).
Commenced a partnership with TrakCel Ltd. to build a scheduling and logistics software tool that automates the supply chain for the company’s TIL therapy.
Clinical

Presented clinical data from the first cohort of the company’s Phase 2 trial investigating LN-144 for the treatment of patients with metastatic melanoma, known as C-144-01, at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting in June.
Began patient dosing in the second cohort of C-144-01 and reported preliminary data at the SITC (Free SITC Whitepaper) Annual Meeting in November.
Began patient dosing in C-145-03, the company’s Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck and reported preliminary data from this study in January 2018.
Began patient dosing in C-145-04, the company’s Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma and provided early response data from evaluable patients in early 2018 as well.
Entered into a new clinical grant agreement with Moffitt to provide funding for a clinical study of TIL therapy in non-small cell lung cancer (NSCLC) and Moffitt began patient enrollment in this study in patients with advanced NSCLC cancer combining TIL and nivolumab in patients who have progressed on nivolumab.
First site was activated in the Iovance IOV-LUN-201 study to treat checkpoint naïve patients with NSCLC.
Entered into a multi-year strategic alliance with M.D. Anderson.
First clinical site was activated in Europe for the C-144-01 melanoma study.
Regulatory

Received Fast Track designation in the U.S. for LN-144 for the treatment of advanced melanoma.
Submitted Clinical Trial Applications in multiple countries in Europe in support of the company’s Phase 2 clinical trials and received multiple approvals to commence clinical trials in Europe.
Research

Entered into a collaboration with the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute to evaluate TILs, marrow infiltrating lymphocytes (MILs), and peripheral-blood associated lymphocytes in acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL).
Late-breaking abstract, titled Anti-OX40 agonistic antibody enhances ex vivo CD8+ TIL expansion with increased T-cell effector function, accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018. The poster will be available on April 16, 2018.
Corporate

Changed corporate name from Lion Biotechnologies, Inc. to Iovance Biotherapeutics, Inc. and reincorporated from a Nevada corporation to a Delaware corporation.
Appointed Timothy E. Morris as the company’s chief financial officer in August 2017.
Raised approximately $53.7 million in net proceeds, after deducting underwriting discounts and offering expenses, through a public offering that closed in September 2017.
In January 2018, the company closed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $11.50 per share, before underwriting discounts. The shares sold at closing included 1,956,521 shares issued upon the exercise in full by the underwriter of its option to purchase additional shares at the public offering price less the underwriting discount. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the company, were $172.5 million with estimated net proceeds to the company of approximately $161.7 million.
Fourth Quarter and Full-Year 2017 Financial and Operating Results

At December 31, 2017, the company held $145.4 million in cash, cash equivalents and short-term investments, compared to $166.5 million at December 31, 2016. Net cash used in operating activities was $78.7 million during the year ended December 31, 2017.

Iovance anticipates cash, cash equivalents and investments to be between $190 million and $210 million at December 31, 2018.

The company is providing both GAAP and non-GAAP financial information. All non-GAAP information excludes amounts related to stock-based compensation. See "Use of Non-GAAP Financial Measures" below for a description of the company’s non-GAAP Financial Measures. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

GAAP and Non-GAAP Net Loss Attributable to Common Stockholders

GAAP net loss attributable to common stockholders for the quarter ended December 31, 2017 was $25.9 million, or $0.36 per share, compared to GAAP net loss of $15.7 million or $0.25 per share for the quarter ended December 31, 2016.

Non-GAAP net loss attributable to common stockholders for the quarter ended December 31, 2017 was $23.1 million, or $0.32 per share, compared to $12.6 million, or $0.20 per share for the quarter ended December 31, 2016. The non-GAAP net loss for the quarters ended December 31, 2017 and 2016 excludes $2.8 million and $3.1 million of non-cash stock-based compensation, respectively.

GAAP net loss attributable to common stockholders for the year ended December 31, 2017 was $92.1 million, or $1.41 per share, compared to $102.3 million or $1.85 per share for the year ended December 31, 2016. The 2016 GAAP net loss attributable to common stockholders included a one-time deemed dividend related to a charge of $49.5 million incurred because of the conversion feature of the Series B convertible preferred stock. Non-GAAP net loss for the year ended December 31, 2017 was $80.1 million, or $1.23 per share, compared to non-GAAP net loss of $34.0 million or $0.62 per share for the year ended December 31, 2016. The non-GAAP net loss for the years ended December 31, 2017 and 2016 excludes $12.0 million and $18.9 million of non-cash stock-based compensation, respectively. The 2016 non-GAAP net loss also excludes the one-time charge of $49.5 million related to the deemed dividend.

GAAP and Non-GAAP Expenses

GAAP research and development (R&D) expenses were $20.7 million for the quarter ended December 31, 2017, an increase of $10.6 million compared to $10.1 million for the quarter ended December 31, 2016. The increase in R&D expenses is due to increased spending on clinical activities and manufacturing. R&D associated stock-based compensation expense was $0.9 million for the three months ended December 31, 2017 and $1.5 million for the three months ended December 31, 2016. Non-GAAP R&D expenses were $19.8 million for the quarter ended December 31, 2017, an increase of $11.1 million, compared to $8.7 million for the quarter ended December 31, 2016.

GAAP general and administrative (G&A) expenses were $5.4 million for the quarter ended December 31, 2017, a decrease of $0.5 million compared to $5.8 million for the quarter ended December 31, 2016. G&A associated stock-based compensation expense was $1.8 million for the three months ended December 31, 2017 and $1.7 million for the three months ended December 31, 2016. Non-GAAP G&A expenses were $3.5 million for the quarter ended December 31, 2017, a decrease of $0.6 million, compared to $4.1 million for the quarter ended December 31, 2016.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles (GAAP), and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are: (i) the non-cash stock-based compensation expense which may fluctuate from period-to-period based on factors including the timing and accounting of grants for stock options and changes in the company’s stock price which impacts the fair value of options granted, and (ii) the one-time non-cash deemed dividend related to the conversion feature of the Series B Preferred Stock. The company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to the company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of Iovance’s ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release. Beginning in 2018, Iovance will no longer report non-GAAP expenses or non-GAAP net loss per share.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss these fourth quarter and full-year 2017 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 1497629. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from March 12, 2018 at 7:30 p.m. ET to April 18, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID number for the replay is 1497629. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source

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On March 12, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today provided a regulatory update for its lead product candidate, tipifarnib, and reported fourth quarter and full year 2017 financial results (Press release, Kura Oncology, MAR 12, 2018, View Source [SID1234524678]).

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"Following a successful end of Phase 2 meeting with the FDA, we plan to initiate a single-arm, registration-directed trial of tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant squamous cell head and neck cancer (HNSCC) with objective response rate (ORR) as the primary endpoint," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We expect to initiate this trial, which we are calling the AIM-HN trial, in the second half of 2018. We are encouraged by the feedback we received from the FDA regarding the development path for tipifarnib in HRAS mutant HNSCC, and we look forward to providing more specific information regarding the design and execution of the trial in the months ahead."

Recent Operational Highlights

Feedback from end of Phase 2 clinical meeting with the FDA – Based on feedback from the FDA, Kura is planning for the initiation of its AIM-HN trial of tipifarnib in HRAS mutant HNSCC patients, pending completion of site feasibility activities and submission of the final protocol to the FDA. The AIM-HN trial will be a global, multi-center, single-arm, study of at least 59 recurrent or metastatic patients with measurable disease as determined by RECIST version 1.1 criteria. The primary endpoint will be ORR, as determined by independent radiological review. The FDA indicated in the minutes from the meeting that the AIM-HN trial, as currently designed, may be adequate to support an NDA seeking accelerated approval.

Update on Phase 2 trial of tipifarnib in HRAS mutant HNSCC – In February 2018, Kura reported updated preliminary results from its Phase 2 trial of tipifarnib in patients with HRAS mutant HNSCC at the 2018 Multidisciplinary Head and Neck Cancers Symposium. The update showed that five of the six evaluable patients achieved a confirmed, partial response. Two of these patients achieved durable responses beyond a year and a half. The one evaluable patient who did not achieve a response, based on standard RECIST criteria, experienced prolonged disease stabilization for more than six months. Tipifarnib has been generally well-tolerated with adverse events observed consistent with its known safety profile.

Potential biomarkers identified for tipifarnib in hematologic malignancies – In December 2017, Kura presented new findings at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that identified activation of the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of tipifarnib’s activity in certain hematologic malignancies, including peripheral T-cell lymphoma (PTCL), myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML). Based on these observations, the company is now prospectively investigating these potential biomarkers in its ongoing Phase 2 trials in various hematologic malignancies.
Upcoming Potential Milestones and Expectations for Clinical Programs

Preclinical data for tipifarnib in HRAS mutant squamous non-small cell lung tumor models at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2018

Preclinical biomarker data from KO-947 in squamous cell carcinomas at AACR (Free AACR Whitepaper) in April 2018

Initiation of the tipifarnib SEQ-HN trial, a screening and outcomes study in HRAS mutant HNSCC in the first half of 2018

Initiation of the tipifarnib AIM-HN trial in HRAS mutant HNSCC in the second half of 2018

Data from Phase 1 dose-escalation trial of KO-947 in the second half of 2018

Additional updates from the ongoing Phase 2 study of tipifarnib in HRAS mutant HNSCC in the second half of 2018

Initiation of a proof-of-concept study of tipifarnib in HRAS mutant squamous non-small cell lung cancer through the Spanish Lung Cancer Group in 2018

Additional clinical data from tipifarnib in hematologic malignancies in the second half of 2018

Submission of an investigational new drug (IND) application for KO-539 in late 2018 or early 2019
Financial Results for the Fourth Quarter and the Full Year 2017

Research and development expenses for the fourth quarter of 2017 were $8.1 million, compared to $5.5 million for the fourth quarter of 2016. Research and development expenses for the full year 2017 were $26.4 million, compared to $20.4 million for the prior year.

General and administrative expenses for the fourth quarter of 2017 were $2.9 million, compared to $2.0 million for the fourth quarter of 2016. General and administrative expenses for the full year 2017 were $9.7 million, compared to $8.0 million for the prior year.

Net loss for the fourth quarter of 2017 was $10.7 million, compared to a net loss of $7.3 million for the fourth quarter of 2016. Net loss for the full year 2017 was $35.4 million, compared to a net loss of $27.6 million for the prior year.

Cash, cash equivalents and short-term investments totaled $93.1 million as of December 31, 2017, compared with $100.8 million as of September 30, 2017 and $67.8 million as of December 31, 2016.

Subsequently, in January 2018, Kura sold an aggregate of approximately 3.1 million shares of its common stock under an ATM facility for net proceeds of $57.4 million.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund its current operations into the first half of 2020.
Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, March 12, 2018, to discuss the regulatory update and financial results. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and using conference ID # 5196505. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

On March 12, 2018 Merrimack Pharmaceuticals Inc. saw a slight uptick in pre-market trading this morning after the company reported it is expanding enrollment in a Phase II lung cancer study (Press release, BioSpace, MAR 11, 2018, View Source [SID1234524670]).

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Cambridge, Mass.-based Merrimack said it has seen a "tremendous interest" in its open-label Phase II SHERLOC study assessing progression-free survival in patients who have received MM-121 in combination with docetaxel. The trial is comparing the combination treatment with docetaxel as a stand-alone therapy in patients with heregulin-positive non-small cell lung cancer who have progressed after a platinum-containing regimen.

In its announcement, Merrimack said it will expand trial enrollment from 80 patients to 100. The trial patients must have received a prior platinum-based therapy, as well as prior immunotherapy where available and clinically indicated, the company said.

The trial expansion followed a year in which Merrimack reset its focus on its 10 wholly-owned clinical and preclinical programs that target biomarker-defined cancers. Merrimack began its internally-developed focus in early January after the company sold some assets, including FDA-approved pancreatic cancer treatment Onivde to Ipsen for $575 million. That placed the company’s futures on its wholly-owned assets, including MM-121.

Investors have not been too happy with Merrimack since the Ipsen deal. Over the course of 2017, the company saw its share prices drop by 63 percent. Shares of Merrimack closed at $11.58 on March 9.

Merrimack’s MM-121 (seribantumab) is a fully human anti-HER3 (ErbB3) monoclonal antibody. The drug is designed to target phenotypically distinct heregulin positive cancer cells within solid tumors. Typically heregulin positive cancer cells have been able to "escape the effects" of targeted, cytotoxic and anti-endocrine therapies, Merrimack said. That ability provides the potential for the rapid progression of the disease. When MM-121 is used in combination with the chemotherapy drug docetaxel, the company believes the dual treatment will block the heregulin/HER3 signaling axis, which will make tumor cells more sensitive to the effects of the combination therapy.

In October 2017 the U.S. Food and Drug Administration granted orphan drug designation to MM-121 in this setting. The orphan drug designation is granted to drugs that are being developed to treat a patient population of fewer than 200,000 people in the United States.

Sergio Santillana, Merrimack’s chief medical officer, said enrollment in the SHERLOC study has been faster than the company expected. Calling that an encouraging sign, Santillana said the interest reflects what the company believes is "the significant unmet medical need among this patient population."

"This expansion enables us to maximize this opportunity to gain meaningful insight, by strengthening the statistical design of the study, and emerge with a clear path forward," Santillana said in a statement.

Even with the additional patients added to the trial, Merrimack said it anticipates rolling out top-line data for the study in the second half of 2018.

In addition to heregulin-positive non-small cell lung cancer, Merrimack is also testing MM-121 in patients with heregulin-positive, hormone receptor-positive and HER2-negative post-menopausal metastatic breast cancer. In February the company dosed its first patient in a randomized Phase II trial. The mid-stage study, called SHERBOC, is testing the combination of MM-121 with chemotherapy treatment fulvestrant against placebo.

On March 9, 2018 ChemoCentryx, Inc., (Nasdaq: CCXI), reported financial results for the fourth quarter and full year ended December 31, 2017 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, MAR 9, 2018, View Source [SID1234524611]).

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"2017 was a truly remarkable year for ChemoCentryx," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We made marked progress in the global Phase III ADVOCATE trial of our lead compound avacopan in patients with ANCA vasculitis; we submitted a Conditional Marketing Authorization (CMA) application in Europe for avacopan for ANCA treatment, and we successfully expanded the Company’s clinical development program to include treatment of the devastating kidney diseases C3G and FSGS. 2018 is also off to a very strong start, exemplified by the EMA’s validation of our CMA application, resulting in a milestone payment of $50 million, itself a part of a considerably strengthened financial position of up to $100 million in new capital commitments. Our commercial planning efforts are underway too. We are advancing towards our goal of building a fully-integrated biopharmaceutical company, delivering precision medicines to patients suffering from serious diseases. Make no mistake, clinical momentum is strong; our advance continues. We intend to extend further the reach of avacopan, beginning clinical studies in hidradenitis suppurativa, a debilitating and disfiguring chronic skin disease, later this year."

Recent Highlights

• ChemoCentryx’s Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA vasculitis has 200 sites activated and 220 patients enrolled to date. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment and will include approximately 300 patients. In addition to testing the effect of avacopan on improving active vasculitis, the ADVOCATE trial will also test avacopan’s efficacy in preventing the recurrence of vasculitis, one of the major limitations of the current standard of care for patients with ANCA vasculitis.

• In December 2017, ChemoCentryx strengthened its balance sheet with up to $100 million in new capital commitments, including a milestone of $50 million from partner Vifor Pharma upon the European Medicines Agency’s validation of the Company’s Conditional Marketing Authorization (CMA) application for avacopan for the treatment of patients with ANCA vasculitis, along with the growth capital financing agreement of up to $50 million. Such additional capital is expected to provide ChemoCentryx sufficient funding to advance avacopan through data from the Phase III ADVOCATE trial, as well as associated potential registration filings in the U.S. and EU.
• Patient enrollment is ongoing in a clinical trial evaluating avacopan in a second renal indication, C3 Glomerulopathy (C3G), a rare disorder that often affects the young, requiring dialysis and often kidney transplant. In addition, the Company’s CCR2 inhibitor CCX140 is being evaluated in two sub-populations of primary Focal Segmental Glomerulosclerosis (FSGS), an orphan kidney disease for which there is no approved treatment option. One trial involves non-nephrotic primary FSGS patients, whose disease cause is idiopathic; and the other trial is for primary FSGS patients with nephrotic syndrome, where reduction in proteinuria may constitute the registration endpoint.

• ChemoCentryx intends to initiate the clinical development of avacopan in hidradenitis suppurativa (HS), an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin. The Company plans to initiate clinical studies with avacopan in HS by the end of 2018.

• In anticipation for potential commercialization in the U.S., William (Bill) J. Fairey, Jr. joined ChemoCentryx as Executive Vice President and Chief Operating Officer to lead the Company’s commercial strategy along with other key operational functions of the Company. Mr. Fairey brings extensive experience in commercialization, marketing, and operations from his 25 years in the pharmaceutical industry and most recent position as President of Actelion Pharmaceuticals U.S.

• In January 2018, data from the ongoing Phase Ib clinical trial of CCX872, the Company’s second CCR2 inhibitor, in locally advanced/metastatic pancreatic patients were presented at the 2018 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, demonstrating promising overall survival (OS) of all patients randomized of 29% at 18 months with CCX872 and FOLFIRINOX combination therapy. This compares favorably with previously published OS rates of 18.6% at 18 months using FOLFIRINOX alone to treat pancreatic cancer patients with metastatic disease.
Fourth Quarter and Full Year 2017 Financial Results

Pro forma cash, cash equivalents and investments, including remaining upfront commitments and milestone payments, totaled $195.2 million at December 31, 2017.

Revenue was $56.3 million for the fourth quarter of 2017, compared to $4.9 million for the same period in 2016. For the full year ended December 31, 2017, revenue was $82.5 million, compared to $11.9 million for 2016. The increase in revenue from 2016 to 2017 was due to the CMA application validation milestone, amortization of the upfront license fee commitments from Vifor pursuant to the avacopan and CCX140 agreements and collaboration revenue for development services under the CCX140 agreement. These increases were partially offset by a decrease in grant revenue from the FDA to support the clinical development of avacopan for the treatment of patients with ANCA vasculitis.

Research and development expenses were $12.9 million for the fourth quarter of 2017, compared to $9.2 million for the same period in 2016. Full year 2017 research and development expenses were $49.5 million compared to $37.9 million in 2016. The increase from 2016 to 2017 was primarily due to the initiation and patient enrollment of the avacopan Phase III ADVOCATE trial in patients with ANCA vasculitis and start-up expenses related to the Phase II clinical trials in patients with FSGS and C3G. These increases were partially offset by lower Phase II clinical development expenses primarily due to the completion of the avacopan CLEAR and CLASSIC clinical trials for the treatment of ANCA vasculitis in 2016 and lower Phase I development expense due to the completion of enrollment in the clinical trial for CCX872 in patients with advanced pancreatic cancer in 2016.

General and administrative expenses were $4.1 million for the fourth quarter of 2017, compared to $3.6 million for the same period in 2016. Full year 2017 general and administrative expenses were $16.5 million, compared to $14.7 million in 2016. The increase from 2016 to 2017 was primarily due to higher intellectual property related expenses and accounting related fees associated with preparing to meet the requirements pursuant to the Sarbanes-Oxley Act of 2002, partially offset by lower travel expenses.

Net income for the fourth quarter of 2017 was $39.7 million, compared to a net loss of $7.7 million for the same period in 2016. Full year 2017 net income was $17.9 million, which compares favorably to the $40.0 million net loss in 2016.

Total shares outstanding at December 31, 2017 were approximately 48.8 million shares.

The Company expects to utilize cash and investments between $65 million and $75 million in 2018.

Conference Call and Webcast

The Company will host a conference call and webcast today, March 9, 2018 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 4887708. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.