On May 10, 2017 ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer, reported financial results for the first quarter ended March 31, 2017 (Press release, ChemoCentryx, MAY 10, 2017, View Source [SID1234519027]).

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"We end the first quarter of 2017 with a strengthened balance sheet thanks to our expanded kidney health alliance with Vifor Pharma and also with our Phase III trial for avacopan in ANCA Vasculitis (AAV) underway," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We are pleased to have received a third orphan drug designation for avacopan from the FDA, adding C3 glomerulopathy to the previous orphan designations for AAV and atypical hemolytic uremic syndrome (aHUS). By the end of this year, we plan to have four late stage clinical trials in rare renal indications in progress, each of which, if successful, may support registration; one for each of avacopan’s three orphan indications, and one for CCX140 in the treatment of focal segmental glomulerosclerosis."

Recent Highlights

In April 2017, the Journal of the American Society of Nephrology (JASN) published the clinical results from the Company’s Phase II CLEAR trial, which demonstrated that avacopan provides rapid and effective control of AAV while eliminating the need for chronic high doses of steroids, which are associated with significant safety issues. AAV is an autoimmune disease that destroys blood vessels and can lead to renal failure. The ADVOCATE Phase III trial of avacopan in AAV is now underway, a randomized, double-blind two arm multi-center study enrolling 300 patients.

In March 2017, ChemoCentryx announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for avacopan for the treatment of patients with C3 glomerulopathy (C3G), a disease in which deposits of proteins from the body’s complement system disrupt kidney function and trigger a destructive inflammation of the kidney. There is currently no approved treatment for C3G and relapse is common even after kidney transplant. This is the third disease area for which avacopan has been granted U.S. orphan-drug designation, highlighting its potential to help patients with rare renal diseases. The Company is in discussion with the FDA and the European Medicines Agency (EMA) on the design of a clinical trial, which could lead to submission for regulatory approvals.

In February 2017, ChemoCentryx announced an expanded agreement with Vifor Pharma that provides Vifor the rights to commercialize avacopan for orphan and rare renal diseases in all international markets except China, while ChemoCentryx retains the rights to commercialize avacopan in the United States. This agreement harmonizes the international rights for avacopan with those in the agreement signed with Vifor in December 2016 for the Company’s late stage drug candidate CCX140 in the treatment of focal segmental glomerulosclerosis (FSGS). FSGS is a disease for which no FDA-approved treatment exists, and which if left untreated leads to end stage renal disease. The $20 million upfront commitment to ChemoCentryx under the latest agreement brings the total of upfront cash payments and commitments from Vifor Pharma to $155 million, as well as milestone payments and tiered double-digit royalties on potential net sales.
First Quarter 2017 Financial Results

Pro forma cash, cash equivalents, investments and remaining upfront commitments totaled $179.7 million at March 31, 2017.

Revenue was $8.2 million for the first quarter, compared to zero for the same period in 2016.

Research and development (R&D) expenses were $10.0 million for the first quarter, compared to $11.2 million for the same period in 2016.

General and administrative (G&A) expenses were $4.6 million for the first quarter, compared to $4.1 million for the same period in 2016.

Net losses for the first quarter were $6.0 million, compared to $15.2 million for the same period in 2016.

Total shares outstanding at March 31, 2017 were approximately 48.2 million shares.

The Company expects to utilize cash and cash equivalents between $50 million and $55 million in 2017.

On May 10, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported new data on 20 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 2 June to 6 June in Chicago, United States (Press release, Hoffmann-La Roche, MAY 10, 2017, View Source [SID1234519024]). More than 190 abstracts have been accepted, including two "late breakers" and 24 oral presentations.

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"We are making significant advances with personalised medicines and cancer immunotherapies," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development."

With continued research and collaborations, we are striving to develop medicines and combinations, incorporate sophisticated diagnostics and integrate big data in our effort to get closer to the goal of curing cancer."

Key highlights from the Roche oncology portfolio include new results from the APHINITY study in early breast cancer and the ALEX study in lung cancer. Both of these studies will be highlighted as part of ASCO (Free ASCO Whitepaper)’s official press program on Monday 5 June. APHINITY is a randomised phase III study, investigating Perjeta plus Herceptin (trastuzumab) and chemotherapy as an adjuvant (after surgery) treatment for patients with HER2-positive early breast cancer.
The APHINITY study was conducted in collaboration with the Breast International Group (BIG), Breast European Adjuvant Study Team (BrEAST) and Frontier Science Foundation (FS). ALEX is a randomised, multicentre, open-label phase III study that compared Alecensa and crizotinib in people with previously untreated ALK-positive non-small cell lung cancer (NSCLC).

There has been great progress in the area of cancer immunotherapy in recent years and Roche continues to investigate novel ways to harness the immune system in the fight against cancer as part of its vision to bring the next generation of cancer immunotherapies to patients. With more than 20 investigational cancer immunotherapies in development and 12 in clinical trials, Roche will be presenting early results on its first T-cell bispecific antibody (CEA-CD3 TCB: RG7802; RO6958688) for the treatment of CEA-positive cancers, including metastatic colorectal cancer (mCRC). These data have been generated from two ongoing dose-escalation phase I studies in which CEA-CD3 TCB is used alone or in combination with TECENTRIQ (atezolizumab).

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2017 scientific program, as well as Roche’s wider progress in cancer care, will be featured during the Roche media briefing from 09:00–10:45 CDT on
Friday, 2 June at the Chicago Marriott Hotel Downtown Magnificent Mile.

On May 10, 2017 Heron Therapeutics, Inc. (Nasdaq:HRTX) (the Company or Heron), a commercial-stage biotechnology company focused on developing novel best-in-class treatments to address some of the biggest unmet patient needs, reported financial results for the three months ended March 31, 2017 and highlighted recent corporate progress (Press release, Heron Therapeutics, MAY 10, 2017, View Source [SID1234519014]).

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Recent Corporate Progress
Pain Franchise
Expanded Phase 2 Program of HTX-011 with Initiation of TKA and Nerve Block Studies. Heron initiated Phase 2 studies of HTX-011 in two new surgical models, total knee arthroplasty (TKA) and breast augmentation (pectoral pocket nerve block), to complement its four successful Phase 2 studies in abdominoplasty, bunionectomy, and hernia repair. Heron anticipates initiating Phase 3 studies of HTX-011 this year and filing a New Drug Application (NDA) in 2018.

CINV Franchise
SUSTOL Sales Increase; Product Added to National Comprehensive Cancer Network (NCCN) Antiemesis Guidelines. Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2017 were $3.6 million, compared to $1.3 million for the three months ended December 31, 2016. In addition, SUSTOL was granted a Category 1 recommendation by the NCCN for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). The NCCN guidelines identify SUSTOL as a "preferred" agent for preventing CINV following MEC and highlight the unique, extended-release formulation of SUSTOL.

Received Notice of CINVANTI (HTX-019) PDUFA Date. The U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee Act (PDUFA) goal date of November 12, 2017 for a decision on the Company’s NDA for CINVANTI. If approved, CINVANTI will strengthen Heron’s CINV portfolio by adding a second, complementary therapeutic agent in this category.

"The first quarter of 2017 was a productive period for Heron, highlighted by the completion of several highly-successful Phase 2 studies of HTX-011 in multiple post-operative pain models and the inclusion of SUSTOL in the NCCN guidelines," said Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "Looking ahead, we are focused on the commencement of Phase 3 studies of HTX-011, as well as the approval of CINVANTI by year-end 2017."

Financial Results
In January 2017, Heron completed an underwritten public offering of its common stock for net proceeds of $163.7 million. As of March 31, 2017, the Company had cash, cash equivalents and short-term investments of $165.2 million, compared to $51.1 million as of December 31, 2016. Based on the Company’s current operating plan and projections, it believes that available cash, cash equivalents and short-term investments are sufficient to fund operations for at least one year.

Net product sales of SUSTOL for the three months ended March 31, 2017 were $3.6 million, which represents 184% sequential quarter-over-quarter growth over the $1.3 million of net product sales of SUSTOL for the three months ended December 31, 2016.

Heron’s net loss for the three months ended March 31, 2017 was $50.3 million, or $1.00 per share, compared to $33.4 million, or $0.92 per share for the same period in 2016. Net loss for the three months ended March 31, 2017, included non-cash, stock-based compensation expense of $8.0 million compared to $5.4 million for the same period in 2016.

Heron’s net cash used for operating activities for the three months ended March 31, 2017 was $50.6 million, compared to $32.4 million for the same period in 2016.
The increases in net loss and net cash used for operating activities for the three months ended March 31, 2017 compared to the same period in 2016 were primarily due to increased clinical and manufacturing costs related to the development of HTX-011 and CINVANTI.

On May 10, 2017 Array BioPharma Inc. (Nasdaq: ARRY), a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, reported results for its third quarter of fiscal 2017 and provided an update on the progress of its key clinical development programs (Press release, Array BioPharma, MAY 10, 2017, View Source [SID1234519007]).

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COLUMBUS PHASE 3 TRIAL: Positive Part 2 Results Announced
On May 9, 2017, Array announced top-line results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with binimetinib 45mg twice daily plus encorafenib 300mg daily (COMBO300) to patients treated with encorafenib 300mg daily as a single agent. The median PFS (mPFS) for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with a HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally well-tolerated and reported dose intensity and adverse events were consistent with binimetinib (45mg twice daily) plus encorafenib 450mg daily (COMBO450) results from Part 1 of the COLUMBUS trial. Part 2 of COLUMBUS was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. Further results from Part 2 will be presented at a medical meeting during the second half of 2017.

"The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS suggest the combination represents a potential important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma.

Based on the strength of data from Part 1 and Part 2, Array is on track to file an NDA for COLUMBUS in June or July 2017. The primary endpoint for the COLUMBUS trial is a PFS comparison of COMBO450 versus vemurafenib in Part 1. Array’s European partner, Pierre Fabre, remains on track to file the Marketing Authorization Application during the summer.

Melanoma is the fifth most common cancer among men and the sixth most common cancer among women in the United States, with more than 87,000 new cases and over 9,700 deaths from the disease expected in 2017. Novel therapies that target the RAS-RAF-MEK-ERK pathway have a strong scientific rationale for activity in this disease, as up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Currently marketed MEK/BRAF combination agents have a run rate approaching $1 billion in annual worldwide sales.

MERCK COLLABORATION: Binimetinib and KEYTRUDA combination trial announced in MSS colorectal cancer patients
Array entered into a clinical trial collaboration agreement with Merck to investigate the safety and efficacy of binimetinib with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC). The companies entered into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as KEYTRUDA, can be enhanced when combined with a MEK inhibitor, such as binimetinib.

Under the agreement, Array and Merck will collaborate on a clinical trial to investigate the safety and efficacy of the combination of binimetinib with KEYTRUDA, in MSS CRC patients. The trial is expected to establish a recommended dose regimen of binimetinib and KEYTRUDA, as well as explore the preliminary anti-tumor activity of several novel regimens. The study is expected to begin in the second half of 2017. Results from this first study will be used to determine optimal approaches to further clinical development of these combinations.

Merck will act as the sponsor of this clinical trial, and Array will supply Merck with binimetinib for use in the trial. This agreement does not include a non-competition provision that generally prohibits Merck or Array from entering into agreements with third parties to perform other clinical studies.

BEACON CRC PHASE 3 TRIAL: Randomized portion of trial now enrolling; patients receiving treatment
Array is advancing BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant CRC who have previously received first- or second-line systemic therapy. Based on an attractive safety profile and with early encouraging clinical activity observed in the safety lead-in, the randomized portion of the trial is now enrolling and patients are receiving treatment. Array expects to present early data from the safety lead-in later this year.

BEACON CRC was initiated based on results from a Phase 2 study including the combination of encorafenib and cetuximab in patients with advanced BRAF-mutant CRC, which were presented at the 2016 ASCO (Free ASCO Whitepaper) annual meeting. In this study median Overall Survival for these patients exceeded one year, which is more than double several historical published benchmarks for this population.

Colorectal cancer is the second most common cancer among men and third most common cancer among women in the United States, with more than 135,000 new cases and more than 50,000 deaths from the disease projected in 2017. In the United States, BRAF mutations occur in 8 to 15 percent of patients with colorectal cancer and represent a poor prognosis for these patients.

ARRY-382 + KEYTRUDA PHASE 1/2 TRIAL: Phase 1b/2 expansions to begin shortly
Array is advancing a Phase 1/2 dose escalation immuno-oncology trial of ARRY-382 in combination with KEYTRUDA, in patients with advanced solid tumors. ARRY-382 is a wholly-owned, highly selective and potent, small molecule inhibitor of CSF-1R kinase activity. Planned expansions include patients with melanoma and non-small cell lung cancer.

FINANCIAL HIGHLIGHTS
Novartis continues to substantially fund all ongoing trials with binimetinib and encorafenib that were active or planned as of the close of the Novartis Agreements in 2015, including the NEMO and COLUMBUS Phase 3 trials. Reimbursement revenue from Novartis was approximately $119 million for the previous 12 months, of which $26 million was recorded over the quarter ending March 31, 2017.

Third Quarter of Fiscal 2017 Compared to Second Quarter of Fiscal 2017 (Sequential Quarters Comparison)

Revenue for the third quarter of fiscal 2017 was $33.3 million, compared to $44.5 million for the prior sequential quarter. The decrease was primarily due to non-recurring milestones received in the prior quarter.
Cost of partnered programs for the third quarter of fiscal 2017 was $7.4 million, compared to $9.0 million for the prior quarter.
Research and development expense was $46.1 million, compared to $46.5 million in the prior quarter.
Loss from Operations for the quarter was $31.9 million, which includes $2.9 million of stock-based compensation and $0.5 million of depreciation expense. This compares to a loss from operations of $20.0 million in the previous quarter, which included $2.1 million of stock-based compensation and $0.5 million of depreciation expense.
Net loss for the third quarter was $35.3 million, or ($0.21) per share, compared to $23.3 million, or ($0.14) per share, in the prior quarter. The increase in net loss was primarily due to non-recurring milestones received in the prior quarter.
Cash, Cash Equivalents and Marketable Securities as of March 31, 2017 were $207 million.
Third Quarter of Fiscal 2017 Compared to Third Quarter of Fiscal 2016 (Prior Year Comparison)

Revenue for the third quarter of fiscal 2017 decreased $9.8 million compared to the same quarter of fiscal 2016. The decrease was primarily due to decreased reimbursement revenue for the Novartis transitioned studies.
Cost of partnered programs increased $1.6 million compared to the third quarter of fiscal 2016. The increase was primarily due to higher costs incurred for the BEACON CRC trial.
Research and development expense decreased $2.7 million, compared to the third quarter of fiscal 2016. The decrease was due to greater expenses associated with the Novartis transitioned binimetinib and encorafenib studies.
Net loss for the third quarter of fiscal 2017 was $35.3 million, or ($0.21) per share, compared to $22.7 million, or ($0.16) per share, for the same quarter in fiscal 2016.
LEADERSHIP
Array announced that Shalini Sharp, Chief Financial Officer and Executive Vice President of Ultragenyx Pharmaceutical Inc., joined the company’s Board of Directors, effective April 27, 2017. Ms. Sharp has been appointed to the Audit Committee of the Board.

– See more at: View Source#sthash.OHkqR53X.dpuf

On May 10, 2017 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported its first quarter 2017 financial results for the period ended March 31, 2017 (Press release, Merrimack, MAY 10, 2017, View Source [SID1234519006]).

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"The first quarter of 2017 was transformative for Merrimack. Following our pipeline prioritization and the strategic review of our business, we emerged with clear priorities as a refocused research and clinical development company. We outlined three programs – MM-121, MM-141 and MM-310 – as the most promising clinical programs on which we will focus our development efforts going forward," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "Critical to this transition was the sale of assets to Ipsen, including ONIVYDE, our first commercial product. The reduced operational costs and proceeds from the sale will pave our redefined path forward and allow us to pay down our debt, pay a special dividend to stockholders and fund our expected operations into the second half of 2019. As we look forward to the year ahead, we are confident that the significant potential of our programs in development, our strong cash position and our refined strategy will drive Merrimack’s long-term success."

First Quarter and Recent Highlights

In April 2017, Merrimack launched as a new, refocused research and clinical development company. In conjunction with this strategic shift, key events from the first quarter and more recently include:

Prioritization of three clinical programs: MM-121 (seribantumab) targeting heregulin positive non-small cell lung cancer and heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer; MM-141 (istiratumab) targeting high IGF1 expression in metastatic pancreatic cancer patients; and MM-310, the antibody-directed nanotherapeutic (ADN) containing a prodrug of docetaxel for solid tumors;
Initiation of a Phase 1 clinical study to assess safety, pharmacology and preliminary activity of MM-310 in solid tumors. Merrimack expects to report safety data and a recommended Phase 2 dose from this study in 2018;
Closing of the sale of ONIVYDE and Merrimack’s generic version of doxorubicin hydrochloride liposome injection to Ipsen S.A. for $575 million in cash upon closing and up to $450 million in additional regulatory approval-based milestone payments. Merrimack also retained the right to receive net milestone payments of up to $33 million that may become payable pursuant to its previous license and collaboration agreement with Shire plc for the ex-U.S. development and commercialization of ONIVYDE;
Authorization by the Board of Directors of a special cash dividend of $140 million to holders of Merrimack’s common stock, which is payable on May 26, 2017 from the proceeds of the asset sale to Ipsen; and
Appointment of Daryl Drummond, Ph.D. as Head of Research.
Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

Initiation this year of a Phase 2 randomized clinical study of MM-121 in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer;
Top-line results in 2018 from the Phase 2 randomized clinical study of MM-121 in patients with heregulin positive non-small cell lung cancer;
Top-line results in 2018 from the Phase 2 randomized clinical study of MM-141 in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1; and
Safety data and the recommended Phase 2 dose in 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.
First Quarter 2017 Financial Results

The following summarizes Merrimack’s financial results for the three months ended March 31, 2017:

In connection with the completion of the sale of ONIVYDE and Merrimack’s generic version of doxorubicin hydrochloride liposome injection to Ipsen on April 3, 2017, the commercial business has been recorded in the financial statement within discontinued operations;
Research and development expenses were $21.6 million for the three months ended March 31, 2017, compared to $28.0 million for the three months ended March 31, 2016, a decrease of $6.4 million, or 23%. This decrease was primarily attributable to the transition to the refocused clinical and preclinical pipeline;
General and administrative expenses were $5.6 million for the three months ended March 31, 2017, compared to $6.5 million for the three months ended March 31, 2016, a decrease of $0.9 million, or 14%. This decrease was primarily attributable to lower headcount related to the restructuring activities that occurred in the fourth quarter of 2016; and
Net loss attributable to Merrimack for the three months ended March 31, 2017, was $29.7 million, or $0.23 per share, compared to a net loss attributable to Merrimack of $38.5 million, or $0.33 per share, for the three months ended March 31, 2016.
FY 2017 Updated Financial Outlook

On April 3, 2017, Merrimack received a $575.0 million upfront cash payment from Ipsen. Merrimack used these proceeds to redeem the $175 million in outstanding Senior Secured Notes due in 2022, plus approximately $20 million of costs associated with the redemption. Merrimack has also declared a special cash dividend of $140.0 million to stockholders that is payable on May 26, 2017. Merrimack has also invested $125.0 million in the further development of its streamlined oncology pipeline. If certain milestones are met pursuant to its previous license and collaboration agreement with Shire, Merrimack expects to receive up to an aggregate of $33.0 million in net milestone payments within its cash runway. Merrimack believes that at its currently forecasted spending rates, its financial resources existing immediately following the completion of the asset sale, together with the net milestone payments it expects to receive from Shire, will be sufficient to fund its operations into the second half of 2019.

Special Cash Dividend to Stockholders

The special cash dividend of $140 million that is payable on May 26, 2017 will be paid in U.S. dollars. Merrimack expects that the distribution will be treated as paid out of its current earnings and profits, and thus would be taxable as a dividend for U.S. federal income tax purposes. Stockholders should consult their own tax advisors concerning the U.S. federal income tax consequences of the special cash dividend to them, in light of their particular circumstances, and any consequences arising under the laws of any state, local or foreign taxing jurisdiction.