On May 9, 2017 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2017 (Press release, Calithera Biosciences, MAY 9, 2017, View Source [SID1234518933]). As of March 31, 2017, cash, cash equivalents and investments totaled $207.1 million.

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"During the first quarter, we significantly strengthened the company’s financial position and we believe we are well positioned to execute on our strategy. Our collaboration and license agreement with Incyte maximizes the clinical and commercial potential of CB-1158, and we are pleased to have achieved the first milestone in March," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2017, we are on track to highlight new clinical data from each of our clinical programs at scientific meetings, including an oral presentation of CB-1158 data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, and multiple clinical updates on CB-839 in renal cell carcinoma and triple negative breast cancer in the second half of 2017. We also plan to present initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo."

First Quarter 2017 and Recent Highlights

CB-1158 Global Research, Development and Commercialization Collaboration with Incyte. In January 2017, Incyte and Calithera announced the global collaboration and license agreement for the research, development and commercialization of the first in class, small molecule arginase inhibitor CB-1158. Under the terms of the collaboration and license agreement, Calithera received an up-front payment of $45.0 million from Incyte in addition to an $8.0 million equity investment. CB-1158 entered clinical trials in September 2016 and a $12.0 million pharmacodynamic and pharmacokinetic milestone was achieved in March 2017. Payment of the milestone was received in the second quarter of 2017.

CB-1158 Data Accepted for Oral Presentation. Data from the Phase 1 solid tumor trial has been accepted for oral presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Clinical results to be presented in an oral presentation on June 5 include monotherapy data from Calithera’s Phase 1 trial in solid tumors.

CB-839 Enrollment Continues in Renal Cell Carcinoma and Triple Negative Breast Cancer. Calithera continues to enroll patients in combination trials in renal cell carcinoma and triple negative breast cancer, with updates from each of these trials expected in the second half of 2017. Phase 2 trials are expected to begin the second half of 2017 in both renal cell carcinoma and triple negative breast cancer. In addition, initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo are expected in the second half of 2017.

Completed Public Offering of Common Stock. In March 2017, Calithera completed an underwritten public offering of common stock, raising gross proceeds of $80.5 million.

At-the-Market progam. In the first quarter of 2017, Calithera received $38.0 million in gross proceeds from the sale of common stock pursuant to its at-the-market offering program.
Selected First Quarter 2017 Financial Results

Cash, cash equivalents and investments totaled $207.1 million at March 31, 2017, compared with $51.8 million at December 31, 2016. Calithera achieved a $12.0 million milestone under its global collaboration and license agreement with Incyte in March 2017, and payment was received in the second quarter of 2017.

Revenue was $4.2 million for the three months ended March 31, 2017 and represents the portion of deferred revenue recognized in the first quarter from the Company’s collaboration and license agreement with Incyte.

Research and development expenses were $6.6 million for the three months ended March 31, 2017, compared with $7.1 million for the same period in the prior year. The decrease of $0.5 million was primarily from the CB-1158 program, including Incyte’s co-funding of development costs, partially offset by an increase in the CB-839 program, including for Phase 2 start-up activities, as well as investment in our early stage research programs.

General and administrative expenses were $3.3 million for the three months ended March 31, 2017, compared with $2.6 million for the same period in the prior year. The increase of $0.7 million was primarily due to costs associated with the Incyte agreement and non-recurring expenses for the sublease of office and laboratory space in March 2017.

Net loss from operations for the three months ended March 31, 2017 was $5.6 million, or $0.22 per share.

Revised Financial Guidance for 2017

Calithera expects that its cash, cash equivalents and investments will be between $180 and $190 million at the end of 2017, exclusive of any funds arising from new collaborations or partnerships, achievement of additional milestones, additional equity financings or other new sources.

On May 9, 2017 Array BioPharma (Nasdaq: ARRY) reported 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 (Press release, Array BioPharma, MAY 9, 2017, View Source [SID1234518932]).

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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 for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with 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 COMBO450 results in COLUMBUS Part 1. Part 2 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 totality of the COLUMBUS results, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of binimetinib plus encorafenib as an attractive treatment option for patients diagnosed with BRAF-mutant melanoma," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School.

Ron Squarer, Chief Executive Officer at Array BioPharma noted: "The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS Part 2 once again demonstrates the combination represents a potentially important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma. The results of Part 2 confirm the contribution of binimetinib to the combination."

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.

About the Phase 3 COLUMBUS Study
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 study evaluating the efficacy and safety of the combination of binimetinib plus encorafenib to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the study. Patients were randomized into two parts:

In Part 1, 577 patients were randomized 1:1:1 to receive 45mg binimetinib plus 450mg encorafenib (COMBO450), 300mg encorafenib alone, or 960mg vemurafenib alone. The dose of encorafenib in the combination arm is 50% higher than the single agent maximum tolerated dose of 300mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was a PFS comparison of COMBO450 versus vemurafenib. PFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the PFS of encorafenib monotherapy to that of COMBO450 and a comparison of overall survival (OS) for COMBO450 to that of vemurafenib alone.
In November 2016, results from Part 1 were presented at the Society for Melanoma Research Annual Congress. The study met its primary endpoint, with COMBO450 significantly improving PFS compared with vemurafenib alone. In the analysis of the primary endpoint, the mPFS for patients treated with COMBO450 was 14.9 months versus 7.3 months for patients treated with vemurafenib; hazard ratio (HR) 0.54, (95% CI 0.41-0.71, P<0.001). As part of the trial design, the primary analysis was based on a BICR of patient scans, while results by local review at the investigative site were also analyzed. The chart below outlines the mPFS results, as determined by both assessments, for COMBO450 versus vemurafenib, COMBO450 versus encorafenib, and encorafenib versus vemurafenib:



mPFS BICR

mPFS Local Review
COMBO450
vs.
Vemurafenib

COMBO450
Vemurafenib

COMBO450
Vemurafenib

14.9 months
7.3 months

14.8 months
7.3 months

HR (95% CI): 0.54 (0.41-0.71); P<0.001

HR (95% CI): 0.49 (0.37-0.64); P<0.001

COMBO450
vs.
Encorafenib

COMBO450
Encorafenib

COMBO450
Encorafenib

14.9 months
9.6 months

14.8 months
9.2 months

HR (95% CI): 0.75 (0.56-1.00); P=0.051

HR (95% CI): 0.68 (0.52-0.90); P=0.006

Encorafenib
vs.
Vemurafenib

Encorafenib
Vemurafenib

Encorafenib
Vemurafenib

9.6 months
7.3 months

9.2 months
7.3 months

HR (95% CI): 0.68 (0.52-0.90); P=0.007

HR (95% CI): 0.70 (0.54-0.91); P=0.008
COMBO450 was generally well-tolerated and reported adverse events (AEs) were overall consistent with previous bini/enco combination clinical trial results in BRAF-mutant melanoma patients. Grade 3/4 AEs which occurred in more than 5 percent of patients receiving COMBO450 included increased gamma-glutamyltransferase (GGT), increased blood creatine phosphokinase (CK), and hypertension. The incidence of AEs of special interest (toxicities commonly associated with commercially available MEK+BRAF-inhibitor treatments), for patients receiving COMBO450 included: rash (23 percent), pyrexia (18 percent), retinal pigment epithelial detachment (13 percent) and photosensitivity (5 percent).

In Part 2, 344 patients were randomized 3:1 to receive 45mg binimetinib plus 300mg encorafenib or 300mg encorafenib alone. Part 2 is designed to provide additional data to help evaluate the contribution of binimetinib to the combination of binimetinib and encorafenib. As the comparison of COMBO450 to encorafenib in Part 1 did not achieve statistical significance, the statistical analysis conducted in Part 2 is descriptive.
About BRAF-Mutant Melanoma
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. Up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Current marketed MEK/BRAF combination agents have a run rate approaching $1 billion in annual worldwide sales.

About Binimetinib & Encorafenib
MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Binimetinib and encorafenib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial with encorafenib in combination with cetuximab with or without binimetinib in patients with BRAF V600E-mutant colorectal cancer.

Binimetinib and encorafenib are investigational medicines and are not currently approved in any country. Array BioPharma retains exclusive rights to binimetinib and encorafenib in key markets including the U.S., Japan, Canada, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.

On May 9, 2017 Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported financial results for the three months ended March 31, 2017 (Press release, Delcath Systems, MAY 9, 2017, View Source [SID1234518928]).

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Highlights for the first quarter of 2017 and recent weeks include:

First quarter 2017 revenue of $0.74 million, an increase of 100% compared with revenue of $0.37 million in prior year quarter;
CHEMOSAT treatment milestone set by SPIRE Southampton Hospital in the U.K. with more than 100 CHEMOSAT treatments performed, including eight treatments on a single patient;
Announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a pivotal trial of Melphalan/HDS to treat patients with intrahepatic cholangiocarcinoma (ICC);
The American Journal of Clinical Oncology published a single-center retrospective review finding that the Company’s investigational percutaneous hepatic perfusion (PHP) with Melphalan/HDS offered promising results with a doubling of overall survival (OS), significantly longer progression-free survival (PFS) and hepatic progression-free survival (hPFS) compared with other targeted therapies; and
Favorable data from two institutions were presented at the Regional Cancer Therapies Symposium and showed strong tumor response and overall survival with the Company’s investigational PHP therapy in patients with ocular melanoma that metastasized to the liver.
"During the first three months of 2017 we continued to advance our clinical development programs in ocular melanoma liver metastases and intrahepatic cholangiocarcinoma, while making steady progress with commercialization of CHEMOSAT in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "As we announced recently, we have concluded a new SPA agreement with the FDA for the initiation of a pivotal trial for the use of Melphalan/HDS in patients with ICC. This new trial will enroll approximately 295 ICC patients at about 40 clinical sites in the U.S. and Europe, with the primary endpoint of overall survival and with secondary and exploratory endpoints that include safety, progression-free survival, objective response rate and quality-of-life measures. The trial is designed to be cost-effective and conducted in a financially prudent manner, with modest investment in this fiscal year. In conjunction with the FOCUS Trial in ocular melanoma liver metastases, our clinical development programs now include two paths toward potential U.S. market approvals.

"In Europe, we continue to make steady progress with the commercialization of CHEMOSAT. Our first quarter revenue of more than $0.7 million was double the prior year period’s sales, driven primarily by national reimbursement in Germany under the ZE system. With coverage under the ZE system now in place, we expect product sales growth from this market for the remainder of 2017. Elsewhere in Europe, we continue to focus on building the clinical and pharmacoeconomic data to support reimbursement applications in other key markets. We expect that positive negotiations for coverage in Germany will support our efforts for payment levels in other markets such as the U.K. and the Netherlands. Securing reimbursement coverage in additional European markets remains critical to future revenue growth for CHEMOSAT," concluded Dr. Simpson.

First Quarter Financial Results

Revenue for the three months ended March 31, 2017 was $0.74 million, an increase of 100% from $0.37 million for the prior year period. Selling, general and administrative expenses were approximately $2.4 million, unchanged from the prior year quarter. Research and development expenses for the current quarter increased to $2.3 million from $1.3 million in the prior year quarter. Total operating expenses for the current quarter were $4.7 million compared with $3.7 million in the prior year quarter.

The Company reported a net loss for the 2017 first quarter of $11.3 million, or $0.25 per share based on 45.1 million weighted average common shares outstanding, compared with a net loss in the prior year period of $1.8 million or $1.25 per share based on 1.5 million weighted average common shares outstanding. The increase is primarily due to an $8.4 million increase in interest expense primarily related to the amortization of debt discounts, a non-cash item, and a $1.0 million increase in operating expenses primarily related to increased investment in clinical trial initiatives. This was offset by a $0.4 million change in the fair value of the warrant liability, a non-cash item, and a $0.27 million improvement in gross profit due to higher sales.

Balance Sheet Highlights

As of March 31, 2017, Delcath had cash and cash equivalents of $6.4 million, compared with $4.4 million as of December 31, 2016. During the first quarter of 2017, the Company used $3.8 million of cash to fund operating activities. Delcath believes it has sufficient capital and access to committed capital to fund its operating activities through the end of 2017.

Recent Financial Transactions

On April 2, 2017, Delcath entered into separate Warrant Repurchase Agreements with each of the investors named on the Schedule of Buyers attached to our Securities Purchase Agreement dated June 6, 2016. Pursuant to the Warrant Repurchase Agreements, each investor agreed to a Controlled Account Release in an aggregate amount equal to $7,876,312, which funds in each case were paid to the respective investor in exchange for cancellation of the Warrants issued to each investor under the Securities Purchase Agreement. Delcath anticipates that the cash remaining in the Controlled Accounts after this transaction will be sufficient to fund operating activities through the end of 2017.

On May 9, 2017 Corvus Pharmaceuticals, Inc. (Nasdaq:CRVS), a clinical-stage biopharmaceutical company, reported that it has licensed global rights to an undisclosed novel immuno-oncology program, which includes a lead product candidate, from Monash University (Press release, Corvus Pharmaceuticals, MAY 9, 2017, View Source [SID1234518927]).

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Corvus Pharmaceuticals, which focuses on the development and commercialization of novel immuno-oncology therapies, plans to develop any product candidates that result from the collaboration. These would be developed as monotherapies and potentially as combination therapies with its existing product candidates that target the adenosine receptor pathway. The terms of the agreement were not disclosed.

"This novel immuno-oncology program, developed at one of the leading universities in Australia, has the potential to bolster our drug development capabilities within, and outside of, the adenosine receptor pathway," said Richard A. Miller, MD, an oncologist and co-founder, president and chief executive officer of Corvus.

"With this program, we are combining our strong internal R&D with promising new targets and product candidates from an in-licensing opportunity to build a deep immuno-oncology pipeline."

"With Corvus’ strengths in immunology and oncology and its clinical translational platform, we believe it is well-positioned to advance this promising program into clinical development," said Professor John Carroll, Director of the Biomedicine Discovery Institute at Monash University.

"Professor Charles MacKay and Dr. Remy Robert have created a first-class asset for the treatment of cancer. We look forward to collaborating with the Corvus team to help them develop improved therapies for patients," Professor Carroll said.

On May 9, 2017 Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported its results for the three-month period ended March 31, 2017 (Filing, Q1, Cellectis, 2017, MAY 9, 2017, View Source [SID1234518926]).

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RECENT CORPORATE HIGHLIGHTS

Cellectis – Therapeutics

UCART123 – Cellectis’ most advanced, wholly controlled TALEN gene-edited product candidate

Investigational New Drug (IND) approval received from the U.S. Food and Drug Administration (FDA) to conduct Phase I clinical trials in patients with AML and BPDCN.
First clinical trial approval by the FDA for an allogeneic, "off-the-shelf" gene-edited CAR T-cell product candidate.
AML clinical program to be led, at Weill Cornell, by Gail J. Roboz, MD, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.
BPDCN clinical program to be led, at MD Anderson Cancer Center, by Naveen Pemmaraju, MD, Assistant Professor, and Hagop Kantarjian, MD, Professor and Department Chair, Department of Leukemia, Division of Cancer Medicine.
Completion of cGMP manufacturing runs of UCART123 at large scale, to provide doses for initiating planned Phase I clinical trials in AML and BPDCN patients.
UCART19, exclusively licensed to Servier

The FDA has granted Pfizer and Servier with Investigational New Drug (IND) clearance to proceed in the U.S. with Phase I clinical development of UCART19 to treat patients with relapsed/refractory acute lymphoblastic leukemia.
Phase I clinical trials in pediatric and adult ALL patients are ongoing at University College London (UCL) and Kings College London (KCL), UK, sponsored by Servier.
Scientific Conferences

Data on both wholly-controlled Cellectis programs and Pfizer/Cellectis collaboration programs have been presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
UCART22: An allogeneic adoptive immunotherapy for leukemia targeting CD22 with CAR T-cells
Allogeneic EGFRvIII Chimeric Antigen Receptor T-cells for treatment of glioblastoma
Differential modulation of the PD-1 pathway impacts the anti-tumor activity of CAR T-cells
Clinical Advisory Board

Formation of a Clinical Advisory Board (CAB) comprising leading experts in the hematologic malignancies / stem cell transplant, immunotherapy and hematology-oncology clinical research fields to serve as a strategic resource to Cellectis in connection with the clinical development of UCART123.
Calyxt Inc. – Cellectis’ plant science subsidiary

In April 2017, Cellectis announced that it is exploring the possibility of an initial public offering (IPO) of a minority interest in its plant sciences business, Calyxt.
New Technology Framework Agreement with Plant Bioscience Limited pursuant to which Calyxt received an option to obtain exclusive license to new crops traits.
Former Cargill executive Manoj Sahoo joined Calyxt as the Company’s Chief Commercial Officer. As part of Calyxt’s executive team Mr. Sahoo is building a commercial partnership network and executing a go-to-market plan for Calyxt. Mr. Sahoo is joining Calyxt from Cargill, where he worked in the Food Ingredients and Bio-industrial Enterprise
Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("IASB").

First quarter 2017 Financial Results

Cash: As of March 31, 2017 Cellectis had €258.5 million in total cash, cash equivalents and current financial assets compared to €276.2 million as of December 31, 2016. This decrease of €17.7 million reflects (i) net cash flows used by operating activities of €15.3 million, (ii) capital expenditures of €0.5 million and (iii) the unrealized negative translation effect of exchange rate fluctuations on our U.S. dollar cash, cash equivalents and current financial assets of €1.9 million.

Cellectis expects that its cash, cash equivalents and current financial assets of €258.5 million as of March 31, 2017 will be sufficient to fund its current operations to 2019.

Revenues and Other Income: During the quarters ended March 31, 2016 and 2017, we recorded €9.5 million and €9.7 million, respectively, in revenues and other income. This increase primarily reflects (i) an increase of €0.8 million in research tax credit, (ii) a decrease of €0.4 million in collaboration revenues, due primarily to a decrease of €1.4 million in upfront recognition and a decrease of €0.3 million in R&D costs reimbursement, been partially offset by an increase of €1.3 million in supply agreements with Servier, and (iii) a decrease in revenue from licenses of €0.2 million.

Total Operating Expenses: Total operating expenses for the first quarter of 2017 were €28.2 million, compared to €29.9 million for the first quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were €12.8 million and €13.4 million, respectively.

R&D Expenses: For the quarters ended March 31, 2016 and 2017, research and development expenses decreased by €0.5 million from €18.9 million in 2016 to €18.4 million in 2017. Personnel expenses decreased by € 2.1 million from €11.9 million in 2016 to €9.8 million in 2017, primarily due to a €1.7 million decrease in social charges on stock option grants and a €0.5 million decrease in non-cash stock based compensation expense, partly offset by a €0.1 million increase in wages and salaries. Purchases and external expenses increased by €1.5 million from €6.6 million in 2016 to €8.2 million in 2017, mainly due to increased expenses related to UCART123 and the development of other product candidates, including payments to third parties, purchases of biological materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the quarters ended March 31, 2016 and 2017, we recorded €10.5 million and €9.1 million, respectively, of selling, general and administrative expenses. The increase of €1.4 million primarily reflects (i) a decrease of €1.1 million in personnel expenses from €8.3 million to €7.2 million, attributable, to a decrease of €1.5 million of social charges on stock options grants and a decrease of €0.1 million of non-cash stock-based compensation expense, partly offset by a €0.5 million increase in wages and salaries, and (ii) a decrease of €0.4 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was €9.1 million for the first quarter of 2016 compared with an almost nil financial result for the first quarter of 2017. The change in financial result was primarily attributable to a decrease in net foreign exchange loss of €7.6 million due to the effect of exchange rate fluctuations on our USD cash and cash equivalent accounts, an increase of €1.0 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and a €0.2 million net gain realized on the repositioning of foreign exchange derivative instruments.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the quarters ended March 31, 2016 and 2017, we recorded a net loss of €29.5 million (or €0.84 per share on both a basic and a diluted basis) and a net loss of €18.6 million (or €0.53 per share on both a basic and a diluted basis), respectively. Adjusted loss attributable to shareholders of Cellectis for the first quarter of 2017 was €5.8 million (€0.16 per share on both a basic and a diluted basis) compared to adjusted income attributable to shareholders of Cellectis of €16.1 million (€0.46 per share on both a basic and a diluted basis), for the first quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis excludes non-cash stock-based compensation expense of €12.8 million and €13.4 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to Adjusted income (loss) attributable to shareholders of Cellectis.


CELLECTIS S.A.

STATEMENT OF CONSOLIDATED FINANCIAL POSITION
(€ in thousands)

As of
December 31, 2016
Audited

March 31, 2017
Unaudited

ASSETS
Non-current assets
Intangible assets 1 274 1 332
Property, plant, and equipment 16 033 16 068
Other non-current financial assets 656 886
Total non-current assets 17 963 18 286

Current assets
Inventories and accumulated costs on orders in process 112 106
Trade receivables 3 441 5 035
Subsidies receivables 8 276 11 564
Other current assets 8 414 11 405
Cash and cash equivalent and Current financial assets 276 216 258 527
Total current assets 296 459 286 638
TOTAL ASSETS 314 422 304 924

LIABILITIES
Shareholders’ equity
Share capital 1 767 1 767
Premiums related to the share capital 473 306 485 991
Treasury share reserve (307) (159)
Currency translation adjustment 2 501 1 422
Retained earnings (157 695) (218 505)
Net income (loss) (60 776) (18 567)
Total shareholders’ equity – Group Share 258 795 251 948
Non-controlling interests 1 779 1 984
Total shareholders’ equity 260 574 253 932

Non-current liabilities
Non-current financial liabilities 28 21
Non-current provisions 532 551
Total non-current liabilities 560 572

Current liabilities
Current financial liabilities 1 641 379
Trade payables 9 223 12 170
Deferred revenues and deferred income 36 931 33 109
Current provisions 563 563
Other current liabilities 4 930 4 199
Total current liabilities 53 288 50 420
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 314 422 304 924

CELLECTIS S.A.

STATEMENT OF CONSOLIDATED OPERATIONS – First quarter
(unaudited)
(€ in thousands, except per share data)

For the three-month period
ended March 31,
2016 2017

Revenues and other income
Revenues 6 978 6 328
Other income 2 521 3 334
Total revenues and other income 9 499 9 662
Operating expenses
Royalty expenses (433) (574)
Research and development expenses (18 870) (18 392)
Selling, general and administrative expenses (10 529) (9 143)
Other operating income and expenses (76) (99)
Total operating expenses (29 908) (28 208)

Operating income (loss) (20 409) (18 546)

Financial gain (loss) (9 055) (21)

Net income (loss) (29 464) (18 567)
Attributable to shareholders of Cellectis (29 464) (18 567)
Attributable to non-controlling interests
–

-

Basic earnings attributable to shareholders of Cellectis per share (€/share) (0.84) (0.53)

Diluted earnings attributable to shareholders of Cellectis per share (€/share) (0.84) (0.53)

Note Regarding Use of Non-GAAP Financial Measures

Cellectis S.A. presents Adjusted Income (Loss) attributable to shareholders of Cellectis in this press release. Adjusted Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We have included in this press release a reconciliation of this figure to Net Income (Loss) attributable to shareholders of Cellectis, the most directly comparable financial measure calculated in accordance with IFRS. Because Adjusted Income (Loss) attributable to shareholders of Cellectis excludes Non-cash stock-based compensation expense—a non-cash expense, we believe that this financial measure, when considered together with our IFRS financial statements, can enhance an overall understanding of Cellectis’ financial performance. Moreover, our management views the Company’s operations, and manages its business, based, in part, on this financial measure. In particular, we believe that the elimination of Non-cash stock-based expenses from Net Income (Loss) attributable to shareholders of Cellectis can provide a useful measure for period-to-period comparisons of our core businesses. Our use of Adjusted Income (Loss) attributable to shareholders of Cellectis has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under IFRS. Some of these limitations are: (a) other companies, including companies in our industry which use similar stock-based compensation, may address the impact of Non-cash stock-based compensation expense differently; and (b) other companies may report Adjusted Income (Loss) attributable to shareholders or similarly titled measures but calculate them differently, which reduces their usefulness as a comparative measure. Because of these and other limitations, you should consider Adjusted Income (Loss) attributable to shareholders of Cellectis alongside our IFRS financial results, including Net Income (Loss) attributable to shareholders of Cellectis.

RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – First quarter
(unaudited)
(€ in thousands, except per share data)

For the three-month period
ended March 31,
2016 2017

Net Income (Loss) attributable to shareholders of Cellectis (29 464) (18 567)
Adjustment:
Non-cash stock-based compensation expense 13 414 12 788
Adjusted Income (Loss) attributable to shareholders of Cellectis (16 050) (5 779)

Basic Adjusted Income (Loss) attributable to shareholders of Cellectis (€/share) (0.46) (0.16)

Weighted average number of outstanding shares, basic (units) 35 195 281 35 289 932

Diluted Adjusted Income (Loss) attributable to shareholders of Cellectis (€/share) (0.46) (0.16)

Weighted average number of outstanding shares, diluted (units) 35 563 743 35 784 930