On November 13, 2018 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems for the treatment of diseases with significant unmet medical need and commercial potential, reported results for its first fiscal quarter ended September 30, 2018 (Press release, Palatin Technologies, NOV 13, 2018, View Source [SID1234531294]).

Recent Highlights and Program Updates

Female Sexual Dysfunction / Vyleesi (bremelanotide)

●Vyleesi, the trade name for bremelanotide – Under development for Hypoactive Sexual Desire Disorder ("HSDD"):

¯FDA (U.S. Food and Drug Administration) set the PDUFA (Prescription Drug User Fee Act) action goal date of March 23, 2019 for completion of the review of the New Drug Application (NDA) for Vyleesi.

oSee 8-K filing today regarding the FDA’s review of the NDA submission for Vyleesi and the request for additional data.

¯AMAG Pharmaceuticals is the exclusive licensee for North America.

¯Palatin is in discussions with potential collaboration partners for certain regions outside of the licensed territories of North America, China and South Korea.

Anti-Inflammatory / Autoimmune Programs

●Melanocortin receptor 1 and 1/5 (MC1r, MC1/5r) agonists under development for the treatment of inflammatory and autoimmune diseases such as dry eye, uveitis, diabetic retinopathy and inflammatory bowel diseases:

¯PL-8177:

oAnnounced positive pharmacokinetics and pharmacodynamic results with no reported safety or tolerability concerns from a first-in-human Phase 1 safety study of subcutaneous dosing of PL-8177 in single and multiple ascending doses.

oData from a separate clinical study investigating an oral formulation of PL-8177 is currently expected by the end of calendar year 2018.

oProgram is under internal evaluation for orphan designations.

¯PL-8331 for ocular indications:

oPreclinical IND enabling activities commenced.

oProgram is under internal evaluation for orphan designations.

Natriuretic Peptide Program

¯PL-3994: Phase 2a, open label study in heart failure patients with preserved ejection fraction, targeted to commence in the first half of 2019.

¯PL-5028: Preclinical studies evaluating potential use in fibrotic disease ongoing.

Genetic Obesity Program

¯MC4r selective peptide and oral small molecule agonists: Commenced preclinical IND activities.

¯Program is under internal evaluation for orphan designations.

Corporate

¯Decreased debt from $7.2 million at June 30, 2018 to $5.3 million at September 30, 2018.

First Quarter Fiscal 2019 Financial Results

For the first fiscal quarter ended September 30, 2018, the Company reported a net loss of $(5.7) million, or $(0.03) per basic and diluted share, compared to net income of $10.6 million, or $0.05 per basic and diluted share, in the same period in 2017. The difference was primarily attributable to the recognition of $26.9 million in license and contract revenue during the 2017 period pursuant to our license agreements with AMAG and Fosun and secondarily attributable to the decrease in research and development expenses pursuant to the completion of our Vyleesi Phase 3 clinical trial program.

Revenue
The Company recognized $34,505 of revenue for the first fiscal quarter ended September 30, 2018, compared to $21.9 million in license and contract revenue related to our license agreement with AMAG and $5.0 million in license revenue related to the license agreement with Fosun for the quarter ended September 30, 2017.

Operating Expenses
Total operating expenses were $5.7 million for the first fiscal quarter ended September 30, 2018, compared to $15.7 million in the same period of 2017. The decrease in operating expenses was mainly attributable to the completion of the Vyleesi Phase 3 clinical trial program and ancillary studies necessary to file the NDA in HSDD in March 2018.

Other Income/Expense
Total other expense, net was $53,288 for the first fiscal quarter ended September 30, 2018 compared to $0.4 million for the same period of 2017. Total other expense, net for both periods consisted primarily of interest expense related to the Company’s venture debt offset by investment income.

Income Tax
Pursuant to the license agreement with Fosun, $500,000 was withheld in accordance with tax withholding requirements in China and was recorded as an expense during the fiscal year ended June 30, 2018. For the quarter ended September 30, 2017, Palatin incurred $225,255 in income tax expense utilizing an estimated effective annual income tax rate applied to income for the quarter and the remaining balance of $274,745 was included in prepaid expenses and other current assets at September 30, 2017. Any potential credit to be received by Palatin on its United States tax returns is currently offset by Palatin’s valuation allowance.

There was no income tax expense recorded in the quarter ended September 30, 2018.

Cash Position
At September 30, 2018, the Company had cash, cash equivalents, and accounts receivable aggregating $32.7, compared to cash and cash equivalents and accounts receivable of $38.0 million at June 30, 2018. Current liabilities were $8.5 million as of September 30, 2018, compared to $10.8 million as of June 30, 2018.

The Company believes that existing capital resources will be sufficient to fund its planned operations through at least the 2019 calendar year.

Palatin Drug Discovery Programs
In the conference call and webcast, management will update and discuss next steps in Palatin’s portfolio of drug development programs. These include Palatin’s melanocortin receptor­1 and receptor-1/5 agonist peptides for treatment of anti-inflammatory and autoimmune indications, receptor-4 peptide and small molecule agonists for the treatment of genetic obesity indications and natriuretic peptide receptor agonist compounds for treatment of cardiovascular and pulmonary indications.

Conference Call / Webcast
Palatin will host a conference call and webcast on November 13, 2018 at 11:00 a.m. Eastern Time to discuss the quarter ended September 30, 2018 results of operations and also provide an update on its programs under development. Individuals interested in listening to the conference call live can dial 1-877-260-1479 (US/Canada) or 1-334-323-0522 (international), conference ID 5988704. The webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1-719-457-0820 (international), passcode 5988704. The webcast and telephone replay will be available through November 20, 2018.

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On November 13, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, will participate in the Evercore ISI HealthConX Conference on Tuesday, November 27, 2018. Bill Chase, executive vice president, finance and administration, will present at 8 a.m. Eastern time.

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On November 13, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported its financial results for the quarter ended September 30, 2018 (Press release, Delcath Systems, NOV 13, 2018, View Source;p=RssLanding&cat=news&id=2377027 [SID1234531279]).

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Highlights from the third quarter of 2018 and recent weeks include:

First patients treated in the Company’s amended Phase 3 clinical trial in ocular melanoma liver metastases (the FOCUS Trial)
Raised $7.0 million in net proceeds from the September 2018 rights offering
Revenue from European sales for the quarter of approximately $0.8 million and $2.4 million for the first nine months of 2018, an increase of approximately 20% over the first nine-months of 2017
First patient treated in global Phase 3 clinical trial for intrahepatic cholangiocarcinoma (ICC) (the ALIGN Trial)
Publication of ICC outcomes data in European Radiology
Positive results from prospective and retrospective studies on CHEMOSAT presented at 2018 CIRSE annual conference
3rd Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial has again recommended that the study continue without modification;
Management Commentary

"Our third quarter was a productive period for Delcath during which we took major steps to advance our Clinical Development Program while working to resolve the cash constraints and other restrictions that have impeded our ability to operate," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.

"During the quarter, we began aggressively rolling out the amended protocol for our FOCUS registration trial in ocular melanoma liver metastases, activating centers in both the United States and Europe and treating the first patients under the new single arm protocol. We continue to work toward our goal of completing enrollment in this trial by the end of the first half of 2019."

"In October, we announced treatment of the first patient in our registration trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with ICC (the ALIGN Trial.) The ALIGN Trial is based on a positive efficacy signal observed in a multi-center analysis in the ICC tumor type with CHEMOSAT in Europe, which were published in European Radiology. In this orphan population where there exists an unmet medical need, this trial provides us with a second pathway to commercial drug approval in the United States, and, if successful, we believe will be an important value driver for the Company."

"During our third quarter we also completed our September 2018 Rights Offering, through which we secured approximately $7.2 million in net proceeds. Though the Rights Offering provided the capital that allowed us to advance our plans during the quarter, it fell short of our expectations. We will require and continue to seek additional capital to complete the clinical trials on which shareholder value ultimately depends."

"Though we still face many challenges, we have taken significant steps to advance our clinical and commercial programs and to obtain the financial resources required to realize PHP therapy’s potential," concluded Dr. Simpson.

Third Quarter 2018 Financial Results

Revenue for the three months ended September 30, 2018 was $0.8 million, up from $0.7 million for the prior year period driven by the establishment of reimbursement coverage of CHEMOSAT procedures in Germany. Selling, general and administrative expenses were approximately $2.3 million compared to $2.9 million in the prior year quarter, a decrease related to costs associated with the Company’s shareholder meetings held in 2017 that were not incurred in 2018, and a reduction in independent audit fees incurred in 2017 that were not required in 2018. Research and development expenses for the current quarter increased to $4.1 million from $2.3 million in the prior year quarter, driven by increase costs associated primarily due to the ongoing accrual of the Company’s Phase 3 FOCUS trial. Total operating expenses for the current quarter were $6.4 million compared with $5.1 million in the prior year quarter.

The Company recorded a net loss for the three months ended September 30, 2018, of $8.9 million, a decrease of $3.7 million, or 29.5%, compared to a net loss of $12.6 million for the same period in 2017. This decrease in net loss is primarily due to a $1.9 million decrease in interest expense, a $1.8 million reduction in loss on debt extinguishment and a $1.2 million increase in the change in the fair value of the warrant liability, all non-cash items. This decrease was slightly offset by a $1.2 million increase in operating expenses primarily related to increased investment in our clinical trial initiatives.

Balance Sheet Highlights
At September 30, 2018, the Company had cash, cash equivalents and restricted cash totaling $10.0 million, as compared to cash, cash equivalents and restricted cash totaling $5.3 million at December 31, 2017 and $10.9 million at September 30, 2017. During the nine months ended September 30, 2018 and September 30, 2017, the Company used $12.9 million and $11.7 million respectively, of cash in its operating activities. Including the $850,000 raised in November 2018 through the issuance of Series D Preferred Shares, the Company believes that its capital resources are adequate to fund its operating activities into December 2018.

September 2018 Rights Offering

In September 2018, the Company completed the sale of 4,667,811 shares of its common stock, with net proceeds after expenses of approximately $7.0 million.

On November 13, 2018 Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results for the third quarter ended September 30, 2018 and provided a business update (Press release, Forty Seven, NOV 13, 2018, View Source [SID1234531273]).

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"Our recent accomplishments reflect our commitment to establishing Forty Seven as a pioneer in the development of a new class of checkpoint therapies, which harness the innate immune system to help patients more effectively defeat their disease," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc.
"We were pleased to have the New England Journal of Medicine publish our Phase 1b NHL data for 5F9 in combination with rituximab earlier this month, which speaks to the potential of macrophage activation for the treatment of cancer.

"In addition to progressing our ongoing clinical trials of 5F9 toward data readouts in 2019, we advanced our pipeline in the third quarter with additional efforts on FSI-189 as our next development candidate," continued Dr. McCamish. "FSI-189 is an anti-SIRPα antibody, designed to interfere with CD47 activity through a distinct modality, which enables us to more fully exploit the potential of the CD47/SIRPα pathway as a novel oncology target. We look forward to building on this momentum in the coming months, as we work together with our newly appointed SAB to advance our pipeline and maximize our impact."

Upcoming Milestones:

Forty Seven plans to present preclinical data providing new insights into the mechanism of action of its priming and maintenance dose strategy for 5F9 in a poster session at the 60th ASH (Free ASH Whitepaper) Annual Meeting, which will be held December 1-4, 2018 in San Diego, California. Also at ASH (Free ASH Whitepaper), Forty Seven will present a poster detailing new preclinical data that supports the combination of 5F9 and azacitidine for the treatment of acute myeloid leukemia (AML). Patients with AML have already been dosed with this combination based on these promising preclinical results.

Third Quarter and Recent Business Highlights:

In October 2018, Forty Seven advanced FSI-189, an anti-SIRPα antibody, as its second product candidate for the treatment of cancer. SIRPα is the cognate receptor of CD47 and, in preclinical models, FSI-189 blocked SIRPα binding to CD47 and enhanced macrophage phagocytosis of cancer cells. SIRPα is only expressed on certain cells types, including macrophages. As a result, Forty Seven believes that FSI-189 may be effective at low doses. FSI-189 is currently in preclinical development, and Forty Seven plans to initiate IND-enabling studies in 2019.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

In October 2018, Forty Seven announced that proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory NHL were published in the New England Journal of Medicine. In the Phase 1b portion of the study, 5F9 demonstrated signs of clinical efficacy, and was safe and well-tolerated in the patients treated.

Corporate:

In October 2018, Forty Seven announced the formation of its SAB, including the appointment of four leading scientists in the fields of immunotherapy and oncology: 2018 Nobel Laureate for Medicine, James Allison, Ph.D.; Ronald Levy, M.D.; Padmanee Sharma, M.D., Ph.D.; and Louis Weiner, M.D.

In August 2018, the European Patent Office Opposition Division ruled in favor of Forty Seven, rejecting challenges to the company’s licensed European patent, EP ‘512, which covers the use of CD47 antibodies designed to treat cancer through phagocytosis. This decision strengthens Forty Seven’s patent protection for 5F9 in Europe.

Third Quarter 2018 Financial Results:

Cash Position: As of September 30, 2018, cash, cash equivalents and short-term investments were $154.0 million, as compared to $88.1 million as of December 31, 2017. This increase reflects net proceeds of $116.3 million from Forty Seven’s initial public offering of common stock, which closed in July 2018. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into 2020.

R&D Expenses: R&D expenses were $18.0 million for the third quarter ended September 30, 2018, as compared to $8.8 million for the same period in 2017. This increase was primarily due to non-recurring upfront payments on two licensing deals of $6.3 million, as well as the continued advancement of the company’s clinical development efforts and preclinical and discovery programs. This increase was partially offset by $1.7 million in grant and cost-share funding recognized under the company’s grants from the California Institute of Regenerative Medicine, the Leukemia and Lymphoma Society and Merck KGaA.

G&A Expenses: G&A expenses were $4.4 million for the third quarter ended September 30, 2018, as compared to $2.1 million for the same period in 2017. This increase was primarily due to increased personnel costs and expenses incurred in connection with operating as a public company.

Net Loss: Net loss was $21.7 million for the third quarter ended September 30, 2018, or $0.71 per basic and diluted share, as compared to a net loss of $10.8 million, or $1.67 per basic and diluted share, for the same period in 2017.

On November 13, 2018 Cellectis S.A. (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported its results for the three-month period ended September 30, 2018 and for the nine-month period end September 30, 2018 (Press release, Cellectis, NOV 13, 2018, View Source [SID1234531264]).

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1 Cash position includes cash, cash equivalent and current financial assets

Third Quarter 2018 and Recent Highlights

UCART123 (wholly controlled) – AML & BPDCN patients

The Phases 1 dose escalation studies of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients at MD Anderson Cancer Center and Weill Cornell Medical Center remain ongoing.

For the AML clinical trial, the current dose level of 2.5×105 UCART123 cells per kilogram will be followed by dose levels 2 and 3 with 6.25×105 and 5.05×106 UCART123 cells per kilogram. We are expecting to dose 2-4 patients per dose cohort, with a treatment follow-up period of 4 weeks per patient as well as an option to re-dose responding patients.

UCART22 (wholly controlled) – B-ALL patients

The FDA approved an IND for UCART22, with a first Phase 1 clinical study in B-cell acute lymphoblastic leukemia (B-ALL) adult patients.

UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR T-cell product candidate developed by Cellectis to enter clinical trials.

UCART22 is designed for the treatment of CD22-expressing cancer cells. Like CD19, CD22 is a cell surface antigen expressed from the pre-B-cell stage of development through mature B-cells and is expressed in more than 90% of patients with B-ALL. Approximately 85% of ALL cases involve precursor B-cells (B-ALL). The clinical research for UCART22 will be led by Dr. Nitin Jain, Assistant Professor at The University of Texas MD Anderson Cancer Center in Houston, and Prof. Hagop Kantarjian, Professor and Chair in the Department of Leukemia and University Chair in Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston.

UCARTCS1 (wholly controlled) – Multiple Myeloma patients

A clinical trial for UCARTCS1 is expected to start in 2019 in Multiple Myeloma patients.

UCARTCS1 is our first allogeneic CAR T-cell product candidate for the treatment of Multiple Myeloma (MM) patients. We have chosen CS1 (also known as SLAMF7) as the targeted antigen for this program, based on the high levels of expression of CS1 in MM patients on malignant cells relative to the low level of expression on non-malignant cells as well as on the results of third parties’ proof of concept for this high value target achieved with the elotuzumab monoclonal antibody in MM patients.

UCART19 (partnered, exclusively licensed to Servier) – ALL patients

Recently, an abstract titled "896 Preliminary Data on Safety, Cellular Kinetics and Anti-Leukemic Activity of UCART19, an Allogeneic Anti-CD19 CAR T-Cell Product, in a Pool of Adult and Pediatric Patients with High-Risk CD19+ Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia" for oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, was published online, showing the continued progress of UCART19 in Phase 1 clinical trials, for both pediatric and adult ALL patients.

After UCART19 infusion, 88% of evaluable patients (14/16) achieved a complete remission (CR) or complete remission with incomplete blood cell recovery (CRi) by day 28 or day 42 post UCART19 infusion and 86% (12/14) of these patients were ‘measurable residual disease’ (MRD) negative (MRD- stands for less than 1 leukemic cell among 104 normal cells) assessed by flow or qPCR.

We are pleased to see continued progress for UCART19 under the management of our partner Servier.

Under the collaboration agreement with Servier from 2014, Cellectis is entitled to receive up to $350 million in clinical and regulatory milestone payments, as well as tiered royalties in the high single digits on worldwide sales.

ALLO-715 (BCMA) and ALLO-819 (Flt3) (partnered, exclusively licensed to Allogene)

In addition, Allogene has released (i) an abstract for oral presentation at ASH (Free ASH Whitepaper) 2018 annual meeting, describing pre-clinical research on ALLO-715, an allogeneic BCMA CAR T therapy possessing an off-switch for the treatment of Multiple Myeloma, and (ii) an abstract for a poster presentation for ALLO-819, an allogeneic Flt3 CAR T therapy possessing an off-switch for the treatment of acute myeloid leukemia (AML).

ALLO-715 and ALLO-819 were progressed under a joint research collaboration with Allogene, and are directed to targets that were licensed exclusively from Cellectis. Allogene holds the exclusive global development and commercial rights for these product candidates.

Cellectis remains eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets, and tiered royalties in the high single digits on worldwide sales of any products that are developed by Allogene, as originally agreed to under the June 17, 2014 Collaboration Agreement with Pfizer.

Manufacturing

We are currently in the process of internalizing large parts of our proprietary manufacturing chain for clinical supplies and we are planning to build a proprietary cGMP, commercial scale manufacturing facility in the United States.

Corporate Governance

On August 2, 2018, Cellectis announced the appointment of Dr. Stefan Scherer, M.D., Ph.D., to the role of Senior Vice President Clinical Development and Deputy Chief Medical Officer.

On September 19, 2018, Cellectis announced that Stephan A. Grupp, MD, Ph.D., a leading pediatric oncologist at Children’s Hospital of Philadelphia and Chief of the Section of Cellular Therapy and Transplant at the Children’s Hospital of Philadelphia (CHOP) joined the Company’s Clinical Advisory Board (CAB).

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 ("GAAP").

Third Quarter and Nine-months 2018 Financial Results

Cash: As of December 31, 2017, Cellectis had $297.0 million in total cash, cash equivalents and current financial assets compared to $475.9 million as of September 30, 2018. This increase of $178.9 million primarily reflects $227.4 million net cash proceeds provided by follow-on offerings completed by Cellectis and Calyxt, partially offset by the net cash flows used by operating activities of $47.5 million.

We believe that our cash, cash equivalents and current financial assets of $475.9 million as of September 30, 2018 will be sufficient to fund our operations until 2022.

Revenues and Other Income: Total revenues and other income were $2.2 million for the three months ended September 30, 2018 compared to $7.3 million for the three months ended September 30, 2017. Total revenues and other income were $18.5 million for the nine months ended September 30, 2018 compared to $26.7 million for the nine months ended September 30, 2017. The decrease in both periods was primarily attributable to a decrease in recognition of upfront fees already paid to Cellectis and research and development cost reimbursements in relation to collaborations.

R&D Expenses: Total R&D expenses were $18.7 million for the three months ended September 30, 2018 compared to $20.3 million for the three months ended September 30, 2017. Total R&D expenses were $55.2 million for the nine months ended September 30, 2018 compared to $58.5 million for the nine months ended September 30, 2017. The decrease in both periods was primarily driven by decreased non-cash stock-based compensation expenses partially offset by increased wages and salaries.

SG&A Expenses: Total SG&A expenses were $11.6 million for the three months ended September 30, 2018 compared to $12.2 million for the three months ended September 30, 2017. The decrease was primarily attributable by decreased non-cash stock-based compensation expenses partially offset by increased in purchases and external expenses. Total SG&A expenses were $36.8 million for the nine months ended September 30, 2018 compared to $31.8 million for the nine months ended September 30, 2017. The increase was primarily driven by increased purchases and external expenses and wages and salaries partially offset by a decrease in non-cash stock-based compensation.

Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to Shareholders of Cellectis was $22.8 million (or $0.54 per share) for the three months ended September 30, 2018 compared to $26.2 million (or $0.73 per share) for the three months ended September 30, 2017. Net loss attributable to Shareholders of Cellectis was $55.4 million (or $1.38 per share) for the nine months ended September 30, 2018 compared to 72.3 million (or $2.03 per share) for the nine months ended September 30, 2017. The decrease in both periods was primarily driven by financial gains and decrease in non-cash stock-based compensation expense, partially offset by decreased revenues and other income and increased purchases and external expenses and wages and salaries.

Adjusted Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to Shareholders of Cellectis was $15.1 million ($0.36 per share), for the three months ended September 30, 2018 compared to $14.3 million ($0.40 per share) for the three months ended September 30, 2017. Net loss attributable to Shareholders of Cellectis was $28.0 million ($0.70 per share) for the nine months ended September 30, 2018 compared to $34.3 million ($0.96 per share) for the nine months ended September 30, 2017. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.