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

On May 9, 2017 NantCell and NantKwest Inc. (NASDAQ:NK), two pioneering, next generation, clinical-stage immunotherapy companies focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reported that the U.S. Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND) Application for the NANT Cancer Vaccine for clinical trial enrollment for pancreatic cancer patients (ClinicalTrials.gov NCT03136406) (Press release, NantKwest, MAY 9, 2017, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2271181 [SID1234518925]).

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The NANT Cancer Vaccine is the first combination immunotherapy protocol to orchestrate the delivery of metronomic low-dose radiation and chemotherapy with molecularly-informed, tumor-associated antigen vaccines and natural killer cells, to activate the innate and adaptive immune system and to induce immunogenic cell death. By inducing immunogenic cell death and protecting as well as enhancing the innate and adaptive immune system, the NANT Cancer Vaccine seeks to attain long-term sustainable remission of multiple tumor types with lower toxicity and higher efficacy than current standards of care.

"Abraxane, a nanoparticle albumin-bound (Nab) paclitaxel, was the first protein-based drug to alter the survival of metastatic pancreatic cancer in over 20 years," noted Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "But we were not content just with the approval of Abraxane as being sufficient to transform this disease. In January 2016, we announced our Cancer Breakthroughs 2020 journey towards developing effective personalized cancer treatments to further harness the human body’s innate immune system as a paradigm change to treating patients with cancer. Today’s FDA clearance is a further step in our 25-year quest to develop this cancer vaccine that seeks to induce immunogenic cell death and orchestrate the innate and adaptive immune system of the patient through the delivery of molecularly informed, biological platforms. To our knowledge this is the first clinical study whereby protein nanoparticles (Nab) delivering low dose metronomic chemotherapy is combined with molecularly informed (GPS Cancer) tumor associated antigens activating dendritic and T cells by adenoviral and yeast vectors, and orchestrated with both endogenous (IL-15) and exogenous (off the shelf) activation of NK cells. This NANT Cancer Vaccine will be studied in patients suffering from all types of cancers and at all stages of disease in the coming 12 months, a Cancer Breakthroughs 2020 goal," Dr. Soon-Shiong added.

"Cancer has historically been one of the most complex challenges that the medical community has tried to combat," said John Lee, MD, FACS, Senior Vice President of Clinical Development at NantKwest. "Receiving authorization from the FDA for the IND application for the NANT Cancer Vaccine is a testament to our novel immunotherapy approach. Today marks an important milestone for cancer care and reinforces the need for a paradigm shift in the way we approach this deadly disease. NantKwest and NantCell are actively working to initiate the clinical trial across investigational centers and we look forward to offering the NANT Cancer Vaccine regimen to pancreatic cancer patients."

"Cancer cells often go undetected by the immune system; recently, it was found that cancer cells place a brake on the immune system by checkpoint receptors. This discovery has brought forth a new revolution of immuno-oncology with the launch of multiple checkpoint inhibitors. We realize, however, that checkpoint inhibition alone is insufficient to fully activate the immune system to combat the cancerous tumor," stated Leonard S. Sender, M.D., Senior Vice President of Medical Affairs for Pediatric, Adolescent and Young Adult Oncology at NantKwest. "NANT Cancer Vaccine is a unique, multi-agent protocol aimed at orchestrating all the components of the immune system needed to combat cancer."

On May 9, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the first quarter ended March 31, 2017 (Press release, Loxo Oncology, MAY 9, 2017, View Source [SID1234518923]). Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

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"We had a very productive first quarter. We fully enrolled our larotrectinib registrational program, announced a diagnostics collaboration with Roche, presented proof-of-concept clinical data in glioblastoma at the AACR (Free AACR Whitepaper) Annual Meeting, and announced the acceptance of two oral presentations at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "For the upcoming quarter, we eagerly look forward to the larotrectinib presentations at ASCO (Free ASCO Whitepaper) and beginning the clinical development of LOXO-292, our highly selective RET kinase inhibitor."

Recent Highlights

Larotrectinib Oral Presentations Accepted at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: On April 5, 2017, Loxo Oncology announced that larotrectinib (LOXO-101) interim clinical data for RECIST-evaluable TRK fusion patients, integrated across all three ongoing clinical trials, will be presented as a late-breaking oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting held June 2 – 6, 2017 in Chicago, Illinois. The presentation is entitled, "The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers." Loxo Oncology also announced that interim pediatric Phase 1 clinical trial data, included in the aforementioned data set, will also be presented in a separate oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, entitled, "A pediatric phase 1 study of larotrectinib, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family." Loxo Oncology will be hosting a conference call in association with the ASCO (Free ASCO Whitepaper) Annual Meeting and details are included below.
Proof-of-Concept Clinical Data for Larotrectinib in TRK Fusion Glioblastoma Presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: On April 5, 2017, investigators from Memorial Sloan Kettering Cancer Center presented a poster describing initial clinical data across the larotrectinib program for all patients with TRK fusion primary CNS cancers at the AACR (Free AACR Whitepaper) meeting in Washington D.C. The cases include three patients with glioblastoma: one patient treated under an expanded access protocol and two patients treated in the ongoing Phase 2 NAVIGATE trial. In the cases presented, larotrectinib showed preliminary evidence of anti-tumor activity.
Collaboration with Ventana Medical Systems, Inc., a member of the Roche Group for Larotrectinib Pan-TRK IHC Companion Diagnostic: Loxo Oncology announced a collaboration agreement with Ventana Medical Systems, Inc., a member of the Roche Group (Roche), to develop and commercialize a pan-TRK immunohistochemistry (IHC) test as a companion diagnostic to identify patients across tumor types suitable for treatment with larotrectinib. The parties plan to first globally commercialize an analytical assay and then develop a Class III assay for pre-market approval from the U.S. Food and Drug Administration.
ASCO Conference Call

In conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting, Loxo Oncology will host a conference call and live webcast with slide presentation and Q&A on Sunday, June 4, 2017 at 6 p.m. CT to discuss the larotrectinib oral presentations. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 14447513. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 90 days following the call.

First Quarter 2017 Financial Results

As of March 31, 2017, Loxo Oncology had aggregate cash, cash equivalents and investments of $244.3 million, compared to $141.8 million as of December 31, 2016. Based on the current operating plan, the company continues to believe existing capital resources will be sufficient to fund anticipated operations to mid-2019.

Research and development expenses were $20.2 million for the first quarter of 2017 compared to $8.4 million for the first quarter of 2016. This increase was primarily due to expanded larotrectinib development activities including clinical costs and costs related to the companion diagnostics agreement with Roche, as well as additional expenses related to LOXO-292 and the preclinical pipeline and increases in employment costs primarily due to increased headcount. Loxo Oncology also recognized research and development-related stock-based compensation expense of $2.4 million during the first quarter of 2017 compared to $0.3 million for the first quarter of 2016.

General and administrative expenses were $4.8 million for the first quarter of 2017 compared to $3.4 million for the first quarter of 2016. The increase was primarily due to increases in employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $1.6 million during the first quarter 2017 compared to $1.0 million for the first quarter of 2016.

Net loss was $24.5 million and $11.6 million for the first quarters 2017 and 2016, respectively.

On May 9, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2017 (Press release, Cascadian Therapeutics, MAY 9, 2017, View Source [SID1234518921]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"In the first quarter, we continued to build a solid management team and the financial foundation that will help us execute our core objectives over the next several years," said Scott Myers, President and CEO of Cascadian Therapeutics. "We are focused on enrolling HER2CLIMB, our pivotal study of tucatinib in combination for late-stage HER2-positive metastatic breast cancer for patients with and without brain metastases. We are very pleased with the current pace of enrollment and are expanding HER2CLIMB globally."

First Quarter and Recent Highlights

In April 2017, the Company announced data highlights from presentations of preclinical data for the Company’s investigational orally bioavailable, potent and selective checkpoint kinase 1 (Chk1) inhibitor known as CASC-578 and data from the first public presentation on the Company’s preclinical antibody program targeting the immune checkpoint receptor TIGIT. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017.

In March 2017, the Company announced the appointment of Robert W. Azelby to the Company’s Board of Directors. Mr. Azelby is a biotechnology and pharmaceutical industry veteran. The Company also announced that Richard L. Jackson, Ph.D., retired from the Board.

In January 2017, the Company closed an $88 million net public offering of common and Series E preferred stock. The net proceeds, along with cash on hand, support the development of tucatinib, the registrational HER2CLIMB trial through top-line data, with funds to carry on operations for a period of time thereafter. On May 8, 2017, in connection with the registration rights agreement entered into for the Series E preferred stock issued in this financing, the Company filed a required resale S-3 registration statement to allow the holder of these preferred shares to sell shares of common stock issuable upon conversion of the preferred shares. The S-3 relates to these shares and does not provide for any future issuance of new common shares for financings.
First Quarter Financial Results

Cash, cash equivalents and investments totaled $136.1 million as of March 31, 2017, compared to $62.8 million at December 31, 2016, an increase of $73.3 million, or 116.7 percent. The increase was primarily due to the result of net proceeds of $88.0 million from the Company’s January 2017 financing offset by cash used to fund operations of $14.6 million.

Net loss attributable to common stockholders for the first three months ended March 31, 2017 was $12.4 million, or $0.30 per share, compared to a net loss attributable to common stockholders of $12.9 million, or $0.81 per share, for the same period in 2016. The $0.5 million decrease in net loss attributable to common stockholders for the quarter was primarily due to a decrease in general and administrative expense of $3.7 million related to the retirement and separation of the former chief executive officer in the first quarter of 2016. This decrease was offset by higher research and development expenses of $2.3 million due to greater activity related to the development of the Company’s product candidate and a non-cash deemed dividend of $1.0 million related to the beneficial conversion feature on the Series E convertible preferred stock.
2017 Financial Outlook

Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, primarily due to an increase in activities related to the ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations for 2017 is expected to be approximately $50.0 million to $54.0 million.

Cascadian Therapeutics believes the above financial guidance to be correct as of the date provided and is providing the guidance as a convenience to investors and assumes no obligation to update it.