8-K – Current report

On March 10, 2016 Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, reported financial results for the year ending December 31, 2015 (Filing, Annual, Cellectar Biosciences, 2015, MAR 17, 2016, View Source [SID:1234509612]).
Summary of Recent Key Accomplishments:

· Positive initial data in phase 1 study of CLR 131 in multiple myeloma

· Research collaboration with Pierre Fabre involving PDC Delivery Platform

· $2.3 million NCI Fast Track SBIR Grant for study of CLR 125

· New IP protection for PDC Delivery Platform with CTX patent application

Summary of Financial Results:

Research and development expenses for 2015 were $5.2 million, a reduction of $0.8 million from the prior year. This reflects the company’s continued focus on research and development efforts and implementation of operating improvements that have resulted in reductions to its cost structure. General and administrative expenses for the year totaled $3.4 million, which is an improvement from 2014 of $0.3 million. The company also incurred $0.2 million of restructuring charges in fiscal 2015, which is consistent with 2014.

Operating loss was $8.8 million for 2015, compared to $9.9 million in 2014. Other income was $3.3 million for fiscal 2015, as compared to $1.8 million in 2014. These amounts are almost exclusively non-cash in nature, and are due to changes in the valuation of certain warrants that are classified as liabilities on Cellectar’s balance sheet. As a result, the company’s net loss for the year ended December 31, 2015 was $5.5 million, or ($7.03) per share, compared to a 2014 net loss of $8.1 million, or ($17.53) per share.

As of December 31, 2015, the company had $3.9 million in cash and cash equivalents on hand, compared to $9.4 million in cash and cash equivalents at December 31, 2014. While Cellectar anticipates its available cash and cash equivalents should fund its planned operations into the second quarter of 2016, management believes capital will be required to complete its planned clinical and preclinical development.

"The last two quarters of 2015 through the first quarter of 2016 continue to represent a significant shift in corporate objectives, culture and branding for Cellectar Biosciences," said Jim Caruso, president and CEO of Cellectar Biosciences. "Significant progress has been achieved and we remain confident in our corporate strategy, operating plan execution and our PDC Delivery Platform technology. We are pleased with the resulting program advancements and look forward to providing further details about our objectives for continued success on today’s call."

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

December 31,
2015 December 31,
2014
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 3,857,791 $ 9,422,627
Restricted cash 55,000 55,000
Prepaid expenses and other current assets 267,783 220,611
Total current assets 4,180,574 9,698,238
FIXED ASSETS, NET 1,728,471 2,033,944
GOODWILL 1,675,462 1,675,462
OTHER ASSETS 11,872 11,872
TOTAL ASSETS $ 7,596,379 $ 13,419,516

LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current maturities of notes payable $ 243,590 $ 119,923
Accounts payable and accrued liabilities 675,924 933,988
Derivative liability 4,781,082 5,176,915
Capital lease obligations, current portion 2,449 2,180
Total current liabilities 5,703,045 6,233,006
LONG-TERM LIABILITIES:
Notes payable, less current maturities 86,632 330,077
Deferred rent 148,924 147,774
Capital lease obligations, less current portion 7,975 11,126
Total long-term liabilities 243,531 488,977
Total liabilities 5,946,576 6,721,983
TOTAL STOCKHOLDERS’ EQUITY: 1,649,803 6,697,533
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 7,596,379 $ 13,419,516

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Year Ended December 31,
2015 2014

COSTS AND EXPENSES:
Research and development $ 5,158,874 $ 5,964,453
General and administrative 3,395,360 3,704,676
Restructuring costs 203,631 221,816
Total costs and expenses 8,757,865 9,890,945

LOSS FROM OPERATIONS (8,757,865 ) (9,890,945 )

OTHER INCOME (EXPENSE):
Gain on revaluation of derivative warrants 3,667,826 2,285,157
Loss on issuance of derivative warrants (404,150 ) —
Interest expense, net (841 ) (446,314 )
Total other income, net 3,262,835 1,838,843
NET LOSS $ (5,495,030 ) $ (8,052,102 )
BASIC AND DILUTED NET LOSS PER COMMON SHARE $ (7.03 ) $ (17.53 )
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS
PER COMMON SHARE 781,975 459,266

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!


Adaptimmune Reports Financial Results for the Six-Month Period ended December 31, 2015

On March 17, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP) ("Adaptimmune" or the "Company"), a leader in the use of T-cell therapy to treat cancer, reported financial results for the six-month period ended December 31, 2015 (Press release, Adaptimmune, MAR 17, 2016, View Source;p=RssLanding&cat=news&id=2149178 [SID:1234509609]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Adaptimmune previously announced its decision to change its fiscal year end to align fiscal reporting more closely with comparable companies in the industry which use calendar years and to provide more efficient reporting for U.S. investors. As a result of the change, the Company is required to and has filed with the Securities and Exchange Commission ("SEC") today a transition report on Form 20-F (the "Transition Report") for the transition period of July 1, 2015 to December 31, 2015.

As of December 31, 2015, Adaptimmune had a total liquidity position1 of $247.6 million (£167.9 million). The Company is reiterating its cash burn guidance and expects its liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million.

"The six months ended December 31, 2015 marked an important period of execution throughout our organization," commented James Noble, Adaptimmune’s Chief Executive Officer. "We initiated a study in non-small cell lung cancer with our affinity-enhanced T-cell therapy targeting NY-ESO. We also made strong progress in moving our proprietary pipeline forward, including initiating a study in non-small cell lung cancer with our wholly-owned affinity-enhanced T-cell therapy targeting MAGE-A10. Further, we received RAC approval for our wholly-owned T-cell therapeutic candidate targeting AFP and anticipate filing an IND for this therapy during the first half of 2016."

Mr. Noble continued, "Since the start of 2016, we have already reached two key milestones. Firstly, we and GlaxoSmithKline ("GSK") expanded the terms of our strategic collaboration to enable us to accelerate the development of this candidate therapy into pivotal trials and conduct a range of combination studies. Secondly, we were recently awarded breakthrough therapy designation for our NY-ESO therapy in synovial sarcoma."

Recent Corporate and Clinical Highlights:

Expanded terms of strategic collaboration agreement with GSK to accelerate Adaptimmune’s lead clinical cancer program, an affinity-enhanced T-cell therapy targeting NY-ESO, with goal of initiating pivotal trials around year end 2016;

Received breakthrough therapy designation from U.S. Food and Drug Administration for affinity enhanced T-cell therapy targeting NY-ESO in synovial sarcoma;

Initiated Phase I/II trial evaluating affinity enhanced T-cell therapy targeting NY-ESO in patients with non-small cell lung cancer ("NSCLC");

Initiated Phase I/II trial evaluating the Company’s wholly-owned affinity enhanced T-cell therapy targeting MAGE-A10 in patients with NSCLC;

Received Recombinant Advisory Committee ("RAC") approval for Adaptimmune’s wholly-owned T-cell therapeutic candidate targeting AFP

Completed preclinical assessment of wholly-owned affinity-enhanced T-cell therapy targeting AFP; the Company expects to file an Investigational New Drug ("IND") application for Phase I/II studies in hepatocellular cancer in 1H2016; and

Announced strategic alliance with Universal Cells to develop allogeneic T-cell therapies.

Financial Results for the six-month period ended December 31, 2015

Cash / liquidity position: As of December 31, 2015, Adaptimmune had a total liquidity position of $247.6 million (£167.9 million). This consists of $193.2 million (£131.0 million) of cash and cash equivalents and $54.3 million (£36.8 million) of short-term deposits.
Cash burn: The net decrease in cash and cash equivalents was $21.6 million (£14.6 million) for the six months ended December 31, 2015, which includes the impact of unrealized foreign exchange gains of $10.0 million (£6.8 million) and $10.3 million (£7.0 million) of milestone payments received under the Company’s collaboration with GSK.

Revenue: For the six months ended December 31, 2015, revenue was $8.1 million (£5.5 million) compared to $3.6 (£2.4 million) for the six months ended December 31, 2014 (unaudited). The increase in revenue was due to an increase in services performed and achievement of development deliverables under the Company’s collaboration with GSK.

Research and development ("R&D") expenses: R&D expenses were $24.3 million (£16.5 million) for the six months ended December 31, 2015 compared to $8.4 (£5.7 million) for the six months ended December 31, 2014 (unaudited), primarily due to increased period-over-period costs associated with: ongoing clinical trials of the Company’s affinity-enhanced T-cell therapy targeting NY-ESO-1; preparation for, and initiation costs associated with, NSCLC studies with the Company’s affinity-enhanced T-cell therapies targeting NY-ESO-1 and MAGE-A10, and personnel expenses for an increased number of employees engaged in R&D.
General and administrative ("G&A") expenses: G&A expenses were $10.8 million (£7.3 million) for the six months ended December 31, 2015 compared to $3.1 (£2.1 million) for the six months ended December 31, 2014 (unaudited). The increase was primarily due to increased personnel costs, increased property costs and other costs associated with being a public company.

Net loss: Net loss attributable to holders of the Company’s ordinary shares was $10.9 million (£7.4 million) for the six months ended December 31, 2015. This equates to $(0.03) or £(0.02) per ordinary share, or $(0.15) per American Depositary Share. This loss is stated after recognizing $12.9 million (£8.8 million) of finance income, which primarily represents unrealized foreign exchange gains.

The Company will not be holding a conference call to discuss these results and instead will provide a full update during its 2016 Analyst Day to be held on April 22, 2016.

Financial Guidance
Adaptimmune is reiterating its cash burn guidance. For the full year 2016, the Company expects its cash burn to be between $80 and $100 million and expects its liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million. This guidance excludes any cash burn associated with potential new business development activities.

The Company prepared the Transition Report under International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board. The Company’s next fiscal year end will be December 31, 2016. Starting with the first quarter of 2016, the Company will file with the SEC quarterly reports on Form 10-Q and annual reports on Form 10-K prepared under U.S. Generally Accepted Accounting Principles ("GAAP").

Dynavax Announces Data Presentations at AACR Annual Meeting

On March 17, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will present data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting next month in New Orleans, Louisiana (Press release, Dynavax Technologies, MAR 17, 2016, View Source [SID:1234509605]). The details for the poster presentations are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Date and Time: Monday, April 18, 2016, 1:00 p.m. – 5:00 p.m. EDT

Abstract Title: SD-101, a novel intratumoral class C CpG-ODN, given with low-dose radiation in patients with untreated low-grade B-cell lymphoma: interim results of a phase I trial

Session Title: Phase I Clinical Trials 1

Abstract Control Number: 7361

Permanent Abstract Number: CT047

Location: Convention Center, Halls G-J, Poster Section 13

Poster Board Number: 3

Please click here for the full abstract. The poster presentation with updated data will be made available on or after April 18, 2016.

Date and Time: Monday, April 18, 2016, 1:00 p.m. – 5:00 p.m. EDT

Abstract Title: Intratumoral treatment with a highly interferogenic TLR9 agonist reverts tumor escape from PD-1 blockade

Session Title: Immune Checkpoints 1

Abstract Control Number: 4045

Permanent Abstract Number: 2322

Location: Convention Center, Halls G-J, Poster Section 26

Please click here for the full abstract. The poster presentation with updated data will be made available on or after April 18, 2016.

Date and Time: Wednesday April 20, 2016, 8:00 a.m. – 12:00 p.m. EDT

Abstract Title: Radiation potentiates systemic anti-tumor immunity unleashed by a novel TLR9 agonist (SD-101)

Session Title: Immune Modulation from Non-Immunotherapy and Antibodies: Clinical

Abstract Number: 4985

Location: Convention Center, Halls G-J, Poster Section 26

Poster Board Number: 9

Please click here for the full abstract. The poster presentation with updated data will be made available on or after April 20, 2016.

About SD-101

SD-101, the subject of AACR (Free AACR Whitepaper) abstracts CT047, 2322 and 4985, is Dynavax’s proprietary, second-generation, CpG-C class oligodeoxynucleotide TLR 9 agonist. SD-101 activates multiple anti-tumor mechanisms of innate immune cells and activates plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and induce high levels of Type I interferons and maturation of plasmacytoid dendritic cells and B cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its preliminary safety and activity.

OncoSec Announces Presentation at Upcoming American Association for Cancer Research (AACR) Annual Meeting 2016

On March 17, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that new clinical data will be presented at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held on April 16-20, 2016 in New Orleans, LA (Press release, OncoSec Medical, MAR 17, 2016, View Source [SID:1234509604]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

This new data relates to the Company’s Phase II monotherapy clinical study of its investigational intratumoral plasmid IL-12 with electroporation (IT-pIL12-EP) in patients with melanoma. After completing treatment with IT-pIL12-EP, a subset of patients subsequently received anti-PD-1/PD-L1 therapies. Patients with documented follow-up history and evaluable for anti-PD-1/PD-L1 response were included in this single-site retrospective analysis.

Details of the presentation are as follows:

Abstract Title: Intratumoral electroporation of plasmid IL-12 can prime response to anti-PD1/PD-L1 blockade in patients with Stage III/IV-M1a melanoma (Abstract #CT134)
Session Title: Early Clinical Trials Evaluating Cell-based Checkpoint Inhibitors and Novel Immunotherapeutics
Date and Time: April 19, 2016 at 3:45 – 4:00 PM
Location: Room 343, Morial Convention Center

AACR 2016: Innate Pharma displays broad innovative pipeline in immuno-oncology

On March 17, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that new preclinical data will be presented at the American Association Of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 taking place from 16 to 20 April 2016, in New Orleans, Louisiana, USA (Press release, Innate Pharma, MAR 17, 2016, View Source [SID:1234509600]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

These data supports the rationale of four of Innate’s clinical and preclinical programs:

One poster will present preclinical data supporting the rationale for combining an NKG2A checkpoint inhibitor with a PD-1 or a PD-L1 checkpoint inhibitor in mouse models;
One poster will present new data reinforcing the rationale for IPH4301, a first-in-class anti-MICA/B humanized antibody;
Three posters will present preclinical data on new discovery programs targeting CD73 and CD39, immune checkpoints regulating the adenosine pathway, including one poster reporting data generated by OREGA Biotech, Innate’s collaborator on the CD39 project.
Nicolai Wagtmann, Chief Scientific Officer of Innate Pharma, said: "The AACR (Free AACR Whitepaper) annual meeting is one of the major events in our field. This year, we are proud to present 5 posters, demonstrating the progress of our pipeline and the excellence of Innate Pharma’s science. These data supports the rationale and the potential of our assets, and strengthens Innate’s unique positioning in the immuno-oncology field".

******

Beyond posters presentations, Innate Pharma’s team will be present with a booth (#2604) to receive its peers and the financial community at AACR (Free AACR Whitepaper).

Nicolai Wagtmann, Chief Scientific Officer of Innate Pharma, will hold a conference call to the attention of analysts and portfolio managers to discuss the data published and Company’s innovative pipeline.

Time and dial in: Tuesday, April 19th 10:30am Eastern Time

USA: 888 504 7963

International: +1 719 325 2452

Access code: 1890466

*******

About the posters to be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2016:

IPH4301, an antibody targeting MICA and MICB exhibits potent cytotoxic activity and immunomodulatory properties for the treatment of cancer

Permanent Abstract Number: 1491
Session Category: Immunology
Session Title: Immune Modulating Agents and Therapeutic Antibodies
Session Date and Time: Monday Apr 18, 2016 8:00 AM – 12:00 PM
Location: Convention Center, Halls G-J, Poster Section 25
Presented by Mathieu Bléry, PhD
NKG2A immune checkpoint blockade enhances the anti-tumor efficacy of PD1/PD-L1 inhibitors in a preclinical model

Permanent Abstract Number: 2342
Session Category: Immunology
Session Title: Immune Checkpoints 1
Session Date and Time: Monday Apr 18, 2016 1:00 PM – 5:00 PM
Location: Convention Center, Halls G-J, Poster Section 26
Presented by Pascale André, PhD
Discovery and characterization of new original blocking antibodies targeting the CD73 immune checkpoint for cancer immunotherapy

Permanent Abstract Number: 2344
Session Category: Immunology
Session Title: Immune Checkpoints 1
Session Date and Time: Monday Apr 18, 2016 1:00 PM – 5:00 PM
Location: Convention Center, Halls G-J, Poster Section 26
Presented by Ivan Perrot, PhD
Disruption of the CD39 immune checkpoint pathway increases the efficacy of various anticancer therapies in syngeneic mouse models

Permanent Abstract Number: 3218
Session Category: Immunology
Session Title: Immune Checkpoints 2
Session Date and Time: Tuesday Apr 19, 2016 8:00 AM – 12:00 PM
Location: Convention Center, Halls G-J, Poster Section 25
Presented by Jérémy Bastid, PharmD, PhD (OREGA Biotech)
Preclinical development of a humanized blocking antibody targeting the CD39 immune checkpoint for cancer immunotherapy

Permanent Abstract Number: 3222
Session Category: Immunology
Session Title: Immune Checkpoints 2
Session Date and Time: Tuesday Apr 19, 2016 8:00 AM – 12:00 PM
Location: Convention Center, Halls G-J, Poster Section 25
Presented by Ivan Perrot, PhD