On March 17, 2016 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company, reported highlights and financial results for the fourth quarter and full year ended December 31, 2015 (Press release, Kura Oncology, MAR 17, 2016, View Source;p=RssLanding&cat=news&id=2149364 [SID:1234509615]).

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"Over the past year, we have made significant progress toward positioning Kura Oncology to realize the promise of precision medicines for cancer," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We advanced our lead product candidate tipifarnib into three Phase 2 clinical trials, progressed our preclinical programs, and strengthened our balance sheet. We look forward to further applying our expertise in cancer pathways, genetics and companion diagnostics in 2016, as we seek to improve patient outcomes by identifying those most likely to benefit from treatment with our drug product candidates."

Development Program Updates and Company Highlights:

Tipifarnib in HRAS Mutant Solid Tumors

In May 2015, Kura initiated a Phase 2 clinical trial of tipifarnib in patients with advanced tumors that carry HRAS mutations. The primary objective of the study is to investigate the antitumor activity, in terms of objective response rate, of tipifarnib in patients with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations. Secondary objectives include evaluation of progression-free survival, duration of response, and safety. Top-line data from the trial is anticipated during the second half of 2016.
In November 2015, a Phase 2 clinical trial of tipifarnib was initiated in patients with advanced urothelial carcinoma tumors with HRAS mutations. The study is being conducted under the direction of Se Hoon Park, M.D., Ph.D., in the Division of Hematology-Oncology at the Samsung Medical Center in Seoul, South Korea. The primary objective of the study is objective response rate, and secondary objectives include evaluation of progression-free survival, duration of response, and safety.

Tipifarnib in Peripheral T-Cell Lymphoma

In September 2015, Kura initiated a Phase 2 clinical trial of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL consists of a group of rare and usually aggressive forms of non-Hodgkin’s lymphoma that develop from mature T-cells. These patients generally have a poor prognosis with a low response rate to available treatment options and commonly experience repeated treatment failures. The primary objective of the study is to evaluate the efficacy of tipifarnib in terms of objective response rate. Secondary objectives include evaluation of progression-free survival, duration of response, and safety. Top-line data from the trial is anticipated in the second half of 2017.

Tipifarnib in Lower-Risk Myelodysplastic Syndromes

Kura plans to initiate a Phase 2 clinical trial to investigate the anti-tumor activity of tipifarnib in patients with lower risk myelodysplastic syndromes (MDS) in the second quarter of 2016. MDS are a group of hematopoietic stem cell malignancies with significant morbidity and mortality. MDS is characterized by ineffective blood cell production, or hematopoiesis, leading to low blood cell counts, or cytopenias, and high risk of progression to acute myeloid leukemia. Kura’s interest in MDS arose from the results of a prior Phase 2 clinical trial sponsored by Johnson & Johnson in patients with intermediate to high risk MDS and additional work by Kura to identify potential biomarkers that could be predictive of response to tipifarnib in MDS patients. Lower risk MDS has been prioritized because of the prevalence of this disease and the company’s belief that treatment of lower risk MDS remains a significant unmet need.

KO-947

Kura plans to submit an investigational new drug application for KO-947, a small molecule inhibitor of extracellular receptor kinase (ERK1/2), in the second quarter of 2016. KO-947 demonstrates potent and selective inhibition of ERK kinase and has shown promising activity in patient-derived xenograft models. Kura is advancing KO-947 as a potential treatment for patients who have tumors with dysregulated activity of the MAPK pathway, including patients with lung, colorectal, pancreatic, melanoma and other cancers.

Menin-MLL

Kura’s menin-MLL program is focused on the identification of product candidates with the potential to treat patients with MLL-rearranged as well as MLL-PTD leukemias, both of which have no current effective therapy. The company anticipates nominating a development candidate for the menin-MLL program during the second half of 2016.

Financial Highlights

$60 Million Private Placement and Reverse Merger

In March 2015, Kura announced that it had completed a private placement of its common stock to new institutional investors and existing investors that resulted in gross proceeds of approximately $60 million to the company, including approximately $7.5 million in bridge notes that converted into common stock at the closing. EcoR1 Capital was the lead investor in the financing, which included significant participation from Fidelity Management & Research Company, ARCH Venture Partners, Boxer Capital of Tavistock Life Sciences, Partner Fund Management, and Nextech Invest, as well as a number of other well-known healthcare investors. In conjunction with the private placement, Kura completed a reverse merger with Zeta Acquisition Corp III, a public reporting company with no prior business operations. Following the effectiveness of its registration statement prepared in connection with the reverse merger, Kura was cleared for quotation on the OTC Market.

Public Offering and Listing on NASDAQ

In November 2015, Kura closed a public offering that raised gross proceeds of approximately $55 million, and the company’s shares were approved for quotation on NASDAQ under the symbol "KURA".

Upcoming Clinical and Preclinical Milestones for Kura Programs

Initiation of a Phase 2 clinical trial for tipifarnib in lower-risk MDS, anticipated in the second quarter of 2016
IND submission for ERK inhibitor, KO-947, anticipated in the second quarter of 2016
Initiation of Phase 1 clinical trial for KO-947, anticipated in the second half of 2016
Topline data from Phase 2 clinical trial for tipifarnib in HRAS mutant solid tumors, anticipated in the second half of 2016
Nomination of development candidate for menin-MLL program, anticipated in the second half of 2016

Financial Results for the Fourth Quarter and the Full Year

Cash, cash equivalents and short-term investments totaled $85.7 million as of December 31, 2015, compared with $41.2 million as of September 30, 2015. The difference is attributable to the net proceeds of approximately $50.3 million from Kura’s November 2015 public offering, less cash expenses for the quarter.

Operating expenses for the fourth quarter of 2015 were $6.8 million, compared to $3.9 million for the fourth quarter of 2014. Operating expenses for the full year 2015 were $23.9 million, compared to $3.9 million for the period from August 2014 (Inception) to December 31, 2014. Kura was incorporated in August 2014; therefore, there were minimal operations for the period from August 2014 (Inception) to December 31, 2014. Operating expenses for 2015 consisted of expenses related to the expansion of Kura’s research and development activities and its transition to a public company.

Research and development expenses for the fourth quarter of 2015 were $5.1 million, compared to $2.6 million for the fourth quarter of 2014. Research and development expenses for the full year 2015 were $17.8 million, compared to $2.7 million for the period from August 2014 (Inception) to December 31, 2014.

General and administrative expenses for the fourth quarter of 2015 were $1.7 million, compared to $1.2 million for the fourth quarter of 2014. General and administrative expenses for the full year 2015 were $6.1 million, compared to $1.3 million for the period from August 2014 (Inception) to December 31, 2014.

Net loss for the fourth quarter of 2015 was $6.5 million, compared to a net loss of $3.6 million for the fourth quarter of 2014. Net loss for the full year 2015 was $22.6 million, compared to a net loss of $3.7 million for period from August 2014 (Inception) to December 31, 2014.

Financial Guidance

Kura expects that its current cash, cash equivalents and short-term investments of $85.7 million as of December 31, 2015 will be sufficient to fund its current operations into 2018.

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

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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]).

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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").

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:

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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.

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]).

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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