On May 11, 2016 Cellectis S.A. (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, 2016 (Press release, Cellectis, MAY 11, 2016, View Source [SID:1234512287]).

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"We are excited to monitor the results presented by Great Ormond Street Hospital – University College of London describing clinical application of allogeneic, off-the-shelf CAR T-cells in young ALL patients with high medical need who exhausted all other treatment options. We are looking forward to seeing more data updates from our partners and bringing our CAR T-cell programs into the clinic, starting with UCART123 for AML patients" said André Choulika, CEO, Cellectis.

Recent Corporate Highlights
• New agreement with CELLforCURE for the cGMP manufacturing of clinical batches of UCART123, Cellectis’ lead product candidate, and for the implementation of cGMP manufacturing processes designed and developed by Cellectis.

• Supply and license agreement with Takara Bio Inc. for recombinant human fibronectin fragment RetroNectin to support Cellectis’ manufacturing processes and production capabilities.

• Publication in Scientific Reports, part of Nature Publishing Group, describing the design and development of a new CAR architecture with an integrated switch-on system that allows control over CAR T-cell functions.

• Research collaboration and license agreement with MabQuest SA for the development of a new class of anti PD-1 monoclonal antibodies.

• Cellectis gave a presentation at the Cowen and Company 36th Annual Health Care Conference on March 9, 2016 in Boston, MA.

• Scientific presentations at AACR (Free AACR Whitepaper), New Orleans:

Allogeneic TCRα/CS1 double knockout T-cell bearing an anti-CS1 chimeric antigen receptor: an improved immunotherapy approach for the treatment of Multiple Myeloma, presented by Roman Galetto, Cellectis.
Improved safety by a non-lethal switch to control CAR activity at the T-cell surface membrane, presented by Laurent Poirot, Cellectis.
• Appointment of Dr. Loan Hoang-Sayag to the role of Chief Medical Officer. Dr. Hoang-Sayag joined Cellectis from Quintiles Transnational, where she was most recently Senior Director of Medical Science.

• Calyxt, Cellectis’ plant science subsidiary, has purchased a 10-acre parcel in the St. Paul suburb of Roseville, MN, to build a new greenhouse and company headquarter.

Financial Results
As previously announced, commencing with this report of first quarter results Cellectis will now publish quarter-over-quarter comparative figures.

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").

First Quarter 2016 Financial Results

Cash: As of March 31, 2016 Cellectis had €276.5 million in total cash, cash equivalents and current financial assets compared to €314.2 million as of December 31, 2015. This notably reflects (i) the initiation of industrial GMP UCART123 production, (ii) increased expenses in GMP materials (iii) payment of €7.2 million of Value Added Taxes related to the proceeds received in the fourth quarter of 2015 from Servier and (iv) Calyxt’s acquisition of a 10-acre parcel for €5.2 million. The change was also attributable to the unrealized translation effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Revenues and Other Income: During the three months ended March 31, 2015 and 2016, we recorded €9.2 million and €9.5 million, respectively, in revenues and other income.

Total Operating Expenses and Other Operating Income: Total operating expenses and other operating income for the first quarter of 2016 were €29.9 million, compared to €12.8 million for the first quarter of 2015. The non-cash stock-based compensation expenses included in these amounts were €13.4 million and €0.8 million, respectively.

R&D Expenses: For the three months ended March 31, 2015 and 2016, research and development expenses increased by €11.4 million from €7.4 million in 2015 to €18.9 million in 2016. Personnel expenses increased by €7.2 million from €4.7 million in 2015 to €11.9 million in 2016, notably due to a €1.0 million increase in wages and salaries, and a €7.2 million increase in non-cash stock based compensation expense, partly offset by a €1.0 million decrease in social charges on stock option and free shares grants. Purchases and external expenses increased by €4.2 million from €2.4 million in 2015 to €6.6 million in 2016, due to increased expenses related to innovation and platform development, including payments to third parties participating in product development, purchases of biological raw materials and expenses associated with the use of laboratories and other facilities.

SG&A Expenses: During the three months ended March 31, 2015 and 2016, we recorded €5.4 million and €10.5 million, respectively, of selling, general and administrative expenses. The increase of €5.2 million primarily reflects (i) an increase of €4.5 million in personnel expenses from €3.7 million to €8.3 million, attributable, among other things, to an increase of €5.4 million of non-cash stock-based compensation expense, partly offset by a decrease of €1.1 million of social charges on stock options and free share grants, and (ii) an increase of €0.8 million in purchases and external expenses.

Financial gain (loss): The financial gain was €9.9 million for the first quarter of 2015 compared with financial loss of €9.1 million for the first quarter of 2016, which does not reflect actions undertaken to mitigate the impact of currency exchange rate fluctuations that were adopted at the end of the first quarter of 2016. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts.

Net Loss Attributable to Shareholders of Cellectis: During the three months ended March 31, 2015 and 2016, we recorded a net income of €6.3 million (or €0.20 per share on a basic basis and €0.19 per share on a diluted basis) and a loss of €29.5 million (or €0.84 per share on both a basic and diluted basis), respectively. Adjusted net loss attributable to shareholders of Cellectis for the first quarter of 2016 was €16.1 million (€0.46 per share on both a basic and a diluted basis) compared to adjusted net income attributable to shareholders of Cellectis of €7.0 million (€0.22 per share on both a basic and a diluted basis), for the first quarter of 2015. Adjusted net income (loss) attributable to shareholders of Cellectis for the first quarter of 2016 and 2015 excludes a non-cash stock-based compensation expense of €13.4 million and €0.8 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net income to adjusted net income.

Financial Guidance: Cellectis expects that its cash, cash equivalents and Current financial assets of €276.5 million as of March 31, 2016 will be sufficient to fund its current operations through 2018.

On May 11, 2016 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the first quarter ended March 31, 2016 (Press release, Cyclacel, MAY 11, 2016, View Source [SID:1234512282]).

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The Company’s net loss applicable to common shareholders for the first quarter ended March 31, 2016 was $3.1 million, or $0.09 per basic and diluted share, compared to net loss applicable to common shareholders of $5.0 million, or $0.19 per basic and diluted share for the first quarter ended March 31, 2015. As of March 31, 2016, cash and cash equivalents totaled $17.1 million.

"In SEAMLESS, our Phase 3 pivotal study in acute myeloid leukemia (AML), approximately 2.6% of required events remain to be observed before mature data become available," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The primary endpoint of the study is overall survival. After top-line data readout, the mature data will be evaluated for submissibility to regulatory authorities. In parallel, we have been progressing our CDK inhibitor programs. We have reported encouraging interim data from the ongoing Phase 1/2 combination trial of seliciclib and sapacitabine in solid tumors, including durable partial responses and stable disease in patients with BRCA positive breast, ovarian and pancreatic cancers. Updated data from this combination study will be reported in an oral presentation at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. In light of these data and investigator interest, we started enrollment of an extension cohort in a BRCA-enriched population of breast cancer patients. We continue to enroll patients in a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor, in patients with solid tumors and lymphomas. Data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2016 highlighted CYC065’s potential as an agent to treat hematological malignancies, such as B-cell lymphoma. The Cyclacel team continues to pursue the vision of our founders, as appreciation of the importance of CDK inhibitors is increasing among the medical community."

Recent Business Highlights

SEAMLESS Study

Continued follow up of patients enrolled in SEAMLESS, a Phase 3 study of orally-administered sapacitabine alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit or refused intensive chemotherapy.
Approximately 2.6% of the pre-specified events remain to be observed until mature data become available for analysis.
Cyclin Dependent Kinase (CDK) 2/9 Inhibitor Programs

Continued patient follow-up in a Phase 1/2 combination study of seliciclib and sapacitabine in patients with advanced solid tumors. In the first part of the study, several patients with BRCA positive breast, ovarian and pancreatic cancers achieved durable partial responses and stable disease.
Started enrollment of an extension cohort in a BRCA-enriched population of patients with breast cancer.
Dosed the fourth dose escalation level in the first-in-human, Phase 1 trial of CYC065, a second-generation CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetic profile in patients with solid tumors and lymphomas.
Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 demonstrating the therapeutic potential of CYC065 as a targeted anti-cancer agent in B-cell lymphoma, including double-hit lymphomas, and beneficial combinations with Bcl-2 (venetoclax) and BET inhibitors. The data validate the mechanism of action of CYC065, which is to reduce MYC and Mcl-1 levels, both of which can be elevated in B-cell lymphoma.
Cyclacel’s Key Milestones for 2016

Sapacitabine in SEAMLESS

Continue follow-up of patients until the requisite number of events occur, which is anticipated around the end of the first half of 2016.
Report top-line results.
Determine submissibility to regulatory authorities for marketing approval following analysis of the mature data set.
Progress a Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
Sapacitabine in myelodysplastic syndromes (MDS):

Initiate a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
CDK Inhibitor Programs

Progress the seliciclib and sapacitabine Phase 1/2 extension study in a breast cancer patient population enriched for BRCA mutations.
Report at an oral presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting updated seliciclib and sapacitabine Phase 1/2 data in patients with advanced solid tumors.
Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.
Report data when available from on-going investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease, rheumatoid arthritis, and in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
First Quarter 2016 Financial Results

Grant Revenue

Revenue for the three months ended March 31, 2016 was $0.1 million compared to $0.5 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.

Research and Development Expenses

Research and development expenses decreased to $2.5 million for the three months ended March 31, 2016 compared to $4.3 million for the same period in the previous year. The decrease was primarily due to reduced study and clinical supply costs associated with the SEAMLESS Phase 3 trial, which completed enrollment in December 2014, offset by increased expenditures primarily related to the first-in-human, Phase 1 study of CYC065 and grant supported research and development.

General and Administrative Expenses

General and administrative expenses for the three months ended March 31, 2016 decreased to $1.4 million compared to $1.5 million for the same period in 2015.

Based on current plans, the Company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the end of 2017.

On May 11, 2016 Transition Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH; NASDAQ: TTHI), a biopharmaceutical development company advancing novel therapeutics for CNS, metabolic disease and androgen deficiency indications, reported its financial results for the three and nine month periods ended March 31, 2016 (Press release, Transition Therapeutics, MAY 11, 2016, View Source [SID:1234512277]). Investors are invited to participate in a conference call today at 4:30pm EST to discuss these results. Dial in information for the call is as follows: (800) 698-9012 (North America) and (303) 223-4374 (International). A live webcast can be accessed via Transition’s website www.transitiontherapeutics.com, with a replay available for seven days following the call.

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Selected Highlights
Highlights for the Company during the nine month period ended March 31, 2016 and up to the date of this press release include the following:

ELND005:
ELND005 is an oral small molecule drug candidate with a proposed dual mechanism of action which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels. Transition’s subsidiary Transition Therapeutics Ireland ("TTIL") owns all ELND005 development and commercialization rights.

October 28, 2015 – Transition announced that data from the Phase 2/3 clinical study of ELND005 in Alzheimer’s disease patients with moderate and severe agitation and aggression was presented at the Clinical Trials in Alzheimer’s Disease (CTAD) meeting. A copy of the CTAD oral presentation is available on the Company website at www.transitiontherapeutics.com;
October 15, 2015 – Transition announced that its subsidiary, TTIL, has completed a thorough review of the data related to the Phase 2/3 study of ELND005 in AD patients with moderate or severe agitation and aggression. The analysis identified a significant clinical benefit of ELND005 in AD patients with severe agitation and aggression, and will serve as the basis for patient selection in a Phase 3 clinical study. The review was performed in consultation with a group of key opinion leaders in the field of neuropsychiatry.

TT401:
TT401 is an oxyntomodulin analogue that has dual agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors.
April 18, 2016 – Transition announced that Lilly will not elect to advance diabetes drug candidate, TT401 into Phase 3 development. Under the companies’ collaboration agreement, all TT401 development and commercialization rights will be transferred to Transition. Transition is unencumbered to advance TT401 on its own or with a third party;
February 1, 2016 – Transition announced the results of a Phase 2 clinical study of drug candidate TT401 (LY2944876) for the treatment of type 2 diabetes. TT401 development collaborator Eli Lilly and Company performed the Phase 2 study enrolling 420 type 2 diabetes subjects into a 24 week study consisting of a 12-week randomized blinded stage followed by a 12-week open-label stage. The study included 4 once-weekly dose arms of TT401 (10mg, 15mg, 30mg, 50mg), a placebo arm, and an active comparator arm (exenatide extended release – 2mg). TT401 demonstrated HbA1c improvements of up to -1.43% (similar to the exenatide arm). All TT401 dose arms and the exenatide arm were statistically significant relative to the placebo arm at Weeks 12 and 24. TT401 also produced dose dependent weight loss (up to -3.3 kg). The weight loss observed in the highest dose arm (50mg of TT401) was statistically significant relative to both the placebo and exenatide arms at weeks 12 and 24.

TT701 SARM:
TT701 is an oral drug candidate that is a selective androgen receptor modulator (SARM). TTIL owns all TT701 development and commercialization rights. TT701 is in Phase 2 clinical development as a therapy to ameliorate the symptoms associated with androgen deficiency.

April 25, 2016 – Transition announced the dosing of the first patient of a Phase 2 study of selective androgen receptor modulator (SARM) drug candidate TT701. Brigham and Women’s Hospital (BWH) is conducting the investigator-led Phase 2 clinical study which is expected to enroll up to 125 subjects at selected specialized clinical sites including BWH. The principal investigator for the Phase 2 study is Dr. Shalender Bhasin, Director of the Research Program in Men’s Health: Aging and Metabolism at BWH and an internationally recognized endocrinologist with expertise in testosterone biology and men’s aging;
October 29, 2015 – Transition announced that its subsidiary, TTIL, has entered into an agreement with BWH for an investigator-led clinical study of drug candidate TT701. TTIL will support a Phase 2 study to evaluate SARM drug candidate TT701 as a therapy to improve the symptoms of androgen deficiency in men with prostate cancer that have undergone a radical prostatectomy procedure.

Financial Liquidity
At March 31, 2016, the Company had cash resources of $24,768,772 and a working capital of $23,095,324.
The Company’s current cash projection indicates that the existing cash resources should enable the Company to execute its core business plan and meet its projected cash requirements beyond the next 12 months.

Financial Review
During the three month period ended March 31, 2016, the Company recorded a net loss of $4,177,942 ($0.11 loss per common share) compared to a net loss of $4,748,096 ($0.13 loss per common share) for the three month period ended March 31, 2015.
For the nine month period ended March 31, 2016, the Company recorded a net loss of $10,675,178 ($0.28 loss per common share) compared to a net loss of $37,353,559 ($1.04 loss per common share) for the nine month period ended March 31, 2015.

Research and Development
Research and development expenses decreased by $3,309,363 from $4,888,272 for the three month period ended March 31, 2015 to $1,578,909 for the three month period ended March 31, 2016. For the nine month period ended March 31, 2016, research and development expenses decreased $28,860,717 to $7,967,335 from $36,828,052 for the same period in fiscal 2015.
The decreases in research and development expenses for both the three and nine month periods ended March 31, 2016 are primarily due to a decrease in clinical development costs related to ELND005 and reduced salary and related expenses which resulted from cost cutting efforts. The decrease in research and development expenses for the nine month period ended March 31, 2016 is also due to a decrease in funding obligations relating to TT401 as the Company paid US$14 million in milestone payments to Lilly during the comparative nine month period.

General and Administrative
General and administrative expenses decreased by $69,073 from $1,268,531 for the three month period ended March 31, 2015 to $1,199,458 for the three month period ended March 31, 2016. For the nine month period ended March 31, 2016, general and administrative expenses increased $40,848 to $3,818,660 from $3,777,812 for the same period in fiscal 2015.
The decrease in general and administrative expenses for the three month period ended March 31, 2016 are primarily due to reduced professional fees which have been partially offset by inflationary increases in compensation costs.
The increase in general and administrative expenses for the nine month period ended March 31, 2016 are primarily due to business taxes paid for the Company’s US subsidiary and inflationary increases in compensation costs which have been partially offset by reduced professional fees.

On May 11, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of truly individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported the company will participate in the World Stem Cells and Regenerative Medicine Congress to be held May 18-20, 2016 at the Business Design Centre in London (Press release, Argos Therapeutics, MAY 11, 2016, View Source [SID:1234512276]).

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Fred Miesowicz, Ph.D., special advisor and former chief operating officer of Argos, will join a panel titled, "Thinking beyond efficacy — considerations for commercial success," beginning at 5pm BST on Wednesday, May 18th. Dr. Miesowicz will also participate in a roundtable discussion, "Biotech updates: from head-to-toe," at 11:25am BST on Thursday, May 19th.

For more information about the Congress, visit View Source

About the Arcelis Technology Platform
Arcelis is a truly personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.

On May 11, 2016 Bionor Pharma ASA reported Q1 2016 Interim Financial Report (Press release, Bionor Pharma, MAY 11, 2016, View Source [SID:1234512274]).

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HIGHLIGHTS Q1 2016
In the first quarter of 2016, Bionor continued its preparation of the BIOSKILL trial and other clinical activities. Additional clinical trial applications for BIOSKILL were forwarded to competent authorities, and the company also reported further data from the REDUC Part B trial. The company’s working capital was strengthened with the support from existing and new shareholders in a NOK 45 million private placement and a subsequent NOK 16 million repair offering.

REDUC Part B results, primarily related to latent reservoir size, were given as an oral presentation at the prestigious Conference on Retroviruses and Opportunistic Infections (CROI), in Boston, MA (USA)
Bionor announced that the third and final assay for measuring latent HIV reservoir size, the primary endpoint in the REDUC Part B trial, supports that the combination of Vacc-4x and the latency reversing agent romidepsin (Istodax, Celgene) leads to a reduction in latent viral reservoir
Clinical trial applications for the BIOSKILL clinical trial were submitted to authorities in France and Australia, and approval was obtained in Denmark and the United Kingdom. In addition, a request for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) was submitted
Bionor was granted up to NOK 9.2 million from Research Council of Norway to further advance Vacc-4x in a combination treatment regimen
The company’s shareholders approved the completion of a private placement raising NOK 45 million in gross proceeds, which is expected to fund the company through the first half of 2016, and a subsequent repair offering for existing shareholders raising gross proceeds of NOK 16 million
A new Chairman and two new board members were elected at an extraordinary general meeting on 11 March 2016
Net cash flow in Q1 2016 was NOK -31.2 million (Q1 2015: NOK -17.8 million)
Cash and cash equivalents at 31 March 2016 was NOK 41.8 million (31 March 2015: NOK 75.3 million).
Events after the balance sheet date

At the company’s annual general meeting on 22 April 2016, a number of resolutions were rejected by the shareholders. Mr. Steen Krøyer was elected as new board member, replacing Thomas Hofstaetter. An extraordinary general meeting will be convened shortly to handle the rejected proposals
On 26 April 2016, the company announced that Dr. David Horn Solomon and Bionor’s Board of Directors had agreed that Dr. David Horn Solomon on the same day would leave his position as Chief Executive Officer of Bionor Pharma ASA, owing to a shareholder led change in company strategy. The Board of Directors will initiate a search process for a new CEO. Until such search is concluded, the Board has appointed MSc Pharm Unni Hjelmaas as acting CEO
Three board members, Benedicte Fossum, Kirsten Drejer and Jerome B. Zeldis resigned from the Board on 28 April 2016.
Financial guidance for 2016
For the full year 2016, Bionor maintains its financial guidance of a Core cost base in the range of NOK 58-66 million. The Core cost base is defined as Employee Benefit Expenses plus Other operating expenses.

Per S. Thoresen, Chairman of the Board of Directors, commented:
"The new Board maintains its focus on HIV immunotherapy and the overall strategy to advance Vacc-4x in combination with other medicines in order to contribute to a possible functional HIV cure. With 36 million people world-wide living with HIV, it is of paramount importance that treatment options for HIV-positive individuals are improved. We have a strong asset in Vacc-4x, and as Board and company, we look forward to advancing our functional HIV cure strategy to the future benefit of HIV-positive individuals and their caregivers as well as to our shareholders. The timing and details in the clinical development program as well as the core cost base are under consideration in light of the company’s cash position and market capitalization. Any possible changes will be disclosed in due course in a stock exchange announcement."

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