On May 12, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the first quarter of 2016 (Press release, ImmunoCellular Therapeutics, MAY 12, 2016, View Source [SID:1234512328]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We continue to make progress in all aspects of implementing our ICT-107 registration trial in patients with newly diagnosed glioblastoma. Over half of the targeted clinical sites in the US have been activated and are screening patients. We anticipate that all sites in the US can be activated by the middle of 2016. In Europe, the process of gaining regulatory approval for the trial and bringing clinical trial sites online is going very well. Clinical trial applications have been approved by the regulatory authorities in the Netherlands and the UK, and we are involved in interactions with the six other country authorities where the trial will be conducted. We also have received regulatory approval to start the trial in Canada. We expect to manufacture clinical supplies for the first qualifying patients in Canada and Europe in the third quarter. As the competitive landscape in newly diagnosed glioblastoma evolves, we continue to think that our phase 3 registration program, with the strong foundational support of placebo-controlled phase 2 data, is the best designed program underway in this indication. We are pleased with the progress we made in the first quarter, and believe that 2016 will be a year of accomplishment and value creation for our company."

For the quarter ended March 31, 2016, ImmunoCellular incurred a net loss of $5.6 million, or $0.06 per basic and diluted share, compared to a net loss of $1.4 million, or $0.02 per basic and diluted share, for the quarter ended March 31, 2015.

During the first quarter 2016, the Company incurred $4.7 million of research and development expenses compared to $2.1 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.6 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107. During the first quarter of 2016, the Company recorded a credit to other income of $500,000 related to reflect a write-down of the Company’s warrant liability, compared to a credit to other income of $1.8 million during the same period in 2015.

The Company also reported that cash used in operations in the first quarter of 2016 was $5.4 million compared to $3.0 million in the prior year quarter. The increase primarily reflects that additional research and development expenditures in the current year. As of March 31, 2016, the Company had $17.5 million in cash.

On May 12, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the first quarter ended March 31, 2016 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 12, 2016, View Source [SID:1234512326]).

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"We have gotten off to a strong start in 2016. In the first quarter, we were able to accomplish a number of critical activities," said Jeff Abbey, president and chief executive officer. "The most significant of these was securing a financing agreement for up to $60 million. This financing, if fully funded, would provide us with funding for our operations into the second quarter of 2017, which is when we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur from the Phase 3 ADAPT trial of our lead product, AGS-003, in metastatic renal cell carcinoma. We look forward to the upcoming review of ADAPT trial data at the meeting of the Independent Data Monitoring Committee (IDMC) in June."

"Also, during the quarter, Dr. Lee Allen joined Argos as our chief medical officer. His experience and guidance have already made an impact on the development of AGS-003, including, in particular, with our preparation for the submission of our Biologics License Application (BLA) that would follow completion of the ADAPT trial, in addition to helping facilitate investigator-initiated trials of AGS-003," Mr. Abbey continued. "Lastly, and to that end, we announced that an investigator-initiated trial of AGS-003 in non-small cell lung cancer opened for enrollment during the quarter. We are excited for this first trial of AGS-003 outside of kidney cancer as we explore the potential activity of this novel immunotherapy in other solid tumors. These developments are all meaningful stepping stones as we continue on the pathway to achieving our goal of becoming a fully-integrated commercial biotechnology company."

First Quarter 2016 Operational Highlights:

In January 2016, Dr. Lee F. Allen joined the Company as chief medical officer
In March 2016, the Company entered into an equity financing agreement for up to $60 million
Will take place in up to three tranches: approximately $20 million in March 2016, approximately $30 million subject to and following the June 2016 IDMC meeting and a company controlled option for up to an additional $10 million subject to and following the late 2016 IDMC meeting
In March 2016, investigator-initiated Phase 2 study of AGS-003 in non-small cell lung cancer opened for enrollment at the Cancer Research Network of Nebraska (CRNN)
Selected First Quarter 2016 Financial Results

Net loss for the three months ended March 31, 2016 was $12.8 million, or $0.57 per share, compared to a net loss of $17.5 million, or $0.89 per share, for the same period in 2015.

Revenue for the three months ended March 31, 2016 totaled $0.1 million compared to $0.2 million for the same period in 2015.

Research and development expenses for the three months ended March 31, 2016 totaled $9.5 million compared to $14.8 million for the same period in 2015. General and administrative expenses for the three months ended March 31, 2016 totaled $3.0 million compared to $2.4 million for the same period in 2015.

As of March 31, 2016, Argos’ cash, cash equivalents and short-term investments totaled $13.8 million compared to $7.2 million as of December 31, 2015.

Conference Call and Webcast Details

Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 7392695. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision 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 12, 2016 GenVec, Inc. (NASDAQ: GNVC) reported financial results for the first quarter ended March 31, 2016 (Press release, GenVec, MAY 12, 2016, View Source [SID:1234512307]). For the three months ended March 31, 2016, the company reported a net loss of $1.9 million, or $0.11 per share, compared with a net loss of $1.5 million, or $0.09 per share, for the three months ended March 31, 2015. The company ended the first quarter with $6.9 million in cash, cash equivalents, and liquid investments.

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"The recommendation to continue the Phase 1/2 study of CGF166 by the trial’s Data Safety Monitoring Board (DSMB) was an essential hurdle to pass," said Douglas J. Swirsky, president and CEO of GenVec. "The decision was based on a thorough and objective review of the available safety and efficacy data from all patients enrolled in the study. As a result, we believe the trial is on track to be completed in 2017 as previously expected."

"Our partnered pipeline continues to advance, and we expect our partner TheraBiologics to advance a second-generation neural stem cell-based cancer treatment utilizing our technology into the clinic later this year," Mr. Swirsky continued. "Our recent financing further enables GenVec to remain focused on finding new collaborations to maximize the value of our AdenoVerse gene delivery platform and we are excited by the response from potential partners."

Cash Position

As of May 10, 2016, the company had $10.6 million in cash, cash equivalents, and liquid investments (unaudited), which includes the proceeds of the company’s May 2016 financing.

Updated 2016 Guidance

For 2016, GenVec anticipates a cash burn between $6.0 million and $6.5 million and believes its existing resources are sufficient to fund operations into 2018.

Financial Results for the Three Months Ended March 31, 2016

Revenues for the three-month period ended March 31, 2016 were $0.3 million, which represents a decrease of 28% as compared to revenues of $0.4 million in the comparable prior year period.

The decrease in revenue for the three-month period ended March 31, 2016 is primarily attributable to the completion of our contract with the DHS related to our animal health program in February 2015. In connection with this contract we recognized $0.2 million in revenue in 2015 with no corresponding revenue in 2016. Also contributing to the decrease was a reduced work scope under our hearing loss and balance disorders program, which resulted in a $0.1 million reduction in revenue in the current period as compared to the same period in 2015. Partially offsetting these decreases was an increase in revenue from our malaria program of $0.2 million primarily attributable to our grant with the NIH. Work under this grant was completed in March 2016.

Operating expenses were $2.1 million for the three-month period ended March 31, 2016, which represents an increase of 11% as compared to $1.9 million in the comparable prior year period.

General and administrative expenses for the three-month period ended March 31, 2016 increased 9% with expense of approximately $1.4 million in 2016 as compared to $1.3 million in 2015. The increase is primarily attributable to higher personnel costs due to the expansion of our workforce by three full-time employees as compared to the same period in 2015.

Research and development expenses for the three-month period ended March 31, 2016 increased 14% with expense of approximately $0.7 million in 2016 as compared to $0.6 million in 2015. The increase is primarily attributable to higher professional, material, and facility costs.

DpC, a unique small molecule invented by Des Richardson and David Lovejoy at the University of Sydney has been shown to dramatically impair the growth of cancer cells in preclinical models (Company Web Page, Collaborative Medicinal Development, MAY 12, 2016, View Source [SID:1234512305]).

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On May 12, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP) ("Adaptimmune" or the "Company"), a leader in T-cell therapy to treat cancer, reported financial results for the first quarter ended March 31, 2016 (Press release, Adaptimmune, MAY 12, 2016, View Source;p=RssLanding&cat=news&id=2167834 [SID:1234512303]).

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As of March 31, 2016, Adaptimmune had a total liquidity position1 of $226.1 million. The Company is reiterating its cash burn guidance and expects its total liquidity position at December 31, 2016, including cash, cash equivalents and short term deposits, to be at least $150 million.

"As we described at our Investor and Analyst meeting in April, we have made substantial progress toward our goal of delivering the first affinity optimized T-cell therapy to market," commented James Noble, Adaptimmune’s Chief Executive Officer. "The first quarter of 2016 was marked by strong momentum as we continued development of our comprehensive pipeline of SPEAR T-cell therapies covering solid and hematologic cancers. In addition to our ongoing clinical activities, we received orphan drug designation and breakthrough therapy designation for our NY-ESO SPEAR T-cell therapy. We also opened our IND for our therapeutic candidate targeting AFP in liver cancer and announced MAGE-A4 as our next target with the goal of achieving IND acceptance in 2017."

Recent Corporate and Clinical Highlights:

Hosted inaugural Investor and Analyst Day on April 22, 2016;
Received orphan drug designation from U.S. Food and Drug Administration ("FDA") for NY-ESO SPEAR T-cell therapy in soft tissue sarcoma;
Received breakthrough therapy designation from FDA for NY-ESO SPEAR T-cell therapy in synovial sarcoma;
Received FDA acceptance of investigational new drug ("IND") application for AFP SPEAR T-cell therapy in liver cancer;
Announced that the Company’s next IND would be for its MAGE-A4 SPEAR T-cell therapy, with the goal of achieving IND acceptance in 2017;
Announced update on NY-ESO SPEAR T-cell data in patients with multiple myeloma, including a 90 percent response rate in conjunction with autologous stem cell transplant and median overall survival of approximately three years (as of January 2016);
Filed patents on over 60 targets expressed on multiple cancers;
Presented overview of commercial-ready manufacturing process, including progress toward opening of manufacturing facility in 2017;
Expanded terms of strategic collaboration agreement with GSK in February 2016 to accelerate Adaptimmune’s lead clinical cancer program, a SPEAR T-cell therapy targeting NY-ESO, with goal of initiating pivotal trials in 4Q16/1Q17;
Established Scientific Advisory Board of leading immunotherapy experts; and
Adopted brand of SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cells to describe proprietary technology that uniquely delivers correctly identified targets and enhanced affinity T-cell receptors with potency to attack tumors, but optimum specificity to minimize risks of cross-reactivity.
Financial Results for the three-month period ended March 31, 2016

Cash / liquidity position: As of March 31, 2016, Adaptimmune had a total liquidity position of $226.1 million, consisting of $163.8 million of cash and cash equivalents and $62.3 million of short-term deposits. As of December 31, 2015, Adaptimmune had a total liquidity position of $248.9 million, consisting of $194.3 million of cash and cash equivalents and $54.6 million of short-term deposits.
Cash burn: The net decrease in the total liquidity position was $22.8 million for the three months ended March 31, 2016, consisting of a $30.5 million decrease in cash and cash equivalents and a $7.7 million increase in short-term deposits.
Revenue: For the three months ended March 31, 2016, revenue was $2.9 million compared to $2.7 million for the three months ended March 31, 2015. This increase was primarily due to revenue relating to development milestones related to the GSK Collaboration and License Agreement achieved in August and December 2015, which is being recognized over the period in which we are delivering services.
Research and development ("R&D") expenses: R&D expenses increased to $13.9 million for the three months ended March 31, 2016 from $6.0 million for the three months ended March 31, 2015, primarily due to increased period-over-period costs associated with: ongoing clinical trials of the Company’s NY-ESO and MAGE-A10 SPEAR T-cell therapies; preparation for a study with the Company’s SPEAR T-cell therapy targeting AFP; and personnel expenses for an increased number of employees engaged in R&D.
General and administrative ("G&A") expenses: G&A expenses were $5.9 million for the three months ended March 31, 2016 compared to $2.4 million for the three months ended March 31, 2015. The increase was primarily due to increased personnel costs, increased share-based payment expenses, 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 $15.6 million for the three months ended March 31, 2016. This equates to $(0.04) per ordinary share or $(0.22) per American Depositary Share.
The Company will not hold a conference call to discuss these results having provided a full update during its 2016 Investor and Analyst Day held on April 22, 2016. A replay of the webcast from the event will be available on the Company’s website for 30 days following the event at ir.adaptimmune.com

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 total 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.

As previously announced, in order to align more closely with many of its peer group of biotechnology companies, the Company has changed its fiscal year to a calendar year and is reporting its financial results in U.S. dollars under U.S. GAAP, effective from January 2016. Further information on these changes is set forth below under ‘Initial Adoption of U.S. GAAP’. The Company’s next fiscal year end will be December 31, 2016.