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 Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, reported financial results and corporate updates for the first quarter of 2016 (Press release, MediGene, MAY 12, 2016, View Source [SID:1234512338]).

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Major events since the beginning of 2016:
Immunotherapies:

Phase II of Phase I/II trial with DC vaccine for the treatment of acute myeloid leukaemia (AML) initiated following positive recommendation by DSMB
Early IIT clinical data for DC vaccines presented at AACR (Free AACR Whitepaper) by academic partner Oslo University
DC patent portfolio strengthened
Additional viral vector production capacities secured for clinical TCR studies
Research collaboration started with University of Lausanne for TCRs
Company:

Management change: CSO Prof Dolores Schendel appointed CEO/CSO, Dave Lemus takes over as COO
Strengthened management team with appointment of three Senior Vice Presidents
Key figures in the first quarter of 2016:

Increase in total revenue by 132% to €3,909 k (3M 2015: €1,686 k)
Increase in R&D expenses for immunotherapies by 64% to €1,907 k (3M 2015: €1,166 k)
EBITDA loss reduced by 54% to €939 k (3M 2015: €2,042 k)
Cash and cash equivalents and time deposits of €46,310 k as at 31 March 2016 (31 December 2015: €46,759 k)
Confirmation of financial guidance 2016
Prof. Dr Dolores Schendel, Chief Executive Officer of Medigene AG, comments: "In the first quarter of 2016, the clinical development of our immunotherapy programmes progressed further. We are making extensive efforts now towards putting into practice our first clinical studies with TCRs. As Medigene’s new CEO, I’m delighted about these important examples of progress."

Dave Lemus, Chief Operating Officer of Medigene AG, adds: "Medigene’s transformation into a leading immuno-oncology company begins increasingly to take shape. Accordingly, the planned increase in expenses for immunotherapy-driven research and development in the first quarter of 2016 evidences this change, and is enabled by the company’s positive financial condition."

Key figures in Q1 2016:

IN € K Q1 2016

Q1 2015

Change

Results of operations
Total revenue 3,909 1,686 132%
Veregen revenue 624 714 -13%
Other operating income 3,285 972 >200%
thereof gain on sale of intangible assets, net (EndoTAG) 2,365 0 -
Gross profit 3,594 1,418 153%
Selling and general administrative expenses -2,312 -1,740 33%
Research and development expenses -2,395 -1,932 24%
Operating result -1,113 -2,254 -51%
Net profit/loss for the period -1,387 -3,672 -62%
EBITDA -939 -2,042 -54%
Earnings per share (€) -0.07 -0.26 -73%
Personnel expenses -2,452 -1,758 39%

Cash flows
Net cash used in operating activities -1,064 -1,777 -40%
Net cash provided by/used in investing activities 626 -53 >-200%
Net cash used in financing activities -11 0 -

Balance sheet data as at 31 March 2016 and 31 December 2015
Cash and cash equivalents and time deposits 46,310 46,759 -1%
Total assets 110,095 113,531 -3%
Current liabilities 9,013 9,664 -7%
Non-current liabilities 12,970 13,879 -7%
Shareholders’ equity 88,112 89,988 -2%
Equity ratio (%) 80 79 1%

Employees as at 31 March 81 69 17%
FTE as at 31 March 75 62 20%

Medigene share as at 31 March
Total number of shares outstanding 19,688,202 13,956,417 41%
The Company generates its revenue and other operating income from its non-core business. Total revenue of the Company increased by 132% to €3,909 k in the reporting period (3M 2015: €1,686 k) on account of extraordinary effects related to the sale of EndoTAG agreed in December 2015.

Medigene increased research and development expenses by 24% in the first three months of 2016 to €2,395 k (3M 2015: €1,932 k). The increase in these expenses is mainly due to the intended increase in expenditure for preclinical and clinical trials for Medigene’s immunotherapies, which increased significantly by 64% to €1,907 k in the first three months of 2016 (3M 2015: €1,166 k).

In spite of higher development expenses for its immunotherapy programmes, Medigene reduced its EBITDA loss in the first three months of 2016 by 54% to €939 k (3M 2015: EBITDA loss of €2,042 k). Medigene’s EBITDA is derived from the net profit/loss for the period; it does not include any taxes, financial result, foreign exchange gains or losses, share of result of associates, or depreciation or amortisation.

Medigene reduced its net loss in the first three months of 2016 by 62% to €1,387 k (3M 2015: €3,672 k).

Medigene reduced its net cash used in operating activities significantly in the first three months of 2016 to €1,064 k (3M 2015: €1,777 k). This represents an average monthly cash outflow of €0.4 m in the first three months of 2016 (3M 2015: €0.6 m). The major part of the cash used was directed at research and development as well as sales and administration.

The cash and cash equivalents and time deposits of the Company amounted to €46,310 k as at the end of the reporting period (31/12/2015: €46,759 k).

Financial forecast 2016:
Medigene confirms its financial guidance for 2016 published in the 2015 annual report. In 2016, Medigene is planning to expand its clinical development programs, which will significantly increase R&D expenses in the field of immunotherapies to €9 – 11 m (2015: €5.5 m). The EBITDA loss is estimated to be €10 -12 m (2015: €9.5 m).

Medigene expects total Veregen revenue of €3 – 4 m (2015: €3.1 m), and stable or increasing total revenue for 2016 (2015: €6.8 m). Since this revenue is not generated in the Company’s core business of immunotherapies, these figures are not indicative of the same. This financial guidance does not include any possible proceeds from potential new partnership agreements, or any exchange rate fluctuation.

The detailed Q1 statement 2016 is available online at:
www.annualreport2015.medigene.com View Source

Press and analysts’ conference call: A press and analysts conference call (in English) will be held today at 3:00 pm CEST / 9:00 am EDT (USA) and will be webcast live. Please access the synchronized presentation slides and a recording via Medigene’s website, www.medigene.com.

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.

On May 12, 2016 Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics, reported financial results for the first quarter of 2016 and provided an update on recent developments (Press release, Mirna Therapeutics, MAY 12, 2016, View Source [SID:1234512339]).

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"During the first quarter we continued to make progress advancing our lead product candidate MRX34, the first microRNA therapeutic in clinical development in cancer," commented Paul Lammers, M.D., M.Sc., Mirna’s President and CEO. "To date, MRX34 has produced clinically significant responses in patients with various types of late-stage cancers, demonstrating its ability to affect multiple pathways involved in cancer growth and immune evasion. We are continuing to advance MRX34 toward Phase 2 in late 2016 and also pushing ahead with our preclinical program to study its potential in combination with other cancer drugs."

Dr. Lammers continued, "On the corporate front, we were pleased to welcome Peter Greenleaf, Chief Executive Officer of Sucampo Pharmaceuticals, to our Board of Directors, and Dr. Vincent J. O’Neill as our new Chief Medical Officer. We look forward to their unique contributions as we advance our clinical development strategy in the promising new field of microRNA therapeutics."

FIRST QUARTER AND MRX34 PROGRAM UPDATES

Update from MRX34 Phase 1 trial planned at ASCO (Free ASCO Whitepaper). The Company expects to present additional clinical data from the ongoing Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in early June. To date, MRX34 has demonstrated compelling clinical results as a single agent therapy, including confirmed partial responses in patients with renal cell carcinoma, acral melanoma, and hepatocellular carcinoma. Additionally, several patients with solid tumors have achieved long-term stable disease during treatment with MRX34. These responses were observed in cancer patients with advanced Stage 4 metastatic disease, whose cancer had progressed after previously receiving multiple rounds of therapy. Top-line data from this study are expected in 2017.
Phase 1b translational medicine trial on track to begin in late 2016. This study will include serial tumor biopsies and is intended to develop deeper insights into the mechanism of action of MRX34 in melanoma patients and identify potential biomarkers of drug activity and treatment response.
MRX34 expected to begin Phase 2 by end of 2016. Studies in renal cell carcinoma and melanoma patients are being planned based on the responses observed to date in the ongoing Phase 1 trial, and on the high unmet medical need despite the availability of new therapies.
Preclinical studies ongoing of combination regimens with potential to enhance effectiveness of standard cancer therapies. At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April, Mirna researchers presented in vitro findings that demonstrated the synergistic anticancer effects between MRX34 and platinum and other commonly used cytotoxic chemotherapy drugs across a range of non-small cell lung cancer (NSCLC) cell lines. Synergistic anticancer effects were also shown between MRX34 and tyrosine kinase inhibitors. These results suggest a broad potential for combination of MRX34 with other standard of care drug classes.

Preclinical studies are also ongoing to support selection of a second microRNA product candidate from the Company’s pipeline, with an Investigational New Drug (IND) application planned in late 2017.
CORPORATE UPDATES

Further strengthened management with the appointments of Peter Greenleaf to the Company’s Board of Directors and Dr. Vincent J. O’Neill to the role of Chief Medical Officer. Mr. Greenleaf, an industry veteran with over 20 years of experience in drug development and commercialization, including three years as President of Medimmune, currently serves as the Chief Executive Officer of Sucampo Pharmaceuticals. Dr. O’Neill is a medical oncologist with 15 years of therapeutic and diagnostic product development experience, and has held senior leadership roles at several global pharmaceutical companies, including Sanofi, Genentech and GlaxoSmithKline.
FIRST QUARTER 2016 FINANCIAL RESULTS

Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $80.6 million as of March 31, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt. Based on the current operating plan, the Company expects that current cash resources will be sufficient to meet operating requirements into 2018.
Research and Development Expenses: Research and development expenses were approximately $4.5 million for the three months ended March 31, 2016 as compared to $3.4 million for the same period in 2015. The increase was primarily attributable to increased employee compensation expense due to a higher headcount to support the advancement of the Company’s clinical and preclinical development programs, as well as increases in manufacturing, clinical, and intellectual property costs.
General and Administrative Expenses: General and administrative expenses were approximately $2.1 million for the three months ended March 31, 2016 as compared to approximately $0.9 million for the same period in 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were costs to comply with public company operating and reporting requirements.
Net Loss: Net loss was approximately $6.6 million for the first quarter of 2016 compared to $4.3 million in the comparable period in 2015. The results included non-cash, stock-based compensation charges of approximately $447,000 in the three months ended March 31, 2016 and approximately $134,000 in the same period in 2015.

On May 12, 2016 GlobeImmune, Inc. (NASDAQ: GBIM) reported an update on the Company’s business and clinical programs and announced financial results for the first quarter 2016 (Filing, Q1, GlobeImmune, 2016, MAY 12, 2016, View Source [SID:1234512345]).

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The Company continues to seek potential strategic transactions. Cantor Fitzgerald & Co. has been retained by the Company to assist in reviewing ways to maximize stockholder value. There is not a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

The Company has three ongoing clinical trials being conducted by the Company’s corporate collaborators, Gilead Sciences, Inc. and Celgene Corporation. GS-US-330-1401, the GS-4774 Phase 2 clinical trial in patients with chronic HBV infection who are currently not receiving treatment, is fully enrolled and the 48-week results are projected to be available in the second half of 2016. The 24-week results for this trial did not show a statistical difference between control and treatment arms. The results from a GI-6207 Phase 2 trial in subjects with medullary thyroid cancer are projected to be available in the second half of 2016. A Phase 2 clinical trial designed to investigate the safety and efficacy of evaluating GI-6301 in combination with radiation therapy in patients with chordoma is still enrolling patients.

Financial Results – First Quarter Ended March 31, 2016

GlobeImmune reported a net loss of $0.9 million for the three months ended March 31, 2016 compared to $1.6 million for the same period in 2015. The decrease in net loss for 2016 was due to lower compensation expense due to layoffs in research and development and general and administrative expenses. GlobeImmune reported a loss applicable to common stockholders of $0.15 per share, for three months ended March 31, 2016 compared to loss applicable to common stockholders of $0.27 per share for the same period in 2015.

Research and development for proprietary programs expense for the three months ended March 31, 2016 was $0.3 million compared to $0.4 million for the same period in 2015, a decrease of $0.1 million. The decrease was primarily due to a decrease in salary expense due to layoffs in 2015. Costs of manufacturing services for the three months ended March 31, 2016 were $0 compared to $0.2 million for the same period in 2015. The decrease was primarily due to a decrease in expenses relating to manufacturing services for Gilead for the Phase 2 HBV trial. Costs of collaboration license and services for the three months ended March 31, 2016 was $0.5 million compared to $0.9 million for the same period in 2015, a decrease of $0.4 million. The decrease was primarily due to a decrease in expenses related to the clinical trial for GS-4774 and reduction in salary expense due to layoffs in 2015. General and administrative expense for the three months ended March 31, 2016 was $0.9 million compared to $1.2 million for the same period in 2015, a decrease of $0.3 million. The decrease was due to a reduction in salary expense due to layoffs in 2015.

At March 31, 2016, GlobeImmune had cash and equivalents of $8.7 million. The Company believes it has sufficient cash to operate the company as a going concern through the middle of 2017 as it continues to evaluate strategic alternatives. If a strategic alternative is not found in the near future, we could decide to wind down the operations of the Company which will consume cash faster than currently planned as a going concern.