SciClone Reports First Quarter 2016 Financial Results

On May 10, 2016 SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) reported financial results for the quarter ended March 31, 2016 (Press release, SciClone Pharmaceuticals, MAY 10, 2016, View Source [SID:1234512322]).

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Revenues: In the first quarter 2016, SciClone reported revenues of $36.5 million, compared to $33.6 million for the same period in 2015.
GAAP Diluted EPS: In the first quarter 2016, SciClone reported GAAP diluted earnings per share of $0.15, compared to $0.17 for the same period in 2015.
Non-GAAP Diluted EPS: In the first quarter 2016, SciClone reported non-GAAP diluted earnings per share of $0.19, compared to $0.19 for the same period in 2015.
Revenues in the first quarter of 2016 were $36.5 million, a $2.9 million or 9% increase, compared to $33.6 million for the same period in 2015. ZADAXIN revenues were $33.6 million in the first quarter of 2016, a $2.3 million or 7% increase, compared to $31.3 million for the same period in 2015. Promotion services revenues were $1.2 million for the first quarter of 2016, a $0.8 million or 195% increase, compared to $0.4 million in the same period in 2015.

On a GAAP basis, SciClone reported net income in the first quarter of 2016 of $7.9 million, or $0.16 and $0.15 per share on a basic and diluted basis, respectively, compared to net income of approximately $9.0 million, or $0.18 and $0.17 per share on a basic and diluted basis, respectively, for the same period in 2015.

SciClone’s non-GAAP net income in the first quarter of 2016 was $9.7 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $9.8 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, for the same period of the prior year.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer commented: "Building on our 2015 momentum, we delivered another strong quarterly performance. Our core business, driven by ZADAXIN, continued to outpace the growth rate of the China pharma market. Today, ZADAXIN has achieved more than 40% of the value share in the thymalfasin market category in China, and our volume share has increased to 17%, an impressive achievement. We achieved substantial growth in our oncology portfolio this quarter compared to prior quarters, including the products we promote for our pharmaceutical partners, Baxter and Pfizer. While still modest in size, our oncology portfolio is a key strategic asset for our Company. We anticipate continued growth in the coming years as we introduce additional anticancer products into the market."

Continued Dr. Blobel: "We are continuing to implement academic marketing strategies to build the market for DC Bead as a novel treatment for liver cancer and alternative to conventional TACE procedures using gels. We are seeing increased utilization in the market, which we believe will translate into growing sales this year. Our development portfolio continues to progress on track, and we anticipate achieving important regulatory milestones in the next few years."

For the first quarter of 2016, sales and marketing (S&M) expenses were $12.4 million, compared with $11.4 million for the same period in 2015. The increase in S&M for first quarter of 2016, compared to the same period in 2015, related to increases in sales and marketing efforts for ZADAXIN.

For the first quarter of 2016, research and development (R&D) expenses were $1.5 million, compared with $1.1 million of R&D expenses for the same period of 2015. R&D was higher for the first quarter of 2016, compared to the first quarter of 2015, related to in-licensing agreements with certain business partners and R&D activities in China.

For the first quarter of 2016, general and administrative (G&A) expenses were $7.4 million, compared with $7.0 million for the same period in 2015. G&A was higher for the first quarter of 2016, compared to the first quarter of 2015, related to higher legal costs primarily in connection with the Company’s strategic review to maximize shareholder value and related to higher stock-based compensation expenses.

For the first quarter of 2016, tax provision was $1.9 million, compared with $0.6 million for the same period in 2015. The $1.9 million tax provision for the first quarter of 2016 included a $1.2 million uncertain tax provision for our China operations from 2013 to 2015.

As of March 31, 2016, cash, cash equivalents and short-term investments totaled $114.7 million, compared to $101.4 million as of December 31, 2015, excluding the $12.8 million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which was released and paid in February 2016.

SciClone has presented non-GAAP information above as the Company believes this non-GAAP information is useful for investors, taken in conjunction with SciClone’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of SciClone’s operating results as reported under GAAP. The non-GAAP calculations and reconciliation are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income."

8-K – Current report

On May 10, 2016 Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, reported its financial results for the quarter ended March 31, 2016 (Filing, Q1, Galena Biopharma, 2016, MAY 10, 2016, View Source [SID:1234512490]).

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"The first quarter of this year was significant for Galena as we achieved one of our key NeuVax milestones by reaching the 70th qualifying disease free survival event in our Phase 3 PRESENT clinical trial," said Mark W. Schwartz, Ph.D., President and CEO. "Our clinical team is compiling the data for review by the Independent Data Safety Monitoring Committee (IDMC) and a recommendation of our interim safety and futility analysis is expected from the IDMC at the end of the second quarter. Our NeuVax program has progressed substantially over the past few years. In addition to the landmark PRESENT trial, we are currently conducting two active breast cancer combination trials and are expanding outside of breast to gastric cancer. We are also taking the first step toward broadening the development footprint for NeuVax into primary prevention with an immunology trial initiating this quarter in ductal carcinoma in situ. I could not be more proud of our team as we continue to look for innovative ways to advance NeuVax by engaging with key collaborators with the goal to potentially treat a broader base of patients."

Dr. Schwartz continued, "Keeping with this innovative philosophy, we are announcing today that we sold $25.5 million in principal amount of Debentures to secure our balance sheet. With this debt financing, combined with the other funding mechanisms we have in place, we can now control when and how we execute our next equity offering with the timing and terms that are most appropriate for the company. This gives us the ability to invest in our programs, create and preserve shareholder value, and minimize dilution."

Dr. Schwartz concluded, "We have also added to our Board of Directors with the appointment of Mary Ann Gray, Ph.D. I firmly believe that her strong scientific and financial background will provide valuable insight and perspective to our overall corporate management. I am excited about the momentum we have built this year and look forward to the outcome of our PRESENT interim analysis and the continued advancement of all our programs."

Galena will host a webcast and conference call today at 2:00 p.m. P.T./5:00 p.m. E.T. to discuss its financial and business results. The live webcast will include slides that can be accessed on the Company’s website under the Investors section/Events and Presentations: View Source The conference call can be accessed by dialing (844) 825-4413 toll-free in the U.S., or (973) 638-3403 for participants outside the U.S. The Conference ID number is: 1305222. The archived webcast replay will be available on the Company’s website for 90 days.

FINANCIAL HIGHLIGHTS

Continuing Operations

Operating loss from Galena’s ongoing development programs, classified as continuing operations, for the first quarter of 2016 was $9.0 million, including $0.7 million in stock-based compensation, compared to an operating loss from continuing operations of $8.9 million, including $0.4 million in stock-based compensation for the same period in 2015. Operating loss for the periods presented was consistent with a slight increase in general and administrative expense driven by an increase in non-cash stock-based compensation and personnel-related expenses. The slight increase in general and administrative expense was mostly offset by a slight decrease in research and development expense primarily due to the decrease in enrollment efforts surrounding the Company’s Phase 3 PRESENT clinical trial, which completed over-enrollment in the second quarter of 2015.

Non-operating income or expenses include non-cash changes in the fair value estimates of the Company’s warrant liabilities, non-cash change in the contingent purchase price liability, and interest expense. The increase in non-operating expense during the three months ended March 31, 2016 compared to the three months ended March 31, 2015 was primarily due to an increase in the change in fair value of warrants accounted for as liabilities associated with the underwritten public offering in January 2016. The warrants were initially valued on January 12, 2016 when the financing closed at a stock price of $0.81 and revalued as of March 31, 2016 based on the closing stock price of $1.36, or an increase of 68%. The increase in the stock price over this period resulted in the warrant liability for the January 2016 warrants to increase from an initial valuation of $5.6 million to a valuation of $11.3 million as of quarter end, for a non-cash charge of $5.7 million. The loss on the January 2016 warrants was partially offset by a gain of $1.8 million related to a change in fair value of other warrants accounted for as liabilities associated with previous underwritten public offerings.

Loss from continuing operations for the first quarter of 2016 was $13.1 million, including a $3.9 million non-cash loss on warrant liability, or $0.07 per basic and diluted share. Loss from continuing operations for the first quarter of 2015 was $8.3 million, including a $1.2 million non-cash gain on warrant liability, or $0.06 per basic and diluted share.

Discontinued Operations

As we reported in the fourth quarter of last year, the Company sold its commercial business including its two products: Abstral (fentanyl) Sublingual Tablets and Zuplenz (ondansetron)

Oral Soluble Film. As a result of the sale, the Company has retrospectively recast its previously issued first quarter 2015 financial statements to present the commercial business as discontinued operations for the year of 2015.

Loss from discontinued operations for the first quarter of 2016 was $3.4 million, or $0.02 per basic and diluted share, compared to $2.2 million, or $0.02 per basic and diluted share, for the same period of 2015.

Cash and Cash Equivalents

As of March 31, 2016, Galena had cash and cash equivalents of $34.7 million, compared with $29.7 million as of December 31, 2015. The $5.0 million increase in cash through the first quarter of 2016 represents $20.2 raised from issuance of common stock in a January 2016 underwritten public offering, partially offset by $13.2 million used in operating activities, $1.1 million paid in selling expenses related to the sale of the Company’s commercial products, and $1.0 million in payments on long-term debt.

For the Three Months Ended March 31,

2016

2015
Cash flows from continuing operations:

Cash flows used in continuing operating activities
$
(9,741
)

$
(10,497
)
Cash flows used in continuing investing activities
(6
)

(18
)
Cash flows provided by continuing financing activities
19,251

41,284

Total cash flows provided by (used in) continuing operating activities
9,504

30,769

Cash flows from discontinued operations:

Cash flows used in discontinued operating activities
(3,475
)

(1,059
)
Cash flows used in discontinued investing activities
(1,050
)

(500
)
Total cash flows provided by (used in) discontinued operating activities
(4,525
)

(1,559
)

Total cash flows:

Cash flows used in operating activities
(13,216
)

(11,556
)
Cash flows used in investing activities
(1,056
)

(518
)
Cash flows provided by financing activities
19,251

41,284

Total increase (decrease) in cash and cash equivalents
4,979

29,210

Beginning cash
29,730

23,650

Ending cash
$
34,709

$
52,860

Net Loss and Net Loss Per Share

Net loss for the first quarter of 2016 was $16.5 million, or $0.9 per basic and diluted share, compared to $10.5 million, or $0.08 per basic and diluted share, for the same period of 2015.

2016 Debt Financing

On May 10, 2016, Galena entered into a Securities Purchase Agreement with JGB Newton Ltd. to sell $25.5 million principal amount of Debentures. The Debentures include a 6.375% original issue discount, and, after broker and other expenses, the expected net proceeds will be approximately $23.4 million. The Debentures have a thirty month term, carry an interest only period of six months, and interest is payable at the end of each month based on the outstanding principal. Beginning in month seven, the holder of the Debentures can require the Company to redeem up to $1,100,000 of the outstanding principal amount. The Company determines whether to pay the redemption amount in cash or, subject to certain equity conditions, shares of its common stock.

The Securities Purchase Agreement includes one million warrants issued at closing, and an additional one million warrants to be issued upon the Company’s public announcement that the Phase 3 PRESENT trial is continuing in accordance with the Special Protocol Assessment. The first tranche of warrants are priced at a 20% premium to the volume weighted average price (VWAP) of the company’s stock on May 9, 2016, at a price of $1.51. The second tranche of warrants will be priced at a 20% premium to the VWAP of the Company’s stock price following the announcement of the interim analysis. In the event that the PRESENT trial is discontinued following the interim analysis, the holder of the debentures has the right to require the Company to prepay all, or a portion of, the outstanding principal amount plus any accrued interest. If the holder of the debentures elects prepayment of a portion of the Debentures, then the number of shares subject to the warrants issued to the holder will be reduced in proportion to the percentage of principal and accrued interest required to be prepaid by the Company.

The Company intends to use the net proceeds from this offering to fund its Phase 3 PRESENT study of NeuVax and other clinical trials of its product candidates, payoff the $3.1 million of principal and accrued interest of its current loan with Oxford Finance, LLC, to augment working capital and for general corporate purposes.

FIRST QUARTER AND RECENT HIGHLIGHTS

Clinical Development Highlights

Presented GALE-301 Clinical Booster Data. Data from the booster phase of the Company’s GALE-301 Phase 1/2a clinical trial was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The poster, entitled, "Comparing an attenuated booster (E39’) vs. E39 booster to potentiate the clinical benefit of the folate binding protein (FBP)-derived vaccine (E39 + GM-CSF) in a phase I/IIa trial to prevent recurrence in endometrial (EC) and ovarian cancer (OC) patients," randomized patients to two different boosters: E39 (GALE-301), versus E39’ (GALE-302). The purpose was to evaluate the immune responses and determine which booster, if either, would provide a sustained immune response and potentially longer disease free survival (DFS) rates. The use of the wildtype peptide (GALE-301/E39) demonstrated the same tolerable safety profile as the attenuated peptide (GALE-302/E39’) with only Grade 1 local reactions and minimal Grade 2 toxicities. Importantly, the percentage of patients who received two booster inoculations and remained disease free showed a statistically significantly improvement in the drug treatment arm, versus the control arm, regardless of which booster was used.

PRESENT Trial Achieved 70th Qualifying DFS Event. Galena announced that the 70th qualifying DFS event has been achieved in the NeuVax (nelipepimut-S) Phase 3, PRESENT (Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. Based on clinical and radiological data, 70 qualifying DFS events were confirmed by the trial’s independent Endpoint Adjudication Committee (EAC), comprised of two oncologists and one radiologist with expertise in the conduct of clinical trials in breast cancer. For the PRESENT trial, a qualifying DFS event is defined as: a recurrence of the primary breast cancer, either locally in the breast, regionally in the lymph nodes, or distantly as metastatic disease; an occurrence of another cancer; or, death from any cause. All qualifying DFS events are confirmed by the EAC.

Received a Notice of Allowance of a U.S. Patent for NeuVax. Galena announced the United States Patent Office issued a Notice of Allowance for an additional U.S. patent application covering multiple uses of NeuVax: inducing and maintaining an immune response to HER2 expressing tumor cells in patients in clinical remission with a tumor having a fluorescence in situ hybridization (FISH) rating of less than about 2.0 (FISH <2.0); inducing and sustaining a cytotoxic T-lymphocyte (CTL) response to HER2 in patients in clinical remission from a tumor with a FISH rating of less than about 2.0 (FISH < 2.0); reducing risk of cancer recurrence in patients in clinical remission from a tumor with a FISH rating of less than about 2.0 (FISH < 2.0); and preventing bone only recurrence of a HER2 expressing cancer. This patent will expand both the protection and the potential population of cancer patients NeuVax may address. Once issued, the patent will expire in 2028, not including any patent term extensions.

Presented Observational Study Data in Gastric Cancer Patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Gastrointestinal Cancers Symposium. The Company presented data from an observational study in gastric cancer patients at the ASCO (Free ASCO Whitepaper) 2016 Gastrointestinal Cancers Symposium. The study was conducted by Galena’s partner, Dr.

Reddy’s Laboratories Ltd, who will conduct a Phase 2 clinical trial of NeuVax in gastric cancer patients in India. The poster, entitled, "An observational study evaluating the expression of HER2 (1+, 2+, and 3+) with HLA A2+/A3+ in gastric adenocarcinoma patients," showed that approximately 25% of the patients met the projected clinical protocol population of all levels of expression of HER2 and HLA A2+ and/or A3+ as defined for the planned NeuVax Phase 2 clinical trial. Results indicate an acceptable potential for enrollment rate, given the high incidence of gastric cancer in this population, and will inform the screen failure rate in the planned Phase 2 clinical study.

Corporate Highlights

Appointed Mary Ann Gray, Ph.D. to the Company’s Board of Directors. Effective April 25, 2016, the Board increased the number of directors from eight to nine directors and appointed Mary Ann Gray, Ph.D. as a Class III director. Dr. Gray will be in Galena’s 2016 Proxy Statement as a nominee for election at the Company’s 2016 Annual Meeting of Stockholders. Dr. Gray is President of Gray Strategic Advisors, LLC, which provides strategic advice to both public and private biotechnology companies. Previously, she spent three and a half years with the Federated Kaufmann Fund focusing on both public and private healthcare investments. Prior, Dr. Gray was a sell-side biotechnology analyst for nine years. Earlier in her career, Dr. Gray held scientific positions at Schering Plough and NeoRx, managed pre-clinical toxicology studies for the National Cancer Institute through Battelle Memorial Institute, and worked in a hospital laboratory. Dr. Gray currently serves on the board of directors of several publicly traded biotechnology companies: Acadia Pharmaceuticals, TetraLogic, Inc., Juniper Pharmaceuticals, Senomyx, Inc. Previously, Dr. Gray also served on the boards of Dyax Corp., GTC Biotherapeutics, Inc., Telik, and Apthera, Inc. (private). Dr. Gray has a Ph.D. in Pharmacology from the University of Vermont where she focused on novel chemotherapeutic agents for the treatment of cancer, and she received her B.S. in biology from the University of South Carolina. She completed her postdoctoral work at Northwestern University Medical School and Yale University School of Medicine.

Announced Proposed Settlement of Derivative and Securities Class Action Lawsuits. On February 4 and 16, 2016, the United States District Court for the District of Oregon granted preliminary approval of the previously reported settlements that had been reached in In re Galena Biopharma, Inc. Derivative Litigation, Civil Action No. 3:14-cv-00382-SI and in In re Galena Biopharma, Inc. Securities Litigation, Civil Action No. 3:14-cv-00367-SI, respectively. The Court had set the final approval hearings for April 21, 2016 in In re Galena Biopharma, Inc. Derivative Litigation and June 23, 2016 in In re Galena Biopharma, Inc. Securities Litigation. On April 21, 2016, the Court continued the final approval hearing in In re Galena Biopharma, Inc. Derivative Litigation to June 23, 2016 for further argument on the fee request by the derivative plaintiffs’ attorneys.

Closed an Underwritten Public Equity Offering. On January 12, 2016, Galena closed the previously announced underwritten public offering of common stock and warrants. The net proceeds to the Company were approximately $20.2 million.

ChemoCentryx Reports First Quarter 2016 Financial Results and Provides Corporate Update

On May 10, 2016 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, reported financial results for the first quarter ended March 31, 2016 and provided an update on the Company’s corporate and clinical development activities (Press release, ChemoCentryx, MAY 10, 2016, View Source [SID:1234512206]).

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"2016 is proving to be a transformational year for ChemoCentryx," said Thomas J. Schall, Ph.D., President and Chief Executive Officer. "Following the positive results from the CLEAR trial with CCX168 in AAV that we reported in January, we continue to build considerable momentum. Indeed, today I am extremely pleased to announce that we have entered into a strategic regional license agreement with Vifor Pharma to commercialize CCX168 outside the U.S. and most of Asia. This partnership with Vifor Pharma, who will also work together with its nephrology partner company Vifor Fresenius Medical Care Renal Pharma, is an ideal alliance for the CCX168 program. Given Vifor Pharma’s deep experience and focus in the kidney care space, the formation of this partnership validates our approach, and the clinical data that we’ve obtained to date, in blocking chemoattractant receptors to treat patients with rare and other significant renal diseases."

Dr. Schall continued, "Important developments in the CCX168 program are ahead: we look forward to reporting top line data from our Phase II CLASSIC trial of CCX168 in patients with AAV this quarter, and we are preparing for regulatory discussions that we expect will pave the way for Phase III development of CCX168 by the end of this year. In our other clinical development programs, such as our clinical trial in pancreatic cancer with CCX872, we continue to chart excellent progress as well. We anticipate data on initial response rates, as well as progression-free survival data in the CCX872 treated patients as 2016 progresses. It’s truly an exciting time for the Company."

Pipeline Developments Across Key Therapeutic Areas

Orphan and Rare Diseases: CCX168 is an orally-administered complement inhibitor targeting the C5a receptor (C5aR), and is being developed for several rare disease indications, including ANCA-associated vasculitis (AAV) and atypical hemolytic uremic syndrome (aHUS). CCX168 acts by blocking the destructive action of neutrophils that are activated as a consequence of the complement protein known as C5a binding to C5aR on neutrophils during autoimmune inflammatory events including the destruction of blood vessels in AAV.

ChemoCentryx entered into an exclusive collaboration and license agreement with Vifor Pharma to commercialize CCX168 in certain licensed territories outside of the United States and Asia (except South Korea). Under the terms of the agreement, ChemoCentryx will:
Receive a non-refundable upfront payment of $85 million, comprising $60 million in cash in addition to $25 million in an equity investment to purchase ChemoCentryx common stock at a price of $7.50 per share;
Retain control of all ongoing and future development of CCX168, other than country-specific development in the licensed territories;
Retain all commercialization rights to CCX168 in the United States and other countries not licensed to Vifor Pharma;
Receive additional payments upon the achievement of certain regulatory and sales based milestones with CCX168; and
Receive tiered royalties with rates ranging from the teens to mid-twenties on potential net sales of CCX168 by Vifor Pharma in the licensed territories.
The agreement is the first step of a potentially broader kidney health alliance, beyond orphan and rare diseases, as it also provides Vifor Pharma with an exclusive option to negotiate during 2016, a worldwide license agreement for an additional ChemoCentryx drug candidate, CCX140, an orally administered inhibitor of the chemokine receptor known as CCR2 for use in diabetic nephropathy.
ChemoCentryx announced positive top-line data from the Phase II CLEAR trial with CCX168 in patients with AAV. Chronic high dose steroid administration in the current standard of care (SOC) is associated with premature death and a spectrum of other harmful side effects in AAV therapy. The objective of the CLEAR trial was to eliminate chronic high dose steroids and their associated significant safety issues including death, from the SOC regimen in AAV and replace steroids with CCX168.
The CLEAR trial met its primary endpoint based on the BVAS response at week 12 in patients receiving CCX168, compared to those patients receiving the high dose steroid-containing SOC. Specifically, all treatment groups receiving CCX168 demonstrated a numerically superior, statistically significant (P=0.002) non-inferior clinical efficacy outcome when compared to SOC.

Immuno-Oncology: CCX872 is a potent and selective inhibitor of the chemokine receptor known as CCR2, which is being evaluated in patients with non-resectable pancreatic cancer. In an ongoing, multi-center clinical trial with CCX872, 50 patients with non-resectable pancreatic cancer have been enrolled. In addition to evaluating objective response rate data after 12 weeks of treatment, the primary outcome measurement of this study is progression-free survival after at least 24 weeks of treatment. In addition, ChemoCentryx is conducting preclinical research with various chemokine receptor inhibitors, such as CCX9588, an inhibitor of the chemokine receptor known as CCR1, in combination with checkpoint inhibitors.

Presented combination data with check point (PD-L1) and chemokine receptor (CCX9588) inhibitors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting showing synergistic effect with combination treatment in triple negative breast cancer models.
Combination treatment was shown to significantly decrease circulating and tumor infiltrating granulocytic myeloid-derived suppressor cells which are known to be responsible for the induction of a metastatic phenotype in primary tumors, leading to the early dissemination of cancer cells.
Overall tumor size and progression was also significantly reduced by the combination treatment.

Anticipated Milestones

Orphan and Rare Diseases:

Oral presentation of results from the Phase II CLEAR trial in patients with AAV treated with CCX168 at the 53rd ERA-EDTA Congress;
Report top-line results from the Phase II CLASSIC trial in patients with AAV in North America with CCX168 in June 2016;
Conduct End of Phase II meetings with regulatory agencies to review CLEAR and CLASSIC AAV Phase II clinical results and discuss the potential Phase III plan in mid-2016;
Initiate Phase III development program with CCX168 for the treatment of AAV by the end of 2016;
Report early results from the Phase II pilot study of CCX168 in aHUS patients who are on dialysis in 2016; and
Report results from preclinical model using CRISPR-CAS9 designed to assess the contribution of C5a on two aspects of complement over-activation which can manifest as renal damage in aHUS and complement factor 3 glomerulopathy at the 53rd ERA-EDTA Congress.

Immuno-Oncology:

Advance pancreatic cancer trial of CCX872 in combination with FOLFIRINOX; report initial overall response data in mid-2016 and initial progression free survival data in the second half of 2016.

Chronic Kidney Disease:

The recently announced Vifor Pharma agreement for CCX168 also provides Vifor Pharma with an exclusive option to negotiate in 2016, a worldwide license agreement for CCX140; and
Conduct End of Phase II meeting with the FDA in 2016 to review the Phase II data and discuss the potential Phase III clinical development program for CCX140 in diabetic nephropathy.

First Quarter 2016 Financial Results and Outlook

Cash, cash equivalents and investments totaled $65.3 million at March 31, 2016, excluding the $85.0 million upfront payment in connection with the partnership with Vifor Pharma announced earlier today.

Research and development expenses were $11.2 million for the three months ended March 31, 2016 compared to $8.4 million reported for the same period in 2015. The increase in research and development expense from 2015 to 2016 was primarily attributable to higher costs associated with CCX168, the Company’s C5aR inhibitor, due to the completion of ancillary Phase I studies to support anticipated end of Phase II meetings with regulatory agencies and higher expenses associated with CCX872, the Company’s second CCR2 inhibitor, for the ongoing pancreatic cancer trial.

General and administrative expenses were $4.1 million for the three months ended March 31, 2016 compared to $3.7 million for the comparable period in 2015. The increase from 2015 to 2016 was primarily due to increases in intellectual property related expenses and travel and professional fees associated with our business development efforts.

Net loss was $15.2 million for the first quarter ended March 31, 2016 compared to $12.0 million in the same period in 2015.

Total shares outstanding at March 31, 2016 were approximately 44.3 million shares.

About ANCA-Associated Vasculitis and Other Rare Renal Diseases

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, or AAV, is a type of rare autoimmune inflammation caused by auto-antibodies. AAV encompasses granulomatosis with polyangiitis (GPA, formerly known as Wegener’s granulomatosis), microscopic polyangiitis (MPA), eosinophilic polyangiitis (formerly Churg-Strauss syndrome) and renal limited vasculitis.

AAV represents a severe and often fatal autoimmune disease that is characterized by inflammation that can destroy different organ systems. AAV is the lead indication in the Company’s orphan and rare disease program which has the objective of eliminating chronic high dose steroids, which are associated with significant safety issues including death, from the standard of care (SOC) regimen in AAV and replace steroids with CCX168.

AAV affects approximately 40,000 people in the U.S. (with approximately 4,000 new cases each year) and greater than 75,000 people in Europe (with at least 7,500 new cases each year), and is currently treated with courses of immuno-suppressants (cyclophosphamide or rituximab) combined with high dose steroid administration. Following initial treatment, up to 30 percent of patients relapse within six to 18 months, and approximately half of all patients will relapse within three to five years.

Current SOC for AAV is associated with significant safety issues. First year mortality is approximately 11 to 18 percent. The single major cause of premature mortality is not disease-related adverse events, but rather infection that is thought largely to be a consequence of steroid administration. Indeed, the multiple adverse effects of courses of steroid treatment (both initial courses and those that are repeated as a consequence of relapse) are major causes of both short-term and long-term disease and death. Such therapy related adverse events contribute significantly to patient care costs, as well as to the diminution of quality of life for patients.

By damaging the body’s small blood vessels, AAV affects many organ systems, mostly the kidneys, eyes, lungs, sinuses and nerves. This damage is caused by the destructive activity of inflammatory leukocytes in the body, with neutrophils considered to be the terminal effector cell. In AAV, neutrophils are attracted to sites of vascular destruction as well as activated at those sites by the activity of the complement system product known as C5a and its receptor, C5aR, which is the target of CCX168. By blocking the C5aR, CCX168 is thought to reduce vasculitis by reducing neutrophil activation, accumulation, and adhesion, as well as vascular permeability.

Atypical hemolytic uremic syndrome, or aHUS, an ultra-rare, life threatening disease that causes chronic blood vessel damage, thrombosis or clotting within blood vessels, hemolysis or red blood cell rupture, and sudden, progressive organ failure, such as kidney failure. The disease is caused by genetic defects in factors that control the activation of the complement system. Current treatment options are still quite limited and prognosis and quality of life are extremely poor.

About Pancreatic Cancer

It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year, accounting for 2.4 percent of all cancers. The incidence of pancreatic cancer in the U.S. is about 45,000, with prevalence being only negligibly higher owing to the poor survival rates on current therapy. Current standards of care include surgical resection and chemotherapeutic regimens such as gemcitabine and FOLFIRINOX. These regimens are limited by marked toxicities. Almost 67 percent of cases are diagnosed in people aged 65 and over. In the U.S., pancreatic cancer is the fourth most common cause of deaths due to cancer. Pancreatic cancer has a low survival rate regardless of stage of disease, with 93 percent of patients dying from their disease within five years.

BioTime, Inc. Reports First Quarter Results and Recent Corporate Accomplishments

On May 10, 2016 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported financial results for the first quarter ended March 31, 2016 and provided a corporate update (Press release, BioTime, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2167228 [SID:1234512255]). The Company also announced that management will host a conference call with investors to discuss the recent operating progress and corporate developments on Tuesday, May 17, 2016 at 4:30 p.m. Eastern / 1:30 p.m. Pacific. Details on how to access the call are provided later in this news release.

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"We are off to a strong start in 2016 as we continue to make progress with BioTime’s key clinical therapeutic programs, Renevia in medical aesthetics and OpRegen in dry AMD," said Adi Mohanty, Co-Chief Executive Officer. "We are also pleased with the significant operating progress achieved by our non-core assets as these companies mature towards standalone businesses. In particular, we are excited to see our digital health subsidiary, LifeMap Solutions, gaining more traction with clients and partners, including best-in-class institutions. Meanwhile, we in the BioTime organization continue to sharpen our focus on clinical progress and simplifying our corporate structure and seeking ways to unlock the value of our more mature revenue-generating subsidiaries for BioTime shareholders."

First Quarter and Recent Highlights

Clinical Progress

OpRegen (retinal pigment epithelial cells)

The first cohort was successfully dosed earlier this year in a Phase I/IIa clinical trial evaluating the safety and efficacy of OpRegen for the treatment of the advanced form of dry age-related macular degeneration (AMD). The trial is evaluating three different dose regimens. BioTime expects the Data Safety Monitoring Board (DSMB), an independent group of experts established for the Phase I/IIa trial, will complete its review of the initial safety data from the first cohort and recommend dose escalation to the second cohort during the second quarter of 2016. The second cohort will receive a higher, more clinically significant, dose of OpRegen. The Company expects to complete enrollment in the second cohort in 2016 and, if the data are positive, anticipates DSMB approval to proceed to the third cohort by the end of 2016. OpRegen has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of dry AMD, which occurs in approximately 90% of those afflicted with AMD.
Renevia (adipose cells + cell delivery matrix)

The Company expects to complete enrollment for its Renevia pivotal clinical trial in Europe in the second half of 2016 with top line data availability in early 2017. If the data are positive, BioTime plans to submit an application for CE Mark approval in the first half of 2017. The objective of the trial is to assess the efficacy of Renevia, which consists of BioTime’s HyStem hydrogel cell-transplantation delivery matrix combined with the patient’s own adipose cells, in restoring normal skin contours in patients whose subcutaneous fat, or adipose tissue, has been lost due to antiviral drug treatment for HIV. Positive data from the pivotal trial is expected to provide the foundation for studying Renevia in the much broader applications of fat tissue deficits in various medical aesthetics applications, such as for age-related and trauma related facial fat loss.
AST-VAC1 (antigen-presenting autologous dendritic cells)

In February, BioTime’s subsidiary Asterias Biotherapeutics, Inc. completed the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AST-VAC1, the company’s lead clinical program targeting maintenance of relapse-free-survival in acute myeloid leukemia (AML) patients. Asterias is planning for the initiation of a single pivotal Phase 3 trial that could support an accelerated development pathway towards a potential future biologic license application (BLA) filing.
Asterias presented data from the Phase II clinical trial of its cancer immunotherapy AST-VAC1 in acute myeloid leukemia (AML) at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 19th Annual Meeting on May 5, 2016.
AST-OPC1 (oligodendrocyte progenitor cells)

Asterias Biotherapeutics presented an overview of the AST-OPC1 therapeutic development program that is currently in a Phase I/IIa dose escalation clinical trial in spinal cord injury at the Stem Cell Summit 2016 meeting on April 27, 2016.
Cancer Diagnostics

OncoCyte Corporation, the cancer diagnostics subsidiary of BioTime and developer of novel, non-invasive blood and urine based tests for the early detection of cancer, announced that its bladder cancer abstract has been selected for presentation in a poster session, including a live panel discussion on the results, at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois to be held on June 3-7, 2016. The study to be presented at the upcoming ASCO (Free ASCO Whitepaper) annual meeting is based on the continued development of the diagnostic first reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2015 Annual Meeting. At AACR (Free AACR Whitepaper), OncoCyte presented interim clinical study data for the non-invasive detection of bladder cancer that demonstrated a high level of sensitivity and specificity in the detection of urothelial carcinoma, the most common type of bladder cancer.
On April 4, 2016, OncoCyte and the Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, announced positive research results for a lung cancer diagnostic test being developed at Wistar. This study of 620 subjects replicates a previous study that was carried out at Wistar, which was presented at the American Thoracic Society conference in May 2015. The results of this study are being further evaluated by OncoCyte and mark a successful transition of the assay platform from Illumina microarrays to a Nanostring nCounter machine, which is the platform that OncoCyte intends to use for commercialization. OncoCyte has exclusive commercial rights to the lung cancer diagnostic test developed by Wistar. OncoCyte must now independently validate these results in its own follow-up study based on the results of Wistar’s latest study. OncoCyte will attempt to finalize and lock down both the assay and the classifier or algorithm that interprets test results, and if successful, will initiate an internal analytical validation study.
Non-core Assets

LifeMap Solutions, the digital health subsidiary of BioTime and co-developer of ResearchKit-enabled app Asthma Health, launched its new mobile health app design and development service to help research institutions and health companies worldwide develop custom smartphone apps and research studies. Through the new service, LifeMap offers clients its deep expertise in medical science, consumer behavior, app analytics, and design. LifeMap’s innovative, data-driven mobile health (mHealth) apps are designed to recruit clinical study participants, obtain patient consent through the iPhone, and passively collect participants’ health information. LifeMap Solutions has developed innovative digital health apps in collaboration with leading research institutions including the Icahn School of Medicine at Mount Sinai, Stanford University School of Medicine, and National Jewish Health, as well as with strategic partners like 23andMe.
Corporate Developments

On May 10, 2016, Asterias finalized the pricing of an underwritten public offering of 5,147,059 units at a public offering price of $3.40 per unit. Each unit consists of one share of common stock and 0.5 of a warrant to purchase a share of common stock at an exercise price of $4.37 per share. The warrants are immediately exercisable and expire on the fifth anniversary of the date of issuance. The offering is expected to close on May 13, 2016, subject to customary closing conditions. If completed, Asterias would receive net proceeds of $16,275,000 after underwriting discounts but before paying other costs of the offering. Asterias has granted the underwriters a 30-day option to purchase up to an additional 772,059 shares of common stock and/or additional warrants to purchase up to 386,029 shares of common stock to cover over-allotments, if any. If the over-allotment option is exercised in full, net proceeds of the offering after underwriting discounts but before other expenses are expected to be approximately $18.7 million.
On April 28, 2016, Howard I. Scher, M.D., one of the world’s leading oncology experts, was appointed to the Board of Directors of Asterias Biotherapeutics.
In February, pharmaceutical industry veteran Stephen L. Cartt was appointed as President and Chief Executive Officer of Asterias, and member of the company’s Board of Directors. Mr. Cartt previously served as Chief Operating Officer of Questcor Pharmaceuticals Inc. until its sale in 2014 to Mallinckrodt, plc for $5.6 billion. In addition, Don M. Bailey was appointed to Asterias’ Board of Directors and named Chairman of the Board of Directors. Mr. Bailey previously served as President and Chief Executive Officer of Questcor until its sale in 2014 to Mallinckrodt.
First Quarter Financial Results

Cash (and available-for-sale securities) Position: Cash and cash equivalents totaled $27.1 million as of March 31, 2016, compared to $42.2 million as of December 31, 2015. The cash on hand as of March 31, 2016 includes $16.4 million held by subsidiaries. As of March 31, 2016, BioTime held $829,000 in available-for-sale securities. As of March 31, 2016, BioTime owned 21.7 million shares of Asterias common stock and 14.7 million shares of OncoCyte common stock, which represented an aggregate market value of $170 million as of that date.

Revenues: BioTime’s operating revenues are currently generated from research grants, licensing fees and advertising from the marketing of online database products. Total consolidated revenues were $2.1 million for the first quarter, compared to $1.3 million in the first quarter of 2015. The increase was primarily due to increases in grant revenue and subscription and advertising revenues.

R&D Expenses: Research and development expenses were $13.7 million for the first quarter, compared to $9.3 million for the comparable period in 2015. The increase is in part a result of increased expenses primarily related to regulatory and clinical trials of Asterias’ AST-OPC1 program, and OncoCyte’s cancer diagnostics.

G&A Expenses: General and administrative expenses were $11.9 million for the first quarter, compared to $5.2 million for the first quarter of 2015. The increase is in part a result of $3.1 million in non-cash expense for the estimated fair value of the distribution of 3,331,229 warrants to purchase Asterias common stock to Asterias shareholders other than BioTime declared by the Asterias board of directors on March 30, 2016, increased staffing needed to advance programs under development at BioTime, including non-cash stock-based compensation from BioTime, Asterias, and OncoCyte.

Net Loss attributable to BioTime: Net loss attributable to BioTime was $17.1 million for the three months ended March 31, 2016, or $0.19 per share. There was no deferred income tax benefit recorded in the three months ended March 31, 2016. For the first quarter of 2015, net loss attributable to BioTime was $10.2 million, or $0.13 per share including deferred income tax benefits of $1.2 million. Net loss attributable to BioTime includes losses from BioTime’s majority owned and consolidated subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.

Evotec AG reports results of first quarter 2016

On May 10, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first quarter of 2016 (Press release, Evotec, MAY 10, 2016, View Source [SID:1234512324]).

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FINANCIAL PERFORMANCE: BEST Q1 FINANCIAL RESULTS IN COMPANY’S HISTORY

– Significant Group revenue growth of 74% to EUR 37.5 m (2015: EUR 21.5 m); base revenues up 83% to EUR 33.9 m

– Revenue growth in both operating segments: EVT Execute revenues up 67% to EUR 38.6 m, EVT Innovate revenues up 67% to EUR 6.4 m

– Adjusted Group EBITDA significantly increased to EUR 7.2 m (2015: EUR (0.3) m)

– Adjusted EBITDA of EUR 9.6 m for EVT Execute (2015: EUR 3.5 m)

– Increase in R&D expenses of 14% to EUR 4.4 m primarily focused on oncology projects and CNS

– Strong strategic liquidity position of EUR 122.5 m

EVT Execute – ACCELERATED GROWTH IN BASE BUSINESS

– Important milestone achievement in Padlock collaboration

– Multi-year compound management agreement closed with Pierre Fabre (after period-end)

– Milestone achievement in Bayer collaboration (after period-end)

EVT Innovate – FIRST-IN-CLASS CURE X/TARGET X STRATEGY

– Good progress in Cure X/Target X programmes

– Grant from The Michael J. Fox Foundation for Parkinson’s Research

– Good progress in existing partnerships (e.g. EVT201, EVT801 and other Sanofi oncology projects, kidney disease collaboration with AstraZeneca)

– Partnership on immuno-oncology therapeutics with ex scienta

– Phase out of EVT100 in TRD by Janssen Pharmaceuticals

EVT EQUITY – COMPANY FORMATION TO ACCELERATE DRUG DISCOVERY AND PRODUCT DEVELOPMENT

– Formation of a spin-off company (Topas Therapeutics GmbH) in the field of nanoparticle-based therapeutics to treat immunological disorders; completed Series A funding of EUR 14 m

MANAGEMENT BOARD UPDATES AND STRENGTHENING OF GLOBAL HUMAN RESOURCES CAPACITIES

– CEO, COO and CSO contracts extended

– Contract of Colin Bond, CFO, will end 30 June 2016

– Appointment of Enno Spillner as new CFO effective 18 July 2016

– Appointment of Monika Conradt as Global Head of Human Resources effective 01 June 2016

GUIDANCE 2016 CONFIRMED

1. Financial performance

BEST Q1 FINANCIAL RESULTS IN COMPANY’S HISTORY

The 2015 and 2016 results are not fully comparable. The difference stems from the acquisition of Evotec (France) SAS, effective 01 April 2015. While the results of Evotec (France) SAS are fully included in the accompanying consolidated income statement for the first three months of 2016, they were not included in the comparable period of the previous year.

The presented financial statements include a change in presentation in the first three months of 2015 and 2016. From 01 January 2016 onwards, amortisation of intangible assets are no longer presented in a separate line in the consolidated income statement but are allocated to the relating cost lines in the income statement. The prior-year period was changed accordingly resulting in higher costs of revenue (EUR 0.6 m).

In the first quarter of 2016, Evotec’s Group revenues grew to EUR 37.5 m, an increase of 74% compared to the same period of the previous year (2015: EUR 21.5 m). This increase resulted primarily from an increase in base revenues across all business units and the contribution from the Sanofi collaboration. Excluding milestones, upfronts and licences, Evotec’s revenues for the first quarter of 2016 were EUR 33.9 m, an increase of 83% over the same period of the previous year (2015: EUR 18.5 m). Revenues from milestones, upfronts and licences increased to EUR 3.6 m compared to the same period of the previous year (EUR 3.0 m). The gross margin amounted to 33.3% in the first three months of 2016 (2015: 28.0%). This significant margin increase over 2015 primarily reflects growth in base revenues, improved capacity utilisation as well as favourable foreign exchange rate effects.

In the first quarter of 2016, Evotec’s R&D expenses amounted to EUR 4.4 m (2015: EUR 3.8 m). This increase is in-line with the Company’s strategic plans and primarily results from significant investments in acquired oncology projects and intensified investments in CNS projects. Selling, general and administrative (SG&A) expenses increased by 5% in the first quarter of 2016 to EUR 5.4 m (2015: EUR 5.1 m) and were mainly impacted by ongoing costs at Toulouse site.

Adjusted Group EBITDA in the first quarter of 2016 was positive and amounted to EUR 7.2 m (2015: EUR (0.3) m). EBITDA was adjusted for changes in contingent consideration. Evotec’s operating income in the first quarter of 2016 amounted to EUR 2.7 m (2015: operating loss of EUR 3.3 m).

Liquidity, which includes cash and cash equivalents (EUR 49.2 m) and investments (EUR 73.3 m) amounted to EUR 122.5 m as of 31 March 2016 (31 December 2015: EUR 133.9 m) and remained on a high level even though the first quarter of 2016 was affected by bonuses, extraordinary and advance payments. In the current low and negative interest rate environment, the Company is considering options to reduce outstanding levels of debt during Q2 2016 while maintaining future access to such financing. Debt reduction would be possible due to the current strength of the underlying business and the strong liquidity position of the Company.

Revenues from the EVT Execute segment amounted to EUR 38.6 m in the first quarter of 2016 (2015: EUR 23.1 m) and included EUR 7.5 m of intersegment revenues (2015: EUR 5.4 m). This sharp increase was mainly driven by the strong performance of the base business, the milestone achievement in the Padlock collaboration and the contribution from the Sanofi transaction. The EVT Innovate segment generated revenues of EUR 6.4 m (2015: EUR 3.8 m) consisting entirely of third-party revenues. This increase compared to the prior year results mainly from EVT Innovate projects which were partnered in 2015. Gross margin for EVT Execute amounted to 26.1% while EVT Innovate generated a gross margin of 46.1%. R&D expenses for the EVT Innovate segment amounted to EUR 4.9 m in the first quarter of 2016 (2015: EUR 4.6 m) and continued the upward trend compared to previous quarters. In the first quarter of 2016, the adjusted EBITDA (before changes in contingent consideration) of the EVT Execute segment was strongly positive at EUR 9.6 m and improved compared to the same period of the previous year (2015: EUR 3.5 m). The EVT Innovate segment reported a negative EBITDA before changes in contingent consideration of EUR (2.4) m but has improved over the prior year (2015: EUR (3.8) m) due to new EVT Innovate partnerships based on Cure X/Target X initiatives signed in 2015.

2. EVT Execute and EVT Innovate

EVT Execute – ACCELERATED GROWTH IN BASE BUSINESS

The first quarter of 2016 saw a strong operational performance in the EVT Execute segment. Important milestones were achieved in ongoing collaborations (Padlock; Bayer (after period-end)). In addition, the base business gained further momentum, especially with regards to compound management services, which was further demonstrated by new multi-year compound management agreements which Evotec entered with UCB at the end of 2015 and with Pierre Fabre just after period-end.

EVT Innovate – FIRST-IN-CLASS CURE X/TARGET X STRATEGY

In the EVT Innovate segment, Evotec recorded a research grant which was awarded from The Michael J. Fox Foundation to further develop Evotec’s TargetaSN (Targetalpha-synuclein) programme for the treatment of Parkinson’s disease. This programme is part of a larger internal initiative to address neurodegenerative diseases through highly innovative approaches involving patient-derived stem cells and genetically validated mechanisms. Furthermore, good progress was demonstrated in existing partnerships and development projects in the first quarter: The clinical studies for EVT201 in China are running according to plan. EVT801 and other oncology projects are progressing well. Good progress was achieved in the kidney collaboration with AstraZeneca. Regarding Evotec’s legacy pipeline, Evotec was informed by Janssen Pharmaceuticals, Inc. that Janssen intends to phase out the agreement regarding NMDA antagonists as of August 2016. This is reflected in a full impairment of the asset in the amount of EUR 1.4 m.

3. EVT Equity – Company formation to accelerate drug discovery and product development

In March 2016, Evotec announced the formation of a spin-off company, called Topas Therapeutics GmbH ("Topas"), focused on the field of nanoparticle-based therapeutics to treat immunological disorders. Epidarex Capital, EMBL Ventures and Gimv participated together with Evotec in a EUR 14 m ($ 15.75 m) Series A financing round of Topas. Evotec will remain the largest shareholder after the financing round. The new company aims to build a unique pipeline of clinical-stage development projects to treat autoimmune diseases. The establishment of Topas is the first example of an acceleration of Evotec’s business model to take advantage of carving out promising programmes with upside potential on a shared risk and shared success basis.

4. Management Board updates and strengthening of Global Human Resources capacities

The Supervisory Board has agreed to the extension of the service contract of Dr Werner Lanthaler as CEO of the Company for another five years to 2021 and the extensions of the contracts of Dr Mario Polywka as COO and Dr Cord Dohrmann as CSO for a further three years to 2019. Colin Bond has decided not to extend his contract and will leave the Company at his own request when his current contract as CFO expires at the end of June 2016.

The Supervisory Board of Evotec has appointed Enno Spillner as its new Chief Financial Officer and member of the Management Board effective 18 July 2016. Enno Spillner has most recently served as Chairman of the Management Board and CEO/CFO of 4SC AG since April 2013. He joined 4SC AG as CFO in September 2005. Before working for 4SC AG, Enno Spillner was Head of Finance and Controlling at BioM AG, a German regional biotech venture fund, which he joined at the beginning of 1999. In this role, he was responsible for managing investments in the equity portfolio and also held the position of interim Managing Director at two portfolio companies. Enno Spillner earned his Dipl.-Kaufmann degree (Masters in Economics) at the University of Bamberg, Germany. He also is a member of the Supervisory Board and Chairman of the audit committee at Nanobiotix, Paris.

To support the growth and increase attention to its human talent, the Management Board of Evotec has appointed Ms Monika Conradt Global Head of Human Resources. Ms Conradt joins Evotec from Boehringer Ingelheim, where she has been HR Manager Europe.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "On behalf of the Management Board and the Company, I would like to thank Colin for his most valuable contributions over the past six years. He was outstanding in the challenge and balance that he provided to the Management Team. Colin Bond has made many essential contributions to the strategic development of Evotec. We will closely stay in touch with him and we wish him ongoing success for his future endeavours in a key position at one of our drug discovery partners. I am delighted to welcome Enno Spillner to our team as new Chief Financial Officer and Monika Conradt as Global Head of Human Resources."

5. Guidance 2016 confirmed

Guidance 2016 Actual 2015
Base revenues1) >15% EUR 115.4 m
Adjusted Group EBITDA2) Positive and significantly improved to prior year EUR 8.7 m
R&D expenses Approx. EUR 20 m EUR 18.3 m
Liquidity3) Similar level to prior year EUR 134.5 m
Capex investments Up to EUR 10 m EUR 11.2 m
1) Excluding milestones, upfronts and licences

2) Before contingent considerations, income from bargain purchase and excluding impairments on goodwill, other intangible and tangible assets as well as the total non-operating result
3) Excluding M&A and related payments