On May 10, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported business highlights and financial results for the first quarter ended March 31, 2016 (Press release, Celator Pharmaceuticals, MAY 10, 2016, View Source [SID:1234512203]).

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"The first quarter of 2016 was transformative for Celator," said Scott Jackson, chief executive officer of Celator. "Our Phase 3 trial of VYXEOS demonstrated a statistically significant improvement in overall survival, among other benefits, in patients with high-risk acute myeloid leukemia (AML) and we plan to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) by the end of the third quarter of this year. We look forward to presenting additional data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting next month. In addition, following the positive Phase 3 results, we raised capital that we believe is sufficient to fund planned operations into 2018."

Celator anticipates achieving the following key objectives:

Continue to execute on the VYXEOS commercial readiness in the United States;
Submit the New Drug Application (NDA) for VYXEOS by the end of Q3 2016;
Continue to expand the clinical development of VYXEOS via investigator-initiated studies, oncology cooperative groups and company-sponsored studies;
Prescription Drug User Fee Act (PDUFA) date (assuming FDA grants priority review) by mid-2017; and
United States commercial launch (assuming FDA approval in mid-2017) in Q3 2017.
Recent Business and First Quarter 2016 Highlights

April – Celator announced that a late-breaking abstract was submitted to ASCO (Free ASCO Whitepaper) and accepted for an oral presentation on June 4, 2016 at 3:00 pm CT and will be presented by Dr. Jeffrey Lancet from H. Lee Moffitt Cancer Center & Research Institute.
March – Celator announced that Phase 3 trial data for VYXEOS in patients with high-risk AML demonstrated a statistically significant improvement in overall survival and induction response rate and meaningfully lower 60-day mortality. There was no substantial difference in Grade 3-5 adverse events between VYXEOS and the control arm (7+3 regimen). The company plans to submit an NDA for VYXEOS by the end of the third quarter.
March – Celator completed an underwritten public offering of 4,600,000 shares of the company’s common stock, resulting in net proceeds of approximately $40.6 million.
Financial Highlights

Cash Position: Cash and cash equivalents as of March 31, 2016 were $67.5 million, compared to $23.3 million as of December 31, 2015. The increase was primarily due to the underwritten public offering that netted approximately $40.6 million during the first quarter of 2016 and $9.8 million in net proceeds from the issuance of common stock through an at-the-market equity offering program. Management believes that the cash and cash equivalents at March 31, 2016 will be sufficient to meet estimated working capital requirements and fund planned operations into 2018.
R&D Expenses: Research and development expenses were $2.7 million for the three months ended March 31, 2016 consistent with the same period in 2015.
G&A Expenses: General and administrative expenses were $2.5 million for the three months ended March 31, 2016, as compared to $1.8 million for the same period of 2015. The increase was primarily attributable to increases in compensation, pre-launch commercial activities, public company expenses and professional fees.
Net Loss: Net loss increased to $5.5 million for the three months ended March 31, 2016, from $4.7 million for the same period in 2015.

On May 10, 2016 Repros Therapeutics Inc. (Nasdaq:RPRX) reported financial results for the first quarter ended March 31, 2016 (Press release, Repros Therapeutics, MAY 10, 2016, View Source [SID:1234512321]).

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Financial Results

Net loss for the three month period ended March 31, 2016 was ($4.8) million, or ($0.20) per share, as compared to a net loss of ($8.5) million, or ($0.35) per share, for the same period in 2015. The decrease in net loss for the three month period ended March 31, 2016 as compared to the same period in 2015 was primarily due to decreases in clinical development expenses related to the Company’s enclomiphene product candidate, research and development payroll and benefits expenses and legal expenses, partially offset by an increase in clinical development expenses related to Proellex.

Research and development ("R&D") expenses decreased 49%, or $3.5 million, to $3.8 million for the three month period ended March 31, 2016, as compared to $7.3 million for the same period in the prior year. R&D expenses related to the clinical development of enclomiphene decreased 71%, or approximately $2.9 million, for the three month period ended March 31, 2016 as compared to the prior year period, primarily due to the submission of the NDA to the FDA in the first quarter of 2015. R&D expenses related to the clinical development of Proellex increased 41%, or approximately $336,000, from the 2015 period to the 2016 period, due to increased expenses associated with our ongoing Phase 2B clinical trials for the treatment of uterine fibroids. Payroll and benefits expenses decreased 45%, or approximately $580,000, to $712,000 for the three month period ended March 31, 2016 as compared to $1.3 million for the same period in the prior year. Included in payroll and benefits expense is a charge for non-cash stock-based compensation of $193,000 for the three month period ended March 31, 2016 as compared to $574,000 for the same period in the prior year. Additionally, salaries for the three month period ended March 31, 2016 were $422,000 as compared to $579,000 for the same period in the prior year. Operating and occupancy expenses decreased 37%, or approximately $423,000, to $716,000 for the three month period ended March 31, 2016 as compared to $1.1 million for the same period in the prior year, primarily due to decreased legal expenses.

General and administrative ("G&A") expenses decreased 9%, or approximately $109,000, to $1.1 million for the three month period ended March 31, 2016 as compared to $1.2 million for the same period in the prior year. Payroll and benefits expense decreased 17%, or approximately $123,000, to $620,000 for the three month period ended March 31, 2016 as compared to $743,000 for the same period in the prior year. Included in payroll and benefits expense is a charge for non-cash stock based compensation expense of $323,000 for the three month period ended March 31, 2016 as compared to $448,000 for the same period in the prior year. Additionally, salaries for the three month period ended March 31, 2016 were $257,000 as compared to $255,000 for the same period in the prior year. G&A operating and occupancy expense increased 3%, or approximately $14,000, to $476,000 for the three month period ended March 31, 2016 as compared to $462,000 for the same period in the prior year primarily due to an increase in legal expenses.

Interest income increased to $17,000 for the three month period ended March 31, 2016 as compared to $1,000 for the same period in the prior year. The increase was primarily due to higher yields for the three month period ended March 31, 2016 as compared to the prior year.

Liquidity and Capital Resources

The Company had cash and cash equivalents of $16.0 million as of March 31, 2016 as compared to $21.4 million as of December 31, 2015. Net cash of approximately $5.3 million and $8.8 million was used in operating activities during the three month periods ended March 31, 2016 and 2015, respectively. The major use of cash for operating activities for the three month period ended March 31, 2016 was to fund our clinical development programs and associated administrative costs. No cash was used in investing activities during the three month period ended March 31, 2016 and no cash was provided by financing activities during the three month period ended March 31, 2016.

As of March 31, 2016, the Company had 24,318,111 shares of common stock outstanding.

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."

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.

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.