Repros Therapeutics Inc.® Reports First Quarter 2016 Financial Results

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.

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.

PRM-151

PRM-151: Lead Product Candidate

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Promedior’s lead product, PRM-151, is a recombinant form of human pentraxin-2 protein (rhPTX-2) formulated for intravenous injection (Company Pipeline, Promedior, MAY 9, 2016, View Source [SID:1234512082]). Promedior is initially focusing the clinical development of PRM-151 on rare systemic fibrotic diseases, such as Idiopathic Pulmonary Fibrosis (IPF) and myelofibrosis. Highlights of PRM-151’s clinical development include:

· A Phase 1a clinical study in healthy subjects and IPF patients demonstrated that PRM-151 was safe and well-tolerated
· A Phase 1b randomized, double-blind, placebo-controlled, multiple ascending dose study in IPF patients demonstrated that PRM-151 was generally safe and well‐tolerated and resulted in a mean improvement in Forced Vital Capacity (FVC) at 8 weeks after dosing for only two weeks, whereas patients receiving placebo had a decline in FVC. These data were · presented at the American Thoracic Society Annual Meeting on May 22, 2013.

· A Phase 2 clinical trial to evaluate PRM-151 in patients with myelofibrosis is ongoing. This trial is a multi-center, two-stage, adaptive design study to determine the efficacy and safety of PRM-151 as a single agent or added to a stable dose of ruxolitinib in patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF). Data were presented at the 2014 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the 2014 European Hematology Association (EHA) (Free EHA Whitepaper) meetings in June. Positive preliminary data demonstrated biologic activity with improvements across clinically relevant measures, including bone marrow fibrosis, hemoglobin, platelets, spleen volume, and symptoms. Clinical data showed improvements in four independent treatment groups of myelofibrosis patients who received PRM-151 weekly or monthly, either as a single agent or in patients with no further improvements on a stable dose of ruxolitinib1. Importantly, PRM-151 demonstrated safety and tolerability both alone and in combination with ruxolitinib, with no evidence of the myelosuppression commonly observed with other treatments. This recent data in myelofibrosis demonstrates the potential of Promedior’s immuno-oncology approach in fibrotic cancers.

PRM-151 has demonstrated efficacy in multiple preclinical models of fibrotic disease, including the reduction of established pulmonary fibrosis.

Neuralstem Reports Fiscal First Quarter 2016 Results and Business Update

On May 9, 2016 Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company focused on the development of central nervous system therapies based on its neural stem cell technology, reported its financial results for the three months ended March 31, 2016 and provided a business update (Press release, Neuralstem, MAY 9, 2016, View Source [SID:1234512122]).

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Business Highlights
On May 6, 2016, the Company closed a public offering resulting in net proceeds of $7.42 million. The net proceeds will be used for general corporate purposes, including the Phase 2 NSI-189 major depressive disorder (MDD) clinical trial and ongoing research and development activities.

In March 2016, we commenced the NSI-189 Phase 2 clinical trial for the treatment of Major Depressive Disorder (MDD).
In February 2016, we strengthened our management team with the appointment of Richard Daly as our President and Chief Executive Officer.

In January 2016, we announced an initiative to pursue collaborations for our stem cell therapy programs in order to utilize additional expertise, expedite clinical and regulatory pathways and secure alternative funding.

"The Company’s ability to raise significant capital from institutional investors provides us a cash runway to continue to fund our clinical development programs, specifically the NSI-189 Phase 2 MDD clinical trial," said Richard Daly, CEO. "We recently commenced our Phase 2 MDD trial which confirms the Company is on track to have results in the second half of 2017. We are committed to continue to execute our clinical and corporate strategy to create additional stakeholder value."

Small Molecule Pharmaceutical Compounds Clinical Development
Lead asset, NSI-189 Phase 2 clinical trial for the treatment of major depressive disorder (MDD)
In March 2016, we commenced our NSI-189 Phase 2 clinical trial for the treatment of MDD, a double-blind, randomized, placebo-controlled, 220 subject study. For information on the trial please visit View Source

Cell Therapy Platform Clinical Developments
In January 2016, Karl Johe, Founder and Chief Scientific Officer, presented at the Phacilitate Cell & Gene Therapy World Conference. He concluded that the collective trial data analysis showed that our proprietary neural stems cells consistently demonstrated biological activity in all three program indications: amyotrophic lateral sclerosis (ALS), chronic spinal cord injury (cSCI), and motor deficits due to ischemic stroke.

NSI-566 Phase 1 safety trial for the treatment of cSCI
In January 2016, the Company reported preliminary six-month follow-up Phase 1 safety data on all four subjects in the chronic spinal cord injury trial. The stem cell treatment demonstrated feasibility and safety. A self-reported ability to contract some muscles below the level of injury was confirmed via clinical and electrophysiological follow-up examinations in one of the four patients treated. This study was completed with the collaboration of the UCSD School of Medicine, supported by the UCSD Sanford Stem Cell Clinical Center; substantially all of the clinical costs of this study have been funded by grants arranged through the University.

NSI-566 Phase 1 and 2 safety trials for the treatment of amyotrophic lateral sclerosis (ALS)
In September 2015, nine-month Phase 2 and combined Phase 1 and Phase 2 data on the NSI-566 trial in amyotrophic lateral sclerosis (ALS) was presented at the American Neurological Association Annual Meeting by the principal investigator, Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health. The data showed that the intraspinal transplantation of the cells was safe and well tolerated.

In January 2016, the Company announced that it is in discussions with various governmental, state and non-profit organizations regarding funding grants for the next trial. Initiation of the trial will be dependent upon significant funding from such sources.

NSI-566 Phase 1 safety trial for the treatment of motor deficits in stroke
During the three months ended March 31, 2016, the company completed dosing the third of three planned cohorts, each cohort included three patients, for a total of nine patients in a Phase 1 open label, dose-escalation trial evaluating safety and the maximum tolerated dose. The trial is being conducted by Neuralstem China, at BaYi Brain Hospital in Beijing, China.

Results of Operations for the Quarter Ended March 31, 2016:
Cash, cash equivalents and short-term investments on hand was approximately $7.6 million at March 31, 2015, compared to approximately $12.2 million at December 31, 2015. The decrease was primarily due to our ongoing operating expenses primarily related to preparations for the initiation of our NSI-189 Phase 2 clinical trial for the treatment of MDD.

On May 06, 2016, we closed a public offering of 20,000,000 shares of common stock and 20,000,000 common stock purchase warrants at a public offering price of $0.40 per each share and common stock purchase warrant. We received aggregate gross proceeds of $8.0 million and net proceeds of approximately $7,420,000 from the offering. Based upon our cash at March 31, 2016, and the proceeds from our May public offering, we expect to be able to fund our operations through December 31, 2016.

In the quarter ended March 31, 2016, we reported a net loss of approximately $6.6 million or $0.07 per share, compared to a loss of approximately $5.1 million or $0.06 per share in the first quarter of 2015. Our operating loss in the quarter ended March 31, 2016 was approximately $6.2 million compared to a loss of $4.6 million in the same quarter of 2015. The increase in operating loss was primarily attributable to the severance accrual and acceleration of stock based compensation expense related to the departure of our previous CEO. A decrease of approximately $0.1 million in research and development expense was offset by an increase of approximately $1.7 million in general and administrative expenses.

Research and development expenses decreased approximately $117,000 or 4% for the period ended March 31, 2016 compared to the comparable period of 2015 primarily as a result of a decrease in pre-clinical and clinical costs partially offset by an increase in headcount and stock based compensation.

General and administrative expenses increased approximately $1,737,000 or 121% for the period ended March 31, 2016 compared to the comparable period of 2015 primarily due to a severance accrual and increased stock based compensation resulting from the accelerated vesting of options, both related to the termination of our former Chief Executive Officer.

In addition, in the first quarter of 2016 we recognized approximately $0.4 million of other expenses primarily comprised of interest expenses related to our long-term debt.
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Neuralstem, Inc.

Unaudited Condensed Consolidated Balance Sheets

March 31,
2016

December 31,
2015

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$
7,620,746

$
4,716,533

Short-term investments

7,517,453

Trade and other receivables

39,167

37,316

Prepaid expenses

1,077,762

1,159,782

Total current assets

8,737,675

13,431,084

Property and equipment, net

336,974

343,200

Patents, net

1,066,577

1,103,467

Other assets

57,692

71,797

Total assets

$
10,198,918

$
14,949,548

LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY

CURRENT LIABILITIES

Accounts payable and accrued expenses

$
2,627,137

$
1,455,826

Accrued bonuses

287,046

161,362

Current portion of long term debt, net of fees and discount

4,466,081

4,634,742

Other current liabilities

241,008

173,542

Total current liabilities

7,621,272

6,425,472

Long term debt, net of fees, discount and current portion

2,546,296

3,391,808

Other long term liabilities

200,739

164,990

Total liabilities

10,368,307

9,982,270

STOCKHOLDERS’ EQUITY (DEFICIT)

Preferred stock, 7,000,000 shares authorized, zero shares issued and outstanding

Common stock, $0.01 par value; 300 million shares authorized, 92,044,042 and 92,005,705 shares outstanding in 2016 and 2015, respectively

920,440

920,057

Additional paid-in capital

177,473,335

176,002,832

Accumulated other comprehensive income

1,298

3,071

Accumulated deficit

(178,564,462)

(171,958,682)

Total stockholders’ equity (deficit)

(169,389)

4,967,278

Total liabilities and stockholders’ equity (deficit)

$
10,198,918

$
14,949,548

Neuralstem, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

Three Months Ended March 31,

2016

2015

Revenues

$
2,500

$
2,917

Operating expenses:

Research and development expenses

3,065,590

3,182,823

General and administrative expenses

3,170,522

1,433,074

Total operating expenses

6,236,112

4,615,897

Operating loss

(6,233,612)

(4,612,980)

Other income (expense):

Interest income

11,136

13,569

Interest expense

(386,506)

(453,734)

Other income

3,199

Total other income (expense)

(372,171)

(440,165)

Net loss

$
(6,605,783)

$
(5,053,145)

Net loss per share – basic and diluted

$
(0.07)

$
(0.06)

Weighted average common shares outstanding – basic and diluted

92,009,782

89,654,634

Comprehensive loss:

Net loss

$
(6,605,783)

$
(5,053,145)

Foreign currency translation adjustment

(1,773)

13

Comprehensive loss

$
(6,607,556)

$
(5,053,132)
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