Aptose Bioscience Reports Results for the First Quarter Ended March 31, 2016

On May 10, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported unaudited financial results for the three months ended March 31, 2016 and reported on corporate developments (Press release, Aptose Biosciences, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2167184 [SID:1234512240]). Unless specified otherwise, all amounts are in Canadian dollars.

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Net loss for the three months ended March 31, 2016 was $5.1 million ($0.42 per share) compared with $3.6 million ($0.30 per share) during the three months ended March 31, 2015. Total cash and cash equivalents and investments at March 31, 2016 were $15.0 million.

"During the first quarter we made considerable progress towards developing an improved methodology to create a stable formulation of APTO-253 for returning to the clinic," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "Our team has diligently tested the performance of the drug product in the IV delivery system used for patients, as well as performed numerous manufacturing, formulation development and stability and solubility studies. We believe that we are close to defining a methodology that can deliver a clinical drug product of the utmost quality and functionality. We look forward to sharing our findings with the FDA, as we seek to re-initiate dosing at our existing Phase 1b clinical trial sites and initiating dosing at our new sites in patients with acute myeloid leukemia and other hematologic malignancies."

Corporate Highlights
During the first quarter, and in collaboration with a qualified formulation contract manufacturing organization (CMO), Aptose explored numerous methodologies to identify conditions that would enhance the solubility and stability properties of the APTO-253 formulation drug product.

The company has made significant progress toward selecting a formulation methodology to manufacture a new batch of drug product that is unlikely to cause clogging of the in-line filters in the clinical setting.

Aptose scientists demonstrated that, in addition to reversing the leukemogenic dysregulation of the KLF4 gene expression, APTO-253 inhibits expression of the c-Myc oncogene in a concentration and time-dependent manner in AML cells. The c-Myc oncogene is a major driver of cancer cell proliferation, and inhibition of c-Myc gene expression and c-Myc protein levels by APTO-253 suggests APTO-253 may have anti-cancer application among a host of hematologic malignancies and solid tumors.

Aptose’s clinical team has prepared additional clinical sites at major cancer research and treatment centers in preparation to enroll patients for dosing of APTO-253. The expedited engagement of these new sites is intended to ensure an accelerated pace of patient accrual in the company’s ongoing Phase 1b clinical study after lifting of the clinical hold.

Subsequent to the quarter end, the company issued 115,927 common shares under the at-the-market facility for gross proceeds of approximately US $297 thousand.
Financial Results
Net loss for the three months ended March 31, 2016 was $5.1 million ($0.42 per share) compared with $3.6 million ($0.30 per share) during the three months ended March 31, 2015. The increase in net loss is due to increased research and development costs related to APTO-253, as well as a foreign exchange loss on USD cash and cash equivalents balances due to the appreciation of the Canadian dollar during the quarter.
Aptose utilized cash of $4.5 million in operating activities in the three months ended March 31, 2016 compared with $2.2 million in the three months ended March 31, 2015. The increase in cash used in operating activities in the current period is due to an increased net loss compared with the prior year, as well as a reduction in accounts payable and accrual balances during the quarter compared with an increase in these balances in the three months ended March 31, 2015.
Research and Development
Research and development expenses totaled $2.3 million in the three months ended March 31, 2016 compared to $884 thousand in the prior year period. Research and development costs consist of the following:
Components of research and development expenses:
Three months ended
(in thousands) March 31,
2016 March 31,
2015

Program costs $ 2,247 $ 860
Stock-based compensation 56 19
Depreciation of equipment 12 5
$ 2,315 $ 884

The increase in research and development costs in the three months ended March 31, 2016 compared with the three months ended March 31, 2015 is due to the following reasons:
Costs associated with the LALS/Moffitt collaboration developing epigenetic single molecule inhibitors of multiple targets, including the bromodomain and extraterminal domain (BET) proteins, and other kinases for which no comparable expenses existed in the prior year;
Formulation and manufacturing costs associated with APTO-253 and the root cause analysis of the filter clogging identified in November 2015;
Increased Contract Research Organization costs related to consultants and advisors as the company works towards returning APTO-253 to the clinic; and
Increased research and clinical operations headcount.
Stock-based compensation costs allocated to research and development increased in the three months ended March 31, 2016 to reflect option grants to new employees.
General and Administrative
General and administrative expenses totaled $2.6 million for the three months ended March 31, 2016 compared to $2.7 million in the three months ended March 31, 2015. General and administrative expenses consist of the following:
Components of general and administrative expenses:
Three months ended
(in thousands) March 31,
2016 March 31,
2015

General and administrative excluding salaries $ 1,133 $ 1,029
Salaries 975 753
Stock-based compensation 479 940
Depreciation of equipment 21 7
$ 2,608 $ 2,729

General and administrative costs excluding salaries are higher in the three months ended March 31, 2016 compared with the prior year due to higher rent costs associated with an additional office location, additional patent costs due to timing, as well as a depreciation in the Canadian dollar compared with the prior year period which has resulted in an increase to the cost of our US dollar denominated expenditures.
Increased salary costs have increased in the three months ended March 31, 2016 compared with the prior year due to additional headcount, the establishment of a benefits plan for employees in the United States and higher Canadian dollar salary costs for our US employees due to the lower value of the Canadian dollar during the three month period.
Stock-based compensation costs decreased in the three months ended March 31, 2016 compared with prior year due to large option grants in June and July 2014 which vested 50% during the first year and therefore contributed to higher stock based compensation expense during the first twelve-month period.
Finance Expense
Finance expense for the three months ended March 31, 2016 was $196 thousand compared with $60 thousand for the three months ended March 31, 2015. Finance expense includes the following items:
Three months ended
(in thousands) March 31,
2016 March 31,
2015
Interest expense $ − $ 20
Foreign exchange loss 196 40
$ 196 $ 60

Interest expense for the three months ended March 31, 2015 relates to interest accrued at a rate of 10% on the remaining balance of convertible promissory notes issued in September 2013 as well as accretion expense related to the conversion feature of the notes. All of the promissory notes have now been converted into common shares.
Foreign exchange loss in the three months ended March 31, 2016 is the result of a decrease in the value of our US dollar denominated cash and cash equivalents balances during the period due to the appreciation of the Canadian dollar compared to the US dollar.
Finance Income
Finance income, consisting solely of interest income, totaled $47 thousand in the three months ended March 31, 2016 compared to $104 thousand in the three months ended March 31, 2015. Interest income represents interest earned on cash and cash equivalent and investment balances.

Aptose Biosciences Inc.
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(unaudited)

Three Three
months ended months ended
(amounts in 000’s of Canadian Dollars except for per common share data) March 31, 2016 March 31, 2015
REVENUE $ - $ -

EXPENSES

Research and development 2,315 884

General and administrative 2,608 2,729

Operating expenses 4,923 3,613

Finance expense 196 60

Finance income (47 ) (104 )

Net financing income 149 (44 )

Net loss and comprehensive loss for the period 5,072 3,569

Basic and diluted loss per common share $ 0.42 $ 0.30

The press release, the financial statements and the management’s discussion and analysis for the quarter ended March 31, 2016 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml

Provectus Biopharmaceuticals, Inc. Reports First Quarter 2016 Financial Results

On May 10, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported its financial results for the first quarter 2016 ended March 31, 2016 (Press release, Provectus Pharmaceuticals, MAY 10, 2016, View Source [SID:1234512317]).

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First Quarter Results and Balance Sheet Highlights

Our cash and cash equivalents were $9,760,997 at March 31, 2016, compared with $14,178,902 at December 31, 2015. The decrease of approximately $4.4 million was due primarily to the $8.0 million in cash used to fund our operating activities for the quarter offset by $3.6 million in cash received from the warrant exchange offer in the quarter ended March 31, 2016. Additional sales of common stock have been reduced since we are seeking to minimize dilution to our existing stockholders where practicable by limiting the issuance of our equity securities.

By managing variable cash expenses due to minimal fixed costs, we believe our cash and cash equivalents on hand at March 31, 2016, will be sufficient to meet our current and planned operating needs until into 2017 without consideration being given to additional cash inflows that might occur from the exercise of outstanding warrants or future sales of equity securities.

Shareholders’ equity at March 31, 2016 was $14,184,248. This compares to shareholders’ equity at December 31, 2015 of $16,316,941.

For additional information regarding Provectus’ results of operations and financial condition for the first quarter ended March 31, 2016, please see Provectus’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2016.

AVEO Oncology Reports First Quarter 2016 Financial Results and Provides Business Update

On May 10, 2016 AVEO Oncology (NASDAQ:AVEO) reported financial results for the first quarter ended March 31, 2016 (Press release, AVEO, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2167104 [SID:1234512200]).

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"We achieved several important goals in the first quarter critical to advancing the corporate strategy we outlined early in 2015. This includes the submission and validation of an MAA filing in Europe for tivozanib in front-line RCC by our partner EUSA Pharma and the licensing of AV-203 outside of North America by CANbridge Life Sciences. In addition, we also announced the filing of provisional patent applications and the initiation of partnership discussions for AV-353, a legacy discovery program which we will look to develop and commercialize in PAH through a global partnership." said Michael Bailey, president and chief executive officer. "These accomplishments, coupled with our noteworthy progress in 2015, have allowed us to retain significant North American rights to develop our three oncology-focused clinical programs, while positioning five programs to be advanced by partners. We believe these initiatives have the potential to unlock significant future value for patients as well as our shareholders."

Mr. Bailey concluded: "Our next steps in the development of tivozanib in North America include the potential initiation of TIVO-3, a Phase 3 U.S. pivotal study of tivozanib designed to support a first- and third-line indication in renal cell cancer (RCC), and a tivozanib-PD1 combination study in RCC. The Company continues to work toward the potential initiation of patient enrollment in the TIVO-3 Study in the second quarter of 2016."

Recent Highlights

Filing of Provisional Patent Applications for AV-353, a Notch 3-Specific Inhibitor Antibody for PAH. In May 2016, AVEO announced that it had filed provisional patent applications with the United States Patent and Trademark Office covering composition of matter claims for AV-353, the Company’s potent inhibitory antibody specific to Notch 3 for development in Pulmonary Arterial Hypertension (PAH). These patent applications are the second set of applications related to AV-353 and the Company’s Notch 3 antibody program. Current treatments in PAH focus only on controlling symptoms by avoiding vasoconstriction and increasing vasodilation of vessels and do not reverse the underlying cause of the disease. In contrast, with the results of a recently concluded research study supported by AVEO, AV-353 has generated a growing body of preclinical data that supports AV-353’s ability to potentially reverse the disease phenotype, which would represent a potential disease-modifying approach to treatment. Consistent with the Company’s focus on developing oncology therapeutics, AVEO is currently seeking an appropriate partner to develop and commercialize AV-353 worldwide in PAH.
Exclusive Licensing Agreement for AV-203 Outside of North America with CANbridge Life Sciences. In March 2016 AVEO and CANbridge Life Sciences announced an exclusive collaboration and license agreement in which AVEO has granted CANbridge worldwide rights, excluding the United States, Canada, and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate. CANbridge plans to develop AV-203 first in esophageal squamous cell cancer (ESCC). Under the terms of the agreement, CANbridge is obligated to pay AVEO an upfront payment of $1 million plus up to $133 million in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives. AVEO is also eligible for a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in CANbridge’s territories. CANbridge will be responsible for costs associated with the execution of a development plan that includes additional manufacturing requirements as well as pre-clinical and clinical studies necessary to demonstrate proof-of-concept for AV-203 as a treatment for ESCC, including a Phase IIa proof-of-concept study meeting mutually agreed upon criteria. Following completion of the proof-of-concept studies, AVEO and CANbridge will negotiate a possible agreement under which the parties may co-develop AV-203, with each party bearing a percentage of the cost of global development activities based on respective geographic rights.
Submission and validation of a European Marketing Authorization Application for Tivozanib in Renal Cell Carcinoma. In February 2016, AVEO and its European partner, EUSA Pharma announced that EUSA Pharma submitted and received a validation notice for the Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for tivozanib as a first line treatment for renal cell carcinoma (RCC).
Acceptance of Registration Dossier for Tivozanib in RCC by the Ministry of Health of the Russian Federation. In February 2016, AVEO announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced RCC has been accepted by the Ministry of Health of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group, AVEO’s licensing partner in Russia, Ukraine and CIS.
Receipt of $3.5 Million AV-380 Inventory Reimbursement Payment from Novartis. AVEO previously announced that Novartis exercised its right under its license agreement for AV-380, AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), to acquire AVEO’s inventory of clinical quality drug substance. This reimbursement payment of approximately $3.5 million was received in the first quarter of 2016.
First Quarter 2016 Financial Highlights

AVEO ended Q1 2016 with $23.8 million in cash, cash equivalents and marketable securities. The reduction in cash over base operations was primarily attributable to clinical trial startup costs related to the TIVO-3 study and a significant pay down in accounts payable quarter over quarter.
Total collaboration revenue in Q1 2016 was approximately $1.2 million compared with $0.1 million for Q1 2015. The increase was primarily due to an additional $1.0 million in revenue recognized in the first quarter of 2016 in connection with our out-licensing agreement with CANbridge, which was executed in March 2016.
Research and development (R&D) expense was $6.0 million in Q1 2016 compared with $2.7 million for Q1 2015. The increase was primarily attributable to an increase in tivozanib clinical trial costs associated with our preparation for a planned Phase 3 trial.
General and administrative (G&A) expense was $2.5 million in Q1 2016 compared with $3.3 million for Q1 2015. The decrease was primarily the result of a decrease in external legal costs associated with various ongoing legal matters, and a decrease in employee compensation, consulting, facilities and IT costs as a result of our decreased headcount and the reduction of our utilized facility space following our January 2015 restructuring.
There was no restructuring and lease exit expense in Q1 2016, compared with $4.3 million for Q1 2015. The expenses incurred during the three months ended March 31, 2015 related to the January 2015 restructuring, which was substantially completed in March 2015.
Net loss for Q1 2016 was $7.7 million, or a loss of $0.13 per basic and diluted share, compared with net loss of $10.9 million, or a loss of $0.21 per basic and diluted share for Q1 2015.
Financial Guidance

AVEO believe that its cash resources would allow the Company to fund its current operations into the fourth quarter of 2017. This estimate does not include the payment of potential licensing milestones to third parties or the uncommitted costs of conducting any contemplated clinical trials (such as a second phase 3 trial and PD-1 combination trial for tivozanib in RCC), and assumes no milestone payments from our partners, no additional funding from new partnership agreements, no equity financings, no debt financings, no accelerated repayment thereof and no further sales of equity under our ATM.

Aradigm Announces First Quarter 2016 Financial Results

On May 10, 2016 Aradigm Corporation (NASDAQ: ARDM) (the "Company") reported financial results for the first quarter and three months ended March 31, 2016 (Press release, Aradigm, MAY 10, 2016, View Source [SID:1234512241]).

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Liquidity and Capital Resources

On April 22, 2016, the Company announced the pricing of $23 million of its senior convertible notes due 2021 and related warrants to purchase 263,436 shares of the Company’s common stock in a private placement conducted pursuant to Regulation D under the Securities Act of 1933, as amended. The initial conversion rate will be 191.9386 shares of common stock for each $1,000 principal amount of notes, which represents an initial conversion price of approximately $5.21 per share of common stock. Interest on the notes will be paid semi-annually in arrears at the rate of 9% per year. The warrants are exercisable at an exercise price of $5.21 per share beginning on the later of 180 days after the date of issuance or the date the Company issues a press release announcing data related to the ORBIT-3 and ORBIT-4 Phase 3 pivotal clinical trials in non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic respiratory infections with Pseudomonas aeruginosa treated with the Company’s investigational product Pulmaquin (proprietary formulation of inhaled ciprofloxacin). The first closing of the sale of the notes and warrants occurred on April 25, 2016, and the second closing is expected to occur immediately after the Company’s resale registration statement to be filed in connection with the offering has been declared effective, each subject to customary closing conditions.

The Company intends to use the net proceeds from the offering, estimated to be $20.7 million, to fund the current clinical development and regulatory submission for licensure of Pulmaquin and for general corporate purposes.

As of March 31, 2016, the Company reported cash and cash equivalents of $22.4 million which did not include the proceeds from the first closing of the private placement offering of $23 million senior convertible notes.

First Quarter 2016 Financial Results

The Company recorded $6,000 in revenue in the first quarter of 2016 compared with $8.8 million in revenue in the first quarter of 2015. The reduction in revenue occurred because the Company utilized in prior periods the full amount of the $65 million of Grifols-funded budget provided under the inhaled ciprofloxacin collaboration arrangement for funding the bronchiectasis program.

Total operating expenses for the first quarter of 2016 were $8.1 million, compared with total operating expenses of $9.9 million for the first quarter of 2015. The decrease in research and development expenses was due to lower contract manufacturing and clinical trial costs because the manufacturing, labeling and packaging expenses for clinical supplies and the enrollment activities of the Pulmaquin Phase clinical trials are complete, offset by higher employee-related expenses due to the higher number of employees and higher consulting expenses in support of the Pulmaquin bronchiectasis regulatory process towards US and EU approvals for market authorization. General and administrative costs were higher primarily due to increased non-cash stock compensation expense and slightly higher legal expense.

Net loss for the first quarter of 2016 was $8.1 million or $0.55 per share, compared with a net loss of $1.2 million or $0.08 per share in the first quarter of 2015. Net loss increased due to lower contract revenue of $8.7 million, partially offset by lower operating expenses of $1.8 million.

About Pulmaquin

Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas aeruginosa. Pulmaquin is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of patients with non-CF BE who have chronic lung infections with Pseudomonas aeruginosa.

Following Phase 2a development of the liposomal portion of Pulmaquin (Lipoquin) and Phase 1 development of Pulmaquin, the Phase 2b study ORBIT-2 with Pulmaquin was a 24-week multicenter, randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE subjects. This study demonstrated a significant reduction in P.aeruginosa sputum activity (p=0.002) and a decrease in time to first exacerbation in the per protocol population (p=0.046) and the mITT (p=0.057) populations in the Pulmaquin treated subjects compared to placebo. Overall, the incidence of all treatment emergent adverse events was similar between groups. The most frequently reported treatment related adverse events (reported by ≥ 3 patients in either treatment group) included product taste abnormal and nausea in the Pulmaquin group and wheezing in the placebo group. No serious adverse events were considered treatment related. There were no deaths reported during ORBIT-2.

The Phase 3 clinical program for Pulmaquin in non-CF BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial has enrolled patients (278 in ORBIT-3 and 304 in ORBIT-4) into a 48-week double-blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double-blind period is being evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator.

Aradigm has been granted orphan drug designations for liposomal ciprofloxacin as well as for ciprofloxacin for inhalation for non-CF BE in the U.S. In addition, the U.S. Food and Drug Administration (FDA) has designated Pulmaquin as a Qualified Infectious Disease Product (QIDP). The QIDP designation is granted for treatment of non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa. The QIDP designation made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014.

In 2013, Aradigm granted an exclusive, world-wide license for the Company’s inhaled liposomal ciprofloxacin product candidates for the indication of non-CF BE and other indications to Grifols S.A. More information on the terms of this license may be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 13, 2014.

About Non-Cystic Fibrosis Bronchiectasis

Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.

Celator® Pharmaceuticals Announces First Quarter 2016 Financial Results and Business Update

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.