Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) TSC Study Data Published In JNS

Diffusion Pharmaceuticals Inc (NASDAQ:DFFN)

Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) a clinical stage biotech firm focused on the advancement of unique small molecule therapeutics targeting cancer and other hypoxia-related diseases, stated that the report from its Phase 1/2 clinical study assessing the efficacy and safety of trans sodium crocetinate in glioblastoma multiforme has been published in the peer-reviewed “Journal of Neurological Sciences” (JNS).

The update

Report from the Phase 1/2 clinical study in 59 patients demonstrated that 36.3% of the TSC dose patients lived two years, as against the historical two-year survival rates in a range of 27% to 30%. TSC, Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) lead product candidate, is developed to target the tumor’s lowered oxygen microenvironment. The drug re-oxygenates cancerous tissue, hence making the cancer cells more prone to existing radiation therapy and chemotherapy.

David Kalergis, the Chairman and CEO, reported that the publication of the report in the JNS offers peer-reviewed validation and increases the visibility of Diffusion across major stakeholder audiences. The very promising report from Phase 1/2 clinical study supports their plan to advance into Phase III clinical advancement.

The article outlines the report of a Phase 1/2 study intended to evaluate the therapeutic impact of adding TSC to radiation treatment in 59 diagnosed GBM subjects. In this study, all subjects received radiation with the medicine temozolomide beginning either after biopsy or surgery of the tumor.

TSC was given around 45 minutes prior to each radiation session 3 days per week over the 6 weeks of radiation treatment. Considerable tumor shrinkage was noted in many subjects, with tumors in 11 subjects disappearing completely.

Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) reported that JNS is the peer-reviewed periodical of the American Association of Neurological Surgeons. Its data was previously issued in the web edition of JNS last year and was originally reported in July 2015.

Oxygen deprivation at the cellular level is the product of rapid tumor growth, prompting the tumor to expand its blood supply. Cancerous tumor cells flourish with hypoxia and the resultant variations in the tumor microenvironment lead in “treatment-resistance” to chemotherapy and radiation therapy.

Using a unique, proprietary mechanism of action, Diffusion Pharmaceuticals Inc (NASDAQ:DFFN)’s lead drug TSC neutralizes tumor hypoxia , and hence treatment-resistance by carefully re-oxygenating tumor tissue.

In the last trading session, the stock price of Diffusion Pharmaceuticals jumped over 28% to close at $3.16. The 52-week high of the stock is $26 while the 52-week low point is noted at $2.53. After the recent gain, the market cap stands at around $32 million.

 

3/20/2017
Ticker Symbol DFFN
Last Price a/o 3:21 PM EST  $3.16
Average Volume  317.21K
Market Cap (mlns)  $32.71M
Shares Outstanding (mlns) 10.35M
Share Float (mlns) 6.85M
Inside Ownership
Short Float 0.32%
Short Interest Ratio 0.07
Quarterly Return 25.40%
YTD Return 39.82%
Year Return -68.40%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Pulmatrix, Inc. (NASDAQ:PULM) Getting Love From Traders

Pulmatrix, Inc. (NASDAQ:PULM)

Pulmatrix, Inc. (NASDAQ:PULM) reported Q4 2016 an full year earnings yesterday as well as providing a programmatical update on their pipeline. Today PULM shares are being traded in high volumes. The listed average trading volume is 4.5 million but by lunchtime EST over 14 million shares of PULM has traded hands. PULM opened at $2.35, reached a high of $3.77, and has traded between $3.20 and $3.40 from 11:30 – 12:30 EST.

Pulmatrix, Inc. (NASDAQ:PULM) Financials

Pulmatrix, Inc. (NASDAQ:PULM) reported Q4 revenues of $0.12 million versus $0.28 million in Q4 2015. Q4 earnings were -$9.83 in Q4 2016 compared to -$4.54 million in Q4 2015. EPS was a loss of -$0.66 for Q4 2016 against a Q4 2015 loss figure of -$0.31. Revenue for 2016 was $0.8 million, compared to $1.2 million for 2015. Net loss for 2016 was $27.8 million compared to a net loss of $26.2 million in 2015.

Pulmatrix, Inc. (NASDAQ:PULM) Programmatical Update
  • The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Pulmatrix’s wholly-owned drug candidate PUR1900. PUR1900 combines a previously approved anti-fungal drug with its proprietary dry powder iSPERSETM delivery platform to effectively deliver to the lungs a drug used to treat pulmonary fungal infections in patients with cystic fibrosis (CF).
  • Completed the pilot study of PUR0200 for patients with chronic obstructive pulmonary disease (COPD) and announced positive pharmacokinetic bioavailability data that informed our continued development of PUR0200 for European Registration.
  • Announced that its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, had been designated as a “Qualified Infectious Disease Product” (QIDP) by the U.S. Food & Drug Administration.
  • Pulmatrix, Inc. (NASDAQ:PULM) closed two registered direct offerings that brought in net proceeds of approximately $7.5 million.

Lexington, MA-based Pulmatrix, Inc. (NASDAQ:PULM) is not followed by any analysts. PULM shares have a 52-week low of $0.50 and a 52-week high of $6.98. 29% of its shares are owned by institutional investors and 26.5% of its shares are owned by insiders. PULM shares enjoy what many believe is an attractive trading range. Its Average True Range (ATR) is $0.50.

3/17/2017
Ticker Symbol PULM
Last Price a/o 12:42 PM EST  $                      3.33
Average Volume                4,500,000
Market Cap (mlns)  $                    43.52
Sales (mlns) $1.00
Shares Outstanding (mlns) 18.6
Share Float (mlns) 16.7
Shortable Yes
Optionable Yes
Inside Ownership 26.44%
Short Float 6.02%
Short Interest Ratio 0.22
Quarterly Return 277.42%
YTD Return 296.61%
Year Return -27.41%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance.

Is Sunshine Returning to Seres Therapeutics Inc. (NASDAQ:MCRB)?

Seres Therapeutics Inc. (NASDAQ:MCRB)

Seres Therapeutics Inc. (NASDAQ:MCRB) shares closed Wednesday at $9.27, then, on Thursday, MCRB gapped up to open at $10.00 before reaching a high of $13.32 and closing at $12.71. MCRB has a history of gapping and not always up. In the last week of July, MCRB was trading above $35 and gapped down to open below $10. Since that down move, the stock has gapped up three times but none with the force of Thursday’s move which saw a price gain of over 37%.

Seres Therapeutics Inc. (NASDAQ:MCRB) reported in July that its Phase 2 trial (Ser-109) did not meet its primary endpoint. Ser-109 was studying the effectiveness of its lead drug candidate, Ecospor, on patients with gastrointestinal diseases – specifically patients with recurrent Clostridium Difficile infection (CDI). That news wiped out over 70% of shareholder equity.

Fast forward to Thursday when Seres Therapeutics Inc. (NASDAQ:MCRB) released financial results and a programmatical update.

Financials

Seres Therapeutics Inc. (NASDAQ:MCRB) reported a net loss of $91.6 million for the full year, as compared to a net loss of $54.8 million for the prior year. Seres reported a net loss of $25.3 million for the fourth quarter of 2016, as compared to a net loss of $19.6 million for the same period in 2015. The increase in fourth quarter net loss was driven primarily by continued growth in clinical and development expenses as well as increased headcount, and ongoing development of the company’s therapeutic platform.

Programmatical Update
  • Seres Therapeutics Inc. (NASDAQ:MCRB) has consulted with the FDA and has received approval to perform an additional Phase 2 clinical trial for SER-109 (Ecospor III) in approximately 320 patients with multiply recurrent Clostridium difficile infection (CDI).
  • Seres continued to advance the SER-287 Phase 1b clinical study in subjects with mild-to-moderate ulcerative colitis who have failed first line therapy.
  • Seres continued to advance the SER-262 Phase 1b clinical study in patients with primary C. difficile infection. SER-262, an Ecobiotic®, rationally-designed, fermented microbiome therapeutic candidate, is the first synthetically-derived and designed microbiome therapeutic candidate to reach clinical-stage development.
  • Seres continued to strengthen its intellectual property estate related to microbiome therapeutics. The United States Patent and Trademark Office issued a new patent (#9,585,921), assigned to Seres, covering compositions for treating multiple gastrointestinal diseases associated with dysbiosis of the microbiome.

Interested parties should be aware that Seres Therapeutics Inc. (NASDAQ:MCRB) has never reported any sales. Seres’ EPS has been negative each year since 2012 and had its worst year in 2015 when it reported an EPS loss of -$2.33. However of the six firms that cover MCRB, five rate the shares as a “Strong Buy” while one rates the shares as a “Hold”.

3/17/2017
Ticker Symbol MCRB
Last Price a/o 8:07 AM EST  $                    12.98
Average Volume                    223,400
Market Cap (mlns)  $                  515.64
Sales (mlns) $18.70
Shares Outstanding (mlns) 40.57
Share Float (mlns) 32.93
Shortable Yes
Optionable Yes
Inside Ownership 18.72%
Short Float 7.97%
Short Interest Ratio 11.74
Quarterly Return 37.85%
YTD Return 28.38%
Year Return -48.52%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Lipocine Inc (NASDAQ:LPCN) Initiates Dosing Validation Trial

Lipocine Inc (NASDAQ:LPCN)

Lipocine Inc (NASDAQ:LPCN), a specialty pharmaceutical firm, released operational and financial results for the year closed December 31, 2016. The company initiated both a Dosing Flexibility (“DF”) trial and Dosing Validation (“DV”) trial for LPCN 1021, an oral testosterone drug candidate for testosterone replacement therapy in adult males for problems linked to an absence or deficiency of endogenous testosterone, also termed hypogonadism. Top-line data from both trials are anticipated in the second quarter of 2017.

The update

Lipocine Inc (NASDAQ:LPCN) obtained additional guidance pertaining pivotal Phase III clinical trial design from the U.S. FDA for LPCN 1107 – a unique oral hydroxyprogesterone caproate drug candidate that has been given orphan drug designation by the U.S. FDA, in advancement for the proposed indication of mitigating the risk of preterm birth in women  having a history of singleton pregnancies. The recent guidance obtained is in addition to feedback offered at the end of a Phase II meeting with the U.S. FDA.

Lipocine intends to file the LPCN 1107 Phase III protocol with the U.S. FDA through a Special Protocol Assessment in the first half of 2017. Dr. Mahesh Patel, the CEO, Chairman and President, reported that during the quarter and following period, they have recorded notable progress on the advancement of both LPCN 1107 and LPCN 1021. They anticipate this progress to continue in the coming period, with top line data from their on-going LPCN 1021 trials and a SPA submission for LPCN 1107, both anticipated before mid-2017.

Lipocine Inc (NASDAQ:LPCN) posted a net loss of $19.0 million for the full fiscal year of 2016, against a net loss of $18.2 million for the full fiscal of 2015. In 2016, research and development expenses came in at $8.1 million, versus $12.6 million for FY2015. This change was mainly due to lower contract research firm and consultant expenses of $3.8 million. In addition, during the preceding year, the company recorded a fee of $2.3 million to file an NDA for LPCN 1021 with the U.S. FDA. These declines in FY2016 were offset by a jump in validation and commercial batch production costs for LPCN 1021 in FY2016 of $1.7 million

HC Wainwright has set a $25 target price on Lipocine Inc (NASDAQ:LPCN) in a research report released earlier in this week. The firm currently has a ‘Buy’ rating on the stock. Canaccord Genuity released a target price of $15 on LPCN and specified a ‘Buy’ rating.

3/17/2017
Ticker Symbol LPCN
Last Price a/o 3:21 PM EST  $4.13
Average Volume  135.64K
Market Cap (mlns)  $75.99M
Shares Outstanding (mlns) 18.40M
Share Float (mlns) 17.40M
Inside Ownership 15.94%
Short Float 8.08%
Short Interest Ratio 10.37
Quarterly Return 16.01%
YTD Return -12.23%
Year Return -59.39%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Biogen Inc (NASDAQ:BIIB) Appoints Anirvan Ghosh As SVP, Research and Early Development

Biogen Inc (NASDAQ:BIIB)

The potential upsides of Biogen Inc ( NASDAQ:BIIB) are slowly deteriorating, and street analysts are taking note. Its stock was downgraded not by just one but by two major research houses yesterday, sending the stock lower. Geoffrey Porges was one of the analysts to downgrade the stock, lowering its stance to “Market Perform” from “Outperform.” Per Porges, the downgrade comes on a slower than projected ramp for Spinraza, and the closure of a series of key catalysts that have emerged over the last few months.

Biogen Inc (NASDAQ:BIIB) reported the appointment of Anirvan Ghosh, Ph.D., as SVP, Research and Early Development. Dr. Ghosh will head company’s RED unit in the development and discovery of drug candidates from fresh idea through proof of concept. He would be reporting to Michael Ehlers, M.D., Ph.D., EVP, Head of R&D. Dr. Ghosh will commence his service at Biogen next month.

The update

Dr. Ehlers reported that they are thrilled to have Dr. Ghosh join them at Biogen Inc (NASDAQ:BIIB). Prior to this role with Biogen, Dr. Ghosh was associated with E-Scape Bio, where he was chief scientific officer. There he led discovery efforts for neurodegenerative disorders and Alzheimer’s disease. Prior to his association with E-Scape, he was working with Roche, where he guided research and drug discovery for plans addressing neurodegenerative diseases, psychiatric and neurodevelopmental disorders.

On his new role Dr. Ghosh said that Biogen has been a leader in bringing breakthrough drugs to patients with spinal muscular atrophy and multiple sclerosis, as well as finding new ways for Parkinson’s disease, ALS and Alzheimer’s disease, conditions that comprise some of the biggest challenges in medicine.

Prior to joining the industry, he was a professor whose academic research focused on understanding brain development and the impact on it during neurodevelopmental disorders. Dr. Ghosh has authored over 90 scientific publications.

Biogen Inc (NASDAQ:BIIB) is moving to the lead of the line of biotech that have established eye-watering prices for their treatments.

3/17/2017
Ticker Symbol BIIB
Last Price a/o 3:21 PM EST  $278.96
Average Volume  1.58M
Market Cap (mlns)  $60.41B
Shares Outstanding (mlns) 216.56M
Share Float (mlns) 215.33M
Inside Ownership 0.10%
Short Float 1.30%
Short Interest Ratio 1.76
Quarterly Return -2.93%
YTD Return -1.63%
Year Return 11.21%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Why Proteon Therapeutics, Inc. (NASDAQ:PRTO) Pivoted

Proteon Therapeutics, Inc. (NASDAQ:PRTO)

This morning, Proteon Therapeutics, Inc. (NASDAQ:PRTO) released their financial results for the year ending December 31, 2016 and also provided an update on business highlights. The Waltham, MA-based biotechnology firm develops therapeutics to address kidney and vascular diseases.

Financials

Proteon Therapeutics, Inc. (NASDAQ:PRTO) reported no revenues for 2016. Research and Development expenses were $18.9 million which was larger than the 2015 figure of $12.4 million. Total operating expenses increased from $20.9 million in 2015 to $28.7 million for 2016. Proteon’s net loss for 2016 came in at $28.5 million versus the 2015 net loss figure of $21.4 million. The net loss attributable to shareholders on a diluted basis was -$1.72 – lower than in 2015 when PRTO shareholders experienced a net loss per share of -$1.30.

PRTO shares are up over 13%, on heavy volumes, following the news.

Pipeline Highlights

Following the public disclosure of top-line results in December concerning the PATENCY-1 Phase 3 clinical study, Proteon Therapeutics, Inc. (NASDAQ:PRTO) has launched a second Phase 3 study titled PATENCY-2. The second Phase 3 clinical trial was initiated after consultations with the FDA in which it was decided that the study would be amended to reorder the trial’s existing endpoints. The trial as also expanded from 300 to 500 subjects which is believed to be able to provide a greater than 90% power to detect differences between this second Phase 3 trial and the first Phase 3 trial. Proteon is hopeful that if Patency-2 is successful, it will provide a basis to apply for a Biologics License Application which would mandate that no further studies are needed. Proteon is projecting to submit the application in 2019.

Proteon Therapeutics, Inc. (NASDAQ:PRTO) initiated enrollment in a Phase 1 clinical study of vonapanitase in patients with peripheral artery disease (PAD). The multicenter, randomized, double-blind, placebo-controlled Phase 1 dose escalation study is expected to enroll in 2017 up to 24 symptomatic PAD patients being treated with balloon angioplasty of an artery below the knee and to follow each patient for up to seven months. The primary outcome measure of the study will be safety and the secondary outcome measure will be technical feasibility of drug delivery via the catheter.

Proteon Therapeutics, Inc. (NASDAQ:PRTO) is followed by eight analysts. Six rate PRTO shares as a “Hold” while two rate the shares as a “Strong Buy”.

3/16/2017
Ticker Symbol PRTO
Last Price a/o 9:29 AM EST  $                      1.75
Average Volume                    158,500
Market Cap (mlns)  $                  282.00
Sales (mlns) $0.00
Shares Outstanding (mlns) 16.59
Share Float (mlns) 15.35
Shortable Yes
Optionable No
Inside Ownership 0.20%
Short Float 0.99%
Short Interest Ratio 0.96
Quarterly Return -82.83%
YTD Return -10.53%
Year Return -75.00%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

Why Financial Results for Celsion Corporation (NASDAQ:CLSN) Made No Waves

Celsion Corporation (NASDAQ:CLSN)

Celsion Corporation (NASDAQ:CLSN) is a nano-cap biotechnology firm based in Lawrenceville, NJ. Celsion develops cancer treatments. These treatments include directed chemotherapies, DNA-medicated immunotherapy, and RNA-based therapies.

This morning Celsion Corporation (NASDAQ:CLSN) released 2016 financial results. In general, they met expectations and CLSN shares are trading flat in response. Celsion reported a net loss of $22.1 million, or $0.85 per share, compared to a net loss of $22.5 million, or $1.03 per share, in 2015. Operating expenses were $21.1 million in 2016 compared to $21.3 million in 2015. This decrease was primarily due to lower general and administrative expenses and clinical supply costs offset by higher clinical development costs for the Phase 3 OPTIMA Study. Research and development (R&D) costs were constant at $14.6 million in 2016 and 2015.

Celsion Corporation (NASDAQ:CLSN) investors have not had it easy. CLSN shares are down 80% for the year and 4.6% YTD. Still, two analysts continue to rate CLSN shares as a “Strong Buy” and one rates the stock a “Buy”. This could be in anticipation of a successful result in their Phase 3 OPTIMA study which is designed to evaluate the efficacy of ThermoDox – their lead product candidate. ThermoDox is being used I conjunction with standardized RFA in patients with liver cancer. 550 patients in 75 global locations are participating. The primary endpoint is overall survival. The targeted outcome is a 33% increase in overall survival rates. Thermodox is also in a Phase 2 study for the treatment of recurrent chest wall breast cancer.

Celsion Pipeline:

Shareholder Landscape

Aside from the ever-present, expected biotech programmatical challenges, Celsion Corporation (NASDAQ:CLSN) continues to dilute shareholder equity which has propelled shares downward for years. On February 15, 2017 Celsion announced a public offering with expected gross proceeds of $5 million. That announcement sent shares tumbling over 30%. This has continued the trend to issue shares over the years. In 2011 the number of outstanding shares stood at 4.65 million. In the following years the number of outstanding shares grew to 7.73 million, 13.54 million, 18.47 million, and, in 2015, 21.81 million.

Still, traders are active in CLSN. The average daily volume is 2.41 million shares and yesterday over 6.2 million shares traded hands. Insiders are also buying up CLSN. Director Alberto Martinez Jr. purchased 45,000 shares of CLSN worth $9,450 in February. In October, Chairman, President, and CEO Michael Tardugno bought 10,000 shares of CLSN on the open market.

3/16/2017
Ticker Symbol CLSN
Last Price a/o 2:53 PM EST  $                      1.53
Average Volume                2,410,000
Market Cap (mlns)  $                    11.29
Sales (mlns) $0.50
Shares Outstanding (mlns) 38.93
Share Float (mlns) 29.23
Shortable Yes
Optionable Yes
Inside Ownership 1.00%
Short Float 2.02%
Short Interest Ratio 0.25
Quarterly Return -56.39%
YTD Return -4.57%
Year Return -79.29%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT) Releases Updates On Clinical Development Programs

Conatus Pharmaceuticals Inc (NASDAQ:CNAT)

Conatus Pharmaceuticals Inc (NASDAQ:CNAT) released update on its clinical development plans. As of now, the company is advancing Emricasan for the treatment of people with chronic liver disease. The prime focus is on cirrhosis driven by NASH. At the same time, the company is looking forward to EmricasaN for evaluation clinical trials in distinct patient populations.

Last December, Conatus finalized an exclusive option, license and collaboration deal with Novartis (NVS) for the global commercialization and development of Emricasan.

The financial performance

Conatus Pharmaceuticals Inc (NASDAQ:CNAT) reported total revenues of $0.8 million for Q4 2016 compared with $0 million for the same period, a year ago. Total revenues for the reported fourth quarter consisted of collaboration revenue linked to the Novartis deal.

Research and development expenses came at $6.5 million for Q4 2016 as against $4.2 million for Q4 2015. It stood at $20.3 million for the fiscal year closed 2016 as against $16.3 million for the same period, a year earlier. The jump in research and development costs was due to costs linked to emricasan and higher personnel expenses.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT) reported G&A costs came at $3.5 million for Q4 2016 against $1.8 million for Q4 2015. It was $10.3 million for the year closed 2016 as against $7.8 million for FY2015. The increase in general and administrative costs was mainly due to higher expenses for consulting, legal, and personnel costs.

Net loss for Q4 2016 came at $9.1 million as against $6 million for Q4 2015. It came at $29.7 million for FY2016 versus $24.1 million for FY2015.

Earlier in December 2016, Conatus obtained an upfront payment of $50 million under the Novartis deal. In January, the company prepaid a $1 million note to Pfizer which was planned to mature in 2020. Later in February, the company released a $15 million note to Novartis.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT) reported that Cash/cash equivalents stood at $77 million at close of December 2016 versus $36.5 million in the same period, a year ago. This figure is inclusive of marketable securities. The company considers that current financial resources, along with the projected license option exercise record payment and expense reimbursements linked to the Novartis deal, are sufficient to sustain operations and ongoing clinical advancement activities through the close of 2019.

In the last trading session, the stock price of Conatus gained over 6% to close the day at $4.91.

3/16/2017
Ticker Symbol CNAT
Last Price a/o 3:21 PM EST  $4.91
Average Volume  1.99M
Market Cap (mlns)  $127.51M
Shares Outstanding (mlns) 25.97M
Share Float (mlns) 25.19M
Inside Ownership 0.40%
Short Float 4.13%
Short Interest Ratio 0.52
Quarterly Return 159.79%
YTD Return -6.83%
Year Return 158.42%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Why TrovaGene Inc (NASDAQ:TROV) Reported Restructuring Plan?

TrovaGene Inc (NASDAQ:TROV)

TrovaGene Inc (NASDAQ:TROV), a molecular diagnostic firm, released its financial report for the fourth quarter and year closed December 31, 2016. The company also reported a restructuring plan that will support the firm’s expansion into segment of precision cancer therapeutics.

The update

Trovagene reported a license deal with Nerviano Medical Sciences that allows company’s exclusive international commercialization and development rights to PCM-075, which is an oral, investigative medicine and a highly-selective ATP competitive inhibitor of the PLK 1.  A phase I safety trial of PCM-075 was completed in people suffering with advanced metastatic disease. The company intends to advance PCM-075 initially in subjects with acute myeloid leukemia and appears to be initiating a clinical advancement plan this year.

Bill Welch, CEO of TrovaGene Inc (NASDAQ:TROV), reported that they are thrilled to report the implementation of their plan to vertically integrate ctDNA PCM know-how with precision cancer therapeutics by advancing medicines where their deep knowledge of tumor genomics may permit for effective targeting of cancer patients.

TrovaGene Inc (NASDAQ:TROV) projects the restructuring plan will reduce yearly pre-tax costs by almost $8 million per year excluding one-time separation expenses via the decline of almost 30 personnel and costs mainly linked to research, operations and clinical studies.  The company will sustain its CLIA/CAP-accredited lab for clinical services to pharma firms and for internal programs.

A corporate restructuring was required to support Trovagene’s precision cancer therapeutic prospects. They consider the changes to be in the best interest of all investors as they look to establish an industry pioneering precision medicine firm.

TrovaGene Inc (NASDAQ:TROV) recorded a net loss of $8.5 million as against a net loss of $10.2 million for Q3 2016, and a net loss of $7.4 million for Q4 2015.

Total operating expenses came at almost $9.9 million in Q4 2016, slightly down from $10 million in Q3 2016, and a jump from $7.5 million in Q4 2015. Net cash deployed in operating activities in 4Q2016 was $9 million, compared to $7 million in Q3 2016. This quarter-over-quarter jump can be attributed mainly to greater research and development expenses linked with advancement of a multigene panel, a record payment to Boreal Genomics and specific non-recurring administration costs.

As of December 2016, the company had short-term investments and cash/cash equivalents of almost $37.9 million. In the last trading session, the stock price of Trovagene gained more than 6% to close the day at $1.75.

3/16/2017
Ticker Symbol TROV
Last Price a/o 3:21 PM EST  $1.75
Average Volume  245.21K
Market Cap (mlns)  $53.10M
Shares Outstanding (mlns) 30.34M
Share Float (mlns) 27.66M
Inside Ownership 0.80%
Short Float 8.07%
Short Interest Ratio 9.11
Quarterly Return -23.91%
YTD Return -16.67%
Year Return -65.95%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Arena Pharmaceuticlas, Inc. (NASDAQ:ARNA) Gets Financial Boost from Belviq

Arena Pharmaceuticlas, Inc. (NASDAQ:ARNA)

Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) shares are up over 20% in pre-market trading. Trading volumes are heavy. ARNA has a listed average daily volume of just over 1.5 million shares but already in the pre-market over 1 million shares have traded hands and have hit a inter-day high of $1.70. The increased market action comes after the San Diego, CA-based company posted Q4 and full year earnings after the close yesterday.

Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) is a biopharmaceutical company that develops small molecule drugs. Currently Arena has three drugs in its pipeline:

  • Ralinepag – an oral IP receptor for the treatment of pulmonary arterial hypertension.
  • Etrasimod – an oral receptor modulator for the treatment of multiple auto-immune diseases.
  • APD371 – an oral receptor for the treatment of pain in people afflicted with Crohn’s disease.

Arena also has two collaboration efforts:

  • Axovant Sciences Ltd. – marketing and supply agreement for Nelotanserin, a drug for the treatment of people with either dementia or Lewy bodies. Phase 2 clinical trials expected in 2017.
  • Beohringer Ingelheim – research and licensing agreement to identify drug candidates suitable for continued research and development of drug candidates targeting psychiatric diseases.
2016 Financials and History

Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) revenues were reported at $124 million. 21% ($26.3 million) of those revenues were from Belviq product sales and 58% ($72.1 million) were from Belviq upfront payments. Research and development expenses were $66.4 million. Net loss was $22.9 million or $0.09/share. Net income attributable to shareholders on a diluted basis comes in at -$0.16/share. Analysts were expecting revenues of $15.6 million and an EPS loss of -$0.08. Net product sale are being reported at $26.4 million.

In 2015, Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) posted an EPS loss of -$0.45 which was a larger figure than the 2014 EPS loss of -$0.28. Sales for 2014 and 2015 were relatively flat. In 2014 sales were posted at $37 million followed the next year by a figure of $38.3 million.

Four firms follow Arena Pharmaceuticals, Inc. (NASDAQ:ARNA). Two analysts rate ARNA shares as a “Strong Buy” and the other two rate the shares as a “Hold”.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.