Note* This is our third time covering Celsion in 2017 our Feb. 22nd and June 8th reports are available in the “Our Research” section of the site.
Celsion Corporation (NASDAQ: CLSN) is an oncology drug company, focused on the development and commercialization of directed chemotherapy, DNA-mediated immunotherapy, and RNA based therapy products for the treatment of these cancers:
Primary liver cancer/hepatocellular carcinoma (HCC)
Recurrent chest wall (RCW) breast cancer
Glioblastoma multiforme (GBM)
Oct. 03, 2017. The company announced final clinical and translational research data from its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced Stage III/IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.
- 100% Disease Control; 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated in Four Dose-Escalating Cohorts
- Clear Evidence of Biological Activity Including Dose Dependent Increases in Inflammatory Cytokines (IL-12 and IFN-g), Decreases in VEGF Levels and No Dose Limiting Toxicities
- Expert Advisory Board Endorses Randomized Phase II in Newly Diagnosed Stage III and IV Ovarian Cancer
Sept. 27, 2017. provided a detailed update for the Company’s 550 patient, multinational, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radiofrequency ablation for primary liver cancer (the OPTIMA Study) which include recent investigators meetings in Bangkok, Thailand and Shanghai, China.
- OPTIMA Study Enrollment is Approaching 70%
- Independent Data Monitoring Committee Provided Unanimous Recommendation to Continue Study in August 2017
- Investigators Meetings in Thailand and China Attended by 70% of Investigators in China and Asia-Pacific
Products in Clinical Trials:
ThermoDox® uses LTSL (lysolipid thermally sensitive liposome) technology to encapsulate the commonly used cancer drug doxorubicin. The heat-sensitive liposome rapidly changes structure when heated to 40°C-45°C, creating openings that release doxorubicin directly into and around the targeted tumor. ThermoDox is currently being evaluated in clinical studies for primary liver cancer and recurrent chest (RCW) wall breast cancer.
GEN-1, uses TheraPlas™ technology platform to provide localized immunotherapy. GEN-1 is an interleukin-12 (IL-12) DNA plasmid vector formed into nanoparticles with a lipopolymeric delivery system. It is currently under evaluation for the treatment of ovarian cancer and glioblastoma multiforme (GBM).
Pre-Clinical Product Candidates:
Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor and the most aggressive in the central nervous system, with only one-third of patients surviving for 1 year and less than 5% living beyond 5 years. Local delivery of interleukin-12 (IL-12) genes by GEN-1, in combination with the standard of care, offers a novel approach to GBM treatment.
Lung cancer is the second most common cancer in both men and women and the leading cause of cancer death worldwide. In a mouse lung tumor model, VEGFR-2 siRNA (short interfering RNA) was formulated with TheraSilence LNPs. Intravenous treatment resulted in a significant decrease in VEGFR-2 transcript and a significant reduction in tumors found in the lungs.
Bladder cancer is the fourth most common cancer in men and 12th most common cancer in women. A key difficulty in treating bladder cancer is delivering effective medicine to the bladder wall and muscle. In a recent study of ThermoDox in bladder models, it was demonstrated that warm water irrigation of the bladder can release high concentrations of doxorubicin throughout all layers of the bladder wall.
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies, and RNA- or DNA-based therapies. The Company’s lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer and in Phase II development for the treatment of recurrent chest wall breast cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies.
Q2 Financial Review
For the quarter ended June 30, 2017, Celsion reported a net loss of $4.9 million, or $(0.79) per share, compared to a net loss of $4.5 million, or $(2.63) per share, in the same period of 2016. Operating expenses were $4.7 million in the second quarter of 2017 compared to $4.9 million in the same period of 2016. For the six-month period ended June 30, 2017, the Company reported a net loss of $10.1 million, or $(1.75) per share, compared to $10.2 million, or $(6.04) per share, in the same six-month period of 2016. Operating expenses were $9.6 million in the first half of 2017 compared to $10.2 million in the same period of 2016. Net cash used in operations was $7.3 million in the first half of 2017 compared to $9.0 million in the same period last year. The Company ended the second quarter of 2017 with $3.6 million of total cash and investments, which was subsequently increased with proceeds from a $5 million registered direct offering completed in early July 2017.
Research and development costs were $3.0 million in the second quarter of 2017 compared to $3.3 million in the same period last year. Research and development costs were $6.5 million in the first half of 2017 compared to $6.8 million in the same period last year.
General and administrative expenses were $1.6 million in the second quarter of 2017 compared to $1.5 million in the same period of 2016.
Stock Influences and Risk Factors
The company is reporting positive clinical trial results with some of its product candidates;
The potential market for the company’s product candidates is virtually immeasurable;
The company has a history of significant losses from operations and may incur significant losses for the foreseeable future;
Drug development is an inherently uncertain process with a high risk of failure at every stage of development;
The business depends on license agreements with third parties to permit them to use patented technologies;
Legislative and regulatory changes affecting the healthcare industry could adversely affect the company’s business.
In intra-day trading on Tuesday, October 3, 2017, CLSN shares were at $3.84 (+154.30%) on mid-day volume of 34M shares traded. The current RSI (14-day) is 90.31.
CLSN shares are trading above their 50-day and 200-day moving averages of $1.51 and $3.17 respectively.
Free SMS/Texts for our research reports (see below)
See our track record, it speaks for itself…
Traders News Source recent profiles and track record, 380% in verifiable potential gains for our members on 3 small cap alerts alone! These are just three examples from over two dozen winners this year.
January 31st, 2017 (NASDAQ: HIMX) opened at $5.10/share and hit a high of $9.68/share March 24th, 2017 for gains of 89% within 60 days- http://finance.yahoo.com/news/himax-technologies-review-4q-2016-130000319.html
May 23rd, 2016- (NYSE: XXII) opened at $.87/share hit a high of $3.03/share so far our member potential gains- 248% – http://mailchi.mp/tradersnewssource/updates-5-of-our-profiles-for-212-400-and-whats-coming-next?e=[UNIQID]
(NASDAQ: OBCI) coverage began February 7th, 2017 opening at $4.10/share. This coverage was due to the consistent exceptional quarterly growth coupled with a special divvy issued last year and as anticipated was announced again this year. So far OBCI has traded as high as $5.90/share for potential gains of 43% so far. http://mailchi.mp/tradersnewssource/updates-5-of-our-profiles-for-212-400-and-whats-coming-next?e=[UNIQID]
These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So, if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.
We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.
Big Opportunities Trading Small Cap Stocks
We have had the #1 gainer on the entire NASDAQ exchange the day of our profile 8 times this year so far and one that was the #1 gainer on the exchange two days in a row (NASDAQ: SPEX) moved from $1.01 to $4.75/ share within three days.
That is results!
***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP – SMS/text alert service for free, simply text the word “Traders” to the phone number “25827” from your cell phone***
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.