Nymox Pharma (NASDAQ:NYMX) is developing a new treatment (NX-1207) for prostate disease with ongoing pivotal Phase III clinical trials for benign prostatic hyperplasia (BPH) and a Phase II clinical trial for low-risk, localized prostate cancer.
NX-1207 (click here for a published medical journal overview of the drug from late 2011) is an injection (classified as a therapeutic protein which triggers the process of programmed cell death or apoptosis) administered by a urologist in an office procedure that takes a few minutes and results in a smaller prostate with the goal of relieving BPH symptoms such as trouble urinating or removing cancerous prostate tissue.
NX-1207 has been well tolerated in previous clinical trials with a strong safety record to date and does not require any type of numbing agent (anesthesia) or catheterization in an office procedure that involves little in the way of pain or discomfort to patients. Previous Phase II clinical trials have demonstrated significant improvement in BPH symptoms after a single treatment compared to BPH drugs which must be taken every day. Recently presented follow-up results have demonstrated a long-lasting benefit from treatment with NX-1207, persisting for 7+ years after a single treatment without the need to take BPH drugs every day.
In March, Nymox announced a positive DMC safety review for an ongoing Phase II low-risk prostate cancer trial (ClinicalTrials.gov ID NCT01620515 with results expected mid-2013). In addition, NCT00918983 and NCT00945490 are the ClinicalTrials.gov identifiers for two ongoing larger pivotal Phase III clinical trials for the treatment of BPH (Study -0017 is fully enrolled as of November 2012 with results expected during Q4 2013 and Study -0018 is ongoing with results expected during Q1 2014). In January, Nymox announced positive six-month safety results from open-label Phase 3 retreatment study.
Recordati is the company's partner in Europe which began a pivotal (EU) Phase 3 clinical trial in February 2012 and paid Nymox approximately $13.1 million (USD) upfront in December 2010 with additional potential milestone payments pending.
Nymox also markets the following tests under FDA and CE Mark (Europe) marketing clearance:
NicAlert is a simple, cost-effective test to determine smoking status. It is an easy to read test strip that can be used with either saliva or urine samples.
TobacAlert is a home test that provides a quick, accurate, on-the-spot determination of a person's level of exposure to tobacco products including second-hand smoke.
Below is a summary of the financial stats for Nymox (click here for the Company's SEC annual report filing):
- As of 3/15/13, Nymox reported 33.7 million shares of common stock outstanding, no debt and 5.9M options that are currently vested with a strong track record of minimal dilution to shareholders (i.e. at year-end 2010, the company reported 31.9M shares of common stock outstanding and has raised a relatively low total of $70.5M since incorporation in 1995 from the issuance of common stock).
- During 2012, Nymox reported revenue of $0.45M vs. $0.5M in 2011, an operating loss of ($7.6M) in 2012 and approximately $1M in cash at year-end 2012 with an additional $1M raised in early February as outlined below.
- Paul Averback is the Company's CEO and President and a medical doctor who invented the technology behind NX-1207 who owns approximately 11.8M shares (35% ownership stake) following the sale of 465,000 shares through a private transaction announced on 4/2/13 that was conducted for financial planning purposes with no plans at this time to sell or acquire additional shares in the company.
Below is a summary of the company's financing agreement with Lorros-Greyse Investments and recent history of the common stock private purchase agreement that is expected to provide adequate funding for the next 12+ months as outlined in the recently filed annual report:
May 23, 2012: 132,100 common shares were issued by Nymox at a price of $7.57 per share.
August 2, 2012: 88,087 common shares were issued by Nymox at a price of $5.96 per share.
September 20, 2012: 95,652 common shares were issued by Nymox at a price of $5.75 per share.
October 30, 2012: 82,781 common shares were issued by Nymox at a price of $6.04 per share.
November 28, 2012: 160,000 common shares were issued by Nymox at a price of $6.25 per share.
A new agreement is effective as of December 2012 for the purchase of up to $15M of Nymox common stock at a 3% discount to the current market price over a 24-month period:
On February 4, 2013: 153,610 common shares were issued by Nymox at a price of $6.51 per share. As of 3/15/13, $NYMX had approximately $14M of financing available under the facility.
Nymox is an under-the-radar stock with a near-term Phase II prostate cancer trial catalyst along with pivotal Phase III BPH clinical trials with initial results expected in late 2013. In the near-term, I expect shares of Nymox to bounce back toward the 50 and 200-day moving averages (upper $5-low $6 target) as the Phase II results approach mid-year (especially if a more exact timeline to announce or present the results is provided).
Many traders may be concerned over the low cash balance, however Nymox has historically financed operations with minimal dilution through a recently renewed agreement with an investment company to sell common stock at a minimal 3% discount as outlined above. Strong results in the Phase III (US) program for NX-1207 could result in a lucrative partnership for the Company as the EU partnership resulted in a relatively low upfront cash payment since there is the risk of successfully completing Phase 3 development.
Based on long-term follow-up data from previous clinical trials, Nymox has a good chance (75%) at success ($8-9 target with positive results vs. $1-2 target with negative results) in the pivotal Phase III trials for BPH which serve as the major upcoming catalyst for the company, although the Phase II prostate cancer trial will provide data sooner around mid-year with a similar estimate for success (low-mid $6 target with positive results vs. upper $3-low $4 target with negative results) in this trial based on the mode of action of NX-1207 to remove cancerous tissue with minimal side effects.