Shares of Aytu BioScience, a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, continue to move higher and open the Thursday trade at $1.64 per share. The stock is up more than 60% since January as investors continue to see proof that the management team is gaining momentum in driving revenues higher and penetrating their respective drug markets that could return huge dividends from a combined market opportunity of more than $7 billion.
On Thursday, AYTU announced that it will be attending two conferences for its flagship product, Natesto®. The presentations will take place on March 21-24nd and be presented by Dr. Michael Westfield and Dr. Ranjith Ramasamy. The meetings will take place during the 2nd Annual Androgen Society Meeting in New Orleans. LA., and at the ENDO 2019 conferences. Details of those events are here.
The meetings and presentations are expected to offer credible insight into how Natesto® is working to seize a multi-million dollar market opportunity by concentrating on an exclusive segment of patients, roughly 20,000 men, who need testosterone replacement treatment but want to remain fertile.
Focus On Natesto®'s Spermatogenesis Study Presentation
Of key interest to investors will be the new information learned about the Natesto® Spermatogenesis study. This ongoing study is being conducted at the University of Miami's Department of Urology, and Dr. Ranjith Ramasamy, MD, the Director of Reproductive Urology, is the study's principal investigator.
To date, the data released by the study investigator has been extremely encouraging. The interim read-out showed the restoration of hypogonadal patients’ serum testosterone levels while maintaining normal semen parameters for a larger group of study participants. The results to date continue to confirm the prior results reported on September 17, 2018.
Specifically, normal semen parameters, including sperm concentration, sperm motility, and total motile sperm count (TMSC), were maintained at both three months and six months in hypogonadal men taking Natesto® three times daily. Those results were then presented at a meeting held in conjunction with the 19th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America held in Miami, FL November 8-11, 2018. And, if the results, expected this summer, confirm the preliminary data, Natesto® may quickly become a substantial money maker for AYTU.
The Difference In Natesto®, Spermatogenesis Study
From what AYTU has told investors, testosterone therapy (TTH), as a whole, is known to decrease gonadotropin levels, diminish sperm production and function, and decrease the natural production of endogenous testosterone in men being treated with TTh. And, because of these side effects, maintenance of fertility and family planning is an important discussion topic for more than 2 million men considering TTh. That's what makes the opportunity for Natesto® so compelling.
What Natesto® is proving itself capable of doing is to potentially minimize the impact on sperm production, an event that would be clinically relevant and novel by providing a safe and effective approach for treating men with hypogonadism. And, that data is showing that the “possibility” can soon become “reality” in this lucrative market segment.
The data already released from the study may offer insight to the distinguishing features of Natesto®. The Natesto® Spermatogenesis Study is a single-center, prospective study evaluating testosterone levels, gonadotropin levels, and semen parameters in 40 hypogonadal men between 18 and 55 years of age, receiving treatment with Natesto® testosterone nasal gel over six months. This is the first such study utilizing TTh to evaluate preservation of gonadotropins and fertility while restoring serum testosterone levels. Moreover, the results to date are unmatched in the targeted market.
Interim Analysis Summary:
Thirty-nine patients have been enrolled in the study.
Fourteen Natesto®-treated patients have been evaluated at their three-month treatment timepoint, reflecting one complete sperm cycle.
Nine Natesto®-treated patients have been evaluated at their six-month treatment timepoint, reflecting two sperm cycles.
Zero patients in the study have become azoospermic during the study.
Across the cohort of patients treated for three and six months, all three measured semen parameters were maintained.
Median values of sperm concentration, sperm motility, and total motile sperm count (TMSC) remained statistically unchanged
About these unique and promising results, Dr. Ranjith Ramasamy, the principal investigator of the Spermatogenesis study was quoted as saying,
“About two million men in the US with low testosterone are young and interested in maintaining their fertility. The current options to increase testosterone and simultaneously maintain sperm production are not FDA-approved and therefore need to be used off-label. The interim results from the trial with Natesto® are exciting, and we are optimistic that the final results will be similar to the data reported to date. Increasing testosterone while maintaining fertility with Natesto® could be a paradigm shift in the treatment of men with low testosterone.”
Aytu BioScience Pipeline Grows, Revenues Follow
The news today further clarifies our belief that Aytu BioScience, with its growing drug pipeline, may likely continue its run higher. Not only has AYTU posted three consecutive record breaking quarters, but they have also launched an additional product, Tuzistra® XR that is likely to gain sales traction quickly from its already trained sales force. ZolpiMist, as well, will be contributing revenue to the bottom line in the coming quarter and investors are expecting AYTU to post its fourth consecutive record breaking quarter for both revenue and prescription growth.
At roughly $1.64 per share, AYTU is more than worthy of investor consideration.
The author is LONG Aytu BioScience Stock. Also appeared on Soulstring Report
Disclosure: I am/we are long AYTU.