Aytu BioScience $10.00 Price Target Reiterated By Northland Securities Ahead Of Spermatogenesis Study Data Release (NasdaqCM: AYTU)

Aytu BioScience $10.00 Price Target Reiterated By Northland Securities Ahead Of Spermatogenesis Study Data Release (NasdaqCM: AYTU)
Northland Securities reiterates $10.00 price target for Aytu BioScience shares. Highlights expanded agreement with Acerus Pharmaceuticals.

Aytu BioScience is once again attracting the eyes of Wall Street analysts with Northland Securities most recently reiterating its BUY rating on shares of AYTU stock. Northland’s most current update on Tuesday, July 30th, sets a 12-month price target for AYTU at $10.00 per share.

Within the report, the Northland Securities’ analyst highlighted several aspects of Aytu’s recently announced co-promotion agreement with Acerus Pharmaceuticals, saying, “We perceive the co-promotion agreement positively as significantly enhances direct selling of Natesto® while placing a higher promotional focus on urologists and endocrinologists. Pre-open, Aytu BioScience announced that it amended its agreement with Acerus Pharmaceuticals, wherein Natesto® (testosterone nasal gel spray for the treatment of Low-T) will be co-promoted with Acerus Pharmaceuticals. Under the terms of the amended agreement and upon closing, Acerus Pharmaceuticals will launch a complementary US commercial team of at least 25 US-based specialty sales reps that will market Natesto® directly to urologists and endocrinologists. This will nearly double the size of the Natesto® field salesforce.”

Natesto® is on investors’ minds as AYTU nears its release of the final results from its Spermatogenesis Study, an Aytu-sponsored analysis that is evaluating the benefits of Natesto® for patients that need the benefits of testosterone treatment but at the same time want to maintain male fertility.


Video Link: http://www.youtube.com/embed/gp9XnGRkK4s

 

Potential Best-in-Class Data For Natesto®

 

Natesto® has been earning its fair share of headlines during the past three months after interim data continues to suggest that the TRT drug can be a best-in-class alternative over competing TRT drugs. The most recent comparisons that position Natesto® favorably against competing products were published in the Journal of Endocrinology, where study analysis showed a unique achievement in favor of Natesto® that resulted in a short-term return of testosterone to the upper normal range (800 ng/dL; 28 nmol/L) irrespective of how low the patient’s baseline testosterone was prior to the study. The data also showed that in the patient group with the lowest baseline testosterone level, a mean average serum testosterone level of 295 ng/dL (10.2 ng/dL) was achieved after Natesto® exposure, bringing that difficult to treat subset of patients back up to healthy testosterone levels.

Notably, the Journal of Endocrinology publication also showed that Natesto® provides statistically significant improvements in symptom relief (erectile function, mood, and lean body mass) in these patients, as well as showing an indication that in-between Natesto® doses, all patients in the phase 3 study maintained their natural testosterone at the same levels they had before entering into the study. That distinction widens the distance between Natesto® and competing TRT products by demonstrating that Natesto® does not suppress endogenous testosterone production due to its lack of effect on the HPG axis. Furthermore, unlike other marketed products, Natesto® shows a unique mechanism of action whereby the peaks in testosterone generated by Natesto® dosing provide efficacy and improvement of symptoms, while the time between doses (4-8 hours) allows for recovery of the HPG axis that does not inhibit LH and FSH secretion, which is essential to stimulate sperm production.

Investors Focused On Near-Term Spermatogenesis Study Data Release

Investors are sharpening their focus toward the final data readout from the company’s sponsored Natesto® Spermatogenesis Study, which is expected to be released later this summer. AYTU is hoping to publish confirming data that will support the already compelling interim data that can help clinch Natesto®’s position as a best-in-class TRT drug that can target a broad patient base in the billion-dollar-plus TRT market. The results of the study can place Natesto® in a unique position to be the only testosterone drug on the market that can offer the benefits of testosterone but at the same time preserve male fertility.

The already published interim data showed substantial evidence to support a potential paradigm shift in how patients with Low-T get treated. The nearly completed Phase 4 prospective Spermatogenesis Study enrolled 56 men aged between 18 and 55 years who had low levels of testosterone (baseline mean, 233.97 ng/dL), with the median age at 37 years old. The encouraging results already known have led to the lead investigator of the trial, Dr. Ranjith Ramasamy, Director of Reproductive Urology at the University of Miami, to say that, “the levels of testosterone in men rise about an hour or 2 after administration [of Natesto®] and seem to drop off about 2 to 4 hours after the peak.” He added, “that is closer to normal physiology than other delivery systems in which the levels of testosterone are pretty high during the day and therefore could lead to some of the side effects that we see with testosterone.”

These study results to date, combined with the notes from the Journal of Endocrinology publication, are considered first of its kind results that can likely push Natesto® as a treatment of choice for prescribing physicians. An additional benefit from the known data is that Natesto® may be in an ideal position to exclusively target and treat the roughly 20% of men with Low T (2 million men or more) that are still in their ‘family formation’ years, but because of the effects that TRT can have on fertility, until now couldn’t be treated with testosterone.

Now supported by at least two sets of independent data that show the benefits of Natesto® over other TRT drugs, AYTU may be the eventual winner in a multi-billion dollar market opportunity. The drug has already been growing in popularity amongst prescribing physicians because of its superior treatment results combined with other advantages that show it to be safer, has a shorter duration of effect, and can be dosed conveniently throughout the day.

 

Setting Up For A Hot Summer

With AYTU stock consolidating at roughly $1.40 per share, its YTD gains of approximately 68% may serve as the support for the stock to move back toward its 52-week high of $4.80 per share ahead of the Spermatogenesis Study data release.

In what may be a hint for what’s to come, AYTU announced in August that the Natesto® Spermatogenesis Study results have been accepted for presentation as a “Late-Breaking Abstract” by the American Society for Reproductive Medicine (ASRM). The study results will be presented at the 75th ASRM Scientific Congress & Expo in Philadelphia, PA October 12-16, 2019.

Notably, the Natesto® Spermatogenesis Study is one of only six abstracts accepted for presentation by ASRM. Abstracts are accepted for presentation based on the impact of the study findings.

Combining the potential of its already marketed drugs to analyst opinion suggesting much higher share prices in the next 12-months, AYTU may be well-positioned for near-term gains. And, with significant partnership and licensing deals announced during the past two quarters, AYTU looks to be in the best operating position in its operating history. And, at current prices, some investors appear to be ignoring the disconnect between intrinsic value and the current market cap. But, with institutional interest and ownership in the stock growing, and with insider ownership also at high levels, the next burst of buying interest, combined to a tight public float, may send the shares considerably higher… based on merit instead of hype.

 

 

 Aytu BioScience is once again attracting the eyes of Wall Street analysts with Northland Securities most recently reiterating its BUY rating on shares of AYTU stock. Northland’s most current update on Tuesday, July 30th, sets a 12-month price target for AYTU at $10.00 per share.

Within the report, the Northland Securities’ analyst highlighted several aspects of Aytu’s recently announced co-promotion agreement with Acerus Pharmaceuticals, saying, “We perceive the co-promotion agreement positively as significantly enhances direct selling of Natesto® while placing a higher promotional focus on urologists and endocrinologists. Pre-open, Aytu BioScience announced that it amended its agreement with Acerus Pharmaceuticals, wherein Natesto® (testosterone nasal gel spray for the treatment of Low-T) will be co-promoted with Acerus Pharmaceuticals. Under the terms of the amended agreement and upon closing, Acerus Pharmaceuticals will launch a complementary US commercial team of at least 25 US-based specialty sales reps that will market Natesto® directly to urologists and endocrinologists. This will nearly double the size of the Natesto® field salesforce.”

Natesto® is on investors’ minds as AYTU nears its release of the final results from its Spermatogenesis Study, an Aytu-sponsored analysis that is evaluating the benefits of Natesto® for patients that need the benefits of testosterone treatment but at the same time want to maintain male fertility.

 

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