As a biopharma company, Veru Inc. (NASDAQ: VERU) is mainly focused on clinically developing treatments for breast cancer and prostate cancer while exploring additional diseases to treat. In response to the positive results of its phase 3 clinical trials for its Covid-19 treatment, VERU stock surged and has renewed its run with the publication of its treatment’s trial results – triggering a 20% run. With the company awaiting FDA approval for its EUA application, VERU stock is one to watch in anticipation.
VERU Stock News
Given VERU’s wide range of treatments targeting some of the most devastating and widespread cancers and diseases, investors are bullish on the company’s future – especially after the results of its impressive Covid-19 study. If the company receives FDA approval and moves to commercialize sabizabulin, the revenue influx could help pave the way for its research well into the future.
Covid-19 Treatment
Due to the growing demand for Covid-19 treatments, VERU has been developing its own treatment – sabizabulin – to capitalize on this need. In phase 3 of clinical trials, sabizabulin showed promising results compared to the placebo in 150 patients at high risk for Acute Respiratory Distress Syndrome or death. Sabizabulin effectively reduced deaths by 55% leading the Independent Data Safety Monitoring Committee to recommend that the study be halted early due to the drug’s high efficiency and lack of safety concerns.
With this in mind, VERU plans to submit an emergency use authorization application to the FDA. Given that the FDA granted the company a fast track designation previously, VERU is bullish the emergency use authorization application will be accepted. To facilitate this, VERU is improving its manufacturing process to produce the required supply of sabizabulin in anticipation of the potential FDA authorization.
Given that VERU expects this treatment to generate $1 billion in the US alone, the company is in talks with BARDA and other US government agencies to secure deals for the sale of the drug upon its release. Since sabizabulin is the first drug to show such efficiency in reducing Covid-19 deaths, VERU is well-positioned to emerge as a leader in Covid-19 treatments – likely leading to a huge boost in revenues.
*Updated July 7th
VERU stock gained renewed interest after the results of Sabizabulin’s phase 3 clinical trial were published in the New England Journal of Medicine Evidence. Reaffirming Sabizabulin’s previously shared results, the publication highlighted that patients experienced a 55.2% reduction in mortality, a 26% reduction in days spent in the hospital, and a 43% reduction in days spent in the ICU.
At the same time, Sabizabulin’s side effects were acceptable – showing the drug’s safety for patients. In light of these results, VERU could have a high chance of commercializing Sabizabulin which could assist the company in its ongoing trials for breast cancer and prostate cancer treatments. With this in mind, Sabizabulin’s expected launch to the market for severe Covid-19 could allow the company to become consistently profitable due to the high demand it could receive once it is launched.
Cancer Treatments
While the Covid-19 treatments market is lucrative, VERU’s main focus remains on developing treatments for breast and prostate cancers. Breast cancer is the most prevalent cancer among women in the US and this urgent need led VERU to develop Enobosarm after showing its potential to treat skeletal related cancers. Since then Enobosarm has showed its ability to build muscles and improve physical conditions in clinical studies involving breast cancer patients. Moreover, Enobosarm showed no signs of masculinization, liver toxicity, or changes in the proportion of red blood cells.
To accelerate the release of this treatment, VERU is conducting a phase 3 ARTEST clinical study to test the drug’s efficacy and safety. VERU is also developing a companion diagnostic test in collaboration with Roche/Ventana Diagnostics based on the FDA’s recommendation. Additionally, VERU is conducting a phase 3 ENABLAR-2 clinical study to test Enobosarm’s safety when combined with another treatment for breast cancer. Considering the huge market for safe and effective treatments of breast cancer, VERU stock could be positioned for a run as the company releases updates on these studies.
Meanwhile, 5% of men with prostate cancer in the US develop metastatic cancer and VERU is developing a treatment to ease the suffering of these patients. Currently enrolling patients for its phase 3 VERACITY study, VERU intends to treat 245 men suffering from metastatic castration resistant prostate cancer as well as tumor progression using sabizabulin.
Given sabizabulin’s potential to treat several types of cancer, VERU could soon be developing treatments for lung cancer, leukemia, and pancreatic cancer. If VERU’s treatments prove effective then VERU is in a great position to bring its treatments to market – potentially reporting record revenue increases when its treatments are released.
Yet, VERU is currently developing VERU-100 for treating prostate cancer and is researching the optimal dose for this treatment. With phase 2 results expected soon, VERU intends to begin registration for its phase 3 clinical trials in the first half of the year. VERU-100 could be the first of its kind if approved by the FDA since there are no GnRH antagonists approved beyond a one-month depot injection. This could give the treatment a competitive advantage if VERU-100 is approved.
*Updated July 7th
Preparing to conduct phase 3 VERACITY study, VERU shared the final results of the phase 1b/2 study of Sabizabulin in 80 men with metastatic castration resistant prostate cancer. These results highlighted that Sabizabulin’s oral daily dosing was well tolerated with no reports of neurotoxicity or neutropenia.
In addition, Sabizabulin resulted in cytotoxic and cytostatic anticancer activity, as well as reliable tumor responses. Based on this, the phase 3 study has the potential to become a major success as the potential treatment is already showing encouraging results. With VERU already enrolling patients for the phase 3 study, the company expects to complete the enrollment by EOY. In light of this, VERU stock is one to watch this year in anticipation of its upcoming catalysts.
Sexual Health Division
But in order to fund these trials, VERU continues to grow its sexual health division which manufactures and sells its best-selling product – FC2 Female Condom – which provides protection against STIs and unplanned pregnancy. Marketed as the only “woman controlled” device for preventing STIs and pregnancy, FC2 is catering to a huge market which will help offset the cost of its trials.
At the same time, VERU is developing a new drug – ENTADFI – to treat urinary tract symptoms caused by an enlarged prostate which could have negative sexual side effects. Considering that ENTADFI is only a single pill, VERU is bullish that the new drug will increase compliance since poor compliance could potentially lead to death. Exploring new marketing methods, VERU intends to market and distribute ENTADFI through telemedicine and telepharmacy channels in the US in addition to potential partnerships for marketing the drug globally.
Options Flow
While VERU is still up roughly 165%, using unusualwhale’s option flow it appears that bears were winning out at close, with overall bearish premiums reaching 53.47%. On the bull side a whale bought calls at a $240 thousand premium although bears were the majority for premiums above $30 thousand.
*Updated May 13th
FDA Approval of Emergency Use Authorization
VERU has seen a surge in recent days following a stream of bullish news. The trigger for the stock’s recent uptick was FDA approval for its COVID-19 treatment – sabizabulin – to be submitted for a request for Emergency Use Authorization.
This decision was based on the Phase 3 trial of the treatment which is specifically designed for hospitalized COVID-19 patients at high risk for acute respiratory disease syndrome. This is a significant step forward for the company which now expects to submit its request for an EUA application in Q2. It appears that VERU’s chances for approval are high since sabizabulin demonstrated a clear mortality benefit in hospitalized moderate to severe COVID-19 patients.
Seizing the opportunity, Veru shared that the efficacy data from the trial is enough to support not only the EUA request but for its NDA submission as well. Its additional safety data will be collected while sabizabulin is used under the EUA. If the data collected is enough to support its NDA submission, then VERU will not require additional safety clinical studies.
With this in mind, VERU has begun discussions with various government agencies for government purchases of sabizabulin in the U.S. and other countries. In anticipation of its increased demand, VERU has scaled up its manufacturing processes and will be able to produce commercial drug supply following its authorization.
Based on this, Jefferies raised its price target for the stock after adjusting the peak COVID revenues to nearly $1 billion. The analyst – Chris Howerton – raised its price target from $33 to $55. However, it appears that most analysts give VERU stock a price target near $33.
*Updated July 7th
Looking to start commercializing Sabizabulin, VERU submitted an EUA application to the FDA for Sabizabulin in the treatment of moderate to severe Covid-19. This submission is mainly due to the impressive results shown by Sabizabulin in its phase 3 clinical trial. At the same time, VERU is seeking more approvals for its treatment with global agencies. Given that the company has already scaled up the manufacturing of Sabizabulin, VERU could be poised for a surge in revenues once its application for EUA is approved.
VERU Stock Financials
Interestingly, this bullish news for the company came before its Q2 report missed expectations. Its expected EPS was -$.14, however the company reported an EPS of -$.18 when a year ago it had achieved a loss of only $0.04 per share. However, it beat revenue expectations reporting $13 million rather than than the expected $12.2 million.
Meanwhile, its gross profit increased 2% compared to the same year ago period – reaching $11.2 million for the quarter. At the same time, its operating loss increased substantially from $1.5 million in Q2 2021 to $11.8 million this quarter. This contributed to the company’s total net loss of $14.2 million. The company reported cash and cash equivalents totaling $112 million whereas its total current liabilities amount to $21.1 million. Its assets also total $172.8 million.
Media Sentiment
@SDhillon07 is watching VERU stock for a continuation of its run.
@DB_Daytrades believes VERU stock could retest its $17 resistance if it maintains its run.
Technical Analysis
VERU stock is currently trading at $13.03 and has supports at 11.56, and 9.17. The stock also shows resistances near 13.39, 15.1, and 17.09. Following the publication of Sabizabulin’s phase 3 trial results, VERU stock climbed by as much as 20% overnight on a 30.7 million trading volume. With investors anticipating the FDA’s decision on the company’s EUA application, VERU stock could be a profitable hold this quarter.
Meanwhile, VERU retested its VWAP resistance which is a level bullish investors could watch. If the stock breaks this resistance, VERU stock could reach $15 with high trading volume. However, in case the stock fails to break through this resistance, VERU could fall near $11 where it was trading recently.
Considering the bullish sentiment surrounding Sabizabulin, accumulation spiked after the treatment’s test results were published in the NEJM Evidence. Similarly, the MACD is bullish to the upside. Meanwhile, the RSI cooled off from 79 to 65 which indicates that VERU stock is slightly overbought but with enough room to move up.
VERU Stock Forecast
As the company is awaiting the FDA’s approval for Sabizabulin’s EUA application, VERU stock will likely remain on investors’ watchlists. If the EUA application is approved, VERU could be well-positioned to realize record revenues which could allow it to advance the clinical trials of its deep pipeline of cancer treatments. On that note, VERU is already enrolling patients for its phase 3 VERACITY study and intends to complete the enrollment by EOY. Since the phase 1b/2 study showed encouraging results, VERU could be set to emerge as a leader in the cancer treatments sphere based on Sabizabulin’s uses in treating several types of cancers. Given that pharma stocks usually run on FDA approvals or clinical study results, VERU stock could be one to hold this year as the company’s upcoming catalysts could send the stock soaring to new highs.
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