VERU - HERE’S A ROUND-UP ON VERU INC!
HERE’S A ROUND-UP ON VERU INC!
08 JUL HERE’S A ROUND-UP ON VERU INC!
Positive Results from Phase 3 trial of Sabizabulin
Veru, Inc. (NASDAQ: VERU) announced the publication of results from a Phase 3 study evaluating the safety and efficacy of oral sabizabulin for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death in the New England Journal of Medicine (NEJM) Evidence.
Sabizabulin is a novel dual antiviral and anti-inflammatory agent that underwent a double-blind, randomized, multicenter, and global placebo-controlled study to test oral, once-a-day dosing of sabizabulin 9 mg versus placebo in 210 hospitalized patients who were at high risk for ARDS and death. The multicenter trial was conducted in the United States, Brazil, Colombia, Argentina, Mexico, and Bulgaria, and patients were randomized 2:1 ratio to the sabizabulin treatment group versus placebo. The patients in both groups were allowed to get standard of care treatment, including remdesivir, dexamethasone, anti-IL6 receptor antibodies, and JAK inhibitors.
Furthermore, the variants treated included Delta and Omicron. The study was halted early based on the recommendation of the Independent Data Safety Monitoring Committee due to the clear efficacy benefit.
The study’s primary endpoint was death at or before day 60, and the candidate demonstrated a 55.2% relative reduction in deaths (p=0.0042) in the intent to treat population (ITT). The placebo group (n=52) had a 45.1% mortality rate compared to the sabizabulin-treated group (n=98), which had a 20.2% mortality rate. Overall, sabizabulin treatment resulted in a 51.6% reduction in deaths compared to the placebo group. The Secondary endpoint was the effects of sabizabulin treatment on mortality through Day 29. The candidate achieved a treatment mortality rate of 17%, compared to a placebo mortality rate of 35.3%. Sabizabulin treatment also showed a 43% relative reduction in days in ICU (p=0.0013), 49% relative reduction in days on mechanical ventilation (p=0.0013), and 26% relative reduction in days in hospital (p=0.0277) compared to the placebo group.
Gary Barnette, Ph.D., Chief Scientific Officer of Veru and co-author of the NEJMEvidence publication, commented,
“We are proud and honored to have the Phase 3 COVID-19 study results published in The New England Journal of Medicine Evidence, a highly prestigious peer-reviewed medical journal. The overall conclusion of this Phase 3 study is that sabizabulin treatment has a clear mortality benefit compared to placebo in hospitalized COVID-19 patients at high risk for ARDS receiving standard of care treatment with no significant safety signals.”
Veru, Inc. (NASDAQ: VERU)
Market Cap: $1.08B; Current Share Price: $13.46
Data by YCharts
Submission of Emergency Use Authorization in Europe
In June 2022, the Company submitted an Emergency Use Authorization (EUA) to the U.S FDA for its sabizabulin oral 9mg treatment, intended to treat moderate to severe hospitalized COVID-19 patients at high risk for developing acute respiratory distress syndrome (ARDS). The submission was based on the positive results of the Phase 3 trial COVID clinical trials, which tested the efficacy and safety of sabizabulin in approximately 204 hospitalized COVID-19 patients at high risk for ARDS and death.
The candidate has the potential to reduce deaths in hospitalized patients and become and play a critical role in fighting covid-19. Veru has already scaled up the manufacturing of sabizabulin 9mg capsules to meet the demand in the U.S and is gearing up to build an infectious disease commercial franchise. Furthermore, the Company is also pursuing EUA approvals with other regulatory agencies in Europe, Great Britain, and other countries and intends to establish a European Infectious Disease Franchise. Discussion is in progress with potential distribution partners for ex-Us territories.
Veru is also engaged in discussions with CMS and BARDA to secure reimbursement for the sabizabulin in case of EUA approval from the FDA.
According to Company estimates, if there is no surge, then it expects to treat 48,556 patients/month in the US, with 57,000 patients expected to be treated in July 2022, over 1000,000 patients in August 2022, and approximately 250,000 patients/month from September onwards.
Veru is also keen on exploring additional indications for sabizabulin to leverage its broad-spectrum anti-viral and anti-inflammatory properties. Potential indications include Influenza, which causes 177,000 hospitalizations among adults 65 years and older and 58,000 hospitalizations among children younger than five years old.
The Company
Veru Inc is an Oncology and urology-focused Biopharmaceutical Company developing therapeutics for the treatment of COVID-19 and other viral and ARDS-related disorders and breast and prostate cancers. The Company is currently engaged in the development of two drugs, enobosarm, and sabizabulin.
Enbosarm is being evaluated in a Phase 3 ARTEST study in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer that the FDA has granted a fast-track designation. In addition, the candidate is also being evaluated in a Phase 3 trial named ENABLAR-2 studying enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer. The Company has entered into a clinical study and a supply agreement with Eli Lilly (NASDAQ: LLY) for the ENABLAR-2 study, with Lilly supplying Verzenio® (abemaciclib).
Besides COVID-19, sabizabulin will be evaluated in a planned Phase 2b study in AR+ ER+ HER2- metastatic breast cancer. The Company’s late-stage prostate cancer portfolio consists of sabizabulin (oral cytoskeleton disruptor) that is being evaluated in the Phase 3 VERACITY trial; VERU-100 (a GnRH antagonist peptide) currently undergoing Phase 2 trials and Zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist, which is being evaluated in a phase 2b trial.
The Company markets female condoms through The Female Health Company, a division that services markets worldwide, including public sector entities in over 140 countries and the U.S prescription market. The company also sells Roman Swipes, medicated swipes for male genital desensitization to prevent premature ejaculation.
Veru also markets ENTADFI™ (finasteride and tadalafil) capsules approved in December 2021 as a treatment for urinary tract symptoms caused by benign prostatic hyperplasia (BPH).
Market Opportunity
According to the World Health Organization (WHO), Coronavirus (CoV) is a family of viruses that cause illnesses ranging from the common cold to lethal diseases such as the Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and a new strain of CoV named, novel coronavirus (nCoV). The virus is Zoonotic as it is transmitted from animals to humans, with the presence of many strains that have not yet infected humans. The infection manifests in respiratory symptoms, cough, fever, and shortness of breath. It can take the form of pneumonia, severe acute respiratory syndrome, kidney failure, and even death.
There is no definite cure or treatment for the eradication of CoV, with treatment being limited to alleviating symptoms and providing support and care to patients. Scientists have been able to sequence the virus’s genetic code, spurring organizations worldwide into action.
The COVID-19 pandemic is likely to become endemic, similar to the seasonal FLU, and countries have already undertaken vaccinations on a war-footing, even in less developed countries. The initial race to create vaccinations is over, with some emerging as clear winners while others are ruining a missed opportunity.
However, new variants are emerging, the most recent being Omicron, designated as a variant of concern by the WHO on 26 November 2021. Omicron has several mutations and is spreading rapidly worldwide, reinfecting those previously affected by COVID-19. Given the same, WHO has recommended countries enhance surveillance, undertake the sequence of cases, and share them on public databases such as GISAID, besides performing field and laboratory assessments.
Financial Results
AS per the Company’s Q2,2022 financial results, the Cash and cash equivalents were $112.0 million as of March 31, 2022, compared to $122.4 million on September 30, 2021. The total net revenues decreased by 2% to $13.0 million from $13.3 million in the same quarter in 2021. US FC2 prescription net revenues grew by 12% to $11.6 million from $10.3 million. Gross profit increased by 2% to $11.2 million from $10.9 million, while gross margin rose to 86% of net revenues from 82% of net revenues.
The YTD total net revenues decreased by 3% to $27.2 million from $28.0 million. The US FC2 prescription net revenues climbed 19% to $23.2 million from $19.4 million. Gross profit increased by 6% to $23.0 million from $21.7 million, while gross margin increased to 85% of net revenues from 78% of net revenues.
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References
https://finance.yahoo.com/news/veru-submits-emergency-authorization-eua-103000787.html
https://verupharma.com/wp-content/uploads/2022/06/Veru-Jefferies-Presentation-June-2022.pdf