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Veru to Report Fiscal 2020 Fourth-Quarter, Full-Year Financial Results, Host Conference Call on December 9th
MIAMI, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that it will report financial results for its fiscal 2020 fourth quarter and full year ended September 30, 2020, on Wednesday, December 9, 2020, before the market opens.   Veru’s management will host a conference call that same day at 8 a.m. ET to review the Company’s performance and to answer questions. The call will also be accessible via webcast. Event Details Interested parties may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call.   The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months.   A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10149625, for one week.About Veru Inc. Veru Inc. is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta tubulin subunits of microtubules. VERU-111 is being evaluated in an open label Phase 1b/Phase 2 clinical study in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer. The Phase 1b clinical study completed enrollment of 39 men and is ongoing. The Phase 2 clinical trial has completed the enrollment of 40 men who have metastatic castration resistant prostate cancer and who have also become resistant to at least one novel androgen receptor targeting agent, such as abiraterone or enzalutamide, but prior to IV chemotherapy, and is ongoing. VERU-111 is also being evaluated in a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19. VERU-100 is a novel, proprietary peptide formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist administered as a small volume, subcutaneous 3-month depot injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration --- a problem which occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection. A Phase 2 trial to evaluate VERU100 dosing is anticipated to begin in the first quarter of calendar year 2021. Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. Following an End of Phase 2 meeting with the FDA, the Company plans to advance Zuclomiphene Citrate to a Phase 3 clinical trial in men with advanced prostate cancer who experience moderate to severe hot flashes.Veru is also advancing a new drug formulation in its specialty pharmaceutical pipeline addressing unmet medical needs in urology such as the Tadalafil and Finasteride Combination (TADFYN®) for the administration of tadalafil 5mg and finasteride 5mg combination formulation dosed daily for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS®) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5mg PROSCAR®) and male pattern hair loss (finasteride 1mg PROPECIA®). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone. The Company expects to submit the NDA for TADFYN® in early calendar year 2021.The Company's commercial products include the FC2 Female Condom / FC2 Internal Condom® ("FC2"), an FDA-approved product for the dual protection against unwanted pregnancy and the transmission of sexually transmitted infections, and the PREBOOST® 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. The Company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. In the U.S., FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. PREBOOST® is marketed through online sales in the U.S. under the Roman Swipes brand name by Roman Health Ventures Inc. Roman is a leading telemedicine company that discreetly sells men's health products via the internet website www.getroman.com. To learn more about Veru products please visit www.verupharma.com."Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding the regulatory pathway to secure FDA approval of the Company's drug candidates, the anticipated timeframe for clinical studies and FDA submissions, and clinical study results including potential benefits and the absence of adverse events. Any forward-looking statements in this release are based upon the Company's current plans and strategies and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions. If any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; potential delays in the timing of and results from clinical trials and studies, including potential delays in the recruitment of patients and their ability to effectively participate in such trials and studies due to COVID19, and the risk that such results will not support marketing approval and commercialization; potential delays in the timing of any submission to the FDA and regulatory approval of products under development and the risk that disruptions at the FDA caused by the COVID-19 pandemic may delay the review of submissions or approvals for new drugs; the risk of a delay or failure in reaching agreement with the FDA on the design of a clinical trial or in obtaining authorization to commence a clinical trial; clinical results or early data from clinical trials may not be replicated or continue to occur in additional trials or may not otherwise support further development in the specified product candidate or at all; our pursuit of a COVID-19 treatment candidate is at an early stage and we may be unable to develop a drug that successfully treats the virus in a timely manner, if at all; risks related to our commitment of financial resources and personnel to the development of a COVID-19 treatment which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties about the longevity and extent of COVID-19 as a global health concern; government entities may take actions that directly or indirectly have the effect of limiting opportunities for VERU-111 as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the risk that the Company's products may not be commercially successful; risks related to the impact of the COVID-19 pandemic on our business, the nature and extent of which is highly uncertain and unpredictable; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations, including our ability to secure timely grant or other funding to develop VERU-111 as a potential COVID-19 treatment; product demand and market acceptance; competition in the Company's markets and therapeutic areas and the risk of new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; the risk that the Company will be affected by regulatory developments, including a reclassification of products; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays resulting from extensive governmental regulation, and effects of healthcare insurance and regulation, including reductions in reimbursement and coverage or reclassification of products; some of the Company's products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents, the effectiveness of the patents or other intellectual property protections and ability to enforce them against third parties, the uncertainty regarding patent coverages, the possibility of infringing a third party’s patents or other intellectual property rights, and licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay, restructuring or substantial delayed payments; the risk that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount or award; penalties and/or debarment for failure to satisfy tender awards; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; risks related to concentration of accounts receivable with our largest customers and the collection of those receivables; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; risks related to the costs and other effects of litigation, including product liability claims; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the fiscal year ended September 30, 2019 and subsequent quarterly reports on Form 10-Q. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors.Contact: Sam Fisch   800-972-0538 Director of Investor Relations
GlobeNewswire · 4d ago
Veru enrolls in Phase 2 trial for an oral drug for metastatic prostate cancer
Veru ([[VERU]] +2.7%) has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for metastatic castration and novel androgen receptor targeting agent
Seekingalpha · 09/29 14:40
Veru Completes Enrollment Of Phase 2 Clinical Trial Of VERU-111, Novel Oral Drug For Metastatic Prostate Cancer
Veru Completes Enrollment of Phase 2 Clinical Trial of VERU-111, Novel Oral Drug for Metastatic Prostate Cancer MIAMI, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), an oncology and urology
Benzinga · 09/29 12:32
Veru Highlights Oral Presentation Of Resutls From VERU-111 Phase 1b Study In Metastatic Prostate Cancer At European Society for Medical Oncology Congress Sept. 19-21
Veru Inc. (NASDAQ:VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that positive clinical results from its Phase
Benzinga · 09/18 11:30
Veru Announces ESMO Congress 2020 Oral Presentation of Positive Clinical Results from its VERU-111 Phase 1b Study in Metastatic Prostate Cancer
—Advancing VERU-111 to a Pivotal Phase 3 Clinical Program—MIAMI, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that positive clinical results
GlobeNewswire · 09/18 11:30
Insider Buys Veru's Stock
Veru Inc (NASDAQ:VERU) was trading 3.5% higher from the previous closing price. A Form 4 filing filed with the SEC on Tuesday, August 25 showed that and Greco Michele bought 5,000 shares at an average price of $2.65. The transaction moved the executive's stake in Veru Inc. to 96,178 shares.
Benzinga · 08/26 15:47
Veru Extends Agreement with Roman for Verus Premature Ejaculation Treatment Product
GlobeNewswire · 08/18 13:30
Veru Extends Agreement With Roman For Veru's Premature Ejaculation Treatment Product
Benzinga · 08/18 12:35
Veru EPS misses by $0.02, misses on revenue
Veru (VERU): Q3 GAAP EPS of -$0.05 misses by $0.02.Revenue of $10.32M (+6.1% Y/Y) misses by $0.42M.Press Release
Seekingalpha · 08/13 10:32
Veru EPS misses by $0.02, misses on revenue
Veru (VERU): Q3 GAAP EPS of -$0.05 misses by $0.02.Revenue of $10.32M (+6.1% Y/Y) misses by $0.42M.Press Release
Seekingalpha · 08/13 10:32
Veru EPS misses by $0.02, misses on revenue
Veru (VERU): Q3 GAAP EPS of -$0.05 misses by $0.02.Revenue of $10.32M (+6.1% Y/Y) misses by $0.42M.Press Release
Seekingalpha · 08/13 10:32
Veru EPS misses by $0.02, misses on revenue
Veru (VERU): Q3 GAAP EPS of -$0.05 misses by $0.02.Revenue of $10.32M (+6.1% Y/Y) misses by $0.42M.Press Release
Seekingalpha · 08/13 10:32
Veru EPS misses by $0.02, misses on revenue
Veru (VERU): Q3 GAAP EPS of -$0.05 misses by $0.02.Revenue of $10.32M (+6.1% Y/Y) misses by $0.42M.Press Release
Seekingalpha · 08/13 10:32
VERU-111 Suppresses Key Cytokines Responsible for Severe Acute Respiratory Distress Syndrome in COVID-19
\--VERU-111 significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome in COVID-19 in a toxic shock model-- --VERU-111’s ability to disrupt microtubules has potential for dual drug action against COVID-19: treat SARS-CoV-2 virus infect
GlobeNewswire · 08/04 12:30
Veru Receives Positive Input From FDA On Phase 3 Pivital Trial To Evaluate VERU-111 In Metastatic Castration Resistant Prostate Cancer
Benzinga · 07/23 12:31
Veru Receives Positive Input from FDA on Phase 3 Pivotal Trial to Evaluate VERU-111 in Metastatic Castration Resistant Prostate Cancer
\--Pivotal Phase 3 Clinical Trial Expected to Initiate First Quarter Calendar Year 2021--MIAMI, July 23, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the man
GlobeNewswire · 07/23 12:30
Do Options Traders Know Something About Veru (VERU) Stock We Don't?
Zacks · 07/06 14:45
Veru Inc. Added To Russell 2000 And 3000 Indices
Benzinga · 06/29 12:37
Veru (VERU) Soars: Stock Adds 6.9% in Session
Zacks · 06/25 13:44
Hedge Funds Keep Buying Veru Inc. (VERU)
Insider Monkey · 06/24 02:11
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About VERU
Veru Inc. is an oncology and urology biopharmaceutical company developing medicines for prostate cancer treatment and prostate cancer supportive care, as well as urology specialty pharmaceuticals. Its oncology drug candidates include VERU-111, an oral alpha and beta tubulin inhibitor, which is in a Phase 1b/2 study for the treatment of metastatic castration resistant prostate cancer; Zuclomiphene citrate, which is in a Phase II clinical trial for the treatment of hot flashes in men, and VERU-100, which is a gonadotropin-releasing hormone (GnRH) antagonist. Its urology specialty pharmaceutical drug candidate is Tadalafil and Finasteride Combination (TADFIN), which is a tadalafil and finasteride combination oral capsule for the treatment of men with benign prostatic hyperplasia. Its commercial products include the FC2 Female/Internal Condom for prevention of pregnancy and sexually transmitted infections, and PREBOOST wipes for the prevention of premature ejaculation.
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