*more.... In addition, sabizabulin, which has dual antiviral and anti-inflammatory effects, is currently enrolling in a Phase 3 study for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, also known as the cytokine storm, and which has been granted Fast Track designation by the FDA.
Veru also has a commercial sexual health division, the proceeds of which help fund its drug development programs, comprised of:
-- ENTADFI(TM) (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway. -- FC2 Female Condom(R) (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
Forward-Looking Statements
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 expected commencement timing of the Phase 3 ENABLAR-2 study; whether enobosarm in combination with abemaciclib will demonstrate sufficient safety and efficacy to ever be approved by the FDA or any other regulatory as an oral 2nd line therapeutic option for patients who have AR+ER+HER2- metastatic breast cancer; whether and when enobosarm will be approved by FDA for the treatment of any other breast cancers and the timing of the Company's submissions to FDA and FDA's review of such submissions; whether any of the selective clinical properties previously observed in clinical studies of enobosarm will be replicated in the current and planned clinical development program for enobosarm and whether any such properties will be recognized by the FDA in any potential approvals and labeling; whether future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company's drug candidates and companion diagnostic, the anticipated design and scope for clinical trials and FDA acceptance of such design and scope, whether any accelerated regulatory pathways, including Fast Track designation, to secure FDA approval for sabizabulin, enobosarm or any of the Company's drug candidates are available, when clinical results from the ongoing sabizabulin COVID-19 Phase 3 trial will be available, whether sabizabulin, enobosarm, VERU-100, zuclomiphene, and ENTADFI will serve any unmet need, what dosage, if any, might be approved for use in the US or elsewhere, and whether the commencement or enrollment timelines for the clinical trials and development of the companion diagnostic will be met, and also statements about the potential, timing and efficacy of the rest of the Company's development pipeline, including the ability of the Company to successfully launch ENTADFI, whether and when enobosarm will be approved by FDA for the treatment of certain breast cancers and the timing of the Company's submissions to FDA and FDA's review of such submissions; whether any of the selective clinical properties previously observed in clinical studies of sabizabulin, enobosarm or other drug candidates will be replicated in the current and planned clinical development program for such drug candidate and whether any such properties will be recognized by the FDA in any potential approvals and labeling; when commercial launch of ENTADFI will occur; the magnitude of any potential revenues generated by ENTADFI; whether the Company's current or future clinical development program results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company's drug candidates; and whether the companion diagnostic for enobosarm will be developed successfully or be approved by the FDA for use. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company's product portfolio and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development; the timing of any submission to the FDA and any determinations made by the FDA or any other regulatory authority; including 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 or commercialize a product candidate in the U.S.; the possibility that as vaccines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company's existing products and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials, supply chain and other third-party providers, commercial efforts, and business development operations; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company's products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company's ability to successfully commercialize any of its products, if approved; the Company's ability to protect and enforce its intellectual property; the potential 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; 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; the concentration of accounts receivable with our largest customers and the collection of those receivables; 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; 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 from time to time 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, 2021 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. The Company disclaims any intent or obligation to update these forward-looking statements.
Verzenio(R) is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates. |
