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Last Post: 5/5/2021 4:31:18 PM - Followers: 22 - Board type: Free - Posts Today: 0



Veru Sets Another Quarterly Record in Both Net Revenues and in Gross Profit for Fiscal 2021 First Quarter 



VERU-111 for COVID-19

This past Monday we announced positive results from the Phase 2 clinical trial evaluating VERU-111 for the treatment of hospitalized patients with COVID-19 who were at high risk for acute respiratory distress syndrome (ARDS). VERU-111 is a novel once a day orally dosed small molecule that has both broad antiviral and anti-inflammatory activities which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death. We conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating daily oral once a day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. This trial was conducted in 5 sites across the United States. Patients that were hospitalized with documented evidence of COVID-19 infection with symptoms and who were at high risk for ARDS were enrolled. Subjects received either VERU-111 18mg or placebo as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at Day 29.

For the primary endpoint in hospitalized patients that had >1 dose of study drug, VERU-111 for COVID-19 treatment compared to placebo had a statistically significant and clinically meaningful 81% relative reduction in death or respiratory failure at Day 29. With respect to secondary endpoints, VERU-111 had a statistically significant 82% relative reduction in patient mortality and statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation versus placebo. Furthermore, VERU-111 was well tolerated with a good safety profile.

The Company has been granted an expedited End of Phase 2 meeting with the FDA to discuss next steps including a Phase 3 clinical registration trial design for the VERU-111 COVID-19 program. The Company expects that this confirmatory study will have a similar trial design as the Phase 2 study to evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients that are alive without respiratory failure at Day 29. We expect the Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have COVID-19 and are at high risk for ARDS. The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) has granted Veru a meeting to discuss possible grant funding for the Phase 3 study and manufacturing scale up. We plan to commence the VERU-111 for COVID-19 Phase 3 study in April 2021.

Doctor Dean Presentation

VERU Pharma CEO, Dr. Mitchell Steiner Discusses Clinical Trials and COVID-19 on CEORoadshow

Edited Transcript of VERU.OQ earnings conference call or presentation 10-Feb-21 1:00pm GMT


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#99  Sticky Note Oppenheimer-Healthcare-Conference nonsequetor 03/16/21 03:41:01 PM
#131   What a pos smh T695 05/05/21 04:31:18 PM
#130   And there is the double barreled load... next nonsequetor 05/05/21 09:06:13 AM
#129   up nicely premarket...lets see if it holds T695 05/05/21 08:34:22 AM
#128   The market wants hard facts; only pre-market May nonsequetor 05/01/21 11:58:50 AM
#127   Another thought also, if all the information that’s T695 05/01/21 09:33:42 AM
#126   I hope you’re right, I own stock and T695 04/30/21 11:35:56 PM
#125   Within 7 trading days, I bet you will nonsequetor 04/30/21 10:52:22 PM
#124   biggest POS tock out there T695 04/30/21 03:22:20 PM
#123   Cramer says he is positive, but look what nonsequetor 04/27/21 04:18:41 PM
#122   Dig into Cramer's past... he used to be nonsequetor 04/27/21 04:07:39 PM
#121   I think you have that wrong, he was idccwin 04/27/21 01:38:23 PM
#120   Another Cramer-fueled short attack... it never fails! nonsequetor 04/27/21 10:17:21 AM
#119   Seeing rise in the SP premarket. Let's see nonsequetor 04/27/21 09:19:43 AM
#118   Veru on Cramer’s lightning round. Cramer gave the idccwin 04/27/21 12:22:49 AM
#116   $$$$CHACHINGGGGGGGGGGGGG$$$$ nonsequetor 04/26/21 08:44:25 PM
#115   Those $10 calls looking good T695 04/26/21 07:30:24 PM
#114   *LUCK!* nonsequetor 04/16/21 05:48:44 PM
#113   just picked up some 5-21 $10 calls, wish T695 04/16/21 03:56:01 PM
#112   The guy's credibility has definitely been impacted by ILuvGreen3 04/13/21 11:28:06 PM
#111   VERU is scheduled to initiate Phase 3 trials ILuvGreen3 04/13/21 11:22:46 PM
#110   lying, and then doing an offering after he T695 04/13/21 01:53:09 PM
#109   "CEO lying and didn’t doing an offering" nonsequetor 04/13/21 01:32:22 PM
#108   CEO lying and didn’t doing an offering absolutely T695 04/13/21 08:48:18 AM
#107   The good news was we did not incur nonsequetor 04/09/21 09:44:10 PM
#106   The further depreciation in value today was very ILuvGreen3 04/09/21 07:13:00 PM
#105   Pre market 10.90 was an omen? nonsequetor 04/09/21 10:43:54 AM
#104   After-market appreciation is encouraging. ILuvGreen3 04/08/21 08:42:47 PM
#103   Today could be the day it all turns around. nonsequetor 04/08/21 01:03:59 PM
#102   The market's response to the news was underwhelming. ILuvGreen3 03/31/21 12:43:01 AM
#101   VERU-111 TRIAL nonsequetor 03/30/21 12:19:52 PM
#100   Today is the day VERU turns upward. Get nonsequetor 03/26/21 09:59:23 AM
#99   Oppenheimer-Healthcare-Conference nonsequetor 03/16/21 03:41:01 PM
#98   VERU-111 may have efficacy beyond prostate cancer nonsequetor 03/16/21 03:38:57 PM
#97   Many good things happening at VERU. Check out nonsequetor 03/11/21 09:55:17 PM
#96   Slowly but surely... step by step... inch by inch... nonsequetor 03/11/21 01:30:17 PM
#95   It appears an image change is in the nonsequetor 03/08/21 08:52:48 AM
#94   Let’s see if the bulls can finally get T695 03/08/21 08:51:30 AM
#93   Veru Exploring Strategic Alternatives for its Legacy Female nonsequetor 03/08/21 08:50:29 AM
#92   Jim Cramer tweeted this morning: nonsequetor 03/05/21 02:48:37 PM
#91   Very frustrating, especially with no company response to nonsequetor 03/02/21 05:55:01 PM
#90   Sellers are never ending here,could go to $10 T695 03/02/21 12:06:03 PM
#89   Veru Receives FDA Agreement to Advance VERU-111 into nonsequetor 03/01/21 09:05:52 AM
#88   UP OVER 20% PREMARKET!!! nonsequetor 03/01/21 08:49:55 AM
#87   Jump aboard, the train is leaving the station! nonsequetor 03/01/21 08:48:24 AM
#86   FDA agreed in an End of Phase 2 nonsequetor 03/01/21 08:46:40 AM
#85   Finally something to make this thing move again T695 03/01/21 08:42:19 AM
#84   Veru Submits New Drug Application for Proprietary TADFIN nonsequetor 02/23/21 09:02:05 AM
#83   Today we begin the stair-step back up to... nonsequetor 02/19/21 12:07:04 PM
#82   Selling those covered calls turned out to be T695 02/17/21 10:55:31 AM
#81   Buckle up everybody, ETD pre-Friday afternoon. nonsequetor 02/16/21 10:03:09 PM
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