Home > Boards > US Listed > Biotechs >

Organovo Holdings, Inc. (ONVO)

ONVO RSS Feed
Add ONVO Price Alert      Hide Sticky   Hide Intro
Moderator:
Search This Board: 
Last Post: 4/21/2021 10:14:24 AM - Followers: 293 - Board type: Free - Posts Today: 0

From the Last 10Q Nov 5, 2020

Overview

We are an early-stage biotechnology company that is developing and utilizing highly customized 3D human tissues as dynamic models of healthy and diseased human biology for drug development. Our proprietary technology is being used to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. Our advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. We believe these attributes can enable critical complex, multicellular disease models that we will use to develop clinically effective drugs for selected therapeutic areas. Market opportunities may include externally-partnered or internally-directed drug discovery and the clinical development of new molecular entities or repurposed drugs in-licensed from other pharmaceutical companies. Our goal is to establish a pipeline of drug candidates in high-value disease areas, aiming to commence human clinical testing for at least one drug candidate within a three to five year timeframe.
 
Historical Operations and Strategic Alternatives Process
Prior to August 2019, we focused our efforts on developing our in vivo liver tissues to treat end-stage liver disease and a select group of life-threatening, orphan diseases, for which there are limited treatment options other than organ transplantation. We also explored the development of other potential pipeline in vivo tissue constructs in-house and through collaborations with academic and government researchers. In the past, we also explored the development of in vitro tissues, including proof of concept models of diseased tissues, for use in drug discovery and development.

In August 2019, after a rigorous assessment of our in vitro liver therapeutic tissue program, we concluded that the variability of biological performance and related duration of potential benefits no longer supported an attractive opportunity due to redevelopment challenges and lengthening timelines to compile sufficient data to support an Investigational New Drug (“IND”) filing. As a result, we suspended development of our lead program and all other related in-house pipeline development activities.

Our Board of Directors (our “Board”) also engaged a financial advisory firm to explore our available strategic alternatives, including evaluating a range of ways to generate value from our technology platform and intellectual property, our commercial and development capabilities, our listing on the Nasdaq Capital Market, and our remaining financial assets. These strategic alternatives included possible mergers and business combinations, sales of part or all of our assets, and licensing and partnering arrangements. We implemented various restructuring steps to manage our resources and extend our cash runway, including reducing commercial activities related to our liver tissues, except for sales of primary human cells out of inventory, negotiating an exit from our long-term facility lease, selling various assets, and reducing our workforce. Additionally, in November 2019, we sold certain inventory and equipment and related proprietary information held by our wholly-owned subsidiary, Samsara Sciences, Inc. (“Samsara”), and as a result of such sale, Samsara ceased its operations.

After conducting a diligent and extensive process of evaluating strategic alternatives and identifying and reviewing potential candidates for a strategic acquisition or other transaction, which included the receipt of more than 27 non-binding indications of interest from interested parties and careful evaluation and consideration of those proposals, and following extensive negotiation with Tarveda Therapeutics, Inc. (“Tarveda”), on December 13, 2019, we entered into a merger agreement with Tarveda (the “Merger Agreement”). Pursuant to the Merger Agreement, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, our wholly-owned merger subsidiary would merge with and into Tarveda (the “Merger”), with Tarveda becoming a wholly-owned subsidiary of Organovo and the surviving corporation of the Merger . The Merger Agreement included various conditions to the consummation of the Merger, including approval by our stockholders at a Special Meeting of Stockholders scheduled for April 7, 2020 (the “Special Meeting”).

At the Special Meeting, the Merger was not approved by our stockholders. As a result, we terminated the Merger Agreement with Tarveda. Pursuant to the terms of the Merger Agreement, we were obligated to reimburse certain of Tarveda’s merger-related expenses not to exceed $300,000, which was offset by Tarveda’s portion of shared expenses incurred by Organovo in fiscal 2020.
 
The Cooperation Agreement and Advisory Nominees Proposal
Following the Special Meeting and the termination of the Merger Agreement, our Board continued to solicit stockholder feedback regarding our strategic alternatives and how to maximize stockholder value. In response to feedback from our largest stockholder regarding its desire for the Board to consider opportunities in the 3D bioprinting field and suggestion that the Board should speak with Keith Murphy, our founder, stockholder and former Chief Executive Officer and Chairman, for potential business ideas, our Board initiated discussions with Mr. Murphy. Based on these discussions, we entered into a Cooperation Agreement with Mr. Murphy on July 14, 2020 (the “Cooperation Agreement”). Under the terms of the Cooperation Agreement, the Board appointed Mr. Murphy and Adam K. Stern to the Board as Class III directors, and two of our existing directors, Richard Maroun and David Shapiro, resigned from the Board and the committees thereof. The Board also agreed to nominate, recommend, support and solicit proxies for the re-election of Messrs. Murphy and Stern at our 2020 Annual Meeting of Stockholders (the “2020 Annual Meeting”). The Board also agreed to nominate, recommend, support and solicit proxies for an advisory stockholder vote (the “Advisory Nominees Proposal”) at the 2020 Annual Meeting to appoint three individuals, Douglas Jay Cohen, David Gobel and Alison Tjosvold Milhous (collectively, the “Advisory Nominees”), to the Board. Mr. Murphy identified each of the Advisory Nominees. Our Board approved the appointment of the Advisory Nominees, to be automatically effective immediately following the final adjournment of the 2020 Annual Meeting if the final vote tabulation for the Advisory Nominees Proposal received more votes cast “FOR” than “AGAINST” its approval. In addition, each of our then-current directors (other than Messrs. Murphy and Stern) agreed to resign from the Board immediately following the appointment of the Advisory Nominees. At the 2020 Annual Meeting held on September 15, 2020, our stockholders approved the re-election of Messrs. Murphy and Stern to the Board as Class III directors to hold office until the 2023 Annual Meeting of Stockholders and the final vote tabulation for the Advisory Nominees Proposal received more votes cast “FOR” than “AGAINST” its approval and, accordingly, effective upon the final adjournment of the 2020 Annual Meeting, Ms. Milhous was appointed as a Class I director to hold office until the 2021 Annual Meeting of Stockholders and Messrs. Cohen and Gobel were appointed as Class II directors to hold office until the 2022 Annual Meeting (collectively, the “New Director Slate”) and Carolyn Beaver, Taylor Crouch, Mark Kessel and Kirk Malloy, Ph.D. each resigned as directors.
 
Current Drug Discovery Business
Following the election of the New Director Slate, we have recommenced operations and are now focusing our future efforts on developing highly customized 3D human tissues as living, dynamic models of healthy and diseased human biology for drug development. Our proprietary technology is being used to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. Our advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. We believe these attributes can enable critical complex, multicellular disease models that we will use to develop clinically effective drugs for selected therapeutic areas. Market opportunities may include externally-partnered or internally-directed drug discovery and the clinical development of new molecular entities or repurposed drugs in-licensed from other pharmaceutical companies. Our goal is to establish a pipeline of drug candidates in high-value disease areas, aiming to commence human clinical testing for at least one drug candidate within a three to five year timeframe.
 
We have a significant opportunity to change the classic model of drug discovery using 3D bioprinted human tissues and other 3D models (sometimes known as “organoids” or “organs on a chip”). Our new paradigm will involve augmenting or replacing available animal disease models, in the discovery process with more relevant human disease models utilizing 3D human tissues developed by us. Our 3D human tissues may enable us to study the treatment of human disease by replicating key aspects of human biology in areas where this is currently a challenge with existing models. Rather than offering contract research services (as we have done in the past), we will focus on identifying and developing our own drug candidates, including from unique compounds or repurposed drugs in-licensed from other pharmaceutical companies. After identifying a drug candidate, we may out-license the drug candidate or may elect to develop the drug candidate internally. In addition to drug discovery, we will continue to evaluate opportunities to monetize our intellectual property and technologies along the way as a means to generate funds to support our primary business. We will continue to identify and work with partners and collaborators, including leading academic research sites, to develop new enabling applications which can support our discovery and development mission.

To restart our research operations, we have commenced hiring a team of research and development professionals with drug discovery and 3D tissue development experience. This team will leverage 3D models of disease to discover and develop new drugs with improved clinical efficacy.

We expect our research and development staff to grow to seven to ten employees. We also expect to maintain or grow a general and administrative staff of three to five employees to support our operations and reporting requirements as a public company.

We expect to lease sufficient office and laboratory space to support our requirements. We will need space in the short term in the 5,000-10,000 sq. ft. range, with mixed office and laboratory space. We currently plan to lease a new facility in San Diego at prevailing market terms.


Other
200,000,000 shares authorized. 130,618,203 issued as of June 30, 2020
1:20 Reverse split on 8/19/2020
 
ONVO
Current Price
Volume:
Bid Ask Day's Range
  • 1D
  • 1M
  • 2M
  • 3M
  • 6M
  • 1Y
  • 2Y
  • 3Y
  • 5Y
ONVO News: Securities Registration: Employee Benefit Plan (s-8) 03/25/2021 07:32:52 PM
ONVO News: Statement of Changes in Beneficial Ownership (4) 03/10/2021 04:49:11 PM
ONVO News: Statement of Changes in Beneficial Ownership (4) 03/10/2021 04:47:53 PM
ONVO News: Statement of Changes in Beneficial Ownership (4) 03/10/2021 04:47:04 PM
ONVO News: Amended Statement of Ownership (sc 13g/a) 03/10/2021 03:11:33 PM
PostSubject
#10428   Got some $8s. Already have a set point Planopenny 04/21/21 10:14:24 AM
#10427   Everything taking a shit except this badboy! Planopenny 02/11/21 12:21:16 PM
#10426   Will this ever stop? I cashed out pacb Planopenny 02/11/21 11:08:48 AM
#10425   Slow claps!! Planopenny 02/09/21 09:11:48 AM
#10424   Making us money!! Planopenny 02/08/21 11:07:14 AM
#10423   Cathie woods doing what they do best. LORTAP KCOTS 02/06/21 12:19:04 PM
#10422   So thin Planopenny 02/03/21 11:56:35 AM
#10421   Am I reading this correctly? phytokaiser1 01/26/21 07:21:26 PM
#10420   Thanks Kathy Planopenny 01/14/21 12:40:18 PM
#10419   Yep Planopenny 01/09/21 12:11:00 PM
#10418   Small rotation in Ark etf's are not that MWM 01/09/21 12:07:32 PM
#10417   Sold 39, 991 shares yesterday, sure Ark has Porterhouse10 01/09/21 06:30:14 AM
#10416   Saw Cathy Woods sold ONVO yesterday Porterhouse10 01/09/21 05:55:12 AM
#10415   $ONVO An Open Letter to Organovo Shareholders: Organovo MWM 01/06/21 01:04:23 PM
#10414   Boing... slow claps Planopenny 01/06/21 12:52:22 PM
#10413   Adding some here... MWM 01/06/21 12:51:49 PM
#10412   News! From 12-31-2020 8K phytokaiser1 01/03/21 11:58:43 AM
#10411   They say mass will move more Im thinking 100 akamaii 12/26/20 05:53:06 AM
#10410   Anyone know the next ARKK tech stock that LORTAP KCOTS 12/23/20 04:18:18 PM
#10409   I definitely nailed this one. As long as LORTAP KCOTS 12/23/20 12:08:31 PM
#10408   I’m neither of those, I just doubled my LORTAP KCOTS 12/23/20 12:06:04 PM
#10407   Honestly you sound like some of the guys Planopenny 12/23/20 12:03:36 PM
#10406   I don’t think I’m complaining, you are however. LORTAP KCOTS 12/23/20 12:01:58 PM
#10405   Quit complaining about everything, if you don’t like Planopenny 12/23/20 11:38:16 AM
#10404   Thanks. Makes sense. Noticed same thing in nndm pupuguru 12/23/20 10:39:16 AM
#10403   Yes IMHO, Cathie Woods is behind this move LORTAP KCOTS 12/23/20 10:28:04 AM
#10402   OK...I'm stumped as to the "why" of it pupuguru 12/23/20 10:05:03 AM
#10401   Well that was easy money!! LORTAP KCOTS 12/23/20 09:45:37 AM
#10400   I’d say it will get to $21 then LORTAP KCOTS 12/22/20 04:32:40 PM
#10399   Ride it while you can baby!! Planopenny 12/22/20 03:59:12 PM
#10398   Can anyone find any news on this stock? phytokaiser1 12/22/20 01:05:16 PM
#10397   So crazy, rightttt!! LORTAP KCOTS 12/22/20 10:34:38 AM
#10396   Now all we have to worry about is LORTAP KCOTS 12/22/20 10:05:42 AM
#10395   Awesome!! Getting closer most likely will get there LORTAP KCOTS 12/22/20 09:59:58 AM
#10394   Pretty much an easy play if ARKK keeps LORTAP KCOTS 12/21/20 01:42:23 PM
#10393   you are funny...glad you are making $$ Planopenny 12/21/20 01:40:42 PM
#10392   You should be happy, everyone will have a LORTAP KCOTS 12/21/20 01:40:02 PM
#10391   Ok...weeeee Planopenny 12/21/20 01:35:39 PM
#10390   Ok, I’ve been saying they will run it LORTAP KCOTS 12/21/20 11:13:49 AM
#10389   You didn’t know anything...just a simple reread of Planopenny 12/21/20 07:47:30 AM
#10388   I new this was gonna happen super predictable LORTAP KCOTS 12/19/20 03:18:49 PM
#10387   Been following the Co. forever, lost interest with eom7 12/19/20 09:25:41 AM
#10386   Weee Planopenny 12/18/20 01:20:52 PM
#10384   Well the volume came in today, watch for LORTAP KCOTS 12/18/20 12:22:27 PM
#10383   On November 23, 2020, Organovo Holdings, Inc. (the RandolRocketman 12/15/20 07:07:05 PM
#10382   Another red day, how many now? Glad got Porterhouse10 12/15/20 04:32:56 PM
#10381   On a huge up day, this turd sinks.. LORTAP KCOTS 12/15/20 04:28:22 PM
#10380   In the meantime the chart is a disaster, Porterhouse10 12/15/20 01:25:23 PM
#10379   Yeah hope he can pull a Steve Jobs LORTAP KCOTS 12/15/20 11:26:20 AM
#10378   In the past few months ONVO has changed phytokaiser1 12/15/20 10:57:33 AM
PostSubject
Consent Preferences