Proactiveinvestors USA & Canada Organovo Holdings Inc. https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Organovo Holdings Inc. RSS feed en Fri, 24 May 2019 02:14:27 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Organovo tumbles after fiscal 4Q revenue miss, extended timeline for liver tissue program ]]> https://www.proactiveinvestors.com/companies/news/220866/organovo-tumbles-after-fiscal-4q-revenue-miss-extended-timeline-for-liver-tissue-program-220866.html Organovo Holdings Inc (NASDAQ:ONVO) stock tumbled Thursday after the company’s fiscal fourth-quarter earnings showed a decline in revenue driven by lower products and services revenue.

Investors also knocked the shares down about 11% as Organovo indicated more preclinical work had to be done before it could submit its first investigational new drug application for its 3D-bioprinted liver tissue program.

“We’ve determined that we need to conduct additional preclinical studies, optimize our manufacturing processes, and most importantly generate decisive scientific data regarding the prolonged functionality and therapeutic benefits of our liver tissue patch,” said Organovo Holdings CEO Taylor J Crouch.

READ: Organovo expects FDA meeting in 2019 on 3D-bioprinted tissues for liver disease treatment

As a result, Crouch said preclinical development will be extended into calendar 2020.

“Consequently, we now expect to have our pre-IND meeting with the FDA in calendar 2020, rather than the latter part of this calendar year,” disclosed Crouch. “This change in our timeline also pushes the start of our IND-enabling studies back, with our revised plan now supporting an IND submission and the start of first-in-human trials in calendar 2021.”

The San Diego biotechnology company is pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases.

The company’s Phase 1 trial will target patients with end-stage liver disease, and subject to favorable outcomes, Organovo will explore NovoTissues benefits in one or more metabolism disease such as Alpha-1 antitrypsin deficiency, which is an inherited disorder that may cause lung disease and liver disease. The company may also study its product as a bridge-to-transplant.

Well-funded till IND submission

As of March 31, the company had cash and cash equivalents of $36.5 million. Organovo expects a net cash utilization rate of $20 million to $22 million in fiscal 2020, and believes it has sufficient funds, to meet its operating and capital requirements through its forecasted IND submission in calendar 2021.

The company posted a net loss of $7 million, a $0.5 million improvement over the year-ago period, as expenses declined 10% primarily due to lower employee costs.

Total revenue was $0.7 million, a 38% decrease from the year-ago period, primarily driven by lower products and services revenue.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Thu, 23 May 2019 08:59:00 -0400 https://www.proactiveinvestors.com/companies/news/220866/organovo-tumbles-after-fiscal-4q-revenue-miss-extended-timeline-for-liver-tissue-program-220866.html
<![CDATA[News - Organovo expects FDA meeting in 2019 on 3D-bioprinted tissues for liver disease treatment ]]> https://www.proactiveinvestors.com/companies/news/214293/organovo-expects-fda-meeting-in-2019-on-3d-bioprinted-tissues-for-liver-disease-treatment-214293.html Organovo Holdings Inc said it expects to meet this year with the Food and Drug Administration on its development of 3D-bioprinted tissues for the treatment liver diseases and added that it has sufficient cash through fiscal 2020.

The biotech said Thursday in a press release that it’s on track for the submission of its investigational new drug (IND) application with the FDA in 2020.

As part of its third-quarter financial report, the company added that it had cash and cash equivalents of $35.2 million as of December 31. It now expects an improved spending rate of $20.5 million-$21.5 million in fiscal 2019 and estimates it has sufficient funds to meet its operating and capital requirements through fiscal 2020.

READ: Lipocine rallies after therapy candidate achieves meaningful liver fat reduction

Development of the healthy therapeutic liver tissue patch could treat a broad range of liver diseases, according to the company. It said it continues to conduct proof-of-concept studies aimed at treating adult and pediatric liver disease.

"Our objective in implanting a healthy tissue patch is to restore function or offset the deficiencies related to a specific condition," CEO Steve Moster said in a statement.

The company added that it has presented data on the performance of tissues in animal models for Alpha-1-antitrypsin deficiency (A1AT) and hereditary tyrosinemia Type 1 (HTT1) at industry meetings over the past several months. 

With 3D bioprinting, 3D printers are used to produce tissue from materials including living cells.

For the three months ended December 31, Organovo reported that its net loss narrowed to $6.4 million, or $0.06 per share, from $7.8 million, or $0.07 per share, a year earlier. The average estimate of analysts was $0.07.

Shares traded at $0.99 in Friday’s Nasdaq trading.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Fri, 08 Feb 2019 11:34:00 -0500 https://www.proactiveinvestors.com/companies/news/214293/organovo-expects-fda-meeting-in-2019-on-3d-bioprinted-tissues-for-liver-disease-treatment-214293.html
<![CDATA[News - Organovo reports smaller loss and sharp fall in revenue ]]> https://www.proactiveinvestors.com/companies/news/202627/organovo-reports-smaller-loss-and-sharp-fall-in-revenue-202627.html Organovo Holdings Inc (NASDAQ:ONVO) said on Thursday it posted a net loss which was smaller than last year but revenue declined sharply because of a fall in research income.

The company said its net loss for the quarter was at US$7.4mln, a US$2.7mln improvement over the year ago level. The reason for the smaller loss is due to lower employee and lab suuply costs. Total revenue was US$700,000, from US$990,000 in the same period last year.

READ: Shares of Organovo fall after it narrows fiscal 2018 guidance

Revenue was driven down by lower income from liver tissue modeling research services.

Organovo is a biotechnology company that pioneers in the development of 3D bioprinted tissues aimed at treating a variety of liver diseases. The company is based in San Diego, California.

Contact Rene Pastor at rene.pastor@proactiveinvestors.com

 

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Thu, 09 Aug 2018 16:49:00 -0400 https://www.proactiveinvestors.com/companies/news/202627/organovo-reports-smaller-loss-and-sharp-fall-in-revenue-202627.html
<![CDATA[News - Shares of Organovo fall after it narrows fiscal 2018 guidance ]]> https://www.proactiveinvestors.com/companies/news/198054/shares-of-organovo-fall-after-it-narrows-fiscal-2018-guidance-198054.html Shares of Organovo Holdings Inc. (NASDAQ:ONVO) dipped Thursday in extended trade after the San Diego company reported fiscal third-quarter earnings that missed revenue estimates.

Organovo shares lost 8.6% to US$1.80 after hours.

Organovo reported a third-quarter December 2017 loss of US$0.07 per share on revenue of US$1.2mln. The consensus estimate was a loss of US$0.10 per share on revenue of US$1.32mln.

In the same quarter last year, Organovo announced an EPS loss of US$0.10 on revenue of US$812,000.

The company said it expects fiscal 2018 revenue of US$4.50mln to US$5.20 mln. The company's previous guidance was a higher revenue band of US$4.50mln to US$6.50mln.

The San Diego company designs and creates functional human tissues using its proprietary 3-D bioprinting technology.  

"Our liver therapeutic tissue program continues to make excellent progress in achieving critical regulatory and scientific milestones," said Organovo CEO Taylor J. Crouch.

Organovo’s great promise lies in the fact that its 3D human tissues can be employed in drug discovery, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs.

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Thu, 31 May 2018 16:49:00 -0400 https://www.proactiveinvestors.com/companies/news/198054/shares-of-organovo-fall-after-it-narrows-fiscal-2018-guidance-198054.html