Nivalis Therapeutics, Inc. (MM) (NVLS) Quote

$NVLS 15' Chart

Looks like they converted preferred shares to common shares, increasing the shares outstanding to over 25 million, diluting is not a good thing .What is the intellectual property worth if they can't enen get a good result on a phase 2 trial. 55 million in the bank is the only good thing going here .

Yes, indeed.

it's obvious what's going on soon...

Chart looks great

Merger will be come

NEWS -- Nivalis Therapeutics Announces Corporate Restructuring

Date : 01/12/2017 @ 4:10PM
Source : GlobeNewswire Inc.
Stock : Nivalis Therapeutics, Inc. (MM) (NVLS)

Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (CF), today announced that its Board of Directors has approved a restructuring plan as part of the Company’s initiative to explore strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources.

The Company intends to complete a reduction in force affecting 25 employees, including Jon Congleton, President and Chief Executive Officer, and David Rodman, M.D., Chief Medical Officer and Executive Vice President of Discovery. The reductions are expected to occur between January 15, 2017 and March 31, 2017, after which, the Company will have approximately five remaining employees. As a result of the restructuring plan, the Company estimates that it will incur cash severance costs of approximately $3 million, which are expected to be paid during the first half of 2017. The reduction in force is intended to preserve the Company’s cash while it assesses various strategic alternatives, as announced earlier this month. The Company currently projects that it will have approximately $45-$47 million of net cash available for the potential strategic transaction. This projection is based on the Company’s current expectations and assumptions, including the consummation of a transaction during the third quarter of 2017, and the actual amount of net cash available could differ materially from the Company’s current estimate.

“We are extremely grateful for the outstanding leadership of Mr. Congleton and the many contributions of Dr. Rodman, as well as our other impacted employees, who have dedicated themselves to Nivalis’ efforts in cystic fibrosis,” said Howard Furst, M.D., Chairman of the Board of Directors. “Nivalis is committed to maximizing shareholder value by preserving the Company’s cash, and unfortunately this necessitates the announced restructuring.”

Mr. Congleton will be stepping down from his role as President and Chief Executive Officer effective January 15, 2017, at which time he will also resign from the Board of Directors.

The Board of Directors has appointed Mr. Michael Carruthers, the Company’s Chief Financial Officer, as interim President, effective January 15, 2017.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to the workforce reduction plan and the amount and expected timing of costs, expense savings and other charges related to these activities, the potential for, and timing of, a strategic transaction involving the Company and expected net cash available for a potential transaction after payment of costs, expenses and other liabilities in connection with the closing of a potential transaction. These forward-looking statements are based on the current intent and expectations of the management of the Company. These statements are not guarantees of future performance or actions and involve risks and uncertainties that are difficult to predict. The Company’s actual performance in the timing and outcome of actions and events may differ materially from those expressed or implied in the forward-looking statements because such statements are based on assumptions and projections relating to these activities that are inherently uncertain and may also be affected by risks such as: that the costs related to the workforce reduction plan may be higher than estimated; that the savings related to the workforce reduction plan may be lower than expected; that the Company may be unsuccessful in negotiating and successfully completing a strategic transaction or that consummating a transaction takes longer than expected; that costs associated with exploring and closing a strategic transaction are higher than anticipated; and the other risks and uncertainties described in the Company’s SEC reports filed under the Securities Exchange Act of 1934, including its annual report on Form 10-K filed with the Securities and Exchange Commission on March 8, 2016. All information in this press release is as of the date of this release, and Nivalis undertakes no duty to update or revise this information unless required by law.

Contacts:

Investor Relations
John Graziano
1-646-378-2942
mailto://jgraziano@troutgroup.com

Media Relations
Lindsay Rocco
1-862-596-1304
mailto://lrocco@elixirhealthpr.com

A merger is likely to come. Best use for cash & company. Stockholders, too. Bios like to merge for comfort. And I take comfort in $66m:15m shares = $4,4 per share

Ladenburg Thalmann do not take long to look for an ace of spades, they always have the right cards in their pockets, though.

This will soon go up to an appropriate price, imho. No use to wait for long. $$$ Geeez $$$

NVLS 2.33 liking setup for run with recent news strategic options and bios picking up

Moving on up to the east side

you go girl

NEWS -- Nivalis Therapeutics Announces Review of Strategic Alternatives

Date : 01/03/2017 @ 6:00PM
Source : GlobeNewswire Inc.
Stock : Nivalis Therapeutics, Inc. (MM) (NVLS)

Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (CF), today announced that its Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources. Nivalis has engaged Ladenburg Thalmann & Co. Inc. to act as its strategic financial advisor for this process. In conjunction with the exploration of strategic alternatives, the Company also intends to streamline its operations in order to preserve its capital and cash resources.

The Board has established a Special Committee to explore and evaluate strategic alternatives. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. There can be no assurance, however, that this process will result in any such transaction.

In parallel with this process, the Company intends to complete its ongoing SNO-7 trial of cavosonstat in patients with CF who are currently taking KalydecoTM (ivacaftor), which is expected to be completed in the first quarter of 2017.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding a potential strategic transaction and regarding the timing of completion of ongoing clinical trials. These forward-looking statements are based on management’s current expectations of future events and involve substantial risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by the forward-looking statements. These risks and uncertainties include, among others, the ability of the company to successfully and timely negotiate and consummate such a transaction on terms that are favorable to the Company. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Nivalis’ business in general, see the risk factors contained in the company’s annual report on Form 10-K filed with the Securities and Exchange Commission on March 8, 2016, and in other reports filed by Nivalis with the Securities and Exchange Commission. All information in this press release is as of the date of this release, and Nivalis undertakes no duty to update or revise this information unless required by law.

Investor Relations
John Graziano
1-646-378-2942
mailto://jgraziano@troutgroup.com

Media Relations
Lindsay Rocco
1-862-596-1304
mailto://lrocco@elixirhealthpr.com

$66m:15m shares = $4,4 per share

Oh, was wrong, they have $66.2 million cash

As of September 30, 2016, Nivalis has $66.2 million in cash and marketable­ securities­. Nivalis has no outstandin­g debt and there are 15.5 million shares of common stock issued and outstandin­g

Not much cash left...

Company have $16 Million Cash

Gearin up

Another great day :) not sellin this

Movin

Any target?

Yum yum roll call SourDough

Call me butter

Good to see you here Gerd. You've been on a roll lately.

Gerdis the wordis and he picks NvlS as the next runner!!!

Only 15,5 Mio are outstanding

How big is the float?

Finally the share price starting to move up....

CFO Buying Tiny Float has to be more then just the CFO Buying those given the Massive Volume down here thing is trading MORE Shares then it has avaible in the float over the past 10 days Plus I think that they could be a catalyst still in the pipeline anyways at this price and this far under cash Strong BUy reminds me of AQXP at 2$ that one went to 55$ within Days

My brothers and I have been buying too.

Proof?

AQXP 2$ TO 55$ REMINDS ME OF IT

BAKER BROTHERS BUYING

Feed me

I think I'll buy some here near 2 bucks. Lots of cash on the books....very small debt. Worth the risk i think

Any chance this stock going up?

End of last quarter numbers?

NVLS $2.57


from yahoo
Balance Sheet
Total Cash (mrq) 66.19M
Total Cash Per Share (mrq) 4.26

WTH 110% Short interest???

No breakout but failed phase 2 major pipeline. CF is a dead zone, so far.

NEWS -- Nivalis Therapeutics Announces Completion of Enrollment in Second Phase 2 Study of Cavosonstat for Treatment of Cystic Fibrosis

Date : 11/14/2016 @ 4:05PM
Source : GlobeNewswire Inc.
Stock : Nivalis Therapeutics, Inc. (MM) (NVLS)Study is Evaluating Cavosonstat in Patients Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated with Kalydeco™Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical stage pharmaceutical company focused on treating people with cystic fibrosis (“CF”), today announced completion of enrollment, defined as the last patient enrolled receiving their first study dose, in the second of two Phase 2 clinical studies of cavosonstat (N91115), a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. In this study, cavosonstat is being evaluated as add-on therapy to Kalydeco™ (ivacaftor) in adult patients who have one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein. A total of 19 patients have been enrolled in the U.S. and topline results are expected in the first quarter of next year.

“This milestone brings us closer to better understanding the complementary, clinical value of cavosonstat with other CFTR modulators, and in different mutations,” said Jon Congleton, president and chief executive officer of Nivalis. “We are proud to be part of the dedicated research effort within the CF community and those who are working tirelessly to unravel the complexity of modulating mutant CFTR, all with the end goal of improving treatment outcomes for patients and their families.”

Cavosonstat works through a novel mechanism of action called S-nitrosoglutathione reductase (GSNOR) inhibition that is presumed to modulate the unstable and defective CFTR protein responsible for CF. GSNOR inhibition restores GSNO levels, thereby modifying the chaperones responsible for CFTR protein degradation. In preclinical testing, this stabilizing effect was shown to increase and prolong the function of the CFTR protein and may lead to an increase in net chloride secretion. This effect is both complementary and agnostic to other CFTR modulators, like Orkambi™ and Kalydeco.

Study Design

The 12-week, double-blind, randomized, placebo-controlled, parallel group study is designed to investigate the efficacy and safety of 400mg of cavosonstat administered twice daily in adult patients with CF who are heterozygous for F508del-CFTR and a gating mutation that is approved for treatment with Kalydeco. This multicenter study randomized 19 CF patients taking Kalydeco to either cavosonstat or placebo in an approximate four to one ratio.

The primary efficacy endpoint is the within group absolute change from baseline in percent predicted FEV1 in the cavosonstat treatment group. The study includes a 4-week withdrawal and follow-up period once patients have completed 8-weeks of dosing. Results are expected in the first quarter of 2017. For more information on this study, please visit ClinicalTrials.gov and reference Identifier: NCT02724527.N91115.

About Nivalis Therapeutics, Inc.

Nivalis Therapeutics, Inc. (http://www.nivalis.com) is a clinical-stage pharmaceutical company committed to the discovery, development and commercialization of therapeutics for people with CF. In addition to developing innovative solutions intended to extend and improve the lives of people with CF, Nivalis plans to utilize its proprietary GSNOR inhibitor portfolio to develop therapeutics for other diseases.

About Cavosonstat

Cavosonstat works through a novel mechanism of action called GSNOR inhibition that is presumed to modulate the unstable and defective CFTR protein responsible for CF. GSNOR inhibition restores GSNO levels thereby modifying the chaperones responsible for CFTR protein degradation. This stabilizing effect has been shown to increase and prolong the function of the CFTR chloride channel and increase net chloride secretion in preclinical experiments. Nivalis discovered and owns exclusive rights to cavosonstat in the United States (U.S.) and all other major markets, including U.S. composition of matter patent protection until at least 2031. Cavosonstat was granted Orphan Drug and Fast Track designations by the FDA earlier this year. Nivalis Therapeutics has completed clinical studies with cavosonstat, including a Phase 1a dose-escalation safety study in healthy volunteers, and a Phase 1b safety study in people with CF who have two copies of the F508del-CFTR mutation. In preclinical studies, cavosonstat has been shown to increase the function of F508del-CFTR, the mutant protein that is estimated to be present in approximately 86 percent of people with CF in the United States and Europe.

About Cystic Fibrosis

CF is a life-shortening genetic disease that affects an estimated 70,000 people worldwide, predominantly in the United States and Europe, according to the Cystic Fibrosis Foundation (www.cff.org). CF is characterized by a defect in the chloride channel known as the “cystic fibrosis transmembrane conductance regulator,” or CFTR, and is caused by mutations in the CFTR gene.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding statements regarding the timing of completion of and availability of topline clinical results for this trial, Nivalis’ development plans and potential opportunities, and expectations that early stage clinical trials are indicative of later stage clinical trial results or will result in an approved drug. These forward-looking statements are based on management’s current expectations of future events and involve substantial risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including that preclinical responses may not be predictive of clinical results, delays in the timing of regulatory filings and approvals, delays in the commercialization or availability of lumacaftor/ivacaftor, and other matters that could affect the completion of the clinical development and commercial potential of the company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Nivalis’ business in general, see the risk factors contained in the company’s annual report on Form 10-K filed with the Securities and Exchange Commission on March 8, 2016 and in other reports filed by Nivalis with the Securities and Exchange Commission. All information in this press release is as of the date of this release, and Nivalis undertakes no duty to update or revise this information unless required by law.

Contacts:

Investor Relations
John Graziano
1-646-378-2942
mailto://jgraziano@troutgroup.com

Media Relations
Lindsay Rocco
1-862-596-1304
mailto://lrocco@elixirhealthpr.com

Hey Ooooo

Buying the S out of this Monday ez double

NEWS -- Nivalis Therapeutics Announces Appointment of Cynthia Smith to Board of Directors

Date : 11/03/2016 @ 4:05PM
Source : GlobeNewswire Inc.
Stock : Nivalis Therapeutics, Inc. (MM) (NVLS)

Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (CF), today announced that Cynthia Smith, chief commercial officer of ZS Pharma, Inc., a subsidiary of AstraZeneca, has been appointed to the Company’s Board of Directors.

“We are pleased to welcome Cynthia to the Nivalis Board of Directors,” said Jon Congleton, president and chief executive officer. “Cynthia brings to Nivalis impressive industry experience, corporate leadership and commercialization expertise, which will be extremely valuable as we continue executing against our strategic plans for the cavosonstat clinical development program.”

Ms. Smith has more than 20 years of broad leadership experience within the healthcare industry. Since 2013, Ms. Smith has served as chief commercial officer and a member of the executive team of ZS Pharma, where she led efforts to transition the company from the development stage to a commercial enterprise. ZS Pharma was acquired by AstraZeneca in 2015 for approximately $2.7 billion. Prior to joining ZS Pharma, Ms. Smith served as vice president, market access and commercial development at Affymax, Inc. Ms. Smith also held various senior leadership positions in market access, corporate strategy, government relations and external affairs at Merck & Co. Before beginning her career in the biopharmaceutical industry, Ms. Smith served as a healthcare policy analyst in the White House Office of Management and Budget.

Ms. Smith earned her M.B.A. from the Wharton School of the University of Pennsylvania, and a M.S. in public policy from the Eagleton Institute of Politics at Rutgers University. Ms. Smith received a B.A. from the University of North Carolina at Chapel Hill.

“I am delighted to join the Nivalis team and look forward to contributing my experience and helping to further the Company’s efforts to deliver promising therapeutic options for the cystic fibrosis community,” said Cynthia Smith.

Ms. Smith was introduced to Nivalis Therapeutics through LifeSci Advisors’s Board Placement Initiative (BPI), a program started earlier this year to help life sciences companies diversify their corporate boards. “LifeSci’s Board Placement initiative expanded Nivalis’ network of highly qualified candidates with the specific expertise we sought to add to our Board” said Jon Congleton. Ms. Smith is also one of the 20 executives who recently completed the Women In Bio’s Boardroom Ready Program.

About Nivalis Therapeutics, Inc.
Nivalis Therapeutics, Inc. (http://www.nivalis.com) is a clinical-stage pharmaceutical company committed to the discovery, development and commercialization of therapeutics for people with CF. In addition to developing innovative solutions intended to extend and improve the lives of people with CF, Nivalis plans to utilize its proprietary GSNOR inhibitor portfolio to develop therapeutics for other diseases.

About Cavosonstat
Cavosonstat works through a novel mechanism of action called GSNOR inhibition that is presumed to modulate the unstable and defective CFTR protein responsible for CF. GSNOR inhibition restores GSNO levels thereby modifying the chaperones responsible for CFTR protein degradation. This stabilizing effect has been shown to increase and prolong the function of the CFTR chloride channel and increase net chloride secretion in preclinical experiments. Nivalis discovered and owns exclusive rights to cavosonstat in the United States (U.S.) and all other major markets, including U.S. composition of matter patent protection until at least 2031. Cavosonstat was granted Orphan Drug and Fast Track designations by the FDA earlier this year. Nivalis Therapeutics has completed clinical studies with cavosonstat, including a Phase 1a dose-escalation safety study in healthy volunteers, and a Phase 1b safety study in people with CF who have two copies of the F508del-CFTR mutation. In preclinical studies, cavosonstat has been shown to increase the function of F508del-CFTR, the mutant protein that is estimated to be present in approximately 86 percent of people with CF in the United States and Europe.

About Cystic Fibrosis
CF is a life-shortening genetic disease that affects an estimated 70,000 people worldwide, predominantly in the United States and Europe, according to the Cystic Fibrosis Foundation (www.cff.org). CF is characterized by a defect in the chloride channel known as the “cystic fibrosis transmembrane conductance regulator,” or CFTR, and is caused by mutations in the CFTR gene.

Contacts:

Investor Relations
John Graziano
1-646-378-2942
mailto://jgraziano@troutgroup.com

Media Relations
Lindsay Rocco
1-862-596-1304
mailto://lrocco@elixirhealthpr.com

NEWS -- Nivalis Therapeutics to Present at Two Upcoming Investor Conferences

Date : 11/02/2016 @ 4:05PM
Source : GlobeNewswire Inc.
Stock : Nivalis Therapeutics, Inc. (MM) (NVLS)

Nivalis Therapeutics, Inc. (NASDAQ:NVLS), a clinical stage pharmaceutical company focused on treating people with cystic fibrosis (CF), today announced that Chief Executive Officer, Jon Congleton will present a corporate overview at the 25th Annual Credit Suisse Healthcare Conference and the Stifel 2016 Healthcare Conference.

Details of the two presentations are as follows:

25th Annual Credit Suisse Healthcare Conference
Date: Tuesday, November 8th
Location: The Phoenician, Arizona
Presentation Time: 4:00 PM MST
Stifel 2016 Healthcare Conference
Date: Tuesday, November 15th
Location: The Lotte New York Palace Hotel, New York
Presentation Time: 10:15 AM EST

Individuals may access a live webcast of the conference presentations on the Nivalis website at http://www.nivalis.com under "IR Calendar" in the "News / Events" section. A replay of the webcast will be available on this site for 90 days following the live event.

About Nivalis Therapeutics, Inc.

Nivalis Therapeutics, Inc. (http://www.nivalis.com) is a clinical stage pharmaceutical company committed to the discovery, development and commercialization of therapeutics for people with CF. In addition to developing innovative solutions intended to extend and improve the lives of people with CF, Nivalis plans to utilize its proprietary S-nitrosoglutathione reductase (GSNOR) inhibitor portfolio to develop therapeutics for other diseases.

Contacts:

Investor Relations
John Graziano
1-646-378-2942
mailto://jgraziano@troutgroup.com

Media Relations
Lindsay Rocco
1-862-596-1304
mailto://lrocco@elixirhealthpr.com

With this volume? I doubt it

NVLS bullish 7.8804



normal chart


log chart

You are correct sir

Taking a new position here huge upside

Big accumulation should have a big break out next week.

Be careful...and good luck to all

Switched to TNXP

Also they bought at $15 mostly, some $8 and $4