bluebird bio Inc (BLUE) Noticias

As said, Lyfgenia is the value driver for the company https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/gene-therapy-lyfgenia-voucher-denial-puts-sickle-cell-treatment-at-risk-bluebird-bio-says-P6K4SEA2AFDKDF5SZZNZPBH4YM/

Did managing have no communication with the agency? I find that hard to believe, well maybe not when you take into account who runs the company! Their cost cutting measures came too late as well.

The FDA said it is look­ing in­to the ''known risk'' and as­sess­ing po­ten­tial ''fur­ther reg­u­la­to­ry ac­tion.'' https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-hematologic-malignancy-following-skysona-elivaldogene-autotemcel

Along­side the Oc­to­ber NE­JM ar­ti­cle was an ed­i­to­r­i­al from an US NIH haematologist who said more cas­es might ap­pear over time https://www.nejm.org/doi/full/10.1056/NEJMe2409399

It's been a long day, and I always struggle a bit when people don't present clear and concise messages.

But at least you're laughing at something.

lol, seriously?? Board of Directors 😎 :)

What does B.o.D. mean?

B.o.D, lol…non, zippo oversight!! Told proxy & IR ladies to have Andrew amend prop 4 to 1:10, then retail & institutions/funds will overwhelming approve..doubt that happens, but sincerely want Blue to succeed irrespective

https://ih.advfn.com/stock-market/NASDAQ/bluebird-bio-BLUE/stock-news/94916286/form-defa14a-additional-definitive-proxy-solicit

Would Bluebird's board let it go OTC if there was nothing else viable, or drain whatever they may for personal enrichment? Does Hercules demand Nasdaq listing? Is Nasdaq listing in the compliance aspect of the agreement?

IF Bluebird were delisted, it wouldn't be the worst thing in the world, as long as management could deal.

What's that saying? Pink sheets demand toughness....or something like that. Not revoking my vote FOR proposal 4, but I do dislike the simple reference of "Proposal 4" without delineating the 1:15 to 1:20 RS. Leaves room for BS.

[Based on the votes cast prior to the adjournment and the approval of Proposal 7, the Company elected to adjourn the Annual Meeting with respect to the proposal to approve amendments to the Certificate of Incorporation to effect a reverse stock split of the Company’s common stock at a ratio ranging from any whole number between 1-for-15 and 1-for-20, as determined by the Board in its discretion (“Proposal 4”), in order to permit the Company to allow for the solicitation of additional proxies to approve Proposal 4. The Annual Meeting will reconvene on Wednesday, December 4, 2024 at 8:30 a.m., Eastern Time, at the Company’s offices at 455 Grand Union Boulevard, Somerville, MA 02145.]

https://ih.advfn.com/stock-market/NASDAQ/bluebird-bio-BLUE/stock-news/94854006/form-8-k-current-report

[Proposal 3 was not approved by the requisite vote of the Company's stockholders. The voting results were as follows:

Votes For Votes Against Abstentions Broker Non-Votes
45,628,050 28,241,869 1,082,543 53,804,436]

Having just read and spoke to proxy solicitors, I believe Blue is having problems with 1:20 rs…
I recommended they amend Prop 4 to vote 1:10 and many of us would Approve..let’s see what happens ….

November 1, 2024
Fellow Stockholder:
bluebird bio, Inc!'s Annual Meeting of Stockholders is quickly approaching on November 6, 2024. We urge you to vote in favor of all the proposals on the ballot, and in particular, Proposal 4 related to the reverse stock split, which is critical to restoring stockholder value and the Company's future.
bluebird's gene therapies provide transformative - and even potentially curative - benefits to patients, but today, due to our current stock price we are at risk of being de-listed from Nasdaq. In addition, further capital is required in the near term to reach our expected breakeven point in the second half of next year.
A vote FOR Proposal 4 would enable us to regain compliance with Nasdaq's minimum bid price requirement and avoid delisting. It would also increase the number of shares on a relative basis that the Company is authorized to issue, a necessary step to enable us to raise additional capital to extend our cash runway.
ISS and Glass Lewis, independent proxy advisory firms to thousands of institutional stockholders and pension funds, recognize these issues and have both recommended in favor of the reverse stock split in Proposal 4.
If you have not voted, please vote today FOR Proposal 4. If you already voted against Proposal 4, we ask that you please reconsider.

I hear ya, but here's the deal: when BLUE trades, it trades. The real sharks bank on wash sale resolution through the power of Biotechnology volatility. A RS appears bad - but the stability it will bring, including stopping out wash sale resolutions, will bring the true value out, IMO.

Never invest what you can't afford to lose. There's a valid reason this isn't dropping farther. To that end, any prospective talent won't be scared away from employment by the possibility of seasoned BLUE employees facing culpability for whatever criminal actions they've engaged in, if any. Personally, I don't think BLUE management is guilty of anything beyond hubris and true belief in their technology. To that end, I share the belief.

Voted AGAINST ALL proposals except E&Y auditors!!! If C-Ste doesn’t get enough votes for #’s 4&5, it’s because clocking back by factor of 20 is ridiculous!!! Yes, they say lower band, but they will dilute the shit out of us long term holders!!!

If they amend to 1:10, I’ll vote FOR because a raise is needed by year end!! It baffles me why they can’t/wont find a JV to offer capital/royalities/etc..????

I want them to survive, because to get 3 FDA approved drugs is tremendous, but expenditures will crush if overly excessive ( they finally cut head count, but management should take pay hit and offer shares(RSA) at a premium to post split price in lieu of)…GLTA

10.25.2024: DefA14A, urging stake holders to voted FOR Proposals 4 and 5, the RS and Incentive plan. I voted NO on Proposal 3, which adopts EXCULPATION to attract talent, but also holds this sentence: [Certain of our officers would stand to benefit if Proposal 3 is adopted, as it could reduce their potential monetary liability for certain breaches of fiduciary duties.]

It is time for BLUEBIRD management to have actual ownership. This ship burns or sails, it's a big swing.

That all being said, projection of break-even for mid-2025 is dependent upon 40 drug sales per quarter, but is not detailed to be for the first quarter or first two quarters of the year - I would like to think that it is limited to 40 sales in the first quarter, which would still be terribly impressive.

Go Bluebird. The value is here, IMO.

First Lyfgenia patient completed

https://www.beckershospitalreview.com/patient-safety-outcomes/1st-sickle-cell-gene-therapy-patient-completes-treatment.html

There is a pretty simple math equation here - would an otherwise incurable patient rather live with their debilitating illness (for a short time before death or with periods of excruciating pain), or accept a less than or about 10% chance of developing a cancer that can be cured?

Bluebird has no patent or I.P. issues. That's Crisper and Vertex, not Lyfgenia. Again, not Bluebird. Those that have been paying attention and following this company are well aware of the cash issues and impending R/S. This is nothing but fear-mongering.

From the paper: ''Hematologic cancer developed in a subgroup of patients who were treated with eli-cel; the cases are associated with clonal vector insertions within oncogenes and clonal evolution with acquisition of somatic genetic defects.'' https://www.nejm.org/doi/full/10.1056/NEJMoa2405541

Myeloablative conditioning also leads to a higher risk of certain cancers and can cause infertility.

Lyfgenia is the value driver for the company, but uses a viral vector, has a boxed warning, and costs more than Casgevy*.

On top of this, there is little cash (and needed raise), a R/S on the cards, patent/IP issues and more.

* CRSP and VRTX are working on ways to overcome the need for myeloablative conditioning.

Thanks.Doesn't look like any impact in PM. It was already on the warning label, so maybe shouldn't have much effect.Let's hope.

https://www.nejm.org/doi/full/10.1056/NEJMoa2405541

The wall is simply a free registration that anyone can do - for free!

Does anyone have the full article please? The link in the prior post does not show entire article.TIA

Details are important. One might even say RELEVANT. The following paragraph, from the article in the post this comment is responding to, details that 5 of those 7 are fine, 1 of the seven is awaiting the treatment that those 5 received, and the 7th died from complications that had absolutely NOTHING to do with a developed blood cancer.

[Of the patients who developed hematologic cancers, five with MDS underwent allogeneic HSCT, and four remain free of MDS without recurrence of symptoms of CALD, and one died from presumed graft-versus-host disease 20 months after transplant and 49 months after receiving eli-cel. The patient with the most recent case of MDS is awaiting HSCT.

The patient with AML is alive and had full donor chimerism after HSCT.]

7 children developed blood cancer after Bluebird Bio gene therapy for rare neurological disease https://www.statnews.com/2024/10/09/bluebird-bio-gene-therapy-blood-cancer-children/

BLUE new 52 week low

Nah, yer all good. Pretty sure they were talking about KOAN - I was hawking the share structure over there for a long time, as they launched a Cannabis line and failed. From the way they did it, it was primed for a small float blow-out if successful.

Nice!! But major dilution about to hit in Q4, so gaps/ fills won’t matter..I’m positive on long term , but c-ste needs to cut their salaries and conserve cash!! Drunken sailors never can navigate a ship properly, never mind Captain Andrew!! :) At the helm!! Hah

Nice!! But major dilution about to hit in Q4, so gaps/ fills won’t matter..I’m positive on long term , but c-ste needs to cut their salaries and conserve cash!! Drunken sailors never can navigate a ship properly, never mind Captain Andrew!! :) At the helm!! Hah

Sorry to break in on your reply, but if poster is talking bout Blue, they do have an ‘ATM’ available but don’t think they are utilizing*( as of Q2 period end)

In August 2023, the Company entered into an Open Market Sales Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies") to sell shares of the Company's common stock up to $125.0 million, from time to time, through an "at the market" equity offering program under which Jefferies will act as sales agent. As of June 30, 2024, the Company has made no sales pursuant to the Sales Agreement.
On December 19, 2023, the Company entered into an underwriting agreement (the "December Underwriting Agreement") with Goldman and J.P. Morgan Securities LLC, in connection with the public offering, issuance, and sale by the Company of 83.3 million shares of the Company's common stock at a public offering price of $1.50 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 and a related prospectus supplement filed with the Securities and Exchange Commission. Under the terms of the December Underwriting Agreement, the Company also granted the underwriters an option exercisable for 30 days to purchase up to an additional 12.5 million shares of common stock at the public offering price, less underwriting discounts and commissions, which option was not exercised. The offering closed on December 22, 2023. The Company received aggregate net proceeds of $118.1 million.
12. Stock-based compensation
In June 2023, the Company's stockholders approved the bluebird bio, Inc. 2023 Incentive Award Plan (the "2023 Plan"), which replaced the 2013 Stock Option and Incentive Plan ("2013 Plan"). Following approval of the 2023 Plan, no further awards will be granted under the 2013 Plan. As of June 30, 2024, the total number of shares of common stock available for issuance under the 2023 Plan was approximately 2.7 million.

BLUE...5368...Like to see the Open Gap filled in the .57 range...🥳

georgie18

Member Level
Re: georgie18 post# 496

Friday, September 27, 2024 5:29:48 PM

Post#
505
of 510
BLUE...50...🥳...September 27, 2024 04:30 PM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).

With the completion of this filing, the Company is now current in its SEC periodic reporting obligations.

To some degree, but I think you've crossed a stream here from another board we're both on?

You still keeping of outstanding share count? Increased 2.5 million in august and another 2 million Friday. Looks like we have a diluter taking small increments

Great! BLUE has had a productive week of good news/filings one after the other :
Sept 24-Restructuring Plan-https://www.sec.gov/ix?doc=/Archives/edgar/data/0001293971/000129397124000046/blue-20240923.htm
Sept 26-Annual Report & Shareholder letter-https://www.sec.gov/Archives/edgar/data/1293971/000129397124000053/bluears2023x.pdf
Sept 27-Form 10Q https://www.sec.gov/ix?doc=/Archives/edgar/data/0001293971/000129397124000058/blue-20240630.htm

Do read the Shareholder letter of 9/26. Good to see the company finally getting their ducks in a row & nice to know that they are now back in compliance with filings.

[Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”)]

https://ih.advfn.com/stock-market/NASDAQ/bluebird-bio-BLUE/stock-news/94627288/bluebird-bio-announces-completion-of-its-q2-2024-f

Have a Great Weekend Y'all...🥳

BLUE...50...🥳...September 27, 2024 04:30 PM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).

With the completion of this filing, the Company is now current in its SEC periodic reporting obligations.

You are absolutely NOT wrong.

Again - F'ed by the FDA; AND, IF the black box warning truly holds merit, the clinical hold should never have been lifted.

And AGAIN, the SEC should be on this. IF they aren't.

What a JOKE!! Really? Who’s gonna vote for these??

THIS IS NOT A VOTABLE BALLOT
This is an overview of the proposals being presented at the upcoming stockholder meeting. Please follow the instructions on the reverse side to vote these important matters.
Board
Voting Items
Recommen
1. Election of Class Il Directors
Nominees:
1a. John O. Agwunobi
© For


1b. Elisabeth Leiderman
• For
1c. Andrew Obenshain
2. The approval, on a non-binding, advisory basis, of the compensation of our named executive officers.
v For
• For
3. The approval of an amendment to our Amended and Restated Certificate of Incorporation to provide for the exculpation of officers for certain breaches of fiduciary duty to the extent permitted by the General Corporation Law © For of the State of Delaware.

4. The approval of amendments to our Amended and Restated Certificate of Incorporation to effect a reverse stock split of our common stock at a ratio ranging from any whole number between 1-for-15 and 1-for-20, as determined by For our Board of Directors in its discretion.

5. The approval of an amendment and restatement of our 2023 Incentive Award Plan to, among other things, increase For the number of shares of common stock authorized for issuance thereunder.

6. Ratification of the selection of Ernst & Young LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024.

7. The approval of an adjournment of the Annual Meeting, if necessary, to solicit additional proxies if there are not @ For sufficient votes at the time of the Annual Meeting to approve Proposal 3, Proposal 4 and/or Proposal 5.

NOTE: To transact any other business that may properly come before the meeting or any adjournment thereof.

Right now Blue should be worth $500-1b EV!!!
Bad C_Ste. Acting like drunken sailors keeps us under $100mm Cap!! Ridiculous!!

Pfizer's Oxbryta exit may hasten trials of rival experimental sickle cell drugs, analysts say Reuters 11:36AM ET, 09/26/2024
*
EMA raises concerns about deaths in Oxbryta trials
*
Shares of Agios and Fulcrum rise after Pfizer's decision
By Kashish Tandon and Christy Santhosh
Sept 26 (Reuters) - Pfizer's decision late on Wednesday to withdraw its sickle cell disease treatment due to the risk of death could help speed up trials of new experimental rivals, Wall Street analysts said.
Oxbryta, one of at least six treatments for the disease, is mostly used in patients with mild-to-moderate symptoms…..

Two recently approved gene therapies - bluebird bio's Lyfgenia and Vertex Pharmaceuticals' and partner CRISPR
Therapeutics' Casgevy - are reserved for people with severe form of the disease.
The removal of Oxbryta likely leaves the vast majority of patients, who have mild-moderate symptoms, relying on chemotherapy medicine hydroxyurea, said Stifel analyst Dae Gon Ha on Thursday.
Sickle cell disease affects an estimated 100,000 people in the U.S., most of whom are Black.

https://www.businesswire.com/news/home/20240924257891/en/ ...🥳

yes,encouraging news it is. These 3 factors stand out for me from today's news,let's only hope these work out as planned:

Cash Flow Break-Even next year....anticipates approximately 40 patient starts in Q4 2024.....restructuring intended to optimize the Company’s cost structure

A raise and even an R/S will not be too bad.

This is encouraging, but still a raise Is necessary in q4:

bluebird bio Initiates Restructuring Intended to Optimize Cost Structure and Enable Quarterly Cash Flow Break-Even in the
Second Half of 2025
Actions intended to reduce cash operating expenses by approximately 20%
Management team to host conference call today,
September 24 at 8:00 am ET
SOMERVILLE, Mass.-(BUSINESS WIRE) -- Sep. 24, 2024--Following a comprehensive review of its operations, bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Company is implementing a restructuring intended to optimize the Company's cost structure and enable quarterly cash flow break-even in the second half of 2025.
The restructuring is expected to result in a 20% reduction in cash operating expenses when fully realized in Q3 2025, compared to the prior reporting period. The initiative includes a reduction in the Company's workforce of approximately 25%. The Company's cash flow break-even target assumes scaling to approximately 40 drug product deliveries per quarter, realizing the 20% reduction in cash operating expenses, and obtaining additional cash resources to extend the Company's cash runway.

Another gene therapy treatment start for BLUE, this time for beta-thalassemia, another dreaded blood disorder. Looks like this article was published this evening around the time we had that spike in a/h. Wonder if this could have also been one reason for the A/H action?
https://www.detroitnews.com/story/news/local/michigan/2024/09/23/dmc-hospital-starts-new-gene-treatments-for-blood-disorders-sickle-cell-anemia/75346376007/

I assumed they must've filed the Q2 financials when I saw the pop,but I suppose that will also be coming soon. One thing at a time,go BLUE.

BLUE...52s clearing...Hit .74...Strong volume hitting here...🥳

Oh thanks for that piece sr, missed seeing it! I thought maybe they filed the June quarter financials.

BLUE............................https://stockcharts.com/h-sc/ui?s=BLUE&p=W&b=5&g=0&id=p86431144783

On September 20, 2024, bluebird bio, Inc. (the "Company") and Henogen SRL, a part of Thermo Fisher Scientific ("Henogen") entered into a Master Services Agreement for Viral Vector Services, effective as of September 15, 2024 (the "Henogen Agreement"). The Henogen Agreement replaces the Company's former manufacturing agreement with Henogen, which expired on September 15, 2024.
Pursuant to the Henogen Agreement, Henogen agrees to manufacture lentiviral vector ("LVV"), currently used in the Company's gene therapy product LYGENIA. Under the terms of the Henogen Agreement, Henogen is responsible for manufacturing LVV, conducting quality control, quality assurance, validation activities, stability testing, packaging and shipping, and providing related services for LVV for clinical or commercial use. The Henogen Agreement is structured so that individual project agreements may be entered into by the parties for the manufacture of a particular product. The Company has agreed to order LVV for commercial use based on a 12-quarter rolling forecast, subject to certain binding and semi-binding forecast periods.
The Henogen Agreement remains in effect until September 15, 2029, and will automatically renew for additional two-year periods unless either party provides advance notice of non-renewal. Either party may terminate the Henogen Agreement in the event of the other party's material uncured breach or bankruptcy proceedings, or due to certain force majeure events.
The Henogen Agreement contains certain representations, warranties, limitations of liabilities, confidentiality and indemnity obligations and other provisions customary for an agreement of its type.

BLUE (0.64) up 31% spiking in A/H,don't see any news,maybe they completed their filing dues?

BLUE...Big Blocks taking out 49s...🥳

That is as real as it gets...BLUE is doing great things...🥳https://www.nytimes.com/2024/09/16/health/sickle-cell-gene-therapy-kendric-cromer.html?unlocked_article_code=1.Mk4.G6Jx.YEbBz53pCfq5&smid=url-share

This article will be of interest for believers in sickle cell gene therapy & BLUE.Hoping for that kids treatment to be a success,even if our investment in the company doesn't pan out. Money can always be made elsewhere, but relief from this horrible disease will be huge.
https://www.nytimes.com/2024/09/16/health/sickle-cell-gene-therapy-kendric-cromer.html?unlocked_article_code=1.Mk4.G6Jx.YEbBz53pCfq5&smid=url-share

Have a Great Weekend Y'all...🥳