stocksrising
2 days ago
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.
stocksrising
2 days ago
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.
stocksrising
1 week ago
They said cash runway thru q1, 2025 and the way they burn*, 💯 positive of a raise as soon as SEC reviews Financials most likely..clock it back and do simultaneous offering .. they also want to access final tranches of Hercules**
*Material and Other Risks Associated with Our Business—
Below is a summary of the material risks to our business, operations and the investment in our common stock. This summary does not address all of the risks that we face:
• We have incurred significant losses since our inception and we may not achieve our goal of becoming profitable in the timeframe we expect, or at all.
• There is substantial doubt regarding our ability to continue as a going concern. We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our commercial programs, product development efforts or other operations.
• Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome. Any such adverse events may require us to halt or delay further clinical development of our products or any future product candidates or to suspend or cease commercialization, and the commercial potential of our products and any such future product candidates may be materially and negatively impacted.
• We rely on complex, single-source supply chains for SKYSONA, ZYNTEGLO, and LYFGENIA, respectively. The manufacture, testing and delivery of LVV and drug products present significant challenges for us, and we may not be able to produce our vector and drug products at the quality, quantities, or timing needed to support our clinical programs and commercialization.
**The Loan and Security Agreement ("LSA") requires the Company to comply with customary affirmative and negative covenants, including, among other things, a requirement to deliver annual financial statements within 90 days of each fiscal year and quarterly financial statements within 45 days of each fiscal quarter. A failure to comply with these covenants, or failure to obtain a waiver for any non-compliance, would result in an event of default under the LSA and would allow Hercules to accelerate repayment of the debt, which could materially and adversely affect the business, results of operations and financial condition of the Company. On April 30, 2024, July 9, 2024, August 13, 2024, and August 29, 2024 the Company and Hercules entered into amendments to the LSA providing for revised monthly financial reporting metrics for each month through September 30, 2024 and extension of the deadlines by which the Company must provide certain annual and quarterly financial statements.
On August 13, 2024, the Company and Hercules entered into a third amendment to the LSA (the "Third Amendment"), pursuant to which the parties agreed to, among other things, revised terms for the availability of the second and third tranches of funding under the LSA. In accordance with the Third Amendment, the Company may draw the second tranche of $25.0 million during the period commencing on the date the Company has (x) received at least $75.0 million in gross cash proceeds from qualified financing transactions by December 20, 2024 and (y) completed patient starts (cell collections) for at least
50 LYFGENIA patients by March 31, 2025 or 70 LYFGENIA patients by June 30, 2025 (collectively, the "Tranche 2 Milestone") and ending on the earlier of
(i) the date that is 30 days immediately following achievement of the Tranche 2 Milestone and ii) July 31, 2025. The Company may draw the third tranche of $25.0 million during the period commencing on the date the Company has (x) received at least $100.0 million in gross cash proceeds from qualified financing transactions by December 20, 2024 or at least $125.0 million by June 30, 2025 and (y) completed 70 drug product deliveries within a given six-month period ending no later than December 31, 2025, at least 40 of which are for LYFGENIA (collectively, the "Tranche 3 Milestone") and ending on the earlier of (i) the date that is 30 days immediately following the date the Company achieves the Tranche 3 Milestone and (ii) December 31, 2025. Additionally, the Company and Hercules agreed to increase the minimum cash coverage requirement from 40% to 45% of the outstanding principal of the term loan.
I realize these are ‘safe harbor’ jargon statements, however a raise is needed is necessary before year end :(