On August 14, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the second quarter ended June 30, 2024, and provided an overview of recent and upcoming business highlights (Press release, Plus Therapeutics, AUG 14, 2024, View Source [SID1234645895]).

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Q2 2024 RECENT HIGHLIGHTS AND MILESTONES

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Presented positive ReSPECT-LM Phase 1 study data at the 2024 Society for NeuroOncology /American Society for Clinical Oncology (SNO/ASCO) CNS Metastases Conference. Rhenium (186Re) Obisbemeda was safe and well-tolerated in the first 4 dosing cohorts (n=16 patients). Current median overall survival is 12 months with 8 of 16 patients treated remaining alive. Additional detail can be found here
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Reported topline FORESEE clinical trial results at SNO/ASCO. The trial demonstrated that CNSide, PLUS’ novel diagnostic platform met its primary clinical endpoint. The CNSide test was found to help clinical decision making in over 90% of provider decisions (n=50/55 clinical decisions) and helped to inform therapy selection in 24% of provider decisions (n=13/55 clinical decisions). Furthermore, the CNSide test improved tumor cell detection in LM patients compared to cytology (80% vs. 29%) in matched samples. Additional details can be found here
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Reported that isotopic rhenium-186, the active radioisotope in Rhenium (186Re) Obisbemeda, substantially spared the spinal cord vs. other beta-emitting radionuclides at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting
•
Submitted a new clinical protocol to the U.S. Food and Drug Administration (FDA), under its active Investigational New Drug application (IND 153715) for a Phase 1 study to evaluate multiple administrations of Rhenium (186Re) Obisbemeda for the treatment of patients with LM
•
Received $3.3 million grant payment from Cancer Prevention & Research Institute of Texas (CPRIT) in June 2024 to support the clinical development of Rhenium (186Re) Obisbemeda for LM

"Plus’ lead investigational drug Rhenium (186Re) Obisbemeda continues to show safety and promising signs of efficacy after a single administration in patients with LM," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We are on track to complete the single administration ReSPECT-LM Phase 1 trial soon, expand to multiple doses, and move to Phase 2 funded by our existing CPRIT award."

UPCOMING EVENTS AND MILESTONES

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Presentations planned for the following upcoming medical conferences:
o
Congress of Neurological Surgeons (CNS) Annual Conference (September 28-October 2, 2024)
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Treatment Of Recurrent Glioblastoma (rGBM) Via Convection Enhanced Delivery (CED) With Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update

o
Society for Neuro-Oncology (SNO) Annual Conference (November 22-26, 2024)
▪
Rhenium (186Re) obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the phase 1 dose escalation study and phase 2 administered dose selection
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CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment helps in clinical management of breast cancer and Non-Small Cell Lung cancer patients having Leptomeningeal Disease
▪
The Oncogenetic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor
•
Complete ReSPECT-LM Phase 1 single administration trial and determine the recommended Phase 2 dose
•
Initiate ReSPECT-LM Phase 1 multiple administration trial
•
Obtain IND approval for a Phase 1/2 trial of Rhenium (186Re) Obisbemeda via convection enhanced delivery (CED) funded by the Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP) for pediatric ependymoma and high-grade glioma

FIRST HALF 2024 FINANCIAL RESULTS

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The Company’s cash and investments balance was $8.4 million at June 30, 2024 compared to $8.6 million at December 31, 2023
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The Company recognized $3.0 million in grant revenue in the first half of 2024 compared to $2.4 million in the same period of 2023, which represents CPRIT’s share of the costs incurred for our Rhenium (186Re) Obisbemeda development for the treatment of patients with LM
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Total operating loss for the first half of 2024 was $7.0 million compared to $6.2 million in the same period of 2023. The increase is primarily due to increased spend related to the ReSPECT-LM trial
•
Net loss for first half of 2024 was $6.2 million, or $(1.15) per basic share, compared to a net loss of $6.3 million, or $(2.60) per basic share, for the same period the prior year

SECOND QUARTER 2024 RESULTS CONFERENCE CALL

The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On August 14, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported second quarter financial results and provided a business update (Press release, Cyclacel, AUG 14, 2024, View Source [SID1234645894]).

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"Following oral fadraciclib data presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Phase 2 stage of our 065-101 study is enrolling well," said Spiro Rombotis, President and Chief Executive Officer. "We are on track to report in the fourth quarter of 2024 initial data from the precision medicine cohort of 065-101 with our CDK2/9 inhibitor as monotherapy in patients with advanced solid tumors and later on in patients with T-cell lymphoma."

"We are enrolling patients prospectively selected for CDKN2A/CDKN2B alterations in the Phase 2, proof of concept (PoC) stage of 065-101," said Brian Schwartz, M.D., interim Chief Medical Officer. "We are pleased with strong investigator interest and are nearing completion of recruitment in the precision medicine cohort. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. A second cohort to evaluate fadraciclib in patients with T-cell lymphoma is open for enrollment. We are encouraged about fadraciclib’s prospects and look forward to presenting emerging data from the 065-101 study later in the year."

Financial Highlights

As of June 30, 2024, cash equivalents totalled $6.0 million, compared to $3.4 million as of December 31, 2023. Net cash used in operating activities was $3.6 million for the six months ended June 30, 2024 compared to $8.2 million for the same period of 2023. Net cash provided by financing activities was approximately $6.3 million, net of expenses, for the six months ended June 30, 2024 from the issuance of common stock and warrants. The Company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.

Research and development (R&D) expenses were $2.0 million for the three months ended June 30, 2024, as compared to $4.7 million for the same period in 2023. R&D expenses relating to fadraciclib were $1.5 million for the three months ended June 30, 2024, as compared to $3.0 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to plogosertib were $0.5 million for the three months ended June 30, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing costs and other non-clinical expenditures.

General and administrative expenses remained flat at approximately $1.6 million for each of the three months ended June 30, 2024 and 2023.

Total other expenses, net, for the three months and year ended June 30, 2024 were $0.1 million for each of the three months ended June 30, 2024 and 2023.

United Kingdom research & development tax credits for the three months ended June 30, 2024 were $0.4 million, compared to $0.6 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended June 30, 2024, was $3.3 million (including stock-based compensation expense of $0.2 million), compared to $5.5 million (including stock-based compensation expense of $0.4 million) for the same period in 2023.

Conference call information:

Call: (800) 225-9448 / international call: (203) 518-9708

Archive: (800) 934-7884 / international archive: (402) 220-6987

Code for live and archived conference call is CYCCQ224. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On August 14, 2024 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the second quarter ended June 30, 2024 and other recent business developments (Press release, Celcuity, AUG 14, 2024, View Source [SID1234645893]).

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"We made significant strides advancing the clinical development of gedatolisib this quarter. Overall enrollment in VIKTORIA-1 remains robust and on-track relative to our previous projections," said Brian Sullivan, CEO and co-founder of Celcuity. "We also initiated efforts to launch VIKTORIA-2, a Phase 3 study to evaluate gedatolisib as a first-line treatment option for patients with HR+, HER2- advanced breast cancer."

"In our VIKTORIA-1 study, while overall enrollment is on track, the proportion of patients who have PIK3CA wild-type tumors, versus those with PIK3CA mutations, has recently shifted lower than our original estimates. As a result, we expect to reach the enrollment target for the PIK3CA wild-type cohort in the fourth quarter, rather than the third quarter, as we originally forecasted. In light of this, we expect topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025."

Second Quarter 2024 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial expects to provide topline data for the PIK3CA wild-type cohort in late Q4 2024 or Q1 2025 and for the PIK3CA mutant cohort in the first half of 2025.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.
○ Enrollment of the PIK3CA wild-type cohort is more than 80% complete and expected to reach the enrollment target during Q4 2024. The PIK3CA wild-type cohort represents approximately 60% of the total patients enrolled to date in VIKTORIA-1.

● In May, the Company announced its plan to initiate VIKTORIA-2, a Phase 3 study to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for patients with HR+/HER2- advanced breast cancer.

○ A safety run-in study to evaluate the safety of gedatolisib combined with ribociclib and fulvestrant will precede initiation of the Phase 3 portion of the study.
○ The Phase 3 portion of the study is expected to enroll approximately 638 patients at up to 200 sites across North America, Europe, Latin America, and Asia.
○ First patient enrollment is expected in the second quarter of 2025.

● During the quarter, the Company secured a combined total of $129 million in gross proceeds from equity and debt financings, which extended the cash runway for current clinical development program activities through 2026.

● The Phase 1b/2 trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC), remains on track to report preliminary data in the first half of 2025.

○ Enrollment is ongoing and the trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.

● Three manuscripts reporting clinical and nonclinical results for gedatolisib were published recently.

○ In April, The Lancet Oncology published results from the dose expansion groups of its Phase 1b study evaluating gedatolisib in combination with palbociclib and endocrine therapy in HR+/HER2- advanced breast cancer. The published manuscript is available online and on the publications section of Celcuity’s website.
○ In June, npj Breast Cancer published results of nonclinical studies showing gedatolisib’s superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. The article is available online and on the publications section of Celcuity’s website.
○ In August, Molecular Oncology published results of nonclinical studies in prostate cancer models showing gedatolisib’s superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors. The article is available online and will soon be available on the publications section of Celcuity’s website.

Second Quarter 2024 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2024, compared to the second quarter ended June 30, 2023.

Total operating expenses were $24.3 million for the second quarter of 2024, compared to $15.1 million for the second quarter of 2023.

Research and development (R&D) expenses were $22.5 million for the second quarter of 2024, compared to $13.8 million for the prior-year period. Of the approximately $8.7 million increase in R&D expenses, $6.6 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial, and $2.1 million was related to increased employee and consulting expenses.

General and administrative (G&A) expenses were $1.8 million for the second quarter of 2024, compared to $1.3 million for the prior-year period. Employee and consulting related expenses accounted for $0.3 million of the increase. Professional fees and other administrative expenses accounted for the remaining increase of approximately $0.2 million.

Net loss for the second quarter of 2024 was $23.7 million, or $0.62 loss per share, compared to a net loss of $14.6 million, or $0.66 loss per share, for the second quarter of 2023. Non-GAAP adjusted net loss for the second quarter of 2024 was $22.2 million, or $0.58 loss per share, compared to non-GAAP adjusted net loss of $11.1 million, or $0.51 loss per share, for the second quarter of 2023. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the second quarter of 2024 was $18.1 million, compared to $9.7 million for the second quarter of 2023.

At June 30, 2024, Celcuity reported cash, cash equivalents and short-term investments of $283.1 million.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2024 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 or 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=c55c86e8c3. A replay of the webcast will be available on the Celcuity website following the live event.

On August 14, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported the ESMO (Free ESMO Whitepaper) Congress decided to move C4T’s previously accepted preliminary monotherapy Phase 1 abstract for CFT1946, a novel BiDAC degrader in mutant BRAF V600 solid tumors, to an oral presentation (Press release, C4 Therapeutics, AUG 14, 2024, View Source [SID1234645892]). This oral presentation session at the ESMO (Free ESMO Whitepaper) Congress 2024 is scheduled for Friday, September 13, 2024, at 4:00 pm to 5:30 pm CEST. Additionally, C4T announced it will host an investor webcast on Friday, September 13, 2024.

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Updated Details for ESMO (Free ESMO Whitepaper) Congress 2024 Presentation
Title: Preliminary Results from a Phase 1 Study of CFT1946, a Novel BiDAC Degrader in Mutant BRAF V600 Solid Tumors
Presentation Date and Time: Friday, September 13, 2024, 4:00 – 5:30 pm CEST
Final Publication Number: 612O
Presenter: Maria Vieito, M.D., Msc (Barcelona, Spain)

C4T Webcast for Analysts and Investors
C4T will host an investor webcast on Friday, September 13, 2024 to discuss the CFT1946 monotherapy data from ongoing CFT1946 Phase 1 trial in BRAF V600 solid tumors. The time of the webcast and access information will be shared closer to the webcast event.

On August 14, 2024 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird bio" or the "Company") reported second quarter results and business highlights for the quarter ended June 30, 2024, including recent commercial and operational progress (Press release, bluebird bio, AUG 14, 2024, View Source [SID1234645891]).

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"We are seeing clear evidence that our commercial launch is accelerating, with over 20 cell collections completed in sickle cell disease and beta-thalassemia to date in 2024, and more than 40 additional patients already scheduled to initiate the treatment journey for a bluebird gene therapy by the end of this year," said Andrew Obenshain, chief executive officer, bluebird bio. "We are further encouraged by the commitment to provide patient access across both commercial and government payers, most recently conveyed through multiple positive Medicaid decisions and the growing number of published coverage policies for LYFGENIA, and we expect approximately 85 patient starts across our portfolio this year."

COMMERCIAL LAUNCH UPDATES

LYFGENIA launch building (lovotibeglogene autotemcel); continued commercial momentum for ZYNTEGLO (betibeglogene autotemcel) and SKYSONA (elivaldogene autotemcel)

27 patient starts completed across portfolio to date in 2024 (19 ZYNTEGLO, 4 LYFGENIA, 4 SKYSONA).
Launch momentum building with more than 40 additional patients scheduled for cell collection across commercial portfolio through year end.
Successfully completed manufacturing and release testing for first commercial LYFGENIA patient and the first infusion is being scheduled.
Rapid acceleration projected for ZYNTEGLO following the recent approval of additional manufacturing capacity.
Validated access and reimbursement strategy is driving favorable coverage landscape

Significant progress with formalized paths to market access. To date, more than half of Medicaid-insured individuals with sickle cell disease in the U.S. live in a state that has affirmed coverage for LYFGENIA through a preferred drug list or published coverage criteria.
Nearly 20% of Medicaid-insured individuals with sickle cell disease in the U.S. live in a state that has already completed prior authorization approval for the use of LYFGENIA for at least one patient.
Multiple outcomes-based agreements are published and in place for LYFGENIA with national commercial payer organizations, representing more than 200 million U.S. lives.
Timely access to ZYNTEGLO and SKYSONA has continued, with zero ultimate denials to date for either therapy across both Medicaid and commercial payers.
Substantial QTC footprint established

bluebird has activated more than 70 total QTCs for LYFGENIA and ZYNTEGLO (defined as a signed MSA).
Six centers are activated to administer SKYSONA for patients with cerebral adrenoleukodystrophy (CALD).
RECENT COMPANY UPDATES

James Sterling appointed as Chief Financial Officer

Effective June 10, 2024, James Sterling became Chief Financial Officer of bluebird bio. Mr. Sterling most recently served as chief financial officer of Renalytix plc, a diagnostics company focused on clinical management of kidney disease. Mr. Sterling was previously managing partner at Renwick Capital LLC, and managing director at investment banks Brock Capital Group LLC and Aleutian Capital Group. He also serves as a board director for a fund managed by Star Mountain Capital. Mr. Sterling has experience as a management consultant at Booz Allen Hamilton. He received his B.A. from Boston University and an M.B.A. from Columbia Business School.
Michael Cloonan appointed to bluebird bio’s Board of Directors

On June 20, 2024, Michael Cloonan was appointed to bluebird bio’s Board of Directors. Mr. Cloonan is currently President and Chief Executive Officer of Sionna Therapeutics. He was previously Chief Operating Officer at Sage Therapeutics leading all business and G&A functions. During his four years with Sage, he helped lead the growth of the organization through multiple capital raises, the launch of the company’s first product, and execution of a transformational, multi-billion-dollar collaboration. An experienced and respected global biotech leader, Mr. Cloonan has over 20 years of biopharma experience across global organizations in various business and commercial roles.
2024 GUIDANCE

The Company anticipates approximately 85 patient starts (cell collections) combined across its portfolio of three FDA approved therapies (LYFGENIA, ZYNTEGLO, SKYSONA) in 2024. Consistent with previous quarters, bluebird plans to provide quarterly updates on patient starts by indication for each of its therapies.
The Company continues to anticipate gross-to-net discounts across all three products to be in the range of 20% to 25% of gross revenue in 2024 and expects they will fluctuate based on product and payer mix, as well as utilization of outcomes-based agreements for LYFGENIA and ZYNTEGLO.
Based on projected timelines from cell collection to infusion, the Company anticipates recognizing revenue from its first infusion of LYFGENIA in the third or fourth quarter of 2024.
SECOND QUARTER FINANCIAL HIGHLIGHTS

Cash Position: The Company’s cash, cash equivalents and restricted cash balance was approximately $193 million, including restricted cash of approximately $49 million, as of June 30, 2024.

Based on current operating assumptions, bluebird expects its cash and cash equivalents as of June 30, 2024 will be sufficient to fund its operations into the second quarter of 2025i, not accounting for the cash minimums required under the Company’s loan agreement with Hercules Capital, Inc. and excluding receipt of any future tranches under the agreement.

The Company has also renegotiated certain terms of its loan agreement with Hercules Capital, Inc. and is eligible to receive two future tranches totaling $50 million, contingent upon achievement of patient start and product delivery milestones and completion of additional financing. These tranches take the place of previously agreed tranches tied to patient starts and gross profit.
Revenue, net: Total revenue, net was $16.1 million for the three months ended June 30, 2024, compared to $6.9 million for the three months ended June 30, 2023. The increase of $9.2 million was due to increased ZYNTEGLO product revenue.
On March 26, 2024, bluebird announced that it will restate its consolidated financial statements as of and for the year ended December 31, 2022, and for each of the first three quarters of 2022 and 2023 in its Annual Report on Form 10-K for the year ended December 31, 2023 (the "2023 Form 10-K"). The restatements relate to the identification of leases and the treatment of non-lease components contained in lease agreements. The restatement is not expected to impact the Company’s cash position or revenue. As a result of the restatement, the Company is delayed in filing its 2023 Form 10-K and its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2024 (the "Q1 2024 Form 10-Q") and June 30, 2024 (the "Q2 2024 Form 10-Q"). The Company is continuing to work expeditiously to complete these filings.

The financial results included in this press release represent the most current information available to the Company’s management. The Company expects that its actual results to be reported in its Q2 2024 Form 10-Q will not differ materially from the results included herein, however, these results are subject to change following the completion of the Company’s financial close procedures and the review of its consolidated financial statements for the quarter ended June 30, 2024.

CONFERENCE CALL DETAILS

bluebird will hold a conference call to discuss its second quarter 2024 results and business updates today, Wednesday, August 14, 2024, at 8:00 am ET.

To participate in the conference call, please dial +1 (800) 715-9871 (U.S. and Canada) and ask to be joined into the bluebird call or provide the Conference ID 2776050.

The live webcast of the call may be accessed by visiting the "Events & Presentations" page within the Investors & Media section of the bluebird website at View Source A replay of the webcast will be available on the bluebird website for 90 days following the event.