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Allogene's Q3 Loss Narrower Than Expected, Sales Nil
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Allogene Therapeutics (ALLO - Free Report) incurred an adjusted loss (excluding impairment of long-lived asset) of 27 cents per share in third-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 34 cents.
Inclusive of impairment charges, the company posted a loss of 32 cents per share in the quarter. In the year-ago period, the company reported a loss of 37 cents. There was no impairment charge in the year-ago period.
Allogene did not generate revenues during the reported quarter. The Zacks Consensus Estimate for third-quarter sales was pegged at $0.04 million. In the year-ago period, management recorded revenues of $0.02 million.
Year to date, shares of Allogene have lost 0.6% compared with the industry’s 2.4% decline.
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More on ALLO’s Earnings
Research & development (R&D) expenses totaled $44.7 million, down 3% from the year-ago quarter’s level.
General and administrative (G&A) expenses declined 4% year over year to $16.3 million.
As of Sept. 30, 2024, Allogene had $403.4 million of cash, cash equivalents and investments, compared with $444.6 million as of June 30, 2024. Management claims that this cash will help the company extend its cash runway into the second half of2026.
ALLO’s 2024 Guidance
Allogene reiterated its previously issued guidance for 2024. It anticipates incurring operating expenses to be $300 million, including estimated non-cash stock-based compensation expenses of nearly $60 million. Cash burn for the year is expected to be $200 million.
Updates on ALLO’s Pipeline
In a separate press release, Allogene reported new data from the phase I TRAVERSE study, evaluating ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed following treatment with an immune checkpoint inhibitor and VEGF-targeting therapy. As of the data cut-off date of Oct. 14, 2024, 26 patients were evaluated for efficacy outcomes, most of whom were heavily pre-treated with high CD70 expression (defined as a Tumor Proportion Score of more than 50%).
Data from the TRAVERSE study showed that patients with high CD70 expression who were infused with ALLO-316 achieved an overall response rate (ORR) of 50% and a confirmed response rate of 33%. Based on this data, the FDA recently granted ALLO-316 Regenerative Medicine Advanced Therapy (RMAT) designation in advanced or metastatic RCC. Additional data from the TRAVERSE study are expected in mid-2025.
Allogene’s main focus is on the pivotal phase II ALPHA3 study evaluating lead drug cema-cel as a potential first-line treatment for newly-diagnosed and treated large B cell lymphoma (LBCL) patients who are likely to relapse and need further therapy. While management expects a data readout by 2026-end, it expects to make a regulatory submission in 2027.
During the first quarter, management started a new cohort in the phase I ALPHA2 study evaluating cema-cel in patients with chronic lymphocytic leukemia (CLL) based on investigator enthusiasm. It intends to report initial data from this new cohort by early 2025.
Allogene is also planning to explore the potential of CRISPR-based allogenic CAR-T cell therapies in autoimmune diseases. In this regard, management plans to file an investigational new drug (IND) application with the FDA for a new candidate, ALLO-329, by the first quarter of 2025. It plans to explore the potential of this candidate in lupus/systemic lupus erythematosus (SLE) indication and expects to have proof-of-concept before the end of next year.
In the past 60 days, estimates for Amicus Therapeutics’ 2024 earnings per share (EPS) have risen from 20 cents to 22 cents. EPS estimates for 2025 have increased from 49 cents to 53 cents during the same period. Year to date, shares of FOLD have lost 20.8%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 27.09%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 51.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.37. EPS estimates for 2025 have improved from $17.09 to $17.15. Year to date, shares of BIIB have lost 32.6%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.
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Allogene's Q3 Loss Narrower Than Expected, Sales Nil
Allogene Therapeutics (ALLO - Free Report) incurred an adjusted loss (excluding impairment of long-lived asset) of 27 cents per share in third-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 34 cents.
Inclusive of impairment charges, the company posted a loss of 32 cents per share in the quarter. In the year-ago period, the company reported a loss of 37 cents. There was no impairment charge in the year-ago period.
Allogene did not generate revenues during the reported quarter. The Zacks Consensus Estimate for third-quarter sales was pegged at $0.04 million. In the year-ago period, management recorded revenues of $0.02 million.
Year to date, shares of Allogene have lost 0.6% compared with the industry’s 2.4% decline.
Image Source: Zacks Investment Research
More on ALLO’s Earnings
Research & development (R&D) expenses totaled $44.7 million, down 3% from the year-ago quarter’s level.
General and administrative (G&A) expenses declined 4% year over year to $16.3 million.
As of Sept. 30, 2024, Allogene had $403.4 million of cash, cash equivalents and investments, compared with $444.6 million as of June 30, 2024. Management claims that this cash will help the company extend its cash runway into the second half of2026.
ALLO’s 2024 Guidance
Allogene reiterated its previously issued guidance for 2024. It anticipates incurring operating expenses to be $300 million, including estimated non-cash stock-based compensation expenses of nearly $60 million. Cash burn for the year is expected to be $200 million.
Updates on ALLO’s Pipeline
In a separate press release, Allogene reported new data from the phase I TRAVERSE study, evaluating ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed following treatment with an immune checkpoint inhibitor and VEGF-targeting therapy. As of the data cut-off date of Oct. 14, 2024, 26 patients were evaluated for efficacy outcomes, most of whom were heavily pre-treated with high CD70 expression (defined as a Tumor Proportion Score of more than 50%).
Data from the TRAVERSE study showed that patients with high CD70 expression who were infused with ALLO-316 achieved an overall response rate (ORR) of 50% and a confirmed response rate of 33%. Based on this data, the FDA recently granted ALLO-316 Regenerative Medicine Advanced Therapy (RMAT) designation in advanced or metastatic RCC. Additional data from the TRAVERSE study are expected in mid-2025.
Allogene’s main focus is on the pivotal phase II ALPHA3 study evaluating lead drug cema-cel as a potential first-line treatment for newly-diagnosed and treated large B cell lymphoma (LBCL) patients who are likely to relapse and need further therapy. While management expects a data readout by 2026-end, it expects to make a regulatory submission in 2027.
During the first quarter, management started a new cohort in the phase I ALPHA2 study evaluating cema-cel in patients with chronic lymphocytic leukemia (CLL) based on investigator enthusiasm. It intends to report initial data from this new cohort by early 2025.
Allogene is also planning to explore the potential of CRISPR-based allogenic CAR-T cell therapies in autoimmune diseases. In this regard, management plans to file an investigational new drug (IND) application with the FDA for a new candidate, ALLO-329, by the first quarter of 2025. It plans to explore the potential of this candidate in lupus/systemic lupus erythematosus (SLE) indication and expects to have proof-of-concept before the end of next year.
ALLO’s Zacks Rank
Allogene currently has a Zacks Rank #2 (Buy).
Allogene Therapeutics, Inc. Price
Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote
Other Key Picks Among Biotech Stocks
Some other top-ranked stocks from the sector are Amicus Therapeutics (FOLD - Free Report) , Biogen (BIIB - Free Report) and Castle Biosciences (CSTL - Free Report) . While FOLD and CSTL sport a Zacks Rank #1 (Strong Buy) each, BIIB currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Amicus Therapeutics’ 2024 earnings per share (EPS) have risen from 20 cents to 22 cents. EPS estimates for 2025 have increased from 49 cents to 53 cents during the same period. Year to date, shares of FOLD have lost 20.8%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 27.09%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 51.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.37. EPS estimates for 2025 have improved from $17.09 to $17.15. Year to date, shares of BIIB have lost 32.6%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.