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Allogene (ALLO) Misses on Q3 Earnings, Addresses Clinical Hold
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Allogene Therapeutics, Inc. (ALLO - Free Report) incurred a loss of 57 cents per share in third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 56 cents as well as the year-ago loss of 52 cents per share.
The company recorded revenues of $49,000 during the quarter. The company did not record any revenues in the year-ago quarter.
Allogene’s shares were up 1.8% in after-hours trading on Nov 4. Shares of Allogene have declined 23% so far this year compared with the industry’s decrease of 6.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Research & development (R&D) expenses were $58.7 million, up 14.2% from the year-ago quarter.
General and administrative (G&A) expenses increased 14.3% year over year to $19 million.
The company had $861.7 million in cash, cash equivalents and investments as of Sep 30, 2021, compared with $913.2 million as of Jun 30, 2021.
Maintains 2021 Guidance
Allogene maintained its previous guidance for operating expenses for 2021. Operating expenses are expected to be between $300 million and $330 million.
Pipeline Update
Allogene has six pipeline candidates in early-stage of clinical development, including five AlloCAR T cell product candidates — ALLO-501, ALLO-501A, ALLO-715, ALLO-605 and ALLO-316 — and a monoclonal antibody (mAB), ALLO-647. Please note that the company utilizes ALLO-647 as part of its differentiated lymphodepletion regimen in clinical studies evaluating ALLO-501 or ALLO-715.
In October, the FDA placed Allogene’s clinical studies — ALPHA, ALPHA2, IGNITE, TRAVERSE, UNIVERSAL — evaluating AlloCAR T-based cancer therapies on clinical hold. The decision was taken by the regulatory authority following the report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II study — ALPHA2 — evaluating ALLO-501A. The company is currently working with the FDA to resolve the clinical hold.
The FDA is also currently reviewing the end of phase I materials submitted by the company to support the start of a pivotal phase II study on ALLO-501A.
Allogene plans to present updated data from the AlloCAR T studies at the American Society of Hematology annual meeting next month. The updated data to be presented at the meeting from the ALPHA2 study demonstrated that consolidation dosing of ALLO-501A is well tolerated and has the potential for enhanced efficacy compared to a single dose. The updated data from the UNIVERSAL study demonstrated that a single dose of ALLO-715 has the potential toinduce deep responses and can be delivered rapidly without the need for bridging therapy for treating relapsed/refractory multiple myeloma. ALLO-715 was granted orphan-drug designation for treating multiple myeloma in August.
Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise
Estimates for Agenus’ loss per share have narrowed from 28 cents to 23 cents for 2021 and from 97 cents to 77 cents for 2022 in the past 30 days. The company delivered an earnings surprise of 54.45%, on average, in the last four quarters. The stock has gained 31.9% so far this year.
Vertex’s earnings per share estimates have increased from $12.37 to $12.63 for 2021 and from $13.13 to $13.16 for 2022 in the past 30 days. The company delivered an earnings surprise of 8.00%, on average, in the last four quarters.
Estimates for Vanda’s earnings per share estimates have increased from 62 cents to 67 cents for 2021 and from 80 cents to $1.01 for 2022 in the past 30 days. The company delivered an earnings surprise of 23.66%, on average, in the last four quarters. The stock has rallied 21.3% so far this year.
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Allogene (ALLO) Misses on Q3 Earnings, Addresses Clinical Hold
Allogene Therapeutics, Inc. (ALLO - Free Report) incurred a loss of 57 cents per share in third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of 56 cents as well as the year-ago loss of 52 cents per share.
The company recorded revenues of $49,000 during the quarter. The company did not record any revenues in the year-ago quarter.
Allogene’s shares were up 1.8% in after-hours trading on Nov 4. Shares of Allogene have declined 23% so far this year compared with the industry’s decrease of 6.9%.
Quarter in Detail
Research & development (R&D) expenses were $58.7 million, up 14.2% from the year-ago quarter.
General and administrative (G&A) expenses increased 14.3% year over year to $19 million.
The company had $861.7 million in cash, cash equivalents and investments as of Sep 30, 2021, compared with $913.2 million as of Jun 30, 2021.
Maintains 2021 Guidance
Allogene maintained its previous guidance for operating expenses for 2021. Operating expenses are expected to be between $300 million and $330 million.
Pipeline Update
Allogene has six pipeline candidates in early-stage of clinical development, including five AlloCAR T cell product candidates — ALLO-501, ALLO-501A, ALLO-715, ALLO-605 and ALLO-316 — and a monoclonal antibody (mAB), ALLO-647. Please note that the company utilizes ALLO-647 as part of its differentiated lymphodepletion regimen in clinical studies evaluating ALLO-501 or ALLO-715.
In October, the FDA placed Allogene’s clinical studies — ALPHA, ALPHA2, IGNITE, TRAVERSE, UNIVERSAL — evaluating AlloCAR T-based cancer therapies on clinical hold. The decision was taken by the regulatory authority following the report of a chromosomal abnormality with unclear clinical significance in a patient in the phase I/II study — ALPHA2 — evaluating ALLO-501A. The company is currently working with the FDA to resolve the clinical hold.
The FDA is also currently reviewing the end of phase I materials submitted by the company to support the start of a pivotal phase II study on ALLO-501A.
Allogene plans to present updated data from the AlloCAR T studies at the American Society of Hematology annual meeting next month. The updated data to be presented at the meeting from the ALPHA2 study demonstrated that consolidation dosing of ALLO-501A is well tolerated and has the potential for enhanced efficacy compared to a single dose. The updated data from the UNIVERSAL study demonstrated that a single dose of ALLO-715 has the potential toinduce deep responses and can be delivered rapidly without the need for bridging therapy for treating relapsed/refractory multiple myeloma. ALLO-715 was granted orphan-drug designation for treating multiple myeloma in August.
Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise
Allogene Therapeutics, Inc. price-consensus-eps-surprise-chart | Allogene Therapeutics, Inc. Quote
Zacks Rank & Key Picks
Allogene currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks from the biotech sector are Agenus Inc. (AGEN - Free Report) , Vertex Pharmaceuticals (VRTX - Free Report) and Vanda Pharmaceuticals Inc. (VNDA - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Agenus’ loss per share have narrowed from 28 cents to 23 cents for 2021 and from 97 cents to 77 cents for 2022 in the past 30 days. The company delivered an earnings surprise of 54.45%, on average, in the last four quarters. The stock has gained 31.9% so far this year.
Vertex’s earnings per share estimates have increased from $12.37 to $12.63 for 2021 and from $13.13 to $13.16 for 2022 in the past 30 days. The company delivered an earnings surprise of 8.00%, on average, in the last four quarters.
Estimates for Vanda’s earnings per share estimates have increased from 62 cents to 67 cents for 2021 and from 80 cents to $1.01 for 2022 in the past 30 days. The company delivered an earnings surprise of 23.66%, on average, in the last four quarters. The stock has rallied 21.3% so far this year.