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Allogene Therapeutics, Inc. (ALLO - Free Report) incurred loss of 53 cents per share in second-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of 55 cents. The bottom line was flat year over year.
The company recorded revenues of $44,000 during the quarter, missing the Zacks Consensus Estimate of $0.95 million. The company did not record any revenues in the year-ago quarter.
Shares of Allogene have declined 12.3% so far this year against the industry’s increase of 1%.
Image Source: Zacks Investment Research
Quarter in Detail
Research & development (R&D) expenses were $52.3 million, up 10.6% from the year-ago quarter.
General and administrative (G&A) expenses increased 18.4% year over year to $18.8 million.
The company had $913.2 million in cash, cash equivalents and investments as of Jun 30, 2021, compared with $964.2 million at the end of Mar 31, 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 four pipeline candidates in early-stage of clinical development, including four CAR 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 June, the company announced updated data from two separate phase I studies evaluating ALLO-501 and ALLO-501A for treating relapsed/refractory (r/r) non-Hodgkin lymphoma (NHL).
Data from the phase I ALPHA study evaluating ALLO-501 supported potential of a single administration of CAR T therapy in generating deep and durable responses. The therapy achieved an objective response rate (ORR) of 75%, including complete response (CR) of 50%, in CAR T naïve patients. Data from the phase I ALPHA2 study showed that ALLO-501A has comparable efficacy and safety profile relative to ALLO-501.
The company plans to provide updated data from these early-stage studies in late 2021. Following availability of updated data from the ALPHA and ALPHA2 studies and a potential positive regulatory feedback, the company is expected to start a pivotal phase II study to evaluate ALLO-501A by the end of 2021.
A phase I study — UNIVERSAL — is evaluating ALLO-715 as monotherapy in patients with relapsed/refractory multiple myeloma (r/rMM). During the second quarter, the company started dosing patients in the recently-approved cohort of the UNIVERSAL study to evaluate ALLO-715 in combination with SpringWorks Therapeutics’ (SWTX - Free Report) late-stage candidate, nirogacestat, as a potential treatment for r/rMM. Updated data from the monotherapy arm is expected in the fourth quarter.
A phase I study — TRAVERSE — is evaluating its first CAR T candidate for solid tumors, ALLO-316. Initial data from the study is expected in 2022.
The company initiated a clinical study during the second quarter to evaluate its first anti-BCMA TurboCAR T cell therapy, ALLO-605, in r/rMM. The candidate has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise
Repligen’s earnings per share estimates have moved up from $2.26 to $2.69 for 2021 and from $2.56 to $2.94 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.
Vanda’s earnings per share estimates 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) Q2 Earnings Top, Sales Lag, Pipeline Advances
Allogene Therapeutics, Inc. (ALLO - Free Report) incurred loss of 53 cents per share in second-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of 55 cents. The bottom line was flat year over year.
The company recorded revenues of $44,000 during the quarter, missing the Zacks Consensus Estimate of $0.95 million. The company did not record any revenues in the year-ago quarter.
Shares of Allogene have declined 12.3% so far this year against the industry’s increase of 1%.
Image Source: Zacks Investment Research
Quarter in Detail
Research & development (R&D) expenses were $52.3 million, up 10.6% from the year-ago quarter.
General and administrative (G&A) expenses increased 18.4% year over year to $18.8 million.
The company had $913.2 million in cash, cash equivalents and investments as of Jun 30, 2021, compared with $964.2 million at the end of Mar 31, 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 four pipeline candidates in early-stage of clinical development, including four CAR 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 June, the company announced updated data from two separate phase I studies evaluating ALLO-501 and ALLO-501A for treating relapsed/refractory (r/r) non-Hodgkin lymphoma (NHL).
Data from the phase I ALPHA study evaluating ALLO-501 supported potential of a single administration of CAR T therapy in generating deep and durable responses. The therapy achieved an objective response rate (ORR) of 75%, including complete response (CR) of 50%, in CAR T naïve patients. Data from the phase I ALPHA2 study showed that ALLO-501A has comparable efficacy and safety profile relative to ALLO-501.
The company plans to provide updated data from these early-stage studies in late 2021. Following availability of updated data from the ALPHA and ALPHA2 studies and a potential positive regulatory feedback, the company is expected to start a pivotal phase II study to evaluate ALLO-501A by the end of 2021.
A phase I study — UNIVERSAL — is evaluating ALLO-715 as monotherapy in patients with relapsed/refractory multiple myeloma (r/rMM). During the second quarter, the company started dosing patients in the recently-approved cohort of the UNIVERSAL study to evaluate ALLO-715 in combination with SpringWorks Therapeutics’ (SWTX - Free Report) late-stage candidate, nirogacestat, as a potential treatment for r/rMM. Updated data from the monotherapy arm is expected in the fourth quarter.
A phase I study — TRAVERSE — is evaluating its first CAR T candidate for solid tumors, ALLO-316. Initial data from the study is expected in 2022.
The company initiated a clinical study during the second quarter to evaluate its first anti-BCMA TurboCAR T cell therapy, ALLO-605, in r/rMM. The candidate has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise
Allogene Therapeutics, Inc. price-consensus-eps-surprise-chart | Allogene Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Allogene currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the biotech sector are Repligen Corporation (RGEN - Free Report) and Vanda Pharmaceuticals Inc. (VNDA - Free Report) , both carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings per share estimates have moved up from $2.26 to $2.69 for 2021 and from $2.56 to $2.94 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.
Vanda’s earnings per share estimates 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.