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Allogene (ALLO) Beats on Q4 Earnings, Resumes Clinical Studies

·4 min read

Allogene Therapeutics, Inc. ALLO incurred a loss of 54 cents per share in fourth-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of 61 cents but wider than the year-ago loss of 53 cents per share.

The company recorded revenues of $51,000 during the quarter. The company did not record any revenues in the year-ago quarter.

Allogene’s shares were down 2.3% in after-hours trading on Feb 23. Shares of Allogene have declined 72.2% in the past year compared with the industry’s decrease of 37.9%.

Zacks Investment Research
Zacks Investment Research

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Quarter in Detail

Research & development (R&D) expenses were $54 million, up 3.4% from the year-ago quarter.

General and administrative (G&A) expenses increased 16.5% year over year to $20 million.

The company had $809.5 million in cash, cash equivalents and investments as of Dec 31, 2021, compared with $861.7 million as of Sep 30, 2021.

Full-Year Results

Allogene reported revenues of $38.5 million for 2021. The company did not record any revenues in 2020. In 2021, the company incurred a loss of $1.89 per share, narrowing 9.1% from the year-ago period.

2022 Guidance

Allogene issued guidance for operating expenses for 2021. Operating expenses are expected to be between $360 million and $390 million.

Clinical Studies Resumed

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. The company resumed all clinical activities on these candidates earlier this month, following the removal of the clinical hold last month.

In January, the FDA removed the clinical hold on all five allogeneic CAR T (“AlloCAR T”) studies of the company. The FDA had placed the clinical hold based on a report of a chromosomal abnormality in a clinical study evaluating ALLO-501A. However, investigations concluded that chromosomal abnormality is not related to Allogene’s manufacturing process or the TALEN gene-editing technology and had no clinical significance. The company has been working with clinical trial investigators to resume study activities across AlloCAR T development programs since last month.

Allogene is evaluating ALLO-501 and ALLO-501A in two separate phase I studies across different oncology indications. Data from these studies presented last year at the Annual American Society of Hematology (ASH) annual meeting showed that there were no relapses in CAR T naïve patients with large B cell lymphoma (LBCL) at six months following the treatment with either of the candidate.

Based on these developments, Allogene is planning to start the pivotal, phase II study — ALPHA2 — in mid-2022 to evaluate ALLO-501A in patients with relapsed/refractory LBCL. The company is currently finalizing the clinical trial design with the FDA.

The company is evaluating ALLO-715 and ALLO-605 in early-stage studies. Updated data from these studies are expected by the end of 2022.

Meanwhile, Allogene plans to launch a separate registrational trial for its lymphodepletion regimen, ALLO-647, concurrently with the pivotal ALPHA2 study. The company intends to show the safety and contribution of the lymphodepletion regimen to overall benefit.

The company resumed enrollment in the phase I study evaluating ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma.

Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise

Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise
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 carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same sector include Collegium Pharmaceutical COLL, Catalyst Pharmaceuticals CPRX, and Gamida Cell GMDA. While Collegium sports a Zacks Rank #1 (Strong Buy), Catalyst and Gamidacarry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Collegium’searnings per share estimates have moved north from $3.50 to $5.86 for 2022 in the past 30 days. COLL has gained 20.4% so far this year.

Collegiumdelivered a negative earnings surprise of 22.76%, on average, in the last four quarters.

Catalyst’s earnings per share estimates have improved from 50 cents to 69 cents for 2022 in the past 30 days. CPRX has risen 9.7% so far this year.

Catalyst delivered an earnings surprise of 30.56%, on average, in the last four quarters.

Estimates for Gamida have narrowed from a loss of $1.83 to $1.35 for 2022 in the past 30 days. GMDA has risen 20.1% so far this year.

Gamida delivered a negative earnings surprise of 22.6%, on average, in the last four quarters.

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