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Allogene Therapeutics, Inc. ALLO incurred loss of 53 cents per share in fourth-quarter 2020, narrower than the Zacks Consensus Estimate of 56 cents as well as the year-ago quarter’s loss of 58 cents.
With no marketed products, the company did not record any revenues during the quarter.
Shares of Allogene have gained 28.8% in the past year compared with the industry’s increase of 11.5%.
Quarter in Detail
Research & development (R&D) expenses were $52.2 million, up 5.8% from the year-ago quarter.
General and administrative (G&A) expenses increased 12.6% year over year to $17.1 million.
The company had $1 billion in cash, cash equivalents and investments as of Dec 31, 2020, same as at the end of Sep 30, 2020
Allogene did not report any revenues for the full year. The company incurred loss of $2.08 per share for 2020, wider than the loss of $1.83 in the year-ago period.
Allogene issued its guidance for operating expenses in 2021, which is expected to be between $300 million and $330 million.
Allogene has four pipeline candidates in early-stage of clinical development, including three CAR T cell product candidates — ALLO-501, ALLO-501A and ALLO-715 — 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
A phase I study — UNIVERSAL — is evaluating ALLO-715 in combination with ALLO-647 in patients with relapsed/refractory multiple myeloma (r/rMM). Initial data from the study presented in December demonstrated that there were no graft-vs-host disease or Immune Effector Cell-Associated Neurotoxicity Syndrome. Moreover, data from the cohort evaluating a dose of 320M CAR T+ cells demonstrated overall response rate of 60%. Data from the study also showed that higher the dose, higher was the response rate.
The company is currently enrolling patients in the newly-approved clinical study to evaluate ALLO-715 in combination with SpringWorks Therapeutics’ SWTX late-stage candidate, nirogacestat, as a potential treatment for r/rMM.
Meanwhile, the FDA has cleared an investigational new drug (“IND”) application for initiation of a clinical study to evaluate its first CAR T candidate for solid tumors, ALLO-316. A study is expected to start by this quarter end. The company also plans to initiate a clinical study this year to evaluate its first anti-BCMA TurboCAR T cell therapy, ALLO-605, in r/rMM in 2021. The candidate has the potential to improve efficacy, overcome cell exhaustion, and reduce dosing requirements of AlloCAR T therapy.
The company plans to announce initial data from the phase I ALPHA2 study evaluating ALLO-501A in the second quarter. It intends to start a pivotal, phase II study on the candidate, subject to positive data and regulatory approvals.
Allogene Therapeutics, Inc. Price, Consensus and EPS Surprise
Allogene Therapeutics, Inc. price-consensus-eps-surprise-chart | Allogene Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Allogene currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the biotech sector include Lexicon Pharmaceuticals, Inc. LXRX and Atea Pharmaceuticals, Inc. AVIR, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lexicon’s loss per share estimates have narrowed from 63 cents to 17 cents for 2021 in the past 60 days. The company delivered an earnings surprise of 21.72%, on average, in the last four quarters. The stock has risen 170% in the past year.
Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 in the past 60 days. The stock has surged 168% since its IPO in October 2020.
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