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Allogene (ALLO) Q1 Earnings Beat, Pipeline Progressing Well

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Allogene Therapeutics, Inc. (ALLO - Free Report) incurred a loss of 52 cents per share in second-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 61 cents and the year-ago quarter’s loss of 53 cents.

ALLO recorded revenues of $0.09 million during the quarter, which beat the Zacks Consensus Estimate of $0.08 million. In the year-ago quarter, Allogene recorded $0.04 million of revenues.

Shares of Allogene have moved up 0.7% in the year so far against the industry’s decline of 17.3%.

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Quarter in Detail

Research & development (R&D) expenses were $57.2 million, up 9.3% from the year-ago quarter’s level.

General and administrative (G&A) expenses increased 3.9% year over year to $19.5 million.

Allogenehad $686.1 million of cash, cash equivalents and investments as of Jun 30, 2022, compared with $733.1 million as of Mar 31, 2022.

2022 Guidance Updated

Though Allogene anticipates an increase in operating expenses in the second half of the year compared with the first half, it expects operating expenses for the full year to be at the lower end of the previously-provided guidance of $360 million-$390 million.

Cash burn for the full year is expected to be around $250 million.

Pipeline Update

Allogene has six pipeline candidates in early-stage of clinical development, including five AlloCAR T cell product candidates, namely ALLO-501, ALLO-501A, ALLO-715, ALLO-605 and ALLO-316, and a monoclonal antibody (mAB) ALLO-647.

Allogene’s most advanced product candidates are ALLO-501 and ALLO-501A, designed to target CD19 protein expressed on the cell surface of B-cells. ALLO is evaluating ALLO-501 and ALLO-501A in two separate early-stage clinical studies across different oncology indications. The company expects to provide an update on both studies by year-end. This update will focus on longer-term follow up of participants previously treated in both studies.

In the coming weeks, ALLO expects to receive FDA’s approval to start the pivotal phase II portion of phase I/II ALPHA2 study. This study will evaluate ALLO-501A in patients with relapsed/refractory large B cell lymphoma (LBCL). If this phase II portion is initiated, ALLO expects the study to be the industry’s first pivotal phase II study for an allogenic CAR T therapy.

Allogene is evaluating ALLO-715 and ALLO-605 in early-stage studies for relapsed/refractory multiple myeloma (MM). The company also plans to explore a pivotal phase II study approach and timing for both candidates by year-end. It also expects to provide a clinical update on ALLO-715, focusing on longer-term follow-up of participants previously treated in phase I UNIVERSAL study by year-end.

Management also announced its decision not to advance the combination of ALLO-715 and SpringWorks Therapeutics’ investigational gamma-secretase inhibitor, nirogacestat, into dose escalation cohorts of the UNIVERSAL study. This decision was taken due to a lack of a clear indication that this combination would meaningfully improve the benefit-risk profile of ALLO-715 as monotherapy.

The mAB candidate, ALLO-647, is part of the lymphodepletion regimen, which is likely to increase the potency of allogeneic CAR T cell therapies. Allogene is utilizing ALLO-647 in all its clinical studies and planning to launch a separate registrational study (EXPAND study) for the candidate concurrently with the pivotal ALPHA2 study. The EXPAND study intends to demonstrate the safety of ALLO-647 and its contribution to the overall benefit of the lymphodepletion regimen.

Allogene is enrolling patients in the phase I TRAVERSE study, which is evaluating ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC).

 

Zacks Rank & Other Stocks to Consider

Allogene currently has a Zacks Rank #3 (Hold).

A few better-ranked stocks in the overall healthcare sector include Alkermes (ALKS - Free Report) , Geron (GERN - Free Report) and Morphic (MORF - Free Report) . While Geron and Morphic sport a Zacks Rank #1 (Strong Buy) at present, Alkermes carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, estimates for Geron’s 2022 loss per share have narrowed from 38 cents to 36 cents. Loss estimates for 2023 have narrowed from 36 cents to 35 cents during the same period. Shares of Geron have surged 69.7% in the year-to-date period.

Earnings of Geron beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 1.07%, on average. In the last reported quarter, GERN delivered an earnings surprise of 18.18%.

In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $2.90. Loss estimates for 2023 have narrowed from $3.96 to $3.90 during the same period. Shares of Morphic have lost 34.6% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

Alkermes’ stock has risen 10.1% this year so far. Alkermes’ estimates for 2022 have improved from a loss of 17 cents per share to earnings of 20 cents per share. The consensus estimate for 2023 earnings has increased from 31 cents per share to 50 cents per share in the past 30 days.

Alkermes beat earnings estimates in each of the last four quarters, delivering an average earnings surprise of 325.48%, on average. In the last reported quarter, ALKS reported an earnings surprise of 50.00%.

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