Allogene (ALLO) Q1 Earnings Beat, Pipeline Progresses Well

Allogene Therapeutics, Inc. ALLO incurred a loss of 56 cents per share in first-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 59 cents but wider than the year-ago loss of 25 cents.

ALLO recorded revenues of $61,000 during the quarter. The Zacks Consensus Estimate was $0.0 million. In the year-ago quarter, Allogene recorded $38.3 million of revenues.

Allogene’s shares were up 4.1% in after-hours trading on May 4. Yet, the stock has declined 35.9% in the year so far compared with the industry’s decrease of 20.1%.

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Quarter in Detail

Research & development (R&D) expenses were $60.2 million, up 9% from the year-ago quarter’s level.

General and administrative (G&A) expenses increased 21.6% year over year to $19.9 million.

Allogenehad $733.1 million of cash, cash equivalents and investments as of Mar 31, 2022, compared with $809.5 million as of Dec 31, 2021.

2022 Guidance

Allogene reiterated its guidance for 2022 operating expenses. Operating expenses are expected between $360 million and $390 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.

Earlier in January this year, Allogene announced that the FDA removed the clinical hold on all five AlloCAR T therapies after the agency concluded from its investigations that the chromosomal abnormality discovered in one of ALLO’s study participants was not related to its manufacturing process or the TALEN gene-editing technology and had no clinical significance.

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.

ALLO is planning to start the pivotal phase II portion of the phase I/II ALPHA2 study in mid-2022 to evaluate ALLO-501A in patients with relapsed/refractory LBCL. Allogene is currently finalizing the design of the clinical study with the FDA.

ALLO is evaluating ALLO-715 and ALLO-605 in early-stage studies for relapsed/refractory multiple myeloma (MM). Earlier this month, ALLO-605 was granted an Orphan drug designation by the FDA for treating MM.

Allogene intends to provide an update on all the above candidates by this year-end.

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).

Allogene Therapeutics, Inc. Price

Allogene Therapeutics, Inc. price | Allogene Therapeutics, Inc. Quote

Zacks Rank & Other Stocks to Consider

Allogene currently has a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector are Alkermes ALKS, Amicus Therapeutics FOLD and Angion Biomedica ANGN. While Alkermes and Angion Biomedica sport a Zacks Rank #1 (Strong Buy) at present, Amicus Therapeutics carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ loss per share estimates for 2022 have narrowed from 14 cents to 3 cents in the past 30 days. The stock of ALKS has risen 24.5% in the year-to-date period.

Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, ALKS delivered an earnings surprise of 1,100%.

Amicus Therapeutics’ loss per share estimates for 2023 have narrowed from 19 cents to 16 cents in the past 30 days. Shares of FOLD have declined 37.9% in the year-to-date period.

Earnings of Amicus Therapeutics missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 28%, on average. In the last reported quarter, FOLD delivered a negative earnings surprise of 107.1%.

In the past 30 days, estimates for Angion Biomedica’s 2022 loss per share have narrowed from $1.92 to $1.79. Shares of ANGN have declined 44.1% in the year-to-date period.

Earnings of Angion Biomedica beat estimates in three of the last four quarters and missed the mark on one occasion, witnessing a negative surprise of 47.5%, on average. In the last reported quarter, ANGN delivered an earnings surprise of 198.3%.

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