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Allogene (ALLO) Incurs Narrower-Than-Expected Loss in Q4
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Allogene Therapeutics (ALLO - Free Report) incurred a loss of 66 cents per share in fourth-quarter 2022, narrower than the Zacks Consensus Estimate and our model estimate of a loss of 71 cents and 75 cents, respectively. In the year-ago quarter, the company had reported a loss of 54 cents.
ALLO recorded revenues of $0.05 million during the quarter, in line with the Zacks Consensus Estimate. Revenues were flat year over year.
Shares of Allogene have lost 26.1% in the past year compared with the industry’s 11% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research & development (R&D) expenses were $75.4 million, up 39.7% from the year-ago quarter’s level.
General and administrative (G&A) expenses rose 5.2% year over year to $21.0 million.
Allogene had $576.5 million of cash, cash equivalents and investments as of Dec 31, 2022, compared with $637.3 million as of Sep 30, 2022.
2023 Guidance
Allogene anticipates operating expenses for the full year to be approximately $350 million.
Cash burn for 2023 is expected to be approximately $250 million. Management expects the cash runway to be sufficient to fund operations into 2025.
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.
The mAB candidate, ALLO-647, is part of the lymphodepletion regimen, which is likely to increase the potency of allogeneic CAR T cell therapies. The company intends to start a separate registrational study (EXPAND study) to demonstrate the contribution of ALLO-647 to the standard fludarabine and cyclophosphamide lymphodepletion regimen. The EXPAND study intends to demonstrate the safety of ALLO-647 and its contribution to the overall benefit of the lymphodepletion regimen. It subsequently plans to utilize ALLO-647 in all its clinical studies to enable the expansion and persistence of AlloCAR T product candidates. The EXPAND study will be open to enrollment early in the second quarter.
Lead candidate, ALLO-501 is being evaluated in a phase I ALPHA study for relapsed/refractory (r/r) non-Hodgkin lymphoma (NHL) subtypes. A second-generation version of ALLO-501, ALLO-501A is also being developed for NHL in the phase I/II ALPHA2 study. Both these candidates are being developed in collaboration with partner Servier.
Allogene started the pivotal phase II portion of the ALPHA2 study in October 2022, which is evaluating ALLO-501A in patients with r/r large B cell lymphoma (LBCL).
In November 2022, Allogene reported long-term follow-up data from the extensive phase I program (ALPHA studies), which evaluated ALLO-501A combined with its mAb candidate ALLO-647 in LBCL patients. Data from the study showed that this combination achieved an overall response rate of 67%, including a complete response rate (CRR) of 58%. The responses in patients that received this combination dose were durable, with a 50% CRR at both six months and 12 months, with the longest complete response ongoing at more than 26 months.
Allogene is evaluating ALLO-715 in the UNIVERSAL study targeting B-cell maturation antigen (BCMA) in adult patients with r/r multiple myeloma (MM). Similar to ALLO-501, ALLO-605 is a second-generation version of ALLO-715, which is also being evaluated in r/r MM in the IGNITE study. In November 2022, Allogene reported longer-term follow-up of participants previously treated in the UNIVERSAL study, which showed that strong durability, especially when combined with a higher dose of ALLO-647. The company is also planning to start a pivotal phase II study evaluating ALLO-715 in r/r MM in the future.
ALLO-316 is being evaluated in a phase I TRAVERSE study for advanced or metastatic clear cell renal cell carcinoma (ccRCC). In November, Allogene presented initial data from the TRAVERSE study demonstrating promising anti-cancer activity in a subset of nine patients with confirmed CD70-positive RCC.
Loss estimates for eFFECTOR Therapeutics for 2023 have narrowed from 96 cents to 88 cents in the past 60 days.
Earnings of eFFECTOR Therapeutics beat estimates in each of the trailing four quarters. The average earnings surprise for EFTR is 104.56%. EFTR stock has declined 88.7% in the past year. eFFECTOR Therapeutics is expected to report its fourth-quarter results next month.
Loss estimates for 89BIO for 2023 have narrowed from $2.67 per share to $2.59 per share in the past 60 days.
89BIO’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 10.08%. Shares of 89BIO have increased 207.5% in the past year. 89BIO is expected to report its fourth-quarter results next month.
In the past 60 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 20 cents to 19 cents. Shares of ADMA Biologics have increased 116.5%.
ADMA’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%. ADMA Biologics is expected to report its fourth-quarter results next month.
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Allogene (ALLO) Incurs Narrower-Than-Expected Loss in Q4
Allogene Therapeutics (ALLO - Free Report) incurred a loss of 66 cents per share in fourth-quarter 2022, narrower than the Zacks Consensus Estimate and our model estimate of a loss of 71 cents and 75 cents, respectively. In the year-ago quarter, the company had reported a loss of 54 cents.
ALLO recorded revenues of $0.05 million during the quarter, in line with the Zacks Consensus Estimate. Revenues were flat year over year.
Shares of Allogene have lost 26.1% in the past year compared with the industry’s 11% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research & development (R&D) expenses were $75.4 million, up 39.7% from the year-ago quarter’s level.
General and administrative (G&A) expenses rose 5.2% year over year to $21.0 million.
Allogene had $576.5 million of cash, cash equivalents and investments as of Dec 31, 2022, compared with $637.3 million as of Sep 30, 2022.
2023 Guidance
Allogene anticipates operating expenses for the full year to be approximately $350 million.
Cash burn for 2023 is expected to be approximately $250 million. Management expects the cash runway to be sufficient to fund operations into 2025.
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.
The mAB candidate, ALLO-647, is part of the lymphodepletion regimen, which is likely to increase the potency of allogeneic CAR T cell therapies. The company intends to start a separate registrational study (EXPAND study) to demonstrate the contribution of ALLO-647 to the standard fludarabine and cyclophosphamide lymphodepletion regimen. The EXPAND study intends to demonstrate the safety of ALLO-647 and its contribution to the overall benefit of the lymphodepletion regimen. It subsequently plans to utilize ALLO-647 in all its clinical studies to enable the expansion and persistence of AlloCAR T product candidates. The EXPAND study will be open to enrollment early in the second quarter.
Lead candidate, ALLO-501 is being evaluated in a phase I ALPHA study for relapsed/refractory (r/r) non-Hodgkin lymphoma (NHL) subtypes. A second-generation version of ALLO-501, ALLO-501A is also being developed for NHL in the phase I/II ALPHA2 study. Both these candidates are being developed in collaboration with partner Servier.
Allogene started the pivotal phase II portion of the ALPHA2 study in October 2022, which is evaluating ALLO-501A in patients with r/r large B cell lymphoma (LBCL).
In November 2022, Allogene reported long-term follow-up data from the extensive phase I program (ALPHA studies), which evaluated ALLO-501A combined with its mAb candidate ALLO-647 in LBCL patients. Data from the study showed that this combination achieved an overall response rate of 67%, including a complete response rate (CRR) of 58%. The responses in patients that received this combination dose were durable, with a 50% CRR at both six months and 12 months, with the longest complete response ongoing at more than 26 months.
Allogene is evaluating ALLO-715 in the UNIVERSAL study targeting B-cell maturation antigen (BCMA) in adult patients with r/r multiple myeloma (MM). Similar to ALLO-501, ALLO-605 is a second-generation version of ALLO-715, which is also being evaluated in r/r MM in the IGNITE study. In November 2022, Allogene reported longer-term follow-up of participants previously treated in the UNIVERSAL study, which showed that strong durability, especially when combined with a higher dose of ALLO-647. The company is also planning to start a pivotal phase II study evaluating ALLO-715 in r/r MM in the future.
ALLO-316 is being evaluated in a phase I TRAVERSE study for advanced or metastatic clear cell renal cell carcinoma (ccRCC). In November, Allogene presented initial data from the TRAVERSE study demonstrating promising anti-cancer activity in a subset of nine patients with confirmed CD70-positive RCC.
Zacks Rank & Other Stocks to Consider
Allogene currently has a Zacks Rank #2 (Buy).
Allogene Therapeutics, Inc. Price and Consensus
Allogene Therapeutics, Inc. price-consensus-chart | Allogene Therapeutics, Inc. Quote
Some other top-ranked stocks in the drug sector include eFFECTOR Therapeutics (EFTR - Free Report) , 89BIO (ETNB - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , While eFFECTOR Therapeutics sports a Zacks Rank #1 (Strong Buy), 89BIO and ADMA Biologics have a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for eFFECTOR Therapeutics for 2023 have narrowed from 96 cents to 88 cents in the past 60 days.
Earnings of eFFECTOR Therapeutics beat estimates in each of the trailing four quarters. The average earnings surprise for EFTR is 104.56%. EFTR stock has declined 88.7% in the past year. eFFECTOR Therapeutics is expected to report its fourth-quarter results next month.
Loss estimates for 89BIO for 2023 have narrowed from $2.67 per share to $2.59 per share in the past 60 days.
89BIO’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 10.08%. Shares of 89BIO have increased 207.5% in the past year. 89BIO is expected to report its fourth-quarter results next month.
In the past 60 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 20 cents to 19 cents. Shares of ADMA Biologics have increased 116.5%.
ADMA’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%. ADMA Biologics is expected to report its fourth-quarter results next month.