Industry Overview - The biotech sector experienced a volatile performance in 2024, starting positively but facing declines in the second half due to disappointing third-quarter results, guidance cuts, pipeline setbacks, and the appointment of Robert F. Kennedy Jr. as head of Health and Human Services [1] Company Summaries Immunocore Holdings (IMCR) - IMCR is focused on developing TCR bispecific immunotherapies, with Kimmtrak being the first FDA-approved immunotherapy for metastatic uveal melanoma, generating $226 million in sales in the first nine months of 2024, a 32% year-over-year increase [3] - Despite strong sales growth, IMCR's stock has dropped 58% year to date due to perceived risks in pipeline development, particularly concerning brenetafusp's efficacy beyond cutaneous melanoma [12] - Analysts expect a significant upside for IMCR in early 2025 with anticipated positive updates on an investigational HIV therapy and ongoing late-stage studies for Kimmtrak [13] Allogene Therapeutics (ALLO) - ALLO is developing allogeneic CAR T therapies for cancer treatment, with a strategic pivot that has delayed the initial market introduction of its lead drug cema-cel to 2027 [6] - The stock has declined 35% year to date, but loss per share estimates for 2025 have improved from $1.45 to $1.34 [7][15] - ALLO is also exploring CAR-T therapies for multiple myeloma and renal cell carcinoma, with plans to initiate a study for lupus by early 2025 [16] Day One Biopharmaceuticals (DAWN) - DAWN focuses on therapies for pediatric cancer, with its drug Ojemda being the only systemic therapy for pLGG in the U.S., generating over $28 million in revenue in the first nine months of 2024 [8][17] - The company is conducting a pivotal late-stage study for Ojemda and has two other investigational candidates in its pipeline [9] - DAWN's stock has decreased over 13% year to date, but loss per share estimates for 2025 have improved from $2.03 to $0.99 [10]

Investors might want to bet on Allogene Therapeutics (ALLO) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a cha ...

The year 2024 has been a mixed ride for the biotech industry. It started on a positive note, attracting investors’ attention in areas with great commercial potential, like obesity, immunology and gene therapy.However, their interest started to wane in the second half of the year amid lower-than-expected third-quarter results, guidance cuts and pipeline setbacks. While Wall Street viewed Trump’s victory as an accelerant for M&A activity in the sector, the President-elect’s decision to nominate vaccine skepti ...

SOUTH SAN FRANCISCO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene, will present at the 43rd Annual J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco. 43rd Annual J.P. Morgan Healthcare Conferen ...

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today acknowledged the passing of founding board member, David Bonderman. David died at the age of 82, surrounded by his family. “We are deeply saddened by the passing of our founding board member and dear friend,” said Arie Belldegrun, M.D., Executive Chairman ...

Shares of Allogene Therapeutics (ALLO) have lost nearly 23% year to date, underperforming the industry’s 7.0% decline. The stock has also underperformed the sector and the S&P 500 during the same period, as shown in the chart below. ALLO’s shares are trading below the 50 and 200-day moving averages.ALLO Stock Underperforms Industry, Sector & S&P 500 Image Source: Zacks Investment ResearchThe decline in stock price can be attributed to the strategic changes in Allogene’s pipeline, announced at the start of t ...

Allogene Therapeutics (ALLO) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing ea ...

Company Overview - Allogene Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases [3] - The company aims to provide "off-the-shelf" CAR T cell product candidates that are readily available on-demand, more reliably, and at greater scale to a larger patient population [3] Upcoming Events - Allogene will participate in two investor conferences in December 2024, including the Citizens JMP Hematology and Oncology Summit on December 2 and the 36th Annual Piper Sandler Healthcare Conference on December 3 [2] - The presentation time for the Jefferies London Healthcare Conference on November 20, 2024, has been updated to 11:30 AM GMT / 6:30 AM ET [2] Communication and Accessibility - Webcasts of the presentations will be available on the company's website under the Investors tab in the News and Events section, with replays accessible for approximately 30 days [2]

Allogene Therapeutics (ALLO) incurred an adjusted loss (excluding impairment of long-lived asset) of 27 cents per share in third-quarter 2024, narrower than the Zacks Consensus Estimate of a loss of 34 cents.Inclusive of impairment charges, the company posted a loss of 32 cents per share in the quarter. In the year-ago period, the company reported a loss of 37 cents. There was no impairment charge in the year-ago period.Allogene did not generate revenues during the reported quarter. The Zacks Consensus Esti ...

Financial Data and Key Metrics Changes - The cash balance at the end of Q3 2024 was $403.4 million, extending the cash runway into the second half of 2026 [30] - Q3 2024 research and development expenses were $44.7 million, including $5.6 million in non-cash stock-based compensation [30] - General and administrative expenses for Q3 were $16.3 million, which included $7.8 million of non-cash stock-based compensation [30] - The net loss for Q3 2024 was $66.3 million, or $0.32 per share, including non-cash stock-based compensation of $13.4 million and $10.7 million in non-cash impairment of long-lived asset expense [31] Business Line Data and Key Metrics Changes - The pivotal Phase II ALPHA3 trial of cema-cel for large B cell lymphoma is advancing, with 27 of the planned 50 sites activated [17] - ALLO-316 showed a confirmed response rate of 33% and a best overall response rate of 50% in heavily pretreated patients with high CD70 expression [9][19] - ALLO-329 is designed to target both CD19 positive B cells and CD70 positive T cells, addressing a broader spectrum of autoimmune diseases [10] Market Data and Key Metrics Changes - The ALLO-316 program received RMAT designation from the FDA, indicating its potential as a treatment for advanced renal cell carcinoma [24] - The company is focusing on community centers for trial site activation to ensure broad accessibility for CAR T therapies [17] Company Strategy and Development Direction - The company aims to redefine cell therapy for cancer and autoimmune diseases, with a long-term vision for each program [13] - The strategy includes pursuing best-in-class therapies with differentiated development approaches to maximize the attributes of AlloCAR T [13] - The focus on ALLO-329 is to address the challenge of lymphodepleting chemotherapy, aiming to reduce or eliminate its need [12][51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the advancements of the pivotal cema-cel trial and the promising data for ALLO-316 [15] - The company acknowledges the challenges in a highly competitive field but remains optimistic about the potential of its therapies [13] - Management highlighted the importance of understanding the differences in patient populations and indications when assessing safety and efficacy [40] Other Important Information - The company plans to present data on ALLO-316 at the International Kidney Cancer Symposium and the Society for Immunotherapy of Cancer annual meeting [25] - The company expects a cash burn of approximately $200 million for 2024, with full-year GAAP operating expenses projected at approximately $300 million [31] Q&A Session Summary Question: Insights on RCC data and expansion cohort timeline - Management indicated that approximately 20 patients are expected to be enrolled in the expansion cohort, with updates anticipated next year [35] Question: Safety in autoimmune settings and read-through from ALLO-316 data - Management expressed confidence in the safety profile for autoimmune applications, noting that the intensity of therapy required will be lower compared to oncology [39] Question: Grade 5 events and management algorithm for IECHS - Management acknowledged the complexity of adverse events in heavily pretreated patients and detailed the management algorithm for IECHS, which is similar to those used for CRS [42][43] Question: Enrollment dynamics in autoimmune studies - Management noted that enrollment in autoimmune studies is picking up, with a focus on engaging investigators who may lack CAR T experience [98]