On May 13, 2025 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, reported corporate updates and announced financial results for the quarter ended March 31, 2025 (Press release, Allogene, MAY 13, 2025, View Source [SID1234652953]).

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"We are executing on a strategy that is grounded in science, shaped by real-world insights, and supported by a platform purpose-built to scale," said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene. "From transforming the role of CAR T in first line LBCL through ALPHA3 to breaking new ground in autoimmune disease with ALLO-329 to showing what’s possible in solid tumors with ALLO-316, we are leading where others have yet to go. The experience we’ve gained from our trials, the commitment from our partners, and the unmatched efficiencies of our allogeneic platform reinforce my confidence that our approach is not only working but also defining the future of cell therapy. We have never been clearer about our path or more certain about the value we can deliver to patients and the field."

Program Updates
Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The ALPHA3 trial evaluating cema-cel as 1L consolidation therapy for LBCL remains a cornerstone of Allogene’s clinical strategy. The trial now includes nearly 50 activated sites across the U.S., spanning both community cancer centers and leading academic institutions. The trial uniquely identifies high-risk patients using Foresight CLARITY powered by PhasED-Seq, an Investigational Use Only (IUO) MRD test, and randomizes approximately 240 patients to assess whether early intervention with cema-cel improves event-free survival (EFS) compared to observation, which is the current standard of care.

As the first study of its kind, ALPHA3 has delivered valuable real-world insights. Since launching in mid-2024, Allogene has partnered closely with sites to refine patient identification strategies; educated patients on their relapse risk and opportunity for additional therapy based on MRD status; and navigated expected and unforeseen challenges. Chief among these has been industry-wide factors that have delayed site readiness to initiate screening activities for three months or more after activation. As a result, the milestone for lymphodepletion regimen selection and futility analysis has been shifted by approximately two quarters and is now expected in the first half of 2026.

The momentum behind ALPHA3 however has been tangible and significant, driven by a strong partnership between Allogene and its clinical sites. Several sites have proactively collaborated with the Company to develop and share best practices, fostering a coordinated network. An important measure of success is the identification of patients early in 1L treatment who are interested in the trial and consenting them for MRD testing at completion of therapy. This metric is now being consistently met as earlier introduction to the trial has increased the proportion of screening-eligible patients advancing to MRD testing and, if positive, agreeing to randomization. With the earliest activated sites now screening regularly and newly activated sites implementing best practices immediately, we have now consented over 250 patients for MRD screening, with nearly half of these consents occurring in the last three months. Meanwhile, growing international interest has prompted expansion of the trial footprint outside the U.S., a move expected to accelerate enrollment further and strengthen trial execution.

The Company will intentionally hold off on projecting additional milestones until after the first milestone for lymphodepletion regimen selection and futility analysis. Recognizing the strategic significance of this inflection point and guided by stakeholder feedback, the Company is re-evaluating what data will be appropriate to share at the time of the lymphodepletion announcement.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
ALLO-329 offers a novel approach to treating autoimmune diseases as the first allogeneic CD19/CD70 dual CAR T product specifically designed to target CD19+ B-cells and CD70+ activated T-cells, both of which are key players in autoimmune diseases. The investigational product utilizes CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion, believed to be a potentially significant obstacle to the broader adoption of CAR T therapies in autoimmune indications.

The Phase 1 RESOLUTION basket trial in rheumatology will begin in mid-2025. The trial will include patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. The innovative design of the RESOLUTION trial will include two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone and another that eliminates lymphodepletion entirely. The Company has shifted timing for its first update to this program to 1H 2026 to allow for both biomarker and clinical proof-of-concept data.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. Enrollment has completed in the Phase 1b cohort, which is evaluating the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) in patients with heavily pretreated advanced or metastatic RCC. The Company will present updated data from the Phase 1b cohort in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 1, 2025, in Chicago, Illinois.

2025 First Quarter Financial Results

Research and development expenses were $50.2 million for the first quarter of 2025, which includes $5.0 million of non-cash stock-based compensation expense.
General and administrative expenses were $15.0 million for the first quarter of 2025, which includes $7.1 million of non-cash stock-based compensation expense.
Net loss for the first quarter of 2025 was $59.7 million, or $0.28 per share, including non-cash stock-based compensation expense of $12.2 million.
The Company had $335.5 million in cash, cash equivalents, and investments as of March 31, 2025.
In recognition of the evolving macroeconomic environment and the importance of preserving capital, the Company has taken steps to optimize its operations and extend the financial runway. Strategic cost-realignment efforts have been implemented to prioritize high-impact, value-generating programs, which include the clinical advancement of cema-cel in the ALPHA3 trial and ALLO-329 in the RESOLUTION trial. Operational savings have been achieved through a tactical reduction in manufacturing operations, leveraging prior infrastructure investments and the inherent efficiencies of the Company’s allogeneic CAR T platform, while preserving core capabilities. These actions have extended the cash runway into the second half of 2027, allowing the Company to strengthen its ability to weather market uncertainty as it executes clinical programs through key milestones. As a result of these efforts, new guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are now expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its first quarter 2025 financial results and provided a corporate update (Press release, Instil Bio, MAY 13, 2025, View Source [SID1234652970]).

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Recent Highlights:

ImmuneOnco’s Phase 1b/2 trial of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC in China is ongoing and ImmuneOnco anticipates initial clinical data from first-line NSCLC patients in 2H 2025.
U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated to commence before the end of 2025: Instil anticipates initiating a U.S. clinical trial of AXN-2510/IMM2510 in combination with chemotherapy for 1L NSCLC patients before the end of 2025, assuming the necessary regulatory approvals are obtained.
First Quarter 2025 Financial and Operating Results:

As of March 31, 2025, Instil had $111.8 million in total cash, cash equivalents, restricted cash, marketable securities and long-term investments, which consisted of $15.4 million in cash and cash equivalents, approximately $1.0 million in restricted cash, $88.3 million in marketable securities and $7.2 million in long-term investments, compared to $115.1 million in total cash, cash equivalents, restricted cash and marketable securities, which consisted of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities, as of December 31, 2024. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of March 31, 2025 will enable it to fund its current operating plan beyond 2026.

Research and development expenses were $5.4 million for the three months ended March 31, 2025, compared to $7.3 million for the three months ended March 31, 2024.

General and administrative expenses were $9.1 million for the three months ended March 31, 2025, compared to $12.4 million for the three months ended March 31, 2024.

Restructuring and impairment charges were $16.1 million for the three months ended March 31, 2025, compared to $4.3 million for the three months ended March 31, 2024.

Net loss per share, basic and diluted were $4.32 for the three months ended March 31, 2025, compared to $3.74 for the three months ended March 31, 2024. Non-GAAP net loss per share, basic and diluted were $1.32 for the three months ended March 31, 2025, compared to $2.39 for the three months ended March 31, 2024.

Note Regarding Use of Non-GAAP Financial Measures

In this press release, Instil has presented certain financial information that has not been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures include non-GAAP net loss and non-GAAP net loss per share, which are defined as net loss and net loss per share, respectively, excluding non-cash stock-based compensation expense and restructuring and impairment charges. Instil believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Instil’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Instil’s operating results. In addition, these non-GAAP financial measures are among the indicators Instil’s management uses for planning purposes and to measure Instil’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by Instil may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. Please refer to the below reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures.

On May 13, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported financial results for the quarter ended March 31, 2025 and provided a corporate update (Press release, Tempest Therapeutics, MAY 13, 2025, View Source [SID1234652990]).

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"The amezalpat program continues to produce data that reinforce its potential as a cancer therapy, most recently in a presentation at AACR (Free AACR Whitepaper) showing that amezalpat reduced immunosuppression and activated the immune system to attack tumors. We were pleased to present these data that elucidate one part of the amezalpat mechanism of action and support the positive randomized Phase 2 data, including the benefit seen in patients with markers of immune resistance," said Stephen Brady, president and chief executive officer of Tempest. "We are actively engaged in exploring strategic alternatives to advance our promising clinical-stage programs and maximize stockholder value and, given the data, continue to have strong conviction in the potential of our oncology portfolio to drive meaningful impact for patients facing cancer."

Recent Highlights

Amezalpat (TPST-1120) (clinical PPARα antagonist):
Reported new data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the immune component of amezalpat’s dual mechanism of action and reinforcing its potential as a novel cancer treatment.
Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist):
Granted Orphan Drug designation by the FDA to treat patients with FAP.
Received a "Study May Proceed" letter from the FDA for the Phase 2 trial for the treatment of FAP.
This trial, run by CP-CTNet and financially supported by the NCI’s Division of Cancer Prevention, underscores the urgent need for innovative cancer prevention strategies in high-risk patient populations. The Phase 2 study is expected to begin in 2025.
Corporate:
Announced (i) plans to explore a full range of strategic alternatives to advance the company’s promising clinical-stage programs and maximize stockholder value and (ii) a reduction in force that was completed on April 30, 2025.
Using cash on hand, the company repaid $3.5 million in full satisfaction of Loan and Security Agreement with Oxford Finance LLC in April 2025.

Financial Results

First Quarter 2025

Tempest ended the quarter with $21.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by proceeds of $1.5 million from the at-the-market offering program.
Net loss and net loss per share for the quarter were $10.9 million and $3.16, respectively, compared to $7.9 million and $4.62, respectively, for the same period in 2024.
Research and development expenses for the quarter were $7.6 million compared to $4.3 million for the same period in 2024. The $3.3 million increase was primarily due to an increase in costs incurred from engaging contract research and manufacturing organizations in preparation for our pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC.
General and administrative expenses for the quarter were $3.3 million compared to $3.6 million for the same period in 2024. The $0.3 million decrease was primarily due to a decrease in consulting services.

On May 13, 2025 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported its decision to file an application for opening of insolvency proceedings with the local court of Mannheim in Germany.

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As previously reported, Affimed N.V. (the "Company") has been engaged in discussions with potential investors and partners with respect to potential strategic transactions to raise additional capital. Despite its continuous and ongoing fundraising efforts, the Company has not been able to raise sufficient additional funds to continue the operations of the Company and its controlled (and wholly owned) subsidiaries Affimed GmbH and Affimed Inc. Further, based on currently available information, the Company’s liquidity condition raises substantial doubt about the Company’s ability to continue as a going concern.

As a consequence, the members of the management board of the Company have determined in respect of the Company and the managing directors of Affimed GmbH have determined in respect of Affimed GmbH that the companies are overindebted (Überschuldung). The management of the Company and the management of Affimed GmbH have determined with regards to the respective company that they must file for insolvency under German law.

Following such determination, on May 13, 2025, the members the management board of the Company filed for the opening of ordinary insolvency proceedings over the assets of the Company and the managing directors of Affimed GmbH filed for the opening of ordinary insolvency proceedings over the assets of Affimed GmbH with the local court of Mannheim in Germany. There can be no assurance as to the outcome of any preliminary or formal insolvency proceedings with respect to the Company or Affimed GmbH or as to whether the companies will emerge from insolvency as a going concern. Further, the insolvency filing in respect of the Company and resulting preliminary and formal insolvency proceedings will also result in the Company’s common shares being suspended from trading on, and subsequent delisting from, The Nasdaq Global Market.

(Press release, Affimed, MAY 13, 2025, View Source [SID1234661338])

On May 13, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that it will host a webcast event on May 20, 2025, to provide an update on ALX2004, the Company’s potentially best- and first-in-class investigational antibody-drug conjugate (ADC) (Press release, ALX Oncology, MAY 13, 2025, View Source [SID1234652954]). The webcast will highlight the novel mechanism of action, preclinical data and clinical development strategy for ALX2004 following clearance of the Investigational New Drug application from the U.S. Food and Drug Administration earlier this year.

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ALX2004 was fully designed and developed in-house by ALX Oncology scientists. By leveraging the Company’s proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX2004 optimizes ADC-based mechanisms of anti-tumor activity and is designed to improve outcomes in patients with EGFR-expressing tumors.

ALX Oncology leadership Jason Lettmann, Chief Executive Officer, Alan Sandler, Chief Medical Officer and Marija Vrljic, Vice President of Antibody Technologies, will discuss planned clinical progress and updates for ALX2004 during the virtual webcast event.

ALX2004 Webcast Information
The virtual event will be webcast live and a replay will be available after the event by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations."

Date & Time: Tuesday, May 20, 2025, 8:00 a.m. PT/11:00 a.m. ET
Webcast Access: View Source