Atara Biotherapeutics to Participate in Cell Therapy Panel Discussion at the Cowen 44th Annual Health Care Conference

On February 28, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Pascal Touchon, President and Chief Executive Officer, will participate in a cell therapy panel discussion at the Cowen 44th Annual Health Care Conference on Wednesday, March 6, 2024 at 6:10 a.m. PST / 9:10 a.m. EST (Press release, Atara Biotherapeutics, FEB 28, 2024, View Source [SID1234640625]).

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A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

Arcellx Provides Fourth Quarter and Year-End 2023 Financial Results and Business Highlights

On February 28, 2024 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2023 (Press release, Arcellx, FEB 28, 2024, View Source [SID1234640624]).

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"In 2023, our team built upon the momentum that has propelled Arcellx forward over the past two years," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "We expanded our partnership with Kite, through a $200M investment, extending our cash runway into 2027 and deepened our collaboration by expanding into lymphomas. Additionally, we presented robust long-term data from our Phase 1 expansion study of anito-cel at the 65th ASH (Free ASH Whitepaper) Annual Meeting. These data support the potential for anito-cel to be a best-in-class treatment option for patients with relapsed or refractory multiple myeloma. In parallel to these milestones, we continued to scale our organization to deliver both operationally and strategically, strengthening our foundation with key progress in manufacturing, development, research, and commercial readiness. This year is poised to be another year of meaningful progress for our organization. We are focused on completing enrollment in the iMMagine-1 trial, initiating our clinical trial in earlier lines of multiple myeloma, and completing the technical transfer to Kite. Patients with relapsed or refractory multiple myeloma still have limited therapeutic options, and with our partners at Kite, we are committed to delivering anito-cel to help as many patients as possible. We believe that with our technology coupled with Kite’s recognized global leadership and established manufacturing expertise, we are well positioned to achieve this goal. Additionally, we continue to invest in research and believe the differentiation of the D-Domain technology provides an opportunity for us to expand our development pipeline in other therapeutic areas."

Recent Business Progress

Expanded strategic partnership with Kite Pharma, Inc., a Gilead Company, to include co-development of anito-cel for lymphomas and Kite exercising its option to license ACLX-001. On November 15, 2023, Arcellx and Kite, a Gilead Company, announced an expansion in their existing partnership, which was originally announced in December 2022. Kite has exercised its option to negotiate a license for Arcellx’s ARC-SparX program, ACLX-001. The companies have also expanded the scope of the collaboration to include lymphomas. Upon closing in December 2023, Arcellx received a $200 million equity investment at $61.68 per share and an $85 million upfront cash payment.

Presented continued robust long-term responses from lead product candidate anito-cel evaluated in a Phase 1 expansion trial in patients with relapsed or refractory multiple myeloma, at 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. On December 11, 2023, Arcellx presented new clinical data from its ongoing Phase 1 expansion study of autologous anitocabtagene autoleucel (anito-cel), formerly known as CART-ddBCMA, at the 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The data continued to demonstrate deep and durable responses in patients with poor prognostic factors. Of the 38 evaluable patients with a median follow-up of 26.5 months, 100% overall response rate (ORR) was achieved in all patients and 29 of 38 (76%) evaluable patients achieved a complete response (CR) or a stringent complete response (sCR). Additionally, anito-cel continued to be well tolerated with no delayed neurotoxicity or parkinsonian symptoms observed. Median duration of response, progression free survival (PFS), and overall survival were not reached at the time of the October 15, 2023 data cut. Anito-cel continued to be well-tolerated at the time of the October 15, 2023 data cut.

Fourth Quarter and Full Year 2023 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of December 31, 2023, Arcellx had cash, cash equivalents, and marketable securities of $729.2 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027.

Collaboration revenue:
Collaboration revenue was $63.1 million and zero for the quarters ended December 31, 2023 and 2022, respectively. Collaboration revenue was $110.3 million and zero for the twelve months ended December 31, 2023 and 2022, respectively. The revenue results from the recognition of research and development performed under the arrangement described in the recent license and collaboration agreement with Kite Pharma, Inc. (Kite).

R&D expenses:
Research and development expenses were $28.8 million and $25.9 million for the quarters ended December 31, 2023 and 2022, respectively, an increase of $2.9 million. This increase was driven primarily by an increase in personnel and facility costs. Research and development expenses were $133.8 million and $149.6 million for the twelve months ended December 31, 2023 and 2022, respectively, a decrease of $15.8 million. This decrease was primarily driven by the accounting treatment for our Lonza manufacturing services agreement, which resulted in a non-cash expense in both years ended December 31, 2023 and 2022. This decrease was partially offset by an increase in personnel costs, which includes non-cash stock-based compensation expense.

G&A expenses:
General and administrative expenses were $19.4 million and $14.1 million for the quarters ended December 31, 2023 and 2022, respectively, an increase of $5.3 million. General and administrative expenses were $66.4 million and $41.7 million for the twelve months ended December 31, 2023 and 2022, respectively, an increase of $24.7 million. The increases were driven primarily by non-cash stock-based compensation expense.

Net income or loss:
Net income was $20.5 million for the quarters ended December 31, 2023 and net loss was $39.0 million for the quarter ended December 31, 2022. Net loss for the twelve months ended December 31, 2023 and 2022 were $70.7 million and $188.7 million, respectively.

The promising results of a phase II clinical study for Akeso’s Cadonilimab (PD-1/CTLA-4) combined standard treatment for first-line treatment of R/M cervical cancer has been published in Clinical Cancer Research

On February 28, 2024 Akeso (9926.HK) reported that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody(cadonilimab)combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had been published in the official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Clinical Cancer Research, with an impact factor of 11.5 (Press release, Akeso Biopharma, FEB 28, 2024, View Source [SID1234640623]).

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The article comprehensively elaborates on the excellent therapeutic effects of cadonilimab as first-line treatment for the whole population of cervical cancer, demonstrating the good safety profile of this treatment regimen. The publication of this article further enriches the evidence-based medicine evidence for the clinical application of cadonilimab.

The study data published in Clinical Cancer Research this time continues to demonstrate the pronounced advantages presented in the data published at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, and with further extension of follow-up time, the efficacy advantage of cadonilimab combined with standard treatment for first-line treatment of recurrent/metastatic cervical cancer becomes more evident. Once again, it shows the clinical potential of cadonilimab for the entire population of recurrent/metastatic cervical cancer regardless of PD-L1 expression status, with the main research data superior to the data disclosed in current standard of care with immunotherapy-based combination therapy (non-head-to-head).

Compared to the data disclosed at ASCO (Free ASCO Whitepaper) in 2022, the overall objective response rate (ORR) remains at a high level, with the disease control rate (DCR) increasing to 100%, and the complete response (CR) rate further increasing.
63.6% of patients experienced tumor reduction of more than 50%. The ORR of the 10mg/kg Q3W dose group (cadonilimab 10mg/kg Q3W + chemotherapy +/- bevacizumab) reached 79.3%, and when combined with bevacizumab, the ORR was as high as 92.3%. The population with PD-L1 CPS <1 accounted for 41.4%, and the ORR of this population was 75.0%, indicating that cadonilimab combined with standard treatment could provide clinical benefit for PD-L1-negative patients.

Cadonilimab combined standard treatment brings excellent long-term survival benefits.
The median follow-up time for the cadonilimab 15mg/kg Q3W + chemotherapy group was 20.24 months, the median progression-free survival (mPFS) was 11.10 months, the median overall survival (mOS) was not reached, and the 12-month OS rate was 93.3%. The median follow-up time for the cadonilimab 10mg/kg Q3W + chemotherapy group was 18.3 months, the mPFS was 7.06 months, the mOS was not reached, and the 12-month OS rate was 87.5%. The median follow-up time for the Cadonilimab 10mg/kg Q3W + chemotherapy + bevacizumab group was 15.01 months, and neither mPFS nor mOS was reached.

The safety of cadonilimab combined with standard treatment is manageable, and no new safety signals have been observed.
Reports indicate that in 2020, there were approximately 604,000 new cases of cervical cancer globally, with over 110,000 cases in China. It is estimated that by 2040, the number of deaths from cervical cancer in China will reach 75,000 cases, representing a 26.3% increase compared to 2020. The 5-year survival rate for advanced cervical cancer is only about 17.0%. In first-line treatment for advanced cervical cancer, chemotherapy+/-bevacizumab is the standard treatment regimen domestically, with limited efficacy and no approved immune combination therapy.

Cadonilimab was approved by the China National Medical Products Administration (NMPA) in June 2022 for second-line treatment of recurrent/metastatic cervical cancer. Since its launch, Cadonilimab’s outstanding clinical value and good safety profile have been strongly validated in numerous clinical studies and real-world clinical applications. It has demonstrated prominent benefits for the entire population of patients with advanced cervical cancer, improving survival rates and quality of life, thus addressing the current important clinical need.

In November 2023, an interim analysis of a randomized, double-blind, placebo-controlled phase III study of cadonilimab as first-line treatment for cervical cancer showed that the primary endpoint of progression-free survival (PFS) had been met. Soon, the population of patients with advanced cervical cancer in China will have access to immune combination therapy. Additionally, a randomized, double-blind, placebo-controlled Phase III study of cadonilimab combined with chemotherapy as first-line treatment for gastric cancer also met the primary endpoint of overall survival (OS) in the interim analysis, and a new drug application had been accepted by CDE. With positive results from registration trials of cadonilimab in first-line treatments of multiple tumor types, the population benefiting from cadonilimab will rapidly expand, better realizing the clinical value of this cadonilimab for tumor treatment and benefiting more patients.

About Cadonilimab

Cadonilimab is a first-in-class bispecific antibody targeting both PD-1 and CTLA-4 which is developed by Akeso. In Jun 2022, the China National Medical Products Administration (NMPA) approved cadonilimab for recurrent or metastatic cervical cancer. Cadonilimab has been included and recommended in multiple clinical practice guidelines such as CSCO. Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies.

Currently, a phase III study of cadonilimab for first-line treatment of gastric cancer has met its endpoint of OS. A phase III study of cadonilimab has also met one of its primary endpoints of PFS for first-line treatment of recurrent/metastatic cervical cancer (R/M CC).

Elevation Oncology to Participate in Upcoming Investor Conferences

On February 28, 2024 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that members of management will participate in upcoming investor conferences in March (Press release, Elevation Oncology, FEB 28, 2024, View Source [SID1234640622]):

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TD Cowen 44th Annual Health Care Conference. Fireside chat on Wednesday, March 6, 2024 at 10:30 AM ET in Boston, MA.
Leerink Global Biopharma Conference. Management will participate in investor meetings on Tuesday, March 12, 2024 in Miami, FL.
A live webcast and replay of the fireside chat at the TD Cowen 44th Annual Health Care Conference will be available on the Events page of the Company’s Investor Relations website at View Source

Inhibrx Reports Fourth Quarter and Fiscal Year 2023 Financial Results

On February 28, 2024 Inhibrx, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a biopharmaceutical company with three clinical programs in development and a strong emerging pipeline, reported financial results for the fourth quarter and fiscal year 2023 (Press release, Inhibrx, FEB 28, 2024, View Source [SID1234640621]).

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Key Highlights

Sale of INBRX-101 to Sanofi: In January 2024, the Company announced that it entered into a definitive agreement with Aventis, Inc. ("Aventis"), a subsidiary of Sanofi, whereby Sanofi will indirectly acquire, through Aventis, all of the assets and liabilities associated with INBRX-101 ("the Merger"). Immediately prior to the closing of the Merger, all non-101 assets and liabilities will be spun out into a new publicly traded company, Inhibrx Biosciences, Inc. ("New Inhibrx"). Sanofi will acquire all outstanding shares of the Company and, in turn, each shareholder will receive (i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone, and (iii) one SEC-registered, publicly-traded, share of New Inhibrx per every four shares of Inhibrx common stock held. In addition, in connection with the transaction, Sanofi will assume and retire the Company’s outstanding third-party debt and fund New Inhibrx with $200.0 million in cash. Sanofi will also retain an equity interest in New Inhibrx of 8%. The Company expects the transaction to close in the second quarter of 2024.

INBRX-105: The Company decided to terminate its INBRX-105 program after evaluation of the totality of data from the expansion cohorts, in which it determined the initial signal was not sufficiently validated to support the continuation of the program. The Company is in the process of winding down the clinical trial and expects it to be completed within the first half of 2024.

All Company Employees and Directors are Currently Subject to a Company-wide Blackout Restricting the Trading of Inhibrx Stock: The Company plans to file the proxy statement related to the sale of INBRX-101 in the next few days. Shortly after public filing of the Company’s proxy statement, and in accordance with the Company’s insider trading policy, the Company expects to lift the Company-wide blackout. As of today, employees and board members hold approximately 3.5 million vested and in-the-money options in Inhibrx common stock. The shares issuable upon exercise of these options are generally freely tradable. Any in-the-money options still outstanding at the Merger close will be converted into the Merger Consideration, as defined in the Merger Agreement, and will not convert into New Inhibrx shares.
Financial Results

Cash and Cash Equivalents. As of December 31, 2023, Inhibrx had cash and cash equivalents of $277.9 million, compared to $337.3 million as of September 30, 2023.

R&D Expense. Research and development expenses were $82.1 million during the fourth quarter of 2023 as compared to $30.5 million during the fourth quarter of 2022. Research and development expenses were $191.6 million during the fiscal year 2023 as compared to $110.2 million during the fiscal year 2022. The increase in research and development expenses during both periods was primarily due to the following factors:

an increase in contract manufacturing expenses due to the nature of the development and manufacturing activities performed during the current period at our CDMO and CRO partners supporting our clinical and preclinical therapeutic candidates, primarily due to large scale drug substance manufacturing services, including the utilization of raw materials during the fourth quarter of 2023, performed by one of our CDMO partners for INBRX-101, in addition to other activities performed with our CDMO partners which reflect the stage-specific needs of each of our programs, including early and late stage drug substance clinical manufacturing, drug product manufacturing, and selected BLA-enabling activities;

an increase in clinical trial expenses, primarily related to costs incurred following the initiation of the registration-enabling Phase 2 trial for INBRX-101 for the treatment of emphysema due to AATD, which was initiated during the current year, as well as the progression of the Company’s INBRX-109 registration-enabling Phase 2 trial for the treatment of unresectable or metastatic conventional chondrosarcoma. The Company also incurred increased costs associated with the utilization of Keytruda used in combination with INBRX-105 in our Phase 1/2 clinical trial; and

an increase in personnel-related costs, primarily related to an increase in headcount as a result of a significant expansion of the Company’s clinical team, as well as the issuance of additional stock options and the expansion of the bonus eligibility pool during the current year.

G&A Expense. General and administrative expenses were $7.8 million during the fourth quarter of 2023, compared to $5.3 million during the fourth quarter of 2022. General and administrative expenses were $29.4 million during the fiscal year 2023, compared to $21.1 million during the fiscal year 2022. This increase in general and administrative expenses during both periods was primarily due to the following factors:

an increase in personnel-related costs, primarily related to an increase in headcount as the Company continues to build its commercial strategy and medical affairs team, as well as increased expense related to additional stock option grants to employees and the expansion of the bonus eligibility pool in the current year;

an increase in pre-commercialization expenses, primarily related to increases in consulting services to support the Company’s commercial operations business intelligence strategies and market research expenses related to INBRX-101 and INBRX-109; and

an increase in professional service expenses related to accounting and legal services which support the Company in its general corporate and intellectual property matters, including services performed during the fourth quarter of 2023 as related to the Company’s proposed Merger.

Net Loss. Net loss was $93.6 million during the fourth quarter of 2023, or $1.73 per share, compared to $40.9 million during the fourth quarter of 2022, or $0.95 per share. Net loss was $241.4 million during the fiscal year 2023, or $5.12 per share, compared to $145.2 million during the fiscal year 2022, or $3.62 per share.