Company Overview - Arcellx, Inc. (ACLX) shares increased by 6.7% to close at $92.98, with notable trading volume compared to typical sessions, and a 7.8% gain over the past four weeks [1][2] - The rise in stock price is linked to positive investor sentiment regarding Arcellx's clinical-stage oncology pipeline, which includes candidates for multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome [2] Financial Expectations - The company is projected to report a quarterly loss of $0.54 per share, reflecting a year-over-year increase of 33.3%, with expected revenues of $35.21 million, up 135.3% from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Arcellx operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Liquidia Technologies, Inc. (LQDA), closed 2% higher at $10.64, but has seen a -5.4% return over the past month [4] - Liquidia Technologies has a consensus EPS estimate of -$0.37 for its upcoming report, which is a -54.2% change from the previous year, and also holds a Zacks Rank of 3 (Hold) [5]

Company Overview - Arcellx, Inc. (NASDAQ:ACLX) is a biotechnology company focused on innovative oncology CAR-T cell therapies, leveraging proprietary platforms such as DDomain, ddCAR, and ARC-SparX to enhance immune responses against cancer [1][2] - The leading product candidate, anitocabtagene autoleucel (Anito-cel), shows promising results in patients with relapsed/refractory multiple myeloma (r/r MM), including high-risk groups [1][6] Product Pipeline - ACLX's pipeline includes therapies targeting multiple myeloma, acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and solid tumors [1][7] - The company has initiated pivotal and confirmatory trials for Anito-cel, with preliminary data expected by year-end 2024 [3][8] - The ddCAR platform enhances CAR-T therapies, while the ARC-SparX platform allows for precise control of T-cell activity, improving safety profiles and effectiveness [4][5] Clinical Trials and Results - Anito-cel has demonstrated a 100% overall response rate (ORR) and a 76% complete or near-complete remission (CR/sCR) rate in Phase 1 trials, with no significant adverse effects reported [9][10] - The iMMagine-3 Phase 3 trial is set to enroll 450 patients and aims to provide additional efficacy and safety data [8][10] Financial Overview - ACLX has a market capitalization of $3.8 billion, with $100 million in cash and equivalents, and $416.7 million in marketable securities, indicating a strong liquidity position [11][12] - The company is projected to generate $117.4 million in revenues by 2025, primarily from milestone and collaboration payments, particularly from its partnership with Kite Pharma [12][13] Market Potential - The market for r/r MM is projected to reach $34.4 billion by 2034, presenting a significant opportunity for ACLX if Anito-cel receives FDA approval [13][16] - The partnership with Gilead's Kite Pharma validates ACLX's intellectual property and provides potential for substantial milestone payments, estimated at up to $935 million [12][16]

Company Performance - Arcellx, Inc. reported a quarterly loss of $0.51 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.54, and compared to a loss of $0.50 per share a year ago, indicating a 2% increase in loss year-over-year [1] - The company achieved an earnings surprise of 5.56% and has surpassed consensus EPS estimates three times over the last four quarters [1] - Revenues for the quarter ended June 2024 were $27.38 million, missing the Zacks Consensus Estimate by 1.23%, but showing a significant increase from $14.3 million in the same quarter last year [1] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.33 on revenues of $40.01 million, and for the current fiscal year, it is -$1.70 on revenues of $123.84 million [4] - The estimate revisions trend for Arcellx is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [4] Industry Context - The Medical - Biomedical and Genetics industry, to which Arcellx belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [5] - Another company in the same industry, Cara Therapeutics, is expected to report a quarterly loss of $0.29 per share, reflecting a year-over-year change of +50%, with revenues anticipated to be $1.26 million, down 81.9% from the previous year [5]

Financial Performance - The company reported net losses of $34.4 million for the six months ended June 30, 2024, compared to $51.2 million for the same period in 2023, with an accumulated deficit totaling $423.9 million as of June 30, 2024[69]. - Collaboration revenue increased to $27.4 million for the three months ended June 30, 2024, up from $14.3 million for the same period in 2023, representing a growth of $13.1 million[87]. - For the six months ended June 30, 2024, collaboration revenue was $66.6 million, up from $32.2 million in 2023, an increase of $34.4 million[95]. - Total operating expenses for the six months ended June 30, 2024, were $117.4 million, compared to $92.2 million in the same period of 2023, an increase of $25.2 million[94]. - Research and development expenses rose to $40.9 million for the three months ended June 30, 2024, compared to $28.3 million in the prior year, an increase of $12.6 million[89]. - General and administrative expenses increased to $21.4 million for the three months ended June 30, 2024, up from $15.5 million in 2023, reflecting a rise of $5.9 million[90]. - Other income, net was $8.1 million for the three months ended June 30, 2024, compared to $5.4 million in the same period last year, an increase of $2.7 million[91]. - Net cash used in operating activities for the six months ended June 30, 2024, was $68.2 million, primarily due to a net loss of $34.4 million[105]. Clinical Development - The company earned a clinical milestone payment of $68.3 million under its collaboration with Kite Pharma related to the iMMagine-1 trial enrollment[73]. - The company is advancing its lead product candidate, anito-cel, in a pivotal Phase 2 trial for relapsed or refractory multiple myeloma, with a global Phase 3 trial (iMMagine 3) initiated by Kite Pharma[67]. - The company has two clinical-stage ARC-SparX programs in Phase 1 trials targeting BCMA and CD123, with plans to evaluate anito-cel for non-oncology indications, including generalized myasthenia gravis[68]. - The company expects to incur substantial additional losses in future periods as it continues to develop and seek regulatory approvals for its product candidates[101]. Financial Position and Funding - The company believes its current cash and cash equivalents are adequate to fund operations into 2027[72]. - The company may require substantial additional funding to support ongoing operations and product development efforts[71]. - As of June 30, 2024, the company had cash and cash equivalents and marketable securities totaling $646.8 million[100]. - Cash, cash equivalents, and marketable securities totaled $646.8 million as of June 30, 2024, primarily invested in U.S. government agency securities and treasuries[112]. Operating Expenses and Future Expectations - The company expects significant increases in operating expenses and capital requirements as it advances clinical programs and expands its manufacturing infrastructure[70]. - The company anticipates that general and administrative expenses will increase as it expands its headcount to support growth[82]. - The company maintains a full valuation allowance against its net deferred tax assets, recording an income tax expense of $0.3 million for the three months ended June 30, 2024[84]. Market Risks - The company is exposed to market risk related to interest rate changes, particularly affecting the value of available-for-sale securities[112]. Other Information - As of June 30, 2024, there were no material changes in contractual obligations and commitments from the previous Annual Report[108]. - There have been no material changes to critical accounting policies and estimates during the six months ended June 30, 2024[110]. - Net cash used in financing activities was $13.4 million for the six months ended June 30, 2024, primarily due to finance lease payments of $21.0 million, offset by $7.5 million from stock options and employee stock purchase plan[107]. - Net cash provided by financing activities was $95.6 million for the six months ended June 30, 2023, mainly from net proceeds of $100.0 million from the issuance of 3,478,261 shares at $28.75 per share, with $3.9 million from stock options and employee stock purchase plan, offset by $8.3 million in finance lease payments[107].

Exhibit 99.1 Arcellx Provides Second Quarter 2024 Financial Results and Business Updates — Earned a $68M milestone payment from Kite for iMMagine-1 enrollment — — Submitted an abstract for the iMMagine-1 study at the 66th ASH Annual Meeting — — The global Phase 3 trial, iMMagine-3, has been initiated by Kite — — U.S. FDA clears anito-cel IND application for myasthenia gravis, an autoimmune disease — REDWOOD CITY, Calif., August 8, 2024 (BUSINESS WIRE) — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company ...

Nemes Laszlo/iStock via Getty Images Arcellx's Anito-cel: A Promising Contender in Multiple Myeloma Therapy Arcellx (NASDAQ:ACLX) is developing cell therapies for multiple myeloma [MM], acute myeloid leukemia, and myelodysplastic syndrome. Anito-cel (formerly CART-ddBCMA), the company's flagship product, is being developed in a Phase 2 pivotal trial for relapsed or refractory MM (rrMM). My last article on Arcellx was in September, a month after the FDA lifted the partial clinical hold (limits some trial asp ...

Company Performance - Arcellx, Inc. reported a quarterly loss of $0.14 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.51, and an improvement from a loss of $0.58 per share a year ago, indicating a 72.55% earnings surprise [1] - The company generated revenues of $39.26 million for the quarter ended March 2024, exceeding the Zacks Consensus Estimate by 32.55%, and up from $17.91 million in the same quarter last year [1] - Over the last four quarters, Arcellx has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [1] Market Outlook - Arcellx shares have declined approximately 5.9% since the beginning of the year, contrasting with the S&P 500's gain of 8.8% [2] - The company's future stock performance will largely depend on management's commentary during the earnings call and the sustainability of the recent earnings numbers [2][3] Earnings Estimates - The current consensus EPS estimate for the upcoming quarter is -$0.40 on revenues of $29.52 million, and for the current fiscal year, it is -$1.69 on revenues of $121.41 million [4] - The estimate revisions trend for Arcellx is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [4] Industry Context - The Medical - Biomedical and Genetics industry, to which Arcellx belongs, is currently ranked in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [5] - Another company in the same industry, Lumos Pharma, is expected to report a quarterly loss of $1.21 per share, reflecting a year-over-year change of -36%, with revenues projected at $0.51 million, down 26.1% from the previous year [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-41259 ARCELLX, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 47-2855917 (State or other jurisd ...

Exhibit 99.1 Arcellx Provides First Quarter 2024 Financial Results REDWOOD CITY, Calif., May 9, 2024 (BUSINESS WIRE) — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today reported business highlights and financial results for the first quarter ended March 31, 2024. First Quarter 2024 Financial Highlights Cash, cash equivalents, and marketable securities: As of March 3 ...

Biotech breakthrough stocks, along with the sector overall, faced significant challenges over the past two years, with venture capital drying up, shifts in the post-pandemic healthcare landscape and tighter regulatory conditions squeezing already-thin margins. However, 2024 may herald a resurgence for biotech stocks, spurred by an FDA approval spree throughout 2023. Last year, the FDA approved 55 treatment protocols that included previously unapproved ingredients or compounds, a significant increase from th ...