Company Performance - Arcellx, Inc. (ACLX) has gained approximately 78.7% year-to-date, significantly outperforming the Medical sector, which has returned an average of 4% [4] - The Zacks Consensus Estimate for ACLX's full-year earnings has increased by 5.2% over the past quarter, indicating improved analyst sentiment and earnings outlook [3] Industry Comparison - Arcellx, Inc. is part of the Medical - Biomedical and Genetics industry, which includes 504 stocks and currently ranks 87 in the Zacks Industry Rank. The average gain for this group is 0.2% year-to-date, highlighting ACLX's superior performance [5] - AbbVie (ABBV), another Medical stock, has also outperformed the sector with a year-to-date increase of 29.4%. It belongs to the Large Cap Pharmaceuticals industry, which has gained 10.6% since the beginning of the year and ranks 47 [6]

Core Insights - Arcellx, Inc. reported a quarterly loss of $0.48 per share, which was better than the Zacks Consensus Estimate of a loss of $0.54, and improved from a loss of $0.81 per share a year ago, indicating an earnings surprise of 11.11% [1] - The company generated revenues of $26.03 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 26.06%, but showing growth from $14.96 million in the same quarter last year [2] - Arcellx shares have increased approximately 67.5% year-to-date, outperforming the S&P 500's gain of 24.3% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.55 on revenues of $26.63 million, and for the current fiscal year, it is -$1.65 on revenues of $128.46 million [7] - 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 [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Arcellx belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, Revance Therapeutics, Inc., is expected to report a quarterly loss of $0.35 per share, reflecting a year-over-year change of +52.7%, with revenues projected at $67.73 million, up 19.3% from the previous year [9]

Financial Performance - For the nine months ended September 30, 2024, the company reported net losses of $60.3 million, compared to $90.5 million for the same period in 2023, resulting in an accumulated deficit of $449.7 million[66]. - Collaboration revenue for the three months ended September 30, 2024, was $26.0 million, an increase of $11.0 million from $15.0 million in the same period of 2023[85]. - For the nine months ended September 30, 2024, collaboration revenue was $92.7 million, an increase of $45.5 million from $47.2 million in 2023[90]. - Other income, net rose to $8.0 million for the three months ended September 30, 2024, up from $5.5 million in 2023, an increase of $2.5 million[88]. - Other income, net for the nine months ended September 30, 2024, was $24.7 million, an increase of $10.3 million from $14.4 million in 2023[95]. Expenses - The company expects to incur significant operating expenses and increasing losses as it advances clinical programs, expands manufacturing infrastructure, and hires additional personnel[66][68]. - Research and development expenses decreased to $39.2 million for the three months ended September 30, 2024, down from $43.8 million in 2023, a reduction of $4.6 million[93]. - Research and development expenses for the nine months ended September 30, 2024, were $112.4 million, an increase of $7.3 million from $105.1 million in 2023[93]. - General and administrative expenses increased to $20.5 million for the three months ended September 30, 2024, compared to $16.0 million in 2023, an increase of $4.5 million[87]. - General and administrative expenses for the nine months ended September 30, 2024, were $64.6 million, an increase of $17.6 million from $47.0 million in 2023[94]. Cash and Funding - The company believes its current cash and cash equivalents are adequate to fund operations into 2027, but may require substantial additional funding for ongoing development[69][68]. - As of September 30, 2024, the company had cash and cash equivalents and marketable securities totaling $676.7 million[96]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $676.7 million, primarily invested in U.S. government agency securities and treasuries[111]. Clinical Development - The company is advancing its lead program, anito-cel, in a pivotal Phase 2 trial for relapsed or refractory multiple myeloma (rrMM) and has initiated a global Phase 3 trial (iMMagine-3) in collaboration with Kite Pharma[63][70]. - The company has two clinical-stage ARC-SparX programs in Phase 1 trials, targeting BCMA and CD123, with Kite exercising its option to negotiate a license for ACLX-001 in November 2023[64]. - The company has received FDA clearance for an IND application for generalized myasthenia gravis, indicating plans to evaluate anito-cel for non-oncology indications[65]. Tax and Accounting - The company recorded an income tax expense of $0.6 million for the nine months ended September 30, 2024, compared to $41 thousand for the same period in 2023[82]. - The company maintains a full valuation allowance against its net deferred tax assets, indicating uncertainty regarding the realization of tax benefits[83]. - The company’s financial statements are prepared in accordance with GAAP in the United States[108]. - Critical accounting estimates involve significant estimation uncertainty and may materially impact the company's financial condition or results of operations[109]. - There have been no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2024[109]. Market Risk - The company's primary exposure to market risk is interest rate sensitivity, particularly due to investments in short-term securities[111]. - The company is exposed to market risk related to changes in interest rates, with available-for-sale securities subject to interest rate risk[111]. - There have been no material changes in information related to market risk disclosures from the end of the preceding year until September 30, 2024[111]. - Recent accounting pronouncements that may impact the company's financial position are disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023[110].

Financial Position - As of September 30, 2024, Arcellx had cash, cash equivalents, and marketable securities totaling $676.7 million, expected to fund operations into 2027[11] - Cash, cash equivalents, and marketable securities as of September 30, 2024, were $676.68 million, down from $729.19 million as of December 31, 2023[20] - Total assets decreased to $764.91 million as of September 30, 2024, from $825.13 million as of December 31, 2023[20] - Total liabilities decreased to $281.89 million as of September 30, 2024, from $339.75 million as of December 31, 2023[20] Revenue and Expenses - Collaboration revenue increased to $26.0 million for Q3 2024, up from $15.0 million in Q3 2023, reflecting an $11.0 million increase due to the expanded agreement with Kite Pharma[12] - Revenue for the three months ended September 30, 2024, was $26.03 million, compared to $14.96 million for the same period in 2023, representing a 74.5% increase[21] - Total operating expenses for the three months ended September 30, 2024, were $59.65 million, slightly down from $59.82 million in the same period of 2023[21] - General and administrative expenses rose to $20.5 million in Q3 2024 from $16.0 million in Q3 2023, an increase of $4.5 million driven by higher personnel costs[14] - Research and development expenses decreased to $39.2 million in Q3 2024 from $43.8 million in Q3 2023, a reduction of $4.6 million primarily due to a prior year's expense related to manufacturing services[13] Net Loss and Comprehensive Loss - Net losses narrowed to $25.9 million in Q3 2024 compared to $39.3 million in Q3 2023[14] - The net loss for the three months ended September 30, 2024, was $25.87 million, compared to a net loss of $39.34 million for the same period in 2023, indicating a 34.2% improvement[21] - The company reported a comprehensive loss of $23.18 million for the three months ended September 30, 2024, compared to a comprehensive loss of $39.39 million for the same period in 2023[21] Clinical Trials and Research - The Phase 1 study of anito-cel showed a median progression-free survival of 30.2 months with a median follow-up of 38.1 months, while median overall survival has not yet been reached[7] - Preliminary results from the Phase 2 iMMagine-1 study indicated a 95% overall response rate and a 62% complete response/stringent complete response rate at a median follow-up of 10.3 months[4] - No delayed neurotoxicities were observed in over 140 patients treated with anito-cel, including no cases of parkinsonism or Guillain-Barré syndrome[5] - The iMMagine-3 study has commenced, assessing anito-cel in patients previously treated with both an immunomodulatory drug and an anti-CD38 monoclonal antibody[10] Strategic Partnerships and Future Plans - Arcellx's partnership with Kite enhances its competitive advantage through established commercial capabilities and manufacturing reliability[2] - The company anticipates the potential commercial launch of anito-cel, subject to FDA approval, and plans to present updated Phase 1 data and iMMagine-1 preliminary data in the future[19] - Arcellx expects to have sufficient cash, cash equivalents, and marketable securities to fund operations into 2027[19] Share Information - The weighted-average common shares outstanding for the three months ended September 30, 2024, were 53,821,893, compared to 48,348,094 for the same period in 2023[21]

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 ...