Financial Performance - The company incurred net losses of $70.7 million and $188.7 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $389.5 million as of December 31, 2023[246]. - The company expects to continue incurring significant losses for the foreseeable future as it advances its product candidates and expands its pipeline[246]. - The company has incurred substantial losses historically and does not expect to achieve profitability in the near future[372]. Product Development and Clinical Trials - The company has no products approved for commercial sale and has not generated any revenue from product sales, continuing to incur significant research and development expenses[246]. - The company is still developing its D-Domain, ddCAR, and ARC-SparX platforms while conducting drug discovery and preclinical studies for multiple product candidates[256]. - The company has only recently begun clinical trials for its first product candidates, making it difficult to predict future success and viability[255]. - Clinical trials are lengthy and expensive, with a high risk of failure at any stage, impacting the development of other product candidates[274]. - The results of earlier clinical trials may not predict later-stage outcomes, and unforeseen safety or efficacy issues may arise[275]. - Treatment with product candidates may cause side effects unrelated to the candidates, potentially impacting clinical trial success[277]. - The company may encounter regulatory delays or rejections that could impact the development of its product candidates[256]. - The company faces a high failure rate for biopharmaceutical products in clinical trials, with significant setbacks occurring even after promising early results[257]. - The company may incur unplanned costs and delays in obtaining marketing approval if clinical trials yield inconclusive results[279]. - The company faces significant competition for patient enrollment in clinical trials, which may affect the timing and outcome of ongoing studies[287]. - The company may face significant delays or increased costs in clinical trials if additional serious adverse events or undesirable side effects arise, potentially affecting patient recruitment and completion rates[301]. Regulatory and Compliance Risks - The company has identified a material weakness in its internal control over financial reporting, which was remediated as of December 31, 2022[251]. - The company faces increasing regulation as it advances product candidates through clinical trials and pursues commercialization[346]. - The company may face substantial penalties if unable to comply with healthcare fraud and abuse laws and regulations[345]. - The company may face significant exposure under healthcare laws and regulations if FDA approval is obtained for product candidates, leading to increased compliance costs[347]. - The company must comply with the Physician Payment Sunshine Act, requiring annual reporting of payments to healthcare professionals and teaching hospitals[353]. Competition and Market Risks - The company faces significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results[238]. - The company anticipates substantial direct competition from organizations developing advanced CAR-T and other genetically modified cell therapies, including major players like Novartis, Pfizer, and Abbvie[324]. - Competitors possess greater financial and technical resources, including larger R&D teams and established sales forces, which may hinder the company's market position[326]. - The market opportunities for certain product candidates may be limited to patients who are ineligible for or have failed prior treatments, potentially resulting in a smaller addressable market than anticipated[319]. Manufacturing and Supply Chain Risks - The company relies on third parties for conducting clinical trials and manufacturing, which poses risks if those parties do not meet their obligations[240]. - The company has not exhaustively explored different manufacturing options for its product candidates, which may require further regulatory approvals and delay development[269]. - The company must establish adequate manufacturing capacity and achieve cost efficiencies to meet clinical trial and commercial requirements[265]. - Manufacturing genetically engineered products is complex and subject to risks, including supply constraints and variations in key components, which could delay clinical trials or product availability[307]. - The company relies on third-party manufacturers for clinical product supplies, exposing it to risks related to quality, compliance, and timely delivery[391]. Collaboration and Strategic Alliances - The company has entered into a Collaboration Agreement with Kite Pharma, Inc. to co-develop and co-commercialize CAR-T cell therapy products for multiple myeloma, with an option for autologous CAR T-cell therapy products[403]. - The Kite Collaboration Agreement was amended in December 2023 to expand the collaboration scope to include lymphomas, and Kite exercised its option to negotiate a license for ACLX-001[403]. - The company is at risk of delays or inability to develop or commercialize product candidates if Kite terminates the collaboration or fails to allocate sufficient resources[407]. - Future collaborations may be sought, but if not established on commercially reasonable terms, the company may need to alter its development and commercialization plans[408]. Intellectual Property Risks - The company’s ability to maintain patent protection is critical, as failure to do so could allow competitors to commercialize similar products[415]. - The patent position of biopharmaceutical companies is uncertain and may be affected by complex legal questions and litigation outcomes[420]. - The patent application process is subject to numerous risks and uncertainties, with no assurance of success in obtaining patents[422]. - Noncompliance with procedural requirements during the patent process can result in abandonment or loss of patent rights, allowing competitors to enter the market earlier[423]. - The strength of patents in biotechnology is uncertain, and issued patents may be challenged, leading to potential invalidation or narrowing[429]. Financial Position and Funding - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $729.2 million, but market volatility could negatively impact this portfolio[333]. - The company anticipates needing substantial additional funding to advance its product candidates through clinical development and commercialization activities[247]. - Economic downturns and market instability could make financing more difficult and costly, adversely affecting growth strategies[329]. Management and Operational Risks - The company is highly dependent on key personnel, and the loss of any executive or key employee could delay product development and harm business operations[334]. - Future growth may impose significant responsibilities on management, including recruiting and integrating additional personnel and improving operational controls[336]. - The company plans to transition some regulatory and manufacturing capabilities in-house, but success depends on recruiting experienced teams[339]. - Security breaches or incidents could disrupt development programs and lead to the loss of confidential information, impacting business operations[340].

Financial Results Announcement - Arcellx, Inc. announced its financial results for the fiscal year ended December 31, 2023, on February 28, 2024[4]. - The press release detailing the financial results is attached as Exhibit 99.1[4]. - The report does not include specific financial metrics or performance indicators in the provided content[4]. - The report does not provide details on user data, future outlook, or new product developments[4]. Company Classification and Compliance - The company is classified as an emerging growth company under the Securities Act of 1933[2]. - The filing is made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934[4]. - The company has not elected to use the extended transition period for complying with new financial accounting standards[3]. Company Information - The company is headquartered at 800 Bridge Parkway, Suite A, Redwood City, California 94065[2]. - Rami Elghandour serves as the Chief Executive Officer of Arcellx, Inc.[6]. - The trading symbol for Arcellx, Inc. is ACLX, listed on the Nasdaq Stock Market[2].

-- Expanded strategic partnership with Kite -- -- Presented continued robust long-term responses from Phase 1 expansion trial of anito-cel (formerly CART-ddBCMA) in patients with relapsed or refractory multiple myeloma -- -- Ended the quarter with $729.2M, extending cash runway into 2027 -- REDWOOD CITY, Calif., Feb. 28, 2024 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other ...

Industry Overview - The pharmaceutical industry is expected to see continued mergers and acquisitions (M&A) in 2024 as companies aim to strengthen their pipelines ahead of a significant patent cliff, with the top 20 pharmaceutical companies projected to lose approximately $180 billion in sales by 2028 due to patent expirations [1] Company Highlights - Johnson & Johnson announced the acquisition of Ambrx Biopharma for $2 billion, while Pfizer acquired Seagen for $43 billion and Sanofi purchased Inhibrx for about $2.2 billion [1] - Novartis has also acquired MorphoSys for $2.9 billion, indicating a trend of large pharmaceutical companies seeking to bolster their portfolios through strategic acquisitions [1] Potential Buyout Targets - Viking Therapeutics has seen its stock rise from around $26 to $32.23, driven by demand for weight loss treatments and speculation of a potential acquisition by Pfizer, which is focusing on the obesity treatment market [2] - ADC Therapeutics' stock increased from $3.90 to $4.86 following successful trial results for a combination treatment for relapsed follicular lymphoma, positioning it as a potential takeover target [4] - Arcellx's lead product candidate, CART-ddBCMA, is being recognized as a promising treatment for relapsed or refractory multiple myeloma, with the company maintaining a strong financial position with approximately $482.7 million in cash and equivalents as of September 30 [5]

Industry Overview - Biotech stocks have faced significant challenges over the past two years due to reduced venture capital, shifts in the healthcare landscape post-pandemic, and tighter regulatory environments, but 2024 may signal a recovery for the sector [1] - The FDA approved 50% more novel therapeutics in 2023 compared to 2022, with a total of 55 treatment protocols approved, indicating a potential resurgence in biotech stock performance [1] Regeneron Pharmaceuticals (REGN) - Regeneron Pharmaceuticals has demonstrated consistent stock performance, with a low beta of 0.16, indicating stability even during economic turmoil [2] - The company received FDA approval in August 2023 for a high-dosage variant of its eye disease therapeutic Eylea, enhancing its competitive position against price negotiations from Medicare [2] - Regeneron's flagship drug Dupixent is being tested for chronic obstructive pulmonary disease (COPD), showing a 34% decrease in symptoms, with potential annual sales reaching $20 billion if successful [3] - The company is actively developing compounds in high-interest areas such as monoclonal antibody therapeutics, gene therapy, and gene editing [3] Arcellx Inc (ACLX) - Arcellx is focused on cancer and autoimmune disease treatments, particularly through CAR-T therapeutics, which utilize the patient's immune system to combat cancer [5] - The company has secured significant financial backing from Gilead Sciences, including an $85 million cash payment and a $200 million stock purchase plan, ensuring operational stability through 2027 [6] Beam Therapeutics (BEAM) - Beam Therapeutics is engaged in gene therapy and editing, with a focus on sickle cell treatments, currently in testing stages [7] - The company anticipates significant developments in 2024, supported by a robust cash position of approximately $1.2 billion, allowing for sustained operations through 2027 [8]

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 September 30, 2023 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 ju ...

Financial Performance - The company reported net losses of $51.2 million for the six months ended June 30, 2023, compared to $56.8 million for the same period in 2022, with an accumulated deficit of $370.0 million as of June 30, 2023[135]. - The company has incurred significant operating losses primarily due to research and development activities and general administrative costs, with expectations of continued losses in the foreseeable future[135]. - Net loss for the six months ended June 30, 2023, was $51.2 million, compared to a net loss of $56.8 million in the same period in 2022, a decrease of $5.6 million[161]. - Total operating expenses for the six months ended June 30, 2023, were $92.2 million, up from $57.4 million in the same period in 2022, representing an increase of $34.9 million[161]. - Research and development expenses for the six months ended June 30, 2023, were $61.3 million, an increase of $21.1 million from $40.1 million in the same period in 2022[163]. - General and administrative expenses for the six months ended June 30, 2023, were $31.0 million, up from $17.2 million in the same period in 2022, an increase of $13.8 million[164]. - The company expects to incur substantial additional losses in future periods as it continues the development of its product candidates[166]. Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying on collaboration agreements for potential revenue recognition[144]. - Collaboration revenue for the six months ended June 30, 2023, was $32.2 million, a significant increase compared to $0 in the same period in 2022[161]. - The company has not recognized any royalty revenue from its collaborative arrangements to date, with revenue recognition timing potentially differing from contract billings[190]. Cash and Funding - As of June 30, 2023, the company had cash and cash equivalents and marketable securities totaling $506.5 million[165]. - The company expects its current cash and cash equivalents to fund operations into 2026, but will require substantial additional funding for product development[138]. - A sales agreement was established for an at-the-market offering program with a potential aggregate offering amount of up to $350.0 million, although no sales have been made as of June 30, 2023[139]. - Net cash provided by operating activities for the six months ended June 30, 2023, was $159.4 million, compared to net cash used of $55.1 million in the same period in 2022[170]. - Net cash used in investing activities for the six months ended June 30, 2023, was $15.5 million, a decrease from $69.9 million in the same period in 2022[171]. - Net cash provided by financing activities for the six months ended June 30, 2023, was $95.6 million, compared to $261.0 million in the same period in 2022[172]. Clinical Development - The company is advancing its lead program, CART-ddBCMA, in a pivotal Phase 2 trial, with preliminary data expected in the second half of 2024[141]. - The FDA lifted a partial clinical hold on the iMMagine-1 trial, allowing the company to resume screening and enrollment of patients[141]. - The company is developing a new class of D-Domain powered cell therapies to address limitations of traditional CAR-T therapies, targeting hematologic cancers and other diseases[133]. - The company plans to increase operating expenses significantly to support ongoing clinical trials and expand its product pipeline, including the ARC-SparX candidates[135]. Accounting and Compliance - The company recognizes revenue when a customer obtains control of promised goods or services, following a five-step model to identify contracts and performance obligations[178]. - Variable consideration is estimated using methods such as the expected value method or the most likely amount method, and adjustments are made at the end of each reporting period if necessary[179]. - The company evaluates milestone payments based on the probability of achievement, with significant revenue reversals considered before including them in the transaction price[187]. - Changes to collaboration agreements are assessed to determine if they represent a modification or a new contract, impacting revenue recognition[182]. - The company maintains a full valuation allowance for its net deferred tax assets, with income tax expense for the six months ended June 30, 2023, related to revenue from the Kite Collaboration Agreement[191]. - The company is currently classified as an emerging growth company, allowing it to delay adopting new accounting standards until it ceases to be classified as such[192]. - The company has effective disclosure controls and procedures, as evaluated by its management, ensuring timely and accurate reporting[198]. - There were no changes in internal control over financial reporting during the most recent fiscal quarter that materially affected the company's controls[199]. - The company is not currently involved in any litigation or legal proceedings that are expected to have a material adverse effect on its business[200]. Market Position - As of June 30, 2023, the aggregate market value of the company's shares held by non-affiliate stockholders exceeded $700 million, transitioning the company to "large accelerated filer" status by December 31, 2023[194].

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, 2023 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 jurisdiction of (I.R.S ...

Corporate Presentation Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than statements of historical facts contained in this presentation, including statements regarding the anticipated 3202 comple ...