Core Insights - Arcellx, Inc. reported quarterly earnings of $0.42 per share, significantly beating the Zacks Consensus Estimate of a loss of $0.63 per share, and improving from a loss of $0.76 per share a year ago [1] - The company achieved revenues of $63.15 million for the quarter ended December 2023, surpassing the Zacks Consensus Estimate by 163.52%, compared to zero revenues a year ago [1] Financial Performance - The earnings surprise for the recent quarter was 166.67%, while the previous quarter saw a loss of $0.81 per share against an expected loss of $0.56, resulting in a surprise of -44.64% [1] - Over the last four quarters, Arcellx has exceeded consensus EPS estimates two times [1] Stock Performance - Arcellx shares have increased by approximately 21.8% since the beginning of the year, outperforming the S&P 500's gain of 6.5% [2] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.56 on revenues of $20.95 million, and for the current fiscal year, it is -$2.13 on revenues of $107.66 million [4] - The Medical - Biomedical and Genetics industry is ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [4] Industry Context - Cardiff Oncology, another company in the same industry, is expected to report a quarterly loss of $0.26 per share, with revenues projected at $0.08 million, reflecting a year-over-year decline of 42.3% [5]

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 ...

Following a hot year of M&A with biotech stocks, we’ll see more of the same in 2024 as drug makers look to build their pipelines ahead of a massive patent cliff. Between now and 2028, pharmaceutical giants stand to lose billions in revenue as blockbuster drug patents expire. According to EY analysts, the top 20 pharmaceutical giants could lose about $180 billion in sales by the end of the decade. It’s part of the reason Johnson & Johnson (NYSE:JNJ) said it would acquire antibody-drug conjugate (ADC) company ...

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 ...

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 June 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 jurisdi ...

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 ...