[Part I](index=6&type=section&id=PART%20I) [Business](index=6&type=section&id=Item%201.%20Business) Allogene Therapeutics is a clinical-stage immuno-oncology company developing "off-the-shelf" allogeneic T cell therapies for cancer - Allogene is a clinical-stage immuno-oncology company pioneering the development of off-the-shelf allogeneic T cell therapies derived from healthy donors for cancer treatment[11](index=11&type=chunk) - The company's strategy is built on four pillars: minimizing Graft-versus-Host Disease (GvHD), enabling T cell persistence, building a leading manufacturing platform, and leveraging next-generation technologies[15](index=15&type=chunk) - Allogene utilizes Cellectis's TALEN gene-editing technology to engineer T cells, aiming to reduce GvHD risk by inactivating the T cell receptor (TCR) and enhance persistence by inactivating the CD52 gene[16](index=16&type=chunk) - In February 2019, the company leased a facility in Newark, California, to build its own cell therapy manufacturing plant, with manufacturing expected to commence in 2021[28](index=28&type=chunk) [Our Pipeline](index=7&type=section&id=Item%201.%20Business-Our%20Pipeline) Allogene's clinical pipeline overview details product candidates, targets, indications, and development phases Allogene Therapeutics Clinical Pipeline Overview | Product Candidate | Target | Indication(s) | Development Phase | Key Milestone/Status | | :--- | :--- | :--- | :--- | :--- | | **UCART19** | CD19 | Relapsed/Refractory (R/R) ALL | Phase 1 (CALM & PALL trials) | 67% CR/CRi in interim results; potential registrational trials in 2021 | | **ALLO-501** | CD19 | R/R Non-Hodgkin Lymphoma (NHL) | Phase 1 (ALPHA trial) | Initial data expected in Q2 2020 | | **ALLO-501A** | CD19 | R/R Large B-cell Lymphoma | Phase 1/2 (ALPHA2 trial) | IND cleared; trial initiation planned for Q2 2020 | | **ALLO-715** | BCMA | R/R Multiple Myeloma | Phase 1 (UNIVERSAL trial) | Initial data expected in Q4 2020 | | **ALLO-647** | CD52 | Lymphodepletion Agent | Used in ALPHA & UNIVERSAL trials | Designed to enable expansion and persistence of allogeneic CAR T products | [Product Pipeline and Development Strategy](index=17&type=section&id=Item%201.%20Business-Product%20Pipeline%20and%20Development%20Strategy) This section details clinical progress and strategic development plans for Allogene's key product candidates - **UCART19**, for R/R ALL, showed a **67% CR/CRi rate** in interim data from the CALM and PALL Phase 1 trials[80](index=80&type=chunk)[86](index=86&type=chunk) - **ALLO-501A** is a next-generation anti-CD19 candidate for NHL, with the ALPHA2 Phase 1/2 trial planned to start in Q2 2020[92](index=92&type=chunk)[99](index=99&type=chunk) - **ALLO-715**, targeting BCMA for R/R multiple myeloma, initiated its UNIVERSAL Phase 1 trial in Q3 2019, with initial data expected in Q4 2020[101](index=101&type=chunk)[108](index=108&type=chunk) - Future pipeline expansion includes ALLO-316 (anti-CD70), ALLO-819 (anti-FLT3), an anti-DLL3 candidate, and next-gen technologies like TurboCARs and iPSC-derived cell sources[109](index=109&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) [Strategic Agreements](index=27&type=section&id=Item%201.%20Business-Strategic%20Agreements) Allogene's strategic agreements detail key partnerships for technology and product development - The company was founded on an asset acquisition from Pfizer, which included key license and collaboration agreements[23](index=23&type=chunk)[126](index=126&type=chunk) - Allogene holds an exclusive license from Cellectis for TALEN gene-editing technology and an exclusive collaboration with Servier for UCART19, ALLO-501, and ALLO-501A in the U.S[23](index=23&type=chunk)[126](index=126&type=chunk) - A collaboration with Notch Therapeutics was established to research and develop T cell and NK cell products derived from induced pluripotent stem cells (iPSCs)[115](index=115&type=chunk)[126](index=126&type=chunk) [Competition](index=29&type=section&id=Item%201.%20Business-Competition) Allogene faces intense competition from cell therapy developers and other immuno-oncology platforms - The company faces intense competition from established biopharmaceutical companies with greater resources, including Novartis (Kymriah) and Gilead/Kite (Yescarta) in autologous T cell therapy[135](index=135&type=chunk)[137](index=137&type=chunk) - In the allogeneic T cell therapy space, competitors include Atara Biotherapeutics, CRISPR Therapeutics, Fate Therapeutics, and Precision Biosciences[136](index=136&type=chunk) - Competition also arises from non-cell-based immuno-oncology platforms like bispecific antibodies and antibody-drug conjugates from companies such as Amgen, Roche, and GlaxoSmithKline[138](index=138&type=chunk) [Government Regulation and Product Approval](index=29&type=section&id=Item%201.%20Business-Government%20Regulation%20and%20Product%20Approval) Allogene's cell products are subject to extensive government regulation, including FDA approval and post-market requirements - Allogene's cell products are regulated as biologics by the FDA, requiring clinical trials and an approved Biologics License Application (BLA) for marketing[142](index=142&type=chunk) - The U.S. product development process involves preclinical testing, an Investigational New Drug (IND) application, and three phases of clinical trials (Phase 1, 2, 3) under Good Clinical Practices (GCPs)[144](index=144&type=chunk)[148](index=148&type=chunk) - The FDA offers expedited programs like Fast Track, Priority Review, Accelerated Approval, and Regenerative Medicine Advanced Therapy (RMAT) designation, potentially applicable to Allogene's candidates[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - Post-approval, the company is subject to ongoing FDA regulation, including cGMP compliance, adverse event reporting, and restrictions on off-label promotion, with approved biologics entitled to 12-year marketing exclusivity[167](index=167&type=chunk)[171](index=171&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks due to its limited operating history, net losses, and novel allogeneic T cell therapies - The company has a limited operating history, has incurred net losses since inception (**$184.6 million** in 2019), and anticipates substantial future losses[213](index=213&type=chunk)[215](index=215&type=chunk) - Allogene is heavily reliant on partners, particularly Cellectis for TALEN gene-editing technology and Servier for conducting UCART19 clinical trials, creating dependencies and risks[222](index=222&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk) - Product candidates may cause undesirable side effects such as Cytokine Release Syndrome (CRS), neurotoxicity, and Graft-versus-Host Disease (GvHD), which could halt clinical development or prevent regulatory approval[234](index=234&type=chunk)[235](index=235&type=chunk) - The company intends to operate its own manufacturing facility but currently relies on CMOs, facing risks related to scaling up production and potential manufacturing failures[275](index=275&type=chunk)[276](index=276&type=chunk) - The regulatory approval process for novel allogeneic cell therapies is uncertain and complex, potentially delaying or preventing approval due to extensive data requirements or different trial designs[228](index=228&type=chunk)[363](index=363&type=chunk)[376](index=376&type=chunk) [Unresolved Staff Comments](index=78&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the Securities and Exchange Commission - None [Properties](index=78&type=section&id=Item%202.%20Properties) Allogene's corporate headquarters and manufacturing facility are located in South San Francisco and Newark, California, respectively - Corporate headquarters are located in South San Francisco, California, consisting of approximately **68,000 square feet** for office and laboratory space[477](index=477&type=chunk) - In February 2019, the company leased approximately **118,000 square feet** in Newark, California, to develop a state-of-the-art cell therapy manufacturing facility[478](index=478&type=chunk) [Legal Proceedings](index=78&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material litigation or legal proceedings - The company is not currently a party to any material legal proceedings[479](index=479&type=chunk) [Mine Safety Disclosures](index=79&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable [Part II](index=80&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=80&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Allogene's common stock trades on Nasdaq under "ALLO" since its October 2018 IPO, with no cash dividends paid - The company's common stock has been listed on The Nasdaq Global Select Market under the symbol "**ALLO**" since October 11, 2018[482](index=482&type=chunk) - The company has never declared or paid cash dividends and intends to retain all available funds for operations and growth[487](index=487&type=chunk) - The October 2018 IPO raised net proceeds of approximately **$343.3 million**; these proceeds have not been used and are intended to fund the product pipeline and general corporate purposes[488](index=488&type=chunk)[489](index=489&type=chunk) [Selected Financial Data](index=81&type=section&id=Item%206.%20Selected%20Financial%20Data) Selected financial data reflects significant operating losses, consistent with a clinical-stage biopharmaceutical company Selected Financial Data (in thousands) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | **Statements of Operations Data** | | | | Research and development | $144,535 | $151,860 | | General and administrative | $57,473 | $40,982 | | Loss from operations | $(202,008) | $(192,842) | | Net loss | $(184,594) | $(211,505) | | **Balance Sheet Data (as of Dec 31)** | | | | Cash, cash equivalents and investments | $588,855 | $721,350 | | Total assets | $717,802 | $773,855 | | Accumulated deficit | $(396,122) | $(211,528) | | Total stockholders' equity | $629,023 | $703,164 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=82&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Allogene reported a net loss of $184.6 million in 2019, an improvement from $211.5 million in 2018 Comparison of Operating Expenses (in thousands) | Expense Category | 2019 | 2018 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $144,535 | $151,860 | $(7,325) | Decrease due to a $109.4M one-time IPR&D expense in 2018, offset by increased pipeline, personnel, and facilities costs in 2019 | | General and administrative | $57,473 | $40,982 | $16,491 | Increase due to higher personnel-related costs (including stock-based compensation) and professional services | - As of December 31, 2019, the company had **$588.9 million** in cash, cash equivalents, and investments, considered sufficient to fund operations for at least the next 12 months[530](index=530&type=chunk) - Operations have been financed primarily by proceeds from convertible preferred stock, convertible notes, the 2018 IPO (**$343.3 million** net), and a late 2019 at-the-market (ATM) stock offering (**$54.2 million** net)[531](index=531&type=chunk) Cash Flow Summary (in thousands) | Cash Flow Category | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(137,350) | $(44,653) | | Net cash provided by (used in) investing activities | $164,084 | $(632,798) | | Net cash provided by financing activities | $58,960 | $771,182 | [Quantitative and Qualitative Disclosures About Market Risk](index=95&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks, primarily interest rate risk and foreign currency exchange rate risk - The company's primary market risk is interest rate risk on its **$588.9 million** in cash, cash equivalents, and investments; a 10% change in interest rates is not expected to have a material effect[563](index=563&type=chunk) - Foreign currency exchange risk exists due to collaboration payments with Servier denominated in euros; as of December 31, 2019, liabilities were **$2.4 million**, and a 10% rate change is not expected to be material[564](index=564&type=chunk) [Financial Statements and Supplementary Data](index=96&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited financial statements for 2019, 2018, and the inception period - The financial statements were audited by Ernst & Young LLP, which issued an unqualified opinion[569](index=569&type=chunk)[570](index=570&type=chunk) - A critical audit matter identified was the estimation of accrued research and development costs, involving significant management judgment regarding work completed by partners and third-party service providers[573](index=573&type=chunk)[574](index=574&type=chunk) [Notes to Financial Statements](index=104&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Notes%20to%20Financial%20Statements) Notes to financial statements detail accounting policies, strategic agreements, and other financial components - The April 2018 asset acquisition from Pfizer was accounted for as an asset acquisition, with total consideration of **$113.9 million**, of which **$109.4 million** was allocated to in-process research and development (IPR&D) and expensed immediately[651](index=651&type=chunk)[652](index=652&type=chunk)[654](index=654&type=chunk) - The company has significant potential future milestone payments: up to **$840.0 million** to Pfizer, up to **$2.8 billion** to Cellectis, and up to **$215.5 million** to Servier[658](index=658&type=chunk)[664](index=664&type=chunk)[675](index=675&type=chunk) - Total stock-based compensation expense was **$46.1 million** in 2019 and **$18.6 million** in 2018; as of December 31, 2019, there was **$148.6 million** of total unrecognized stock-based compensation[558](index=558&type=chunk)[726](index=726&type=chunk) - The company has significant operating lease obligations, primarily for its headquarters and manufacturing facility, with total undiscounted lease payments of **$93.3 million**[544](index=544&type=chunk)[691](index=691&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=135&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes or disagreements with its accountants on accounting or financial disclosure matters - None [Controls and Procedures](index=135&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2019 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[755](index=755&type=chunk) - Management assessed the effectiveness of internal control over financial reporting and concluded it was effective as of December 31, 2019, based on the COSO framework[757](index=757&type=chunk) - Ernst & Young LLP issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2019[758](index=758&type=chunk)[762](index=762&type=chunk) [Other Information](index=138&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None [Part III](index=139&type=section&id=PART%20III) [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, Certain Relationships and Related Transactions, and Principal Accounting Fees and Services](index=139&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%20and%2014) Information for Items 10-14 is incorporated by reference from the 2020 Proxy Statement - Information regarding Directors, Executive Officers, and Corporate Governance will be provided in the 2020 Proxy Statement and is incorporated by reference[770](index=770&type=chunk) - Information regarding Executive Compensation will be provided in the 2020 Proxy Statement and is incorporated by reference[772](index=772&type=chunk) - Information regarding Security Ownership, Certain Relationships and Related Transactions, and Principal Accounting Fees and Services will be provided in the 2020 Proxy Statement and is incorporated by reference[773](index=773&type=chunk)[775](index=775&type=chunk)[776](index=776&type=chunk) [Part IV](index=140&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=140&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists financial statements from Item 8 and provides an index of all exhibits filed with the Form 10-K - This item contains the list of financial statements and an index of exhibits filed with the Form 10-K[778](index=778&type=chunk)[779](index=779&type=chunk) [Form 10-K Summary](index=142&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no information for this item - None

Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q4 2019 Earnings Conference Call February 27, 2020 8:30 AM ET Company Participants Christine Cassiano – Chief Communications Officer David Chang – President and Chief Executive Officer Raphael Amado – Executive Vice President of Research and Development and Chief Medical Officer Eric Schmidt – Chief Financial Officer Conference Call Participants Marc Frahm – Cowen and Company Salveen Richter – Goldman Sachs Biren Amin – Jefferies Tyler Van Buren – Piper Sandler Mark ...

Table of Contents 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, 2019 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 Numbe ...

Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q3 2019 Earnings Conference Call November 5, 2019 8:30 AM ET Company Participants Christine Cassiano - Chief Communications Officer David Chang - President and Chief Executive Officer Rafael Amado - Executive Vice President of Research and Development and Chief Medical Officer Eric Schmidt - Chief Financial Officer Conference Call Participants Biren Amin - Jefferies & Company, Inc. Philip Nadeau - Cowen and Company Tyler Van Buren - Piper Jaffray Amanda Murphy - BTI ...

PART I: FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed financial statements for June 30, 2019, show a $72.8 million net loss, increased accumulated deficit, and $650.2 million liquidity [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2019, assets decreased to $734.0 million, liabilities increased, and equity decreased to $655.6 million Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $112,584 | $92,432 | | Total investments | $537,609 | $628,918 | | **Total Assets** | **$733,997** | **$773,855** | | **Liabilities & Equity** | | | | Total current liabilities | $38,000 | $29,459 | | **Total Liabilities** | **$78,362** | **$70,691** | | Accumulated deficit | ($284,357) | ($211,528) | | **Total Stockholders' Equity** | **$655,635** | **$703,164** | [Condensed Statements of Operations and Comprehensive Loss](index=3&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net losses for the six months ended June 30, 2019, were $72.8 million, significantly lower than 2018 due to a one-time R&D charge Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $31,774 | $122,486 | $55,177 | $122,486 | | General and administrative | $14,187 | $12,526 | $27,245 | $15,123 | | **Loss from operations** | **($45,961)** | **($135,012)** | **($82,422)** | **($137,609)** | | **Net loss** | **($41,243)** | **($134,902)** | **($72,829)** | **($137,499)** | | Net loss per share | ($0.41) | ($43.82) | ($0.74) | ($9.42) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2019, net cash used in operations was $55.1 million, offset by $77.4 million from investing activities Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($55,148) | ($6,042) | | Net cash provided by (used in) investing activities | $77,380 | ($2,634) | | Net cash provided by financing activities | $920 | $152,603 | | **Net increase in cash, cash equivalents and restricted cash** | **$23,152** | **$143,927** | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Notes detail the company's immuno-oncology business, accounting policies, financial instruments, and key license and lease disclosures - The company is a clinical-stage immuno-oncology company focused on allogeneic T cell therapies for cancer, having incurred cumulative net losses of **$284.4 million** since inception and expecting to raise additional capital to fund future operations[20](index=20&type=chunk)[22](index=22&type=chunk) - The company has a license agreement with Cellectis for its TALEN gene-editing technology, with potential milestone payments of up to **$185.0 million** per product and tiered royalties in the high single-digit percentages[43](index=43&type=chunk)[46](index=46&type=chunk) - Under an agreement with Servier for anti-CD19 CAR T cell products (including UCART19), Allogene is responsible for **60%** of specified development costs and has potential milestone payment obligations up to **$381.5 million**[52](index=52&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) - In February 2019, the company entered into a lease for a **118,000 sq. ft.** manufacturing facility in Newark, CA, with total undiscounted lease payment commitments of **$36.2 million**[67](index=67&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the immuno-oncology pipeline, decreased R&D expenses from a prior year charge, and $650.2 million in liquidity - The company is advancing its pipeline, with the FDA clearing an IND for ALLO-715 in multiple myeloma in May 2019 and plans to initiate the UNIVERSAL trial in 2019[92](index=92&type=chunk) - As of June 30, 2019, the company had **$650.2 million** in cash, cash equivalents, and investments, which management believes is sufficient to fund operations for at least one year[94](index=94&type=chunk)[123](index=123&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Total operating expenses decreased by $55.2 million for the six months ended June 30, 2019, driven by a $67.3 million R&D reduction Comparison of Operating Results (in thousands) | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $55,177 | $122,486 | ($67,309) | (55)% | | General and administrative | $27,245 | $15,123 | $12,122 | 80% | | **Total operating expenses** | **$82,422** | **$137,609** | **($55,187)** | **(40)%** | | **Net Loss** | **($72,829)** | **($137,499)** | **$64,670** | **(47)%** | - The decrease in R&D expenses for the six months ended June 30, 2019, was primarily due to a **$109.4 million** expense in 2018 for acquired in-process R&D assets from Pfizer, partially offset by a **$42.0 million** increase in other R&D costs[119](index=119&type=chunk) [Liquidity, Capital Resources and Plan of Operations](index=25&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Plan%20of%20Operations) As of June 30, 2019, the company held $650.2 million in cash and investments, used $55.1 million in operations, and needs more financing Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Operating activities | ($55,148) | ($6,042) | | Investing activities | $77,380 | ($2,634) | | Financing activities | $920 | $152,603 | - In February 2019, the company entered into a lease for a cell therapy manufacturing facility in Newark, California, with a term of **15 years and 8 months**, expected to commence in May 2020[134](index=134&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks are interest rate fluctuations on the $650.2 million investment portfolio and foreign exchange rate risk - The company is exposed to interest rate risk on its cash and investment portfolio of **$650.2 million** as of June 30, 2019[144](index=144&type=chunk) - Foreign exchange risk exists due to collaboration payments with Servier, with **$5.3 million** of liabilities denominated in foreign currencies as of June 30, 2019[145](index=145&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2019, with no material changes to internal control over financial reporting - The CEO and CFO concluded that as of the end of the quarter, the company's disclosure controls and procedures were effective[146](index=146&type=chunk) - No material changes to the company's internal control over financial reporting were identified during the quarter ended June 30, 2019[147](index=147&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current legal proceedings that would materially adversely affect its financial condition or operations - Management believes there are currently no pending claims or actions against the company that could have a material adverse effect on its business[149](index=149&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Extensive risks include limited operating history, reliance on novel technologies and partners, clinical development, manufacturing, and funding needs - The company's allogeneic T cell product candidates represent a novel approach with significant challenges, including manufacturing, managing potential side effects like GvHD, and navigating an uncertain regulatory landscape[155](index=155&type=chunk) - The business is heavily reliant on partners for key technologies (Cellectis's TALEN gene-editing) and for the clinical development of lead candidates UCART19 and ALLO-501 (Servier)[158](index=158&type=chunk)[160](index=160&type=chunk) - The company faces substantial financial risk, having incurred significant net losses since inception (**$284.4 million** accumulated deficit) and anticipating the need for substantial additional financing to complete development and commercialization[153](index=153&type=chunk)[231](index=231&type=chunk) - The company intends to operate its own manufacturing facility but faces risks in completing the build-out, scaling production, and gaining regulatory approval, which could impact clinical trials and commercial viability[201](index=201&type=chunk)[202](index=202&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=67&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details the use of $343.0 million net IPO proceeds from October 2018, unused and held in cash and investments as of June 30, 2019 - The company completed its IPO in October 2018, raising approximately **$343.0 million** in net proceeds[379](index=379&type=chunk)[380](index=380&type=chunk) - Through June 30, 2019, the company has not used any of the net proceeds from its IPO, which are being held in cash, cash equivalents, and investments[381](index=381&type=chunk) [Other Items (3, 4, 5, 6)](index=67&type=section&id=Other%20Items) The company reports no defaults on senior securities, no mine safety disclosures, and no other information, with Item 6 listing exhibits - The company reports no defaults upon senior securities, no mine safety disclosures, and no other information for the period[382](index=382&type=chunk)[383](index=383&type=chunk)

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, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | | | | F ...

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, 2018 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 001‑38693 Allogene Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-3562771 (State or other jurisdic ...