Part I [Business](index=4&type=section&id=Item%201.%20Business) Crinetics Pharmaceuticals is a clinical-stage company developing oral nonpeptide therapeutics for rare endocrine diseases and tumors, with a pipeline including Paltusotine and CRN04777 [Business Overview and Pipeline](index=4&type=section&id=Business%20Overview%20and%20Pipeline) Crinetics is a clinical-stage pharmaceutical company focused on developing oral small-molecule therapeutics for rare endocrine diseases and tumors, with a diverse pipeline and a radiopharmaceutical collaboration - The company focuses on discovering and developing **oral nonpeptide (small molecule) therapeutics** for rare endocrine diseases and endocrine-related tumors[12](index=12&type=chunk) Product Candidate Pipeline Summary | Product Candidate | Target/Mechanism | Indication(s) | Development Stage | | :--- | :--- | :--- | :--- | | **Paltusotine** | SST2 Agonist | Acromegaly, Neuroendocrine Tumors (NETs) | Phase 3 (Acromegaly), Phase 2 (NETs) | | **CRN04777** | SST5 Agonist | Congenital Hyperinsulinism (HI) | Phase 1 Complete, Phase 2 Planned | | **CRN04894** | ACTH Antagonist | Cushing's Disease, CAH, EAS | Phase 1 Ongoing | | **PTH Antagonist** | PTH Receptor Antagonist | Hyperparathyroidism (PHPT), HHM | Preclinical | - In October 2021, Crinetics co-founded Radionetics Oncology, granting an exclusive worldwide license for radiotherapeutics in exchange for a majority equity stake, potential milestones over **$1.0 billion**, and royalties[20](index=20&type=chunk) [Our Strategy](index=6&type=section&id=Our%20Strategy) The company's strategy focuses on becoming a leader in rare endocrine disease treatment by advancing oral therapies, expanding its pipeline, and retaining commercial rights, with a recent licensing exception for Japan - Focus on rare endocrine diseases and tumors with significant unmet medical need, aiming to advance the standard of care with **orally available therapies**[23](index=23&type=chunk) - Leverage an experienced discovery team to expand the therapeutic pipeline, targeting **peptide hormone GPCRs**[23](index=23&type=chunk) - Intends to retain significant development and commercial rights, with a license agreement for paltusotine commercialization in Japan entered in February 2022[23](index=23&type=chunk) [Paltusotine (SST2 Agonist Program)](index=9&type=section&id=Paltusotine%20(SST2%20Agonist%20Program)) Paltusotine is an oral, selective SST2 agonist in Phase 3 development for acromegaly and Phase 2 for neuroendocrine tumors, with topline data for both expected in 2023 - Paltusotine is an **oral selective nonpeptide SST2 agonist** for treating acromegaly and NETs, holding FDA orphan drug designation for acromegaly[30](index=30&type=chunk) - Two Phase 3 trials for acromegaly, PATHFNDR-1 and PATHFNDR-2, are ongoing with **topline data expected in 2023**, aiming to support broad registration[15](index=15&type=chunk)[40](index=40&type=chunk) - A Phase 2 trial of paltusotine for NETs with carcinoid syndrome has been initiated, with **topline data also expected in 2023**[30](index=30&type=chunk)[40](index=40&type=chunk) - In February 2022, the company licensed exclusive rights to Sanwa Kagaku Kenkyusho Co., Ltd. for paltusotine development and commercialization in Japan[15](index=15&type=chunk)[30](index=30&type=chunk) [CRN04777 (SST5 Agonist Program)](index=12&type=section&id=CRN04777%20(SST5%20Agonist%20Program)) CRN04777 is an oral, selective SST5 agonist for congenital hyperinsulinism, having completed Phase 1 with positive proof-of-concept and planning Phase 2 initiation in H2 2022, holding rare pediatric and orphan drug designations - CRN04777 is an **oral SST5 agonist** for congenital HI, holding rare pediatric disease designation from the FDA and orphan drug designation from the EMA[16](index=16&type=chunk)[43](index=43&type=chunk) - Positive top-line data from Phase 1 single and multiple ascending dose cohorts, announced in September 2021 and March 2022, demonstrated **pharmacologic proof-of-concept**[16](index=16&type=chunk)[47](index=47&type=chunk) - The company plans to initiate a **Phase 2 clinical study in the second half of 2022** following regulatory discussions[16](index=16&type=chunk)[49](index=49&type=chunk) [CRN04894 (ACTH Antagonist Program)](index=14&type=section&id=CRN04894%20(ACTH%20Antagonist%20Program)) CRN04894 is an oral, nonpeptide ACTH antagonist for diseases of ACTH excess, with positive Phase 1 single ascending dose data showing cortisol reduction, and multiple ascending dose data expected in Q2 2022, followed by further clinical studies in H2 2022 - CRN04894 is an **oral ACTH antagonist** for diseases of ACTH excess such as Cushing's disease and CAH[17](index=17&type=chunk)[50](index=50&type=chunk) - Positive data from the single ascending dose cohorts of the Phase 1 study, announced in August 2021, showed the drug was **well-tolerated and reduced cortisol levels**[18](index=18&type=chunk)[55](index=55&type=chunk) - Topline data from the multiple ascending dose portion of the Phase 1 study are expected in **Q2 2022**, with plans to initiate subsequent clinical studies in **H2 2022**[18](index=18&type=chunk)[50](index=50&type=chunk)[55](index=55&type=chunk) [Competition](index=15&type=section&id=Competition) The company faces significant competition from established pharmaceutical and biotech companies across its therapeutic areas, including acromegaly, neuroendocrine tumors, congenital hyperinsulinism, and ACTH excess disorders - For acromegaly, paltusotine competes with injected somatostatin analogs and Amryt Pharma's **oral octreotide product, MYCAPSSA**[56](index=56&type=chunk)[58](index=58&type=chunk) - For congenital HI, CRN04777 would compete with the only approved therapy, **diazoxide (Teva)**, and off-label octreotide use, alongside other developers like Rezolute and Eiger Biopharmaceuticals[58](index=58&type=chunk) - For Cushing's disease and CAH, CRN04894 faces competition from adrenal enzyme inhibitors, glucocorticoid receptor antagonists, and cortisol synthesis inhibitors[59](index=59&type=chunk) [Intellectual Property](index=16&type=section&id=Intellectual%20Property) The company actively protects its technology through patents, with key product patents expiring between 2037 and 2040, and some intellectual property is subject to U.S. government regulations due to funding - Issued patents for **paltusotine** in the U.S. and Japan are estimated to expire in **2037**, excluding potential extensions[63](index=63&type=chunk) - Issued patents for **CRN04894** in the U.S. are estimated to expire in **2039**, and patent applications for **CRN04777**, if issued, are estimated to expire in **2040**[63](index=63&type=chunk) - Intellectual property generated through U.S. government SBIR Grants is subject to federal regulations, including potential government rights under the **Bayh-Dole Act**[63](index=63&type=chunk)[166](index=166&type=chunk) [Government Regulation](index=18&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA and foreign authorities, encompassing drug development, clinical trials, special designations like Orphan Drug status, post-approval compliance, and broader healthcare reform and privacy laws - The FDA drug development process requires extensive preclinical testing and multi-phase human clinical trials to establish **safety and efficacy** before NDA submission[69](index=69&type=chunk)[71](index=71&type=chunk) - The company has obtained **Orphan Drug Designation** for paltusotine (acromegaly) and CRN04777 (congenital HI), potentially providing **seven years of market exclusivity** in the U.S[78](index=78&type=chunk)[119](index=119&type=chunk) - The business is subject to healthcare reform measures like the **ACA**, impacting pricing, reimbursement, and market access, along with federal and state anti-kickback and false claims laws[88](index=88&type=chunk)[89](index=89&type=chunk) - The company must comply with data privacy and security laws such as **HIPAA** in the U.S. and **GDPR** in Europe, governing personal and health information handling[92](index=92&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including significant operating losses, early-stage product development uncertainties, lengthy and costly clinical trials, reliance on third-party manufacturing, and challenges related to intellectual property and market competition - The company has a limited operating history, incurred significant operating losses with a **$275.3 million accumulated deficit as of December 31, 2021**, and anticipates continued losses[101](index=101&type=chunk) - The company relies on third parties for manufacturing and clinical trials, increasing risks related to supply, cost, and regulatory compliance (cGMP, GCP)[126](index=126&type=chunk)[128](index=128&type=chunk) - The **COVID-19 pandemic** could continue to adversely impact business operations, including drug manufacturing, nonclinical activities, and clinical trial enrollment and completion[113](index=113&type=chunk) - The company's success depends on protecting its intellectual property, but patents may not be issued, may be challenged, or may expire prematurely[162](index=162&type=chunk) [Properties](index=67&type=section&id=Item%202.%20Properties) The company leases a 29,499 square foot facility in San Diego, California, serving as its corporate headquarters and R&D functions, with the lease expiring in August 2025 - The company leases a **29,499 square foot facility** in San Diego, California for its corporate headquarters and R&D functions[203](index=203&type=chunk) - The current lease expires in **August 2025**, with a five-year extension option[203](index=203&type=chunk) [Legal Proceedings](index=67&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, Crinetics Pharmaceuticals is not a party to any material legal proceedings - The company is not currently a party to any **material legal proceedings**[204](index=204&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=69&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Global Select Market under "CRNX", has never paid cash dividends, and IPO proceeds have been used for general corporate purposes, primarily product development - Common stock is listed on the **Nasdaq Global Select Market** under the ticker symbol **"CRNX"**[208](index=208&type=chunk) - The company has never declared or paid cash dividends and intends to retain future earnings to finance business operations[209](index=209&type=chunk) - As of December 31, 2021, all proceeds from the **July 2018 IPO** have been used for general corporate purposes, including product development[210](index=210&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=70&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2021, the company reported a net loss of $107.6 million, an increase from 2020, driven by higher R&D and G&A expenses, partially offset by $1.1 million in license revenue, with $333.7 million in cash and investments deemed sufficient for at least 12 months of operations [Results of Operations](index=75&type=section&id=Results%20of%20Operations) In 2021, total revenues were $1.1 million from license agreements, while R&D expenses increased by $27.3 million to $84.3 million and G&A expenses rose by $6.5 million to $24.5 million, resulting in a net loss of $107.6 million Comparison of Results of Operations (2021 vs. 2020) (in thousands) | (In thousands) | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | **Total revenues** | $1,078 | $71 | $1,007 | | Research and development | $84,255 | $56,998 | $27,257 | | General and administrative | $24,525 | $18,026 | $6,499 | | **Total operating expenses** | $108,780 | $75,024 | $33,756 | | Loss from operations | ($107,702) | ($74,953) | ($32,749) | | **Net loss** | **($107,641)** | **($73,812)** | **($33,829)** | - The increase in R&D expenses in 2021 was primarily due to a **$13.5 million** increase in manufacturing and development activities and a **$12.3 million** increase in personnel and related costs[237](index=237&type=chunk) - The increase in G&A expenses in 2021 was mainly due to a **$4.5 million** increase in personnel-related costs and a **$2.1 million** increase in spending on recruiting, consulting, and pre-commercialization activities[237](index=237&type=chunk) [Liquidity and Capital Resources](index=77&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2021, the company held $333.7 million in cash and investments, deemed sufficient for at least one year, having raised approximately $234.6 million from follow-on offerings and $15.0 million from a private placement in 2021 - As of December 31, 2021, the company had **$333.7 million** in unrestricted cash, cash equivalents, and investment securities[243](index=243&type=chunk) - In 2021, the company raised net proceeds of approximately **$72.6 million** from an April follow-on offering, **$15.0 million** from a July private placement, and **$162.0 million** from an October follow-on offering[245](index=245&type=chunk) - The company believes its existing cash, cash equivalents, and investments will be sufficient to fund operations for at least **one year** from the 10-K filing date[243](index=243&type=chunk) [Cash Flows](index=76&type=section&id=Cash%20Flows) In 2021, net cash used in operating activities increased to $88.6 million, net cash used in investing activities was $56.5 million, and net cash provided by financing activities was $252.7 million, leading to a $107.6 million net increase in cash Comparison of Cash Flows (2021 vs. 2020) (in thousands) | (In thousands) | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($88,588) | ($62,027) | | Net cash (used in) provided by investing activities | ($56,483) | $217 | | Net cash provided by financing activities | $252,679 | $114,571 | | **Net change in cash, cash equivalents and restricted cash** | **$107,608** | **$52,761** | - The increase in cash used in operating activities was primarily due to increased development and manufacturing activities for paltusotine and other programs, along with higher personnel costs[239](index=239&type=chunk) - Cash from financing activities in 2021 was primarily from net proceeds of **$234.6 million** from follow-on public offerings and **$15.0 million** from a private placement[240](index=240&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=79&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its short-term cash and investments, which is not expected to be material, and it also faces unhedged foreign currency exchange rate risk from international operations - The primary market risk is interest rate sensitivity on its portfolio of cash, cash equivalents, and investment securities, though the impact is expected to be **minimal** due to the short-term nature of the instruments[247](index=247&type=chunk) - The company is subject to **foreign currency exchange rate risk** from contracts with foreign vendors and its Australian subsidiary, but does not hedge this risk[248](index=248&type=chunk) [Controls and Procedures](index=79&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2021, with no material changes during Q4 2021 - As of December 31, 2021, the principal executive and financial officers concluded that the company's **disclosure controls and procedures were effective**[253](index=253&type=chunk) - Management assessed internal control over financial reporting using the **COSO framework** and concluded it was **effective as of December 31, 2021**[254](index=254&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Compensation, Security Ownership, and Accountant Fees](index=81&type=section&id=Item%2010,%2011,%2012,%2013,%2014) Information for Items 10 through 14, covering directors, executive officers, corporate governance, compensation, and security ownership, is incorporated by reference from the company's 2022 Annual Meeting of Stockholders proxy statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's definitive proxy statement for the **2022 annual meeting of stockholders**[260](index=260&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=82&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists documents filed as part of the Form 10-K, including consolidated financial statements, the independent auditor's report, and the Exhibit Index - This item includes the consolidated financial statements of Crinetics Pharmaceuticals, Inc. and the report from its independent registered public accounting firm, **BDO USA, LLP**[270](index=270&type=chunk) - A list of exhibits filed with the Annual Report is set forth on the **Exhibit Index**[270](index=270&type=chunk) Financial Statements [Consolidated Balance Sheets](index=85&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2021, Crinetics reported total assets of $351.0 million, driven by increased cash and investments, with total liabilities at $19.1 million and stockholders' equity growing to $332.0 million from stock offerings Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $200,695 | $93,087 | | Investment securities | $133,012 | $77,793 | | **Total current assets** | **$344,720** | **$177,492** | | **Total assets** | **$351,015** | **$183,445** | | Total current liabilities | $15,995 | $10,489 | | **Total liabilities** | **$19,071** | **$14,526** | | **Total stockholders' equity** | **$331,944** | **$168,919** | [Consolidated Statements of Operations and Comprehensive Loss](index=86&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For 2021, Crinetics reported a net loss of $107.6 million, or ($2.80) per share, primarily due to increased R&D and G&A expenses, partially offset by $1.1 million in license revenue Statement of Operations Data (in thousands, except per share data) | | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Total revenues | $1,078 | $71 | $1,193 | | Research and development | $84,255 | $56,998 | $41,506 | | General and administrative | $24,525 | $18,026 | $13,519 | | **Loss from operations** | **($107,702)** | **($74,953)** | **($53,832)** | | **Net loss** | **($107,641)** | **($73,812)** | **($50,422)** | | Net loss per share | ($2.80) | ($2.42) | ($2.09) | [Consolidated Statements of Cash Flows](index=88&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2021, net cash used in operating activities was $88.6 million, net cash used in investing activities was $56.5 million, and net cash provided by financing activities was $252.7 million, leading to a $107.6 million net increase in cash Cash Flow Data (in thousands) | | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($88,588) | ($62,027) | | Net cash (used in) provided by investing activities | ($56,483) | $217 | | Net cash provided by financing activities | $252,679 | $114,571 | | **Net change in cash, cash equivalents and restricted cash** | **$107,608** | **$52,761** |

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Condensed Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements) Crinetics Pharmaceuticals reported no revenue and a net loss of $76.8 million for the nine months ended September 30, 2021, with total assets at $209.4 million and stockholders' equity at $193.6 million [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $209.4 million by September 30, 2021, driven by higher cash and equivalents, while stockholders' equity rose to $193.6 million | Balance Sheet Items (In thousands) | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $161,536 | $93,087 | | Investment securities | $31,789 | $77,793 | | Total current assets | $203,973 | $177,492 | | Total assets | $209,359 | $183,445 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $12,440 | $10,489 | | Total liabilities | $15,769 | $14,526 | | Total stockholders' equity | $193,590 | $168,919 | | Total liabilities and stockholders' equity | $209,359 | $183,445 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss widened to $27.9 million for Q3 2021 and $76.8 million for the nine-month period, primarily due to increased research and development expenses | Operating Results (In thousands, except per share data) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Grant revenues | $— | $— | $— | $71 | | Research and development | $21,580 | $13,699 | $59,651 | $40,168 | | General and administrative | $6,227 | $4,752 | $17,163 | $13,065 | | Total operating expenses | $27,807 | $18,451 | $76,814 | $53,233 | | Loss from operations | $(27,807) | $(18,451) | $(76,814) | $(53,162) | | Net loss | $(27,851) | $(18,320) | $(76,847) | $(52,171) | | Net loss per share – basic and diluted | $(0.73) | $(0.56) | $(2.13) | $(1.76) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $65.7 million for the nine months ended September 30, 2021, offset by $88.8 million from financing activities | Cash Flow Summary (In thousands) | Nine months ended Sep 30, 2021 | Nine months ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(65,689) | $(46,089) | | Net cash provided by investing activities | $45,315 | $9,109 | | Net cash provided by financing activities | $88,823 | $114,474 | | Net change in cash, cash equivalents and restricted cash | $68,449 | $77,494 | | Cash, cash equivalents and restricted cash at end of period | $162,036 | $118,320 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical focus, financial position with $193.3 million cash, and the formation of Radionetics Oncology as a key subsequent event - The company is a **clinical-stage pharmaceutical firm** focused on therapeutics for rare endocrine diseases and tumors. In October 2021, it formed **Radionetics Oncology, Inc.** with partners to develop radiopharmaceuticals, in which it maintains an equity interest[23](index=23&type=chunk) - As of September 30, 2021, the company had an accumulated deficit of **$244.5 million** but believes its **$193.3 million** in unrestricted cash, cash equivalents, and investments is sufficient to fund operations for at least the next 12 months[27](index=27&type=chunk) - In 2021, the company completed an underwritten follow-on offering in April raising **$72.6 million net**, a private placement in July for **$15.0 million gross**, and another follow-on offering in October raising approximately **$161.9 million net**[59](index=59&type=chunk) - Subsequent to the quarter end, on October 18, 2021, the company formed **Radionetics Oncology**, licensing its radiotherapeutics technology platform in exchange for a **majority stake**, a warrant, potential sales milestones over **$1.0 billion**, and **single-digit royalties**[71](index=71&type=chunk)[72](index=72&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical pipeline advancements, increased operating expenses leading to a $76.8 million net loss, and substantial equity funding to support future operations [Overview and Pipeline](index=17&type=section&id=Overview%20and%20Pipeline) The company, a clinical-stage pharmaceutical firm, is advancing its pipeline with lead candidate paltusotine in Phase 3 for acromegaly and recently formed Radionetics Oncology - **Paltusotine (SST2 Agonist):** A **Phase 3 development program** for acromegaly has been initiated, with top-line data expected in **2023**[80](index=80&type=chunk) - **CRN04777 (SST5 Agonist):** Currently in a **Phase 1 study** for congenital hyperinsulinism, with positive topline data announced in **September 2021**[81](index=81&type=chunk) - **CRN04894 (ACTH Antagonist):** In a **Phase 1 study** for diseases of excess ACTH, preliminary data showed dose-dependent reductions in cortisol[83](index=83&type=chunk) - **Radionetics Oncology, Inc.:** Formed in **October 2021** with partners to develop radiopharmaceuticals, with Crinetics licensing its technology for a **majority equity stake**, potential milestones, and royalties[85](index=85&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating results show widening net losses for Q3 and the nine months ended 2021, primarily due to increased research and development expenses and personnel costs | Expense Comparison (In thousands) | Three Months Ended Sep 30, 2021 | Three Months Ended Sep 30, 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $21,580 | $13,699 | $7,881 | | General and administrative | $6,227 | $4,752 | $1,475 | | **Net loss** | **$(27,851)** | **$(18,320)** | **$(9,531)** | | Expense Comparison (In thousands) | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | Change | | :--- | :--- | :--- | :--- | | Research and development | $59,651 | $40,168 | $19,483 | | General and administrative | $17,163 | $13,065 | $4,098 | | **Net loss** | **$(76,847)** | **$(52,171)** | **$(24,676)** | - The increase in R&D expenses for the nine-month period was driven by a **$9.4 million** rise in manufacturing and development activities and an **$8.8 million** increase in personnel costs[103](index=103&type=chunk)[105](index=105&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$193.3 million** in cash and investments as of September 30, 2021, bolstered by **$161.9 million** from an October offering, providing sufficient liquidity for the next 12 months - The company had **$193.3 million** in unrestricted cash, cash equivalents, and investment securities as of September 30, 2021[106](index=106&type=chunk) - Net cash used in operating activities increased to **$65.7 million** for the nine months ended Sep 30, 2021, up from **$46.1 million** in the prior year period, due to increased development activities and personnel costs[106](index=106&type=chunk) - In October 2021, the company completed an underwritten public offering, raising approximately **$161.9 million** in net proceeds[111](index=111&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks are interest rate sensitivity on its short-term investments and foreign currency exposure, neither of which is currently material - The company's primary market risk is **interest rate sensitivity**, but its short-term investment portfolio mitigates material impact from rate changes[114](index=114&type=chunk) - Foreign currency exchange rate risk from its Australian subsidiary and foreign vendor contracts has not had a material adverse effect to date[115](index=115&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting - As of September 30, 2021, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective** at a reasonable assurance level[117](index=117&type=chunk) - No material changes occurred in internal control over financial reporting during the third quarter of 2021[117](index=117&type=chunk) [PART II — OTHER INFORMATION](index=28&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - As of the filing date, the company is not involved in any **material legal proceedings**[120](index=120&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No **material changes** have been made to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020[121](index=121&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Approximately **$106.5 million** of the 2018 IPO proceeds have been used for general corporate purposes and development programs as of September 30, 2021 - As of September 30, 2021, the company has used approximately **$106.5 million** of its 2018 IPO proceeds for general corporate purposes and development programs[122](index=122&type=chunk)

Paltusotine (SST2 Agonist) - Crinetics is developing Paltusotine, a potential first-in-class oral nonpeptide SST2 agonist, for Acromegaly, Carcinoid Syndrome, and Nonfunctional Neuroendocrine Tumors[13] - The US prevalence for Acromegaly is 26,000, Carcinoid Syndrome is 33,000, and Nonfunctional NETs is 138,000[9, 14] - Phase 2 ACROBAT Edge study met the primary endpoint, maintaining hormone suppression after switching from injected standard of care to oral paltusotine[36] - Phase 3 program is designed to support potential for broad first-line medical therapy in acromegaly patients[42] CRN04894 (ACTH Antagonist) - Crinetics is developing CRN04894, a potential first-in-class oral nonpeptide ACTH antagonist, for Congenital Adrenal Hyperplasia (CAH) and Cushing's Disease (CD)[45] - The US prevalence for Cushing's Disease is 10,000 and for Congenital Adrenal Hyperplasia (CAH) is 27,000[9, 52] - Phase 1 SAD data showed strong suppression of basal cortisol (56% at 80 mg dose)[69, 76] CRN04777 (SST5 Agonist) - Crinetics is developing CRN04777, a potential first-in-class oral nonpeptide SST5 agonist, for Congenital Hyperinsulinism (HI)[81] - Phase 1 SAD data showed dose-dependent reduction in glucose-induced insulin secretion and reversal of sulfonylurea-induced insulin secretion[110] Market and Financials - The market for Acromegaly and NETs is approximately $3 billion despite limitations of current therapies[16]

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's analysis, market risk, and internal controls for the reporting period [Item 1. Condensed Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements) The unaudited condensed financial statements show increased assets and a larger net loss for the first half of 2021, driven by R&D expenses and stock offerings [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, highlighting assets, liabilities, and stockholders' equity as of June 30, 2021 Condensed Consolidated Balance Sheet Highlights | Account | June 30, 2021 (Unaudited, in thousands) | December 31, 2020 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $178,771 | $93,087 | | Total current assets | $211,355 | $177,492 | | **Total assets** | **$216,929** | **$183,445** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $11,919 | $10,489 | | Total liabilities | $15,489 | $14,526 | | Total stockholders' equity | $201,440 | $168,919 | | **Total liabilities and stockholders' equity** | **$216,929** | **$183,445** | - Total assets increased primarily due to a significant rise in cash and cash equivalents, which grew from **$93.1 million to $178.8 million**, largely funded by stock offerings[7](index=7&type=chunk) - Total stockholders' equity increased from **$168.9 million to $201.4 million**, reflecting capital raised from stock issuances, which offset the accumulated deficit from net losses[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2021 Statement of Operations Highlights | Metric | Three Months Ended June 30, 2021 (in thousands) | Three Months Ended June 30, 2020 (in thousands) | Six Months Ended June 30, 2021 (in thousands) | Six Months Ended June 30, 2020 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Grant revenues | $— | $— | $— | $71 | | Research and development | $20,487 | $12,607 | $38,071 | $26,469 | | General and administrative | $5,602 | $4,322 | $10,936 | $8,313 | | **Loss from operations** | **$(26,089)** | **$(16,929)** | **$(49,007)** | **$(34,711)** | | **Net loss** | **$(26,095)** | **$(16,491)** | **$(48,996)** | **$(33,851)** | | Net loss per share – basic and diluted | $(0.70) | $(0.53) | $(1.40) | $(1.21) | - Research and development expenses increased by **62.5%** for the three-month period and **43.8%** for the six-month period year-over-year, driving the larger net loss[16](index=16&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in stockholders' equity, including the impact of net loss and common stock issuances - Total stockholders' equity increased from **$168.9 million** at the start of 2021 to **$201.4 million** at June 30, 2021, primarily driven by the issuance of common stock, which added **$72.6 million**, offsetting the net loss of **$49.0 million** for the period[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the company's cash inflows and outflows from operating, investing, and financing activities Cash Flow Highlights | Activity | Six Months Ended June 30, 2021 (in thousands) | Six Months Ended June 30, 2020 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(40,016) | $(28,085) | | Net cash provided by investing activities | $52,340 | $33,941 | | Net cash provided by financing activities | $73,360 | $114,632 | | **Net change in cash, cash equivalents and restricted cash** | **$85,684** | **$120,488** | - Cash used in operating activities increased by **42.5%** year-over-year, reflecting higher net loss and changes in operating assets and liabilities[23](index=23&type=chunk) - Financing activities in the first six months of 2021 provided **$73.4 million**, primarily from the net proceeds of a common stock issuance[23](index=23&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides additional disclosures and explanations supporting the condensed consolidated financial statements - The company is a clinical-stage pharmaceutical firm focused on rare endocrine diseases and has an accumulated deficit of **$216.6 million** as of June 30, 2021[26](index=26&type=chunk)[30](index=30&type=chunk) - Management believes its cash, cash equivalents, and investment securities of **$203.8 million** are sufficient to fund requirements for at least the next 12 months[30](index=30&type=chunk) - In April 2021, the company completed a follow-on offering of common stock, raising net proceeds of approximately **$72.6 million**[63](index=63&type=chunk) - Subsequent to the quarter end, on July 28, 2021, the company entered into an agreement for a private placement of common stock, yielding gross proceeds of **$15.0 million**[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses the company's financial condition, operational results, and liquidity, highlighting key drivers and future outlook [Overview and Pipeline](index=16&type=section&id=Overview%20and%20Pipeline) This section provides an overview of the company's business, strategic focus, and clinical development pipeline - Crinetics is a clinical-stage pharmaceutical company focused on developing novel therapeutics for rare endocrine diseases and endocrine-related tumors[79](index=79&type=chunk) - The lead product candidate, paltusotine, is in a Phase 3 development program for acromegaly, with top-line data from two placebo-controlled trials (PATHFNDR-1 and PATHFNDR-2) expected in 2023[80](index=80&type=chunk)[82](index=82&type=chunk) - Other clinical-stage candidates include CRN04777 for congenital hyperinsulinism (HI) and CRN04894 for diseases of excess ACTH, such as Cushing's Disease[83](index=83&type=chunk)[84](index=84&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, focusing on revenue, expenses, and net loss for the reporting periods Comparison of Three Months Ended June 30 | Expense Category | 2021 (in thousands) | 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $20,487 | $12,607 | $7,880 | | General and administrative | $5,602 | $4,322 | $1,280 | | **Total operating expenses** | **$26,089** | **$16,929** | **$9,160** | | **Net loss** | **$(26,095)** | **$(16,491)** | **$(9,604)** | Comparison of Six Months Ended June 30 | Expense Category | 2021 (in thousands) | 2020 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $38,071 | $26,469 | $11,602 | | General and administrative | $10,936 | $8,313 | $2,623 | | **Total operating expenses** | **$49,007** | **$34,782** | **$14,225** | | **Net loss** | **$(48,996)** | **$(33,851)** | **$(15,145)** | - The increase in R&D expenses for Q2 2021 was primarily due to a **$4.1 million** increase in manufacturing and development activities and a **$3.0 million** increase in personnel costs[102](index=102&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's cash position, capital resources, and ability to fund future operations - As of June 30, 2021, the company had **$203.8 million** in unrestricted cash, cash equivalents, and investment securities and an accumulated deficit of **$216.6 million**[105](index=105&type=chunk) - Management believes existing capital resources are sufficient to fund operations for at least the next twelve months[108](index=108&type=chunk) - Net cash provided by financing activities was **$73.4 million** for the first six months of 2021, mainly from an underwritten follow-on offering in April 2021[107](index=107&type=chunk) - The company has an At-The-Market (ATM) offering agreement for up to **$75.0 million**, but did not issue any shares under this program in the first six months of 2021[111](index=111&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section details the company's exposure to market risks, including interest rate and foreign currency fluctuations, and their potential impact - The primary market risk is interest rate sensitivity on cash, cash equivalents, and investment securities, but due to their short-term nature, a sudden change in rates is not expected to have a material impact[114](index=114&type=chunk) - The company is subject to foreign currency exchange rate risk through its Australian subsidiary and foreign vendor contracts, though net gains and losses were not material for the periods presented[115](index=115&type=chunk) - Inflation has not had a material effect on the company's results of operations[116](index=116&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures, with no material changes reported - Based on an evaluation as of June 30, 2021, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[117](index=117&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[117](index=117&type=chunk) [PART II — OTHER INFORMATION](index=26&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section provides information on legal proceedings, risk factors, equity sales, and required exhibits [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[120](index=120&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes have occurred to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020[121](index=121&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports no unregistered equity sales and details the use of IPO proceeds for corporate and clinical development - There were no unregistered sales of equity securities during the reporting period[121](index=121&type=chunk) - As of June 30, 2021, the company has used approximately **$98.9 million** of the net proceeds from its IPO for general corporate purposes and clinical development, with no material change in the planned use of proceeds[122](index=122&type=chunk) [Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including required CEO and CFO certifications - The report includes required certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk)

Financial Performance - For the three months ended March 31, 2021, Crinetics Pharmaceuticals reported a net loss of $22.9 million, compared to a net loss of $17.4 million for the same period in 2020, representing a 31% increase in losses year-over-year[11]. - Total operating expenses for the first quarter of 2021 were $22.9 million, up from $17.9 million in the first quarter of 2020, indicating a 28% increase[11]. - Net cash used in operating activities for Q1 2021 was $20.1 million, compared to $12.2 million in Q1 2020, marking a 64% increase in cash burn[18]. - The company expects to continue incurring net losses for the foreseeable future and will need to raise substantial additional capital to support its business plan[25]. - The company reported an accumulated deficit of $190.5 million as of March 31, 2021, with net losses expected to increase substantially due to ongoing clinical trials and research activities[86]. Research and Development - Research and development expenses increased to $17.6 million in Q1 2021 from $13.9 million in Q1 2020, reflecting a 27% rise[11]. - The company plans to substantially increase research and development expenses in the foreseeable future to support ongoing product candidate development[94]. - Paltusotine, the lead product candidate, is in Phase 3 trials for acromegaly, with top-line data expected in 2023, which could support registration in the U.S. and Europe[79]. - CRN04777, an investigational drug for congenital hyperinsulinism, is undergoing a Phase 1 study, with preliminary data expected in mid-2021[80]. - CRN04894, aimed at treating diseases caused by excess ACTH, is also in a Phase 1 study, with preliminary data anticipated in the second half of 2021[81]. Cash and Investments - As of March 31, 2021, the company had $150.7 million in unrestricted cash, cash equivalents, and investment securities, which is expected to meet funding requirements for at least the next 12 months[25]. - Cash, cash equivalents, and restricted cash at the end of Q1 2021 totaled $106.1 million, up from $51.4 million at the end of Q1 2020[18]. - Total available-for-sale investment securities as of March 31, 2021, amounted to $45.086 million, down from $77.793 million at December 31, 2020[49][50]. - The fair market value of U.S. government and agency obligations was $42.181 million as of March 31, 2021, with gross unrealized losses of $2, compared to $74.223 million with gross unrealized losses of $5 at December 31, 2020[49][50]. - The Company has not recognized any impairment in its financial statements related to its available-for-sale investment securities as of March 31, 2021[51]. Capital Raising - The company raised an additional $72.5 million through a follow-on offering of 4,562,044 shares in April 2021[25]. - The company completed a public offering of 8,222,500 shares at a price of $14.00 per share, raising approximately $107.9 million net of costs[61]. - The company completed a follow-on offering of 4,562,044 shares at $16.44 per share, raising net proceeds of approximately $72.5 million after costs[72]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources, which may dilute stockholder ownership[103]. Expenses and Liabilities - General and administrative expenses rose to $5.3 million for the three months ended March 31, 2021, up from $4.0 million in the same period in 2020, primarily due to increased personnel and legal expenses[98]. - Stock-based compensation expense totaled $3.4 million for the three months ended March 31, 2021, compared to $2.1 million for the same period in 2020, representing a 58.7% increase[70]. - The company reported future minimum payments under non-cancellable operating leases totaling $5,486,000 as of March 31, 2021[59]. Operational Outlook - The company is assessing the impact of COVID-19 on its operations, including clinical trials and timelines, which may affect future forecasts[85]. - The company has not generated any revenues from commercial sales of approved products and does not expect to do so in the foreseeable future[89]. - The company anticipates that general and administrative expenses will increase to support continued research and development and potential commercialization activities[95]. Legal and Compliance - The company does not expect any ongoing litigation to have a material adverse effect on its financial position or results of operations[60]. - There are currently no material legal proceedings involving the company, although it may be subject to claims in the ordinary course of business[114]. - The company has not made any unregistered sales of equity securities during the reporting period[115]. - The company has no off-balance sheet arrangements as defined under applicable SEC rules[106].

Clinical Program Updates - The company plans to initiate two Phase 3 trials (PATHFNDR-1 and PATHFNDR-2) for paltusotine in acromegaly to support broad labeling in the US and Europe [4] - PATHFNDR-1 will evaluate paltusotine in acromegaly patients switching from injectable octreotide or lanreotide depots, with topline data expected in 2023 [4, 8] - PATHFNDR-2 will evaluate paltusotine in untreated acromegaly patients, with topline data also expected in 2023 [4, 12] - A Phase 2 trial of paltusotine in carcinoid syndrome due to NETs is planned to be initiated by the end of 2021 [14] - A Phase 1 study of CRN04894, an investigational ACTH antagonist for Cushing's disease and congenital adrenal hyperplasia (CAH), has been initiated, with SAD data expected in the first half of 2021 and MAD data expected in the second half of 2021 [2, 16, 23] - A Phase 1 study of CRN04777, an investigational SST5 agonist for congenital hyperinsulinism, has been initiated, with SAD data expected in mid-2021 and MAD data expected in the second half of 2021 [2, 18, 23] Financial Position - The company ended 2020 with over $170 million in cash, cash equivalents, and investments [2] - As of December 31, 2020, the company had $170.9 million in cash, cash equivalents, and investments [20] - The company's total operating expenses (OpEx) for the full year 2020 were $75.0 million, including $57.0 million in R&D expenses and $18.0 million in G&A expenses [21] - The company reported a net loss of $73.8 million for the full year 2020 [21]

Financial Data and Key Metrics Changes - Crinetics Pharmaceuticals ended 2020 with over $170 million in cash and investments, an increase from $118.4 million at the end of 2019, providing funding into 2023 [10][41] - Total operating expenses for Q4 2020 were approximately $21.8 million, up from $15.5 million in Q4 2019, and for the full year 2020, total operating expenses were $75 million compared to $55 million in 2019 [42] - The net loss for Q4 2020 was $21.6 million, compared to a net loss of $14.5 million in Q4 2019, and for the full year 2020, the net loss was $73.8 million compared to $50.4 million in 2019 [45] Business Line Data and Key Metrics Changes - The company advanced its clinical pipeline with paltusotine entering Phase III trials, while CRN04894 and CRN04777 progressed to Phase I trials [8][10] - Research and development expenses for Q4 2020 were $16.8 million, up from $12.1 million in Q4 2019, primarily due to clinical development for paltusotine [43] Market Data and Key Metrics Changes - The FDA granted paltusotine an Orphan Drug Designation for acromegaly treatment, and CRN04777 received a rare pediatric disease designation for congenital hyperinsulinism [9] Company Strategy and Development Direction - Crinetics aims to solidify its position as a leader in the design and development of novel small molecule drugs for endocrine diseases, with a focus on paltusotine as a differentiated product [10][11] - The PATHFNDR program for paltusotine consists of two Phase III trials designed to support a broad label for its use as a first-line therapy and for patients switching from injectables [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical milestones and the potential for paltusotine to outperform current standard therapies, with expectations for top-line data from the PATHFNDR studies in 2023 [26][48] - The company is committed to improving patient lives and maintaining a strong financial position while advancing its clinical programs [48] Other Important Information - The company plans to initiate a Phase II trial for paltusotine in neuroendocrine tumors in 2021, leveraging positive data from acromegaly trials [24] - The Phase I studies for CRN04894 and CRN04777 are designed to provide early clinical proof of concept, which is expected to derisk the clinical programs [28][35] Q&A Session Summary Question: What do you anticipate to be the biggest rate-limiting step for the PATHFNDR studies? - Management indicated that patient enrollment is always a challenge in rare disease studies, but they have implemented strategies to enhance enrollment [50][51] Question: What kind of response rate would you like to see in the PATHFNDR study? - Management expects a high responder rate of over 70% in patients switching from injectables, while treatment-naive patients may have a lower rate around one-third [54] Question: Why did you choose a placebo-controlled design for PATHFNDR-2? - The rationale is that placebo-controlled studies provide clearer safety assessments and are more acceptable to regulators [84] Question: How does the treatment duration for PATHFNDR-2 compare to PATHFNDR-1? - The treatment duration for PATHFNDR-2 is shorter, but both studies are expected to read out data in 2023 due to recruitment rates and treatment periods [86]

PART I [Item 1 Business](index=3&type=section&id=Item%201%20Business) Crinetics Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing novel oral nonpeptide therapeutics for rare endocrine diseases and endocrine-related tumors - Crinetics Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors[11](index=11&type=chunk) - The company's pipeline includes **paltusotine** (for acromegaly and neuroendocrine tumors), **CRN04777** (for congenital hyperinsulinism), and **CRN04894** (for diseases of excess adrenocorticotrophic hormone, including Cushing's Disease, congenital adrenal hyperplasia, and Ectopic ACTH Syndrome)[11](index=11&type=chunk) - Paltusotine, the lead product candidate, is an oral selective nonpeptide somatostatin receptor type 2 (SST2) agonist, receiving FDA orphan drug designation for acromegaly in **July 2020**[12](index=12&type=chunk)[14](index=14&type=chunk) - Positive topline results from Phase 2 ACROBAT trials (Evolve and Edge) in acromegaly showed once-daily oral paltusotine maintained IGF-1 levels, with a Phase 3 program (PATHFNDR-1 and PATHFNDR-2) planned for **Q2 2021** and topline data expected in **2023**[14](index=14&type=chunk)[38](index=38&type=chunk) - CRN04777, an SST5 agonist for congenital hyperinsulinism, received FDA rare pediatric disease designation in **September 2020**, with Phase 1 preliminary data expected in **mid-2021 (SAD)** and **H2 2021 (MAD)**[16](index=16&type=chunk)[41](index=41&type=chunk)[47](index=47&type=chunk) - CRN04894, an ACTH antagonist for diseases of excess ACTH, is in Phase 1 clinical development, with preliminary data expected in **H1 2021 (SAD)** and **H2 2021 (MAD)**[17](index=17&type=chunk)[56](index=56&type=chunk) - The company's strategy includes focusing on rare endocrine diseases with unmet medical needs, rapidly advancing multiple product candidates using validated biomarkers, expanding the pipeline through GPCR expertise, and retaining commercialization rights[19](index=19&type=chunk)[20](index=20&type=chunk) - The company relies on third parties for manufacturing product candidates for preclinical and clinical development and plans to build its own commercial organization in major markets, potentially using strategic partners for other territories[63](index=63&type=chunk)[65](index=65&type=chunk) - Intellectual property protection is crucial, with issued U.S. patents for **paltusotine** extending to **2037** (composition of matter), **2039** (crystalline forms), and applications for formulations to **2041**, while **CRN04894** patents extend to **2039**, and **CRN04777** applications to **2040**[60](index=60&type=chunk) [Item 1A Risk Factors](index=28&type=section&id=Item%201A%20Risk%20Factors) The company faces substantial risks due to its limited operating history, significant accumulated losses, and the need for substantial additional financing - The company has a limited operating history (commenced operations in **2010**) and has incurred significant operating losses since inception, with an accumulated deficit of **$167.6 million** as of **December 31, 2020**, expecting to incur significant losses for the foreseeable future[101](index=101&type=chunk) - Substantial additional financing will be required to achieve goals, and failure to obtain necessary capital could force delays or termination of product development programs and commercialization efforts, though existing cash, cash equivalents, and investment securities (**$170.9 million** as of **December 31, 2020**) are estimated to fund operations for at least the next **12 months**[101](index=101&type=chunk)[103](index=103&type=chunk)[241](index=241&type=chunk) - Drug development is a lengthy, expensive, and uncertain process with a high failure rate, where preclinical and early clinical trial results are not necessarily predictive of future outcomes, and product candidates may fail in later stages or not receive regulatory approval[107](index=107&type=chunk) - Clinical trials face risks of delays or termination due to factors such as regulatory disagreements, patient enrollment difficulties (especially for rare diseases like acromegaly, affecting approximately **26,000 people** in the U.S.), unforeseen side effects, and the impact of the **COVID-19 pandemic** on drug manufacturing, nonclinical activities, and trial conduct[109](index=109&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - The company relies heavily on third parties for conducting preclinical studies, clinical trials, and manufacturing product candidates, where failures by these third parties to comply with regulations (e.g., GCP, cGMP) or meet deadlines could significantly delay development and increase costs[125](index=125&type=chunk)[127](index=127&type=chunk) - Commercial success depends on market acceptance, adequate coverage, and reimbursement from third-party payors, which are uncertain and subject to challenges on pricing and cost-effectiveness, especially given the small market for rare endocrine diseases, making patient identification and market share critical[132](index=132&type=chunk)[134](index=134&type=chunk)[138](index=138&type=chunk) - The company's intellectual property, including patents for **paltusotine**, **CRN04894**, and **CRN04777**, may not provide sufficient protection against competitors, and patents can be challenged, invalidated, or circumvented, with some IP subject to **Bayh-Dole Act** provisions due to government funding (SBIR Grants)[160](index=160&type=chunk)[162](index=162&type=chunk)[164](index=164&type=chunk) - Compliance with extensive U.S. and foreign healthcare laws and regulations (e.g., **Anti-Kickback Statute**, **False Claims Act**, **HIPAA**, **GDPR**) is costly and complex, with non-compliance potentially resulting in significant penalties, fines, and reputational harm[147](index=147&type=chunk)[150](index=150&type=chunk) [Item 1B Unresolved Staff Comments](index=67&type=section&id=Item%201B%20Unresolved%20Staff%20Comments) There are no unresolved staff comments from the SEC - No unresolved staff comments[203](index=203&type=chunk) [Item 2 Properties](index=67&type=section&id=Item%202%20Properties) The company's corporate headquarters is a **29,499 square foot** facility in San Diego, California, with a lease expiring in **August 2025** - Corporate headquarters: **29,499 square foot** facility in San Diego, California[204](index=204&type=chunk) - Lease for the facility expires in **August 2025**, with an option to extend for an additional **five years**[204](index=204&type=chunk) [Item 3 Legal Proceedings](index=67&type=section&id=Item%203%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may be involved in claims incident to the ordinary course of business - Not currently a party to any material legal proceedings[205](index=205&type=chunk) [Item 4 Mine Safety Disclosures](index=67&type=section&id=Item%204%20Mine%20Safety%20Disclosures) There are no mine safety disclosures to report - No mine safety disclosures[206](index=206&type=chunk) PART II [Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=69&type=section&id=Item%205%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is listed on the **Nasdaq Global Select Market** under the ticker symbol "**CRNX**", with **13 registered holders** as of **February 26, 2021**, and no cash dividends paid or anticipated - Common stock is listed on the **Nasdaq Global Select Market** under the ticker symbol "**CRNX**"[209](index=209&type=chunk) - As of **February 26, 2021**, there were **13 registered holders** of record of the company's common stock[209](index=209&type=chunk) - The company has never declared or paid any cash dividends on its capital stock and does not anticipate paying any in the foreseeable future[210](index=210&type=chunk) - Net proceeds from the **July 2018 IPO** were approximately **$106.5 million**, of which **$57.9 million** has been used for general corporate purposes, including the development of **paltusotine** and other R&D programs[211](index=211&type=chunk) - No issuer repurchases of equity securities were made[211](index=211&type=chunk) [Item 6 Selected Financial Data](index=69&type=section&id=Item%206%20Selected%20Financial%20Data) This item is not applicable to the company - Item 6, Selected Financial Data, is not applicable[212](index=212&type=chunk) [Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations](index=70&type=section&id=Item%207%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of the company's financial condition and operational results, highlighting its focus on rare endocrine diseases and its pipeline, detailing funding sources, accumulated deficit, and expected increases in expenses and losses - The company is a clinical-stage pharmaceutical company focused on rare endocrine diseases and endocrine-related tumors, with product candidates including **paltusotine**, **CRN04777**, and **CRN04894**[215](index=215&type=chunk) - As of **December 31, 2020**, the company had an accumulated deficit of **$167.6 million** and unrestricted cash, cash equivalents, and investment securities of **$170.9 million**[215](index=215&type=chunk) - The company expects its expenses and operating losses to increase substantially as it continues clinical trials, research and development, hires additional personnel, protects intellectual property, and incurs costs associated with being a public company[215](index=215&type=chunk) Summary of Results of Operations (in thousands) | Metric | 2020 | 2019 | 2018 | | :-------------------------- | :---------- | :---------- | :---------- | | Grant revenues | $71 | $1,193 | $2,428 | | Research and development | $56,998 | $41,506 | $24,479 | | General and administrative | $18,026 | $13,519 | $6,659 | | Total operating expenses | $75,024 | $55,025 | $31,138 | | Loss from operations | $(74,953) | $(53,832) | $(28,710) | | Other income (expense), net | $1,141 | $3,410 | $1,595 | | Net loss | $(73,812) | $(50,422) | $(27,115) | - Research and development expenses increased by **$15.5 million** from **2019** to **2020**, primarily due to increased spending on manufacturing and development activities for product candidates and higher personnel-related costs[234](index=234&type=chunk) - General and administrative expenses increased by **$4.5 million** from **2019** to **2020**, mainly due to higher personnel-related costs and spending on recruiting and pre-commercialization activities[234](index=234&type=chunk) Summary of Cash Flows (in thousands) | Activity | 2020 | 2019 | 2018 | | :-------------------------------------- | :---------- | :---------- | :---------- | | Net cash used in operating activities | $(62,027) | $(46,381) | $(19,459) | | Net cash provided by (used in) investing activities | $217 | $41,667 | $(119,458) | | Net cash provided by financing activities | $114,571 | $67 | $170,198 | | Net change in cash, cash equivalents and restricted cash | $52,761 | $(4,647) | $31,281 | - Net cash provided by financing activities in **2020** was primarily from a public offering (**$107.9 million** net) and an **ATM Offering** (**$6.4 million** net)[239](index=239&type=chunk)[244](index=244&type=chunk) - The company believes its existing cash, cash equivalents, and investment securities will be sufficient to fund operations for at least the next **12 months** from the filing date of the **10-K**[241](index=241&type=chunk) [Item 7A Quantitative and Qualitative Disclosures About Market Risk](index=77&type=section&id=Item%207A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risk primarily through interest rate fluctuations on its cash, cash equivalents, and short-term debt securities, though the short-term nature of these instruments limits material impact - Primary market risk exposure is interest rate sensitivity on cash, cash equivalents, and short-term debt securities; however, the short-term nature of these instruments is not expected to have a material impact[247](index=247&type=chunk) - Foreign currency exchange rate risk arises from contracts with international vendors and the Australian subsidiary (**CAPL**), but realized and unrealized gains/losses from foreign currency transactions were not material for **2020** and **2019**[248](index=248&type=chunk) - Inflation generally affects labor and clinical trial costs, but has not had a material effect on results of operations during the periods presented[249](index=249&type=chunk) [Item 8 Financial Statements and Supplementary Data](index=77&type=section&id=Item%208%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements and the report of the independent registered accounting firm are incorporated by reference from **Item 15** of this report - Consolidated financial statements and the report of the independent registered accounting firm are incorporated by reference from **Item 15**[250](index=250&type=chunk) [Item 9 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=77&type=section&id=Item%209%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with accountants on accounting and financial disclosure - No changes in or disagreements with accountants on accounting and financial disclosure[251](index=251&type=chunk) [Item 9A Controls and Procedures](index=77&type=section&id=Item%209A%20Controls%20and%20Procedures) Management evaluated the effectiveness of the company's disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of **December 31, 2020** - Disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level as of **December 31, 2020**[254](index=254&type=chunk) - Management assessed and concluded that internal control over financial reporting was effective as of **December 31, 2020**[255](index=255&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended **December 31, 2020**[256](index=256&type=chunk) [Item 9B Other Information](index=78&type=section&id=Item%209B%20Other%20Information) There is no other information to report under this item - No other information to report[257](index=257&type=chunk) PART III [Item 10 Directors, Executive Officers and Corporate Governance](index=79&type=section&id=Item%2010%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance, including the Code of Business Conduct and Ethics, is incorporated by reference from the definitive proxy statement for the **2021** annual meeting of stockholders - Information is incorporated by reference from the definitive proxy statement for the **2021** annual meeting of stockholders[260](index=260&type=chunk) - A Code of Business Conduct and Ethics, applicable to officers, directors, and employees, is available on the company's website[261](index=261&type=chunk) [Item 11 Executive Compensation](index=79&type=section&id=Item%2011%20Executive%20Compensation) Information concerning executive compensation is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[262](index=262&type=chunk) [Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=79&type=section&id=Item%2012%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management, and related stockholder matters, is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[263](index=263&type=chunk) [Item 13 Certain Relationships, Related Transactions and Director Independence](index=79&type=section&id=Item%2013%20Certain%20Relationships%2C%20Related%20Transactions%20and%20Director%20Independence) Information on certain relationships, related transactions, and director independence is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[264](index=264&type=chunk) [Item 14 Principal Accounting Fees and Services](index=79&type=section&id=Item%2014%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the definitive proxy statement - Information is incorporated by reference from the definitive proxy statement[265](index=265&type=chunk) PART IV [Item 15 Exhibits, Financial Statement Schedules](index=80&type=section&id=Item%2015%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the report, including the consolidated financial statements and the report of the independent registered public accounting firm, as well as an exhibit index - The financial statements of **Crinetics Pharmaceuticals, Inc.** and the report of its independent registered public accounting firm are included in this Annual Report on Form **10-K**[269](index=269&type=chunk) - An Exhibit Index is provided, listing various documents incorporated by reference or filed herewith, including corporate governance documents, equity plans, employment agreements, and certifications[269](index=269&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk) [Item 16 Form 10-K Summary](index=80&type=section&id=Item%2016%20Form%2010-K%20Summary) There is no Form 10-K Summary provided - No Form 10-K Summary is provided[270](index=270&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=82&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) **BDO USA, LLP**, the independent registered public accounting firm, issued an unqualified opinion on the consolidated financial statements of **Crinetics Pharmaceuticals, Inc.** for the years ended **December 31, 2020, 2019, and 2018**, stating they are presented fairly in all material respects in conformity with U.S. GAAP - **BDO USA, LLP** provided an unqualified opinion on the consolidated financial statements for the three years ended **December 31, 2020**[275](index=275&type=chunk) - The company changed its method of accounting for leases in **2019** due to the adoption of **Accounting Standards Codification Topic 842, Leases**[276](index=276&type=chunk) [Consolidated Balance Sheets](index=83&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets present the company's financial position as of **December 31, 2020**, and **2019**, showing total assets of **$183.4 million** in **2020** (up from **$130.4 million** in **2019**), driven by increases in cash and cash equivalents Consolidated Balance Sheet Highlights (in thousands) | Metric | December 31, 2020 | December 31, 2019 | | :-------------------------------------- | :---------------- | :---------------- | | Cash and cash equivalents | $93,087 | $40,326 | | Investment securities | $77,793 | $78,066 | | Total current assets | $177,492 | $123,339 | | Total assets | $183,445 | $130,377 | | Total current liabilities | $10,489 | $8,340 | | Total liabilities | $14,526 | $13,238 | | Common stock and paid-in capital | $336,508 | $210,793 | | Accumulated deficit | $(167,614) | $(93,802) | | Total stockholders' equity | $168,919 | $117,139 | - Total assets increased from **$130.4 million** in **2019** to **$183.4 million** in **2020**, primarily due to an increase in cash and cash equivalents[280](index=280&type=chunk)[282](index=282&type=chunk) - The accumulated deficit grew from **$93.8 million** in **2019** to **$167.6 million** in **2020**, reflecting ongoing net losses[282](index=282&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=84&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The consolidated statements of operations show the company's financial performance for the years ended **December 31, 2020, 2019, and 2018**, with net loss significantly increasing to **$73.8 million** in **2020** from **$50.4 million** in **2019**, driven by higher research and development and general and administrative expenses Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) | Metric | 2020 | 2019 | 2018 | | :---------------------------------------- | :---------- | :---------- | :---------- | | Grant revenues | $71 | $1,193 | $2,428 | | Research and development | $56,998 | $41,506 | $24,479 | | General and administrative | $18,026 | $13,519 | $6,659 | | Total operating expenses | $75,024 | $55,025 | $31,138 | | Loss from operations | $(74,953) | $(53,832) | $(28,710) | | Total other income, net | $1,141 | $3,410 | $1,595 | | Net loss | $(73,812) | $(50,422) | $(27,115) | | Comprehensive loss | $(73,935) | $(50,335) | $(27,054) | | Net loss per share - basic and diluted | $(2.42) | $(2.09) | $(2.23) | | Weighted average shares - basic and diluted | 30,448 | 24,175 | 12,142 | - Net loss increased by **$23.4 million** from **$50.4 million** in **2019** to **$73.8 million** in **2020**[232](index=232&type=chunk) - Grant revenues decreased significantly from **$1.2 million** in **2019** to **$71 thousand** in **2020**, primarily due to the completion of an **SBIR Grant**[234](index=234&type=chunk) - Research and development expenses increased by **$15.5 million (37.3%)** from **$41.5 million** in **2019** to **$57.0 million** in **2020**[234](index=234&type=chunk) - General and administrative expenses increased by **$4.5 million (33.3%)** from **$13.5 million** in **2019** to **$18.0 million** in **2020**[234](index=234&type=chunk) [Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=85&type=section&id=Consolidated%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20(Deficit)) This statement details changes in the company's convertible preferred stock and stockholders' equity (deficit) for the three years ended **December 31, 2020**, with significant increases in common stock and paid-in capital from public offerings and ATM sales, and an increase in accumulated deficit due to net loss Changes in Stockholders' Equity (Deficit) (in thousands) | Metric | Balance at Jan 1, 2018 | Balance at Dec 31, 2018 | Balance at Dec 31, 2019 | Balance at Dec 31, 2020 | | :-------------------------------------- | :--------------------- | :---------------------- | :---------------------- | :---------------------- | | Common Stock and Paid-In Capital | $1,243 | $203,544 | $210,793 | $336,508 | | Accumulated Other Comprehensive Income | $0 | $61 | $148 | $25 | | Accumulated Deficit | $(16,265) | $(43,380) | $(93,802) | $(167,614) | | Total Stockholders' Equity (Deficit) | $(15,022) | $160,225 | $117,139 | $168,919 | - Common stock and paid-in capital increased by **$114.3 million** in **2020**, primarily from the issuance of common stock, net of transaction costs[288](index=288&type=chunk) - Accumulated deficit increased by **$73.8 million** in **2020** due to the net loss for the year[288](index=288&type=chunk) - Stock-based compensation recognized was **$10.4 million** in **2020**, **$6.3 million** in **2019**, and **$2.3 million** in **2018**[288](index=288&type=chunk) [Consolidated Statements of Cash Flows](index=86&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) The consolidated statements of cash flows detail the cash generated and used across operating, investing, and financing activities for the years ended **December 31, 2020, 2019, and 2018**, showing a net increase in cash of **$52.8 million** in **2020** primarily from public offerings, contrasting with a net decrease in **2019** Consolidated Statements of Cash Flows (in thousands) | Activity | 2020 | 2019 | 2018 | | :-------------------------------------- | :---------- | :---------- | :---------- | | Net cash used in operating activities | $(62,027) | $(46,381) | $(19,459) | | Net cash provided by (used in) investing activities | $217 | $41,667 | $(119,458) | | Net cash provided by financing activities | $114,571 | $67 | $170,198 | | Net change in cash, cash equivalents and restricted cash | $52,761 | $(4,647) | $31,281 | | Cash, cash equivalents and restricted cash - end of period | $93,587 | $40,826 | $45,473 | - Net cash used in operating activities increased to **$62.0 million** in **2020** from **$46.4 million** in **2019**, primarily due to increased development and manufacturing activities and higher personnel costs[239](index=239&type=chunk) - Net cash provided by financing activities significantly increased to **$114.6 million** in **2020**, mainly from net proceeds of **$107.9 million** from a public offering and **$6.4 million** from an **ATM Offering**[239](index=239&type=chunk) [Notes to Consolidated Financial Statements](index=87&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on the company's organization, significant accounting policies, and specific financial statement line items, including revenue recognition, R&D costs, stock-based compensation, and income tax provisions - The company is a clinical-stage pharmaceutical company incorporated in **Delaware** in **2008**, with a wholly-owned Australian subsidiary (**CAPL**) established in **2017**[296](index=296&type=chunk) - The company has an accumulated deficit of **$167.6 million** as of **December 31, 2020**, and expects to incur net losses for the foreseeable future, requiring substantial additional capital[299](index=299&type=chunk) - Grant revenues are recognized as reimbursable grant costs are incurred, with **SBIR Grants** being the primary source, though not expected to be material in the future[314](index=314&type=chunk) - Research and development expenses are recognized as incurred, including external costs for **CROs**, manufacturing, and personnel, with the **Australian Tax Incentive** reducing R&D expense by **$0.6 million** in **2020**, **$1.0 million** in **2019**, and **$1.2 million** in **2018**[315](index=315&type=chunk)[317](index=317&type=chunk) - Stock-based compensation expense, estimated using the **Black-Scholes model**, totaled **$10.4 million** in **2020**, **$6.3 million** in **2019**, and **$2.3 million** in **2018**[351](index=351&type=chunk) - As of **December 31, 2020**, the company had federal, state, and foreign net operating loss (**NOL**) carryforwards of approximately **$118.2 million**, **$124.1 million**, and **$1.6 million**, respectively, with a full valuation allowance established against net deferred tax assets due to uncertainty of realization[352](index=352&type=chunk)[355](index=355&type=chunk) - The company adopted **ASU 2019-12 (Income Taxes)** in **Q4 2020** with no material impact and is evaluating **ASU 2016-13 (Credit Losses)** and **ASU 2020-06 (Convertible Instruments)** for future impact[323](index=323&type=chunk)[325](index=325&type=chunk)[327](index=327&type=chunk)

CORPORATE PRESENTATION February 2021 SAFE HARBOR STATEMENT This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements regarding: the potential benefits of paltusotine for acromegaly patients and patients with carcinoid syndrome; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly and the expected timing thereof; our plans to meet with the FDA in ...

CORPORATE PRESENTATION J.P. Morgan 39th Annual Healthcare Conference January 2021 SAFE HARBOR STATEMENT This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements regarding: the potential benefits of paltusotine for acromegaly patients and patients with carcinoid syndrome; the potential to initiate a pivotal Phase 3 trial of paltusotine in acromegaly and the expected timin ...