Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - FGI Industries Ltd. (FGI) is up 278% at $15.02 [3] - Senmiao Technology Limited (AIHS) is up 96% at $4.22 [3] - Conifer Holdings, Inc. (CNFR) is up 86% at $2.11 [3] - WEBTOON Entertainment Inc. (WBTN) is up 39% at $20.81 [3] - Nukkleus Inc. (NUKK) is up 18% at $6.08 [3] - Tantech Holdings Ltd (TANH) is up 12% at $2.13 [3] - Check-Cap Ltd. (CHEK) is up 9% at $2.33 [3] - Ivanhoe Electric Inc. (IE) is up 8% at $9.71 [3] - Wolfspeed, Inc. (WOLF) is up 8% at $3.21 [3] - Bolt Projects Holdings, Inc. (BSLK) is up 5% at $3.95 [3] Premarket Losers - Envirotech Vehicles, Inc. (EVTV) is down 17% at $2.27 [4] - Dave & Buster's Entertainment, Inc. (PLAY) is down 15% at $20.40 [4] - NanoVibronix, Inc. (NAOV) is down 12% at $9.37 [4] - ADTRAN Holdings, Inc. (ADTN) is down 10% at $9.37 [4] - Rain Enhancement Technologies Holdco, Inc. (RAIN) is down 10% at $6.00 [4] - CNS Pharmaceuticals, Inc. (CNSP) is down 7% at $8.50 [4] - AVITA Medical, Inc. (RCEL) is down 7% at $6.22 [4] - Vince Holding Corp. (VNCE) is down 7% at $2.60 [4] - Monte Rosa Therapeutics, Inc. (GLUE) is down 6% at $6.50 [4] - Meiwu Technology Company Limited (WNW) is down 6% at $2.06 [4]

NAPLES, FL, Aug. 22, 2025 (GLOBE NEWSWIRE) -- Rain Enhancement Technologies Holdco, Inc. (Nasdaq: RAIN) (the “Company”) announced today that it received a notice (the “Notice”) on August 19, 2025 from the Listing Qualifications Staff (“Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has not regained compliance with Nasdaq Listing Rule 5450(b)(2)(A), requiring the Company to maintain a market value of listed securities of at least $50 million, and Nasdaq Listing Rule 5450(b)(2 ...

Financial Data and Key Metrics Changes - The company reported revenue of Rs. 44,010 million and EBITDA of Rs. 6,170 million for Q2 2025, marking a notable improvement over the previous quarter and the same period last year [8][33] - The net profit after tax was Rs. 500 million, with earnings per share (EPS) of Rs. 1.47, indicating a return to profitability after several challenging quarters [9][12] - The company closed the quarter with a strong liquidity position of $339 million and no term debt maturities until October 2028 [10][11] Business Line Data and Key Metrics Changes - In the carbon segment, revenue increased by 14.2% to Rs. 31,910 million, driven by a volume increase of approximately 67,000 metric tons (11%) and higher pricing due to a surge in Chinese CPC prices [13][35] - The advanced materials segment saw a revenue decrease of 13% to Rs. 8,180 million, primarily due to lower demand for seasonal products [18][37] - The cement segment experienced a 1.6% increase in revenue, attributed to a 13% rise in selling prices, contributing positively to margin improvements [21][38] Market Data and Key Metrics Changes - The global aluminum industry outlook remains resilient, with LME prices consistently trading above $2,600, supported by low inventories and rising demand expectations [28][29] - The cement industry in India is expected to grow due to government emphasis on infrastructure development and housing projects, despite a steady volume environment [22] Company Strategy and Development Direction - The company is focusing on restoring normalized operating margins and enhancing cost efficiency across all business lines, particularly in the cement segment [12][21] - Strategic initiatives include investments in R&D for advanced materials and biocarbon production, aligning with global shifts towards cleaner technologies [23][25][26] - The company is actively working to secure reliable sources of raw materials and strengthen its supply chain to support long-term growth [41] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the global economic outlook, despite ongoing geopolitical tensions and tariff concerns [30][42] - The company is closely monitoring market dynamics and adjusting strategies to mitigate risks and protect margins [12][18] - Management emphasized the importance of operational efficiency and strategic investments to drive sustained earnings improvement [40][42] Other Important Information - The company made targeted capital investments totaling $28 million, reflecting its commitment to strengthening operational capabilities [9] - The repayment of $44 million in senior secured notes in March 2025 underscores the company's disciplined financial management [10][11] Q&A Session Summary Question: What is the outlook for the aluminum industry? - The aluminum industry outlook remains promising, with stable pricing and expected demand growth, despite recent tariff increases [28][29] Question: How is the company addressing the challenges in the advanced materials segment? - The company is focusing on strategic sales efforts for specialty products with higher margins and monitoring market developments closely [19][20][37] Question: What steps is the company taking to enhance operational efficiency? - The company is implementing initiatives to reduce power and fuel costs and improve logistics to enhance cost efficiency across its operations [21][22]

Financial Performance - Q2 2025 - Revenue from Operations reached ₹4401 billion, a 17% increase compared to Q1 2025 and an 8% increase compared to Q2 2024[7] - Adjusted EBITDA was ₹617 billion, showing a 42% increase compared to Q1 2025 and a 26% increase compared to Q2 2024[7] - Adjusted Net Profit After Tax was ₹050 billion[7] - The company's liquidity stands at US$339 million, including a cash balance of US$191 million and undrawn loan facilities of US$148 million[7] Segment Performance - Q2 2025 vs Q1 2025 - **Carbon:** Revenue increased by 17% to ₹319 billion, with Adjusted EBITDA increasing by 26% to ₹52 billion Sales volumes increased by 11% to 664 MT[12,8] - **Advanced Materials:** Revenue increased by 13% to ₹82 billion, with Adjusted EBITDA increasing significantly by 317% to ₹08 billion Sales volumes increased by 17% to 70 MT[13] - **Cement:** Revenue increased by 13% to ₹33 billion, with Adjusted EBITDA increasing significantly by 315% to ₹02 billion Sales volumes increased by 01% to 699 MT[14,11] Debt and Cash Flow - Total Capex for the six months period was US$28 million[7] - Net operating cash outflows include a net working capital increase of ₹1195 billion, compared to inflows of ₹143 billion in H1 2024[37,41] - Gross Term Debt is US$834 million as of June 2025[37]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40356 Rain Oncology Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdict ...

PART I. FINANCIAL INFORMATION This section presents Rain Oncology Inc.'s unaudited condensed consolidated financial statements and management's analysis of financial performance [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents Rain Oncology Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, detailing financial position and performance for periods ended June 30, 2023 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents Rain Oncology Inc.'s financial position, detailing assets, liabilities, and equity as of June 30, 2023, and December 31, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 | December 31, 2022 | | :-------------------------- | :------------ | :---------------- | | Total Assets | $91,723 | $135,180 | | Total Liabilities | $18,434 | $22,144 | | Total Stockholders' Equity | $73,289 | $113,036 | | Cash and cash equivalents | $40,076 | $61,955 | | Short-term investments | $46,214 | $68,499 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details Rain Oncology Inc.'s financial performance, including operating expenses, interest income, and net loss for the three and six months ended June 30, 2023 and 2022 Condensed Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands) | Metric | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :------------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $14,980 | $14,257 | $31,657 | $27,812 | | General and administrative | $5,414 | $3,461 | $10,480 | $7,356 | | Restructuring charges | $2,837 | — | $2,837 | — | | Total operating expenses | $23,231 | $17,718 | $44,974 | $35,168 | | Net loss | $(22,064) | $(17,611) | $(42,548) | $(35,005) | | Net loss per share, basic and diluted | $(0.61) | $(0.66) | $(1.17) | $(1.32) | | Interest income | $1,167 | $107 | $2,426 | $163 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section presents changes in Rain Oncology Inc.'s total stockholders' equity, reflecting net loss, stock-based compensation, and unrealized gains or losses on investments Condensed Consolidated Statements of Stockholders' Equity Highlights (in thousands) | Metric | As of Dec 31, 2022 | As of Mar 31, 2023 | As of Jun 30, 2023 | | :-------------------------------- | :----------------- | :----------------- | :----------------- | | Total Stockholders' Equity | $113,036 | $94,557 | $73,289 | | Net Loss (Q1 2023) | | $(20,484) | | | Net Loss (Q2 2023) | | | $(22,064) | | Stock-based compensation expense (H1 2023) | | $1,568 | $837 | | Unrealized gain (loss) on investments (H1 2023) | | $119 | $(53) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes Rain Oncology Inc.'s cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2023 and 2022 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :------------------------------------ | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(45,463) | $(34,542) | | Net cash provided by investing activities | $23,106 | $52,760 | | Net cash provided by financing activities | $478 | $411 | | Net (decrease) increase in cash and cash equivalents | $(21,879) | $18,629 | | Cash and cash equivalents at end of period | $40,076 | $43,409 | [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements, clarifying accounting policies and specific financial items [Note 1 – Organization and Nature of Operations](index=7&type=section&id=Note%201%20%E2%80%93%20Organization%20and%20Nature%20of%20Operations) This note describes Rain Oncology Inc.'s business as a precision oncology company, its lead product candidate milademetan, and its financial condition including accumulated deficit and liquidity - Rain Oncology Inc. is a precision oncology company developing therapies targeting oncogenic drivers, with milademetan as its lead product candidate, an oral inhibitor of the MDM2-p53 complex[17](index=17&type=chunk) - The company has incurred significant net losses and negative cash flows since its inception, with an accumulated deficit of **$208.2 million** as of June 30, 2023[20](index=20&type=chunk)[102](index=102&type=chunk) - Management believes current cash, cash equivalents, and short-term investments are sufficient to meet obligations for at least twelve months from the filing date[21](index=21&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=8&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including significant estimates, available-for-sale securities, and research and development costs - The preparation of financial statements involves significant estimates, particularly for clinical trial expense accruals[22](index=22&type=chunk) - Available-for-sale (AFS) securities are classified as current assets and carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive loss[24](index=24&type=chunk)[25](index=25&type=chunk) - Research and development costs are expensed as incurred, and stock-based compensation is recognized over the requisite service period[28](index=28&type=chunk)[30](index=30&type=chunk) - The company adopted ASU 2016-13 (Topic 326) on January 1, 2023, with no significant impact on its financial statements[39](index=39&type=chunk) [Note 3 – Fair Value Measurements](index=13&type=section&id=Note%203%20%E2%80%93%20Fair%20Value%20Measurements) This note details the fair value hierarchy and measurements for financial assets, including cash equivalents and available-for-sale securities, classified into three levels - Financial assets measured at fair value on a recurring basis include cash equivalents and available-for-sale securities, classified using a three-tier hierarchy[44](index=44&type=chunk) - Money market funds and U.S. government securities are classified as Level 1, while commercial paper and U.S. agency bonds are classified as Level 2[45](index=45&type=chunk)[46](index=46&type=chunk) Fair Value Measurements of Cash Equivalents and Short-term Investments (in thousands) | Category | June 30, 2023 (Total Fair Value) | December 31, 2022 (Total Fair Value) | | :------------------------------------ | :------------------------------- | :----------------------------------- | | Money market funds | $14,051 | $8,528 | | Commercial paper | $36,169 | $83,423 | | U.S. government securities | $16,337 | $10,837 | | U.S. agency bonds | $19,066 | $22,143 | | Corporate debt securities | — | $997 | | **Total** | **$85,623** | **$125,928** | [Note 4 – Investments](index=16&type=section&id=Note%204%20%E2%80%93%20Investments) This note provides details on Rain Oncology Inc.'s available-for-sale securities, including fair value, unrealized gains and losses, and maturity profiles Available-for-Sale Securities (in thousands) | Metric | June 30, 2023 (Fair Value) | December 31, 2022 (Fair Value) | | :-------------------------- | :------------------------- | :--------------------------- | | Total AFS Securities | $85,623 | $125,928 | | Gross Unrealized Gains | $5 | $15 | | Gross Unrealized Losses | $(105) | $(181) | | Due within one year | $46,214 | $63,595 | | Due within one to two years | — | $4,904 | - Unrealized losses as of June 30, 2023, were primarily due to changes in interest rates, not increased credit risks, and the company does not intend to sell these investments before maturity[55](index=55&type=chunk) [Note 5 - Condensed Consolidated Balance Sheet Details](index=18&type=section&id=Note%205%20-%20Condensed%20Consolidated%20Balance%20Sheet%20Details) This note provides a detailed breakdown of specific balance sheet accounts, including prepaid and other current assets, property and equipment, and other accrued liabilities Prepaid and Other Current Assets (in thousands) | Category | June 30, 2023 | December 31, 2022 | | :-------------------------- | :------------ | :---------------- | | Prepaid insurance | $1,821 | $913 | | Prepaid research and development | $1,585 | $1,103 | | Total | $4,703 | $3,174 | Property and Equipment, Net (in thousands) | Category | June 30, 2023 | December 31, 2022 | | :-------------------------- | :------------ | :---------------- | | Total Property and equipment, net | $361 | $93 | | Construction in progress | $312 | $8 | | Accumulated depreciation and amortization expense | $(271) | $(236) | Other Accrued Liabilities (in thousands) | Category | June 30, 2023 | December 31, 2022 | | :-------------------------- | :------------ | :---------------- | | Accrued payroll and related | $1,713 | $229 | | Accrued bonus | $1,055 | $3,379 | | Total | $4,986 | $6,424 | [Note 6 – Stockholders' Equity](index=19&type=section&id=Note%206%20%E2%80%93%20Stockholders%27%20Equity) This note details Rain Oncology Inc.'s capital structure, stock option and restricted stock unit activity, and related stock-based compensation expense - The company's capital structure includes **250 million** authorized common shares (**$0.001 par value**), comprising **200 million** voting and **50 million** non-voting shares, and **10 million** undesignated preferred shares[61](index=61&type=chunk) - The 2021 Equity Incentive Plan reserved **3,246,120 shares** initially, with an automatic increase of **1,451,611 shares** on January 1, 2023[64](index=64&type=chunk) Stock Option and RSU Activity (as of June 30, 2023) | Metric | Stock Options | Restricted Stock Units | | :------------------------------------ | :------------ | :--------------------- | | Outstanding as of Dec 31, 2022 | 2,593,761 | 8,945 | | Granted (H1 2023) | 1,312,762 | 95,333 | | Forfeited or cancelled (H1 2023) | (1,009,324) | (41,906) | | Outstanding as of June 30, 2023 | 2,876,442 | 62,372 | | Weighted-average exercise price (options) | $8.27 | | | Weighted-average grant date fair value (RSUs) | | $9.27 | Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :-------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $534 | $1,203 | $1,660 | $2,093 | | General and administrative | $266 | $214 | $708 | $566 | | Restructuring charges | $37 | — | $37 | — | | **Total** | **$837** | **$1,417** | **$2,405** | **$2,659** | - As of June 30, 2023, total unrecognized compensation cost was **$11.2 million**, expected to be recognized over approximately **2.8 years**[69](index=69&type=chunk)[178](index=178&type=chunk) [Note 7 – License Agreements](index=24&type=section&id=Note%207%20%E2%80%93%20License%20Agreements) This note describes Rain Oncology Inc.'s exclusive license for milademetan, including potential milestone payments and royalties, and the termination of other development agreements - The company holds worldwide exclusive rights to milademetan from Daiichi Sankyo, with potential future milestone payments up to **$223.5 million** and high single-digit royalties on net sales[77](index=77&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk) - A **$2.0 million** milestone fee related to the Phase 3 MANTRA trial remained accrued as of June 30, 2023[80](index=80&type=chunk) - The intellectual property license agreement with Drexel University for the RAD52 program was terminated in February 2023 to focus resources on milademetan[85](index=85&type=chunk) - The clinical supply agreement with Roche for atezolizumab was terminated in May 2023[86](index=86&type=chunk)[124](index=124&type=chunk) [Note 8 – Commitments and Contingencies](index=26&type=section&id=Note%208%20%E2%80%93%20Commitments%20and%20Contingencies) This note outlines Rain Oncology Inc.'s noncancelable operating lease for its corporate headquarters, including recent amendments and future minimum lease payments - The company has a noncancelable operating lease for its corporate headquarters in Newark, California, expiring in September 2024[87](index=87&type=chunk)[90](index=90&type=chunk) - Recent amendments expanded the leased premises, with a new expansion commencing July 2023 and a temporary space provided rent-free (excluding operating costs) until then[91](index=91&type=chunk)[92](index=92&type=chunk) Future Minimum Lease Payments (in thousands, as of June 30, 2023) | Year | Amount | | :--- | :----- | | 2023 (remainder) | $86 | | 2024 | $130 | | **Total minimum lease payments** | **$216** | [Note 9 – Employee Benefits](index=29&type=section&id=Note%209%20%E2%80%93%20Employee%20Benefits) This note details Rain Oncology Inc.'s 401(k) matching contributions for the three and six months ended June 30, 2023 and 2022 401(k) Matching Contributions (in thousands) | Period | 2023 | 2022 | | :-------------------------- | :--- | :--- | | Three Months Ended June 30 | $143 | $156 | | Six Months Ended June 30 | $577 | $231 | [Note 10 – Restructuring Charges](index=29&type=section&id=Note%2010%20%E2%80%93%20Restructuring%20Charges) This note explains the **$2.8 million** restructuring charges incurred due to a May 2023 workforce reduction, detailing cash severance and stock-based compensation components - In May 2023, the company announced a workforce reduction as part of a clinical strategy reprioritization, resulting in **$2.8 million** in restructuring charges for the three and six months ended June 30, 2023[96](index=96&type=chunk) - These charges comprised **$2.8 million** in cash severance, employee transition, and related benefits, plus **$37,000** in stock-based compensation expense[96](index=96&type=chunk) - Approximately **$1.7 million** in unpaid cash severance and related benefits remained outstanding as of June 30, 2023, expected to be paid in Q3 2023[96](index=96&type=chunk) [Note 11 – Net Loss Per Share](index=29&type=section&id=Note%2011%20%E2%80%93%20Net%20Loss%20Per%20Share) This note presents Rain Oncology Inc.'s basic and diluted net loss per share and explains the exclusion of potentially dilutive securities due to the company's net loss position Net Loss Per Share (Basic and Diluted) | Period | 2023 | 2022 | | :-------------------------- | :----- | :----- | | Three Months Ended June 30 | $(0.61) | $(0.66) | | Six Months Ended June 30 | $(1.17) | $(1.32) | - Potentially dilutive securities, including **2,876,442** stock options and **62,372** restricted stock units, were excluded from diluted net loss per share calculations as their inclusion would be anti-dilutive due to the company's net loss position[97](index=97&type=chunk) [Note 12 – Subsequent Event](index=30&type=section&id=Note%2012%20%E2%80%93%20Subsequent%20Event) This note discloses a securities class action lawsuit filed on July 17, 2023, against Rain Oncology Inc. and certain officers, alleging misrepresentations regarding clinical trial design - On July 17, 2023, a securities class action lawsuit was filed against the company and certain officers, alleging violations of Sections 10(b) and 20(a) of the Exchange Act[98](index=98&type=chunk) - The lawsuit claims false and misleading information regarding the Phase 3 MANTRA trial design quality and risks related to clinical development strategy and regulatory approval[98](index=98&type=chunk) - The company believes it has meritorious defenses and intends to defend vigorously, but cannot estimate the possible costs at this early stage[99](index=99&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Rain Oncology Inc.'s financial condition and results of operations, highlighting operating losses, clinical trial setbacks, strategic reprioritization, and liquidity [Overview](index=21&type=section&id=Overview) This section introduces Rain Oncology as a precision oncology company focused on milademetan, detailing its significant operating losses and current liquidity position - Rain Oncology is a precision oncology company focused on developing milademetan, an MDM2-p53 complex inhibitor, for genetically selected patients[101](index=101&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of **$208.2 million** and net losses of **$22.1 million** (Q2 2023) and **$42.5 million** (H1 2023)[102](index=102&type=chunk) - As of June 30, 2023, cash, cash equivalents, and short-term investments totaled **$86.3 million**, which management believes is sufficient for at least the next twelve months, but additional capital will be required for future R&D[102](index=102&type=chunk) [Recent Developments](index=22&type=section&id=Recent%20Developments) This section details the Phase 3 MANTRA trial's failure to meet its primary endpoint, leading to strategic reprioritization, suspension of studies, and a significant workforce reduction - In May 2023, the Phase 3 MANTRA trial for milademetan in dedifferentiated (DD) LPS did not meet its primary endpoint of progression-free survival (PFS)[107](index=107&type=chunk) - The median PFS for milademetan was **3.6 months** compared to **2.2 months** for trabectedin (HR 0.89, p=0.53), leading to the decision not to pursue further development in DD LPS[108](index=108&type=chunk) - Strategic priorities were realigned, including suspending enrollment in the MANTRA-2 basket study, terminating plans for the MANTRA-4 trial, and reducing the full-time employee workforce by approximately **65%**[109](index=109&type=chunk) [Our Development Pipeline](index=23&type=section&id=Our%20Development%20Pipeline) This section describes Rain Oncology Inc.'s lead product candidate, milademetan, and its clinical development plan, including recent trial outcomes and program terminations [Our Lead Product Candidate, Milademetan](index=24&type=section&id=Our%20Lead%20Product%20Candidate%2C%20Milademetan) This section introduces milademetan as a small molecule, oral inhibitor of the MDM2-p53 complex, designed to reactivate p53 in MDM2-dependent cancers - Milademetan is a small molecule, oral inhibitor of MDM2-p53 complex, designed to reactivate p53 in MDM2-dependent cancers[113](index=113&type=chunk)[115](index=115&type=chunk) - The therapy aims to improve peak drug exposure and minimize hematologic toxicity through an optimized dosing schedule[113](index=113&type=chunk) [Clinical Development Plan](index=24&type=section&id=Clinical%20Development%20Plan) This section outlines the outcomes of the Phase 3 MANTRA trial, leading to the decision not to pursue further development in DDLPS and the suspension of other studies - The Phase 3 MANTRA trial for DDLPS patients did not meet its primary endpoint of PFS, leading to the decision not to pursue further development in this indication[107](index=107&type=chunk)[108](index=108&type=chunk)[119](index=119&type=chunk) - Enrollment for the Phase 2 MANTRA-2 MDM2-amplified tumor-agnostic basket study has been suspended[109](index=109&type=chunk)[122](index=122&type=chunk) - Plans for the MANTRA-4 Phase 1/2 trial, evaluating milademetan in combination with atezolizumab for CDKN2A-loss, p53 WT advanced solid tumors, have been terminated[109](index=109&type=chunk)[125](index=125&type=chunk) [Collaboration and License Agreements](index=26&type=section&id=Collaboration%20and%20License%20Agreements) This section refers to Note 7 for details on Rain Oncology Inc.'s license agreements for its product candidates and development programs - The company is party to license agreements for its product candidates and development programs, with details provided in Note 7 to the Condensed Consolidated Financial Statements[126](index=126&type=chunk) [Components of Our Results of Operations](index=28&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section defines the key components of Rain Oncology Inc.'s results of operations, including revenue, research and development expenses, general and administrative expenses, and interest income [Revenue](index=28&type=section&id=Revenue) This section states that Rain Oncology Inc. has not generated any revenue from product sales, licenses, or collaborations since inception - The company has not generated any revenue from product sales, licenses, or collaborations since inception and does not expect to in the foreseeable future[128](index=128&type=chunk) [Operating Expenses](index=28&type=section&id=Operating%20Expenses) This section clarifies that Rain Oncology Inc.'s operating expenses consist solely of research and development costs and general and administrative costs - Operating expenses consist solely of research and development costs and general and administrative costs[129](index=129&type=chunk) [Research and Development Expenses](index=28&type=section&id=Research%20and%20Development%20Expenses) This section defines research and development expenses, including costs for drug discovery, clinical development, personnel, and external services, recognized as incurred - Research and development expenses are recognized as incurred and include costs for drug discovery, preclinical and clinical development, personnel, external CROs, manufacturing, regulatory compliance, and license fees[130](index=130&type=chunk)[131](index=131&type=chunk) [General and Administrative Expenses](index=29&type=section&id=General%20and%20Administrative%20Expenses) This section describes general and administrative expenses, including salaries, legal fees, professional services, and facility-related costs, with expected increases due to public company operations - General and administrative expenses include salaries, legal fees, professional services, and facility-related costs, with expectations for increased costs due to public company operations[134](index=134&type=chunk) [Interest Income](index=29&type=section&id=Interest%20Income) This section clarifies that Rain Oncology Inc.'s interest income is derived from its available-for-sale (AFS) securities - Interest income is derived from the company's available-for-sale (AFS) securities[135](index=135&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of Rain Oncology Inc.'s financial performance for the three and six months ended June 30, 2023 and 2022 [Comparison of Three and Six Months Ended June 30, 2023 and 2022](index=30&type=section&id=Comparison%20of%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section presents a table summarizing Rain Oncology Inc.'s key financial metrics for the comparative periods, including operating expenses, net loss, and interest income Financial Performance Comparison (in thousands) | Metric | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | Change (3M) | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | Change (6M) | | :-------------------------- | :--------------------------- | :--------------------------- | :---------- | :--------------------------- | :--------------------------- | :---------- | | Research and development | $14,980 | $14,257 | $723 | $31,657 | $27,812 | $3,845 | | General and administrative | $5,414 | $3,461 | $1,953 | $10,480 | $7,356 | $3,124 | | Restructuring charges | $2,837 | — | $2,837 | $2,837 | — | $2,837 | | Total operating expenses | $23,231 | $17,718 | $5,513 | $44,974 | $35,168 | $9,806 | | Net loss | $(22,064) | $(17,611) | $(4,453) | $(42,548) | $(35,005) | $(7,543) | | Interest income | $1,167 | $107 | $1,060 | $2,426 | $163 | $2,263 | [Research and Development Expenses](index=30&type=section&id=Research%20and%20Development%20Expenses) This section analyzes changes in Rain Oncology Inc.'s R&D expenses, attributing increases to milademetan clinical trial costs and payroll, with expected future decreases due to strategic reprioritization - R&D expenses increased by **$0.7 million** to **$15.0 million** for Q2 2023 and by **$3.8 million** to **$31.7 million** for H1 2023, primarily due to milademetan clinical trial costs and higher payroll[138](index=138&type=chunk)[139](index=139&type=chunk) - Non-cash stock-based compensation included in R&D was **$0.5 million** for Q2 2023 and **$1.7 million** for H1 2023[138](index=138&type=chunk)[139](index=139&type=chunk) - R&D costs are expected to significantly decrease for the remainder of 2023 following the reprioritization of the clinical strategy[139](index=139&type=chunk) [General and Administrative Expenses](index=30&type=section&id=General%20and%20Administrative%20Expenses) This section examines the increase in Rain Oncology Inc.'s G&A expenses, driven by higher professional services, legal, and payroll costs, with expected future decreases due to business strategy optimization - G&A expenses increased by **$1.9 million** to **$5.4 million** for Q2 2023 and by **$3.1 million** to **$10.5 million** for H1 2023, driven by higher professional services, legal, and payroll costs[140](index=140&type=chunk)[141](index=141&type=chunk) - Non-cash stock-based compensation in G&A was approximately **$0.3 million** for Q2 2023 and **$0.7 million** for H1 2023[140](index=140&type=chunk)[141](index=141&type=chunk) - G&A expenses are expected to significantly decrease for the remainder of 2023 due to the optimization of the company's business strategy[141](index=141&type=chunk) [Restructuring Charges](index=31&type=section&id=Restructuring%20Charges) This section details the **$2.8 million** restructuring charges incurred in Q2 and H1 2023, primarily for cash severance and employee benefits related to a May 2023 workforce reduction - The company recorded **$2.8 million** in restructuring charges for Q2 and H1 2023, primarily for cash severance and employee benefits related to a workforce reduction in May 2023[142](index=142&type=chunk) - Approximately **$1.6 million** of these charges remained unpaid as of June 30, 2023, with expected payment in Q3 2023[144](index=144&type=chunk) [Other Income](index=32&type=section&id=Other%20Income) This section clarifies that Rain Oncology Inc.'s other income primarily represents interest income from money market or short-term investments - Other income for the periods presented primarily represents interest income from money market or short-term investments[145](index=145&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses Rain Oncology Inc.'s historical operating losses, current cash position, future funding requirements, and sources of capital - The company has incurred significant operating losses since inception and expects to continue incurring substantial expenses for R&D, requiring additional capital[146](index=146&type=chunk) - As of June 30, 2023, the company had **$86.3 million** in cash, cash equivalents, and short-term investments, which is estimated to be sufficient for at least the next twelve months[150](index=150&type=chunk) - Funding sources have included convertible promissory notes (**$9.9 million** gross), convertible preferred stock (**$81.9 million** gross), and common stock offerings, including **$52.9 million** net proceeds from the November 2022 offering and **$0.3 million** from the ATM facility in H1 2023[102](index=102&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk) [Future Funding Requirements](index=32&type=section&id=Future%20Funding%20Requirements) This section outlines the expected increase in future expenses due to ongoing development activities and pipeline expansion, highlighting the uncertainty of capital outlays and the need for additional funding - Future expenses are expected to increase substantially due to ongoing development activities, new clinical trials, pipeline expansion, marketing approvals, manufacturing, intellectual property, and public company operations[151](index=151&type=chunk)[154](index=154&type=chunk) - The timing and amounts of future capital outlays are uncertain due to the unpredictable nature of drug development[154](index=154&type=chunk) - Inability to raise additional funds through equity, debt, or collaborations could lead to delays, limitations, or termination of product development and commercialization efforts[159](index=159&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) This section provides a summary of Rain Oncology Inc.'s cash flows from operating, investing, and financing activities for the six months ended June 30 Summary of Cash Flows (in thousands, 6 Months Ended June 30) | Activity | 2023 | 2022 | | :-------------------------- | :----------- | :----------- | | Operating activities | $(45,463) | $(34,542) | | Investing activities | $23,106 | $52,760 | | Financing activities | $478 | $411 | | **Net (decrease) increase** | **$(21,879)** | **$18,629** | [Operating Activities](index=33&type=section&id=Operating%20Activities) This section explains the net cash used in Rain Oncology Inc.'s operating activities, primarily driven by net loss and changes in operating assets and liabilities - Net cash used in operating activities increased to **$45.5 million** for H1 2023, primarily due to a net loss of **$42.5 million** and changes in operating assets and liabilities[161](index=161&type=chunk) [Investing Activities](index=33&type=section&id=Investing%20Activities) This section details the net cash provided by Rain Oncology Inc.'s investing activities, mainly from maturities of short-term investments partially offset by new purchases - Net cash provided by investing activities was **$23.1 million** for H1 2023, mainly from **$50.2 million** in maturities of short-term investments, partially offset by **$26.7 million** in purchases[165](index=165&type=chunk) [Financing Activities](index=33&type=section&id=Financing%20Activities) This section describes the net cash provided by Rain Oncology Inc.'s financing activities, primarily from ATM facility proceeds and equity incentive plans - Net cash provided by financing activities was **$0.5 million** for H1 2023, primarily from **$0.3 million** in net proceeds from the ATM Facility and **$0.2 million** from equity incentive plans and ESPP purchases[167](index=167&type=chunk) [Obligations and other Commitments](index=33&type=section&id=Obligations%20and%20other%20Commitments) This section outlines Rain Oncology Inc.'s potential future milestone and royalty payment obligations under license agreements and accrued research and development obligations - The company has potential future milestone and royalty payment obligations under license agreements, which are generally cancelable[169](index=169&type=chunk) - Incurred and accrued research and development obligations were **$7.4 million** as of June 30, 2023[170](index=170&type=chunk) [Critical Accounting Policies and Use of Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section discusses Rain Oncology Inc.'s critical accounting policies and estimates, including accrued research and development and stock-based compensation - There have been no significant changes to critical accounting policies and use of estimates, except as described in Note 2[172](index=172&type=chunk) [Accrued Research and Development](index=34&type=section&id=Accrued%20Research%20and%20Development) This section explains the estimation process for accrued research and development expenses and the balance of **$7.4 million** as of June 30, 2023 - The company estimates R&D expenses based on contract terms, service progress, and communications with vendors, with accrued R&D balances of **$7.4 million** as of June 30, 2023[173](index=173&type=chunk)[174](index=174&type=chunk) [Stock-Based Compensation](index=34&type=section&id=Stock-Based%20Compensation) This section details the recognition of stock-based compensation expense, fair value estimation methods, and total unrecognized compensation costs - Stock-based compensation expense is recognized over the vesting period, with fair value estimated using the Black-Scholes model for stock options and the closing stock price for RSUs[176](index=176&type=chunk)[177](index=177&type=chunk) Stock-Based Compensation Expense (in millions) | Period | 2023 | 2022 | | :-------------------------- | :--- | :--- | | Six Months Ended June 30 | $2.4 | $2.7 | | Unvested equity compensation costs not yet recognized (as of June 30, 2023) | $11.2 | | | Weighted average period over which unvested awards are expected to be recognized (in years) | 2.8 | | [Recent Accounting Pronouncements](index=34&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to Note 2 for a description of recent accounting pronouncements and their immaterial impact on Rain Oncology Inc.'s financial position or operating results - A description of recent accounting pronouncements is provided in Note 2, with no material impact on the company's financial position or operating results[179](index=179&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Rain Oncology Inc. is not required to provide detailed quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide detailed market risk disclosures[180](index=180&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that Rain Oncology Inc.'s disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting during the quarter - The company's disclosure controls and procedures were deemed effective at the reasonable assurance level as of June 30, 2023[182](index=182&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2023[183](index=183&type=chunk) PART II. OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, updated risk factors, and exhibits [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 12 for details on legal proceedings, specifically a recently filed securities class action lawsuit against Rain Oncology Inc. and certain officers - Legal proceedings are discussed in Note 12, which details a securities class action lawsuit filed on July 17, 2023[186](index=186&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section updates Rain Oncology Inc.'s risk factors, emphasizing new risks associated with resource reallocation and a significant workforce reduction following clinical strategy reprioritization - The company began reallocating resources in Q2 2023 to align with business priorities, which may adversely affect future revenue and operating results[188](index=188&type=chunk) - A workforce reduction of approximately **65%** was approved in May 2023 as part of efforts to reprioritize the clinical strategy and optimize resources[189](index=189&type=chunk) - Managing these organizational changes and potential further reductions imposes significant responsibilities on management and could impact future financial performance[190](index=190&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[191](index=191&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[192](index=192&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) There were no mine safety disclosures to report for the period - No mine safety disclosures to report[193](index=193&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) There was no other information to report for the period - No other information to report[194](index=194&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed or furnished as part of the Quarterly Report on Form 10-Q, including corporate governance documents, certifications, and XBRL interactive data files - The exhibits include corporate governance documents (e.g., Certificate of Incorporation, Bylaws), common stock certificates, investor rights agreements, certifications (31.1, 31.2, 32.1), and Inline XBRL documents[196](index=196&type=chunk) [Signatures](index=36&type=section&id=Signatures) This section contains the required signatures for the Quarterly Report on Form 10-Q, certifying its submission - The report is signed by Avanish Vellanki, Chairman and Chief Executive Officer, and Josephine Bruce, Director of Accounting[200](index=200&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40356 Rain Oncology Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpo ...

[PART I](index=5&type=section&id=PART%20I) Rain Oncology Inc. is a late-stage precision oncology company developing tumor-agnostic therapies for oncogenic drivers [Item 1. Business](index=5&type=section&id=Item%201.%20Business) Rain Oncology Inc. is a late-stage precision oncology company focused on developing therapies targeting oncogenic drivers, primarily through a tumor-agnostic strategy. Its lead product candidate, milademetan, an oral MDM2 inhibitor, is in pivotal Phase 3 trials for liposarcoma (LPS) and Phase 2 for MDM2-amplified solid tumors, with a Phase 1/2 combination trial planned. The company relies on in-licensed assets, third-party manufacturing, and aims for global regulatory approvals, while discontinuing other preclinical programs to focus resources [Company Overview](index=5&type=section&id=Company%20Overview) - Rain Oncology Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers, using a tumor-agnostic strategy[18](index=18&type=chunk) - Milademetan (RAIN-32), an oral MDM2 inhibitor, is the lead product candidate, in-licensed from Daiichi Sankyo in September 2020[19](index=19&type=chunk) - A pivotal Phase 3 trial in LPS (MANTRA) commenced in July 2021 with topline data expected in Q2 2023, and a Phase 2 tumor-agnostic basket trial (MANTRA-2) started in November 2021. A Phase 1/2 combination trial (MANTRA-4) is anticipated in mid-2023[19](index=19&type=chunk) [Our Strategy](index=5&type=section&id=Our%20Strategy) - Rapidly advance milademetan through clinical development towards approval in LPS and expansion across MDM2-dependent tumors, engaging regulatory authorities for potential commercial launch[20](index=20&type=chunk) - Increase the probability of clinical benefit by utilizing biomarker-driven patient selection through comprehensive next-generation sequencing (NGS) diagnostic tests[20](index=20&type=chunk) - Maximize commercial success by focusing on tumor-agnostic clinical trials, leveraging existing NGS for rapid patient enrollment and data collection[20](index=20&type=chunk) - Expand the precision oncology pipeline by identifying novel oncogenic drivers, improving existing therapies with narrow therapeutic windows, and targeting emerging classes like synthetic lethality[24](index=24&type=chunk) [Overview of Precision Oncology and Our Approach](index=6&type=section&id=Overview%20of%20Precision%20Oncology%20and%20Our%20Approach) - Precision oncology harnesses tumor biology to design effective cancer treatments, with recent advancements in companion diagnostics and multi-gene NGS assays facilitating biomarker identification[22](index=22&type=chunk) - The company's approach prioritizes a tumor's biological driver over its type for treatment selection, focusing on therapeutics that target genetic alterations in cell-signaling pathways[23](index=23&type=chunk) - Key pillars for successful programs include targeting unambiguous oncogenic addiction, achieving sufficient therapeutic exposure, and strong target engagement during dosing[28](index=28&type=chunk) [Our Development Pipeline](index=7&type=section&id=Our%20Development%20Pipeline) - Rain Oncology retains global development and commercialization rights to all its product candidates, unified by a strategy to target oncogenic drivers[26](index=26&type=chunk) Milademetan (RAIN-32) Clinical Development Pipeline | INDICATION | MANTRA | PRECLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | PARTNER | PLANNED DATA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | DD Liposarcoma | - | Mila monotherapy | | Enrollment Completed | | | 2Q 2023 | | MDM2-amp Basket | 2 | Mila monotherapy | Enrolling | | | | | | CDKN2A loss, p53 WT Adv Solid Tumors | ব | Mila + atezolizumab | Planned: Mid 2023 | | | Roche | | [Our Lead Product Candidate, Milademetan](index=8&type=section&id=Our%20Lead%20Product%20Candidate%2C%20Milademetan) - Milademetan is an oral MDM2 inhibitor developed for MDM2-dependent cancers, utilizing a rationally designed dosing schedule to mitigate hematologic toxicities and widen the therapeutic window[29](index=29&type=chunk) - Milademetan reactivates p53 by inhibiting MDM2, targeting tumors with wild-type p53 that is functionally suppressed by MDM2 overexpression[30](index=30&type=chunk)[31](index=31&type=chunk) - Phase 1 clinical data showed meaningful antitumor activity in MDM2-amplified liposarcoma (LPS) and other solid tumors, with a **58.5% disease control rate** in LPS patients[32](index=32&type=chunk)[35](index=35&type=chunk) - The pivotal Phase 3 MANTRA trial in DDLPS completed enrollment in August 2022, with topline data expected in Q2 2023. The Phase 2 MANTRA-2 trial for MDM2-amplified solid tumors showed preliminary unconfirmed partial responses in pancreatic and lung cancer[42](index=42&type=chunk)[45](index=45&type=chunk) - A Phase 1/2 MANTRA-4 trial evaluating milademetan in combination with atezolizumab for CDKN2A loss and wildtype p53 advanced solid tumors is planned for mid-2023, based on nonclinical data[47](index=47&type=chunk)[50](index=50&type=chunk) - The Phase 2 MANTRA-3 trial in Merkel cell carcinoma has been deprioritized to rationalize capital use[46](index=46&type=chunk) [Preclinical RAD52 Program](index=11&type=section&id=Preclinical%20RAD52%20Program) - The preclinical program targeting RAD52 in the DNA damage repair pathway was discontinued in **February 2023** to focus financial and personnel resources on the milademetan clinical program[51](index=51&type=chunk)[62](index=62&type=chunk) [Collaboration and License Agreements](index=11&type=section&id=Collaboration%20and%20License%20Agreements) - The company holds an exclusive worldwide license for milademetan from Daiichi Sankyo, involving an initial **$5.0 million upfront payment** and potential future milestone payments up to **$223.5 million**, plus high single-digit royalties on net sales[52](index=52&type=chunk)[54](index=54&type=chunk)[58](index=58&type=chunk) - A **$5.5 million milestone fee** was recorded in 2021 for the MANTRA Phase 3 trial initiation, later reduced by **$1.0 million** in 2022, with the remaining **$2.0 million** due by June 30, 2023[54](index=54&type=chunk)[55](index=55&type=chunk) - A clinical supply agreement with Roche provides atezolizumab for combination trials (MANTRA-4), with Rain Oncology as the sponsor and no financial commitments to Roche[63](index=63&type=chunk) - The Drexel License Agreement for RAD52 inhibitors was terminated in **February 2023** to reallocate resources to the milademetan program[61](index=61&type=chunk)[62](index=62&type=chunk) [Manufacturing and Supply](index=13&type=section&id=Manufacturing%20and%20Supply) - The company relies entirely on third-party contract manufacturing organizations (CMOs) for the manufacture of drug candidates for preclinical, clinical, and potential commercial supplies[64](index=64&type=chunk)[65](index=65&type=chunk) - Manufacturing processes, including those transferred from Daiichi Sankyo, are subject to extensive regulations, including Current Good Manufacturing Practice (cGMP) requirements and periodic FDA inspections[67](index=67&type=chunk)[68](index=68&type=chunk) [Intellectual Property](index=14&type=section&id=Intellectual%20Property) - The company protects its proprietary technologies through patents, trademarks, trade secrets, know-how, and in-licensing, focusing on composition of matter, methods of use, and related technologies for product candidates[69](index=69&type=chunk) - As of December 31, 2022, the milademetan patent portfolio, exclusively licensed from Daiichi Sankyo, includes **14 issued U.S. patents**, over **100 issued foreign patents**, and numerous pending applications, with expected expirations between **2032 and 2037**[74](index=74&type=chunk)[75](index=75&type=chunk) - Patent terms are generally **20 years** from filing, with potential for extensions (e.g., Hatch-Waxman Act in the U.S.) to compensate for regulatory review periods, though such extensions are not guaranteed[77](index=77&type=chunk)[78](index=78&type=chunk) - Trade secret protection and confidentiality agreements are also utilized for proprietary information not amenable to patent protection, though these can be challenging to enforce[80](index=80&type=chunk) [Government Regulations](index=16&type=section&id=Government%20Regulations) - Drug development and commercialization are subject to extensive regulation by authorities like the FDA in the U.S. and EMA in Europe, covering research, testing, approval, manufacturing, and marketing[81](index=81&type=chunk)[132](index=132&type=chunk) - The U.S. regulatory process involves preclinical studies (GLP), IND applications, multi-phase human clinical trials (cGCP), and New Drug Application (NDA) submission and review, with potential for expedited programs like Orphan Drug, Fast Track, Breakthrough Therapy, and Accelerated Approval[82](index=82&type=chunk)[84](index=84&type=chunk)[86](index=86&type=chunk)[88](index=88&type=chunk)[96](index=96&type=chunk)[105](index=105&type=chunk)[110](index=110&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk) - In the EU, clinical trials are governed by the Clinical Trials Regulation (CTR), and marketing authorization requires compliance with EMA procedures, with provisions for data and market exclusivity (e.g., **8+2 years** for New Chemical Entities) and Orphan

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) 8000 Jarvis Avenue, Suite 204 Delaware 82-1130967 (I.R.S. Employer Identification No.) (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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transitio ...

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 June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40356 Rain Therapeutics Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-1130967 ( State ...