UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol Name of exchange on which registered Common stock, par value $0.001 ATNM NYSE American FORM 10-K (Mark One) ☒ Annual Report Pursuant To Section 13 or 15(d) Of The Securities Exchange Act Of 1934 For the fiscal year ended December 31, 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: 00 ...

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: 001-36374 ACTINIUM PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) | --- | - ...

Drug Development and Clinical Trials - Actinium Pharmaceuticals aims to launch two radiotherapy drugs, Iomab-B and Actimab-A, over the next several years to improve outcomes for patients with relapsed or refractory acute myeloid leukemia (r/r AML) [77] - Iomab-B met the primary endpoint of durable Complete Remission (dCR) with a statistical significance of p<0.0001 in the Phase 3 SIERRA trial, demonstrating double the 1-year and median overall survival compared to control arm patients [81] - Actimab-A has shown a survival benefit of 53% and 32% at one and two years in patients typically expected to live two to four months, validating its therapeutic approach [86] - Actinium is working towards submitting a Biologics License Application (BLA) for Iomab-B to the FDA by the end of 2023, aiming for commercialization in the U.S. [83] - The SIERRA trial for Iomab-B demonstrated unprecedented access to bone marrow transplants (BMT) and improved outcomes, establishing operations at 24 leading BMT centers in the U.S. and Canada, representing about 30% of transplant volume [100] - Actimab-A showed a median overall survival (OS) of 59% at one year and 32% at two years in patients who had failed venetoclax treatment, indicating its potential as a backbone therapy for r/r AML [102] - Iomab-B is positioned to become the standard of care for r/r AML patients not considered transplantable, with a Biologics License Application (BLA) expected to be filed in the second half of 2023 [100] - Actimab-A + CLAG-M combination therapy showed a 1-year survival rate of 59% in patients who failed prior venetoclax-based therapy, significantly improving traditional outcomes [146] - Actimab-A + venetoclax combination trial has shown promising results with complete response (CR) and partial response in early cohorts, and proof-of-concept data is expected in the second half of 2023 [147] - Iomab-B achieved a 75% initial remission rate at 30 days post-BMT compared to 6.3% in the control arm, with a p-value of <0.0001 [123] - 22% of patients receiving Iomab-B maintained durable complete remission (dCR) for 6 months or more, while none in the control arm achieved dCR [123] - The 1-year overall survival (OS) rate for patients achieving 6-month dCR was 92.3%, and the 2-year OS rate was 59.9% [126] - Median OS for Iomab-B patients was 6.4 months, double the 3.2 months for non-crossover control patients, and 7.1 months for crossover patients [129] - Iomab-B demonstrated a 78% reduction in the probability of an event in event-free survival (EFS), with EFS at 6 months being 28% for Iomab-B versus 0.2% for the control arm [130] - The incidence of sepsis was significantly lower in the Iomab-B arm at 6.1% compared to 28.6% in the control arm [134] Market Opportunity and Strategy - The market opportunity for Iomab-B and Actimab-A in AML is significant, with approximately 21,000 new cases annually in the U.S. and over 50% of patients developing relapsed or refractory disease [92] - Currently, less than 20% of AML patients can access a bone marrow transplant (BMT), but Iomab-B could potentially expand this market from 400 r/r AML patients currently transplanted to approximately 8,000 unfit patients [93] - The company plans to expand the Iomab-B label into five additional hematologic indications, including MDS, ALL, HL, NHL, and MM, to increase market potential [103] - Iomab-B is being expanded to address over 165,000 patients diagnosed with hematologic cancers who could benefit from transplant but currently lack access [152] - Actinium's strategy focuses on building a specialty radiotherapeutics company targeting the top 100 cancer hospitals, emphasizing treatment for relapsed or refractory (r/r) diseases with high unmet medical needs [96] Financial Overview - Actinium has approximately $91.2 million in cash on hand as of June 30, 2023, expected to fund operations through 2025 [90] - Total revenue for the three months ended June 30, 2023 was $0, compared to $45 thousand for the same period in 2022 [172] - Research and development expenses for the three months ended June 30, 2023 were $11.1 million, an increase of $6.4 million from $4.7 million in the same period of 2022 [178] - General and administrative expenses for the three months ended June 30, 2023 were $4.6 million, up $1.4 million from $3.2 million in the same period of 2022 [179] - Net loss for the three months ended June 30, 2023 was $15.2 million, an increase of $7.4 million from $7.8 million in the same period of 2022 [181] - Total operating expenses for the six months ended June 30, 2023 were $27.2 million, compared to $14.0 million for the same period in 2022 [184] - Cash used in operating activities for the six months ended June 30, 2023 was $28.7 million, an increase of $50.8 million from $22.1 million in the prior-year period [194] - Net cash provided by financing activities for the six months ended June 30, 2023 was $10.8 million, compared to $16.6 million for the same period in 2022 [195] - Research and development expenses for the six months ended June 30, 2023 were $18.9 million, an increase of $9.9 million from $9.0 million in the same period of 2022 [188] - Long-term license revenue deferred was $35.0 million at June 30, 2023, resulting from the receipt from Immedica, to be recognized upon regulatory approval of Iomab-B [177] Intellectual Property and Partnerships - Actinium's intellectual property portfolio includes over 200 issued patents and pending applications worldwide, supporting its innovative pipeline [90] - The company has over 200 issued and pending patent applications worldwide, ensuring strong intellectual property protection for its products, including Iomab-B until 2037 [105] - The company has a patent portfolio of over 200 issued patents and pending applications, with effective lives ranging from 2024 to 2043, supporting its proprietary technology [168] - A CRADA with the NCI was established to accelerate Actimab-A development, providing access to over 2,000 clinical trial sites and support for various combination therapies [149] - Actinium has licensed EUMENA commercial rights for Iomab-B to Immedica, receiving an upfront payment of $35 million and potential additional milestones of $417 million [140] Research and Development Focus - The company is exploring the use of Actimab-A in solid tumor indications, with promising preclinical data presented at the AACR Annual Meeting [87] - Actinium aims to leverage its R&D capabilities and partnerships to advance solid tumor programs and expand its commercial footprint into the top 100 hospitals [106] - Actinium's HER3-targeted radiotherapy showed significant tumor growth suppression (p<0.0001) in preclinical models of ovarian and colorectal cancers, highlighting its therapeutic potential [160] - The company is leveraging its technology platform to develop novel radiotherapeutic assets, with promising preclinical results in various tumor models [158] - Iomab-ACT is being developed for use in conditioning prior to CAR-T and gene therapies, with a clinical trial funded by the NIH expected to present proof-of-concept data in the second half of 2023 [104] - Iomab-ACT is being developed for conditioning prior to CAR-T therapies, with initial cohorts showing promise in reducing common toxicities associated with CAR-T treatments [156] Economic and Market Conditions - As of June 30, 2023, the company's cash equivalents primarily consisted of short-term money market funds, with no significant market risk related to interest rates [219] - An immediate 10% change in interest rates would not materially affect the fair market value of the company's financial position or results of operations [219] - Inflation has not had a material effect on the company's business or financial condition during the six months ended June 30, 2023 [220]

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 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: 001-36374 ACTINIUM PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) | --- | --- | ...

Investor Presentation Targeted Radiotherapies for patients with unmet needs April 2023 ATNM: NYSE AMERICAN Disclaimer and Safe Harbor ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol Name of exchange on which registered Common stock, par value $0.001 ATNM NYSE American Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ FORM 10-K (Mark One) ☒ Annual Report Under Section 13 or 15(d) Of The Securities Exchange Act Of 1934 For the fiscal year ended December 31, 2022 or ☐ Transition Report Under Section 13 or 15(d) ...

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the three months ended March 31, 2022 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements for the three months ended March 31, 2022, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with accompanying notes detailing business description, accounting policies, commitments, leases, revenue, equity, and subsequent events [General Information](index=4&type=section&id=General%20Information) The financial statements are unaudited, prepared by management, and include only normal recurring adjustments, with interim results not indicative of full-year performance - The financial statements are unaudited and prepared by management, including only normal recurring adjustments[6](index=6&type=chunk) - Interim results are not necessarily indicative of the operating results for the full year[6](index=6&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's condensed consolidated balance sheets as of March 31, 2022, and December 31, 2021 Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2022 (Unaudited) (in thousands) | December 31, 2021 (in thousands) | Change (in thousands) | | :----- | :---------------------------------------- | :------------------------------- | :-------------------- | | **Assets** | | | | | Cash and cash equivalents | $72,019 | $77,829 | $(5,810) | | Total Current Assets | $74,053 | $79,749 | $(5,696) | | Total Assets | $74,562 | $80,388 | $(5,826) | | **Liabilities** | | | | | Total Current Liabilities | $5,723 | $6,840 | $(1,117) | | Total Liabilities | $5,725 | $6,843 | $(1,118) | | **Stockholders' Equity** | | | | | Total Stockholders' Equity | $68,837 | $73,545 | $(4,708) | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021 Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Change (in thousands) | YoY Change (%) | | :----- | :----------------------------------------------- | :----------------------------------------------- | :-------------------- | :------------- | | Other revenue | $940 | $622 | $318 | 51.1% | | Total operating expenses | $6,104 | $5,994 | $110 | 1.8% | | Research and development, net | $4,369 | $4,276 | $93 | 2.2% | | General and administrative | $1,735 | $1,718 | $17 | 1.0% | | Loss from operations | $(5,164) | $(5,372) | $208 | -3.9% | | Net loss | $(5,129) | $(5,320) | $191 | -3.6% | | Net loss per share (basic & diluted) | $(0.23) | $(0.29) | $0.06 | -20.7% | | Weighted average shares outstanding | 22,143,974 | 18,375,442 | 3,768,532 | 20.5% | [Condensed Consolidated Statement of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Stockholders%27%20Equity) This section outlines changes in stockholders' equity for the three months ended March 31, 2022 and 2021 Condensed Consolidated Statement of Changes in Stockholders' Equity (January 1, 2022 to March 31, 2022) (in thousands) | Metric | January 1, 2022 (in thousands) | March 31, 2022 (in thousands) | Change (in thousands) | | :----- | :----------------------------- | :---------------------------- | :-------------------- | | Common Stock Amount | $22 | $22 | $0 | | Additional Paid-In Capital | $329,271 | $329,692 | $421 | | Accumulated Deficit | $(255,748) | $(260,877) | $(5,129) | | Total Stockholders' Equity | $73,545 | $68,837 | $(4,708) | Condensed Consolidated Statement of Changes in Stockholders' Equity (January 1, 2021 to March 31, 2021) (in thousands) | Metric | January 1, 2021 (in thousands) | March 31, 2021 (in thousands) | Change (in thousands) | | :----- | :----------------------------- | :---------------------------- | :-------------------- | | Common Stock Amount | $18 | $19 | $1 | | Additional Paid-In Capital | $292,275 | $307,011 | $14,736 | | Accumulated Deficit | $(230,974) | $(236,294) | $(5,320) | | Total Stockholders' Equity | $61,319 | $70,736 | $9,417 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's condensed consolidated statements of cash flows for the three months ended March 31, 2022 and 2021 Condensed Consolidated Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Change (in thousands) | | :----- | :----------------------------------------------- | :----------------------------------------------- | :-------------------- | | Net cash used in operating activities | $(5,781) | $(5,642) | $(139) | | Net cash used in investing activities | $(7) | $(4) | $(3) | | Net cash used in / provided by financing activities | $(22) | $14,340 | $(14,362) | | Net change in cash, cash equivalents and restricted cash | $(5,810) | $8,694 | $(14,504) | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes accompanying the condensed consolidated financial statements, explaining accounting policies and significant events [Note 1 - Description of Business and Summary of Significant Accounting Policies](index=10&type=section&id=Note%201%20-%20Description%20of%20Business%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes the company's biopharmaceutical business, its proprietary technology platform, and key accounting policies - Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and potentially commercializing targeted radiotherapies for patients with unmet needs[21](index=21&type=chunk) - The company applies its proprietary technology platform, consisting of over **190 patents**, know-how, and clinical experience in approximately **600 patients**, to develop novel therapies for blood cancer and solid tumor indications[21](index=21&type=chunk) - Development programs utilize multiple isotopes (Actinium-225, Iodine-131, Lutetium-177) and target various cancer targets (CD45, CD33, CD38, CD47, HER2, HER3)[21](index=21&type=chunk) - The unaudited interim consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC regulations, reflecting management's necessary adjustments[22](index=22&type=chunk) - The COVID-19 pandemic's full impact remains uncertain, potentially affecting global economic activity, business operations, and access to capital, though the company has not experienced significant disruption to date[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) Cash, Cash Equivalents and Restricted Cash (in thousands) | (in thousands) | 2022 (Unaudited) | 2021 | | :------------- | :--------------- | :--- | | Cash and cash equivalents | $72,019 | $77,829 | | Restricted cash – current | $392 | $392 | | Cash, cash equivalents and restricted cash | $72,411 | $78,221 | - Revenue recognition follows ASC Topic 606, involving a five-step model to identify contracts, performance obligations, transaction price, allocation, and recognition as obligations are satisfied[31](index=31&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk) - Research and development costs are expensed as incurred, and reimbursements are recorded as a reduction of these costs[37](index=37&type=chunk) - The company adopted ASU 2021-04 and ASU 2021-10 effective January 1, 2022, neither of which had a material effect on its financial statements[41](index=41&type=chunk)[42](index=42&type=chunk) - FASB issued ASU 2021-08 (Business Combinations) in October 2021, effective January 1, 2023, which the company will evaluate for future business combinations[43](index=43&type=chunk) [Note 2 - Commitments and Contingencies](index=13&type=section&id=Note%202%20-%20Commitments%20and%20Contingencies) This note details the company's commitments, including a license agreement with FHCRC for apamistamab and associated milestone and royalty payments - The company has a license and sponsored research agreement with Fred Hutchinson Cancer Research Center (FHCRC) for apamistamab, granting exclusive rights to the antibody[44](index=44&type=chunk) - A **$1 million** milestone payment is due to FHCRC upon U.S. FDA approval of the first drug utilizing the licensed antibody[44](index=44&type=chunk) - Royalty payments of **2% of net sales** will be due to FHCRC upon commercial sale of the drug[44](index=44&type=chunk) [Note 3 - Leases](index=14&type=section&id=Note%203%20-%20Leases) This note describes the company's operating and finance leases, including associated expenses, terms, and discount rates - The Company has an operating lease for corporate office space and two finance leases for office equipment and furniture[48](index=48&type=chunk) Lease Expense (in thousands) | Lease Expense (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--------------------------- | :-------------------------------- | :-------------------------------- | | Operating lease expense | $93 | $93 | | Amortization of right-to-use assets (Finance) | $20 | $20 | | Interest on lease liabilities (Finance) | $1 | $3 | | Total finance lease cost | $21 | $23 | Lease Term & Discount Rate (as of March 31, 2022) | Lease Term & Discount Rate (as of March 31, 2022) | Operating Leases | Finance Leases | | :------------------------------------------------ | :--------------- | :------------- | | Weighted average remaining lease term | 0.4 years | 0.6 years | | Weighted average discount rates | 8% | 8% | [Note 4 – Other revenue](index=15&type=section&id=Note%204%20%E2%80%93%20Other%20revenue) This note provides a breakdown of other revenue, including collaboration agreements and government grants, for the reported periods Other Revenue (in millions) | Other Revenue (in millions) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | YoY Change (%) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------- | | Collaboration agreements | $0.8 | $0.6 | 33.3% | | Government grant | $0.1 | $0.0 | N/A | | Total Other Revenue | $0.9 | $0.6 | 50.0% | [Note 5 - Equity](index=15&type=section&id=Note%205%20-%20Equity) This note details changes in the company's equity, including stock option and warrant activity, and related compensation expenses [Stock Options](index=16&type=section&id=Stock%20Options) This section summarizes stock option activity and unrecognized compensation expense as of March 31, 2022 Stock Option Activity (as of March 31, 2022) | Stock Option Activity (as of March 31, 2022) | Number of Shares (thousands) | Weighted Average Exercise Price | | :------------------------------------------- | :--------------------------- | :------------------------------ | | Outstanding, January 1, 2022 | 1,362 | $12.45 | | Granted | 5 | $5.89 | | Exercised | (34) | $8.47 | | Outstanding, March 31, 2022 | 1,333 | $12.52 | - Unrecognized compensation expense for unvested options was **$4.4 million** at March 31, 2022, expected to be expensed over a weighted average of **3.1 years**[58](index=58&type=chunk) [Warrants](index=16&type=section&id=Warrants) This section details warrant activity, including outstanding and exercisable warrants, as of March 31, 2022 Warrant Activity (as of March 31, 2022) | Warrant Activity (as of March 31, 2022) | Number of Shares (thousands) | Weighted Average Exercise Price | | :-------------------------------------- | :--------------------------- | :------------------------------ | | Outstanding, January 1, 2022 | 2,112 | $20.52 | | Exercised | (55) | $3.13 | | Outstanding, March 31, 2022 | 2,057 | $20.99 | | Exercisable, March 31, 2022 | 2,052 | $20.56 | [Note 6 – Subsequent Events](index=16&type=section&id=Note%206%20%E2%80%93%20Subsequent%20Events) This note describes significant events occurring after the balance sheet date, including a major licensing agreement and recent stock sales - On April 7, 2022, Actinium signed a license and supply agreement with Immedica Pharma AB for exclusive Iomab-B commercialization rights in the European Economic Area, Middle East, and North Africa (EUMENA)[61](index=61&type=chunk) - The agreement includes a **$35 million upfront payment** (received in May 2022), eligibility for up to approximately **$417 million** in regulatory and commercial milestone payments, and **mid-20% royalties** on net sales[61](index=61&type=chunk) - Since March 31, 2022, the company sold **1.6 million shares** of common stock, resulting in net proceeds of **$11.1 million**, increasing the unaudited cash position to approximately **$115 million** as of May 13, 2022[62](index=62&type=chunk)[132](index=132&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three months ended March 31, 2022, compared to the prior year. It covers the business description, recent developments including the impact of COVID-19, detailed financial results, liquidity, critical accounting policies, and subsequent events [FORWARD-LOOKING STATEMENT NOTICE](index=18&type=section&id=FORWARD-LOOKING%20STATEMENT%20NOTICE) This section warns that the Form 10-Q contains forward-looking statements subject to substantial risks and uncertainties that may cause actual results to differ materially - This Form 10-Q contains forward-looking statements, identified by terms like "may," "will," "expect," and "believe," which involve substantial risks and uncertainties[64](index=64&type=chunk) - Actual results may differ materially due to factors such as economic conditions, competition, technological advances, and the successful development of business relationships[64](index=64&type=chunk) [Description of Business](index=18&type=section&id=Description%20of%20Business) This section describes Actinium Pharmaceuticals as a clinical-stage biopharmaceutical company developing targeted radiotherapies using its proprietary AWE technology platform - Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies for blood cancer and solid tumor indications using its proprietary Antibody Warhead Enabling (AWE) technology platform[65](index=65&type=chunk) - The clinical pipeline focuses on targeted conditioning prior to cell and gene therapies (Iomab-B) and targeted radiotherapy combinations (Actimab-A)[65](index=65&type=chunk) - The AWE platform is protected by over **190 issued and pending patents**, trade secrets, and know-how, and supports collaborations with Astellas Pharma, EpicentRx, and AVEO Oncology[65](index=65&type=chunk) [Targeted Conditioning](index=18&type=section&id=Targeted%20Conditioning) This section details the company's targeted conditioning programs, aiming to improve cell-based therapies by selectively depleting targeted cells - The company is developing multi-target, multi-indication clinical-stage pipeline for targeted conditioning to improve access and outcomes for cell-based therapies (BMT, ACT, gene therapy)[66](index=66&type=chunk) - Targeted conditioning agents aim to selectively deplete targeted cells while sparing normal healthy cells, potentially resulting in lower systemic and off-target toxicities compared to conventional conditioning[66](index=66&type=chunk) [CD45 Targeted Conditioning Program](index=19&type=section&id=CD45%20Targeted%20Conditioning%20Program) This section focuses on Iomab-B, the lead CD45-targeted conditioning agent, including its pivotal Phase 3 SIERRA trial and Iomab-ACT program - Iomab-B (I-131 apamistamab), the lead candidate, is a CD45-targeted conditioning agent for myeloablation prior to BMT, currently in the pivotal Phase 3 SIERRA trial for elderly relapsed or refractory AML patients[68](index=68&type=chunk)[69](index=69&type=chunk) - Enrollment for the SIERRA trial (**150 patients**) was completed in **Q3 2021**, with top-line data for the primary endpoint (durable Complete Remission) expected in **Q4 2022**, supporting a BLA filing in **H1 2023**[69](index=69&type=chunk)[72](index=72&type=chunk) - The Iomab-ACT program uses lower doses of I-131 apamistamab for lymphodepletion prior to CAR-T or gene therapy, with proof-of-concept data from a collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) expected in **H2 2022**[73](index=73&type=chunk)[76](index=76&type=chunk) [CD33 Program: Combinations and Therapeutics](index=21&type=section&id=CD33%20Program%3A%20Combinations%20and%20Therapeutics) This section outlines the CD33 program, evaluating Actimab-A for AML and MDS, with a focus on combination trials as a backbone therapy - The CD33 program evaluates Actimab-A (lintuzumab linked to Actinium-225), a potent alpha-emitting radioisotope, for AML and myelodysplastic syndrome (MDS)[78](index=78&type=chunk) - Development is driven by data from nearly **150 treated patients** and prioritizes combination trials, believing Actimab-A can be a backbone therapy in AML[79](index=79&type=chunk)[81](index=81&type=chunk) [Actimab-A Combination Trials](index=22&type=section&id=Actimab-A%20Combination%20Trials) This section highlights the positive results from Actimab-A combination trials for relapsed/refractory AML, including high response rates and remission - The Actimab-A + CLAG-M Phase 1 trial for relapsed/refractory AML showed a **67% overall response rate** and **72% minimal residual disease (MRD) negativity** across all dose cohorts, with the recommended Phase 2 dose (**0.75 µCi/kg**) achieving **100% remission**[82](index=82&type=chunk) - The Actimab-A + Venetoclax Phase 1/2 trial for relapsed/refractory AML was well-tolerated, demonstrating **67% remission** in patients with TP53 mutation, supporting advancement to Phase 2[83](index=83&type=chunk) [CD47 Based ARC Combinations in Solid Tumors and Blood Cancers](index=23&type=section&id=CD47%20Based%20ARC%20Combinations%20in%20Solid%20Tumors%20and%20Blood%20Cancers) This section explores CD47-based Antibody Radiation Conjugate (ARC) combinations, leveraging synergy between targeted radiotherapy and CD47 agents for enhanced anti-tumor activity - The company is exploring CD47-based Antibody Radiation Conjugate (ARC) combinations, hypothesizing synergy between targeted radiotherapy and CD47 targeting agents to enhance anti-tumor activity[86](index=86&type=chunk) - Preclinical studies of Actimab-A with magrolimab in AML showed increased phagocytosis and survival, with Actimab-A upregulating calreticulin (a pro-phagocytic signal)[86](index=86&type=chunk) - Collaborations with EpicentRx (Actimab-A + RRx-001 for AML) and AVEO Oncology (Ac-225 HER3 antibody for solid tumors) are underway, leveraging clinical-stage assets for potentially faster clinical pathways[87](index=87&type=chunk)[93](index=93&type=chunk) [Antibody Warhead Enabling Technology Platform](index=24&type=section&id=Antibody%20Warhead%20Enabling%20Technology%20Platform) This section describes the proprietary AWE technology platform, supported by over 190 patents, enabling direct labeling of biomolecular targeting agents with radionuclide warheads - The proprietary AWE technology platform is supported by over **190 issued and pending patents**, trade secrets, and know-how, covering the generation, development, methods of use, and manufacture of targeted radiotherapies[89](index=89&type=chunk) - The platform enables direct labeling of biomolecular targeting agents with radionuclide warheads, with particular expertise in Actinium-225, including proprietary cyclotron production technology[89](index=89&type=chunk) - AWE is utilized in collaborations with Astellas (theranostics for solid tumors) and AVEO Oncology (HER3-targeting ARC), and for internal R&D to rapidly translate radiotherapies[90](index=90&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) [Recent Developments](index=25&type=section&id=Recent%20Developments) This section covers recent developments, including the ongoing impact of the COVID-19 pandemic on global economic activity and business operations [Impact of COVID–19 Pandemic](index=25&type=section&id=Impact%20of%20COVID%E2%80%9319%20Pandemic) This section discusses the uncertain risks posed by the COVID-19 pandemic to global economic activity, business operations, and clinical trials - The COVID-19 pandemic continues to pose uncertain risks to global economic activity, business operations, and clinical trials, despite vaccination efforts[95](index=95&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - To date, the company has not experienced significant financial impact or operational delays, having implemented hybrid working and maintained active research staff[96](index=96&type=chunk)[100](index=100&type=chunk) - Potential future impacts include delays in clinical trials, patient enrollment, regulatory approvals, and adverse effects on liquidity and stock value[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) [Results of Operations – Three Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021](index=26&type=section&id=Results%20of%20Operations%20%E2%80%93%20Three%20Months%20Ended%20March%2031%2C%202022%20Compared%20to%20Three%20Months%20Ended%20March%2031%2C%202021) This section analyzes the company's financial performance for the three months ended March 31, 2022, compared to the same period in 2021 Results of Operations (in thousands) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Change (in thousands) | YoY Change (%) | | :----- | :----------------------------------------------- | :----------------------------------------------- | :-------------------- | :------------- | | Total revenue | $940 | $622 | $318 | 51.1% | | Total operating expenses | $6,104 | $5,994 | $110 | 1.8% | | Net loss | $(5,129) | $(5,320) | $191 | -3.6% | [Revenue](index=26&type=section&id=Revenue) This section confirms the absence of commercial revenue for the three months ended March 31, 2022 and 2021 - The company recorded no commercial revenue for the three months ended March 31, 2022, or March 31, 2021[104](index=104&type=chunk) [Other revenue](index=26&type=section&id=Other%20revenue) This section details other revenue, including collaboration agreements and government grants, for the reported periods Other Revenue (in millions) | Other Revenue (in millions) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | YoY Change (%) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :------------- | | Collaboration agreements | $0.8 | $0.6 | 33.3% | | Government grant | $0.1 | $0.0 | N/A | | Total Other Revenue | $0.9 | $0.6 | 50.0% | [Research and development expense](index=26&type=section&id=Research%20and%20development%20expense) This section analyzes research and development expenses, noting an increase primarily due to laboratory activities and grant programs Research and Development Expense (in millions) | Metric | Three Months Ended March 31, 2022 (in millions) | Three Months Ended March 31, 2021 (in millions) | Change (in millions) | YoY Change (%) | | :----- | :---------------------------------------------- | :---------------------------------------------- | :------------------- | :------------- | | Research and development, net | $4.4 | $4.3 | $0.1 | 2.3% | - The increase in R&D expenses was primarily due to research activities at the laboratory space and the government grant program, partially offset by lower expenses on the CD45 program following the completion of enrollment in the SIERRA trial[107](index=107&type=chunk) [General and administrative expense](index=27&type=section&id=General%20and%20administrative%20expense) This section presents general and administrative expenses for the three months ended March 31, 2022 and 2021 General and Administrative Expense (in millions) | Metric | Three Months Ended March 31, 2022 (in millions) | Three Months Ended March 31, 2021 (in millions) | Change (in millions) | YoY Change (%) | | :----- | :---------------------------------------------- | :---------------------------------------------- | :------------------- | :------------- | | General and administrative | $1.7 | $1.7 | $0.0 | 0.0% | [Other income](index=27&type=section&id=Other%20income) This section details other income, specifically interest income, and explains its decrease due to lower average interest rates Other Income (in thousands) | Metric | Three Months Ended March 31, 2022 (in thousands) | Three Months Ended March 31, 2021 (in thousands) | Change (in thousands) | YoY Change (%) | | :----- | :----------------------------------------------- | :----------------------------------------------- | :-------------------- | :------------- | | Interest income - net | $35 | $52 | $(17) | -32.7% | - The decrease in net interest income was due to a lower average interest rate[109](index=109&type=chunk) [Net loss](index=27&type=section&id=Net%20loss) This section reports the net loss for the three months ended March 31, 2022 and 2021, noting a decrease primarily due to increased other revenue Net Loss (in millions) | Metric | Three Months Ended March 31, 2022 (in millions) | Three Months Ended March 31, 2021 (in millions) | Change (in millions) | YoY Change (%) | | :----- | :---------------------------------------------- | :---------------------------------------------- | :------------------- | :------------- | | Net loss | $(5.1) | $(5.3) | $0.2 | -3.8% | - The net loss decreased primarily due to the increase in other revenue recognized during the respective periods[110](index=110&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's historical financing through stock sales, cash flow activities, and its expectation to fund operations for over 12 months - The company has historically financed its operations primarily through sales of shares of its stock[111](index=111&type=chunk) Cash Flow (in thousands) | Cash Flow (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change (in thousands) | | :----------------------- | :-------------------------------- | :-------------------------------- | :-------------------- | | Cash used in operating activities | $(5,781) | $(5,642) | $(139) | | Cash used in investing activities | $(7) | $(4) | $(3) | | Cash used in / provided by financing activities | $(22) | $14,340 | $(14,362) | | Net change in cash, cash equivalents and restricted cash | $(5,810) | $8,694 | $(14,504) | - As of the filing date, the company expects its existing resources to be more than sufficient to fund planned operations for more than **12 months**[115](index=115&type=chunk) [Critical Accounting Policies and Use of Estimates](index=28&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section outlines the company's critical accounting policies and the use of estimates in financial reporting, including revenue recognition and R&D costs - The company's consolidated financial statements are prepared in accordance with GAAP, requiring management to make estimates and judgments that affect reported amounts of assets, liabilities, and expenses[117](index=117&type=chunk) - Estimates are based on historical experience, known trends, and other reasonable factors, but actual results may differ materially under different assumptions or conditions[117](index=117&type=chunk) - Significant accounting policies are described in detail in the notes to the consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2021[118](index=118&type=chunk) - Revenue recognition follows ASC 606, involving a five-step model to identify contracts, performance obligations, transaction price, allocation, and recognition as obligations are satisfied[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - Research and development costs are expensed as incurred, including manufacturing, clinical trials, employee costs, and depreciation, with reimbursements recorded as a reduction of these costs[125](index=125&type=chunk) - The company adopted ASU 2021-04 and ASU 2021-10 effective January 1, 2022, neither of which had a material effect on its financial statements[127](index=127&type=chunk)[128](index=128&type=chunk) - FASB issued ASU 2021-08 (Business Combinations) in October 2021, effective January 1, 2023, which the company will evaluate for future business combinations[129](index=129&type=chunk) [Subsequent Events](index=30&type=section&id=Subsequent%20Events) This section details significant events after March 31, 2022, including a major licensing agreement with Immedica Pharma AB and recent common stock sales - On April 7, 2022, Actinium entered into a license and supply agreement with Immedica Pharma AB for exclusive Iomab-B commercialization rights in EUMENA, including an upfront payment of **$35 million** received in May 2022[131](index=131&type=chunk) - The agreement also includes eligibility for aggregate regulatory and commercial milestone payments of up to approximately **$417 million** and **mid-20% royalties** on net sales[131](index=131&type=chunk) - Since March 31, 2022, the company sold **1.6 million shares** of common stock under its Capital on Demand™ Sales Agreement, resulting in net proceeds of **$11.1 million**, increasing the unaudited cash position to approximately **$115 million** as of May 13, 2022[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is not currently exposed to significant market risk related to changes in interest rates or foreign currency exchange rates. Its cash equivalents are primarily short-term money market funds, and inflation did not have a material effect on its business or financial results for the reported periods - The company is not currently exposed to significant market risk related to changes in interest rates, as cash equivalents consist primarily of short-term money market funds[133](index=133&type=chunk) - The company is not currently exposed to significant market risk related to changes in foreign currency exchange rates, though operations may be subject to fluctuations in the future[133](index=133&type=chunk) - Inflation did not have a material effect on the company's business, financial condition, or results of operations during the three months ended March 31, 2022, and 2021[134](index=134&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2022, management concluded that the company's disclosure controls and procedures were effective, providing reasonable assurance that required information is timely recorded, processed, summarized, and reported. There were no material changes in internal control over financial reporting during the period - As of March 31, 2022, management concluded that the company's disclosure controls and procedures were effective[135](index=135&type=chunk) - Disclosure controls and procedures provide reasonable assurance that required information is recorded, processed, summarized, and reported within specified time periods and communicated to management[135](index=135&type=chunk) - There were no changes in the system of internal controls over financial reporting during the period that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[136](index=136&type=chunk) [PART II – OTHER INFORMATION](index=31&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section presents other information, including legal proceedings, risk factors, equity sales, and exhibits, for the reported period [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings for the period - No legal proceedings were reported[138](index=138&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could adversely affect the company's business, operating results, and financial condition. Key risks include the company's clinical-stage status, dependence on Iomab-B and the SIERRA trial, need for additional financing, impacts of health epidemics like COVID-19, regulatory challenges, reliance on third parties for clinical trials and manufacturing, intellectual property uncertainties, and risks related to common stock ownership - The company is a clinical-stage entity with no commercial revenue and a history of net losses, anticipating continued losses[139](index=139&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk) - High dependence on the success of Iomab-B and the SIERRA trial, with potential for failure to complete clinical development or obtain regulatory approval[139](index=139&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - Significant risks include the need for additional financing, adverse effects from health epidemics (e.g., COVID-19), and challenges in establishing sales and marketing capabilities[139](index=139&type=chunk)[146](index=146&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - Regulatory challenges involve potential disagreements with authorities, delays in clinical trials, and the need for federal approvals for product modifications[163](index=163&type=chunk)[164](index=164&type=chunk)[178](index=178&type=chunk)[183](index=183&type=chunk) - Reliance on third parties for clinical trials and manufacturing poses risks of non-compliance, delays, and supply disruptions[141](index=141&type=chunk)[234](index=234&type=chunk)[243](index=243&type=chunk) - Intellectual property risks include uncertainty of patent protection, potential infringement claims, and reliance on trade secrets[141](index=141&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[268](index=268&type=chunk)[272](index=272&type=chunk) - Operational risks include managing hazardous materials, challenges with international operations, dependence on key personnel, and strains from growth[142](index=142&type=chunk)[275](index=275&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk)[283](index=283&type=chunk) - Risks related to common stock ownership include dilution from future financings, price volatility, and anti-takeover provisions[142](index=142&type=chunk)[287](index=287&type=chunk)[289](index=289&type=chunk)[292](index=292&type=chunk) [Summary of Risk Factors](index=31&type=section&id=Summary%20of%20Risk%20Factors) This section summarizes key risks, including the company's clinical-stage status, dependence on Iomab-B, need for financing, and impacts of health epidemics - The company is a clinical-stage entity with no commercial sales revenue to date and has incurred net losses since its inception, anticipating continued losses[139](index=139&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk) - The business is highly dependent on the success of Iomab-B and the SIERRA trial, with risks of not completing necessary clinical development or failing to receive regulatory approval[139](index=139&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - Risks include the potential need for additional financing, adverse effects from health epidemics like COVID-19, and challenges in demonstrating product safety and efficacy[139](index=139&type=chunk)[146](index=146&type=chunk)[155](index=155&type=chunk)[167](index=167&type=chunk) [Risks Related to Our Business](index=32&type=section&id=Risks%20Related%20to%20Our%20Business) This section details business-specific risks, including the company's clinical-stage status, financing needs, dependence on Iomab-B, COVID-19 impacts, and cybersecurity threats - As a clinical-stage biopharmaceutical company, Actinium has no approved products or commercial revenue, has incurred net losses since inception, and anticipates continued losses[143](index=143&type=chunk)[144](index=144&type=chunk) - Failure to obtain additional financing will prevent product development, and the company has limited access to capital markets, potentially leading to dilutive terms[146](index=146&type=chunk)[149](index=149&type=chunk)[151](index=151&type=chunk) - The business is highly dependent on Iomab-B and the SIERRA trial; failure to complete clinical development or achieve regulatory approval would materially impact operations[152](index=152&type=chunk)[153](index=153&type=chunk) - The COVID-19 pandemic poses ongoing risks to global economic activity, business operations, liquidity, and clinical trial timelines, despite no significant financial impact to date[155](index=155&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[160](index=160&type=chunk) - Cybersecurity risks, including theft of funds or intellectual property, disruption of operations, and reputational damage, could materially affect the business, financial condition, and results of operations[161](index=161&type=chunk)[162](index=162&type=chunk) [Risks Related to Regulation](index=35&type=section&id=Risks%20Related%20to%20Regulation) This section covers regulatory risks, including rigorous FDA approval processes, potential clinical trial delays, ongoing compliance, healthcare reforms, and fraud and abuse laws - Product candidates are subject to rigorous, expensive, and time-consuming FDA and foreign regulatory approval processes, with no guarantee of approval, which could significantly harm the business[164](index=164&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) - Clinical trials may face substantial delays, suspensions, or terminations due to regulatory conditions, enrollment difficulties, inconclusive results, or safety issues, impacting regulatory approval and commercialization[178](index=178&type=chunk)[179](index=179&type=chunk)[182](index=182&type=chunk)[187](index=187&type=chunk) - Regulatory approvals, if obtained, will entail ongoing surveillance, potential REMS requirements, and compliance with extensive manufacturing, labeling, and reporting regulations[216](index=216&type=chunk) - Healthcare legislative reforms (e.g., Affordable Care Act, drug pricing initiatives) could adversely affect future revenue, reimbursement, and business operations[220](index=220&type=chunk)[221](index=221&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - Relationships with customers, healthcare professionals, and third-party payors are subject to complex healthcare fraud and abuse laws, with potential for significant civil, criminal, and administrative penalties for non-compliance[228](index=228&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) - Third-party payors may not adequately reimburse for approved products, imposing coverage restrictions or limitations that could limit sales and commercial success[218](index=218&type=chunk)[219](index=219&type=chunk)[231](index=231&type=chunk)[232](index=232&type=chunk) [Risks Related to Third Parties](index=51&type=section&id=Risks%20Related%20to%20Third%20Parties) This section addresses risks associated with third parties, including reliance on CROs for clinical trials, manufacturing dependencies, competition, and potential product side effects - Heavy reliance on third parties (e.g., CROs, medical institutions) to conduct clinical trials reduces control and poses risks of non-compliance with GCPs, leading to delays or termination[234](index=234&type=chunk)[235](index=235&type=chunk)[237](index=237&type=chunk) - Antibodies used in product candidates may be subject to generic competition, although the final drug constructs are not expected to be directly affected by biosimilar pathways[238](index=238&type=chunk) - Dependence on single third-party manufacturers for preclinical and clinical drug supplies (monoclonal antibodies, linkers, radioisotopes) creates risks of performance failure, supply disruptions, and regulatory non-compliance[243](index=243&type=chunk)[244](index=244&type=chunk)[246](index=246&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk) - Scaling up manufacturing for commercialization, if approved, will require additional validation and potential financial investment, with no assurance of timely or economic success[251](index=251&type=chunk) - Conflicts with partners regarding data interpretation, milestones, contractual obligations, or intellectual property could delay or prevent product development and commercialization[254](index=254&type=chunk)[255](index=255&type=chunk) - The company faces significant competition from larger biotechnology and pharmaceutical companies with greater financial resources and experience[256](index=256&type=chunk) - Product candidates may cause undesirable side effects, leading to clinical trial halts, restrictive labels, or withdrawal from the market, harming business and reputation[257](index=257&type=chunk)[258](index=258&type=chunk)[260](index=260&type=chunk) [Risks Related to Our Intellectual Property](index=55&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses intellectual property risks, including challenges in obtaining and enforcing patents, potential infringement, and reliance on trade secrets - The company's success depends on obtaining and maintaining patents, trade secrets, copyright, and trademark protection, and successfully enforcing them against third-party challenges[261](index=261&type=chunk) - The patent position is highly uncertain, with risks that pending applications may not issue, issued patents may be challenged or invalidated, or competitors may independently develop similar technologies[262](index=262&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk) - Expired patents for key antibodies (e.g., lintuzumab) may allow others to use similar sequences, requiring reliance on other patent protection and potentially leading to competition[196](index=196&type=chunk) - Infringement by others could lead to significant enforcement costs and litigation, which the company may not have the financial resources to fund[265](index=265&type=chunk) - Patent protection does not guarantee the right to commercialize, as FDA authorization and non-infringement of other patents are also required[271](index=271&type=chunk) - Reliance on confidentiality agreements to protect trade secrets; breaches by employees or other parties could expose proprietary information to competitors[272](index=272&type=chunk)[273](index=273&type=chunk) [Risks Related to Our Operations](index=57&type=section&id=Risks%20Related%20to%20Our%20Operations) This section outlines operational risks, including handling hazardous materials, international operations, dependence on key personnel, and challenges of managing growth - Research, development, and manufacturing activities involve hazardous materials (chemicals, radioactive, biological), imposing compliance costs and potential liability for contamination or injury[275](index=275&type=chunk)[276](index=276&type=chunk) - Future international operations would subject the company to inherent risks, including staffing, regulatory changes, trade barriers, intellectual property protection, and currency fluctuations[277](index=277&type=chunk) - The company is highly dependent on key personnel and its ability to attract and retain qualified managerial, technical, clinical, and regulatory staff in a highly competitive biotechnology labor market[278](index=278&type=chunk)[279](index=279&type=chunk)[281](index=281&type=chunk) - Managing rapid growth for clinical trials and commercial operations will strain financial, managerial, and operational resources, requiring increased staffing and capital[283](index=283&type=chunk) - Business expansion through acquisitions of product candidates or technologies involves risks such as substantial cash expenditures, dilutive equity issuance, integration difficulties, and diversion of management attention[284](index=284&type=chunk)[285](index=285&type=chunk) [Risks Related to Ownership of Our Common Stock](index=59&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) This section details risks for common stock owners, including dilution from future financings, price volatility, lack of dividends, and anti-takeover provisions - Future equity or debt financings to fund operations and growth could result in dilution to existing stockholders[287](index=287&type=chunk)[288](index=288&type=chunk) - The common stock is subject to high price volatility due to factors like operating results, clinical trial announcements, regulatory actions, and market conditions, potentially leading to securities class action litigation[289](index=289&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk) - The company does not intend to pay dividends; investment success depends on future appreciation in stock value[292](index=292&type=chunk) - Provisions in the Certificate of Incorporation, Bylaws, and Delaware law (Section 203) may delay or discourage third-party acquisitions or changes in control[293](index=293&type=chunk) - Compliance with federal securities laws (e.g., Exchange Act, Sarbanes-Oxley Act) and maintaining adequate financial infrastructure and internal controls are expensive and critical for reliable financial reporting[294](index=294&type=chunk)[295](index=295&type=chunk)[297](index=297&type=chunk) - The trading market for common stock depends on research from securities analysts; negative or absent coverage could lead to price and volume decline[298](index=298&type=chunk) - Amended and restated bylaws designate U.S. federal district courts as the exclusive forum for Securities Act claims, potentially limiting stockholders' choice of forum and increasing litigation costs[299](index=299&type=chunk)[300](index=300&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=61&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities or use of proceeds were reported[301](index=301&type=chunk) [Item 3. Defaults Upon Senior Securities](index=61&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities for the period - No defaults upon senior securities were reported[301](index=301&type=chunk) [Item 4. Mine Safety Disclosures](index=61&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures for the period - No mine safety disclosures were reported[301](index=301&type=chunk) [Item 5. Other Information](index=61&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - No other information was reported[301](index=301&type=chunk) [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the report, including various amendments to the Certificate of Incorporation, Amended and Restated Bylaws, and certifications required by the Sarbanes-Oxley Act - The report includes exhibits such as Certificate of Incorporation amendments, Amended and Restated Bylaws, and Sarbanes-Oxley Act certifications[303](index=303&type=chunk)[304](index=304&type=chunk) [SIGNATURES](index=63&type=section&id=SIGNATURES) The report was duly signed on May 13, 2022, by Sandesh Seth, Chairman and Chief Executive Officer, and Steve O'Loughlin, Chief Financial Officer - The report was signed by the Chairman and CEO, Sandesh Seth, and the CFO, Steve O'Loughlin, on May 13, 2022[305](index=305&type=chunk)