J.P. Morgan 39th Annual Healthcare Conference January 2021 Forward Looking Safe Harbor Statement 2 | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

[Special Cautionary Notice Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20CAUTIONARY%20NOTICE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section highlights that the report contains forward-looking statements, which are subject to various risks and may differ from actual outcomes - This report contains forward-looking statements concerning the company's expectations for expenses, clinical development, regulatory approval, commercialization of product candidates, and the potential impact of the COVID-19 pandemic. These statements are protected under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[7](index=7&type=chunk) - Actual results may differ materially from those anticipated in forward-looking statements due to a variety of factors, including those discussed in the "Risk Factors" and "Management's Discussion and Analysis" sections of the report[8](index=8&type=chunk) [Summary Risk Factors](index=6&type=section&id=SUMMARY%20RISK%20FACTORS) This section summarizes the company's key business risks, including its limited operating history, ongoing losses, regulatory approval challenges, and reliance on third parties - The company is a biopharmaceutical firm with a limited operating history, no revenue from drug sales, and a history of significant operating losses which are expected to continue[13](index=13&type=chunk) - Key business risks include the inability to obtain regulatory approval for drug candidates, the need to raise substantial additional funding, competition, reliance on third parties for manufacturing and clinical trials, and the potential adverse impact of the COVID-19 pandemic[13](index=13&type=chunk)[16](index=16&type=chunk) - Success is dependent on obtaining and protecting intellectual property, as the company has in-licensed its product candidates from third parties[16](index=16&type=chunk) [Part I: Financial Information](index=10&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1: Financial Statements](index=10&type=section&id=Item%201%20Financial%20Statements%3A) The unaudited condensed consolidated financial statements for the period ended September 30, 2020, show a significant increase in cash and total assets, primarily driven by financing activities. The company continues to incur substantial operating losses, with a significant increase in general and administrative expenses related to pre-commercialization activities. Net loss for the nine-month period widened compared to the prior year [Condensed Consolidated Balance Sheets](index=10&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2020, the company's balance sheet reflects a substantial increase in cash and cash equivalents to **$254.2 million** from **$112.6 million** at year-end 2019. This was primarily driven by equity offerings, leading to a significant rise in total stockholders' equity to **$170.7 million** from **$38.6 million**. Total liabilities decreased, mainly due to a reduction in 'Other current liabilities' and long-term debt Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2020 (Unaudited) | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $254,154 | $112,637 | | Total current assets | $260,335 | $149,151 | | Total assets | $273,856 | $163,014 | | **Liabilities & Equity** | | | | Total current liabilities | $77,670 | $84,449 | | Total liabilities | $103,198 | $124,399 | | Accumulated deficit | $(892,379) | $(701,216) | | Total stockholders' equity | $170,658 | $38,615 | [Condensed Consolidated Statements of Operations](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) For the three and nine months ended September 30, 2020, the company reported a net loss of **$87.2 million** and **$191.2 million**, respectively. This represents a significant increase from the net losses of **$61.9 million** and **$133.3 million** in the corresponding periods of 2019. The wider loss was primarily driven by a substantial increase in general and administrative expenses, particularly noncash compensation, while research and development costs remained relatively stable Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Q3 2020 | Q3 2019 | 9 Months 2020 | 9 Months 2019 | | :--- | :--- | :--- | :--- | :--- | | Total research and development | $50,464 | $57,985 | $122,935 | $123,237 | | Total general and administrative | $35,296 | $2,914 | $63,991 | $7,971 | | Operating loss | $(85,722) | $(60,861) | $(186,812) | $(131,094) | | Net loss | $(87,163) | $(61,930) | $(191,163) | $(133,299) | | Net loss per share (basic & diluted) | $(0.73) | $(0.69) | $(1.70) | $(1.55) | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) For the nine months ended September 30, 2020, net cash used in operating activities was **$162.5 million**. Net cash provided by investing activities was **$27.6 million**, mainly from the maturity of short-term securities. A significant **$276.4 million** in net cash was provided by financing activities, primarily from the sale of common stock. This resulted in a net increase in cash, cash equivalents, and restricted cash of **$141.5 million** Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(162,481) | $(102,413) | | Net cash provided by (used in) investing activities | $27,566 | $(722) | | Net cash provided by financing activities | $276,438 | $105,859 | | **Net increase in cash** | **$141,523** | **$2,724** | [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The notes provide detailed information on the company's business, accounting policies, and financial items. Key details include the company's focus on developing medicines for B-cell mediated diseases with five drug candidates in clinical development. The company has an accumulated deficit of **$892.4 million** and believes its current cash will be sufficient for more than twelve months. Significant financial events include raising capital through stock offerings, a term loan facility, and milestone payments related to its licensed drug candidates - The company is a biopharmaceutical firm focused on B-cell mediated diseases, with five drug candidates in clinical development, including lead therapies ublituximab and umbralisib[27](index=27&type=chunk) - As of September 30, 2020, the company had an accumulated deficit of approximately **$892.4 million** and has incurred operating losses since inception[31](index=31&type=chunk) - During the nine months ended September 30, 2020, the company raised approximately **$111.3 million** net from its At-the-Market (ATM) program and **$165.1 million** net from an underwritten public offering in May 2020[79](index=79&type=chunk)[80](index=80&type=chunk) - The company has a term loan facility of up to **$60.0 million** with Hercules Capital, of which **$30.0 million** was drawn as of the reporting date[95](index=95&type=chunk) [Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, clinical trial progress, financial results, and liquidity. Key clinical updates include the FDA's acceptance of the New Drug Application (NDA) for umbralisib in MZL and FL, with PDUFA dates in February and June 2021, and the UNITY-CLL Phase 3 trial meeting its primary endpoint early. The financial analysis highlights a decrease in R&D expenses due to lower manufacturing costs and a significant increase in G&A expenses for commercial launch preparations. The company ended the quarter with **$254.2 million** in cash, which is expected to fund operations for more than twelve months [Overview](index=42&type=section&id=OVERVIEW) The company is a biopharmaceutical firm developing medicines for B-cell mediated diseases like CLL, NHL, and MS. Its pipeline includes five drug candidates, with lead therapies ublituximab and umbralisib in pivotal trials. The company has not yet generated any product sales and actively evaluates in-licensing and partnership opportunities Advanced Drug Candidate Pipeline | Clinical Drug Candidate | Initial Target Disease | Stage of Development | | :--- | :--- | :--- | | Ublituximab (anti-CD20 mAb) | Chronic Lymphocytic Leukemia | Phase 3 (UNITY-CLL) | | | Relapsing Multiple Sclerosis | Phase 3 (ULTIMATE I & II) | | Umbralisib (PI3K-delta inhibitor) | Marginal Zone Lymphoma | Phase 2b (UNITY-NHL) | | | Follicular Lymphoma | Phase 2b (UNITY-NHL) | | Cosibelimab (anti-PDL1 mAb) | B-cell cancers | Phase 1 trial | | TG-1701 (BTK inhibitor) | B-cell cancers | Phase 1 trial | | TG-1801 (anti-CD47/CD19) | B-cell cancers | Phase 1 trial | [Clinical Trial Highlights](index=44&type=section&id=Phase%203%20and%20Registration-Directed%20Clinical%20Trial%20Highlights) The company provided key updates on its late-stage clinical trials. The UNITY-NHL trial for umbralisib met its primary endpoint in both MZL and FL cohorts, leading to an NDA submission that the FDA accepted for review. The UNITY-CLL Phase 3 trial for the U2 combination (ublituximab + umbralisib) also met its primary endpoint early for superior efficacy. The ULTIMATE I & II trials for ublituximab in MS have completed enrollment - The FDA accepted the New Drug Application (NDA) for umbralisib for Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL). The MZL indication received Priority Review with a PDUFA goal date of **February 15, 2021**, while the FL indication has a standard review PDUFA goal date of **June 15, 2021**[136](index=136&type=chunk) - The UNITY-CLL Phase 3 trial met its primary endpoint at an interim analysis, showing a statistically significant improvement in Progression-Free Survival (PFS) for the U2 combination versus the control arm (**p<0.0001**), and was stopped early for efficacy[138](index=138&type=chunk) - The ULTIMATE I & II Phase 3 trials evaluating single-agent ublituximab in Relapsing Multiple Sclerosis (RMS) completed full enrollment in **October 2018** with approximately **1,100 subjects**[140](index=140&type=chunk) [Results of Operations](index=50&type=section&id=RESULTS%20OF%20OPERATIONS) Comparing the third quarter and first nine months of 2020 to 2019, total operating expenses increased. While 'Other R&D' expenses decreased due to lower manufacturing costs for ublituximab and umbralisib, this was more than offset by a significant rise in G&A expenses. The G&A increase was driven by higher noncash stock compensation and costs associated with building out the commercial infrastructure in preparation for a potential product launch Comparison of Operating Expenses (in millions) | Expense Category | Q3 2020 | Q3 2019 | 9 Months 2020 | 9 Months 2019 | | :--- | :--- | :--- | :--- | :--- | | Other R&D Expenses | $45.8 | $56.5 | $114.8 | $118.8 | | Other G&A Expenses | $11.6 | $2.3 | $25.4 | $6.6 | | Noncash Compensation (G&A) | $23.7 | $0.6 | $38.6 | $1.4 | [Liquidity and Capital Resources](index=52&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) The company's liquidity is primarily sourced from equity and debt financings. As of September 30, 2020, the company held **$254.2 million** in cash and cash equivalents. Management believes these funds, along with capital raised in Q4 2020, are sufficient to support operations for more than twelve months. For the first nine months of 2020, cash used in operations was **$162.5 million**, while cash provided by financing activities was a substantial **$276.4 million** - The company had approximately **$254.2 million** in cash and cash equivalents as of September 30, 2020[164](index=164&type=chunk) - Cash used in operating activities for the nine months ended September 30, 2020, was **$162.5 million**, an increase from **$102.4 million** in the prior-year period, due to manufacturing scale-up and clinical development program costs[165](index=165&type=chunk) - Net cash provided by financing activities was **$276.4 million** for the nine months ended September 30, 2020, primarily from an underwritten public offering and the ATM program[168](index=168&type=chunk) [Item 3: Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is related to interest rate fluctuations on its investments, which consist of cash equivalents. The company does not use derivative financial instruments for speculative purposes. Management has determined that the effect of a hypothetical 100 basis point change in interest rates on its financial instruments and net loss would be immaterial - The company's primary market risk is interest rate risk on its cash and cash equivalents[191](index=191&type=chunk)[192](index=192&type=chunk) - An analysis determined that the effect of a **100 basis point** change in interest rates on the value of financial instruments and the resultant effect on net loss would be immaterial[195](index=195&type=chunk) [Item 4: Controls and Procedures](index=60&type=section&id=Item%204%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2020. There were no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of September 30, 2020, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[196](index=196&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter ended September 30, 2020, that have materially affected, or are reasonably likely to materially affect, internal controls[197](index=197&type=chunk) [Part II: Other Information](index=60&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides information on legal proceedings, detailed risk factors, and exhibits filed with the report [Item 1: Legal Proceedings](index=60&type=section&id=Item%201%20Legal%20Proceedings) The company reports that it and its subsidiaries are not party to any material pending legal proceedings - As of the filing date, the company and its subsidiaries are not a party to, and their property is not the subject of, any material pending legal proceedings[198](index=198&type=chunk) [Item 1A: Risk Factors](index=60&type=section&id=Item%201A%20Risk%20Factors) This section details numerous risks that could materially harm the company's business, financial condition, and operating results. Major risk categories include the adverse impact of the COVID-19 pandemic on operations, the company's financial position and need for capital, the inherent uncertainties of drug development and regulatory approval, challenges related to commercialization, dependence on third parties for manufacturing and clinical trials, and risks associated with intellectual property and public company status [Risks Related to the COVID-19 Pandemic](index=60&type=section&id=Risks%20Related%20to%20the%20COVID-19%20Pandemic) The COVID-19 pandemic poses significant risks to the company's business, including potential delays to ongoing and new clinical trials, disruptions to the global supply chain for its drug candidates, and challenges to commercialization efforts. The company relies on third-party manufacturers in India, South Korea, and China, which have been subject to pandemic-related restrictions - The COVID-19 pandemic could delay or compromise ongoing clinical trials, adversely impact the ability to conduct new trials, disrupt the supply chain, and delay health authority review of regulatory submissions[203](index=203&type=chunk) - The company's drug candidates are manufactured by single-source suppliers in countries that have been impacted by COVID-19, including India (umbralisib), South Korea (ublituximab), and China (TG-1701), increasing supply chain risk[217](index=217&type=chunk)[218](index=218&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=67&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a limited operating history, has never generated revenue from drug sales, and has an accumulated deficit of **$892.4 million** as of September 30, 2020. It will need to raise substantial additional funding to continue its drug development and commercialization efforts, which may cause dilution to existing stockholders - The company has incurred significant operating losses since inception, with an accumulated deficit of **$892.4 million** as of September 30, 2020, and expects to incur continued losses[226](index=226&type=chunk) - Substantial additional funding is required to continue operations, particularly for clinical trials, seeking marketing approval, and building commercial infrastructure. Failure to raise capital could force the company to delay, reduce, or eliminate programs[229](index=229&type=chunk) [Risks Related to Drug Development and Regulatory Approval](index=74&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) The company faces significant risks inherent in drug development, where early positive clinical trial results are not predictive of future success. The lengthy and expensive process of clinical development has an uncertain outcome, and drug candidates may cause undesirable side effects that could delay or prevent regulatory approval - The outcome of preclinical studies and early clinical trials may not be predictive of later clinical trial results, and interim or top-line data may change as more patient data becomes available[252](index=252&type=chunk)[257](index=257&type=chunk) - The company has submitted an NDA for accelerated approval of umbralisib, but there is no guarantee it will be approved, as the FDA has discretion over the sufficiency of clinical trial results[273](index=273&type=chunk) - Manufacturing process improvements for ublituximab have resulted in analytical differences between materials used in the Phase 3 UNITY-CLL trial, which could impact the regulatory review and approvability of the drug combination[296](index=296&type=chunk) [Risks Related to Commercialization](index=94&type=section&id=Risks%20Related%20to%20Commercialization) Even if approved, the company's products face substantial competition from established therapies. Success depends on market acceptance, favorable pricing, and reimbursement from payors. The company is also building its commercial infrastructure, which involves significant expense and risk before any potential revenue is generated - The company faces substantial competition for its target indications from major pharmaceutical companies with greater resources. Key competitors include ibrutinib, venetoclax, and ocrelizumab[304](index=304&type=chunk)[306](index=306&type=chunk)[307](index=307&type=chunk) - The company is making significant investments to build a commercial organization before knowing if its lead product, umbralisib, will receive FDA approval, which could result in significant unrecoverable expenses if approval is delayed or denied[341](index=341&type=chunk) - The business will be subject to extensive healthcare laws, including anti-kickback and false claims statutes, which could expose the company to significant penalties if its practices are found to be non-compliant[346](index=346&type=chunk)[347](index=347&type=chunk) [Risks Related to Dependence on Third Parties](index=113&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company relies heavily on third parties for critical functions. This includes contract research organizations (CROs) to conduct clinical trials and contract manufacturing organizations (CMOs) for the supply of its drug candidates. This dependence increases risks related to quality, cost, and timelines - The company relies on third-party CROs to conduct clinical trials. If these parties do not perform as required, trials may be delayed or terminated, and data may be compromised[362](index=362&type=chunk)[364](index=364&type=chunk) - The company does not own manufacturing facilities and depends on third-party CMOs for clinical and potential commercial supply. This reliance creates risks related to supply sufficiency, quality, cost, and cGMP compliance[371](index=371&type=chunk) - As the company's product candidates are in-licensed, any dispute or non-performance by its licensors regarding intellectual property or other obligations could adversely affect development and commercialization[382](index=382&type=chunk) [Risks Related to Intellectual Property](index=123&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) The company's success is highly dependent on its ability to obtain and maintain patent protection for its in-licensed product candidates. The patent landscape is uncertain and litigious, and the company faces risks of its patents being challenged, invalidated, or circumvented by competitors - Commercial success depends on obtaining and maintaining patent and trade secret protection for its product candidates. The company relies on its licensors to protect the necessary intellectual property rights[393](index=393&type=chunk)[394](index=394&type=chunk) - The company may be sued for infringing the intellectual property rights of third parties, which could be costly and time-consuming and could force the company to cease development or commercialization of a product[414](index=414&type=chunk)[417](index=417&type=chunk) - The company may be involved in expensive and unsuccessful lawsuits to protect or enforce its patents, which could provoke counterclaims of invalidity or infringement[421](index=421&type=chunk) [Item 6: Exhibits](index=146&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications and financial data formatted in iXBRL - The exhibits filed with this report include certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[464](index=464&type=chunk)

PART I FINANCIAL INFORMATION [Item 1. Financial Statements](index=7&type=section&id=Item%201%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, detailing significant asset growth, increased net losses, and improved equity from financing activities [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows substantial asset growth to $294.6 million, driven by increased cash, alongside decreased liabilities and significantly improved stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $260,512 | $112,637 | | Total current assets | $280,938 | $149,151 | | Total assets | $294,621 | $163,014 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $67,537 | $84,449 | | Total liabilities | $100,394 | $124,399 | | Total stockholders' equity | $194,227 | $38,615 | | Total liabilities and stockholders' equity | $294,621 | $163,014 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported increased net losses for Q2 and H1 2020, primarily driven by higher research and development and general and administrative expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2020 | Q2 2019 | H1 2020 | H1 2019 | | :--- | :--- | :--- | :--- | :--- | | License Revenue | $38 | $38 | $76 | $76 | | Total R&D Expense | $36,449 | $32,866 | $72,471 | $65,251 | | Total G&A Expense | $14,434 | $2,716 | $28,695 | $5,057 | | Operating Loss | $(50,845) | $(35,544) | $(101,090) | $(70,232) | | Net Loss | $(52,884) | $(36,213) | $(104,000) | $(71,368) | | Net Loss per Share | $(0.47) | $(0.42) | $(0.95) | $(0.85) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity significantly increased to $194.2 million by June 30, 2020, primarily due to substantial capital raises from public and at-the-market offerings - The company significantly strengthened its equity position through capital raises, including a public offering that netted approximately **$165.0 million** and at-the-market offerings that netted **$76.0 million** during the first six months of 2020[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Operating cash usage increased, but substantial financing activities led to a net cash increase of $147.9 million, boosting total cash to $261.8 million Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(105,949) | $(69,211) | | Net cash provided by (used in) investing activities | $12,655 | $(678) | | Net cash provided by financing activities | $241,173 | $85,164 | | **Net increase in cash** | **$147,879** | **$15,275** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's biopharmaceutical focus, significant accumulated deficit, reliance on financing, and belief in sufficient liquidity for over twelve months - The company is a biopharmaceutical firm focused on B-cell mediated diseases, with lead drug candidates ublituximab and umbralisib in pivotal trials for CLL, NHL, and MS[26](index=26&type=chunk) - As of June 30, 2020, the company had an accumulated deficit of approximately **$805.2 million** and expects to incur operating losses for the foreseeable future[30](index=30&type=chunk) - The company believes its cash, cash equivalents, and investment securities of **$275.6 million** as of June 30, 2020, are sufficient to fund operations for more than twelve months[32](index=32&type=chunk) - In February 2019, the company entered into a term loan facility of up to **$60.0 million** with Hercules Capital, drawing an initial **$30.0 million**, secured by substantially all company assets excluding intellectual property[95](index=95&type=chunk)[98](index=98&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical trial progress, increased R&D and G&A expenses, and strengthened liquidity from recent equity financings, providing over a year of capital - The UNITY-CLL Phase 3 trial met its primary endpoint of Progression-Free Survival (PFS) at a prespecified interim analysis and was stopped early for superior efficacy[138](index=138&type=chunk) - In June 2020, the company completed the rolling submission of a New Drug Application (NDA) to the FDA for umbralisib for the treatment of both marginal zone lymphoma (MZL) and follicular lymphoma (FL)[133](index=133&type=chunk) Comparison of Operating Expenses (in millions) | Expense Category | H1 2020 | H1 2019 | Change | | :--- | :--- | :--- | :--- | | Other Research and Development | $68.9 | $62.3 | +$6.6 | | Other General and Administrative | $13.8 | $4.3 | +$9.5 | - As of June 30, 2020, the company had **$275.6 million** in cash, cash equivalents, and investment securities, which is expected to provide sufficient liquidity for more than twelve months[160](index=160&type=chunk) - Net cash provided by financing activities was **$241.2 million** for the first six months of 2020, primarily from an underwritten public offering and at-the-market (ATM) program sales[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuation, impacting the fair value of investments, with an objective to preserve principal and minimize risk - The company's main market risk is interest rate fluctuation, which can impact the fair value of its portfolio of cash equivalents and investments[181](index=181&type=chunk) [Item 4. Controls and Procedures](index=49&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2020, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2020, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[182](index=182&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, such controls[183](index=183&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=51&type=section&id=Item%201%20Legal%20Proceedings) The company and its subsidiaries are not currently involved in any material pending legal proceedings - The company and its subsidiaries are not a party to any material pending legal proceedings[185](index=185&type=chunk) [Item 1A. Risk Factors](index=51&type=section&id=Item%201A%20Risk%20Factors) This section outlines significant risks including the COVID-19 pandemic's impact, financial position, drug development uncertainty, competition, third-party reliance, and intellectual property concerns [Risks Related to the COVID-19 Pandemic](index=51&type=section&id=Risks%20Related%20to%20the%20COVID-19%20Pandemic) The COVID-19 pandemic poses significant risks to clinical trials, global supply chains, and potential commercialization efforts - The COVID-19 pandemic could delay or compromise clinical trials, disrupt supply chains, and adversely impact regulatory review and commercialization efforts[189](index=189&type=chunk) - The company's supply chain is at risk as umbralisib is manufactured in India, ublituximab in South Korea, and TG-1701 in China, all regions impacted by the pandemic[204](index=204&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=57&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company faces risks from its limited operating history, accumulated deficit of $805.2 million, and ongoing need for substantial additional capital - The company has incurred significant operating losses since inception, with an accumulated deficit of **$805.2 million** as of June 30, 2020[214](index=214&type=chunk) - Substantial additional funding is required to continue operations; if unable to raise capital, the company may be forced to delay, reduce, or eliminate drug development or commercialization efforts[217](index=217&type=chunk) [Risks Related to Drug Development and Regulatory Approval](index=65&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) Drug development faces high risks including unreplicable early trial results, significant delays, trial failures, and uncertain regulatory approval even with SPA - The outcome of early clinical trials is not predictive of later-stage trial results, and drug candidates may fail to demonstrate sufficient safety or efficacy in pivotal studies[234](index=234&type=chunk) - Drug candidates may cause undesirable side effects that could delay or prevent regulatory approval, or result in a restrictive label[255](index=255&type=chunk) - Even with a Special Protocol Assessment (SPA) from the FDA for the UNITY-CLL and ULTIMATE trials, there is no guarantee of regulatory approval[246](index=246&type=chunk) [Risks Related to Commercialization](index=84&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization risks include intense competition, market size uncertainty, unfavorable pricing, and the costly, potentially premature, build-out of sales infrastructure - The company faces substantial competition from numerous sources, including large pharmaceutical companies with greater financial and marketing resources[282](index=282&type=chunk) - The company is building its own sales and marketing infrastructure, which is expensive and time-consuming and could be a lost investment if product approval is delayed or denied[310](index=310&type=chunk)[311](index=311&type=chunk) - Future business operations will be subject to complex healthcare laws (e.g., Anti-Kickback Statute, False Claims Act), with non-compliance leading to significant penalties[313](index=313&type=chunk) [Risks Related to Our Dependence on Third Parties](index=101&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Heavy reliance on third-party CROs and CMOs for clinical trials and manufacturing poses risks to performance, compliance, and supply, alongside potential licensor disputes - The company relies on CROs to conduct clinical trials, and if these third parties do not perform as required, trials could be delayed, extended, or terminated[324](index=324&type=chunk) - The company does not own manufacturing facilities and depends on third-party CMOs, increasing the risk of insufficient supply, quality issues, or regulatory compliance failures[329](index=329&type=chunk) - As product candidates are in-licensed, any dispute with or non-performance by licensors regarding intellectual property or other obligations could adversely affect development and commercialization[339](index=339&type=chunk) [Risks Relating to Our Intellectual Property](index=110&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) Success depends on obtaining and defending intellectual property, facing risks of patent invalidation, insufficient breadth, and costly infringement litigation - Commercial success depends on obtaining and maintaining patent and trade secret protection for its product candidates, which is an uncertain process[350](index=350&type=chunk) - The company may be sued for infringing the intellectual property rights of third parties, which could be costly and time-consuming and could halt the commercialization of its products[370](index=370&type=chunk)[373](index=373&type=chunk) - The company relies on trade secrets and confidentiality agreements, which may be breached or may not provide adequate protection, potentially harming its competitive position[383](index=383&type=chunk) [Item 6. Exhibits](index=132&type=section&id=Item%206%20Exhibits) This section lists exhibits filed with the quarterly report, including an incentive plan amendment and Sarbanes-Oxley Act certifications - The exhibits filed with this report include certifications by the CEO and CFO pursuant to the Sarbanes-Oxley Act of 2002[416](index=416&type=chunk)

TG Therapeutics Inc. (NASDAQ:TGTX) Q2 2020 Earnings Conference Call August 10, 2020 8:30 AM ET Company Participants Michael Weiss - Executive Chairman, President, Chief Executive Officer Sean Power - Chief Financial Officer Jenna Bosco - Senior Vice President, Corporate Communications Conference Call Participants Josh Schimmer - Evercore ISI Ed White - HC Wainwright Matt Kaplan - Ladenburg Roger Song - Jefferies Operator Hello and welcome to the TG Therapeutics second quarter 2020 earnings conference call. ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 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 001-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other ju ...

TG Therapeutics, Inc. (NASDAQ:TGTX) Q4 2019 Results Earnings Conference Call March 3, 2020 8:00 AM ET Company Participants Jenna Bosco - VP, IR & Senior VP of Corporate Communications Sean Power - CFO, Corporate Secretary & Treasurer Michael Weiss - Executive Chairman, CEO & President Conference Call Participants Alethia Young - Cantor Fitzgerald Matt Kaplan - Ladenburg Thalmann Ed White - H.C. Wainwright & Company Chris Howerton - Jefferies Mayank Mamtani - B. Riley FBR Operator Greetings, and welcome to t ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File Number 1-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (Stat ...

TG THERAPEUTICS INVESTOR & ANALYST FIRESIDE CHAT EVENT TG Therapeutics ASH 2019 Investor & Analyst Event | --- | --- | --- | |-------|---------------------------------------------------|-------| | | | | | | PARTICIPANTS | | | • | Paul Barr, MD, University of Rochester | | | • | Javier Pinilla, MD, Moffitt Cancer Center | | | • | Pier Luigi Zinzani, MD, University of Bologna | | | • | Brian Koffman, MD, CLL Society | | | | | | | | Moderators | | | • | Alethia Young – Cantor Biotech Analyst | | | • | Michael ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________________________ FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 000-30929 ___________________________________________ TG THERAPEUTICS, INC. (Exact name of regist ...

TG Therapeutics, Inc. (NASDAQ:TGTX) Q3 2019 Earnings Conference Call November 12, 2019 8:30 AM ET Company Participants Jenna Bosco - VP, IR & SVP, Corporate Communications Sean Power - CFO, Corporate Secretary & Treasurer Michael Weiss - Executive Chairman, CEO & President Conference Call Participants Matthew Kaplan - Ladenburg Thalmann & Co. Edward White - H.C. Wainwright & Co. Christopher Howerton - Jefferies Operator Greetings. Welcome to TG Therapeutics' Third Quarter 2019 Financial Results and Business ...