What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-11-08 compared with 2021-08-06 · 67 added, 78 removed, 149 unchanged (49% of the section changed)

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TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.

In addition to an active research pipeline including five investigational medicines across these therapeutic areas, UKONIQ received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and relapsed or refractory FL who have received at least three prior lines of systemic therapies.

In addition to an active research pipeline including five investigational medicines across these therapeutic areas, UKONIQ received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapies.

Currently, we have three programs in Phase 3 development for the treatment of patients with RMS and patients with CLL and several investigational medicines in Phase 1 clinical development.

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Continued approval for these indications is contingent upon verification and description of clinical benefit in a confirmatory trial.

This application was granted Priority Review for the MZL indication.

In addition, UKONIQ was granted Breakthrough Therapy Designation (BTD) for the treatment of MZL and orphan drug designation (ODD) for the treatment of MZL and FL.

UKONIQ was granted orphan drug designations (ODD) for the treatment of MZL and FL.

Following the FDA approval, we launched UKONIQ, making it available to patients through a distribution network that includes a specialty pharmacy and specialty distributors.

In the U.S., the annual incidence of newly diagnosed MZL is approximately 8,200 and FL is approximately 13,200.

Our commercialization efforts have focused on approximately 3,000 physicians at academic centers and large community practices who treat approximately 80% of MZL and FL patients.

We developed a commercialization plan that accounted for the COVID-19 pandemic, with a focus on enabling virtual interactions to provide healthcare provider education.

Our interactions with healthcare providers during the early part of the second quarter were primarily virtual due to the pandemic, although by the end of the quarter our commercial and medical field teams saw an increased number of live engagements.

Payor coverage of UKONIQ and inclusion in the NCCN guidelines have been consistent with the FDA-approved indications.

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Our Products Under Development

We have leveraged our B-cell platform to develop a robust drug pipeline of targeted orally available, potent and selective small molecule kinase inhibitors and intravenously delivered immunotherapies that leverage the patients’ own immune system to fight cancer.

We have leveraged our B-cell platform to develop a robust drug pipeline of small molecule kinase inhibitors and intravenously delivered immunotherapies that leverage the patients’ own immune system.

The following table summarizes our most advanced drug candidates:

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Stage of Development

Ublituximab (anti-CD20 mAb)

Chronic Lymphocytic Leukemia (CLL)

Phase 3 trial (UNITY-CLL)

Phase 3 trial (ULTRA-V)

Relapsing Multiple Sclerosis (RMS)

Phase 3 trials (ULTIMATE I and II)

UKONIQ (PI3K-delta inhibitor)

Ublituximab (anti-CD20 mAb) and UKONIQ (PI3K-delta and CK1-epsilon inhibitor)

Chronic Lymphocytic Leukemia (CLL) and Relapsed or Refractory Marginal Zone Lymphoma (MZL)

Phase 3 trial (UNITY-CLL)

Phase 3 trial (ULTRA-V)

Relapsed Marginal Zone Lymphoma (MZL)

Phase 2b trial (UNITY-NHL)

Relapsed Follicular Lymphoma (FL)

Phase 2b trial (UNITY-NHL)

Ublituximab (anti-CD20 mAb)

Relapsing Forms of Multiple Sclerosis (RMS)

Phase 3 trials (ULTIMATE I and II)

Cosibelimab/TG-1501 (anti-PDL1 mAb)

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Phase 1 trial

Phase 3 and Registration-Directed Clinical Trial Highlights

The following are highlights from our current Phase 3 trials and registration-directed Phase 2b clinical trials:

Phase 2b and Phase 3 Clinical Trial Updates

The following are updates from our current Phase 2b and Phase 3 clinical trials:

UNITY-NHL Phase 2b Trial:

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There are several exploratory cohorts of the UNITY-NHL trial which are enrolled to and evaluated independently from the others, including cohorts for MZL, FL/SLL, DLBCL, and MCL.

● UNITY-NHL MZL/FL Single Agent UKONIQ:

The MZL cohort enrolled adult patients who had at least one prior line of therapy that included an anti-CD20 monoclonal antibody.

The FL cohort enrolled adult patients who had two or more prior lines of therapy that included an anti-CD20 monoclonal antibody and an alkylating agent.

Both cohorts met the primary endpoint of ORR as determined by Independent Review Committee (IRC) assessment.

Results from these cohorts were presented in December 2020 at the American Society of Hematology Annual meeting.

On February 5, 2021, we announced that the FDA granted accelerated approval of UKONIQ, for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapy.

● On November 4, 2021, TG abstracts to be presented during the American Society of Hematology (ASH) 2021 annual meeting were made publicly available, which included updates from U2 cohort in patients with relapsed or refractory MZL and an update from the U2 plus bendamustine cohort in relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL).

UNITY-CLL Phase 3 Trial Evaluating UKONIQ plus Ublituximab (U2):

UNITY-CLL is a global, multi-center, Phase 3, randomized, controlled clinical trial comparing the U2 combination to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory CLL.

Two additional arms evaluating single-agent ublituximab and single-agent UKONIQ were also enrolled for purposes of evaluating the contribution of each in the U2 combination regimen.

Two additional arms evaluating single-agent ublituximab and single-agent UKONIQ were also enrolled for purposes of evaluating the contribution of each drug in the U2 combination regimen.

The primary endpoint for this study was progression-free survival (PFS).

The study completed enrollment in October 2017 with over 600 patients across the four treatment arms, with approximately 420 patients in the U2 and the active control arms combined.

This trial was conducted under a Special

Protocol Assessment (SPA) with the FDA.

The study completed enrollment in October 2017 with over 600 patients across the four treatment arms, with approximately 420 patients enrolled in the U2 and the active control arms combined.

This trial was conducted under a Special Protocol Assessment (SPA) with the FDA.

The UNITY-CLL trial was led by John Gribben, MD, Professor of Medical Oncology, Barts Cancer Institute, United Kingdom.

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Grade 3/4 adverse events (AEs) of clinical interest (U2 vs Obin+Chl) included elevated ALT (8.3% vs 1.0%), elevated AST (5.3% vs 2.0%), non-infectious colitis (1.9% vs 0%), infectious colitis (0.5% vs 0.5%), pneumonitis (0.5% vs 0%), rash (2.4% vs 0.5%), and opportunistic infections (5.8% vs.

Based on this data, submissions of a Biologics License Application (BLA) and a supplemental New Drug Application (sNDA) were made for ublituximab, in combination with UKONIQ, as a treatment for patients with CLL and small lymphocytic lymphoma (SLL).

● Based on data from the UNITY-CLL Phase 3 trial, submissions of a Biologics License Application (BLA) and a supplemental New Drug Application (sNDA) were made for ublituximab, in combination with UKONIQ, as a treatment for patients with CLL and small lymphocytic lymphoma (SLL).

The BLA and sNDA have been accepted by the FDA and a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022 has been set for both applications.

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Each trial is a global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.

The primary endpoint for each study is annualized relapse rate (ARR) following 96 weeks of treatment, which we intend to use to support a BLA submission for approval of ublituximab in the treatment of RMS.

These trials were both conducted under a SPA with the FDA.

These trials were conducted under a SPA with the FDA.

The ULTIMATE I and II trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University.

Full enrollment was completed in October 2018, with approximately 1,100 subjects enrolled in both studies combined.

● In April 2021, data from the ULTIMATE I and II trials were presented at the American Academy of Neurology Annual meeting.

Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in ARR over a 96-week period (p<0.005 in each trial).

Both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial).

Key secondary MRI endpoints were also met.

ULTRA-V Phase 2 and Phase 3 Trials Evaluating U2 Plus Venetoclax in CLL:

The ULTRA-V Phase 2 and Phase 3 trials are designed to investigate the efficacy and safety of U2 in combination with venetoclax in subjects with treatment-naïve CLL and relapsed or refractory CLL.

● The ULTRA-V Phase 2 trial is an open-label, multi-center, clinical trial, and the primary endpoints for this study are ORR and Complete Response (CR) rate.

● In September 2021, a BLA was submitted to the FDA for ublituximab to treat patients with RMS, based on data from the ULTIMATE I and II Phase 3 trials.

ULTRA-V Phase 2/3 Trial Evaluating U2 Plus Venetoclax in CLL:

The ULTRA-V Study is being conducted in two parts.

The initial Phase 2 portion completed enrollment in 1Q21.

The Phase 3 portion commenced at approximately the same time.

The ULTRA-V trial is designed to investigate the efficacy and safety of U2 in combination with venetoclax in subjects with treatment-naïve CLL and relapsed or refractory CLL.

The ULTRA-V Phase 2 trial is being led by Dr.

Furman, Morton Coleman, MD Distinguished Professor of Medicine Weill Cornell Medical College.

● The ULTRA-V Phase 2 portion of the trial is an open-label, multi-center, clinical trial, and the primary endpoints for this study are ORR and Complete Response (CR) rate.

This trial completed enrollment with approximately 165 patients.

● The ULTRA-V Phase 3 trial is an open-label, multi-center, randomized, controlled clinical trial comparing the time-limited triple combination of U2 plus venetoclax to an active control arm of continuous U2.

● The ULTRA-V Phase 3 portion of the trial is an open-label, multi-center, randomized, controlled clinical trial comparing the time-limited triple combination of U2 plus venetoclax to an active control arm of continuous U2.

The Phase 3 trial includes two independent randomized cohorts of CLL subjects:

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The primary endpoint for the trial is PFS.

This trial is being led by Richard R.

Furman, MD, Director of CLL Research Center at Weill Cornell Medicine.

RESULTS OF OPERATIONS

Three months ended June 30, 2021 and 2020

Three months ended September 30, 2021 and 2020

Product Revenues (Net).

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sales from our sole commercial product, UKONIQ, which was approved by the FDA on February 5, 2021.

During the three months ended June 30, 2021, net product revenues were $1.5 million.

During the three months ended September 30, 2021, net product revenues were $2.0 million.

Sales allowances and accruals consisted of government rebates, patient financial assistance, distribution fees, discounts, and chargebacks.

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Cost of Product Revenue.

Cost of product revenue for the three months ended June 30, 2021 was $0.2 million.

Cost of product revenue for the three months ended September 30, 2021 was $0.3 million.

Cost of product revenue primarily relates to freight and royalties owed to our licensing partner for UKONIQ sales.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the three months ended June 30, 2021 were expensed prior to the February 5, 2021 FDA approval, and therefore are not included in costs of product revenue during the current period.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the three months ended September 30, 2021 were expensed prior to the February 5, 2021 FDA approval, and therefore are not included in costs of product revenue during the current period.

We expect the cost of product revenue to increase in relation to product revenues as we deplete these inventories and we expect to use the remaining pre-commercialization inventory for product sales through the second quarter of 2022.

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We recognize upfront license fee revenues ratably over the estimated period in which we will have certain significant ongoing responsibilities under the sublicense agreement, with unamortized amounts recorded as deferred revenue.

License revenue was approximately $38,000 for each of the three months ended June 30, 2021 and 2020 related to the amortization of an upfront payment of $2.0 million received in 2012 associated with our license agreement with Ildong.

License revenue was approximately $38,000 for each of the three months ended September 30, 2021 and 2020 related to the amortization of an upfront payment of $2.0 million received in 2012 associated with our license agreement with Ildong.

The upfront payment from Ildong will be recognized as license revenue on a straight-line basis through December 2025, which represents the estimated period over which the Company will have certain ongoing responsibilities under the sublicense agreement.

Noncash Compensation Expense (Research and Development).

Noncash compensation expense (research and development) related to equity incentive grants totaled $7.0 million for the three months ended June 30, 2021, as compared to $1.6 million during the comparable period in 2020.

The increase in noncash compensation expense was primarily due to vesting of milestone-based grants, an increase in research and development personnel and the vesting of grants with a higher stock price during the three months ended June 30, 2021, as compared to the prior period.

Noncash compensation expense (research and development) related to equity incentive grants totaled $4.5 million for the three months ended September 30, 2021, as compared to $4.6 million during the comparable period in 2020.

The decrease in noncash compensation expense was primarily due to vesting of milestone-based grants in the prior period.

Other Research and Development Expenses.

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We expense our research and development costs as they are incurred.

Other research and development expenses increased by $3.0 million to $37.9 million for the three months ended June 30, 2021, as compared to $34.9 million for the three months ended June 30, 2020.

The increase in R&D expense is primarily attributable to the achievement of license milestones during the three months ended June 30, 2021.

Other research and development expenses increased by $1.6 million to $47.4 million for the three months ended September 30, 2021, as compared to $45.8 million for the three months ended September 30, 2020.

The increase in R&D expense is primarily attributable to increased headcount and ongoing late-stage clinical development programs , offset by a decrease in license milestones .

Noncash Compensation Expense (Selling, General and Administrative).

Noncash compensation expense (selling, general and administrative) related to equity incentive grants increased by $3.5 million to $9.3 million for the three months ended June 30, 2021, as compared to $5.8 million for the three months ended June 30, 2020.

The increase in noncash compensation expense was primarily related to greater compensation expense during the three months ended June 30, 2021 related to restricted stock and stock options granted to executive personnel.

Noncash compensation expense (selling, general and administrative) related to equity incentive grants decreased by $14.2 million to $9.5 million for the three months ended September 30, 2021, as compared to $23.7 million for the three months ended September 30, 2020.

The decrease in noncash compensation expense was primarily related to greater compensation expense during the three months ended September 30, 2020 related to restricted stock and stock options granted to executive personnel.

Other Selling, General and Administrative Expenses .

Our selling, general and administrative expenses consist primarily of salaries and related expenses for executive, finance, commercial, medical, and other administrative personnel, recruitment expenses, expenses for commercialization activities (including the build out of our medical affairs and commercial organizations and infrastructure), professional fees and other corporate expenses, including investor relations, legal activities and facilities-related expenses.

Other selling, general and administrative expenses was $24.7 million for the three months ended June 30, 2021, as compared to $8.6 million for the three months ended June 30, 2020.

Other selling, general and administrative expenses was $25.4 million for the three months ended September 30, 2021, as compared to $11.6 million for the three months ended September 30, 2020.

The increase was due primarily to increased personnel and other selling, general and administrative costs, associated with execution of the launch of UKONIQ and planning for the potential launches of U2 in CLL and ublituximab in RMS.

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Interest Expense .

Interest expense decreased by $0.6 million to $1.6 million for the three months ended June 30, 2021, as compared to $2.2 million for the three months ended June 30, 2020.

The period ended June 30, 2020 had higher interest expense related to administrative fees in connection with contract manufacturing costs.

Interest expense decreased by $0.6 million to $1.0 million for the three months ended September 30, 2021, as compared to $1.6 million for the three months ended September 30, 2020.

The decrease is mainly due to greater interest expense related to administrative fees in connection with contract manufacturing costs during the three months ended September 30, 2020.

Other Income .

Other income was $0.6 million for the three months ended June 30, 2021, as compared to $0.2 million for the three months ended June 30, 2020.

The increase is mainly due to greater interest income and an increase in the change in fair value of notes payable for the three months ended June 30, 2021.

Other income was $0.5 million for the three months ended September 30, 2021, as compared to $0.2 million for the three months ended September 30, 2020.

The increase is mainly due to greater interest income and an increase in the change in fair value of notes payable for the three months ended September 30, 2021.

We expect our other income to remain at a comparable level for the remainder of 2021.

Six months ended June 30, 2021 and 2020

Nine months ended September 30, 2021 and 2020

Product Revenues (Net).

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sales from our sole commercial product, UKONIQ, which was approved by the FDA on February 5, 2021.

During the six months ended June 30, 2021, net product revenues were $2.3 million.

During the nine months ended September 30, 2021, net product revenues were $4.3 million.

Sales allowances and accruals consisted of government rebates, patient financial assistance, distribution fees, discounts, and chargebacks.

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Cost of Product Revenue.

Cost of product revenue for the six months ended June 30, 2021 was $0.3 million.

Cost of product revenue for the nine months ended September 30, 2021 was $0.6 million.

Cost of product revenue primarily relates to freight and royalties owed to our licensing partner for UKONIQ sales.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the six months ended June 30, 2021 were expensed prior to the February 5, 2021 FDA approval, and therefore are not included in costs of product revenue during the current period.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the nine months ended September 30, 2021 were expensed prior to the February 5, 2021 FDA approval, and therefore are not included in costs of product revenue during the current period.

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License revenue was approximately $76,000 for each of the six months ended June 30, 2021 and 2020 related to the amortization of an upfront payment of $2.0 million received in 2012 associated with our license agreement with Ildong.

License revenue was approximately $114,000 for each of the nine months ended September 30, 2021 and 2020 related to the amortization of an upfront payment of $2.0 million received in 2012 associated with our license agreement with Ildong.

Noncash Compensation Expense (Research and Development).

Noncash compensation expense (research and development) related to equity incentive grants totaled $14.5 million for the six months ended June 30, 2021, as compared to $3.5 million during the comparable period in 2020.

The increase in noncash compensation expense was primarily due to vesting of milestone-based grants, an increase in research and development personnel and the vesting of grants with a higher stock price during the six months ended June 30, 2021, as compared to previous periods.

Noncash compensation expense (research and development) related to equity incentive grants totaled $19.1 million for the nine months ended September 30, 2021, as compared to $8.1 million during the comparable period in 2020.

The increase in noncash compensation expense was primarily due to vesting of milestone-based grants, an increase in research and development personnel and the vesting of grants with a higher stock price during the nine months ended September 30, 2021, as compared to previous periods.

Other Research and Development Expenses.

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We expense our research and development costs as they are incurred.

Other research and development expenses increased by $24.5 million to $93.4 million for the six months ended June 30, 2021, as compared to $68.9 million for the six months ended June 30, 2020.

The increase in R&D expense is primarily attributable to the achievement of license milestones as well as manufacturing costs for UKONIQ during the six months ended June 30, 2021.

Other research and development expenses increased by $26.1 million to $140.9 million for the nine months ended September 30, 2021, as compared to $114.8 million for the nine months ended September 30, 2020.

The increase in R&D expense is primarily attributable to consulting fees associated with the submission of our BLA for ublituximab in RMS, the achievement of license milestones, and increased manufacturing costs during the nine months ended September 30, 2021.

Noncash Compensation Expense (Selling, General and Administrative).

Noncash compensation expense (selling, general and administrative) related to equity incentive grants increased by $3.5 million to $18.4 million for the six months ended June 30, 2021, as compared to $14.9 million for the six months ended June 30, 2020.

The increase in noncash compensation expense was primarily related to greater compensation expense during the six months ended June 30, 2021 related to restricted stock and stock options granted to executive personnel.

Noncash compensation expense (selling, general and administrative) related to equity incentive grants decreased by $10.8 million to $27.9 million for the nine months ended September 30, 2021, as compared to $38.6 million for the nine months ended September 30, 2020.

The decrease in noncash compensation expense was primarily related to greater compensation expense during the nine months ended September 30, 2020 related to restricted stock and stock options granted to executive personnel.

Other Selling, General and Administrative Expenses .

Other selling, general and administrative expenses was $42.4 million for the six months ended June 30, 2021, as compared to $13.8 million for the six months ended June 30, 2020.

Other selling, general and administrative expenses was $67.8 million for the nine months ended September 30, 2021, as compared to $25.4 million for the nine months ended September 30, 2020.

The increase was due primarily to increased personnel and other selling, general and administrative costs associated with execution of the launch of UKONIQ and planning for the potential launches of U2 in CLL and ublituximab in RMS.

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Interest Expense .

Interest expense remained relatively consistent at $3.5 million for the six months ended June 30, 2021, as compared to $3.4 million for the six months ended June 30, 2020.

Interest expense remained relatively consistent at $4.6 million for the nine months ended September 30, 2021, as compared to $5.0 million for the nine months ended September 30, 2020.

Other Income .

Other income was $1.1 million for the six months ended June 30, 2021, as compared to $0.5 million for the six months ended June 30, 2020.

The increase is mainly due to greater interest income and an increase in the change in fair value of notes payable for the six months ended June 30, 2021.

Other income was $1.6 million for the nine months ended September 30, 2021, as compared to $0.7 million for the nine months ended September 30, 2020.

The increase is mainly due to greater interest income and an increase in the change in fair value of notes payable for the nine months ended September 30, 2021.

We expect our other income to remain at a comparable level for the remainder of 2021.

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We may continue to incur substantial operating losses even as we begin to generate revenues from product sales.

As of June 30, 2021, we had $456.2 million in cash and cash equivalents, and investment securities.

We anticipate that our cash and cash equivalents, and investment securities as of June 30, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q.

As of September 30, 2021, we had $381.4 million in cash and cash equivalents, and investment securities.

We anticipate that our cash and cash equivalents, and investment securities as of September 30, 2021 will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10Q.

The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our UKONIQ commercialization efforts, preparations for the commercialization of our other drug candidates, and the timing, design and conduct of clinical trials for our drug candidates.

We are dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations, including the commercialization of any additional drug candidates.

In addition, we may in-license additional compounds that may require upfront fees and milestone payments.

Discussion of Cash Flows

Cash used in operating activities for the six months ended June 30, 2021 was $141.5 million as compared to $105.9 million for the six months ended June 30, 2020.

Cash used in operating activities for the nine months ended September 30, 2021 was $208.7 million as compared to $162.5 million for the nine months ended September 30, 2020.

The increase in cash used in operating activities was due primarily to increased expenditures associated with execution of the launch of UKONIQ, our scale-up for manufacturing, ongoing clinical development programs and paydown of accounts payable and accrued expenses.

Net cash used in investing activities for the six months ended June 30, 2021, was $3.0 million as compared to cash provided by investing activities of $12.7 million for the six months ended June 30, 2020.

The increase in net cash used in investing activities was primarily due to greater investment in short-term and long-term securities during the six months ended June 30, 2021.

Net cash used in financing activities for the six months ended June 30, 2021, was $7.2 million as compared to cash provided by financing activities of $241.2 million for the six months ended June 30, 2020.

The period ended June 30, 2020 included proceeds from the issuance of common stock as part of our underwritten public offering in May 2020 and our ATM program.

Net cash used in investing activities for the nine months ended September 30, 2021, was $3.6 million as compared to cash provided by investing activities of $27.6 million for the nine months ended September 30, 2020.

The increase in net cash used in investing activities was primarily due to greater investment in short-term and long-term securities during the nine months ended September 30, 2021.

Net cash used in financing activities for the nine months ended September 30, 2021, was $14.6 million as compared to cash provided by financing activities of $276.4 million for the nine months ended September 30, 2020.

The period ended September 30, 2020 included proceeds from the issuance of common stock as part of our underwritten public offering in May 2020 and our ATM program.

On September 5, 2019, we filed an automatic “shelf registration” statement on Form S-3 (the 2019 WKSI Shelf) as a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act, which registered an unlimited and indeterminate amount of debt or equity securities for future issuance and sale.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis