Market Newsdesk

ADC Therapeutics Reports Third Quarter 2020 Financial Results and Provides Recent Business Highlights

– Submitted BLA for lead program, Lonca, for treatment of relapsed or refractory DLBCL on September 21, 2020

– Commercial launch activities on track for potential U.S. launch of Lonca in mid-2021

– Initiated Phase 3 confirmatory trial of Lonca in combination with rituximab in second-line DLBCL

– Strong balance sheet with $494 million in cash and cash equivalents as of September 30, 2020 after completing an upsized follow-on public offering in September 2020

– Company to host conference call today at 8:30 a.m. ET

LAUSANNE, Switzerland–(BUSINESS WIRE)–
ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

“The third quarter was one of tremendous execution as we prepare for the U.S. launch of our first drug, Lonca, for the treatment of relapsed or refractory diffuse large B-cell lymphoma,” said Chris Martin, Chief Executive Officer of ADC Therapeutics. “We have submitted our Biologics License Application to the U.S. Food and Drug Administration and are now working diligently to prepare for a planned commercial launch in mid-2021, including U.S. organizational build-out, the establishment of U.S. operations to ensure distribution, access and reimbursement of Lonca, and significant appropriate physician engagement. In addition to our commercial preparations, we are expanding our Lonca development activities, having initiated our Phase 3 LOTIS 5 clinical trial evaluating Lonca in combination with rituximab as a second-line therapy in DLBCL and are preparing to initiate our Phase 2 trial of Lonca in follicular lymphoma next year.”

Dr. Martin continued, “Across our Cami programs, we have now enrolled more than half of the 100-patient pivotal Phase 2 trial in Hodgkin lymphoma and continue to see promising preliminary data from our Phase 1b trial in solid tumors that show robust immune activity following treatment, as well as recently published preclinical data highlighting the anti-tumor activity of CD25-targeted antibody drug conjugates. With these promising data, we expanded our Phase 1b trial to evaluate Cami in combination with pembrolizumab to better understand its potential as both a monotherapy and in combination and have dosed the first patient in the combination arm. To support these exciting developments and ensure continued growth across our pipeline, we completed an upsized public offering in September. With these additional funds, we look forward to continuing to deliver on our vision to bring transformative therapies to cancer patients as quickly and effectively as possible.”

Recent Clinical and Business Highlights:

• Submitted a BLA to the FDA for Lonca for treatment of relapsed or refractory DLBCL: On September 21, 2020, the Company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Lonca for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The submission is based on data from LOTIS 2, a pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior systemic therapy.

• Opened Phase 3 LOTIS 5 clinical trial of Lonca in combination with rituximab for enrollment: This Phase 3 confirmatory trial will evaluate the efficacy of Lonca in combination with rituximab in patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The trial will evaluate the safety and efficacy of Lonca in combination with rituximab versus standard immunochemotherapy, and the primary endpoint will be progression-free survival. LOTIS 5 is designed to fulfill the Company’s post-marketing requirement to the FDA for full approval, if accelerated approval is received for relapsed or refractory DLBCL, and is intended to support a supplemental Biologics License Application (sBLA) for Lonca as a second-line therapy for patients with DLBCL who have relapsed or refractory disease following at least one multi-agent systemic treatment regimen.

• Actively enrolling patients in the pivotal Phase 2 portion of LOTIS 3 clinical trial of Lonca in combination with ibrutinib: Enrollment continues in the pivotal Phase 2 portion of LOTIS 3, a 161-patient Phase 1/2 clinical trial of Lonca in combination with ibrutinib, which is being evaluated in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL). The first patient was dosed in the pivotal Phase 2 portion of this trial in July 2020.

• Planning to initiate a pivotal Phase 2 clinical trial of Lonca in follicular lymphoma (FL) in H1 2021: The Company continues to consider rapid expansion opportunities for Lonca across other non-Hodgkin lymphoma indications. Following consultation with the FDA, the Company plans to initiate a pivotal Phase 2 trial to evaluate the safety and efficacy of Lonca in patients with relapsed or refractory FL.

• Dosed first patient in Phase 1b clinical trial of Cami in combination with pembrolizumab for treatment of solid tumors: Earlier this month, the Company announced that the first patient was dosed with Cami in combination with pembrolizumab, a checkpoint inhibitor, in an ongoing Phase 1b trial in patients with selected advanced solid tumors. Based on preclinical data and initial pharmacodynamic data from the Phase 1b monotherapy trial, the Company has expanded the Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of Cami in combination with pembrolizumab in select solid tumors. Pharmacokinetic and biomarker data from the Phase 1b trial were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, and preclinical data were published in the Journal for ImmunoTherapy of Cancer.

• Announced multiple abstracts accepted for presentation at ASH: The Company announced earlier in November that six clinical abstracts and two preclinical abstracts have been accepted for presentation at the 62^nd American Society of Hematology (ASH) Annual Meeting, including an oral presentation of Cami Phase 2 data in Hodgkin lymphoma (HL) and poster presentations of Lonca subgroup data from the pivotal Phase 2 LOTIS 2 trial in relapsed or refractory DLBCL and the Phase 1b pivotal trial of Lonca combined with ibrutinib in relapsed or refractory DLBCL and MCL.

• Amended 2013 collaboration and license agreement with Genmab for Cami: In October 2020, the Company and Genmab agreed to amend their original 2013 agreement to allow the Company to continue the development and commercialization of Cami. Under the amendment, Genmab agreed, among other things, to convert its economic interest into a mid-to-high single-digit royalty on net sales.

• Completed upsized public offering: In September 2020, the Company completed an upsized public offering of 6,000,000 common shares at a price of $34.00 per share. Gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $204 million.

Anticipated Upcoming Milestones:

• FDA feedback on BLA submission for Lonca for the treatment of patients with relapsed or refractory DLBCL.
• Initiation of a pivotal Phase 2 trial of Lonca in relapsed refractory FL in the first half of 2021.
• Reporting of interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021.
• Potential FDA approval and launch of Lonca in mid-2021.

Third Quarter 2020 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $494.4 million as of September 30, 2020, compared to $115.6 million as of December 31, 2019.

Research and Development (R&D) Expenses

R&D expenses were $32.2 million for the quarter ended September 30, 2020, compared to $30.5 million for the same quarter in 2019. The increase was primarily due to increased share-based compensation expense.

General and Administrative (G&A) Expenses

G&A expenses were $20.3 million for the quarter ended September 30, 2020, compared to $2.3 million for the same quarter in 2019. The increase was primarily due to an increased number of Commercial employees, increased costs due to new commercial activities and increased share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $20.3 million, or a net loss of $0.29 per basic and diluted share, for the quarter ended September 30, 2020, compared to $31.3 million, or a net loss of $0.62 per basic and diluted share, for the same quarter in 2019. The net loss for the quarter ended September 30, 2020 includes a $33.9 million non-cash gain related to the changes in fair value of derivatives associated with the convertible loans under the Convertible Credit Facility with Deerfield. The decrease in fair value was driven by the decrease in the Company’s share price from June 30, 2020. In addition, net loss included share-based compensation expense of $11.0 million for the quarter ended September 30, 2020, compared to $0.2 million for the same quarter in 2019.

Adjusted net loss was $41.3 million, or an adjusted net loss of $0.58 per basic and diluted share, for the quarter ended September 30, 2020, compared to $31.1 million, or an adjusted net loss of $0.62 per basic and diluted share, for the same quarter in 2019. The increase in adjusted net loss was primarily driven by higher employee headcount across the organization and costs associated with the build out of the Company’s commercial organization in preparation for the anticipated launch of Lonca in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2020 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the call, please dial +41 225 675632 (international) or (833) 249-8403 (U.S.). A live webcast of the presentation will be available on the Investors section of the ADC Therapeutics website at www.ir.adctherapeutics.com. The archived webcast will be available after the completion of the event.

About ADC Therapeutics

ADC Therapeutics SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

Loncastuximab tesirine (Lonca, formerly ADCT-402), the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. In September 2020, ADC Therapeutics submitted a Biologics License Application to the U.S. Food and Drug Administration seeking accelerated approval for Lonca for the treatment of patients with relapsed or refractory DLBCL. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

Use of Non-IFRS Financial Measures

In addition to financial information prepared in accordance with IFRS, this document also contains certain non-IFRS financial measures based on management’s view of performance including:

• Adjusted net loss
• Adjusted net loss per share

Management uses such measures internally when monitoring and evaluating our operational performance, generating future operating plans and making strategic decisions regarding the allocation of capital. We believe that these adjusted financial measures provide useful information to investors and others in understanding and evaluating our operating results in the same manner as our management and facilitate operating performance comparability across both past and future reporting periods. These non-IFRS measures have limitations as financial measures and should be considered in addition to, and not in isolation or as a substitute for, the information prepared in accordance with IFRS. When preparing these supplemental non-IFRS measures, management typically excludes certain IFRS items that management does not believe are indicative of our ongoing operating performance. Furthermore, management does not consider these IFRS items to be normal, recurring cash or non-cash operating expenses; however, these items may not meet the IFRS definition of unusual or non-recurring items. Since non-IFRS financial measures do not have standardized definitions and meanings, they may differ from the non-IFRS financial measures used by other companies, which reduces their usefulness as comparative financial measures. Because of these limitations, you should consider these adjusted financial measures alongside other IFRS financial measures.

The following items are excluded from adjusted net loss and adjusted net loss per share:

Shared-Based Compensation Expense: We exclude share-based compensation from our adjusted financial measures because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Share-based compensation has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy.

Certain Other Items: We exclude certain other significant items that may occur occasionally and are not normal, recurring operating expenses, cash or non-cash, from our adjusted financial measures. Such items are evaluated by management on an individual basis based on both quantitative and qualitative aspects of their nature and generally represent items that, either as a result of their nature or significance, management would not anticipate occurring as part of our normal business on a regular basis. While not all-inclusive, examples of certain other significant items excluded from our adjusted financial measures would be: changes in the fair value of derivatives, and the effective interest expense, associated with the Convertible Credit Facility with Deerfield, as well as transaction costs associated with debt or equity issuances that are expensed pursuant to IFRS.

See the attached Reconciliation of IFRS Measures to Non-IFRS Measures for explanations of the amounts excluded and included to arrive at the non-IFRS financial measures for the three- and nine-month periods ended September 30, 2020 and 2019.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

(i) Share-based compensation expense represents the cost of equity awards issued to our directors, management and employees. The fair value of awards is computed at the time the award is granted and is recognized over the vesting period of the award by a charge to the income statement and a corresponding increase in other reserves within equity. These accounting entries have no cash impact.

(ii) Change in the fair value of the convertible loan derivatives results from the valuation at the end of each accounting period of the derivatives associated with the convertible loans, as explained in note 11 “Convertible notes” to the unaudited condensed consolidated interim financial statements. There are several inputs to these valuations, but those most likely to provoke significant changes in the valuations are changes in the value of the underlying instrument (i.e., changes in the price of our common shares) and changes in expected volatility in that price. Any change in the estimated probability of the regulatory approval of Lonca would directly affect the valuation related to the second tranche. These accounting entries have no cash impact.

(iii) The transaction costs allocated to the convertible loan first tranche derivative represent actual costs. These are not expected to recur on an ongoing basis.

(iv) Effective interest expense relates to the increase in the value of our convertible loan in accordance with the effective interest method. As the initial value of the loan is recorded net of the value of the embedded derivative, the increase in the loan value necessary to attain the amount necessary to fund the cash outflows of interest payments, repayment of capital and exit fee is considerably higher than the payments of interest at coupon rate and of the exit fee.

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INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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New Community Offers Lineup of Never-Before-Seen Floor Plans

Organicell Provides Update on Its COVID-19 Clinical Trial Using Zofin^TM

• Anticipates Phase I/II trial completion by end of year
• Anticipates Phase IIb trial to begin in Q1 2021
• Seeks to retain a global contract research organization (“CRO”)

MIAMI–(BUSINESS WIRE)–
Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today provided an update on its Phase I/II clinical trial for treatment of COVID-19 using Organicell’s proprietary therapeutic, Zofin™, which is currently underway as well as an update on its expanded access protocol for outpatients with COVID-19.

The Company’s current Phase I/II clinical trial which commenced on September 8, 2020, is a randomized, double-blinded, placebo-controlled phase I/II trial designed to investigate its proprietary therapeutic, Zofin™, as a potential treatment for moderate to severe acute respiratory syndrome (SARS) related to COVID-19. To date, several patients have been enrolled, dosed and treated at Larkin Hospital in Miami, Florida. Organicell expects to finish enrollment and complete the trial by December 31, 2020. It is the Company’s intention, subject to favorable results, careful data analysis, discussion with and approvals from the FDA, to begin a Phase IIb confirmatory trial as early as the first quarter of 2021.

In September 2020, Organicell announced that the FDA granted it an expanded access protocol. This protocol allows Organicell to provide Zofin™ to a certain amount of mild to moderate COVID-19 patients in both outpatient and inpatient settings.

In connection with its planned Phase IIb confirmatory trial, the Company is negotiating an agreement with a nationally known CRO to support the needed services related to running its clinical trials. The Company expects this agreement to be finalized in the coming days.

“We’re very pleased in the progress we are making in our clinical trials,” said Albert Mitrani, Chief Executive Officer of Organicell. “Our planned CRO partnership is intended to support our efforts to efficiently and expeditiously conduct our clinical trial programs which, if successful, may ultimately afford a potentially effective treatment for patients suffering from the effects of COVID-19.”

About Organicell Regenerative Medicine, Inc.:

Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Maria Ines Mitrani, Chief Science Officer. To learn more, please visit https://organicell.com/.

About Zofin^TM:

Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

Forward-Looking Statements

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as “will,” “believes,” “expects,” “potential” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company’s periodic reports that are filed with the SEC and available on the SEC’s website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.

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INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Health FDA Infectious Diseases Clinical Trials

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Exicure, Inc. Reports Third Quarter 2020 Financial Results and Corporate Progress

CHICAGO & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today reported financial results for the quarter and nine months ended September 30, 2020 and provided an update on corporate progress.

“Exicure has seen growth and clinical and pre-clinical advancement during the third quarter of this year,” said Dr. David Giljohann, Exicure’s Chief Executive Officer. “During the third quarter of 2020, Exicure hosted a virtual KOL event where we presented promising interim results from our ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) and we announced that our poster on the safety and preliminary efficacy of intertumoral cavrotolimod (AST-008) in combination with pembrolizumab in the Phase 1b stage was accepted for presentation at the 2020 SITC Annual Meeting. We also entered into a $25.0 million senior secured term loan during the third quarter of 2020 which extends our cash runway into 2022,” concluded Dr. Giljohann.

Exicure’s candidate, XCUR-FXN

• Despite the ongoing COVID-19 pandemic, the Company’s laboratories have continued operations with limited impact on our research and development activities.
• The Company remains on track to initiate IND-enabling studies for Friedreich’s ataxia in the fourth quarter of this year.

Exicure announced promising interim results from ongoing Phase 1b/2 clinical trial of cavrotolimod (AST-008) in September 2020

• Confirmed overall response rate (ORR) of 21% in the dose-escalation stage across all doses, confirmed ORR 33% at the highest dose cohort and recommended Phase 2 dose.
• Target tumor shrinkage was observed in 37% of patients.
• Preliminary data show activity in patients with melanoma, Merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (CSCC).
• Phase 2 arms in both MCC and CSCC are currently recruiting.

Cavrotolimod (AST-008) Phase 1b/2 clinical trial is open and actively enrolling patients

• In the second quarter of 2020, the Company began enrolling patients in the Phase 2 dose expansion phase of its Phase 1/2 clinical trial of intra-tumoral cavrotolimod (AST-008) in combination with approved checkpoint inhibitors pembrolizumab or cemiplimab, for the treatment of patients with advanced or metastatic MCC or CSCC.
• Currently, 14 clinical trial sites are open for enrollment and 7 additional sites are pending activation; the Company expects to open up to 25 sites for the Phase 2 stage of the clinical trial.
• We continue to monitor the impact that COVID-19 may be having on patient enrollment and safety, site initiation, and study integrity. We have put in place and continue to maintain a variety of measures to mitigate the effects of COVID-19 and our top priority is to maintain patient safety and clinical trial continuity. During the third quarter of 2020, we have observed delays in our enrollment plans for the Phase 2 dose expansion phase of this clinical trial. The effects of the COVID-19 pandemic or its impact may have contributed to such delays. As a result, we have taken additional measures to increase the enrollment of patients, including frequent interaction with our clinical trial sites currently open as well as increasing the number of clinical trial sites that potentially are activated for this clinical trial so that we may continue to enroll patients as planned. However, these delays have caused us to lengthen our clinical development timeline for cavrotolimod (AST-008) and we now expect to report ORR results in the first half of 2022 rather than by year-end 2021 as previously guided.

Third Quarter Financial Results, Financial Guidance and Recent Developments

Cash Position: Cash, cash equivalents, and short-term investments were $94.1 million as of September 30, 2020 compared to $85.8 million as of June 30, 2020, and the increase is attributed to the borrowing of the first tranche ($17.5 million) of the $25.0 million senior secured term loan with MidCap Financial Trust (MidCap), as agent, and Silicon Valley Bank (SVB).

Research and Development (R&D) Expenses: Research and development expenses were $9.1 million for the quarter ended September 30, 2020, as compared to $4.2 million for the quarter ended September 30, 2019. The Company continues to increase staffing in the R&D function, increasing headcount from 26 at September 30, 2019 to 48 at September 30, 2020 and the associated increase in hiring, in addition to growth in cavrotolimod (AST-008) clinical trial activities, has driven the Company’s increase in R&D costs. The associated increases in platform and discovery-related costs reflected increased preclinical R&D activities associated with the Company’s collaboration with AbbVie Inc. (AbbVie), increased costs related to XCUR-FXN, as well as other preclinical discovery work in neurology and ophthalmology.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.4 million for the quarter ended September 30, 2020, as compared with $2.2 million for the quarter ended September 30, 2019.

Net Loss: The Company had a net loss of $8.8 million for the quarter ended September 30, 2020 compared to a net loss of $5.8 million for the quarter ended September 30, 2019 reflecting a higher net loss of $3.0 million. This increase in net loss was driven principally by the increases in R&D expenses and G&A expenses discussed above, partially offset by the recognition of $2.4 million of revenue associated with our collaboration with AbbVie.

Cash Runway Guidance: The Company believes that, based on its current operating plans and estimates of future expenses, as of the date of this press release, its existing cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

Response to COVID-19: With the global spread of the ongoing COVID-19 pandemic in 2020, we have been closely monitoring developments and have taken active measures to protect the health of our employees and their families, our communities, as well as our clinical trial investigators, patients and caregivers. We continue to carefully manage laboratory staffing and take other appropriate managerial actions to maintain progress on our preclinical and collaboration programs. We also continue to work closely with our third-party manufacturers and other partners to manage our supply chain activities and will take such action as we believe appropriate with our clinical operations to maintain patient safety and clinical trial continuity.

Resignation of Director: On November 10, 2020, Helen S. Kim resigned as a Class II director of our Board of Directors, or the Board, as well as from the Nominating and Corporate Governance Committee of the Board, effective immediately. Ms. Kim’s decision to resign was not the result of any disagreement between Ms. Kim and our Company, management, the Board or any committee thereof, on any matter relating to our operations, policies or practices. We thank Ms. Kim for her six years of service on the Board.

About Exicure, Inc.

Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for neurology, immuno-oncology, inflammatory diseases and other genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure is in preclinical development of XCUR-FXN an SNA–based therapeutic candidate, for the treatment of Friedreich’s ataxia (FA). Exicure’s therapeutic candidate cavrotolimod (AST-008) is in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Exicure is based in Chicago, IL and in Cambridge, MA.

For more information, visit Exicure’s website at www.exicuretx.com.

Exicure Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical fact could be deemed forward looking including, but not limited to, statements regarding the anticipated and potential impact of the COVID-19 pandemic and its impact and effects on the company’s business and operations, including the conduct of and timeline for its ongoing Phase 1b/2 clinical trial for cavrotolimod (AST-008); the company’s plans, initiatives and expectations in light of and in response to the COVID-19 pandemic; the company’s expectations regarding its ability to adapt its business to the evolving COVID-19 pandemic, mitigate its impacts on the business and maintain business continuity; the design, timing and results of its Phase 1b/2 clinical trial of cavrotolimod (AST-008) including patient enrollment expectations and opening of additional clinical trial sites; the initiation, timing and results of its other preclinical studies and clinical trials, including XCUR-FXN; the potential of the company’s SNA technology to provide therapeutic benefit to target diseases, including its ability to address the genetic challenges posed by Friedreich’s ataxia and other neurological conditions; the potential of the company’s collaborations and R&D efforts; the company’s ability to advance its clinical and pre-clinical pipelines; the company’s expectations with respect to its continued growth; and the company’s anticipated extended cash runway. The forward-looking statements in this press release speak only as of the date of this press release, and the company undertakes no obligation to update these forward-looking statements. Forward-looking statements are based on management’s current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risks that the ongoing COVID-19 pandemic or its impact or effects may disrupt the company’s business and/or the global healthcare system more severely than it has to date or more severely than anticipated, which may have the effect of impacting or delaying the company’s ongoing Phase 1b/2 clinical trial; unexpected costs, charges or expenses that reduce the company’s capital resources; the company’s preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the cost, timing and results of clinical trials; that many drug candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; regulatory developments; risks that preliminary results from clinical trials are not necessarily predictive of future clinical trial results; and the ability of the company to protect its intellectual property rights. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by the company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the company undertakes no duty to update this information, except as required by law. In addition, the COVID-19 pandemic and the associated containment efforts have had and continue to have a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts have only partially mitigated the consequences. The extent and duration of the impact on the company’s business and operations is highly uncertain, and that impact includes effects on its clinical trial operations, timelines and supply chain. Factors that will influence the impact on the company’s business and operations include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The COVID-19 pandemic or its impact or effects could have a material adverse impact on the company’s business, operations and financial results for an extended period of time.

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First American Docutech Announces New Integration With Encompass^{by Ellie Mae}

—Lenders can now implement dynamic document generation and eClosing faster—

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–First American Docutech^®, the leading provider of document, eSign, eClose and digital to print fulfillment technology, and a member of the First American family of companies, today announced a new streamlined integration with Encompass^® loan origination software by Ellie Mae^®. With the integration, Encompass lenders can accelerate their closing process by easily implementing First American Docutech’s suite of digital mortgage and closing solutions. The integration seamlessly updates key disclosure tracking fields, and automatically delivers documents into Encompass.

“Lenders of all sizes are focusing on digitizing as much of their loan process as possible to optimize the borrower experience, maximize loan production, and reduce costs,” said Amy Brandt, president, First American Docutech. “For smaller lenders though, it’s been challenging to compete with the larger financial institutions on a level technology playing field. Now, through a new integration with Encompass, lenders can easily implement our suite of solutions with very limited effort, enabling them to digitize their process from point-of-sale origination through closing, and on to secondary market delivery.”

Ellie Mae, now a part of Intercontinental Exchange, Inc. (NYSE: ICE), is a leading cloud-based loan origination platform provider for the mortgage industry. Lenders across the U.S. trust Ellie Mae’s Encompass loan origination system to help them originate more loans, lower costs and reduce time to close. The combination of Encompass with First American Docutech provides lenders with higher efficiencies towards enabling an end-to-end digital mortgage experience.

“We are thrilled to expand our digital solution suite integration within Encompass,” said Brandt. “As a long-time Ellie Mae partner and market leader in dynamic document generation and eClosing, we recognized the need to provide lenders with more options and the ability to choose the right solution at the right time based on their unique strategy. This new integration model was designed with small- to medium-sized lenders in mind to give them the ability to close more loans, faster and deliver a superior customer experience.”

About First American Docutech

First American Docutech, a part of the First American family of companies, provides an end-to-end integrated digital mortgage experience that enables lenders to accelerate the real estate closing process. The company digitizes and streamlines the creation, delivery, execution and perfection of mortgage documents. First American Docutech sets the standard in providing market-proven technology and unrivaled customer service to the financial industry. For more information, visit the company’s website at www.firstam.com/docutech or follow them on LinkedIn or Twitter (@Docutech).

About First American

First American Financial Corporation (NYSE: FAF) is a leading provider of title insurance, settlement services and risk solutions for real estate transactions that traces its heritage back to 1889. First American also provides title plant management services; title and other real property records and images; valuation products and services; home warranty products; property and casualty insurance; banking, trust and wealth management services; and other related products and services. With total revenue of $6.2 billion in 2019, the company offers its products and services directly and through its agents throughout the United States and abroad. In 2020, First American was named to the Fortune 100 Best Companies to Work For^® list for the fifth consecutive year. More information about the company can be found at www.firstam.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005181/en/

Media Contact:

Marcus Ginnaty

Corporate Communications

First American Financial Corporation

(714) 250-3298

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INDUSTRY KEYWORDS: Professional Services Technology Residential Building & Real Estate Software Finance Construction & Property Banking

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eCommerce Transactions Will Soar During Holiday Shopping Season as Pandemic Leads to More Lockdowns, per New Data from ACI Worldwide

As consumers prepare for holiday shopping season, concern over lockdowns drives early shopping with a 53 percent increase in the retail sector in October 2019 vs. 2020

NAPLES, Fla.–(BUSINESS WIRE)–
New benchmark data from ACI Worldwide (NASDAQ: ACIW), a leading global provider of real-time digital payment software and solutions, revealed a 23 percent increase in global eCommerce transactions in October 2020 compared to October 2019. This increase was driven by the retail, gaming, DIY and digital sectors as consumers prepare for further lockdowns. In addition, the data, based on hundreds of millions of eCommerce transactions from global merchants, showed a projected 25 percent increase in volume of transactions for all sectors combined (including those impacted by the pandemic, such as airline and ticketing) in Q4 2020 compared to Q4 2019.

ACI’s data also showed that the second wave of COVID-19 lockdowns in the EMEA region has already resulted in a more than 100 percent increase in eCommerce transactions in the retail sector from November 1-4, 2020.

“With the U.K. already in another lockdown and the U.S. potentially heading toward one, we’re seeing consumers prepare to hunker down for the holidays and get their shopping done earlier than ever,” said Debbie Guerra, executive vice president, ACI Worldwide. “Related, merchants are offering deals earlier, which has also driven increases in transaction volumes in October compared to the same time last year. We’re expecting this trend to continue as we move further into the holiday season.”

ACI’s data from October 2020 showed a slight increase to 4.1 percent in the value of fraud attempts compared to the same period in 2019 as genuine consumers continue to outpace fraudulent consumers.

The gaming sector continued to see record levels of transactions, with a 90 percent increase in October 2020 compared to 2019. Sectors that continue to see a decline in transactions include travel (33%) and ticketing (79%).

“Lockdowns have led many consumers to cancel any plans to travel—such as holiday getaway vacations—or attend large group gatherings, leading to an even greater decline in airline and ticketing compared to the previous year,” Guerra concluded.

Key Findings:

eCommerce purchasing trends:

• Sectors that continue to experience major increases in purchases in October include gaming (90% increase) and retail (53% increase).
• Sectors that continue to experience major decreases in purchases in October include travel (33% decrease) and ticketing (79% decrease).
• The average ticket price of genuine purchases dropped by $21 in 2020 compared to 2019, driven by declines within the airline and ticketing sectors, which yield higher ticket prices on average.

Fraud trends:

• Transactional value of fraud attempts increased 0.4 percent in October, driven by purchases of electronics, with buy online, pick-up in-store (BOPIS) being the channel of choice for fraudsters.
• The average ticket price for fraud attempts decreased by $9 in the period January through October 2020, compared to the same period in 2019.
• Non-fraud chargebacks* increased by 10 percent in October 2020 compared to October 2019; this has been declining compared to March-June 2020. Reasons include the following:
  • Backlog of processing returns since employees have been unable to work due to stay at home restrictions, and safety concerns around opening boxes due to COVID-19
  • Call centers were not staffed for several days in March to answer incoming customer calls
  • Shipment delays
  • Product back order

*Chargebacks often take approximately 45 days to process.

About ACI Worldwide

ACI Worldwide powers digital payments for more than 6,000 organizations around the world. More than 1,000 of the largest financial institutions and intermediaries, as well as thousands of global merchants, rely on ACI to execute $14 trillion each day in payments and securities. In addition, myriad organizations utilize our bill presentment and payment services. Through our comprehensive suite of software solutions delivered on customers’ premises, through the public cloud or through ACI’s private cloud, we provide real-time payment capabilities and enable the industry’s most complete omni-channel payments experience.

© Copyright ACI Worldwide, Inc. 2020

ACI, ACI Worldwide, ACI Payments, Inc., ACI Pay, Speedpay and all ACI product/solution names are trademarks or registered trademarks of ACI Worldwide, Inc., or one of its subsidiaries, in the United States, other countries or both. Other parties’ trademarks referenced are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005159/en/

Dan Ring

[email protected]

781-370-3600

Nidhi Alberti

[email protected]

781-370-3600

KEYWORDS: Florida Massachusetts United States North America

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Ford to Discuss the All-New E-Transit All-Electric Van and Opportunities for Connected Commercial Vehicles

DEARBORN, Mich.–(BUSINESS WIRE)–
Ford Motor Company leaders will discuss the all-new, all-electric E-Transit with Wolfe Research on Tuesday, Nov. 17.

The call, hosted by Wolfe’s Rod Lache, will feature:

• Ted Cannis, general manager, North American commercial vehicle business, and
• Lynn Antipas Tyson, executive director, Investor Relations.

Participants can listen to the Nov. 17 Wolfe Research fireside chat “live” at 11 a.m. ET by accessing the webcast for the event at shareholder.ford.com.

With a 45% share in the U.S. of the commercial pickup and van commercial market, Ford is extending its leadership by introducing the zero-emissions, all-electric E-Transit – a new era of the world’s best-selling cargo van brand. Ford team will provide details about E-Transit’s customer benefits and future revenue opportunities from expanded dealer services, integrated charging solutions, connected data networks, mobile applications and subscriptions.

Ford will reveal the BEV E-Transit on Thursday, Nov. 12, at 9:00 a.m. ET. A video of the reveal will be available at shareholder.ford.com.

About Ford Motor Company

Ford Motor Company is a global company based in Dearborn, Michigan. The company designs, manufactures, markets and services a full line of Ford cars, trucks, SUVs, electrified vehicles and Lincoln luxury vehicles, provides financial services through Ford Motor Credit Company and is pursuing leadership positions in electrification; mobility solutions, including self-driving services; and connected services. Ford employs approximately 187,000 people worldwide. For more information regarding Ford, its products and Ford Motor Credit Company, please visit www.corporate.ford.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005204/en/

Equity Investment Community:

Lynn Antipas Tyson

914.485.1150

[email protected]

Fixed Income Investment Community:

Karen Rocoff

313.621.0965

[email protected]

Shareholder Inquiries:

1.800.555.5259 or 313.845.8540

[email protected]

Media:

Ford Media Center

[email protected]

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: General Automotive Automotive Alternative Vehicles/Fuels

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Castle Biosciences Presents Data on DecisionDx^®-Melanoma and DecisionDx^® DiffDx™-Melanoma Tests at American Society of Dermatopathology (ASDP) 57^th Virtual Annual Meeting

FRIENDSWOOD, Texas–(BUSINESS WIRE)–
Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced the presentation of data on two of its skin cancer gene expression profile tests during the 57^th Meeting of The American Society of Dermatopathology (ASDP).

DecisionDx®-Melanoma:

“Identifying predictors of sentinel lymph node metastasis in cutaneous melanoma patients using molecular and clinicopathologic high-risk features” was presented by Federico Monzon, M.D.

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

“DecisionDx-Melanoma uses primary tumor biology to delineate patient metastatic risk, including the risk of SLN metastasis,” said Monzon. “In this study, among all features evaluated, DecisionDx-Melanoma was the most significant factor in predicting rates of SLN positivity, justifying a role for the test alongside other commonly used features in considering the sentinel lymph node biopsy surgical procedure.”

Study methods and findings:

• Authors modeled decision trees using the statistical R package for a cohort of 3,093 patients with cutaneous melanoma to determine which molecular and clinicopathologic features could best stratify the risk of patients’ receiving a positive result from a sentinel lymph node biopsy (SLNB).
• DecisionDx-Melanoma was the most significant factor in distinguishing between high and low SLN-positivity rates (p<0.001).
  • Patients with a Class 2 (high-risk) DecisionDx-Melanoma result under age 75 or with a very high mitotic rate (>10/mm²)^{had the highest SLN-positivity rates (>20%).}
  • Conversely, patients with a Class 1A result over age 47 with tumors with no mitoses and those age 47 or younger with a Breslow thickness of 0.85mm or less had the lowest positivity rates (<5%), indicating they could potentially forego SLNB.
• Patients of all ages and Breslow thicknesses with a Class 2 result had a greater than 10% risk of SLN positivity, indicating that a Class 2 DecisionDx-Melanoma result can be considered a high-risk factor when considering the SLNB procedure for individual patients.

DecisionDx^® DiffDx™-Melanoma:

“Development and validation of a diagnostic gene expression profile test for ambiguous or difficult-to-diagnose pigmented skin lesions” was presented by Sarah Estrada, M.D., FCAP.

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

“Approximately 300,000 melanocytic lesions biopsied each year cannot be confidently identified as either malignant or benign, so the nature of these lesions remains ambiguous with discordant rates of diagnoses ranging from 25-43%,” said Estrada. “The accuracy metrics shown in the development and validation study suggest DecisionDx DiffDx-Melanoma could help alleviate uncertainty in difficult-to-diagnose lesions, leading to decreased unnecessary procedures while appropriately identifying at-risk patients.”

Study methods and findings:

• DecisionDx DiffDx-Melanoma was designed to refine diagnoses of melanocytic neoplasms by providing clinicians with an objective ancillary tool with high accuracy.
• A total of 503 formalin-fixed paraffin-embedded(FFPE) tissue samples sourced from primary cutaneous melanoma tumors and melanocytic nevi were used, of which 273 were benign and 230 were malignant lesions. Samples underwent quantitative polymerase chain reaction (qPCR) to evaluate expression of 76 genes with potential diagnostic utility.
• Artificial intelligence approaches were used to select and prioritize gene sets, ultimately identifying 32 differentially expressed genes that reliably classified benign versus malignant melanocytic lesions.
• The resulting 35-gene expression profile (GEP) test, DecisionDx DiffDx-Melanoma, (32 discriminant genes and 3 control genes) accurately diagnosed malignant and benign cases with 99.1% sensitivity, 94.3% specificity, 93.6% positive predictive value (PPV) and 99.2% negative predictive value (NPV).

About DecisionDx-Melanoma

DecisionDx®-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through September 30, 2020, DecisionDx-Melanoma has been ordered more than 64,560 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.SkinMelanoma.com.

About DecisionDx DiffDx-Melanoma

DecisionDx® DiffDx™-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx^®-Melanoma, DecisionDx^®-CMSeq), cutaneous squamous cell carcinoma (DecisionDx^®-SCC), suspicious pigmented lesions (DecisionDx^® DiffDx™-Melanoma) and uveal melanoma (DecisionDx^®-UM, DecisionDx^®-PRAME and DecisionDx^®-UMSeq). For more information about Castle’s gene expression profile tests, visit www.CastleTestInfo.com. Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq and are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the ability of DecisionDx DiffDx-Melanoma to accurately characterize difficult-to-diagnose melanocytic lesions, the ability of DecisionDx-Melanoma test results to help identify patients with low probability of sentinel lymph node positivity, and statements concerning each of their impact to optimize or improve treatment decisions and reduce healthcare costs. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business and our ability to maintain compliance with the covenants in our debt facility, the timing and amount of revenue we are able to recognize in a given fiscal period, unexpected delays in planned launch of our pipeline products, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019 and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005108/en/

Investor and Media Contact:

Camilla Zuckero

832-835-5158

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