Saia Provides Second Quarter LTL Operating Data

JOHNS CREEK, Ga., June 02, 2021 (GLOBE NEWSWIRE) — Saia, Inc. (NASDAQ: SAIA), a leading transportation provider offering multi-regional less-than-truckload (LTL), non-asset truckload, expedited and logistics services, is providing LTL shipment and tonnage data for the first two months of the second quarter. In April 2021, final LTL shipments per workday increased 27.8%, LTL tonnage per workday increased 30.5% and LTL weight per shipment increased 2.2% to 1,364 pounds compared to 1,335 pounds in April 2020.   In May 2021, LTL shipments per workday increased 12.7%, LTL tonnage per workday increased 22.5% and LTL weight per shipment increased 8.6% to 1,404 pounds compared to 1,292 pounds in May 2020. Prior year results were impacted by the onset of the COVID-19 pandemic and the resulting significantly lower business levels experienced.

Actual second quarter and annual shipments, tonnage and weight per shipment could differ materially from the data expressed in this press release, including by reason of the risk factors included in Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in other filings with the Securities and Exchange Commission. The information herein speaks as of the date of this press release and is subject to change. Saia is under no obligation, and expressly disclaims any obligation to update or alter such information, whether as a result of new information, future events, or otherwise, except as required by law.

Saia, Inc. (NASDAQ: SAIA) offers customers a wide range of less-than-truckload, non-asset truckload, expedited and logistics services. With headquarters in Georgia, Saia LTL Freight operates 170 terminals in 44 states. For more information on Saia, Inc. visit the Investor Relations section at www.saia.com.

Cautionary Note Regarding Forward-Looking Statements

The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand the future prospects of a company and make informed investment decisions. This news release may contain these types of statements, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

Words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “may,” “plan,” “predict,” “believe,” “should” and similar words or expressions are intended to identify forward-looking statements. Investors should not place undue reliance on forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statements. All forward-looking statements reflect the present expectation of future events of our management as of the date of this news release and are subject to a number of important factors, risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These factors, risks, uncertainties and assumptions include, but are not limited to, (1) general economic conditions including downturns or inflationary periods in the business cycle; (2) operation within a highly competitive industry and the adverse impact from downward pricing pressures, including in connection with fuel surcharges, and other factors; (3) industry-wide external factors largely out of our control; (4) cost and availability of qualified drivers, purchased transportation and fuel; (5) claims expenses and other expense volatility, including for personal injury, cargo loss and damage, workers’ compensation, employment and group health plan claims; (6) cost and availability of insurance coverage, including the possibility the Company may be required to pay additional premiums, assume additional liability under its auto liability policy or be unable to obtain insurance coverage; (7) failure to successfully execute the strategy to expand our service geography; (8) costs and liabilities from the disruption in or failure of our technology or equipment essential to our operations, including as a result of cyber incidents, security breaches, malware or ransomware attacks; (9) failure to keep pace with technological developments; (10) labor relations, including the adverse impact should a portion of our workforce become unionized; (11) cost and availability of real property and revenue equipment; (12) capacity and highway infrastructure constraints; (13) risks arising from international business operations and relationships; (14) seasonal factors, harsh weather and disasters caused by climate change; (15) economic declines in the geographic regions or industries in which our customers operate; (16) the creditworthiness of our customers and their ability to pay for services; (17) our need for capital and uncertainty of the credit markets; (18) the possibility of defaults under our debt agreements (including violation of financial covenants); (19) failure to operate and grow acquired businesses in a manner that support the value allocated to acquired businesses; (20) dependence on key employees; (21) increased costs of healthcare benefits; (22) damage to our reputation from adverse publicity, including from the use of or impact from social media; (23) failure to make future acquisitions or to achieve acquisition synergies; (24) the effect of litigation and class action lawsuits arising from the operation of our business, including the possibility of claims or judgments in excess of our insurance coverages or that result in increases in the cost of insurance coverage or that preclude us from obtaining adequate insurance coverage in the future; (25) the potential of higher corporate taxes and new regulations, including with respect to climate change, employment and labor law, healthcare and securities regulation; (26) the effect of governmental regulations, including hours of service for drivers, engine emissions, the Compliance, Safety, Accountability (CSA) initiative, regulations of the Food and Drug Administration and Homeland Security, and healthcare and environmental regulations; (27) unforeseen costs from new and existing data privacy laws; (28) changes in accounting and financial standards or practices; (29) widespread outbreak of an illness or any other communicable disease, including the COVID-19 pandemic, or any other health crisis or business disruptions that may arise from the COVID-19 pandemic in the future; (30) increasing investor and customer sensitivity to social and sustainability issues, including climate change; (31) anti-terrorism measures and terrorist events; (32)  provisions in our governing documents and Delaware law that may have anti-takeover effects; (33) issuances of equity that would dilute stock ownership; and (34) other financial, operational and legal risks and uncertainties detailed from time to time in the Company’s SEC filings.

As a result of these and other factors, no assurance can be given as to our future results and achievements. Accordingly, a forward-looking statement is neither a prediction nor a guarantee of future events or circumstances and those future events or circumstances may not occur. You should not place undue reliance on the forward-looking statements, which speak only as of the date of this news release. We are under no obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.

CONTACT: Saia, Inc.
  Melanie Baker
  [email protected] 
  770.232.4088



Arbutus Announces Multiple Abstracts Accepted for Oral and Poster Presentations at the EASL 2021 International Liver Congress in June

Conference Call and Webcast to discuss the new data being presented at EASL 
scheduled for 8:00 AM ET, Monday, June 28, 2021

WARMINSTER, Pa., June 02, 2021 (GLOBE NEWSWIRE) — Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection, as well as therapies to treat coronaviruses (including COVID-19), today announced that five abstracts have been accepted for presentation at the upcoming International Liver CongressTM (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in June 2021.

Arbutus will hold a conference call at 8:00 AM ET, Monday June 28, 2021 to discuss the new data being presented at EASL.

The accepted abstracts include two oral presentations, one of which is a late breaker, and three poster presentations. The presentation details and schedules are as follows:


Oral Presentations


LBO-2764

Title: Repeat dosing of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B results in robust and sustained HBsAg suppression

Presenter: Prof. Man-Fung Yuen, D.Sc., M.D., Ph.D., Deputy Head of Department, Chief of Division of Gastroenterology and Hepatology, Master of Lap Chee, University of Hong Kong.

Session: Late Breaker June 26, 2021 / 12:00 PM – 1:30 PM CET (6:00 AM – 7:30 AM ET)

AB-729 Presentation Time: 1:15 PM CET (7:15 AM ET)


OS-595

Title: Preclinical antiviral profile of AB-836, a potent highly selective hepatitis B virus capsid inhibitor

Presenter: Dr. Nagraj Mani, Ph.D., Research Fellow, Arbutus Biopharma Corp.

Session: Hepatitis B: Novel Therapeutic Approaches

Session Date / Time: June 25, 2021 / 2:00 PM – 3:30 PM CET (8:00 AM – 9:30 AM ET)

AB-836 Presentation Time: 2:45 PM CET (8:45 AM ET)

Presentation available to ILC participants on June 21, 2021 at 10:00 AM CET (4:00 AM ET)


Poster Presentations


Poster 2823

Title: Inhibition of hepatitis B surface antigen in chronic hepatitis B subjects by RNA interference therapeutic AB-729 is accompanied by upregulation of HBV-specific T cell activation markers

Presenter: Dr. Emily Thi, Ph.D., Director, Immunology and Biomarkers, Arbutus Biopharma Corp.

Poster available to ILC participants on June 21, 2021 at 10:00 AM CET (4:00 AM ET)


Poster 2822

Title: Inhibition of hepatitis B surface antigen by RNA interference therapeutic AB-729 in chronic hepatitis B patients correlates with suppression of all HBsAg isoforms and HBV RNA

Presenter: Dr. Bhavna Paratala, Ph.D., Senior Scientist, Immunology and Biomarkers, Arbutus Biopharma Corp.

Poster available to ILC participants on June 21, 2021 at 10:00 AM CET (4:00 AM ET)


Poster 2829

Title: A single dose of the GalNAc-siRNA, AB-729, results in prolonged reductions in HBsAg, HBcrAg, HBV DNA and HBV RNA in the absence of nucleos(t)ide analogue therapy in HBeAg negative subjects with chronic hepatitis B infection

Presenter: Prof. Edward Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit

Poster available to ILC participants on June 21, 2021 at 10:00 AM CET (4:00 AM ET)


About AB-729

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Based upon clinical data generated thus far in an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 has demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.


About AB-836

AB-836 is an oral HBV capsid inhibitor. HBV core protein assembles into a capsid structure, which is required for viral replication. The current standard-of-care therapy for HBV, primarily nucleos(t)ide analogues that work by inhibiting the viral polymerase, significantly reduce virus replication, but not completely. Capsid inhibitors inhibit replication by preventing the assembly of functional viral capsids. They also have been shown to inhibit the uncoating step of the viral life cycle thus reducing the formation of new covalently closed circular DNA (cccDNA), the genetic reservoir which the virus uses to replicate itself.


About HBV

Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.


About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily focused on discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple product candidates with distinct mechanisms of action that it believes have the potential to provide a new curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, visit www.arbutusbio.com.


Forward-Looking Statements and Information


This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include, but may not be limited to, statements about Arbutus’ expectations regarding the potential for its product candidates to provide a curative regimen for chronic HBV infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at sec.report. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.


Contact Information

Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: [email protected]

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: [email protected]

 



Qualigen Therapeutics, Inc. to Present at the LD Micro Invitational XI Conference

CARLSBAD, Calif., June 02, 2021 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today that its CEO and Chairman Michael Poirier will present and participate at the virtual LD Micro Invitational XI Conference, hosted by Sequire Virtual Events, taking place on June 8-10, 2021.


Details for this presentation are as follows:

Conference name: LD Micro Invitational XI Conference
Presentation time: Qualigen will present on June 9, 2021 @12:30 pm PT / 3:30 pm ET (Track 4)
Format: LD Micro Invitational XI
Webcast: https://ldmicrojune2021.mysequire.com/Virtual Conference

Qualigen will present on June 9, 2021 at 2:30 pm PT / 3:30 pm ET (Track 4). The presentation will provide an overview of the Company’s therapeutics pipeline which provides multiple opportunities to develop treatments where substantial unmet medical needs exist, especially in oncology and viral diseases. They will also discuss their established line of diagnostics FastPack® products.

Management will be available throughout the day on June 9, 2021 for virtual one-on-one meetings. Please send all meeting requests to: [email protected].

For investors interested in attending, please e-mail [email protected].


About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for 20 years. Our cancer therapeutics pipeline includes QN-247 (formerly referred to as ALAN or AS1411-GNP), RAS-F and STARS. QN-247 is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects; the nanoparticle coating technology is similar to the core nanoparticle coating technology used in our blood-testing diagnostic products. The foundational aptamer of QN-247, QN-165 (formerly referred to as AS1411), is also a drug candidate for treating COVID-19 and other viral-based infectious diseases; we currently plan that our first clinical trial would be a trial of QN-165 against COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes’ proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds.

Because Qualigen’s therapeutic candidates are still in the development stage, Qualigen’s only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world.

The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men’s health, hormone function, and vitamin D status. Qualigen’s facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC.

For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com.

Forward-Looking Statements

This news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. These statements include those related to the Company’s prospects and strategy for the development of therapeutic drug candidates. Actual events or results may differ from the Company’s expectations. For example, there can be no assurance that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company’s drugs or therapeutic devices will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company’s owned and in-licensed patent applications; that such patents, if any, and the Company’s current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company’s prospective therapeutic products; or that the Company will be able to maintain or expand market demand and/or market share for the Company’s diagnostic products. The Company’s stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company’s business (including events beyond the Company’s control, such as epidemics and resulting changes) can be found in the Company’s prior filings with the Securities and Exchange Commission, available at www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

For further information: David Kugelman
Atlanta Capital Partners, LLC
(404) 856-9157 or (866) 692-6847 Toll Free – U.S. & Canada
[email protected]

Tony Schor
Investor Awareness, Inc.
(847) 971-0922
[email protected]

-0-



Southwestern Energy Announces Agreement to Acquire Indigo Natural Resources

Southwestern Energy Announces Agreement to Acquire Indigo Natural Resources

Two premier US natural gas basins, one leading natural gas company

SPRING, Texas–(BUSINESS WIRE)–
Southwestern Energy Company (NYSE: SWN) (the “Company” or “Southwestern”) today announced that it has entered into a definitive merger agreement with Haynesville producer Indigo Natural Resources, LLC (“Indigo”) under which it will acquire Indigo for approximately $2.7 billion. The transaction is expected to close early in the fourth quarter of 2021, subject to customary closing conditions. Transaction highlights include:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210602005565/en/

SWN + Indigo Acreage Position (Graphic: Business Wire)

SWN + Indigo Acreage Position (Graphic: Business Wire)

  • Increases projected cumulative free cash flow to approximately $1.2 billion from 2021 to 2023;
  • Improves estimated 2022 free cash flow per share ~30% and cash flow per debt adjusted share ~15%;
  • Accelerates expected delivery of sustainable leverage ratio below 2.0x in 2021 and progressing to 1.7x in 2022;
  • Expands 2022 estimated margins by 12% resulting from low cost access to premium markets in the growing Gulf Coast LNG corridor;
  • Complements existing portfolio, increases high-return dry gas inventory with over 1,000 locations added; and
  • Leverages operational expertise of integrating and developing operated, large-scale natural gas assets; increases net production to over 4 Bcfe per day, consisting of approximately 85% natural gas.

“Today we are proud to announce another accretive transaction that will benefit the Company’s shareholders for years to come. This acquisition enhances Southwestern’s position as a leading natural gas producer and aligns with our disciplined strategy to generate free cash flow, enhance our balance sheet, optimize performance and build scale. Indigo has done a terrific job building its business, and its balance sheet strength, low cost structure and high-quality acreage position in the core of the Haynesville play accelerates the delivery of our strategic goals,” said Bill Way, Southwestern Energy President and Chief Executive Officer.

Way continued, “Our footprint now extends across the two premier natural gas basins in the country and includes top-tier dry gas and liquids rich inventory. The value of this high-quality inventory is further enhanced by our diverse transportation portfolio providing access to premium markets in the Gulf Coast and within Appalachia. Southwestern Energy’s unique combination of a strong balance sheet, high-quality assets and resilient vertically integrated business is positioned to deliver long-term value creation.”

Indigo is one of the largest private US natural gas producers, with core dry gas assets across the stacked pay Haynesville and Bossier zones in northern Louisiana. Its high-margin assets are located in close proximity to the growing demand in the Gulf Coast LNG corridor. Indigo currently produces 1.0 Bcf per day net and expects to produce approximately 1.1 Bcf per day net upon closing. As of March 31, 2021, and adjusted for the recent sale of its non-core Cotton Valley assets, Indigo had $631 million of net debt and a leverage ratio of 1.1 times.

Outlook

Southwestern Energy expects to invest at maintenance capital levels again in 2022, with activity across all of its operating areas. On the acquired acreage, the Company expects to run a 4 rig program in 2022, placing 30 to 40 wells to sales. With a maintenance capital program, the Company projects 14 years of economic inventory at current strip prices across its assets in Appalachia and Haynesville.

Preliminary 2022 estimates for certain key metrics of the newly combined enterprise are shown below. Estimates are based on $2.75 NYMEX and $58 WTI.

Preliminary 2022 Estimates

 

SWN

 

SWN + Indigo

 

Increase

(Decrease) (1)

 

 

 

 

 

 

 

EBITDA (non-GAAP) ($ in billions)

 

$1.3

 

$2.0

 

54%

Net cash flow (non-GAAP) ($ in billions)

 

$1.2

 

$1.9

 

58%

Capital investment ($ in billions)

 

$0.9

 

$1.4

 

56%

Free cash flow (non-GAAP) ($ in billions)

 

$0.24

 

$0.47

 

96%

Net debt to EBITDA (non-GAAP)

 

2.1x

 

1.7x

 

(0.4x)

E&P margin ($ per Mcfe) (2)

 

$1.15

 

$1.30

 

12%

Net Production (Bcfe/day)

 

3.0

 

4.1

 

37%

(1)

Change represents SWN+Indigo as compared to SWN.

(2)

E&P Margin defined as weighted average realized price less lease operating expenses, general and administrative expenses and taxes other than income.

Synergies are expected to be approximately $20 million in G&A reductions with further operational and financial cost savings anticipated. There are opportunities for additional value creation by leveraging the Company’s core competencies for large scale, operated natural gas development, including its vertically integrated business, reservoir and base decline optimization, and use of innovation and data analytics. The Company’s increased scale provides the opportunity for credit upgrades and cost of capital reductions, which would deliver additional accretion to financial performance.

Transaction and Timing

The total consideration of $2.7 billion will be comprised of $400 million in cash, approximately $1.6 billion in SWN common stock and $700 million of assumed 5.375% senior notes due 2029.

The stock consideration consists of approximately 339 million shares of Southwestern Energy common stock, calculated utilizing the 30-day volume-weighted average price as of May 28, 2021, of $4.72. No Indigo shareholder will receive more than 10% of Southwestern Energy’s pro forma outstanding shares in connection with this transaction.

The transaction was unanimously approved by each of Southwestern Energy’s and Indigo’s board of directors. The transaction is expected to close early in the fourth quarter of 2021, subject to regulatory approvals, customary closing conditions and the approval by Southwestern Energy’s shareholders.

Advisors

Goldman Sachs & Co. LLC served as the exclusive financial advisor to Southwestern and Skadden, Arps, Slate, Meagher & Flom LLP serve as legal advisor. Credit Suisse Securities (USA) LLC served as the exclusive financial advisor to Indigo and Kirkland & Ellis LLP served as legal advisor.

Conference Call

Southwestern Energy will host a conference call today, June 2, 2021, at 10:00 a.m. Central to discuss this transaction. To participate, dial US toll-free 877-883-0383, or international 412-902-6506 and enter access code 0998867. A live webcast will also be available at ir.swn.com.

About Southwestern Energy

Southwestern Energy Company is an independent energy company engaged in natural gas, natural gas liquids and oil exploitation, development, production and marketing.

About Indigo Natural Resource

Indigo Natural Resources LLC is one of the largest natural gas producers in the Haynesville Shale and the third largest private natural gas producer in the U.S. Indigo is an experienced operator, focused in northern Louisiana with direct access to Gulf Coast markets and associated industrial and LNG demand growth. Indigo is headquartered in Houston, Texas. For more information, please visit the Company’s website at www.ndgo.com.

Forward-Looking Statements

Certain statements and information in this news release may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act, as amended. The words “believe,” “expect,” “anticipate,” “plan,” “predict,” “intend,” “seek,” “foresee,” “should,” “would,” “could,” “attempt,” “appears,” “forecast,” “outlook,” “estimate,” “project,” “potential,” “may,” “will,” “likely,” “guidance,” “goal,” “model,” “target,” “budget” and other similar expressions are intended to identify forward-looking statements, which are generally not historical in nature. Statements may be forward looking even in the absence of these particular words. Examples of forward-looking statements include, but are not limited to, statements regarding the proposed acquisition of Indigo Natural Resources LLC (the “Proposed Transaction”), expected synergies and other benefits from and costs in connection with the Proposed Transaction, estimated financial metrics giving effect to the Proposed Transaction, our financial position, business strategy, production, reserve growth and other plans and objectives for our future operations, and generation of free cash flow. These forward-looking statements are based on our current expectations and beliefs concerning future developments and their potential effect on us. The forward-looking statements contained in this document are largely based on our expectations for the future, which reflect certain estimates and assumptions made by our management. These estimates and assumptions reflect our best judgment based on currently known market conditions, operating trends, and other factors. Although we believe such estimates and assumptions to be reasonable, they are inherently uncertain and involve a number of risks and uncertainties that are beyond our control. As such, management’s assumptions about future events may prove to be inaccurate. For a more detailed description of the risks and uncertainties involved, see “Risk Factors” in our most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other SEC filings. We do not intend to publicly update or revise any forward-looking statements as a result of new information, future events, changes in circumstances, or otherwise. These cautionary statements qualify all forward-looking statements attributable to us, or persons acting on our behalf. Management cautions you that the forward-looking statements contained herein are not guarantees of future performance, and we cannot assure you that such statements will be realized or that the events and circumstances they describe will occur. Factors that could cause actual results to differ materially from those anticipated or implied in the forward-looking statements herein include, but are not limited to: the timing and extent of changes in market conditions and prices for natural gas, oil and natural gas liquids (“NGLs”), including regional basis differentials and the impact of reduced demand for our production and products in which our production is a component due to governmental and societal actions taken in response to COVID-19 or other public health crises and any related company or governmental policies and actions to protect the health and safety of individuals or governmental policies or actions to maintain the functioning of national or global economies and markets; our ability to fund our planned capital investments; a change in our credit rating, an increase in interest rates and any adverse impacts from the discontinuation of the London Interbank Offered Rate; the extent to which lower commodity prices impact our ability to service or refinance our existing debt; the impact of volatility in the financial markets or other global economic factors; difficulties in appropriately allocating capital and resources among our strategic opportunities; the timing and extent of our success in discovering, developing, producing and estimating reserves; our ability to maintain leases that may expire if production is not established or profitably maintained; our ability to realize the expected benefits from recent acquisitions or the Proposed Transaction; costs in connection with the Proposed Transaction; the consummation of or failure to consummate the Proposed Transaction and the timing thereof; costs in connection with the Proposed Transaction; integration of operations and results subsequent to the Proposed Transaction; our ability to transport our production to the most favorable markets or at all; the impact of government regulation, including changes in law, the ability to obtain and maintain permits, any increase in severance or similar taxes, and legislation or regulation relating to hydraulic fracturing, climate and over-the-counter derivatives; the impact of the adverse outcome of any material litigation against us or judicial decisions that affect us or our industry generally; the effects of weather; increased competition; the financial impact of accounting regulations and critical accounting policies; the comparative cost of alternative fuels; credit risk relating to the risk of loss as a result of non-performance by our counterparties; and any other factors listed in the reports we have filed and may file with the SEC that are incorporated by reference herein. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.

Use of Non-GAAP Information

This news release contains non-GAAP financial measures, such as net cash flow, free cash flow, net debt and adjusted EBITDA, including certain key statistics and estimates. We report our financial results in accordance with accounting principles generally accepted in the United States of America (“GAAP”). However, management believes certain non-GAAP performance measures may provide users of this financial information additional meaningful comparisons between current results and the results of our peers and of prior periods. Please see the Appendix for definitions of the non-GAAP financial measures that are based on reconcilable historical information.

Additional Information and Where To Find It

This news release is being made in respect of the proposed acquisition (the “Proposed Transaction”) of Indigo Natural Resources LLC (“Indigo”) by Southwestern Energy Company (“SWN”). The issuance of the stock consideration for the Proposed Transaction will be submitted to the shareholders of SWN for their approval. In connection with the proposed transaction, SWN will file with the U.S. Securities and Exchange Commission (the “SEC”) a proxy statement (the “proxy statement”). INVESTORS AND SHAREHOLDERS OF SWN ARE URGED TO CAREFULLY READ THE PROXY STATEMENT, AND OTHER RELEVANT DOCUMENTS TO BE FILED WITH THE SEC BY SWN, IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SWN, INDIGO, THE PROPOSED TRANSACTION AND RELATED MATTERS. The definitive proxy statement and other relevant materials (when they become available) and any other documents filed by SWN with the SEC may be obtained free of charge at the SEC’s website, at www.sec.gov or through SWN’s website at www.swn.com. These documents may also be obtained free of charge from SWN by requesting them by mail at Investor Relations, 10000 Energy Drive, Spring, Texas 77389, or by telephone at (832) 796-7906.

Participants in the Solicitation

SWN and its directors, executive officers and certain other members of management and employees may be deemed to be participants in the solicitation of proxies from SWN’s shareholders with respect to the approval of the issuance of shares of SWN common stock in the Proposed Transaction. Information regarding the ownership of SWN’s stock and other securities by SWN’s directors and executive officers is included in SEC filings on Forms 3, 4, and 5, which can be found through SWN’s website (www.swn.com) or through the SEC’s website at www.sec.gov. Information can also be found in SWN’s other SEC filings, including the company’s Annual Report on Form 10-K for the fiscal year ended 2020 filed with the SEC on March 1, 2021, and its definitive proxy statement for the 2021 annual meeting of shareholders filed with the SEC on April 8, 2021. More detailed and updated information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement and other materials to be filed with the SEC in connection with the Proposed Transaction. Shareholders should read the proxy statement carefully when it becomes available before making any voting or other decisions.

Use of Projections

The financial, operational, industry and market projections, estimates and targets in this news release are forward-looking statements that are based on assumptions that are inherently subject to significant uncertainties and contingencies, many of which are beyond SWN’s and Indigo’s control. The assumptions and estimates underlying the projected, expected or target results are inherently uncertain and are subject to a wide variety of significant business, economic, regulatory and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the financial, operational, industry and market projections, estimates and targets, including assumptions, risks and uncertainties described in “Forward-looking Statements” above.

Explanation of Non-GAAP Financial Measures

The Company reports its financial results in accordance with accounting principles generally accepted in the United States of America (“GAAP”). However, management believes certain non-GAAP performance measures may provide financial statement users with additional meaningful comparisons between current results, the results of its peers and of prior periods.

Non-GAAP financial measures the Company may present from time to time are net debt, net cash flow, free cash flow and EBITDA, which excludes certain charges or amounts. Net debt is defined as short-term debt plus long-term debt less cash and cash equivalents. EBITDA is defined as net income (loss) plus interest, income tax expense (benefit), depreciation, depletion and amortization, expenses associated with the restructuring charges, impairments, legal settlements and gains (losses) on unsettled derivatives less gains (losses) on sale of assets and gains on early extinguishment of debt over the prior 12 month period. Net cash flow is defined as cash flow from operating activities before changes in operating assets and liabilities. Free cash flow is defined as net cash flow less accrual based capital expenditures, and estimated free cash flow for future periods is based on strip pricing as of April 30, 2021. The Company has included information concerning Net debt / EBITDA because it is used by certain investors as a measure of the ability of a company to service or incur indebtedness and because it is a financial measure commonly used in the energy industry. Net debt / EBITDA should not be considered in isolation or as a substitute for net income, net cash provided by operating activities or other income or cash flow data prepared in accordance with generally accepted accounting principles or as a measure of the Company’s profitability or liquidity. Net debt / EBITDA, as defined above, may not be comparable to similarly titled measures of other companies. Management presents these measures because (i) they are consistent with the manner in which the Company’s position and performance are measured relative to the position and performance of its peers, (ii) these measures are more comparable to earnings estimates provided by securities analysts, and (iii) charges or amounts excluded cannot be reasonably estimated and guidance provided by the Company excludes information regarding these types of items. These adjusted amounts are not a measure of financial performance under GAAP.

The Company does not provide a reconciliation to estimated free cash flow because the Company does not provide the GAAP financial measures of net income or loss or net cash provided by operating activities on a forward-looking basis because it is unable to predict, without unreasonable effort, certain components thereof including, but not limited to capital expenditures, production and realized prices for production. These items are inherently uncertain and depend on various factors, many of which are beyond its control. As such, any associated estimate and its impact on GAAP performance and cash flow measures could vary materially based on a variety of acceptable management assumptions.

Investor Contacts

Brittany Raiford

Director, Investor Relations

(832) 796-7906

[email protected]

Bernadette Butler

Investor Relations Advisor

(832) 796-6079

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Energy Natural Resources Oil/Gas

MEDIA:

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SWN + Indigo Acreage Position (Graphic: Business Wire)

Origin Materials to Participate in Upcoming Investor Events

Origin Materials to Participate in Upcoming Investor Events

WEST SACRAMENTO, Calif.–(BUSINESS WIRE)–Origin Materials, Inc. (“Origin Materials”), the world’s leading carbon negative materials company, today announced its participation in several upcoming investor events:

  • Reddit Ask Me Anything (June 3, 2021)
  • ICR De-SPAC Webinar hosted by Stephens’ Analyst Mark Connelly (June 4, 2021)
  • Morgan Stanley 6th Annual Sustainable Futures Conference (June 9-10, 2021)
  • Raymond James Renewable Energy and Clean Technology Call Series – Origin Materials (June 9, 2021)

The Reddit Ask Me Anything and ICR De-SPAC event will be open to the public. Additional details will be posted to Origin Materials’ social media channels.

About Origin Materials

Headquartered in West Sacramento, Origin Materials is the world’s leading carbon negative materials company. Origin Materials’ mission is to enable the world’s transition to sustainable materials. Over the past 10 years, Origin Materials has developed a platform for turning the carbon found in non-food biomass into useful materials, while capturing carbon in the process. Origin Materials’ patented drop-in core technology, economics and carbon impact are supported by a growing list of major global customers and investors. Origin Materials’ first commercial plant is expected to be operational in 2022 with a second commercial plant expected to be operational by 2025 and plans for additional expansion over the next decade.

On February 17, 2021, Origin Materials and Artius Acquisition Inc. (“Artius”) (Nasdaq: AACQU, AACQ), a publicly-traded special purpose acquisition company, announced a definitive agreement for a business combination that is expected to result in Origin Materials becoming a public company. Upon closing of the transaction, expected in the second quarter of 2021, the combined company will be named Origin Materials and remain listed on the Nasdaq under the new ticker symbol “ORGN.” The transaction, together with anticipated financing and grants, is expected to fully fund Origin Materials until EBITDA positive, and allow Origin Materials to scale and commence commercial production to begin to meet signed customer offtake and capacity reservations of $1.9 billion across a diverse range of industries.

For more information, visit www.originmaterials.com.

Important Information for Investors and Shareholders

In connection with the proposed business combination transaction, Artius filed an amended registration statement on Form S-4 (the “Registration Statement”) with the SEC on May 3, 2021, which includes a proxy statement to be distributed to holders of Artius’s ordinary shares in connection with Artius’s solicitation of proxies for the vote by Artius’s shareholders with respect to the proposed transaction and other matters as described in the Registration Statement, as well as the prospectus relating to the offer of securities to be issued to Artius’s shareholders and Origin Materials’ stockholders in connection with the proposed transaction. The Registration Statement was declared effective on May 27, 2021, and the definitive proxy statement/prospectus and other proxy materials were mailed on or about June 1, 2021 to Artius’s shareholders of record as of May 19, 2021. Investors and security holders and other interested parties are urged to read the definitive proxy statement/prospectus, any amendments thereto and any other documents filed with the SEC carefully and in their entirety when they become available because they will contain important information about Artius, Origin Materials and the proposed transaction. The documents relating to the proposed transaction can be obtained free of charge from the SEC’s website at www.sec.gov. Free copies of these documents may also be obtained from Artius by directing a request to: Artius Management LLC, 3 Columbus Circle, Suite 2215, New York, New York 10019.

Cautionary Note on Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including with respect to the proposed transaction between Origin Materials and Artius. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding Origin Materials’ business strategy, estimated total addressable market, commercial and operating plans, product development plans and projected financial information. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management of Origin Materials and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Origin Materials and Artius. These forward-looking statements are subject to a number of risks and uncertainties, including that Origin Materials may be unable to successfully commercialize its products; the effects of competition on Origin Materials’ business; the uncertainty of the projected financial information with respect to Origin Materials; disruptions and other impacts to Origin Materials’ business as a result of the COVID-19 pandemic and other global health or economic crises; changes in customer demand; Origin Materials and Artius may be unable to successfully or timely consummate the proposed business combination, including the risk that any regulatory approvals may not obtained, may be delayed or may be subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the business combination, or that the approval of the shareholders of Artius or stockholders of Origin Materials may not be obtained; failure to realize the anticipated benefits of the business combination; the amount of redemption requests made by Artius’s shareholders, and those factors discussed in the Registration Statement under the heading “Risk Factors,” and other documents Artius has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Artius and Origin Materials presently do not know, or that Artius and Origin Materials currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Artius’s and Origin Materials’ expectations, plans, or forecasts of future events and views as of the date of this press release. Artius and Origin Materials anticipate that subsequent events and developments will cause its assessments to change. However, while Artius and Origin Materials may elect to update these forward-looking statements at some point in the future, Artius and Origin Materials specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Artius’s and Origin Materials’ assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Participants in the Solicitation

Artius, Origin Materials and their respective directors, executive officers and employees and other persons may be deemed to be participants in the solicitation of proxies from Artius’s shareholders in connection with the proposed business combination. Information about Artius’s directors and executive officers and their ownership of Artius’s securities is set forth in the Registration Statement described above. Additional information regarding the interests of those persons who may be deemed participants in the solicitation of proxies in connection with the proposed transaction is set forth in the definitive proxy statement/prospectus.

Non-Solicitation

This communication is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Artius, the combined company or Origin Materials, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Origin Investors:

[email protected]

Media:

[email protected]

Artius Investors:

Jason Ozone

[email protected]

+1-212-309-7668

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Engineering Other Natural Resources Chemicals/Plastics Environment Manufacturing Natural Resources

MEDIA:

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World Health Organization Authorizes SINOVAC’s CoronaVac® for Emergency Use

World Health Organization Authorizes SINOVAC’s CoronaVac® for Emergency Use

BEIJING–(BUSINESS WIRE)–
SINOVAC Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed by SINOVAC Life Sciences Co., Ltd. (“SINOVAC”), a subsidiary of the Company, was approved for emergency use under the World Health Organization (“WHO”) Emergency Use Listing (“EUL”) procedure. Prior to this, the Strategic Advisory Group of Experts on Immunization (“SAGE”) had recommended CoronaVac® for use in adults 18 years and older in a two-dose schedule with an interval of 2 to 4 weeks.

The WHO EUL procedure is a technical review process to assess and review unlicensed vaccines and other products to expedite their availability to people affected by public health emergencies. SINOVAC had submitted clinical and non-clinical research data, as well as manufacturing and control (“CMC”) data, to the WHO review group to evaluate the quality, safety, efficacy data and risk management plan of CoronaVac®. In February 2021, the WHO conducted an on-site inspection of SINOVAC’s manufacturing facilities of CoronaVac®, as well as its quality management system. SAGE also conducted a systematic review of CoronaVac® and concluded that the benefits of using SINOVAC’s inactivated coronavirus vaccine are greater than the known risks, recommending the use of this vaccine.

In addition, the European Medicine Agency (“EMA”) has initiated the rolling review of CoronaVac®. This marks the first step in the process for CoronaVac® to obtain EU approval for use.

Mr. Weidong Yin, the Chairman, President, and CEO of SINOVAC, said, “The phase III clinical research and follow-up real-world studies in Brazil, Turkey, Indonesia and Chile represent good examples of the collaborative, global action against the pandemic. These studies have provided a solid scientific foundation for CoronaVac® to be approved by more than 40 countries, as well as the WHO. These achievements could not have happened without the efforts of global partners and scientists. As the COVID-19 pandemic persists, SINOVAC will continue to participate in pandemic prevention and control actions, acknowledging the value of China’s COVID-19 vaccine as a global public good and contributing to the international triumph over the COVID-19 pandemic.

In June 2020, CoronaVac® became the first vaccine approved for emergency use in China and was further approved for conditional marketing use on February 5th, 2021.

On April 1st, 2021, the third phase of a CoronaVac® bulk production manufacturing facility was completed and began operations, allowing the annual production capacity to exceed 2 billion doses. SINOVAC’s manufacturing control system of CoronaVac® has been inspected by China, Brazil, Indonesia, Chile and Saudi Arabia, as well as the WHO. Large-scale production of hundreds of batches have proven the stability and reliability of SINOVAC’s vaccine manufacturing control system. At this time, SINOVAC has provided CoronaVac® to nearly 40 countries and regions, including mainland China, directly and indirectly. The total supply has already exceeded 600 million doses. Moreover, according to incomplete statistics, over 430 million doses have been administrated worldwide. SINOVAC has become the largest domestic supplier and exporter of China’s COVID-19 vaccine. The safety and effectiveness of CoronaVac® has been verified all over the world.

About SINOVAC

SINOVAC Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent pneumococcal polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella and mumps. SINOVAC’s COVID-19 vaccine, CoronaVac®, has been granted emergency use approval or conditional marketing authorization by over 40 countries or regions worldwide. Healive®, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by SINOVAC against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, SINOVAC was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing several new products including a Sabin-strain inactivated polio vaccine and combined vaccines. SINOVAC primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China. For more information please see the Company’s website at www.sinovac.com.

Safe Harbor Statement

This press release may include certain statements that are not descriptions of historical facts, but are forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Forward-looking statements involve risks, uncertainties, and other factors that could cause actual results to differ materially from those contained in any such statements. In particular, the outcome of any litigation is uncertain, and the Company cannot predict the potential results of the litigation it filed or filed against it by others. Additionally, the triggering of a shareholder rights plan is nearly unprecedented, and the Company cannot predict the impact on the Company or its stock price as a result of the trigger of the rights plan.

SINOVAC Biotech Ltd.

Helen Yang

Tel: +86-10-8279-9871 or

+86-10-5693-1897

Fax: +86-10-6296-6910

Email: [email protected]

ICR Inc.

Bill Zima

U.S.: 1-646-308-1707

Email: [email protected]

KEYWORDS: China Asia Pacific

INDUSTRY KEYWORDS: Research Medical Devices Medical Supplies Infectious Diseases Biotechnology Health Pharmaceutical Other Science Science

MEDIA:

Nicholas Financial Reports 4th Quarter and Fiscal Year 2021 Results

  • Income year-over-year before income taxes for the three months ended March 31, 2021 increased by 399.6% compared to prior year fourth quarter
  • Pre-tax yield as a percentage of average finance receivables for the three months ended March 31, 2021 increased to 4.92% compared to 1.03% during the prior year fourth quarter
  • Net Portfolio Yield for the three months ended March 31, 2021 increased to 24.22% compared to 17.10% during the prior year fourth quarter
  • Contracts purchased year-over-year for the three months ended March 31, 2021 increased by 25.3% compared to prior year fourth quarter
  • Amount financed year-over-year on Direct Loans for the three months ended March 31, 2021 increased by 5.8% compared to prior year fourth quarter
  • Accounts 60+ days delinquent decreased to 1.9%, excluding Chapter 13 bankruptcy accounts, compared to 2.9% as of the prior year fourth quarter

CLEARWATER, Fla., June 02, 2021 (GLOBE NEWSWIRE) — Nicholas Financial, Inc. (NASDAQ: NICK) announced net income for the three months ended March 31, 2021 of $1.9 million compared to $2.3 million for the three months ended March 31, 2020. Diluted net income per share was $0.24 for the three months ended March 31, 2021 as compared to $0.29 for the three months ended March 31, 2020. Total revenue decreased 10.8% to $13.3 million for the three months ended March 31, 2021 as compared to $14.9 million for the three months ended March 31, 2020, which included gains of $0.5 million on equity investments during the three months ended March 31, 2021. The Company reported income before income taxes for the three months ended March 31, 2021 of $2.8 million compared to $0.6 million for the three months ended March 31, 2020. The Company recorded an income tax expense of approximately $0.9 million during the three months March 31, 2021 compared to an income tax benefit of $1.7 million during the three months ended March 31, 2020.

The Company announced net income for the year ended March 31, 2021 of $8.4 million compared to $3.5 million for the year ended March 31, 2020. Diluted net income per share was $1.09 for the year ended March 31, 2021 as compared to $0.45 for the year ended March 31, 2020. Total revenue decreased 9.8% to $56.0 million for the year ended March 31, 2021 as compared to $62.1 million for the year ended March 31, 2020, which included gains of $1.8 million on equity investments during the year ended March 31, 2021. The Company reported income before income taxes for the year ended March 31, 2021 of $10.9 million compared to $2.2 million for the year ended March 31, 2020. The Company recorded an income tax expense of approximately $2.6 million during the year ended March 31, 2021 compared to an income tax benefit of $1.2 million during the year ended March 31, 2020.

For the year ended March 31, 2021, the Company originated $88.2 million in finance receivables, collected $118.6 million in principal payments, reduced debt by a net amount of $35.3 million, repurchased $0.9 million of common stock, and increased cash by $8.3 million.

“We are very pleased with our 4th Quarter and overall Fiscal Year-end results,” commented Doug Marohn, President and CEO of Nicholas Financial, Inc. “We continue to produce excellent portfolio performance, recognizing very low delinquency and net write-offs, the likes of which we have not seen in years. We were also able to enjoy year-over-year increases in both Indirect and Direct originations and loan volumes. The year-over-year increase on Indirect originations was the first we have seen since my return to Nicholas, and it was especially gratifying to see this during the pandemic.”

“The ability to once again report substantially increased earnings is a testament to our core business strategy as well as to the hard-working men and women who execute that strategy every day,” Marohn continued. “Our commitment to the branch-based model with a local office in every market we service allows us to better support our dealer partners and our borrowing customers. This approach has also facilitated the expansion of our Direct Loan products to virtually every NFI branch office. As we continue to increase our core product market share in the existing branch markets, we remain focused on growing the Direct Loan business, as well as expanding our branch network in Western States.”

   
Key Performance Indicators on Contracts Purchased  
(Purchases in thousands)  
      Number of       Principal      Average                              
Fiscal Year     Contracts     Amount     Amount     Average       Average       Average  
/Quarter     Purchased     Purchased#     Financed*^     APR*       Discount%*       Term*  
2021       7,307     $ 74,025     $ 10,135       23.4   %     7.5   %     46  
4       2,429       24,637       10,143       23.2   %   7.5   %     46  
3       1,483       15,285       10,307       23.4   %     7.5   %     46  
2       1,709       17,307       10,127       23.5   %     6.8   %     46  
1       1,686       16,796       9,962       23.5   %     8.0   %     46  
2020       7,647     $ 76,696     $ 10,035       23.4   %     7.9   %     47  
4       1,991       19,658       9,873       23.5   %   7.9   %     46  
3       1,753       17,880       10,200       23.3   %   7.6   %     47  
2       2,011       20,104       9,997       23.5   %   7.9   %     46  
1       1,892       19,054       10,071       23.4   %   8.3   %     47  
2019       7,684     $ 77,499     $ 10,086       23.5   %     8.2   %     47  
4       2,151       21,233       9,871       23.5   %     8.0   %     46  
3       1,625       16,476       10,139       23.5   %     8.1   %     47  
2       1,761       17,845       10,133       23.5   %     8.4   %     47  
1       2,147       21,945       10,221       23.7   %     8.3   %     48  

Key Performance Indicators on Direct Loans Originated

(Originations in thousands)
 
    Number of     Principal     Average                    
Fiscal Year   Loans     Amount     Amount     Average       Average  
/Quarter   Originated     Originated     Financed*^     APR*       Term*  
2021     3,497     $ 14,148     $ 4,131       29.6   %     25  
4     753       3,284       4,362       29.6   %     25  
3     1,265       4,605       3,641       30.9   %     22  
2     924       3,832       4,147       29.2   %     25  
1     555       2,427       4,373     28.7   %     26  
2020     3,142     $ 12,638     $ 4,017     28.2   %     25  
4     720       3,104       4,310     28.6   %     25  
3     1,137       4,490       3,949     28.4   %     24  
2     739       2,988       4,043     27.4   %     25  
1     546       2,056       3,765     28.2   %     24  
2019     1,918     $ 7,741     $ 4,036     26.4   %     25  
4     236       1,240       4,654     27.3   %     24  
3     738       2,999       4,063     25.9   %     25  
2     495       1,805       3,646     26.5   %     25  
1     449       1,697       3,779     25.7   %     28  

*Each average included in the tables is calculated as a simple average.

^Average amount financed is calculated as a single loan amount.

#Bulk portfolio purchase excluded for period-over-period comparability

Nicholas Financial, Inc. (NASDAQ:NICK) is a specialized consumer finance company, operating branch locations in primarily Southeastern and Midwestern U.S. States. The Company engages primarily in acquiring and servicing automobile finance installment contracts (“Contracts”) for purchases of used and new automobiles and light trucks. Additionally, Nicholas Financial originates direct consumer loans (“Direct Loans”) and sells consumer-finance related products. For an index of Nicholas Financial, Inc’s new releases or to obtain a specific release, please visit our website at www.nicholasfinancial.com.

Cautionary Note regarding Forward-Looking Statements

Except for the historical information contained herein, the matters discussed in this news release include forward-looking statements, including expectations regarding the impact of COVID-19 on the Company’s business, its ability to obtain the expected financial and tax benefits from the CARES Act, and its ability to obtain loan forgiveness under its PPP loan, that involve risks and uncertainties, including risk relating to competition and our ability to increase and maintain yield and profitability at desirable levels, as well as risks relating to general economic conditions, including in connection with the current COVID-19 pandemic, access to bank financing, our ability to expand the geographical scope of, and otherwise continue growing, our Direct Loan operations, and other risks detailed from time to time in the Company’s filings and reports with the Securities and Exchange Commission including the Company’s Annual Report on Form 10-K for the year ended March 31, 2020. When used in this document, the words “anticipate”, “estimate”, “expect”, “will”, “may”, “plan,” “believe”, “intend” and similar expressions are intended to identify forward-looking statements. Such statements are based on the beliefs of Company management as well as assumptions made by and information currently available to Company management. Actual events or results may differ materially from those anticipated, estimated or expect. All forward-looking statements and cautionary statements included in this document are made as of the date hereof based on information available to the Company as of the date hereof, and the Company assumes no obligation to update any forward-looking statement or cautionary statement.

Nicholas Financial, Inc.

Condensed Consolidated Statements of Income

(Unaudited, Dollars in Thousands, Except Share and Per Share Amounts)

  Three months ended     Twelve months ended  
    March 31,     March 31,  
    2021     2020     2021     2020  
Revenue:                                  
Interest and fee income on finance receivables   $ 12,816     $ 14,896     $ 54,211       $ 62,095  
Gain on equity investments     470             1,809          
Total revenue     13,286       14,896       56,020         62,095  
Expenses:                                  
Operating expenses     8,963       8,583       31,844         34,432  
Provision for credit losses     250       3,919       7,250         16,901  
Interest expense     1,320       1,843       5,980         8,515  
Total expenses     10,533       14,345       45,074         59,848  
Income before income taxes     2,753       551       10,946         2,247  
Income tax expense (benefit)     884       (1,744 )     2,595         (1,219 )
Net income   $ 1,869     $ 2,295     $ 8,351       $ 3,466  
Earnings per share:                                  
Basic   $ 0.24     $ 0.29     $ 1.09       $ 0.45  
Diluted   $ 0.24     $ 0.29     $ 1.09       $ 0.45  
                                   

Condensed Consolidated Balance Sheets

(Unaudited, In Thousands)

    March 31,     March 31,  
    2021     2020  
Cash and restricted cash   $ 32,977     $ 24,684  
Finance receivables, net     170,318       199,781  
Repossessed assets     685       1,340  
Operating lease right-of-use assets     3,392       2,598  
Other assets     5,066       10,415  
Total assets   $ 212,438     $ 238,818  
Credit facility, net of debt issuance costs   $ 86,154     $ 124,255  
Note payable     3,244        
Operating lease liabilities     3,367       2,652  
Other liabilities     4,451       4,332  
Total liabilities     97,216       131,239  
Shareholders’ equity     115,222       107,579  
Total liabilities and shareholders’ equity   $ 212,438     $ 238,818  
Book value per share   $ 14.95     $ 13.78  

               
    Three months ended     Twelve months ended    
    March 31,     March 31,    
    (In thousands)     (In thousands)    
Portfolio Summary   2021     2020     2021     2020    
Average finance receivables (1)   $ 185,750     $ 213,666     $ 199,102       $ 226,541    
Average indebtedness (2)   $ 92,761     $ 121,733     $ 107,615       $ 132,552    
Interest and fee income on finance receivables   $ 12,816     $ 14,896     $ 54,211       $ 62,095    
Interest expense     1,320       1,843       5,980         8,515    
Net interest and fee income on finance receivables   $ 11,496     $ 13,053     $ 48,231       $ 53,580    
Portfolio yield (3)     27.60   %   27.89   %   27.23   %     27.41   %
Interest expense as a percentage of average finance receivables     2.84   %   3.45   %   3.00   %     3.76   %
Provision for credit losses as a percentage of average finance receivables     0.54   %   7.34   %   3.64   %     7.46   %
Net portfolio yield (3)     24.22   %   17.10   %   20.59   %     16.19   %
Operating expenses as a percentage of average finance receivables     19.30   %   16.07   %   15.99   %     15.20   %
Pre-tax yield as a percentage of average finance receivables (4)     4.92   %   1.03   %   4.60   %     0.99   %
Net charge-off percentage (5)     6.83   %   11.29   %   6.16   %     10.01   %
Finance receivables                   $ 184,237       $ 219,366    
Allowance percentage (6)                     3.34   %     5.09   %
Total reserves percentage (7)                     7.49   %     9.18   %

Note: All three-month statement of income performance indicators expressed as percentages have been annualized.        

(1) Average finance receivables represent the average of finance receivables throughout the period.
(2) Average indebtedness represents the average outstanding borrowings under the Credit Facility.
(3) Portfolio yield represents interest and fee income on finance receivables as a percentage of average finance receivables. Net portfolio yield represents (a) interest and fee income on finance receivables minus (b) interest expense minus (c) the provision for credit losses, as a percentage of average finance receivables.
(4) Pre-tax yield represents net portfolio yield minus operating expenses, as a percentage of average finance receivables.
(5) Net charge-off percentage represents net charge-offs (charge-offs less recoveries) divided by average finance receivables, outstanding during the period.
(6) Allowance percentage represents the allowance for credit losses divided by finance receivables outstanding as of ending balance sheet date.
(7) Total reserves percentage represents the allowance for credit losses, purchase price discount, and unearned dealer discounts divided by finance receivables outstanding as of ending balance sheet date.
   

The following tables present certain information regarding the delinquency rates experienced by the Company with respect to automobile finance installment contracts (“Contracts”) and direct consumer loans (“Direct Loans”), excluding any Chapter 13 bankruptcy accounts:

(In thousands, except percentages)

Contracts   Balance                                                  
    Outstanding     30 – 59 days     60 – 89 days       90 – 119 days       120+       Total    
March 31, 2021   $ 170,195     $ 6,289     $ 2,430       $ 896       $ 42       $ 9,657    
              3.70   %   1.43   %     0.53   %     0.02   %     5.67   %
March 31, 2020   $ 207,247     $ 14,977     $ 4,290       $ 1,893       $ 19       $ 21,179    
              7.23   %   2.07   %     0.91   %     0.01   %     10.22   %
             
Direct Loans   Balance                                                  
    Outstanding     30 – 59 days     60 – 89 days       90 – 119 days       120+       Total    
March 31, 2021   $ 13,909     $ 253     $ 101       $ 81       $ 10       $ 445    
              1.82   %   0.73   %     0.58   %     0.07   %     3.20   %
March 31, 2020   $ 11,844     $ 344     $ 136       $ 59       $ 0       $ 539    
              2.90   %   1.15   %     0.50   %     0.00   %     4.55   %
                                                         

The following table presents selected information on Contracts purchased and Direct Loans originated by the Company:    

    Contracts     Direct Loans    
    Three months ended     Three months ended    
    March 31,     March 31,    
    (Purchases in thousands)     (Originations in thousands)    
    2021     2020     2021     2020    
Purchases/Originations   $ 24,637     $ 19,658     $ 3,284       $ 3,104    
Average APR     23.2   %   23.5   %   29.6   %   28.6   %
Average discount     7.5   %   7.9   % N/A       N/A    
Average term (months)     46       46       25         25    
Average amount financed   $ 10,143     $ 9,873     $ 4,362       $ 4,310    
Number of contracts     2,429       1,991       753         720    
                                     
    Contracts     Direct Loans    
    Twelve months ended     Twelve months ended    
    March 31,     March 31,    
    (Purchases in thousands)     (Originations in thousands)    
    2021     2020     2021     2020    
Purchases/Originations   $ 74,025     $ 76,696     $ 14,148       $ 12,638    
Average APR     23.4   %   23.4   %   29.6   %     28.2   %
Average discount     7.5   %   7.9   % N/A       N/A    
Average term (months)     46       47       25         25    
Average amount financed   $ 10,135     $ 10,035     $ 4,131       $ 4,017    
Number of contracts     7,307       7,647       3,497         3,142    
                                     

The following table presents selected information on the entire Contract and Direct Loan portfolios of the Company:

    Contracts     Direct Loans    
    As of     As of    
    March 31,     March 31,    
Portfolio   2021     2020     2021     2020    
Average APR     22.8   %   22.6   %   28.5   %     27.3   %
Average discount     7.6   %   7.6   % N/A       N/A    
Average term (months)     51     52     26       26    
Number of active contracts     22,760       26,894       4,017         3,481    

Contact:  Irina Nashtatik   NASDAQ: NICK
  CFO
Ph # (727)-726-0763
  Web site: www.nicholasfinancial.com



Arrowhead Pharmaceuticals to Participate in Upcoming Conferences

 Arrowhead Pharmaceuticals to Participate in Upcoming Conferences

PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events:

Jefferies Virtual Healthcare Conference – June 1-4, 2021

June 3, 2021, 2:30 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

Goldman Sachs 42nd Annual Global Healthcare Conference – June 8-11, 2021

June 10, 2021, 2:10 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

2021 Virtual Alpha-1 National Conference – June 10-12, 2021

June 12, 2021 – Javier San Martin, M.D., Arrowhead’s chief medical officer, will deliver an oral presentation

Virtual Dana-Farber Harvard Cancer Center Symposium on HIF, VHL, and Kidney Cancer – June 17, 2021

June 17, 2021 – So Wong, Ph.D., Arrowhead’s senior director of biology, will deliver an oral presentation on the preclinical development of ARO-HIF2

LifeSci Partners Genetic Medicines Summit 2021 – June 22, 2021

June 22, 2021 – Members of Arrowhead management will participate in a fireside chat presentation

The International Liver Congress™ 2021 – The Annual Meeting of the European Association for the Study of the Liver (EASL) – June 23-26, 2021

Title: ARO-HSD reduces hepatic HSD17B13 mRNA expression and protein levels in patients with suspected NASH

Authors: Edward Gane, et al.

Type: Late-Breaking Poster

Date and Time: June 23, 2021 at 8:00 CEST

Title: Short interfering RNA JNJ-3989 combination therapy in chronic hepatitis B shows potent reduction of all viral markers but no correlate was identified for HBsAg reduction and baseline factors

Authors: Edward Gane, et al.

Type: Oral Presentation

Date and Time: June 25, 2021 at 15:15 CEST

Title: ARO-AAT an investigational RNAi therapeutic demonstrates improvement in liver fibrosis with reduction in intra-hepatic Z-AAT burden

Authors: Pavel Strnad, et al.

Type: Late-Breaking Oral Presentation

Date and Time: June 26, 2021 at 12:15 CEST

28th Annual FSHD Society International Research Congress – June 24-25, 2021

June 25, 2021 – Jonathan Van Dyke, Ph.D., Arrowhead’s senior scientist II of biology, will deliver an oral presentation on the preclinical development of ARO-DUX4

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “plan,” “project,” “could,” “estimate,” or “continue” are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our businesses, or other characterizations of future events or circumstances are forward-looking statements. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the continuing impact of the COVID-19 pandemic, the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

[email protected]

Investors:

LifeSci Advisors, LLC

Brian Ritchie

212-915-2578

[email protected]

www.lifesciadvisors.com

Media:

LifeSci Communications, LLC

Josephine Belluardo, Ph.D.

646-751-4361

[email protected]

www.lifescicommunications.com

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Cardiology Biotechnology FDA Health General Health Public Relations/Investor Relations Pharmaceutical Oncology Communications Infectious Diseases Genetics

MEDIA:

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Skillz to Acquire Aarki to Form First Integrated Esports Advertising Platform

Skillz to Acquire Aarki to Form First Integrated Esports Advertising Platform

  • Aarki’s Advanced Machine Learning Algorithms to be Augmented by Skillz’s Deep First Party Data
  • Aarki’s Reach of More Than 465 Million Monthly Users Will Extend Skillz’s Player Acquisition Capabilities
  • Acquisition Agreement Expected to Close in Third Quarter 2021

SAN FRANCISCO–(BUSINESS WIRE)–Skillz (NYSE: SKLZ), the leading mobile games platform bringing fair and fun competition to players worldwide, today announced it has entered into an agreement to acquire Aarki, a leading technology-driven marketing platform. The highly complementary acquisition will broaden Skillz’s footprint across the rapidly expanding mobile gaming industry by combining its competitive platform with Aarki’s advanced advertising capabilities.

Aarki is a growing demand-side platform (DSP) with global scale and a proven track record in the mobile gaming market. Aarki engages in more than five trillion monthly advertising auctions. The company leverages its robust creative services, rich data engines, and proprietary machine learning algorithms to deliver industry-leading ROI for performance advertisers.

“Aarki’s proven machine learning will pair with Skillz’s robust first-party data to create an unrivaled value proposition for game developers,” said Skillz CEO Andrew Paradise. “The integrated ecosystem will unlock new points of connectivity between consumers, developers, and brands, pairing the right impression with the right user at the right time, all while delivering a superior user experience.”

“Joining Skillz will offer tremendous advantages to both the Aarki team and our customer community,” said Aarki CEO Levon Budagyan. “Harnessing the combined power of our data science platforms will further increase our industry-leading performance marketing.”

Aarki is headquartered in Sunnyvale, CA and its approximately 160 employees will join the Skillz workforce, with Budagyan continuing to lead the business as a division of Skillz.

Skillz will acquire 100% of Aarki for approximately $150 million in cash and stock. The transaction is subject to customary closing conditions and is expected to close in the third quarter of 2021.

LionTree Advisors served as financial advisor and Latham & Watkins LLP served as legal advisor to Skillz in the transaction.

Investor Conference Call and Webcast

The Company will host a conference call and audio webcast at 8:30 am Eastern Time, June 2, 2021 to discuss the transaction. The conference call can be accessed by registering online at registration, at which time registrants will receive dial-in information as well as a passcode and registrant ID. At the time of the call, participants will dial in using the numbers in the confirmation email and enter their passcode and ID, upon which they will enter the conference call. An audio replay of the conference call will be available from 11:30 am Eastern Time on June 2, 2021 through June 9, 2021 and can be accessed by dialing (800) 585-8367 (domestic) or (416) 621-4642 (international).

The conference call can also be accessed online by registering at webcast registration. An archived replay of the webcast will be available on the Skillz investor relations website following the conclusion of the call.

About Skillz Inc.

Skillz is the leading mobile games platform that connects players in fair, fun, and meaningful competition. The Skillz platform helps developers build multi-million dollar franchises by enabling social competition in their games. Leveraging its patented technology, Skillz hosts billions of casual esports tournaments for millions of mobile players worldwide, and distributes millions in prizes each month. Skillz has earned recognition as one of Fast Company’s Most Innovative Companies, CNBC’s Disruptor 50, Forbes’ Next Billion-Dollar Startups, and the #1 fastest-growing company in America on the Inc. 5000. www.skillz.com

About Aarki

Aarki helps brands grow and re-engage their mobile users, using machine learning (AI), big data, and engaging creative. We strive to deliver performance at scale across different marketing objectives to meet the target return on investment. Our data offers deep insights into user intent and usage habits. To drive performance, we activate our data assets through proprietary machine learning algorithms and engage users in real time with personalized creative. Aarki raised one institutional round of capital led by Walden Venture Capital. www.aarki.com

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The Company’s actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements.

These forward-looking statements involve significant risks and uncertainties that could cause the Company’s actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to, the ability of Skillz to: close the proposed acquisition of Aarki within the expected timeframe or at all; achieve the intended benefits of acquiring Aarki; acquire any regulatory approvals that may be required for the transaction; manage the impact of the transaction on the Company’s business, including any synergies from the transaction; effectively compete in the global entertainment, gaming, and mobile advertising industries; attract and retain successful relationships with the third party developers that develop and update all of the games hosted on Skillz’s platform; comply with laws and regulations applicable to its business; and as well as other risks and uncertainties indicated from time to time in the Company’s SEC filings, including those under “Risk Factors” therein, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that the Company makes from time to time with the SEC. In addition, any forward-looking statements contained in this press release are based on assumptions that the Company believes to be reasonable as of this date. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Source: Skillz Inc.

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Electronic Games Technology Mobile/Wireless Entertainment Other Technology Mobile Entertainment Software General Entertainment Internet

MEDIA:

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SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections

  • Approval of BREXAFEMME
    (ibrexafungerp) represents the first approved drug in a novel antifungal class in more than 20 years

  • BREXAFEMME, a one-day oral treatment for vaginal yeast infection, is the first FDA-approved indication of the ibrexafungerp development pipeline

  • U.S. commercial launch expected in the second half of 2021 in partnership with Amplity Health, marking the evolution of SCYNEXIS to a commercial-stage antifungal company

  • Leveraging 14 years of patent protection, SCYNEXIS continues to advance its pipeline of ibrexafungerp indications to create a long-lasting antifungal franchise in both hospital and community settings

  • SCYNEXIS to host a conference call today at 8:30 a.m. ET

JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets), for oral use in patients with vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. SCYNEXIS has partnered with Amplity Health, a leading global contract commercialization organization, to support U.S. commercialization of BREXAFEMME, with commercial launch scheduled in the second half of this year.

“The FDA approval of BREXAFEMME is the culmination of years of work and a significant milestone for SCYNEXIS, marking our evolution to a commercial-stage antifungal company. We are pleased with the approved label, highlighting the unique attributes of BREXAFEMME, and thrilled to be able to offer a new treatment option to women with vaginal yeast infections,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe ibrexafungerp has significant commercial potential. This first approval in the U.S. is a major step towards building the ibrexafungerp antifungal franchise as we intend to leverage an extended 10-year period of regulatory exclusivity and 14 years of patent protection. We are in a strong financial position to execute on our commercial plans and are committed to advancing our hospital programs to maximize the broad potential of this novel therapeutic class to help patients with serious and often resistant fungal infections.”

David Angulo, M.D., Chief Medical Officer of SCYNEXIS, added, “We are pleased to bring this much needed innovation to the antifungal field and to offer a new one-day oral antifungal treatment for vaginal yeast infections to millions of women who could benefit from a new therapeutic option. BREXAFEMME has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA in the first half of 2022. We thank all the clinical investigators and patients who participated in our VANISH clinical trials who made this significant advancement possible.”

Ibrexafungerp benefits from both Qualified Infectious Disease Product (QIDP) and Fast Track designations granted by the FDA for the treatment of VVC and prevention of recurrent VVC. Under QIDP designation, BREXAFEMME is expected to receive ten years of market exclusivity in the U.S.: five years of new chemical entity exclusivity plus five additional years of exclusivity extension due to the QIDP designation. BREXAFEMME is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection in the U.S. 

SCYNEXIS Conference Call and Webcast Details

SCYNEXIS management will hold a conference call today at 8:30 a.m. ET to discuss the FDA approval of BREXAFEMME®.

Dial-in Number: 1-877-705-6003
Conference ID: 13719935

The slide and audio webcast can be accessed by visiting the Investors section of the Company’s website at http://ir.scynexis.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 30 days.

SCYNEXIS plans to also discuss its commercial plans at a virtual Investor Day to be held on June 29

th

.

About Vulvovaginal Candidiasis
VVC, commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although these infections are frequently caused by Candida albicans, infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be on the rise. VVC can be associated with substantial morbidity, including significant genital discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. Typical VVC symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of them will experience multiple episodes.

Currently approved treatments for VVC include BREXAFEMME (ibrexafungerp tablets), several topical antifungals, and oral fluconazole, which is the only other orally administered antifungal approved for the treatment of VVC in the U.S. and which has typically accounted for over 90% of the prescriptions written for this condition every year.

About BREXAFEMME

®

(ibrexafungerp tablets), for oral use
BREXAFEMME is the trade name for ibrexafungerp, a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells. The New Drug Application (NDA) for BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole. For more information, visit www.brexafemme.com.

Please click here for full Prescribing Information.

Indication

BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).

Dosage and Administration

The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food.

Important Safety Information

  • BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
  • BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
  • When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
  • Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting

To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. We are developing our lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The New Drug Application (NDA) for BREXAFEMME® (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. For more information, visit www.brexafemme.com. We are also continuing late-stage clinical development of ibrexafungerp for the prevention of recurrent VVC as well as the treatment of life-threatening invasive fungal infections in hospitalized patients. For more information, visit www.scynexis.com

Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: the commercial launch of BREXAFEMME is scheduled in the second half of 2021; the commercial potential for ibrexafungerp; expected duration of commercial exclusivity; SCYNEXIS’ financial position will enable it to execute on its commercial plans; and SCYNEXIS’ expectation that it will be submitting a supplemental NDA in the first half of 2022 for the use of BREXAFEMME for the prevention of recurrent VVC. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS’ ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS’ need for additional capital resources; and SCYNEXIS’ reliance on third parties to conduct SCYNEXIS’ clinical studies and commercialize its products. These and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including in each case under the caption “Risk Factors,” and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


CONTACT



Investor Relations

Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
[email protected]

Media Relations

Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/63045483-5b8f-475e-995a-6143e068df39.