Market Newsdesk

November 11, 2020 4:08 pm

Atlas Financial Holdings Announces Sale of Large Paratransit Account Renewal Rights to National Interstate Insurance Company; Reiterates Extension of Small Account Underwriting Agreement

Atlas Financial Holdings Announces Sale of Large Paratransit Account Renewal Rights to National Interstate Insurance Company; Reiterates Extension of Small Account Underwriting Agreement

CHICAGO–(BUSINESS WIRE)–Atlas Financial Holdings, Inc. (OTC: AFHIF) (“Atlas” or the “Company”) today announced that further to the extension and expansion of its agreement with National Interstate Insurance Company (“NATL”), which was previously announced in July 2020, the Company and NATL executed a renewal rights agreement with respect to paratransit accounts with eight or more vehicles (“Large Paratransit Accounts”). Pursuant to this agreement, the Company and NATL will work together to transition the handling of Large Paratransit Accounts to NATL during the next year. The Company received $2.9 million as consideration from NATL for this transaction.

Under the previously announced expanded agreement, the Company’s managing general agency (“MGA”) subsidiary, Anchor Group Management, Inc. (“AGMI”), will continue to manage owner operators and fleets with seven or less vehicles (“Small Paratransit Accounts”) until at least August 2021. If the Small Paratransit Account program is not extended further, NATL continues to retain the option to purchase renewal rights on this segment at the expiration of the agreement period. Under the terms of the agreements, the Company will not compete with NATL for Large Paratransit Accounts for a period of three years following the Large Paratransit Account renewal rights transaction. Other previously disclosed material terms of the agreements between the parties remains unchanged.

Management Commentary

Scott D. Wollney, Atlas’ President & CEO said: “We are very pleased with this transaction as well as our continuing relationship with National Interstate, which we believe demonstrates the value that our MGA focused strategy delivers to our business partners, shareholders and other stakeholders. Our team has been working very effectively with the National Interstate team and is extremely pleased to be able to continue offering specialized insurance programs to smaller accounts on a go-forward basis. National Interstate continues to be an extremely valuable partner and we are proud to be working together to support paratransit operators providing essential rides across the U.S.”

Mr. Wollney continued, “Atlas and AGMI’s focus has centered around owner operators and smaller accounts and we believe the ongoing relationship confirms the core competency we’ve developed in this unique area. It is consistent with our emphasis being placed on generating EBITDA at the MGA level while endeavoring to reduce risk and capital requirements related to traditional primary insurance company operations. We will continue to pursue opportunities to leverage this expertise in other areas of specialty commercial auto as a managing agent as well.”

Piper Sandler & Co. acted as exclusive financial advisor to Atlas in connection with this transaction.

About Atlas

The primary business of Atlas is commercial automobile insurance in the United States, with a niche market orientation and focus on insurance for the “light” commercial automobile sector including taxi cabs, nonemergency paratransit, limousine/livery (including full-time transportation network company drivers) and business auto.

The Company’s strategy is focused on leveraging its managing general agency operation (“AGMI”) and its insuretech digital platform (“optOn”). For more information about Atlas, please visit www.atlas-fin.com , www.agmiinsurance.com , and www.getopton.com.

Forward-Looking Statements

This release includes forward-looking statements regarding Atlas and its insurance subsidiaries and businesses. Such statements are based on the current expectations of the management of each entity. The words “anticipate,” “expect,” “believe,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or similar words are used to identify such forward looking information. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Companies, including risks regarding the insurance industry, economic factors and the equity markets generally and the risk factors discussed in the “Risk Factors” section of the Company’s 2018 Annual Report on Form 10-K. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Atlas and its subsidiaries undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005831/en/

At the Company

Atlas Financial Holdings, Inc.

Scott Wollney, CEO

847-700-8600

[email protected]

www.atlas-fin.com

Investor Relations

The Equity Group Inc.

Adam Prior, Senior Vice President

212-836-9606

[email protected]

www.theequitygroup.com

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Insurance Finance Automotive General Automotive Banking Professional Services Other Automotive Other Professional Services Fleet Management

MEDIA:

November 11, 2020 4:08 pm

Resources Connection, Inc. to Participate in the JP Morgan Ultimate Services Investor Conference

IRVINE, Calif.–(BUSINESS WIRE)–
Resources Connection, Inc. (the “Company”) (NASDAQ: RGP), a global consulting firm, today announced that Chief Executive Officer Kate Duchene, President & Chief Operating Officer Timothy Brackney, and Chief Financial Officer Jennifer Ryu will be participating in JP Morgan’s Ultimate Services Investor Conference on Thursday, November 19, 2020, hosting investor meetings throughout the day.

About RGP

RGP is a global consulting firm that enables rapid business outcomes by bringing together the right people to create transformative change. As a human capital partner for our clients, we specialize in solving today’s most pressing business problems across the enterprise in the areas of transactions, regulations, and transformations. Our engagements are designed to leverage human connection and collaboration to deliver practical solutions and more impactful results that power our clients, consultants and partners’ success.

RGP was founded in 1996 to help finance executives with operational needs and special projects created by workforce gaps. Our first-to-market, agile human capital model disrupted the professional services industry at a time when traditional talent models prevailed. Today’s new ecosystem for work embraces our founding principle – quickly align the right resource for the work at hand with a premium placed on value, efficiency and ease of use.

Our pioneering approach to workforce strategy uniquely positions us to support our clients on their transformation journeys. We are their partner in delivering on the future of work. With approximately 3,300 professionals, we annually engage with over 2,400 clients around the world from more than 60 practice offices and multiple virtual offices. Headquartered in Irvine, California, RGP is proud to have served 88 of the Fortune 100.

The Company is listed on the Nasdaq Global Select Market, the exchange’s highest tier by listing standards. To learn more about RGP, visit: http://www.rgp.com. (RGP-F)

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005848/en/

Investor Contact:

Jenn Ryu, Chief Financial Officer

(US+) 1-714-430-6500

[email protected]

Media Contact:

Michael Sitrick, CEO Sitrick Group

(US+) 1-310-788-2850

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Consulting Professional Services Human Resources

MEDIA:

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November 11, 2020 4:08 pm

Repare Therapeutics Reports Third Quarter 2020 Financial Results and Operational Highlights

Repare Therapeutics Reports Third Quarter 2020 Financial Results and Operational Highlights

– Initiated GLP toxicology studies for newly designated RP-6306, the Company’s CCNE-1 synthetic-lethal inhibitor program

– Phase 1 clinical trial for RP-6306 is anticipated to commence in Q3 2021, reflecting an accelerated timeline from prior guidance

– Initiated a Phase 1/2 clinical trial for RP-3500 as a monotherapy and in combination with talazoparib in patients with solid tumors as previously reported

CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today reported financial results for the third quarter ended September 30, 2020, as well as recent business highlights.

“Since the closing of our IPO in June, we have made substantial and consistent progress to advance the development of our lead RP-3500 program, entering the clinic in July following the opening of a Phase 1/2 US IND for use as a monotherapy and in combination with talazoparib, all in patients with solid tumors,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “We also expect to initiate a Phase 1 clinical trial for RP-6306 in the third quarter of 2021, ahead of our previously conveyed timeline where we anticipated an IND filing in the second half of 2021. We believe that our work in advancing a first-in-class product candidate into the clinic further validates our progress in identifying new synthetic lethal pairs and developing potent and selective inhibitors.”

Third Quarter 2020 Review and Operational Updates:

Advanced CCNE-1 synthetic lethal inhibitor (now designated RP-6306) program into Good Laboratory Practice (GLP) toxicology studies ahead of original timeline. The Company anticipates initiating a Phase 1 clinical trial for RP-6306 in the third quarter of 2021, which is ahead of its original guidance of an IND filing in the second half of 2021.

Initiated a Phase 1/2 clinical trial evaluating RP-3500 as a monotherapy and in combination with Pfizer’s PARP inhibitor, talazoparib, in patients with solid tumors. In July 2020, the Company began dosing in a Phase 1/2 clinical trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors in patients with specific genome instability-related genetic alterations, including those in the ATM gene (ataxia telangiectasia mutated kinase). RP-3500 will be evaluated as a monotherapy and in combination with Pfizer’s PARP inhibitor, talazoparib. Topline results are expected to be reported in the second half of 2021.

Inaugurated a newly expanded laboratory and office facility in Montreal, Quebec. In September 2020, the Company materially expanded its research footprint with the addition of 17,000 square feet of combined laboratory and office space in a newly built facility. The new facility more than doubled the Company’s laboratory capacity for its CRISPR-enabled genome-wide synthetic lethal target platform, SNIPRx^®, including dedicated space for work related to accelerating all of Repare’s preclinical assets, including those under its research collaboration with Bristol Myers Squibb.

Appointed new executive officer. In October 2020, Repare appointed Dr. Laurence F. Akiyoshi as its Executive Vice-President, Organizational and Leadership Development. Dr. Akiyoshi has joined Repare’s executive team after having served as an independent consultant to the Company for the past two years. In addition to his work with Repare, Dr. Akiyoshi has operated a private organizational development consulting practice that has advised numerous companies on scaling their organizations to support rapid growth. His clients have included leadership teams at Apple, LinkedIn, CrowdStrike and Box. Dr. Akiyoshi will be principally focused on organization design, leadership development, and attracting and retaining key team members necessary for Repare’s achievement of its corporate objectives.

Third Quarter 2020 Financial Results:

Cash and restricted cash: Cash and restricted cash as of September 30, 2020 were $348.1 million.

Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $10.1 million and $27.7 million for the three and nine month periods ended September 30, 2020, respectively, as compared to $5.6 million and $14.2 million in the same periods in the prior year, respectively. Increases in R&D for the three and nine month periods ended September 30, 2020 were primarily due to increases in development costs related to Repare’s RP-3500 and RP-6306 programs, as well as increases in personnel-related expenses and certain other R&D expenses.

General and administrative (G&A) expenses: G&A expenses were $4.0 million and $9.6 million for the three and nine month periods ended September 30, 2020, respectively, as compared to $1.3 million and $3.4 million in the same periods in the prior year, respectively. Increases in G&A for the three and nine month periods ended September 30, 2020 were due to increases in payroll and personnel costs as well as increases in legal, professional and D&O insurance costs in connection with preparations for becoming and now operating as a public company.

Net loss: Net loss was $13.8 million, or $0.37 per share in the third quarter of 2020 and $38.2 million, or $2.63 per share, in the first nine months of 2020.

About Repare Therapeutics’ SNIPRx^® Platform

Repare’s SNIPRx^® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx^® screening, in order to selectively target those patients most likely to achieve clinical benefit from resulting product candidates.

About Repare Therapeutics, Inc.

Repare Therapeutics is a leading clinical-state precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx^® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as CCNE1-SL inhibitor and Polθ inhibitor programs. For more information, please visit reparerx.com.

SNIPRx^® is a registered trademark of Repare Therapeutics Inc.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the discovery of potential product candidates using SNIPRx^® platform; and the clinical development of the Company’s pipeline and its research and development programs, including the anticipated timing of its clinical trials of RP-3500 and RP-6306; and the development of preclinical assets pursuant to the Company’s collaboration with Bristol Myers Squibb. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the Company’s business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2020 filed with the Securities and Exchange Commission (the “SEC”) on August 13, 20202, and its subsequent filings with the SEC. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.


Repare Therapeutics Inc. Condensed Consolidated Balance Sheets (Unaudited) (Amounts in thousands of U.S. dollars, except share data)

	As of September 30,			As of December 31,
	2020			2019
ASSETS
CURRENT ASSETS:
Cash	$	347,872		$	94,797
Research and development tax credits receivable		1,637			1,080
Other receivables		3,232			1,976
Prepaid expenses and other current assets		8,524			719
Total current assets		361,265			98,572
Property and equipment, net		3,246			2,390
Restricted cash		203			208
Operating lease right-of-use assets		5,022			1,034
Other assets		288			359
Deferred tax assets		218			132
TOTAL ASSETS	$	370,242		$	102,695
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable	$	1,843		$	2,127
Accrued expenses and other current liabilities		4,923			1,276
Operating lease liability, current portion		794			625
Deferred revenue, current portion		2,150			—
Income tax payable		483			218
Total current liabilities		10,193			4,246
Operating lease liability, net of current portion		3,259			439
Deferred revenue, net of current portion		55,992			8,142
TOTAL LIABILITIES		69,444			12,827
Series A convertible preferred shares, no par value per share; 0 shares and unlimited shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 shares and 11,090,135 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 and $52,750 as of September 30, 2020 and December 31, 2019, respectively		—			53,749
Series B convertible preferred shares, no par value per share; 0 shares and unlimited shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 shares and 10,468,258 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 and $82,496 as of September 30, 2020 and December 31, 2019, respectively		—			82,248
TOTAL CONVERTIBLE PREFERRED SHARES		—			135,997
SHAREHOLDERS’ EQUITY (DEFICIT)
Preferred shares, no par value per share; unlimited shares and 0 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively		—			—
Common shares, no par value per share; unlimited shares authorized as of September 30, 2020 and December 31, 2019; 36,765,013 and 1,528,374 shares issued and outstanding as of September 30, 2020, and December 31, 2019, respectively		383,852			1
Additional paid-in capital		5,041			3,811
Accumulated deficit		(88,095	)		(49,941	)
Total shareholders’ equity (deficit)		300,798			(46,129	)
TOTAL LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT)	$	370,242		$	102,695


Repare Therapeutics Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Amounts in thousands of U.S. dollars, except share and per share data)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Operating expenses:
Research and development, net of tax credits	$	10,091		$	5,618		$	27,674		$	14,174
General and administrative		3,996			1,250			9,551			3,358
Total operating expenses		14,087			6,868			37,225			17,532
Loss from operations		(14,087	)		(6,868	)		(37,225	)		(17,532	)
Other income (expense), net
Realized and unrealized gain (loss) on foreign exchange		290			(152	)		(846	)		147
Change in fair value of Series A preferred share tranche obligation		—			(637	)		—			(1,337	)
Interest income		156			—			156			—
Other expense		(4	)		(2	)		(10	)		(5	)
Total other income (expense), net		442			(791	)		(700	)		(1,195	)
Loss before income taxes		(13,645	)		(7,659	)		(37,925	)		(18,727	)
Income tax expense		(106	)		(29	)		(229	)		(158	)
Net loss and comprehensive loss	$	(13,751	)	$	(7,688	)	$	(38,154	)	$	(18,885	)
Net loss attributable to common shareholders—basic and diluted	$	(13,751	)	$	(7,688	)	$	(38,154	)	$	(18,885	)
Net loss per share attributable to common shareholders—basic and diluted	$	(0.37	)	$	(5.03	)	$	(2.63	)	$	(12.36	)
Weighted-average common shares outstanding—basic and diluted		36,756,694			1,528,374			14,486,896			1,528,374


Repare Therapeutics Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) (Amounts in thousands of U.S. dollars)

	Nine Months Ended September 30,
	2020			2019
Cash Flows From Operating Activities:
Net loss and comprehensive loss for the period	$	(38,154	)	$	(18,885	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Share-based compensation expense		1,531			313
Depreciation expense		610			416
Change in fair value of the Series A preferred shares tranche obligation		—			1,350
Non-cash lease expense		520			191
Foreign exchange loss (gain)		835			(432	)
Interest income		(36	)		—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(8,834	)		(142	)
Research and development tax credits receivable		(584	)		(398	)
Other receivables		(1,247	)		(964	)
Deferred tax asset		(86	)		(83	)
Other non-current assets		71			(4	)
Accounts payable		(1,120	)		1,157
Accrued expenses and other current liabilities		3,540			318
Operating lease liability, current portion		(97	)		29
Income tax payable		265			132
Operating lease liability, net of current portion		(351	)		(223	)
Deferred revenue		50,000			8,142
Net cash provided by (used in) operating activities		6,863			(9,083	)
Cash Flows From Investing Activities:
Purchases of property and equipment		(516	)		(561	)
Net cash used in investing activities		(516	)		(561	)
Cash Flows From Financing Activities:
Proceeds from issuance of Series A preferred shares, net		—			20,995
Proceeds from issuance of Series B preferred shares, net		—			82,248
Proceeds from exercise of stock options		510			—
Proceeds from issuance of warrant		15,000			—
Net proceeds from issuance of common shares in initial public offering		232,043			—
Net cash provided by financing activities		247,553			103,243
Effect of exchange rate fluctuations on cash held		(830	)		407
Net Increase In Cash And Restricted Cash		253,070			94,006
Cash and restricted cash at beginning of period		95,005			10,929
Cash and restricted cash at end of period	$	348,075		$	104,935

Reconciliation Of Cash And Restricted Cash
Cash	$	347,872		$	104,731
Restricted cash		203			204
Total cash and restricted cash	$	348,075		$	104,935

Supplemental Disclosure Of Cash Flow Information:
Cash interest received	$	120		$	—
Property and equipment purchases in accounts payable and accrued expenses and other current liabilities	$	950		$	542
Right-of-use asset obtained in exchange for new operating lease liability	$	4,516		$	1,074
Conversion of Series A and B preferred shares into common shares	$	135,997		$	—
Conversion of warrant into common shares	$	15,000		$	—

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005846/en/

Repare Contact:

Steve Forte

Chief Financial Officer

Repare Therapeutics Inc.

[email protected]

Investors:

Kimberly Minarovich

Argot Partners

[email protected]

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

KEYWORDS: United States North America Canada Massachusetts

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

November 11, 2020 4:08 pm

Paycom to Participate in Upcoming Investor Conferences

Paycom to Participate in Upcoming Investor Conferences

OKLAHOMA CITY–(BUSINESS WIRE)–
Paycom Software, Inc. (NYSE:PAYC), a leading provider of comprehensive, cloud-based human capital management software, today announced that the company will participate in the following virtual investor events:

RBC Capital Markets Global Technology, Internet, Media & Telecommunications Conference

Date: November 18, 2020

Time: 2:40 p.m. Eastern time
Credit Suisse 24th Annual Technology Conference

Date: December 2, 2020

Time: 5:30 p.m. Eastern time
Barclays Global Technology, Media and Telecommunications Conference

Date: December 9, 2020

Time: 1:00 p.m. Eastern time

A live webcast of the presentations will be available at investors.paycom.com under the “Events” tab. Presentations may include forward-looking information. Webcast replays will be available for 90 days following the applicable event.

About Paycom

As a leader in payroll and HR technology, Oklahoma City-based Paycom redefines the human capital management industry by allowing companies to effectively navigate a rapidly changing business environment. Its cloud-based software solution is based on a core system of record maintained in a single database for all human capital management functions, providing the functionality that businesses need to manage the complete employment lifecycle, from recruitment to retirement. Paycom has the ability to serve businesses of all sizes and in every industry. As one of the leading human capital management providers, Paycom serves clients in all 50 states from offices across the country.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005839/en/

Investor Relations:

James Samford

[email protected]

KEYWORDS: United States North America Oklahoma

INDUSTRY KEYWORDS: Professional Services Data Management Technology Human Resources Software Accounting

MEDIA:

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November 11, 2020 4:08 pm

Corvus Hosting R&D Symposium on November 12 to Highlight COVID-19 Program and Updated Study Data Presented at SITC Annual Meeting

Data shows CPI-006 provide
d
enhanced and prolonged
polyclonal
humoral immunity to SARS
–
CoV
–
2

Plans
to
initiate pivotal
,
randomized
,
double blind trial
in December
with results expected mid
–
2021

BURLINGAME, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it is hosting an R&D Symposium on November 12, 2020 from 11:00 am – 1:00 pm ET (8:00 – 10:00 am PT) to highlight its COVID-19 program data, including updated data being presented this week in a poster presentation and an oral presentation at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The R&D Symposium will be hosted by Richard A. Miller, M.D., president and chief executive officer of Corvus, and other members of the Corvus team. The agenda includes the following guest speakers:

Tullia C. Bruno, PhD, Assistant Professor, Department of Immunology at UPMC Hillman Cancer Center. Dr. Bruno will provide an overview of B cell biology and antibodies.
Gerard J. Criner, M.D., Chair and Professor, lead investigator of the CPI-006 COVID-19 Phase 1 study, and Chair and Professor, Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University. Dr. Criner will provide an overview of current COVID-19 therapies.

Members of the Corvus team will provide an overview of the preclinical biology and data on CPI-006, plans for the CPI-006 pivotal study for patients with COVID-19, and a general pipeline update covering the Company’s cancer programs. The speakers will be available for questions and answers during the program.

Corvus’ COVID-19 program includes its fully enrolled Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for hospitalized patients with COVID-19. This novel immunotherapy may provide a therapeutic benefit from the activation of a polyclonal antibody response to the SARS-CoV-2 virus and the induction of long term immunity through active immunization. Based on the study data to-date, the Company plans to initiate a pivotal, randomized, double blind study of CPI-006 in hospitalized COVID-19 patients in December with results expected around mid-2021.

Separate from the R&D Symposium, the updated data from the CPI-006 COVID-19 Phase 1 study is being presented in a poster presentation and separate oral presentation at SITC on Friday, November 13 at 12:15 pm ET as part of Session 301, which is titled “Hot Topic Symposium: COVID-19 and Cancer.” The oral presentation, entitled “Immunotherapy with B cell activating antibody CPI-006 in patients with mild to moderate COVID-19 stimulates anti-SARS-CoV-2 antibody response, memory B cells, and memory/effector T cells,” will be delivered by Dr. Criner. The SITC poster presentation is available on Corvus’ website on the COVID-19 page and the oral presentation slides will be available in the same location after the session concludes.

The data presented at SITC include results from 22 patients enrolled in the Phase 1 study utilizing a cut-off date of November 4, 2020. This includes enrollment in all four dosing cohorts of the study (0.3, 1.0, 3.0 and 5.0 mg/kg). All patients received a single dose of CPI-006 administered via a 5-10 minute intravenous (IV) infusion. The median age of the patients was 58 years (range 23-76 years). All of the patients had comorbidities that increased their COVID-19 risk including diabetes, coronary disease, hypertension, obesity, chronic kidney disease, chronic lung disease and/or cancer. 95% of patients were from minority populations that are at high risk of COVID-19 complications. The results from the study support the immune enhancing role of CPI-006 in COVID-19:

All patients had relatively low titers of anti-SARS-CoV-2 antibodies at the time of hospitalization despite having varying durations of prior COVID-19 symptoms from 1-21 days (median 5 days); all patients had a confirmed COVID-19 diagnosis by positive PCR nasal swab testing.
All evaluable patients had prompt anti-SARS-CoV-2 antibody responses within 7 days of administration of CPI-006 at all dose levels.
All patients recovered and were discharged from the hospital at a median of 4 (range 2-23) days.
As of the November 4, 2020 cut-off date, there were no drug-related toxicity or safety issues reported.

The results presented at SITC build on the initial data from the first two cohorts (0.3 mg and 1.0 mg doses) of the study that was published online at medRxiv.org in September 2020. In addition to detailing the initial results, the medRxiv manuscript provided additional details on the unique properties of CPI-006 and on the study rationale and design, along with context on the broad potential for CPI-006 for the treatment and prevention of COVID-19.

Background Information on CPI-006 for the Treatment of COVID-19

Corvus is studying an immunostimulatory humanized monoclonal antibody, designated as CPI-006, which the Company believes has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. In both in vitro and in vivo studies in cancer patients, CPI-006 has demonstrated binding to various immune cells and the inducement of a humoral adaptive immune response – B cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin (IgM and IgG) antibodies. Administration of CPI-006 has also led to increased levels of memory B cells, and increased levels of both memory CD4+ and CD8+ cells, which are the cells responsible for long-term immunity. The similar production of antibodies and memory cells to pathogens such as SARS-CoV-2 may provide immediate and long-term clinical benefits for patients including shortened recovery time and improved long-term protective immunity.

To date, over 90 cancer patients have been treated with CPI-006 in the Corvus Phase 1/1b study, with dosing as high as 24 mg/kg every three weeks. The study design is evaluating CPI-006 monotherapy and in combination with ciforadenant and combination with pembrolizumab. Another cohort of the study is evaluating the triplet of CPI-006, ciforadenant and pembrolizumab. As of the November 4, 2020 cut-off date, CPI-006 had been well tolerated in these patients and evidence of B-cell activation and lymphocyte trafficking was observed in patients that received single doses as low as 1 mg/kg. Corvus’ Phase 1/1b study demonstrated that the administration of CPI-006 was associated with increased memory B cells, the emergence of new B cell clones and, in some patients, the production of novel anti-tumor antibodies. These results have been previously reported in presentations at the Society of Immunotherapy of Cancer annual meeting in 2018 and 2019 and in a presentation at the American Society of Clinical Oncology annual meeting in 2019. CPI-006 was designed to bind to an epitope on an antigen known as CD73. This antigen is known to be involved in lymphocyte migration and activation. CPI-006 is designed to bind to a distinct region of CD73 and behaves as an agonist that serves as a signal to activate certain immune cells in preclinical studies. As previously reported, binding of CPI-006 affects B cells, T cells and antigen presenting cells. The collection of observed changes were consistent with enhanced antigen recognition and induction of an adaptive immune response.

R&D Symposium

Conference Call

,

Webcast

and Presentation Slides

The R&D Symposium conference call can be accessed by dialing 1-877-423-9813 (toll-free domestic) or 1-201-689-8573 (international) and using the conference ID 13712583. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

About Corvus Pharmaceuticals

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. These product candidates are being studied in ongoing Phase 1b/2 and Phase 1/1b clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort Phase 1b/2 trial examining its activity both as a single agent and in combination with an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab. The Company’s third cancer clinical program, CPI-818, is an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. The Company is also evaluating CPI-006 as a treatment for COVID-19 patients. For more information, visit www.corvuspharma.com.

About CPI-006

CPI-006 is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies in development for treatment of cancer, such antibodies have been reported to react with a different region of CD73 and are designed to block production of adenosine, which is not involved in the immunomodulatory processes seen with CPI-006.

About Ciforadenant

Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine.

Adenosine Gene Signature

The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor. These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated CD68+ myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of CPI-006 for certain cancers, as well as the Company’s Phase 1 trial of CPI-006 for COVID-19, the timing of the availability and announcement of clinical data and certain other product development milestones, and the sufficiency of the Company’s cash resources. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission on October 29, 2020, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ciforadenant, CPI-006 and CPI-818; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; whether the FDA accepts data from trials conducted in foreign locations; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; the effects of COVID-19 on the Company’s clinical programs and business operations. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:

Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
[email protected]

MEDIA CONTACT:

Sheryl Seapy
W2O pure
+1-949-903-4750
[email protected]

November 11, 2020 4:08 pm

Leading Independent Advisory Firms ISS and Glass Lewis Recommend Virtusa Stockholders Vote “FOR” the Transaction with Baring Private Equity Asia

Leading Independent Advisory Firms ISS and Glass Lewis Recommend Virtusa Stockholders Vote “FOR” the Transaction with Baring Private Equity Asia

SOUTHBOROUGH, Mass.–(BUSINESS WIRE)–
Virtusa Corporation (NASDAQ GS: VRTU) announced today that leading independent proxy advisory firms, Institutional Shareholder Services Inc. (“ISS”) and Glass Lewis & Co., LLC (“Glass Lewis”), have each recommended that Virtusa stockholders vote “FOR” the pending merger transaction (the “Transaction”) under which funds affiliated with Baring Private Equity Asia (“BPEA”) will acquire all outstanding shares of common stock of Virtusa for $51.35 per share in an all-cash transaction valued at approximately $2.0 billion.

The Transaction, which is expected to close in the first half of 2021, is subject to the approval of Virtusa’s stockholders, customary regulatory requirements, including approval from The Committee on Foreign Investment in the United States (CFIUS), and customary closing conditions. The transaction is not subject to a financing condition.

Special Meeting

A special meeting of stockholders of Virtusa Corporation (the “Meeting”) to consider and vote upon the Transaction, will be held virtually on November 20, 2020 at 10:00 AM, Eastern Time, at https://www.cesonlineservices.com/vrtu20_vm. The Virtusa Board recommends that Virtusa’s stockholders vote “FOR” the proposal to approve the pending merger with funds affiliated with BPEA in advance of the Meeting. The Company encourages stockholders to submit their proxy as soon as possible, whether over the Internet, by telephone or by mail. Further details on how to vote and the requirements with respect to attending the Meeting virtually are contained in the definitive proxy statement on Schedule 14A filed with the Securities Exchange Commission (the “SEC”) and mailed to stockholders of record on October 20, 2020.

About Virtusa

Virtusa Corporation (NASDAQ GS: VRTU) is a global provider of digital business strategy, digital engineering, and information technology (IT) services and solutions that help clients change, disrupt, and unlock new value through innovation engineering. Virtusa serves Global 2000 companies in Banking, Financial Services, Insurance, Healthcare, Communications, Media, Entertainment, Travel, Manufacturing, and Technology industries.

Virtusa helps clients grow their business with innovative products and services that create operational efficiency using digital labor, future-proof operational and IT platforms, and rationalization and modernization of IT applications infrastructure. This is achieved through a unique approach blending deep contextual expertise, empowered agile teams, and measurably better engineering to create holistic solutions that drive business forward at unparalleled velocity enabled by a culture of cooperative disruption.

About BPEA

Baring Private Equity Asia (BPEA) is one of the largest and most established private alternative investment firms in Asia, with assets under management of approximately US$20 billion. The firm runs a private equity investment program, sponsoring buyouts and providing growth capital to companies for expansion or acquisitions with a particular focus on the Asia Pacific region, as well as investing in companies globally that can benefit from further expansion into the Asia Pacific region. BPEA also manages dedicated funds focused on private real estate and private credit. The firm has a 23-year history and over 190 employees located across offices in Hong Kong, China, India, Japan, Singapore, Australia, and the US. BPEA currently has over 40 portfolio companies active across Asia with a total of 224,000 employees and sales of approximately US$39 billion.

For more information, please visit www.bpeasia.com

Additional Information and Where to Find It

This communication relates to the proposed merger transaction involving the Company and may be deemed to be solicitation material in respect of the proposed merger transaction. In connection with the proposed merger transaction, the Company has filed relevant materials with the SEC, including a definitive proxy statement on Schedule 14A (the “Proxy Statement”). Promptly after filing the Proxy Statement with the SEC, the Company mailed the Proxy Statement and a proxy card to each Company stockholder entitled to vote at the special meeting relating to the proposed merger transaction. This communication is not a substitute for the Proxy Statement or for any other document that the Company may file with the SEC or send to the Company’s stockholders in connection with the proposed merger transaction. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF THE COMPANY ARE URGED TO READ THE PROXY STATEMENT AND OTHER DOCUMENTS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE PROPOSED MERGER TRANSACTION AND RELATED MATTERS. The proposed merger transaction will be submitted to the Company’s stockholders for their consideration. Investors and security holders will be able to obtain free copies of the Proxy Statement and other documents filed by the Company with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed by the Company with the SEC will also be available free of charge on the Company’s website at www.virtusa.com or by contacting the Company’s Investor Relations contact at [email protected].

Participants in the Solicitation

The Company and its directors and certain of its executive officers and employees may be deemed to be participants in the solicitation of proxies from the Company’s stockholders with respect to the proposed merger transaction under the rules of the SEC. Information about the directors and executive officers of the Company and their ownership of shares of the Company’s common stock is set forth in its Annual Report on Form 10-K for the year ended March 31, 2020, which was filed with the SEC on May 28, 2020 and was subsequently amended on July 29, 2020, the Proxy Statement, which was filed with the SEC on October 20, 2020 and in subsequent documents filed with the SEC, including the Proxy Statement. Additional information regarding the persons who may be deemed participants in the proxy solicitations and a description of their direct and indirect interests in the merger transaction, by security holdings or otherwise, are also included in the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of this document as described above.

Forward Looking Statements

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The Company generally identifies forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions. The Company has based these forward-looking statements largely on its then-current expectations and projections about future events and financial trends as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with the Company’s ability to obtain the stockholder approval required to consummate the proposed merger transaction and the timing of the closing of the proposed merger transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed merger transaction will not occur; (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (iii) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement; (iv) unanticipated difficulties or expenditures relating to the proposed merger transaction, the response of business partners and competitors to the announcement of the proposed merger transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed merger transaction; and (v) those risks detailed in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as other documents that may be filed by the Company from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. The Company cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005820/en/

Media Contact:

Conversion Marketing

Ron Favali, 727-512-4490

[email protected]

Investor Contact:

ICR

William Maina, 646-277-1236

[email protected]

Additional Investor Contact:

MacKenzie Partners, Inc.

Bob Marese, 212-929-5405

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Consulting Data Management Professional Services Technology Software

MEDIA:

Logo

November 11, 2020 4:08 pm

Cidara Therapeutics to Participate in Two Upcoming Investor Conferences

SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences: the Stifel 2020 Virtual Healthcare Conference and 3^rd Annual Evercore ISI HealthCONx Conference.

Stifel
2020
Virtual Health Conference

Date:	Tuesday, November 17, 2020
Time:	2:00 PM Eastern Time
Format:	Presentation

A live audio webcast of the presentation will be available in the Investors section on the Company’s website at www.cidara.com.

3
^rd
Annual Evercore ISI HealthCONx Conference

Date:	Wednesday, December 2, 2020
Time:	11:20 AM Eastern Time
Format:	Panel Discussion – No Fungus Among Us: Addressing an Important Fungal Need

About Cidara Therapeutics

Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company’s portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara’s proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

INVESTOR CONTACT:

Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

MEDIA CONTACT:

Karen O’Shea, Ph.D.
LifeSci Communications
(929) 469-3860
[email protected]

November 11, 2020 4:08 pm

Datadog to Present at Upcoming Investor Conferences

Datadog to Present at Upcoming Investor Conferences

NEW YORK–(BUSINESS WIRE)–
Datadog, Inc. (NASDAQ:DDOG), the monitoring and security platform for cloud applications, today announced that management will present at the following investor conferences.

The RBC Global Technology, Internet, Media and Telecommunications Virtual Conference. The presentation is scheduled for Tuesday, November 17, 2020 at 10:40 a.m., Eastern Time.
The Wells Fargo TMT Virtual Summit. The presentation is scheduled for Tuesday, December 1, 2020 at 8:40 a.m., Eastern Time.
The Credit Suisse Technology Virtual Conference. The presentation is scheduled for Wednesday, December 2, 2020 at 2:00 p.m., Eastern Time.
The Morgan Stanley Future of Application Development Virtual Conference. The presentation is scheduled for Wednesday, December 9, 2020 at 2:15 p.m., Eastern Time.
The Barclays Global Technology, Media & Telecom Virtual Conference. The presentation is scheduled for Thursday, December 10, 2020 at 11:30 a.m., Eastern Time.

The presentations will be webcast live, and replays will be available for a limited time under the “Events and Presentations” section of the Company’s investor relations website at https://investors.datadoghq.com/.

About Datadog

Datadog is the monitoring and security platform for cloud applications. Our SaaS platform integrates and automates infrastructure monitoring, application performance monitoring and log management to provide unified, real-time observability of our customers’ entire technology stack. Datadog is used by organizations of all sizes and across a wide range of industries to enable digital transformation and cloud migration, drive collaboration among development, operations, security and business teams, accelerate time to market for applications, reduce time to problem resolution, secure applications and infrastructure, understand user behavior and track key business metrics.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005784/en/

AJ Ljubich, CFA

Datadog Investor Relations

(866) 329-4466

[email protected]

Martin Bergman

Datadog Communications

(866) 329-4466

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Software Mobile/Wireless Networks Professional Services Internet Hardware Data Management Technology Security Finance Other Technology Telecommunications

MEDIA:

November 11, 2020 4:08 pm

Cyclacel Pharmaceuticals Reports Third Quarter 2020 Financial Results

– Conference Call Scheduled November 11, 2020 at 4:30 p.m. ET –

BERKELEY HEIGHTS, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today reported its financial results for the third quarter 2020 and certain business highlights.

The Company’s net loss applicable to common shareholders for the three months ended September 30, 2020 was $2.3 million. As of September 30, 2020, cash and cash equivalents totaled $23.1 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development, through the end of 2022.

“We continue to execute on our clinical development plan for fadraciclib and CYC140 in both liquid and solid cancers,” said Spiro Rombotis, President and Chief Executive Officer. “The recent ENA presentation highlighted fadraciclib’s oral bioavailability and deepening confirmed response as a single agent. Recent publications elaborated the mechanistic rationale for fadraciclib highlighting dual inhibition of CDK2 and CDK9 cancer pathways. We are encouraged by evidence of antileukemic activity in our studies of fadraciclib in combination with venetoclax in hematological malignancies, including CLL. Dr. Mark Kirschbaum, our newly appointed CMO, is reviewing our programs and streamlining our clinical work flows to progress our clinical strategy and improve efficiency. We are looking forward to reporting data from ongoing studies and outlining our clinical development plans for fadraciclib and CYC140 to drive shareholder value.”

Key Corporate Highlights

Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. He has management experience in academic research, clinical practice and pharmaceutical industry settings. As CMO, he is responsible for advancing Cyclacel’s pipeline and is leading clinical strategy, patient safety and medical affairs.
Fadraciclib
Oral
Presentation
at the Plenary Session of the 32
^nd
EORTC-NCI-AACR (ENA)
Symposium 2020

• In part 2 of a Phase 1, dose escalation study, fadraciclib was administered intravenously as monotherapy to 24 heavily pretreated patients with various advanced solid tumors.

• Out of 11 patients treated at the fourth dose level one achieved confirmed partial response (PR) and two stable disease (SD).

• The PR was observed after a month and a half on fadraciclib in a patient with MCL1-amplified endometrial cancer who had failed seven lines of prior therapy. The patient remains on treatment after 16 months with 92% reduction in target tumor lesions.

• SD was observed in a patient with cyclin E amplified ovarian cancer who achieved 29% shrinkage in target tumor lesions after four months and a patient with fallopian tube adenocarcinoma with undetermined protein level.

• In three patients treated in part 3 with oral fadraciclib high oral bioavailability and overlapping pharmacokinetics were observed compared to the intravenously administered, identical schedule in part 2.

CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o.
in CLL
– five patients with R/R CLL have been treated in four dose levels up to 150 mg/m² of fadraciclib in combination with venetoclax. Fadraciclib is administered after completion of venetoclax ramp. Antileukemic activity was observed in three patients who achieved MRD negativity on the combination, one in bone marrow and two in bone marrow and peripheral blood. The latter two patients have also demonstrated continued shrinkage of lymph nodes on the combination. In one patient all target lesions and in the other 2 out of 4 lesions have shrunk below 1.5 cm. Both are waiting for confirmation of response. Preclinical data support a dual targeting strategy of both BCL2 and MCL1 in CLL.
CYC065-0
3
Phase 1
fadraciclib
i.v.
and
venetoclax p.o
.
in
AML/MDS
– fourteen heavily pretreated patients with relapsed/refractory (R/R) AML were treated in five dose levels up to 200 mg/m² of fadraciclib in combination with venetoclax. Antileukemic activity has been observed in four out of twelve patients available for assessment. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.
CYC140-01 Phase 1 CYC140 i.v. – We have enrolled 7 patients in our first-in-human, dose escalation study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers. In parallel with hematological malignancies, we are planning studies of CYC140 in solid tumors.
CYC682-11
Phase 1
part 2 sapacitabine p.o.
and venetoclax p.o.
– twelve patients have been enrolled in a dose escalation study in our DNA Damage Response (DDR) program evaluating an oral combination of sapacitabine and venetoclax in patients with R/R AML/MDS. Two patients, previously treated with combination therapies including hypomethylating agents, have achieved 5 and 6 cycles of treatment respectively. Sapacitabine is a nucleoside analogue that is active in AML and MDS R/R to prior therapy such as cytarabine or hypomethylating agents. Preclinical data demonstrated synergy of sapacitabine with a BCL2 inhibitor, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.
Appointed
Karin L. Walker to the Board of Directors. Ms. Walker brings over 30 years of extensive finance experience in biopharmaceuticals, including in public biotechnology companies, and technology companies. Ms. Walker currently serves as the Chief Accounting Officer of Prothena Corporation plc, a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics focused on neurodegenerative and rare peripheral amyloid diseases, and has held this position since 2013.

More information on our clinical trials can be found here.

Key Business Objectives

Treat first patient with orally-administered fadraciclib in Phase 1/2 advanced solid tumors study;
Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
Report safety and PK data from Phase 1 study of fadraciclib oral formulation;
Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;

Financial Highlights

As of September 30, 2020, cash and cash equivalents totaled $23.1 million, compared to $11.9 million as of December 31, 2019. The increase of $11.2 million was primarily due to net proceeds of $18.3 million from an equity financing in April 2020, offset by net cash used in operating activities of $6.8 million. There were no revenues for each of the three months ended September 30, 2020 and 2019.

Research and development expenses were $1.1 million for each of the three months ended September 30, 2020 and 2019. Research and development expenses relating to transcriptional regulation increased by approximately $0.1 million for the three months ended September 30, 2020 as we continue to progress the clinical evaluation of fadraciclib.

General and administrative expenses for the three months ended September 30, 2020 were $1.5 million, compared to $1.3 million for the same period of the previous year. The increase of $0.2 million for the three months ended September 30, 2020 is due to increased professional costs.

Total other income, net, for the three months ended September 30, 2020 was $35,000, compared to $174,000 for the same period of the previous year. The decrease of approximately $140,000 for the three months ended September 30, 2020 is primarily related to reductions in foreign exchange gains and interest income.

United Kingdom research & development tax credits were $0.3 million for each of the three months ended September 30, 2020 and 2019.

Net loss for the three months ended September 30, 2020 was $2.3 million compared to $1.9 million for the same period in 2019.

The Company estimates that cash resources of $23.1 million as of September 30, 2020 will fund currently planned programs through the end of 2022.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 4884678.

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


Contacts

Company:	Paul McBarron, (908) 517-7330, [email protected]

Investor Relations:	Russo Partners LLC, Eric Ando, (646) 218-4604, [email protected]

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF
OPERATIONS (LOSS)

(In $000s, except share and per share amounts)

			Three Months Ended
			September 30,
				2019			2020

Revenues:
Total revenues				–			–
Operating expenses:
	Research and development			1,063			1,075
	General and administrative			1,285			1,497
Total operating expenses				2,348			2,572
Operating loss				(2,348	)		(2,572	)
Other income (expense):
	Foreign exchange gains (losses)			79			(25	)
	Interest income			42			4
	Other income, net			53			56
		Total other income (expense), net		174			35
Loss before taxes				(2,174	)		(2,537	)
Income tax benefit				273			281
Net loss				(1,901	)		(2,256	)
Dividend on convertible exchangeable preferred shares				(50	)		(50	)
Net loss applicable to common shareholders			$	(1,951	)	$	(2,306	)
Basic and diluted earnings per common share:
Net loss per share – basic and diluted			$	(2.27	)	$	(0.47	)
Weighted average common shares outstanding				859,998			4,863,984

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEET

(In $000s, except share, per share, and liquidation preference amounts)

	December 31,		September 30,
	2019		2020

ASSETS
Current assets:
Cash and cash equivalents	$	11,885	$	23,130
Prepaid expenses and other current assets		2,132		2,804
Total current assets		14,017		25,934

Property and equipment, net		27		64
Right-of-use lease asset		1,264		1,215
Total assets	$	15,308	$	27,213
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	890	$	455
Accrued and other current liabilities		1,530		1,257
Total current liabilities		2,420		1,712
Lease liability		1,191		1,063
Total liabilities		3,611		2,775

Stockholders’ equity		11,697		24,438
Total liabilities and stockholders’ equity	$	15,308	$	27,213

SOURCE: Cyclacel Pharmaceuticals, Inc.

November 11, 2020 4:08 pm

SpartanNash Announces Third Quarter Fiscal 2020 Financial Results

SpartanNash Announces Third Quarter Fiscal 2020 Financial Results

Reports Third Quarter Retail Comparable Store Sales of 10.6%

Generates EPS of $0.56; Adjusted EPS Increased 133% to $0.70

Adjusted EBITDA increased 37.2% to $57.0 million

Updates Fiscal Year 2020 Outlook

GRAND RAPIDS, Mich.–(BUSINESS WIRE)–
SpartanNash Company (the “Company”) (Nasdaq: SPTN) today reported financial results for its 12-week third quarter ended October 3, 2020.

Third Quarter Fiscal 2020 Highlights

Net sales growth of 3.1% to $2.06 billion from $2.00 billion in the prior year quarter, representing the eighteenth consecutive quarter of growth.
Retail comparable store sales of 10.6% were positive for the fifth consecutive quarter.
EPS of $0.56 per share, compared to a loss of $(0.01) per share in the prior year quarter; adjusted EPS of $0.70 per share, an increase of 133% over $0.30 per share in the prior year quarter.
Adjusted EBITDA increase of 37.2%, to $57.0 million from $41.6 million in the prior year quarter.
Subsequent to the end of the third quarter, the Company extended its commercial agreement with Amazon. In connection with this agreement, the Company issued stock warrants to a subsidiary of Amazon, subject to certain vesting conditions.

“In the past nine weeks since taking the CEO position I’ve visited a great number of our distribution centers and retail stores. The passion demonstrated by our associates is nothing short of inspirational,” said Tony Sarsam, President and Chief Executive Officer. “I am energized and excited about the profitable growth opportunities that lie ahead for our business. As I immerse further into our business, I will continue to assess our long-term strategy, focus on motivating our associates and recognizing their accomplishments, identifying opportunities to make investments to improve the efficiency and effectiveness of our supply chain, and evaluating how to best position SpartanNash to deliver shareholder value for years to come.”

Consolidated net sales for the third quarter increased $61.0 million, or 3.1%, to $2.06 billion from $2.00 billion in the prior year quarter. The increase in net sales was generated through higher sales attributable to increased consumer demand related to COVID-19 in the Company’s Retail and Food Distribution segments, as well as continued growth with existing Food Distribution customers, partially offset by the continued impact of domestic base access and commissary shopping restrictions associated with COVID-19 in the Military segment.

Gross profit for the third quarter was $324.8 million, or 15.8% of net sales, compared to $290.4 million, or 14.5% of net sales, in the prior year quarter. The improvement in the gross profit rate was driven by improvements in margin rates at all three segments, as well as an increase in the proportion of Retail and Food Distribution segment sales, which generate higher margin rates than the Military segment.

Reported operating expenses for the third quarter were $295.8 million, or 14.4% of net sales, compared to $274.6 million, or 13.7% of net sales, in the prior year quarter. The increase in expenses as a rate of sales compared to the prior year quarter was due to increased incentive compensation related to improved Company performance, a higher mix of Retail segment sales which have higher operating expense rates, higher supply chain expenses in the Food Distribution segment, and a $5.2 million increase in restructuring and asset impairment charges, partially offset by increased leverage of retail store labor expenses and other fixed costs due to the higher sales volume in the quarter.

The Company reported operating earnings of $29.0 million compared to $15.8 million in the prior year quarter. The increase was attributable to increased sales volume, as well as the changes in rates of margin and operating expenses previously mentioned, partially offset by higher impairment charges. Adjusted operating earnings⁽¹⁾ were $35.8 million compared to $20.3 million in the prior year quarter and are adjusted for the items detailed in Table 3.

Interest expense decreased $3.9 million from the prior year quarter due to multiple rate cuts implemented by the Federal Reserve during 2019 and in early 2020, as well as the Company’s pay down of the debt balance made possible by higher earnings and lower required investments in working capital. Postretirement benefit expense was favorable $10.1 million from cycling charges related to the termination of the Company’s pension plan in the prior year quarter.

The Company reported earnings from continuing operations of $20.0 million, or $0.56 per diluted share, compared to a loss from continuing operations of $0.3 million, or $0.01 per diluted share, in the prior year quarter. The improvement reflects the operating earnings and non-operating expense changes noted above. Adjusted earnings from continuing operations⁽²⁾ for the third quarter were $25.1 million, or $0.70 per diluted share. Adjusted earnings from continuing operations for the prior year quarter were $10.9 million, or $0.30 per diluted share. A reconciliation of reported earnings from continuing operations to adjusted earnings from continuing operations is included at Table 4.

Adjusted EBITDA⁽³⁾ increased $15.4 million, or 37.2%, to $57.0 million compared to $41.6 million in the prior year quarter due to factors mentioned above.

Please see the financial tables at the end of this press release for a reconciliation of each non-GAAP financial measure to the most directly comparable measure, prepared and presented in accordance with GAAP.

Segment Financial Results

Food Distribution

Net sales for Food Distribution increased $73.2 million, or 7.8%, to $1.01 billion from $0.94 billion in the prior year quarter. The increase was due to sales growth with existing customers, as well as incremental volume associated with increased consumer demand related to COVID-19, partially offset by the impact of the Company’s decision to exit its Fresh Production operations.

Reported operating earnings for Food Distribution were $9.2 million compared to $11.7 million in the prior year quarter. During the quarter, the Company made the decision to abandon a tradename within this segment to better align with the Company’s overall transportation operations and to provide a more integrated solution to its customers, resulting in a $7.0 million impairment of the associated indefinite-lived tradename asset. The decrease in reported operating earnings for Food Distribution was due to this asset impairment charge, as well as an increase in supply chain and corporate administrative expenses, partially offset by increased earnings due to the higher sales volume. Third quarter adjusted operating earnings⁽¹⁾ were $15.7 million compared to $15.5 million in the prior year quarter. Adjusted operating earnings exclude asset impairment and restructuring charges in both years and losses associated with the Fresh Kitchen operations in the prior year quarter.

Retail

Net sales for Retail increased $35.1 million, or 6.2%, to $596.7 million from $561.6 million in the prior year quarter primarily due to increased consumer demand related to COVID-19, as discussed above. Comparable store sales of 10.6% were partially offset by the impact of lower fuel sales, as well as store closures. During the quarter, the Company experienced more than 175% growth in its eCommerce business.

Reported operating earnings for Retail were $22.3 million compared to $6.7 million in the prior year quarter. The increase in reported operating earnings was due to the increase in sales volume, improvements in margin rates, including inventory shrink, and improved leverage of store labor. These favorable variances were partially offset by higher incentive compensation due to the improved segment performance. Adjusted operating earnings⁽¹⁾ were $22.6 million compared to $7.3 million in the prior year quarter and exclude merger/acquisition and integration expenses in the current year and restructuring charges in the prior year quarter.

Military Distribution

Net sales for Military Distribution decreased $47.2 million, or 9.5%, to $452.0 million from $499.2 million in the prior year quarter. Growth in private label and export sales were more than offset by the impact of domestic base access and commissary shopping restrictions associated with COVID-19, which have led to significant declines in Defense Commissary Agency sales as a whole.

The reported operating loss for Military Distribution was $2.5 million compared to $2.6 million in the prior year quarter. The change was driven by improved margin rates, partially offset by higher corporate administrative expenses, the impact of lower sales volumes and, to a lesser extent, increases in the rate of warehousing expenses. Adjusted operating loss⁽¹⁾ was $2.5 million for the quarter in both years.

Balance Sheet and Cash Flow

Cash flows provided by operating activities for the year-to-date period of fiscal 2020 were $223.8 million compared to $140.0 million in the prior year, driven by increased profitability and reductions in working capital. In 2020, the Company has generated $178.0 million in free cash flow⁽⁴⁾ year-to-date, compared to $93.1 million in the prior year. The Company reduced net long-term debt⁽⁵⁾ by $145.0 million year-to-date in fiscal 2020. The reduction in net long-term debt, combined with increased profitability, resulted in an improvement in the Company’s net long-term debt to adjusted EBITDA ratio over this period of time from 3.7x to 2.3x, calculated on a trailing thirteen periods basis.

Capital expenditures and IT capital⁽⁶⁾ totaled $53.5 million in the year-to-date period compared to $46.9 million in the prior year.

Through the third quarter of fiscal 2020, the Company has declared $20.8 million in quarterly cash dividends equal to $0.1925 per common share. The Company also repurchased 860,752 shares for a total of $10.0 million in the first quarter of fiscal 2020, at an average price of $11.62 per share.

Outlook

For the 53-week fiscal year ending January 2, 2021, the Company is updating its annual outlook from what was previously provided on August 12, 2020 to reflect actual financial results, its expectations for the remainder of the fiscal year, and the forecasted impact of stock warrants, which were granted early in the fourth quarter.

For fiscal year 2020, the Company now anticipates adjusted earnings per share from continuing operations⁽⁷⁾ of approximately $2.42 to $2.50 compared to its prior projection of $2.40 to $2.60. The Company’s updated guidance reflects the continued benefits of sales trends associated with COVID-19 and the related increase in consumer demand, offset by estimated non-cash stock warrant expense of $6.0 million to $7.0 million, or $0.13 to $0.15 per diluted share. Reported earnings per share from continuing operations are expected to range from $2.09 to $2.17 compared to its prior projection of $2.13 to $2.41.

The Company now expects fiscal 2020 adjusted EBITDA to range from $237.0 million to $242.0 million compared to its prior guidance of $232.0 million to $242.0 million.

The Company’s updated guidance now reflects capital expenditures and IT capital in the range of $80.0 million to $85.0 million for the fiscal year. Depreciation and amortization have been updated to a range of $88.0 million to $90.0 million. Interest expense is now expected to range from $18.0 million to $18.5 million. The Company’s updated guidance now reflects an adjusted effective tax rate of 23.5% to 24.0% and a reported effective tax rate of 13.0% to 13.5%.

Conference Call

A telephone conference call to discuss the Company’s third quarter 2020 financial results is scheduled for Thursday, November 12, 2020 at 8:00 a.m. ET. A live webcast of this conference call will be available on the Company’s website, www.spartannash.com/webcasts. Simply click on “For Investors” and follow the links to the live webcast. The webcast will remain available for replay on the Company’s website for approximately ten days.

About SpartanNash

SpartanNash (Nasdaq: SPTN) is a Fortune 400 company whose core businesses include distributing grocery products to a diverse group of independent and chain retailers, its corporate-owned retail stores and U.S. military commissaries and exchanges; as well as operating a premier fresh produce distribution network. SpartanNash serves customer locations in all 50 states and the District of Columbia, Europe, Cuba, Puerto Rico, Honduras, Bahrain, Djibouti and Egypt. SpartanNash currently operates 156 supermarkets, primarily under the banners of Family Fare, Martin’s Super Markets, D&W Fresh Market, VG’s Grocery and Dan’s Supermarket. Through its MDV military division, SpartanNash is a leading distributor of grocery products to U.S. military commissaries.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These include statements preceded by, followed by or that otherwise include the words “outlook,” “believe,” “anticipates,” “continue,” “expects,” “guidance,” “trend,” “on track,” “encouraged” or “plan” or similar expressions. The statements in the “Outlook” section of this press release are inherently forward looking. Forward-looking statements relating to expectations about future results or events are based upon information available to SpartanNash as of today’s date, and are not guarantees of the future performance of the Company, and actual results may vary materially from the results and expectations discussed. Additional risks and uncertainties include, but are not limited to, disruption associated with the COVID-19 pandemic and the Company’s ability to compete in the highly competitive grocery distribution, retail grocery, and military distribution industries. Additional information concerning these and other risks is contained in SpartanNash’s most recently filed Annual Report on Form 10-K, recent Current Reports on Form 8-K and other SEC filings. All subsequent written and oral forward-looking statements concerning SpartanNash, or other matters and attributable to SpartanNash or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. SpartanNash does not undertake any obligation to publicly update any of these forward-looking statements to reflect events or circumstances that may arise after the date hereof.

⁽¹⁾ A reconciliation of operating earnings to adjusted operating earnings, a non-GAAP financial measure, is provided in Table 3 below.

⁽²⁾ A reconciliation of earnings from continuing operations to adjusted earnings from continuing operations, a non-GAAP financial measure, is provided in Table 4 below.

⁽³⁾ A reconciliation of net earnings to Adjusted EBITDA, a non-GAAP financial measure, is provided in Table 2 below.

⁽⁴⁾ A reconciliation of net cash provided by operating activities to free cash flow, a non-GAAP financial measure, is provided in Table 6 below.

⁽⁵⁾ A reconciliation of long-term debt and finance lease obligations to net long-term debt, a non-GAAP financial measure, is provided in Table 5 below.

⁽⁶⁾ A reconciliation of purchases of property and equipment to capital expenditures and IT capital, a non-GAAP financial measure, is provided in Table 7 below.
⁽⁷⁾ A reconciliation of projected earnings per share from continuing operations to adjusted earnings per share from continuing operations, a non-GAAP financial measure, is provided in Table 8 below.

SPARTANNASH COMPANY AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

	12 Weeks Ended						40 Weeks Ended
	October 3,			October 5,			October 3,			October 5,
(In thousands, except per share amounts)	2020			2019			2020			2019
Net sales	$	2,060,816		$	1,999,808		$	7,101,373		$	6,538,112
Cost of sales		1,735,994			1,709,447			6,014,610			5,581,015
Gross profit		324,822			290,361			1,086,763			957,097

Operating expenses
Selling, general and administrative		289,039			273,286			981,066			900,160
Merger/acquisition and integration		242			—			242			1,364
Restructuring charges and asset impairment		6,543			1,296			20,455			10,215
Total operating expenses		295,824			274,582			1,001,763			911,739

Operating earnings		28,998			15,779			85,000			45,358

Other expenses and (income)
Interest expense		3,522			7,375			14,810			27,952
Loss on debt extinguishment		—			329			—			329
Postretirement benefit expense (income)		101			10,221			(597	)		19,677
Other, net		(141	)		(180	)		(547	)		(1,071	)
Total other expenses, net		3,482			17,745			13,666			46,887

Earnings (loss) before income taxes and discontinued operations		25,516			(1,966	)		71,334			(1,529	)
Income tax expense (benefit)		5,564			(1,656	)		7,513			(1,973	)
Earnings (loss) from continuing operations		19,952			(310	)		63,821			444

Loss from discontinued operations, net of taxes		—			(27	)		—			(126	)
Net earnings (loss)	$	19,952		$	(337	)	$	63,821		$	318

Basic earnings (loss) per share:
Earnings (loss) from continuing operations	$	0.56		$	(0.01	)	$	1.78		$	0.01
Loss from discontinued operations		—			—			—			—
Net earnings (loss)	$	0.56		$	(0.01	)	$	1.78		$	0.01

Diluted earnings (loss) per share:
Earnings (loss) from continuing operations	$	0.56		$	(0.01	)	$	1.78		$	0.01
Loss from discontinued operations		—			—			—			—
Net earnings (loss)	$	0.56		$	(0.01	)	$	1.78		$	0.01


Weighted average shares outstanding:
Basic		35,730			36,340			35,900			36,248
Diluted		35,732			36,340			35,900			36,248

SPARTANNASH COMPANY AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

	October 3,			December 28,
(In thousands)	2020			2019
Assets
Current assets
Cash and cash equivalents	$	26,903		$	24,172
Accounts and notes receivable, net		387,114			345,320
Inventories, net		586,351			537,212
Prepaid expenses and other current assets		73,192			58,775
Property and equipment held for sale		21,942			31,203
Total current assets		1,095,502			996,682

Property and equipment, net		562,326			615,816
Goodwill		181,035			181,035
Intangible assets, net		119,039			130,434
Operating lease assets		269,025			268,982
Other assets, net		94,632			82,660

Total assets	$	2,321,559		$	2,275,609

Liabilities and Shareholders’ Equity
Current liabilities
Accounts payable	$	501,099		$	405,370
Accrued payroll and benefits		91,001			59,680
Other accrued expenses		53,439			51,295
Current portion of operating lease liabilities		43,705			42,440
Current portion of long-term debt and finance lease liabilities		5,338			6,349
Total current liabilities		694,582			565,134

Long-term liabilities
Deferred income taxes		52,952			43,111
Operating lease liabilities		261,621			267,350
Other long-term liabilities		48,033			30,272
Long-term debt and finance lease liabilities		540,920			682,204
Total long-term liabilities		903,526			1,022,937

Commitments and contingencies

Shareholders’ equity
Common stock, voting, no par value; 100,000 shares authorized; 35,871 and 36,351 shares outstanding		484,612			490,233
Preferred stock, no par value, 10,000 shares authorized; no shares outstanding		—			—
Accumulated other comprehensive loss		(1,479	)		(1,600	)
Retained earnings		240,318			198,905
Total shareholders’ equity		723,451			687,538

Total liabilities and shareholders’ equity	$	2,321,559		$	2,275,609

SPARTANNASH COMPANY AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

	40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019
Cash flow activities
Net cash provided by operating activities	$	223,832		$	140,034
Net cash used in investing activities		(35,536	)		(117,645	)
Net cash used in financing activities		(185,565	)		(17,385	)
Net cash used in discontinued operations		—			(153	)
Net increase in cash and cash equivalents		2,731			4,851
Cash and cash equivalents at beginning of the period		24,172			18,585
Cash and cash equivalents at end of the period	$	26,903		$	23,436

SPARTANNASH COMPANY AND SUBSIDIARIES SUPPLEMENTAL FINANCIAL DATA Table 1: Net Sales and Operating Earnings (Loss) by Segment (Unaudited)

	12 Weeks Ended										40 Weeks Ended
(In thousands)	October 3, 2020					October 5, 2019					October 3, 2020					October 5, 2019
Food Distribution Segment:
Net sales	$	1,012,204		49.1	%	$	939,047		47.0	%	$	3,471,561		48.9	%	$	3,043,668		46.6	%
Operating earnings		9,191					11,699					34,990					36,564
Retail Segment:
Net sales		596,659		29.0	%		561,605		28.1	%		2,010,483		28.3	%		1,833,347		28.0	%
Operating earnings		22,318					6,726					59,416					14,600
Military Segment:
Net sales		451,953		21.9	%		499,156		24.9	%		1,619,329		22.8	%		1,661,097		25.4	%
Operating loss		(2,511	)				(2,646	)				(9,406	)				(5,806	)
Total:
Net sales	$	2,060,816		100.0	%	$	1,999,808		100.0	%	$	7,101,373		100.0	%	$	6,538,112		100.0	%
Operating earnings		28,998					15,779					85,000					45,358

Non-GAAP Financial Measures

In addition to reporting financial results in accordance with GAAP, the Company also provides information regarding Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (“adjusted EBITDA”), adjusted operating earnings, adjusted earnings from continuing operations, total net long-term debt, free cash flow and projected adjusted earnings per diluted share from continuing operations. These are non-GAAP financial measures, as defined below, and are used by management to allocate resources, assess performance against its peers and evaluate overall performance. The Company believes these measures provide useful information for both management and its investors. The Company believes these non-GAAP measures are useful to investors because they provide additional understanding of the trends and special circumstances that affect its business. These measures provide useful supplemental information that helps investors to establish a basis for expected performance and the ability to evaluate actual results against that expectation. The measures, when considered in connection with GAAP results, can be used to assess the overall performance of the Company as well as assess the Company’s performance against its peers. These measures are also used as a basis for certain compensation programs sponsored by the Company. In addition, securities analysts, fund managers and other shareholders and stakeholders that communicate with the Company request its financial results in these adjusted formats.

Current year adjusted operating earnings, adjusted earnings from continuing operations, and adjusted EBITDA exclude “Fresh Cut operating losses” subsequent to the decision to exit these operations during the first quarter, severance associated with cost reduction initiatives, and fees paid to a third-party advisory firm associated with Project One Team, the Company’s initiative to drive growth while increasing efficiency and reducing costs. Pension termination income related to a refund from the annuity provider associated with the final reconciliation of participant data is excluded from adjusted earnings from continuing operations. These items are considered “non-operational” or “non-core” in nature. Prior year adjusted operating earnings, adjusted earnings from continuing operations, and adjusted EBITDA exclude “Fresh Kitchen operating losses” subsequent to the decision to exit these operations at the beginning of the third quarter, costs associated with organizational realignment, which include significant changes to the Company’s management team, and fees paid to a third-party advisory firm associated with Project One Team, the Company’s initiative to drive growth while increasing efficiency and reducing costs. Pension termination costs, primarily related to non-operating settlement expense associated with the distribution of pension assets, are excluded from adjusted earnings from continuing operations, and to a lesser extent adjusted operating earnings.

Table 2: Reconciliation of Net Earnings to Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA) (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended						40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019			October 3, 2020			October 5, 2019
Net earnings (loss)	$	19,952		$	(337	)	$	63,821		$	318
Loss from discontinued operations, net of tax		—			27			—			126
Income tax expense (benefit)		5,564			(1,656	)		7,513			(1,973	)
Other expenses, net		3,482			17,745			13,666			46,887
Operating earnings		28,998			15,779			85,000			45,358
Adjustments:
LIFO expense		387			1,268			3,158			3,761
Depreciation and amortization		20,858			20,351			68,611			67,513
Merger/acquisition and integration		242			—			242			1,364
Restructuring, asset impairment and other charges		6,543			1,296			20,455			10,215
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Stock-based compensation		1,033			638			5,181			6,735
Non-cash rent		(1,188	)		(1,082	)		(3,981	)		(4,542	)
Costs associated with Project One Team		—			—			493			5,428
Organizational realignment costs		—			935			—			1,812
Severance associated with cost reduction initiatives		40			—			5,121			—
Loss on disposal of assets		35			—			3,462			—
Other non-cash charges		94			187			193			710
Adjusted EBITDA	$	57,042		$	41,576		$	190,197		$	140,558

Table 2: Reconciliation of Net Earnings to Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization, continued (Adjusted EBITDA) (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended						40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019			October 3, 2020			October 5, 2019
Food Distribution:
Operating earnings	$	9,191		$	11,699		$	34,990		$	36,564
Adjustments:
LIFO expense		295			639			1,684			1,869
Depreciation and amortization		7,413			7,390			24,561			25,368
Merger/acquisition and integration		—			—			—			(130	)
Restructuring, asset impairment and other charges		6,538			1,043			19,222			10,724
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Stock-based compensation		522			302			2,524			3,319
Non-cash rent		31			147			125			353
Costs associated with Project One Team		—			—			265			2,877
Organizational realignment costs		—			495			—			960
Severance associated with cost reduction initiatives		—			—			3,143			—
(Gain) loss on disposal of assets		(6	)		—			1,613			—
Other non-cash charges		52			14			103			391
Adjusted EBITDA	$	24,036		$	23,933		$	90,492		$	84,499
Retail:
Operating earnings	$	22,318		$	6,726		$	59,416		$	14,600
Adjustments:
LIFO (gain) expense		(15	)		257			586			858
Depreciation and amortization		10,489			10,197			34,570			33,048
Merger/acquisition and integration		242			—			242			1,494
Restructuring charges (gains) and asset impairment		5			253			1,233			(509	)
Stock-based compensation		364			222			1,756			2,325
Non-cash rent		(1,134	)		(1,149	)		(3,818	)		(4,612	)
Costs associated with Project One Team		—			—			164			1,845
Organizational realignment costs		—			318			—			616
Severance associated with cost reduction initiatives		9			—			1,441			—
Loss on disposal of assets		34			—			1,905			—
Other non-cash charges		30			243			64			410
Adjusted EBITDA	$	32,342		$	17,067		$	97,559		$	50,075
Military:
Operating loss	$	(2,511	)	$	(2,646	)	$	(9,406	)	$	(5,806	)
Adjustments:
LIFO expense		107			372			888			1,034
Depreciation and amortization		2,956			2,764			9,480			9,097
Stock-based compensation		147			114			901			1,091
Non-cash rent		(85	)		(80	)		(288	)		(283	)
Costs associated with Project One Team		—			—			64			706
Organizational realignment costs		—			122			—			236
Severance associated with cost reduction initiatives		31			—			537			—
Loss (gain) on disposal of assets		7			—			(56	)		—
Other non-cash charges (gains)		12			(70	)		26			(91	)
Adjusted EBITDA	$	664		$	576		$	2,146		$	5,984

Notes: Adjusted EBITDA is a non-GAAP operating financial measure that the Company defines as net earnings plus interest, discontinued operations, depreciation and amortization, and other non-cash items including deferred (stock) compensation, the LIFO provision, as well as adjustments for items that do not reflect the ongoing operating activities of the Company and costs associated with the closing of operational locations.

Adjusted EBITDA and adjusted EBITDA by segment are not measures of performance under accounting principles generally accepted in the United States of America and should not be considered as a substitute for net earnings, cash flows from operating activities and other income or cash flow statement data. The Company’s definitions of adjusted EBITDA and adjusted EBITDA by segment may not be identical to similarly titled measures reported by other companies.

Table 3: Reconciliation of Operating Earnings to Adjusted Operating Earnings (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended						40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019			October 3, 2020			October 5, 2019
Operating earnings	$	28,998		$	15,779		$	85,000		$	45,358
Adjustments:
Merger/acquisition and integration		242			—			242			1,364
Restructuring, asset impairment and other		6,543			1,296			20,455			10,215
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Costs associated with Project One Team		—			—			493			5,428
Organizational realignment costs		—			935			—			1,812
Expenses associated with tax planning		(15	)		—			82			—
Pension termination		—			28			—			48
Severance associated with cost reduction initiatives		40			43			5,121			484
Adjusted operating earnings	$	35,808		$	20,285		$	113,655		$	66,913
Reconciliation of operating earnings (loss) to adjusted operating earnings (loss) by segment:
Food Distribution:
Operating earnings	$	9,191		$	11,699		$	34,990		$	36,564
Adjustments:
Merger/acquisition and integration		—			—			—			(130	)
Restructuring, asset impairment and other		6,538			1,043			19,222			10,724
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Costs associated with Project One Team		—			—			265			2,877
Organizational realignment costs		—			495			—			960
Expenses associated with tax planning		(8	)		—			44			—
Pension termination		—			15			—			26
Severance associated with cost reduction initiatives		—			31			3,143			392
Adjusted operating earnings	$	15,721		$	15,487		$	59,926		$	53,617
Retail:
Operating earnings	$	22,318		$	6,726		$	59,416		$	14,600
Adjustments:
Merger/acquisition and integration		242			—			242			1,494
Restructuring charges (gains) and asset impairment		5			253			1,233			(509	)
Costs associated with Project One Team		—			—			164			1,845
Organizational realignment costs		—			318			—			616
Expenses associated with tax planning		(5	)		—			27			—
Pension termination		—			10			—			17
Severance associated with cost reduction initiatives		9			12			1,441			83
Adjusted operating earnings	$	22,569		$	7,319		$	62,523		$	18,146
Military:
Operating loss	$	(2,511	)	$	(2,646	)	$	(9,406	)	$	(5,806	)
Adjustments:
Costs associated with Project One Team		—			—			64			706
Organizational realignment costs		—			122			—			236
Expenses associated with tax planning		(2	)		—			11			—
Pension termination		—			3			—			5
Severance associated with cost reduction initiatives		31			—			537			9
Adjusted operating loss	$	(2,482	)	$	(2,521	)	$	(8,794	)	$	(4,850	)

Notes: Adjusted operating earnings is a non-GAAP operating financial measure that the Company defines as operating earnings plus or minus adjustments for items that do not reflect the ongoing operating activities of the Company and costs associated with the closing of operational locations.

Adjusted operating earnings is not a measure of performance under accounting principles generally accepted in the United States of America and should not be considered as a substitute for operating earnings, cash flows from operating activities and other income or cash flow statement data. The Company’s definition of adjusted operating earnings may not be identical to similarly titled measures reported by other companies.

Table 4: Reconciliation of Earnings (loss) from Continuing Operations to Adjusted Earnings from Continuing Operations (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended
	October 3, 2020						October 5, 2019
				per diluted						per diluted
(In thousands, except per share amounts)	Earnings			share			Earnings			share
Earnings (loss) from continuing operations	$	19,952		$	0.56		$	(310	)	$	(0.01	)
Adjustments:
Merger/acquisition and integration		242						—
Restructuring, asset impairment and other		6,543						1,296
Fresh Kitchen operating losses		—						2,204
Organizational realignment costs		—						935
Loss on debt extinguishment		—						329
Severance associated with cost reduction initiatives		40						43
Expenses associated with tax planning		(15	)					—
Pension termination		—						10,159
Total adjustments		6,810						14,966
Income tax effect on adjustments (a)		(1,830	)					(3,751	)
Impact of CARES Act (b)		212						—
Total adjustments, net of taxes		5,192			0.14	*		11,215			0.31
Adjusted earnings from continuing operations	$	25,144		$	0.70		$	10,905		$	0.30

	40 Weeks Ended
	October 3, 2020						October 5, 2019
				per diluted						per diluted
(In thousands, except per share amounts)	Earnings			share			Earnings			share
Earnings from continuing operations	$	63,821		$	1.78		$	444		$	0.01
Adjustments:
Merger/acquisition and integration		242						1,364
Restructuring, asset impairment and other		20,455						10,215
Fresh Cut operating losses		2,262						—
Fresh Kitchen operating losses		—						2,204
Costs associated with Project One Team		493						5,428
Organizational realignment costs		—						1,812
Loss on debt extinguishment		—						329
Severance associated with cost reduction initiatives		5,121						484
Expenses associated with tax planning		82						—
Pension termination		(1,004	)					19,510
Total adjustments		27,651						41,346
Income tax effect on adjustments (a)		(6,827	)					(10,166	)
Impact of CARES Act (b)		(9,298	)					—
Total adjustments, net of taxes		11,526			0.32			31,180			0.86
Adjusted earnings from continuing operations	$	75,347		$	2.10		$	31,624		$	0.87
* Includes rounding

(a)		The income tax effect on adjustments is computed by applying the applicable tax rate to the adjustments.
(b)		Represents tax impacts attributable to the Coronavirus Aid, Relief and Economic Security (“CARES”) Act, primarily related to additional deductions and the utilization of net operating loss carrybacks.

Notes: Adjusted earnings from continuing operations is a non-GAAP operating financial measure that the Company defines as earnings from continuing operations plus or minus adjustments for items that do not reflect the ongoing operating activities of the Company and costs associated with the closing of operational locations.

Adjusted earnings from continuing operations is not a measure of performance under accounting principles generally accepted in the United States of America and should not be considered as a substitute for net earnings, cash flows from operating activities and other income or cash flow statement data. The Company’s definition of adjusted earnings from continuing operations may not be identical to similarly titled measures reported by other companies.

Table 5: Reconciliation of Long-Term Debt and Finance Lease Obligations to Net Long-Term Debt (A Non-GAAP Financial Measure) (Unaudited)

	October 3,			December 28,
(In thousands)	2020			2019
Current portion of long-term debt and finance lease liabilities	$	5,338		$	6,349
Long-term debt and finance lease liabilities		540,920			682,204
Total debt		546,258			688,553
Cash and cash equivalents		(26,903	)		(24,172	)
Net long-term debt	$	519,355		$	664,381

Notes: Net long-term debt is a non-GAAP financial measure that is defined as long-term debt and finance lease obligations plus current maturities of long-term debt and finance lease obligations less cash and cash equivalents. The Company believes both management and its investors find the information useful because it reflects the amount of long-term debt obligations that are not covered by available cash and temporary investments. Net long-term debt is not a substitute for GAAP financial measures and may differ from similarly titled measures of other companies.

Table 6: Reconciliation of Net Cash Provided by Operating Activities to Free Cash Flow (A Non-GAAP Financial Measure) (Unaudited)

	40 Weeks Ended
(In thousands)	October 3, 2020		October 5, 2019
Net cash provided by operating activities	$	223,832	$	140,034
Less:
Purchases of property and equipment		45,880		46,905
Free cash flow	$	177,952	$	93,129

Notes: Free cash flow is a non-GAAP financial measure calculated by subtracting capital expenditures from cash flows provided by operating activities, the most directly comparable GAAP measure. The Company believes it is a useful indicator of liquidity that provides information to both management and investors about the amount of cash generated from operations that, after capital expenditures, can be used for strategic business objectives, including the repayment of long-term debt. Free cash flow is not a substitute for GAAP financial measures and may differ from similarly titled measures of other companies.

Table 7: Reconciliation of Purchases of Property and Equipment to Capital Expenditures and IT Capital (A Non-GAAP Financial Measure) (Unaudited)

	40 Weeks Ended
(In thousands)	October 3, 2020		October 5, 2019
Purchases of property and equipment	$	45,880	$	46,905
Plus:
Cloud computing spend		7,658		—
Capital expenditures and IT capital	$	53,538	$	46,905

Notes: Capital expenditures and IT capital is a non-GAAP financial measure calculated by adding spending related to the development of cloud computing applications spend to capital expenditures, the most directly comparable GAAP measure. Cloud computing spend only includes costs incurred during the application development phase and does not include ongoing costs of hosting or maintenance associated with these applications, which are expensed as incurred. The Company believes it is a useful indicator of the Company’s investment in its facilities and systems as it transitions to more cloud-based IT systems. Capital expenditures and IT capital is not a substitute for GAAP financial measures and may differ from similarly titled measures of other companies.

Table 8: Reconciliation of Projected Earnings per Diluted Share from Continuing Operations to Projected Adjusted Earnings per Diluted Share from Continuing Operations (A Non-GAAP Financial Measure) (Unaudited)

	53 Weeks Ending January 2, 2021
	Low			High
Earnings from continuing operations	$	2.09		$	2.17
Adjustments, net of taxes:
Merger/acquisition and integration expenses		0.01			0.01
Costs associated with Project One Team		0.01			0.01
Pension termination		(0.02	)		(0.02	)
Restructuring and asset impairment		0.43			0.43
Severance associated with cost reduction initiatives		0.11			0.11
Fresh Cut operating losses		0.05			0.05
Impact of CARES Act		(0.26	)		(0.26	)
Adjusted earnings from continuing operations	$	2.42		$	2.50

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005748/en/

Investors:

Mark Shamber

Chief Financial Officer and Executive Vice President

(616) 878-8023

Chris Mandeville

ICR

(203) 682-8304

Jeff Sonnek

ICR

(646) 277-1263

Media:

Meredith Gremel

Vice President Corporate Affairs and Communications

(616) 878-2830

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: Retail Supermarket Food/Beverage

MEDIA: