Dicerna to Participate in Upcoming Investor Conferences

Dicerna to Participate in Upcoming Investor Conferences

LEXINGTON, Mass.–(BUSINESS WIRE)–Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that Douglas M. Fambrough, Ph.D., president and chief executive officer, will be participating in fireside chats at two upcoming investor conferences:

  • Stifel Virtual Healthcare Conference on Wednesday, Nov. 18, 2020 at 3:20 p.m. ET
  • Evercore ISI 3rd Annual HealthCONx Virtual Conference on Tuesday, Dec. 1, 2020 at 10:05 a.m. ET

A live audio webcast of each event will be accessible from the Investors and Media section of the Dicerna website at www.investors.dicerna.com. An archived replay will be available on the Company’s website following the event.

About Dicerna Pharmaceuticals, Inc.

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference (RNAi) to silence selectively genes that cause or contribute to disease. Using our proprietary RNAi technology platform called GalXC™, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on hepatocytes, Dicerna has continued to innovate and is exploring new applications of its RNAi technology beyond the liver, targeting additional tissues and enabling new therapeutic applications. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH and Alnylam Pharmaceuticals, Inc. Between Dicerna and our collaborative partners, we currently have more than 20 active discovery, preclinical or clinical programs focused on rare, cardiometabolic, viral, chronic liver and complement-mediated diseases, as well as neurodegeneration and pain. At Dicerna, our mission is to interfere – to silence genes, to fight disease, to restore health. For more information, please visit www.dicerna.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements pertaining to the Company’s planned participation at investor conferences, which may include discussion of the Company’s business and operations, including the discovery, development and commercialization of our product candidates and technology platform, and the therapeutic potential thereof, the success of our collaborations with partners and any potential future collaborations. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those relating to our preclinical research and clinical programs and other risks identified under the heading “Risk Factors” included in our most recent Form 10-Q filing and in other future filings with the SEC. The forward-looking statements contained in this press release reflect Dicerna’s current views with respect to future events, and Dicerna does not undertake and specifically disclaims any obligation to update any forward-looking statements.

GalXC™ is a trademark of Dicerna Pharmaceuticals, Inc.

Media:

Amy Trevvett

+1 617-612-6253

[email protected]

Investors:

Lauren Stival

+1 617-514-0461

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Research Finance Genetics Banking Clinical Trials Professional Services Biotechnology Pharmaceutical Health Science

MEDIA:

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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.

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

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

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)

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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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

 

 

$

 

 

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:

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.

Investor Relations:

James Samford

[email protected]

KEYWORDS: United States North America Oklahoma

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

MEDIA:

Logo
Logo

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]

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.

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
Logo

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 3rd 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]

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.

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:

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]     
   

© Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

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.