Market Newsdesk

– Enrollment Complete in the Phase 3
DeFi Trial of Nirogacestat in Adult Patients with Desmoid Tumors –

– Clinical Collaborations Signed with Janssen, Pfizer and Precision Biosciences to Evaluate Nirogacestat in Combination with BCMA-Directed Therapies Across Modalities for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma –

– Entered into Sponsored Research Agreement with Fred Hutchinson Cancer Research Center to Further Evaluate Nirogacestat as a BCMA Potentiator in Multiple Myeloma –

– Completed an Asset Purchase and Exclusive License Agreement of Global Rights to FAAH Inhibitor PF-04457845 to Jazz Pharmaceuticals, Receiving $35 Million Upfront Payment and Potential Future Milestone Payments of Up to $375 Million –

– Raised $269.5 Million in Net Proceeds Through Follow-On Public Offering –

STAMFORD, Conn., Nov. 12, 2020 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2020 and provided an update on recent company developments.

“We are very pleased with our achievements in the third quarter of 2020 across our clinical development, business development and corporate initiatives. We completed enrollment in the Phase 3 DeFi trial, advanced our strategy to develop nirogacestat as a cornerstone of BCMA combination therapy for patients with multiple myeloma by signing additional collaborations with industry and academic leaders, and continued to progress our trials in biomarker defined metastatic solid tumors,” said Saqib Islam, Chief Executive Officer of SpringWorks. “Our ten clinical development programs are progressing as planned and we look forward to providing further updates as we advance our pipeline and continue to execute on our strategy to build a leading targeted oncology company.”

Recent Business Highlights and Upcoming Milestones

Late-Stage Rare Oncology

• Completed enrollment in the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. SpringWorks expects to report topline data from the DeFi study in the second or third quarter of 2021.
• Recruiting patients in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
• Highlighted a publication by investigators at the University of Minnesota and the Dana-Farber Cancer Institute in the Pediatric Cancer & Blood journal reporting data from four pediatric and young adult desmoid tumor patients who received nirogacestat under the SpringWorks Expanded Access Program. In these four patients, the investigators reported one complete response, two partial responses, and one stable disease, with no grade 3 or 4 adverse events.
• Enrollment is ongoing in the Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. SpringWorks expects to provide an update on the ReNeu trial in the fourth quarter of 2020 or first quarter of 2021.

B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

• Enrollment is ongoing in a Phase 1b trial evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK’s anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in patients with relapsed or refractory multiple myeloma.
• Entered into a clinical collaboration with Janssen Biotech, Inc. (Janssen) to evaluate nirogacestat in combination with Janssen’s BCMA CD3 bispecific antibody, teclistamab, in patients with relapsed or refractory multiple myeloma. A Phase 1 study is expected to commence by early 2021, pending discussions with regulators.
• Entered into a clinical collaboration with Pfizer Inc. (Pfizer) to evaluate nirogacestat in combination with Pfizer’s BCMA CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma. A Phase 1b/2 study is expected to commence in the first half of 2021.
• An IND application is expected to be filed by the end of 2020 to evaluate nirogacestat in combination with Allogene’s BCMA AlloCAR T therapy, ALLO-715, in patients with relapsed or refractory multiple myeloma.
• Entered into a clinical collaboration with Precision BioSciences, Inc. (Precision) to evaluate nirogacestat in combination with Precision’s allogeneic CAR T candidate targeting BCMA, PBCAR269A, in patients with relapsed or refractory multiple myeloma. A Phase 1/2a clinical study is expected to commence in the first half of 2021, pending discussions with regulators.
• Entered into a sponsored research agreement with Fred Hutchinson Cancer Research Center (Fred Hutch) to further explore the ability of nirogacestat to modulate BCMA and potentiate BCMA-targeting therapies in a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch.

Biomarker-Defined Metastatic Solid Tumors

• Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. SpringWorks and BeiGene expect to report initial clinical data in 2021.
• Enrollment is ongoing in a Phase 1 trial of BGB-3245 in patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, an entity that is jointly owned by SpringWorks and BeiGene, Ltd. Initial clinical data from the Phase 1 study are expected in 2021.

General Corporate

• In October 2020, SpringWorks completed a follow-on public offering that raised $269.5 million in net proceeds, which included the underwriters’ full exercise of their option to purchase additional shares of common stock.
• SpringWorks and Jazz Pharmaceuticals entered into an asset purchase and exclusive license agreement under which Jazz acquired SpringWorks’ fatty acid amide hydrolase (FAAH) inhibitor program, PF-04457845. Under the terms of the agreement, Jazz assumed all milestone and royalty obligations owned by SpringWorks to Pfizer under the 2017 license agreement pursuant to which SpringWorks obtained rights to this asset. In addition, Jazz made an upfront payment of $35 million to SpringWorks, with potential future milestone payments of up to $375 million payable to SpringWorks based upon the achievement of certain clinical development, regulatory and commercial milestones. SpringWorks is also entitled to receive tiered royalties on future net sales of PF-04457845.

Third Quarter and Year to Date 2020 Financial Results

• Research and Development (R&D) Expenses: R&D expenses were $13.9 million and $36.6 million for the third quarter and year-to-date periods, respectively, compared to $10.7 million and $30.4 million for the comparable periods of 2019, respectively. The increases in R&D expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of R&D personnel, an increase in non-cash share-based compensation expense and increases in external costs related to drug manufacturing and clinical trial costs.
• General and Administrative (G&A) Expenses: G&A expenses were $7.7 million and $20.9 million for the third quarter and year-to-date periods, respectively, compared to $4.6 million and $11.5 million for the comparable periods of 2019, respectively. The increases in G&A expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of G&A personnel supporting the growth of the organization, and an increase in non-cash share-based compensation expenses, as well as increases in expenses related to the expansion of business activities.
• Net Loss Attributable to Common Stockholders: SpringWorks reported net losses of $21.7 million, or $0.51 loss per share, and $56.8 million, or $1.35 loss per share, for the third quarter and year-to-date periods ended September 30, 2020, respectively. This compares to net losses of $16.8 million, or $1.77 loss per share, and $34.4 million, or $9.24 loss per share, for the comparable periods of 2019, respectively.
• Cash Position: Cash, cash equivalents and marketable securities were $276.8 million as of September 30, 2020. This does not include the net proceeds of $269.5 million from the Company’s follow-on public offering completed in October 2020 or the $35 million upfront payment Jazz Pharmaceuticals made to SpringWorks in October 2020.

COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2020 and refer to the Forward-Looking Statements section in this press release.

About SpringWorks Therapeutics

SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

SpringWorks
uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company’s website in the ‘Investors & Media’ section. Accordingly, investors should monitor such portions of the SpringWorks website, in addition to following press releases, SEC filings and public conference calls and webcasts.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding SpringWorks’ clinical trials and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to SpringWorks’ financial results, the timing for completion of SpringWorks’ clinical trials of its product candidates, whether and when, if at all, SpringWorks’ product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in SpringWorks’ SEC filings. SpringWorks cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. SpringWorks disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent SpringWorks’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

SpringWorks Therapeutics, Inc.



Condensed Consolidated Statements of Operations



(Unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
(in thousands, except share and per-share data)		2020				2019				2020				2019
Operating expenses:
Research and development		$	13,923			$	10,745			$	36,597			$	30,373
General and administrative			7,669				4,584				20,946				11,495
Total operating expenses			21,592				15,329				57,543				41,868
Loss from operations			(21,592	)			(15,329	)			(57,543	)			(41,868	)
Other income:
Interest income, net			63				997				1,156				2,280
Total other income			63				997				1,156				2,280
Equity investment loss			(130	)			(2,501	)			(459	)			(2,501	)
Net loss		$	(21,659	)		$	(16,833	)		$	(56,846	)		$	(42,089	)
Reconciliation of net loss to net loss attributable to common stockholders:
Net loss		$	(21,659	)		$	(16,833	)		$	(56,846	)		$	(42,089	)
Net gain attributable to extinguishment of Series A convertible preferred and Junior Series A convertible preferred units			—				—				—				7,729
Net loss attributable to common stockholders		$	(21,659	)		$	(16,833	)		$	(56,846	)		$	(34,360	)
Net loss per share, basic and diluted		$	(0.51	)		$	(1.77	)		$	(1.35	)		$	(9.24	)
Weighted average common shares outstanding, basic and diluted			42,148,837				9,487,329				41,961,691				3,716,877

SpringWorks Therapeutics, Inc.



Selected Balance Sheet Data



(Unaudited)

					September 30, 2020							December 31, 2019
(In thousands)
Cash, cash equivalents and marketable securities					$	276,819						$	327,652
Working Capital (1)						266,150							319,391
Total Assets						286,100							334,831
Total liabilities						13,345							12,759
Accumulated deficit						(129,875				)			(73,029				)
Total stockholders’ (deficit) equity						272,755							322,072

⁽¹⁾ We define working capital as current assets less current liabilities.

Contact:

Kim Diamond
Phone: 203-561-1646
Email: [email protected]

Shenzhen, China, Nov. 12, 2020 (GLOBE NEWSWIRE) — Xunlei Limited (“Xunlei” or the “Company”) (Nasdaq: XNET), a leading innovator in shared cloud computing and blockchain technology in China, today announced its unaudited financial results for the third quarter ended September 30, 2020.

Third Quarter 2020 Financial Highlights:

• Total revenues were US$43.7 million, representing a decrease of 1.4% from the previous quarter.
• Cloud computing and other internet value-added services (“Cloud computing and other IVAS”) revenues were US$21.2 million, representing an increase of 1.1% from the previous quarter.
• Subscription revenues were US$19.6 million, representing a decrease of 5.5% on a sequential basis.
• Online advertising revenues (consisting primarily of revenues from mobile advertising) were approximately US$3.0 million, representing an increase of 10.8% from the previous quarter.
• Gross profit was US$22.7 million, representing an increase of 11.3% on a sequential basis. Gross margin was 51.9% in the third quarter of 2020, compared with 46.0% in the previous quarter.
• Net loss was US$1.5 million in the third quarter of 2020, compared with a net loss of US$11.8 million in the previous quarter.
• Diluted loss per ADS was US$0.02 as compared with a diluted loss of US$0.17 in the previous quarter.

Recent developments

• Collaborated with e-Surfing Cloud Storage, the cloud storage product run by Shijilong Information Network Co., Ltd, a wholly-owned subsidiary of China Telecom, to develop joint cloud storage services and explore other consumer-related products to achieve resource sharing and mutual benefits.
• Launched a BaaS (Blockchain as a Service) platform to free enterprises and developers from dealing with complex technical issues in blockchain infrastructure and to drive innovation and productivity.

Mr. Jinbo Li, Chairman and Chief Executive Officer of Xunlei, stated that “Xunlei delivered a quarter of solid execution. We are encouraged by meaningful improvements across several financial and operating metrics, including an 87% sequential improvement in our bottom-line. Through our relentless focus on reinforcing our core competitiveness, optimizing operating efficiencies, and placing more control on cost and expenses, we are seeing our strengths bolstered and profitability improved across our major product lines. And we are optimistic that the positive momentum would be carried into the fourth quarter of 2020. ”

“We remain committed to uncovering Xunlei’s value by offering our users reliable and secured digital experience. In the third quarter of 2020, we expanded service capabilities in our cloud computing business, explored new partnership and launched the BaaS platform for our blockchain services. Looking forward, we will continue to optimize operating metrics and drive product innovation to deliver value to our users, partners and shareholders,” concluded Mr. Jinbo Li.

Third
Quarter
2020
Financial Results

Total Revenues

Total revenues were US$43.7 million, representing a decrease of 1.4% from the previous quarter.

Revenues from cloud computing and other IVAS combined were US$21.2 million, representing an increase of 1.1% from the previous quarter.

Revenues from subscriptions were US$19.6 million, representing a decrease of 5.5% from the previous quarter. The number of subscribers was 3.8 million as of September 30, 2020, compared with 3.9 million as of June 30, 2020. The average revenue per subscriber for the third quarter of 2020 was RMB35.9, compared with RMB37.5 for the second quarter of 2020. The decrease in subscription revenues was attributable to the decline in pricing and subscriber base compared with the previous quarter.

Revenues from online advertising were US$3.0 million, representing an increase of 10.8% from the previous quarter. The increase in the third quarter was mainly due to the application of precision targeting algorithm to achieve better advertising placement and improve monetization efficiency.

Cost of Revenues

Total cost of revenues was US$21.0 million in the third quarter of 2020, representing 48.1% of our total revenues, compared with US$23.9 million, or 54.0% of our total revenues, in the second quarter. The decrease was mainly due to decreased cost associated with a write-down of our inventory for Onething Cloud hardware products of US$2.5 million in the second quarter.

Bandwidth costs were US$15.4 million, representing 35.1% of our total revenues, compared with US$13.9 million, or 31.4% of our total revenues in the previous quarter, the increased bandwidth cost was primarily due to increased demand for our cloud computing service, which was consistent with the increase of our cloud computing revenues.

The remaining cost of revenues mainly included revenue-sharing costs for our live streaming products.

Gross Profit and Gross Margin

Gross profit for the third quarter of 2020 was US$22.7 million, representing an increase of 11.3% from the previous quarter. Gross margin was 51.9% in the third quarter, compared with 46.0% in the previous quarter. The increase in gross profit was mainly due to (i) an increase in revenue from online advertising services, which have a higher gross margin compared with other businesses, and (ii) a decrease in cost associated with a write-down of our inventory discussed above.

Research and Development Expenses

Research and development expenses for the third quarter of 2020 were US$12.1 million, representing 27.6% of our total revenues, compared with US$14.5 million or 32.8% of our total revenues in the previous quarter. The decrease was mainly due to decreased labor cost as a result of optimization of our organizational structure during the past quarters.

Sales and Marketing Expenses

Sales and marketing expenses for the third quarter of 2020 were US$4.2 million, representing 9.6% of our total revenues, compared with US$4.4 million or 9.9% of our total revenues in the previous quarter.

General and Administrative Expenses

General and administrative expenses for the third quarter of 2020 were US$7.5 million, representing 17.1% of our total revenues, compared with US$10.1 million or 22.8% of our total revenues in the previous quarter. The decrease was mainly due to decreased employee and rental expenses as there were more employee severance compensation as a result of organizational optimization in the previous quarter and the incurrence of a one-time expense associated with terminating several office leases in the second quarter.

Impairment of Assets, Net of
R
ecoveries

No impairment of assets was accrued in the third quarter. The amount for the second quarter was approximately US$5.1 million, which represented a one-time write-off of certain receivables and prepayments in connection with our cloud computing business as we determined that those receivables and prepayments were not recoverable.

Operating Loss

Operating loss was US$1.0 million, compared with US$13.7 million in the previous quarter. The decrease was mainly due to higher gross profit and less operating expenses incurred this quarter as discussed above.

Net
Loss
and
Loss Per
ADS

Net loss was US$1.5 million in the third quarter of 2020, compared with a net loss of US$11.8 million in the previous quarter. Non-GAAP net loss was US$0.9 million in the third quarter of 2020, compared with a Non-GAAP net loss of US$11.2 million in the previous quarter.

Diluted loss per ADS in the third quarter of 2020 was US$0.02, compared with a diluted loss per ADS of US$0.17 in the previous quarter.

Cash Balance
and Short-Term Investments

As of September 30, 2020, the Company had net current assets of approximately US$195.3 million. With cash, cash equivalents and short-term investments of US$246.0 million, compared with US$257.1 million as of June 30, 2020. The Company anticipates adequate liquidity to meet its current obligations.

Share Repurchase Program

The Company approved a share repurchase program to repurchase up to US$20 million of its outstanding shares before June 30, 2021. As of September 30,2020, the Company has repurchased 1,191,392 ADSs using cash of US$4.47 million.

Guidance for
Fourth
Quarter
2020

For the fourth quarter of 2020, Xunlei estimates total revenues to be between US$45 million and US$49 million, and the midpoint of the range represents a quarter-over-quarter increase of approximately 8.0%. This estimate represents management’s preliminary view as of the date of this release, which is subject to change and any changes could be material.

Conference Call Details         

Xunlei’s management will host a conference call at 8:00 a.m. U.S. Eastern Time on November 12, 2020 (9:00 p.m. Beijing/Hong Kong Time), to discuss its quarterly results and recent business activities.

Conference Call Preregistration

Due to the outbreak of COVID-19, operator assisted conference calls are not available at the moment. All participants wishing to attend the call must preregister online before they can receive the dial-in numbers. Preregistration may require a few minutes to complete. The Company would like to apologize for any inconvenience caused by not having an operator as a result of COVID-19.

Please register in advance to join the conference using the link provided below and dial in 10 minutes before the call is scheduled to begin. Conference access information will be provided upon registration.

Participant Online Registration: http://apac.directeventreg.com/registration/event/8999108

Once preregistration has been completed, participants will receive dial-in numbers, an event passcode, and a unique registrant ID.

To join the conference, please dial the number you receive, enter the event passcode followed by your unique registrant ID, and you will be joined to the conference instantly.

The Company will also broadcast a live audio webcast of the conference call. The webcast will be available at http://ir.xunlei.com.

Following the earnings conference call, an archive of the call will be available by dialing:

China (Mandarin):		400-602-2065
Hong Kong:		800-963-117
United States:		1-855-452-5696
International:		61-2-8199-0299
Replay Passcode:		8999108
Replay End Date:		November 20, 2020

About
Xunlei

Founded in 2003, Xunlei Limited (NASDAQ: XNET) is a leading innovator in shared cloud computing and blockchain technology in China. Xunlei provides a wide range of products and services across cloud acceleration, blockchain, shared cloud computing and digital entertainment to deliver an efficient, smart and safe internet experience.

Safe Harbor Statement

This press release contains statements of a forward-looking nature. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by terminology such as “will,” “expects,” “believes,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the management’s quotations, the “Outlook” and “Guidance” sections in this press release, as well as the Company’s strategic, operational and acquisition plans, contain forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company and the industry. Forward-looking statements involve inherent risks and uncertainties, including but not limited to: (i) the Company’s ability to continue to innovate and provide attractive products and services to retain and grow its user base; (ii) the Company’s ability to keep up with technological developments and users’ changing demands in the internet industry; (iii) the Company’s ability to convert its users into subscribers of its premium services; (iv) the Company’s ability to deal with existing and potential copyright infringement claims and other related claims; (v) the risk that Covid-19 or other health risks in China or globally could adversely affect the Company’s operations or financial results; (vi) the Company’s ability to react to the governmental actions for its scrutiny of internet content in China and the Company’s ability to compete effectively. Additionally, these forward‑looking statements, particularly our guidance, involve risk, uncertainties and assumptions, including those related to the impacts of COVID‑19 on our business and global economic conditions. Many of these assumptions relate to matters that are beyond our control and changing rapidly, including, but not limited to, the timeframes for and severity of social distancing and other mitigation requirements, the impact of COVID‑19 on our customers’ purchasing decisions and the length of our sales cycles, particularly for customers in certain industries highly affected by COVID‑19. Significant variation from the assumptions underlying our forward‑looking statements could cause our actual results to vary, and the impact could be significant. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results. Further information regarding risks and uncertainties faced by the Company is included in the Company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of the press release, and the Company undertakes no obligation to update any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

About Non-GAAP Financial Measures

To supplement Xunlei’s consolidated financial results presented in accordance with United States Generally Accepted Accounting Principles (“GAAP”), Xunlei uses the following measures defined as non-GAAP financial measures by the United States Securities and Exchange Commission: (1) non-GAAP operating income/(loss), (2) non-GAAP net income/(loss) from continuing operations, (3) non-GAAP basic and diluted earnings per share for common shares attributable to continuing operations, and (4) non-GAAP basic and diluted earnings per ADS attributable to continuing operations. The presentation of the non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP.

Xunlei believes that these non-GAAP financial measures provide meaningful supplemental information to investors regarding the Company’s operating performance by excluding share-based compensation expenses, which is not expected to result in future cash payments. These non-GAAP financial measures also facilitate management’s internal comparisons to Xunlei’s historical performance and assist the Company’s financial and operational decision making. A limitation of using these non-GAAP financial measures is that these non-GAAP measures exclude share-based compensation charge that has been and will continue to be for the foreseeable future a significant recurring expense in Xunlei’s results of operations. Management compensates for these limitations by providing specific information regarding the GAAP amounts excluded from each non-GAAP measure. The accompanying reconciliation tables at the end of this release include details on the reconciliations between GAAP financial measures that are most directly comparable to the non-GAAP financial measures the Company has presented.

XUNLEI LIMITED
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts expressed in thousands of USD, except for share, per share (or ADS) data)
	September 30,		December 31,
	2020		2019
Assets
Current assets:
Cash and cash equivalents	123,835		162,465
Short-term investments	122,176		102,847
Accounts receivable, net	23,623		27,533
Inventories	1,748		5,537
Due from related parties	6,304		1,658
Prepayments and other current assets	12,762		16,543
Total current assets	290,448		316,583
Non-current assets:
Restricted cash	1,588		2,983
Long-term investments	26,495		26,365
Deferred tax assets	165		1,118
Property and equipment, net	42,962		38,770
Intangible assets, net	8,758		9,426
Goodwill	21,660		20,382
Other long-term prepayments and receivables	213		313
Right-of-use assets	1,999		8,747
Total assets	394,288		424,687
Liabilities
Current liabilities:
Accounts payable	20,260		24,213
Due to related parties	5,002		5,002
Contract liabilities and deferred income, current portion	32,901		31,988
Lease liabilities	2,084		4,693
Income tax payable	2,807		2,550
Accrued liabilities and other payables	32,117		42,840
Total current liabilities	95,171		111,286
Non-current liabilities:
Contract liabilities and deferred income, non-current portion	932		1,223
Lease liabilities, non-current portion	19		4,132
Deferred tax liabilities, non-current portion	1,082		1,179
Interest-bearing bank borrowing	19,089		11,324
Total liabilities	116,293		129,144
Equity
Common shares (US$0.00025 par value, 1,000,000,000 shares authorized, 368,877,205 shares issued and 339,165,241 shares outstanding as at December 31, 2019; 368,877,205 issued and 334,401,981shares outstanding as at September30, 2020)	84		85
Additional paid-in-capital	469,687		472,052
Accumulated other comprehensive loss	(9,798	)	(13,425	)
Statutory reserves	5,132		5,132
Treasury shares (29,711,964 shares and 29,056,264 shares as at December 31, 2019 and June 30, 2020, respectively)	9		7
Accumulated deficits	(185,459	)	(166,973	)
Total Xunlei Limited’s shareholders’ equity	279,655		296,878
Non-controlling interests	(1,660	)	(1,335	)
Total liabilities and shareholders’ equity	394,288		424,687

XUNLEI LIMITED
Unaudited Condensed Consolidated Statements of Income
(Amounts expressed in thousands of USD, except for share, per share (or ADS) data)
	Three months ended
	Sep 30,		Jun 30,		Sep30,
	2020		2020		2019
Revenues, net of rebates and discounts	43,722		44,328		43,839
Business taxes and surcharges	(34	)	(8	)	(77	)
Net revenues	43,688		44,320		43,762
Cost of revenues	(21,004	)	(23,931	)	(24,450	)
Gross profit	22,684		20,389		19,312
Operating expenses
Research and development expenses	(12,069	)	(14,548	)	(17,593	)
Sales and marketing expenses	(4,185	)	(4,382	)	(6,241	)
General and administrative expenses	(7,463	)	(10,100	)	(9,113	)
Assets impairment loss, net of recoveries	–		(5,060	)	427
Total operating expenses	(23,717	)	(34,090	)	(32,520	)
Operating loss	(1,033	)	(13,701	)	(13,208	)
Interest income	404		408		801
Interest expense	–		–		–
Other income, net	(335	)	1,772		(11,761	)
Loss before income taxes	(964	)	(11,521	)	(24,168	)
Income tax expenses	(498	)	(254	)	(448	)
Net loss	(1,462	)	(11,775	)	(24,616	)
Less: net loss attributable to non-controlling interest	(3	)	(247	)	(59	)
Net loss attributable to common shareholders	(1,459	)	(11,528	)	(24,557	)
	Three months ended
	Sep 30,		Jun 30,		Sep 30,
	2020		2020		2019
Loss per share for common shares
Basic	(0.0043	)	(0.0339	)	(0.0726	)
Diluted	(0.0043	)	(0.0339	)	(0.0726	)
Loss per ADS
Basic	(0.0215	)	(0.1695	)	(0.3630	)
Diluted	(0.0215	)	(0.1695	)	(0.3630	)
Weighted average number of common shares used in calculating :
Basic	336,371,957		339,816,984		338,473,633
Diluted	336,371,957		339,816,984		338,473,633
Weighted average number of ADSs used in calculating :
Basic	67,274,391		67,963,397		67,694,727
Diluted	67,274,391		67,963,397		67,694,727

XUNLEI LIMITED
Reconciliation of GAAP and Non-GAAP Results (Excluding discontinued operations)
(Amounts expressed in thousands of USD, except for share, per share (or ADS) data)
	Three months ended
	Sep 30,		Jun 30,		Sep 30,
	2020		2020		2019
GAAP operating loss	(1,033	)	(13,701	)	(13,208	)
Share-based compensation expenses	548		547		1,508
Non-GAAP operating loss	(485	)	(13,154	)	(11,700	)
GAAP net loss from continuing operations	(1,462	)	(11,775	)	(24,616	)
Share-based compensation expenses	548		547		1,508
Non-GAAP net loss	(914	)	(11,228	)	(23,108	)
GAAP loss per share for common shares:
Basic	(0.0043	)	(0.0339	)	(0.0726	)
Diluted	(0.0043	)	(0.0339	)	(0.0726	)
GAAP loss per ADS:
Basic	(0.0215	)	(0.1695	)	(0.3630	)
Diluted	(0.0215	)	(0.1695	)	(0.3630	)
Non-GAAP loss per share for common shares:
Basic	(0.0027	)	(0.0323	)	(0.0681	)
Diluted	(0.0027	)	(0.0323	)	(0.0681	)
Non-GAAP loss per ADS:
Basic	(0.0135	)	(0.1615	)	(0.3405	)
Diluted	(0.0135	)	(0.1615	)	(0.3405	)
Weighted average number of common shares used in calculating:
Basic	336,371,957		339,816,984		338,473,633
Diluted	336,371,957		339,816,984		338,473,633
Weighted average number of ADSs used in calculating:
Basic	67,274,391		67,963,397		67,694,727
Diluted	67,274,391		67,963,397		67,694,727

CONTACT:
Investor Relations
Xunlei Limited
Email: [email protected]
Tel: +86 755 86338443
Website: http://ir.xunlei.com

London, UK, Nov. 12, 2020 (GLOBE NEWSWIRE) —

· Third quarter and post-period highlights: 

–  Completed upsized initial public offering (IPO) on Nasdaq, raising $146.6 million

–  Continued to progress phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression

–  Strengthened board and leadership team with appointments of Linda McGoldrick as non-Executive Director; Greg Ryslik as Senior Vice President, Data Science, Machine Learning and Digital Health Research; and Stephen Schultz as Senior Vice President, Investor Relations

–  Established Drug Discovery Center with the University of the Sciences in Philadelphia, PA

· Conference call today at 1.00pm GMT (8.00am ET)

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter of 2020 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “This has been a significant quarter, with an IPO that gives us the funds needed to advance our mission and transform mental health care. Recent hires for the company build further important expertise within our strong leadership team, including in data science and digital health, which will be core to the future of mental health care. We remain fully focused on execution of our phase IIb trial investigating our COMP360 psilocybin therapy for treatment-resistant depression and, with scientific partners in our recently established Drug Discovery Center, are also evaluating the potential of early stage compounds to address mental health challenges.”

Corporate highlights

In September 2020, we completed our IPO of 8,625,000 American Depositary Shares (ADSs) representing 8,625,000 ordinary shares at a price of $17.00 per ADS. This included 1,125,000 additional ADSs issued upon the exercise in full by the underwriters of their option to purchase additional ADSs. The total gross proceeds from the offering were $146.6 million. All ADSs sold in the offering were offered by COMPASS. The ADSs began trading on the Nasdaq Global Select Market on 18 September 2020.             

Business highlights

We have continued to make steady progress with our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. We are opening a new trial site in Berlin, Germany, this month, bringing our trial to 21 sites in 10 countries. While the COVID-19 pandemic has impacted our trial, our plan to report data from this trial in late 2021 remains unchanged. We are working closely with our trial sites to carefully assess the ongoing COVID-19 situation and will always put the safety of patients and our teams above everything else.

Our team has continued to expand and we have been pleased to welcome several new colleagues to our leadership team during the quarter and post-period. Linda McGoldrick joined our board of directors in September 2020, bringing healthcare and life sciences experience from a range of public and private companies, and non-profit organisations, including Financial Health Associates International, Zillion Inc, Veos plc, and Kaiser Permanente International. In 2018, Linda was appointed by the Governor of Massachusetts to serve on the state’s Health Information Technology Commission. Greg Ryslik PhD joined us on 9 November 2020 as Senior Vice President, Data Science, Machine Learning and Digital Health Research, and Stephen Schultz will join us on 1 December 2020 as Senior Vice President, Investor Relations. Greg is a data scientist and AI (artificial intelligence) executive; he is an instructor at Stanford Continuing Studies and has held senior positions at Mindstrong and at Tesla Inc. Stephen has more than 30 years’ experience in investor relations and joins us from GW Pharmaceuticals; he has previously held senior roles at Amarin Corporation, Acusphere, and Shareholder.com. Earlier in the quarter, Steve Levine MD joined us as Vice President, Patient Access; Steve was formerly Founder and CEO at Actify Neurotherapies. Sarah Bateup was appointed Head of Therapy Research and Training, having previously been Chief Clinical Officer at Ieso Digital Health.

On 5 August 2020, we entered into a sponsored research agreement with the University of the Sciences in Philadelphia, PA, to establish a Drug Discovery Center. The Center is exploring and developing optimised psychedelic and other early stage compounds targeting the 5HT_2A receptor, a receptor in the brain that is recognised as a promising target in the treatment of mental health illnesses.

In July 2020, we were granted our second UK patent, adding to our US patent and German utility model, and including claims covering crystalline psilocybin, pharmaceutical formulations, medical uses, and a method of manufacturing. Our US patent, granted in December 2019, was the subject of a petition for post grant review, filed on 21 February 2020; the petition was dismissed on the merits on 20 August 2020.

We continue to work with a number of academic and other partners to accelerate research or to provide our COMP360 psilocybin for use in their independent studies. We are providing funding and support to the Aquilino Cancer Center at Adventist HealthCare Shady Grove Medical Center, in Rockville, MD, which recently launched the first clinical trial of psilocybin therapy with simultaneous administration and one-on-one patient support to treat depression in cancer patients.

Earlier this month, we joined the Psychiatry Consortium, an international collaboration of medical research charities and pharmaceutical companies focused on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. We will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how. The Psychiatry Consortium seeks project proposals from the global psychiatric research community via biannual open calls for applications – the next call for applications will open in January 2021.

Financial highlights

Cash position

: We held cash and cash equivalents of $196.5 million as of 30 September 2020, compared with $67.6 million at 30 June 2020. This is expected to fund operations into 2023.

Research & development expenses

: R&D expenses were $6.9 million for the three months ended 30 September 2020, compared with $3.1 million during the same period in 2019. The change was primarily related to increased activities associated with our ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360.
 
R&D expenses were $18.8 million for the nine months ended 30 September 2020, compared with $8.0 million during the same period in 2019. The change was primarily related to increased activities associated with our ongoing development of COMP360, increased share-based compensation, and other increases in personnel costs to support the development of COMP360.

General and administrative expenses

: G&A expenses were $6.6 million for the three months ended 30 September 2020, compared with $3.1 million during the same period in 2019. $2.1 million of the increase was related to share-based compensation expenses, and there were also increases in legal and professional fees, personnel and consulting expenses, and facilities costs.
 
G&A expenses were $21.1 million for the nine months ended 30 September 2020, compared with $5.9 million during the same period in 2019. $9.7 million of the increase was related to share-based compensation expenses, and there were also increases in legal and professional fees, personnel and consulting expenses, and facilities costs.

Other income (expense), net: Other income (expense), net was a net expense of $3.1 million for the three months ended 30 September 2020, compared with a net income of $0.6 million during the same period in 2019. $4.3 million of the increase in net expense related to foreign exchange losses.
 
Other income (expense), net was a net expense of $1.5 million for the nine months ended 30 September 2020, compared with a net income of $1.9 million during the same period in 2019. $3.3 million of the increase in net expense related to foreign exchange losses.

Net loss
: The net loss for the three months ended 30 September 2020 was $16.7 million, or $1.30 loss per share, (after including non-cash share-based compensation expense of $5.2 million), compared with $5.7 million, or $0.73 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $1.8 million).

The net loss for the nine months ended 30 September 2020 was $41.5 million, or $3.90 loss per share, (after including non-cash share-based compensation expense of $16.6 million), compared with $12.0 million, or $1.68 loss per share, during the same period in 2019, (after including non-cash share-based compensation expense of $2.5 million).

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm GMT (8.00am ET) on 12 November 2020. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 9377988.

The call will also be webcast live on the investors section of the COMPASS Pathways website (ir.compasspathways.com). The webcast will be archived for 30 days.

-Ends-

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 21 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com),  and on social media (Linkedin), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s Prospectus filed with the US Securities and Exchange Commission (SEC) on 21 September 2020 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries

COMPASS Pathways
Tracy Cheung, [email protected], +44 7966 309024
Amy Lawrence, [email protected], +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, [email protected], +1 646 277 1282

COMPASS PATHWAYS PLC
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
	September 30,			December 31,
	2020			2019
ASSETS
CURRENT ASSETS:
Cash	$	196,505		$	24,966
Restricted cash	29			18
Prepaid expenses and other current assets	10,671			7,187
Total current assets	207,205			32,171
Investments	500			—
Property and equipment, net	231			218
Other assets	59			—
Total assets	$	207,995		$	32,389
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ DEFICIT
CURRENT LIABILITIES:
Accounts payable	$	2,630		$	1,262
Accounts payable – due to a related party	13			63
Accrued expenses and other liabilities	2,277			1,457
Convertible notes payable	—			12,397
Convertible notes payable – due to a related party	—			8,692
Total current liabilities	4,920			23,871
Total liabilities	4,920			23,871
Commitments and contingencies
Convertible preferred shares, £0.008 par value; no shares authorized, issued and outstanding at September 30, 2020; 9,782,505 shares authorized, issued and outstanding at December 31, 2019; aggregate liquidation preference of $39,279	—			38,908
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares, £0.008 par value; 35,930,331 and 10,752,429 shares authorized, issued and outstanding at September 30, 2020 and December 31, 2019, respectively	367			111
Deferred shares, £21,391.504 par value; one share authorized, issued and outstanding at September 30, 2020; no shares authorized, issued and outstanding at December 31, 2019	28			—
Additional paid-in capital	278,098			7,162
Accumulated other comprehensive income (loss)	3,675			-98
Accumulated deficit	-79,093			-37,565
Total shareholders’ equity (deficit)	203,075			-30,390
Total liabilities, convertible preferred shares and shareholders’ deficit	$	207,995		$	32,389

COMPASS PATHWAYS PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
	Three Months Ended September					Nine Months Ended September
	2020			2019		2020			2019
OPERATING EXPENSES:
Research and development	$	6,875		$	3,121		$	18,822		$	7,987
General and administrative	6,551			3,107		20,909			5,730
General and administrative – fees due to a related party	56			42		143			135
Total operating expenses	13,482			6,270		39,874			13,852
LOSS FROM OPERATIONS:	-13,482			-6,270		-39,874			-13,852
OTHER INCOME (EXPENSE), NET:
Other income	109			17		302			52
Foreign exchange gains (losses)	-4,331			45		-3,252			67
Fair value change of convertible notes	—			—		-1,031			—
Fair value change of convertible notes – due to a related party	—			—		-723			—
Benefit from R&D tax credit	1,092			528		3,175			1,756
Total other income (expense), net	-3,130			590		-1,529			1,875
Loss before income taxes	-16,612			-5,680		-41,403			-11,977
Income tax benefit (expense)	-82			—		-125			—
Net loss	-16,694			-5,680		-41,528			-11,977
Other comprehensive (loss) income:
Foreign exchange translation adjustment	4,806			-558		3,773			-577
Comprehensive loss	$	-11,888		$	-6,238		$	-37,755		$	-12,554
Net loss per share attributable to ordinary shareholders—basic and diluted	$	-1.3		$	-0.73		$	-3.9		$	-1.68
Weighted average ordinary shares outstanding—basic and diluted	12,834,889			7,789,132		10,638,738			7,134,760

– Patient enrol
l
ment in Phase 1/2 stud
ies
of
EOS-850 A

_2A

R antagonist
and EOS-448 FCγ
R-enabled anti-TIGIT antibody continue
s
with initial data
expected
in 1H21 – 

– Strong cash position to support ongoing clinical development and operations
into 2023 –

CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 12, 2020 (GLOBE NEWSWIRE) — iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

“We are focused on advancing our two lead candidates, EOS-850, our adenosine A_2A receptor antagonist, and EOS-448, our TIGIT antagonist, both now in Phase 1/2a clinical development, toward initial data readouts in the first half of 2021,” said Michel Detheux, PhD, President and Chief Executive Officer of iTeos. “While we have faced some challenges due to the unpredictable nature of the evolving COVID-19 pandemic, our data readout timelines remain on track and we are building our team and competencies to support our ongoing clinical trials. In addition to our clinical efforts, we also continue to perform rigorous preclinical evaluations to identify potential novel product candidates that will contribute to the further growth of our pipeline. As we continue to advance our efforts to discover and develop highly differentiated immune-oncology therapeutics, we now expect to nominate a new drug product candidate before the end of 2021.”

Pipeline
Highlights

EOS-850: Designed as a highly selective small molecule antagonist of the adenosine A_2A receptor, or A_2AR, to inhibit the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors.

• Enroll
  ment continues in
  Phase 1/2
  a
  clinical trial in adult patients with advanced solid tumors: The multi-arm Phase 1/2a clinical trial of EOS-850 trial in adult patients with advanced solid tumors is ongoing. In addition to the single-agent cohort, dosing has also commenced in the second cohort evaluating EOS-850 in combination with pembrolizumab. The COVID-19 pandemic has resulted in the Company experiencing enrollment delays for its third cohort evaluating EOS-850 in combination with chemotherapy. The Company is now opening additional sites in the U.S., France, Spain and South Korea to support continued enrollment and expects to dose the first patient in the chemotherapy cohort by the end of 2020. The Company remains on-track to report initial single-agent and combination data in the first half of 2021.

EOS-448: Antagonistic antibody specifically designed to target TIGIT (T-cell immunoreceptor with Ig and ITIM domains), a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage the Fc gamma receptor, or FcγR, to promote antibody-dependent cellular cytotoxicity, or ADCC, activity.

• Patient enro
  l
  lment continues in
  Phase 1/2
  a
  clinical trial
  : The dose escalation portion of the Phase 1/2a clinical trial of EOS-448 in multiple advanced solid tumors is ongoing. Initial safety and efficacy data are expected to be reported in the first half of 2021. Following the completion of the dose escalation and determination of the recommended Phase 2 dose, we plan to evaluate EOS-448 in combination with an anti-PD-1 antibody and other standard of care therapies or EOS-850 in specific tumor types.

Preclinical program
s
: The Company continues to progress research programs focused on additional targets that complement its A_2AR and TIGIT programs. The Company is optimizing its screening and selection process to identify potential product candidates and expects to nominate an additional product candidate for Investigational New Drug, or IND, enabling studies before the end of 2021.

Corporate Updates

• Publication in Molecular Cancer Therapeutics: An article on the multiple mechanisms of action of anti-TIGIT antagonistic antibodies highlighting our work in the field and the properties of EOS-448 was accepted for publication in Molecular Cancer Therapeutics.
• Completed Initial Public Offering (IPO) raising $229.7 million in gross proceeds: As previously announced in July 2020, the Company completed its initial public offering of 10,586,316 shares of common stock at a public offering price of $19.00 per share. In August 2020, the underwriters exercised their option to purchase an additional 1,505,359 shares.

Third
Quarter 2020 Financial Results

• Cash Position:
   The Company’s cash and cash equivalent position was $340.0 million as of September 30, 2020, as compared to $19.9 million as of December 31, 2019.
• Research and Development (R&D) Expenses:
   R&D expenses were $8.7 million for the quarter ended September 30, 2020, as compared to $5.0 million for the third quarter of 2019. The increase was primarily due to an increase in activities related to clinical trials for EOS-850 and EOS-448.
• General and Administrative (G&A) Expenses: G&A expenses were $4.8 million for the quarter ended September 30, 2020, as compared to $2.7 million for the third quarter of 2019. The increase was primarily due to an increase in payroll and related costs in the third quarter of 2020.
• Net Loss: Net loss attributable to common shareholders was $11.7 million, or a net loss of $0.48 per basic and diluted share, for the quarter ended September 30, 2020, as compared to $8.0 million, or a net loss of $43.03 per basic and diluted share, for the third quarter of 2019.

About iTeos Therapeutics, Inc.

iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of the tumor microenvironment and immunosuppressive pathways to design novel product candidates with an aim to improve the clinical benefit of oncology therapies. The innovative pipeline includes two clinical-stage programs targeting novel, validated immuno-oncology pathways designed to build on prior learnings in the field to have differentiated pharmacological and clinical profiles. The most advanced product candidate, EOS-850, is designed as a highly selective small molecule antagonist of the adenosine A_2AR, in the adenosine pathway, a key driver of immunosuppression in the tumor microenvironment across a broad range of tumors. EOS-850 is being investigated in an open-label multi-arm Phase 1/2a clinical trial in adult cancer patients with advanced solid tumors and encouraging preliminary single-agent activity was observed in the dose escalation portion of the trial. The lead antibody product candidate, EOS-448, is an antagonist of TIGIT, a checkpoint with multiple mechanisms leading to immunosuppression. EOS-448 was also selected to engage FcγR, to promote ADCC activity. An open-label Phase 1/2a clinical trial of EOS-448 was initiated in adult cancer patients with advanced solid tumors. iTeos Therapeutics is headquartered in Cambridge, MA with a research center in Gosselies, Belgium.

Forward-Looking Statements

This
press release
contains forward-looking statements
within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding iTeos’ future expectations, plans and prospects
, which are based on currently available information. All statements other than statements of historical facts contained in this
press release
, including statements regarding our strategy, future financial condition, future operations, prospects, plans, objectives of management and expected growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as ‘‘aim,’’ ‘‘anticipate,’’ ‘‘assume,’’ ‘‘believe,’’ ‘‘contemplate,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘design,’’ ‘‘due,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘goal,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘objective,’’ ‘‘plan,’’ ‘‘predict,’’ ‘‘positioned,’’ ‘‘potential,’’ ‘‘seek,’’ ‘‘should,’’ ‘‘target,’’ ‘‘will,’’ ‘‘would’’ and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology
and similar expressions that constitute forward-looking statements under the Private Securities L
i
tigati
on
Reform Act of 1995
. These forward-looking statements include statements about the initiation, timing, progress and results of our current and future clinical trials and current and future preclinical studies of our product candidates, including our clinical trials of EOS-850, our clinical trials of EOS-448 and of our research and development programs;
uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical trials;
the enrollment of our ongoing clinical trials;
whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future clinical trials;
our ability to successfully establish or maintain collaborations or strategic relationships for our product candidates;
the expected timing for submissions for regulatory approval or review by governmental authorities;
the composition of our board of directors;
our financial performance;
whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure
requirements
; risks, uncertainties and assumptions regarding the impact of the continuing
COVID-19 pandemic
on our business, operations, strategies and anticipated timelines
, including mitigation efforts and economic effects,
including but not limited to our preclinical studies and future clinical trials; and our plans to develop and commercialize our current product candidates and any future product candidates and the implementation of our business model and strategic plans for our business, current product candidates and any future product candidates
, and other risks concerning iTeos’ programs and operations that are described in additional detail in our Quarterly Report on Form 10-Q and our other filings made with the Securities and Exchange Commission from time to time. Although our forward-looking statements reflect the good faith judgment of management, these statements are based solely on facts and circumstances currently known to iTeos. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. iTeos undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a result of new information, the occurrence of certain events or otherwise.

For further information, please contact:

Investor Contact
s
:

Sarah McCabe, Zofia Mita
Stern Investor Relations, Inc.
+ 1 212 362 1200
[email protected]

Media Contacts:

Amber Fennell, Paul Kidwell
Consilium Strategic Communications
+44 203 709 5700
[email protected]

• The negative impact of COVID-19 on scan volume at all MRI imaging centers managed by FONAR’s subsidiary, Health Management Company of America (HMCA), continued throughout the first quarter of fiscal 2021. However, collective MRI scan volume increased by 50% to 41,566 for the 3-month period ended September 30, 2020, as compared to 27,757 scans for the previous 3-month period ended June 30, 2020. To date, the most severe effects of the pandemic on MRI scan volume occurred during the 3-month ended June 30, 2020.
• Total MRI scan volume at the HMCA-managed sites decreased 13% to 41,566 scans for the three month period ending September 30, 2020 as compared to 47,027 scans one year earlier. The impact from COVID-19 on MRI scan volume for the future cannot be forecasted at this time.

• Cash and cash equivalents and short term investments increased 5% to $38.8 million at September 30, 2020, as compared to June 30, 2020.
• Total Revenues-Net decreased by 4% to $21.0 million for the quarter ended September 30, 2020, as compared to the fiscal quarter ended one year earlier.
• Net Income decreased 28% to $3.3 million for the quarter ended September 30, 2020, as compared to the fiscal quarter ended one year earlier. The decrease is primarily attributable to a $2.2 million increase in reserves against revenue, which are booked in SG&A. Diluted Net Income per Common Share decreased to $0.36 for the quarter ended September 30, 2020, as compared to the fiscal quarter ended one year earlier.
• The 36th and 37th HMCA-managed MRI scanners installed in Pembroke Pines, FL and Islandia, NY respectively, became operational since June 30, 2020. The company expects to install two more MRI scanners during Fiscal Year 2021.

MELVILLE, N.Y., Nov. 12, 2020 (GLOBE NEWSWIRE) — FONAR Corporation (NASDAQ-FONR), The Inventor of MR Scanning™, reported today its financial results for the first quarter of fiscal 2021 which ended September 30, 2020. FONAR’s primary source of income and growth is attributable to its diagnostic imaging management subsidiary, Health Management Company of America (HMCA). In 2009, HMCA managed 9 MRI scanners. HMCA currently manages 37 MRI scanners – 23 in New York and 14 in Florida.

Financial Results

Cash and cash equivalents and short term investments increased 5% to $38.8 million at September 30, 2020 as compared to $36.8 million at June 30, 2020.

Operating Cash Flow at September 30, 2020, decreased 11% to $3.8 million, compared with $4.2 million for the period ended September 30, 2019. For comparison, Operating Cash Flow for the year ended June 30, 2020 was $20.4 million, an increase of 5% versus $19.4 million for the previous fiscal year ended June 30, 2019.

Total Revenues-Net for the quarter ended September 30, 2020 decreased 4% to $21.0 million as compared to $21.7 million for the corresponding quarter ended September 30, 2019.

Revenues from the diagnostic imaging center segment, consisting of patient fee revenue net of contractual allowances and discounts, and management and other fees of related and non-related medical practices, decreased 2% to $19.0 million for the quarter ended September 30, 2020 as compared to $19.5 million for the quarter ended September 30, 2019.

Total Costs and Expenses for the quarter ended September 30, 2020 increased 3% to $16.8 million as compared to $16.3 million for the corresponding quarter ended September 30, 2019.

Selling, general and administrative (SG&A) expenses increased 44% to $6.2 million for the quarter ended September 30, 2020, as compared to $4.3 million for the corresponding quarter ended September 30, 2019. A large portion of this increase was attributable primarily to reserves against management contracts totaling $2.2 million resulting exclusively from business interruptions due to the COVID-19 pandemic. It is too early to know how much of these reserves will be recovered.

Income from Operations decreased 24% to $4.2 for the quarter ended September 30, 2020 as compared to $5.5 million for the quarter ended September 30, 2019. The 44% increase in the SG&A represents a significant portion of this decrease. Other explanations include the 4% decrease in total revenues and 3% increase in total costs and expenses. All of these factors are the result of the interruption of business caused by the COVID-19 pandemic.

Net Income decreased to $3.3 million for the quarter ended September 30, 2020 as compared to $4.5 million for the quarter ended September 30, 2019.

Diluted Net Income per Common Share available to common stockholders decreased to $0.36 for the quarter ended September 30, 2020 as compared to $0.47 for the corresponding quarter ended September 30, 2019.

Total Current Assets at September 30, 2020 were $99.1 million as compared to $95.9 million at June 30, 2020.

Total Current Liabilities at September 30, 2020 were $18.6 million as compared to $18.7 million at June 30, 2020.

Total Liabilities at September 30, 2020 were $53.2 million as compared to $54.0 million at June 30, 2020.

Total Assets at September 30, 2020 were $181.3 million as compared to $180.3 million at June 30, 2020.

Total Fonar Corporation Stockholders’ Equity increased to $128.7 million at September 30, 2020, as compared to $126.2 million at June 30, 2020.

The Current Ratio (Current Assets / Current Liabilities) is 5.3 at September 30, 2020, compared to 5.1 at June 30, 2020.

The Total Assets / Total Liabilities ratio is 3.4 at September 30, 2020, compared to 3.3 at June 30, 2020.

Working Capital increased 4% to $80.5 million at September 30, 2020, compared to $77.2 million at June 30, 2020.

Significant Event

FONAR Celebrates the 50th Anniversary of the Origination and discovery of the MRI

It’s been fifty years since Raymond V. Damadian, M.D., FONAR Founder and Chairman of the Board, took the first step to develop a human-sized scanner using the principles of magnetic resonance to detect cancer. In his September 17, 1969 letter to Dr. George S. Mirick of the Health Research Council of the City of New York, Raymond V. Damadian, FONAR Founder and Chairman of the Board, requested financial support for equipment to pursue his promising line of research. In the letter, Dr. Damadian states his intention to “proceed with the development of instrumentation and probes that can be used to scan the human body externally for early signs of malignancy.” Dr. Damadian’s September 17, 1969 letter to Dr. George S. Mirick may be viewed online at fonar.com/nobel.htm#1969_letter.

On June 18, 1970, Dr. Damadian performed the experiment whereby he discovered the distinctly elongated time-lapsed signal marking differences between normal and cancerous tissue, as well as differences among various normal organs themselves. This was an ‘eureka’ moment. The results were published in the journal ‘Science’ on March 19, 1971. Upon that publication, scientists around the world began their own research, marking the birth of the MRI industry.

On July 3, 1977, Dr. Damadian, and two collaborators, Lawrence Minkoff and Michael Goldsmith, performed the world’s first MRI scan, which was of Minkoff’s chest. It took 4 hours and 20 minutes to complete the scan. Now, fifty years after Dr. Damadian’s discovery, tens of millions of MRI scans are conducted throughout the world every year, each scan seeing magnificently into the human body.

Perhaps Professor Donlin Long, M.D., former Chairman of Neurosurgery, Johns Hopkins University, says it best: MRI is “The Single Most Important Diagnostic Discovery in the History of All of Medicine.” Professor Long made this statement on November 10, 2018, when Dr. Damadian was awarded the Excellence in Medicine Medal of Honor from the Chiari & Syringomyelia Foundation at Brooks’s in London, England. He was joined by Fraser Henderson, M.D., a neurosurgeon and member of the steering committee for the Chiari & Syringomyelia Foundation, who said, “Raymond Damadian revolutionized medicine with the discovery and development of MRI.”

Management Discussion

President and CEO, Timothy R. Damadian, said, “The COVID-19 pandemic has had a significant negative impact on our management subsidiary, HMCA. MRI scan volume in the quarter ending June 30, 2020 was just 27,757, which was 38% lower than the scan volume in the prior quarter (45,123). Thankfully, scan volume for the quarter ending September 30, 2020 grew by 50% to 41,566, bringing us to approximately 90% of our pre-COVID scan volume. Barring any future waves of COVID-19, we expect, in fiscal 2021, a full return to pre-pandemic levels and then steady growth from that point forward. The impact from COVID-19 on MRI scan volume for the current fiscal year cannot be forecasted at this time.

“Our business first experienced the effects of COVID-19 in the latter part of the quarter ending March 30, 2020. Our HMCA management team, comprised of non-controlling-interest group members, quickly and skillfully implemented procedures, practices, and policies that have protected employees and patients from the coronavirus. Further, wherever practical, the team reduced expenses in accordance with reduced scan volume, largely through reduced employee workloads and furloughs. As scan volume has been returning to pre-COVID levels, I am pleased that we have been adding hours to our workforce and welcoming back furloughed employees as needed.

“In regard to growth,” continued Mr. Damadian, “Prior to the pandemic disruption, we had planned to invest between $4 million and $6 million dollars at four (4) HMCA-managed MRI scanning centers in Fiscal 2020. We installed a second MRI scanner in the Ormond Beach, Florida facility in October, 2019, and the first MRI of what will be a two-MRI facility in Pembroke Pines, Florida in June, 2020. COVID-19 delayed the installation of an additional MRI in our Islandia, New York center, but has now been operational since the beginning of October, 2020. Also delayed by the pandemic has been the installation of a second MRI in our Westchester County facility. We now expect it will be installed in mid-fiscal 2021.

“Our vertical growth strategy of installing a second or even a third MRI at high-volume, high-patient-backlog facilities has been very successful, so we are naturally watching for such opportunities in the future. As always, we are also actively searching for promising locations that are currently underserved by FONAR’s UPRIGHT® MRI technology and would enhance and/or expand our existing networks of managed facilities. Beyond the four installations I previously mentioned, we are expecting to establish a de novo center in Bronx County, New York in the latter part of fiscal 2021, making it the third installation expected in fiscal 2021.”

Mr. Damadian concluded, “HMCA’s success is largely due to the efforts of the non-controlling-interest group members of our management team. All of them have been with me for many years. Their extensive experience, concern for patients and employees, skill, and dedication to the company have been on full display throughout the pandemic, to the benefit of FONAR and its shareholders.”

FONAR Founder and Chairman of the Board, Raymond V. Damadian, M.D., said, “It’s pleasing to me to see FONAR continue to be profitable, despite the COVID-19 pandemic. Among the reasons for the Company’s success are its enduring history and ongoing contributions to the MRI industry. The Company has always been recognized as a key player in the MRI industry. Today, we offer the patent-protected UPRIGHT® Multi-Position™ MRI scanner, the world’s only weight-loaded MRI scanner. It is the only MRI scanner in the world to provide UPRIGHT RADIOLOGY™. Our superior technology is what patients and their doctors want and need. The UPRIGHT® MRI, aka the STAND-UP® MRI, is the only whole-body MRI that can scan patients in numerous weight-bearing positions, including sitting, standing, as well as bending in flexion or extension. Most patients sit and watch a large TV while being scanned. Most patients love it. There is no doubt that a key component to the success of HMCA-managed MRI centers is the popularity of the FONAR UPRIGHT® MRI among both physicians and patients.”

Dr. Damadian concluded, “The Company is currently researching Cerebrospinal Fluid (CSF) Flow as it navigates from the brain, down the spine and throughout the brain. It is hopeful that this research will lead to a new understanding of the role of CSF on neurologic diseases, such as MS. In Fiscal 2021, the Company will continue with this valuable research which can only be done on the UPRIGHT® MRI.”

About FONAR

FONAR, the Inventor of MR Scanning™, located in Melville, NY, was incorporated in 1978, and is the first, oldest and most experienced MRI company in the industry. FONAR introduced the world’s first commercial MRI in 1980, and went public in 1981. FONAR’s signature product is the FONAR UPRIGHT® Multi-Position™ MRI (also known as the STAND-UP® MRI), the only whole-body MRI that performs Position™ Imaging (pMRI™) and scans patients in numerous weight-bearing positions, i.e. standing, sitting, in flexion and extension, as well as the conventional lie-down position. The FONAR UPRIGHT® MRI often detects patient problems that other MRI scanners cannot because they are lie-down, ”weightless-only” scanners. The patient-friendly UPRIGHT® MRI has a near-zero patient claustrophobic rejection rate. As a FONAR customer states, “If the patient is claustrophobic in this scanner, they’ll be claustrophobic in my parking lot.” Approximately 85% of patients are scanned sitting while watching TV.

FONAR has new works-in-progress technology for visualizing and quantifying the cerebral hydraulics of the central nervous system, the flow of cerebrospinal fluid (CSF), which circulates throughout the brain and vertebral column at the rate of 32 quarts per day. This imaging and quantifying of the dynamics of this vital life-sustaining physiology of the body’s neurologic system has been made possible first by FONAR’s introduction of the MRI and now by this latest works-in-progress method for quantifying CSF in all the normal positions of the body, particularly in its upright flow against gravity. Patients with whiplash or other neck injuries are among those who will benefit from this new understanding.

FONAR’s substantial list of patents includes recent patents for its technology enabling full weight-bearing MRI imaging of all the gravity sensitive regions of the human anatomy, especially the brain, extremities and spine. It includes its newest technology for measuring the Upright cerebral hydraulics of the cerebro-spinal fluid (CSF) of the central nervous system. FONAR’s UPRIGHT® Multi-Position™ MRI is the only scanner licensed under these patents.

UPRIGHT® and STAND-UP® are registered trademarks and The Inventor of MR Scanning™, CSP™, Multi-Position™, UPRIGHT RADIOLOGY™, The Proof is inthe Picture™, pMRI™, Videography™ and Dynamic™, are trademarks of FONAR Corporation.

This release may include forward-looking statements from the company that may or may not materialize. Additional information on factors that could potentially affect the company’s financial results may be found in the company’s filings with the Securities and Exchange Commission.

CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts and shares in thousands, except per share amounts)
(UNAUDITED)

ASSETS

	September 30, 2020			June 30, 2020
Current Assets:
Cash and cash equivalents	$	38,763		$	36,802
Short term investments		32			32
Accounts receivable – net		4,191			4,313
Accounts receivable – related party		102			6
Medical receivable – net		16,293			16,172
Management and other fees receivable – net		29,011			27,438
Management and other fees receivable – related medical practices – net		7,002			6,896
Inventories		1,698			1,649
Costs and estimated earnings in excess of billings on uncompleted contracts		153			153
Income tax receivable		—			671
Prepaid expenses and other current assets		1,879			1,758
Total Current Assets		99,124			95,890
Accounts receivable – long term		2,839			2,730
Deferred income tax asset		17,961			18,810
Property and equipment – net		20,904			21,364
Right-of-use Asset – operating lease		30,489			31,392
Right-of-use Asset – financing lease		1,276			1,326
Goodwill		3,985			3,985
Other intangible assets – net		4,036			4,109
Other assets		642			653
Total Assets	$	181,256		$	180,259

CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts and shares in thousands, except per share amounts)
(UNAUDITED)

LIABILITIES AND STOCKHOLDERS’ EQUITY

	September 30, 2020			June 30, 2020
Current Liabilities:
Current portion of long-term debt and capital leases	$	169		$	108
Accounts payable		1,848			1,965
Other current liabilities		7,864			8,185
Unearned revenue on service contracts		4,203			4,105
Unearned revenue on service contracts – related party		83			—
Operating lease liability – current portion		3,433			3,370
Financing lease liability – current portion		136			75
Customer deposits		912			855
Total Current Liabilities		18,648			18,663
Long-Term Liabilities:
Unearned revenue on service contracts		2,761			2,656
Deferred income tax liability		234			234
Due to related medical practices		93			93
Operating lease liability – net of current portion		29,246			30,105
Financing lease liability – net of current portion		1,201			1,251
Long-term debt and capital leases, less current portion		859			865
Other liabilities		161			150
Total Long-Term Liabilities		34,555			35,354
Total Liabilities		53,203			54,017

CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts and shares in thousands, except per share amounts)
(UNAUDITED)

LIABILITIES AND STOCKHOLDERS’ EQUITY (Continued)

		September 30, 2020				June 30, 2020
Class A non-voting preferred stock $.0001 par value;     453 shares authorized at September 30, 2020 and     June 30, 2020, 313 issued and outstanding at     September 30, 2020 and June 30, 2020		$	—			$	—
Preferred stock $.001 par value; 567 shares authorized     at September 30, 2020 and June 30, 2020, issued     and outstanding – none			—				—
Common Stock $.0001 par value; 8,500 shares     authorized at September 30, 2020 and June 30,     2020, 6,459 issued at September 30, 2020 and     June 30, 2020, 6,447 outstanding at September 30,     2020 and June 30, 2020			1				1
Class B Common Stock (10 votes per share) $.0001 par     value; 227 shares authorized at September 30, 2020     and June 30, 2020; .146 issued and outstanding at     September 30, 2020 and June 30, 2020			—				—
Class C Common Stock (25 votes per share) $.0001 par     value; 567 shares authorized at September 30, 2020     and June 30, 2020, 383 issued and outstanding at     September 30, 2020 and June 30, 2020			—				—
Paid-in capital in excess of par value			183,076				183,076
Accumulated deficit			(53,707	)			(56,215	)
Treasury stock, at cost – 12 shares of common stock at     September 30, 2020 and June 30, 2020			(675	)			(675	)
Total Fonar Corporation’s Stockholders’ Equity			128,695				126,187
Noncontrolling interests			(642	)			55
Total Stockholders’ Equity			128,053				126,242
Total Liabilities and Stockholders’ Equity		$	181,256			$	180,259

CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(Amounts and shares in thousands, except per share amounts)
(UNAUDITED)

	FOR THE THREE MONTHS ENDED SEPTEMBER 30,
REVENUES	2020				2019
Patient fee revenue – net of contractual allowances and discounts	$	5,091			$	6,045
Product sales – net		28				192
Service and repair fees – net		1,925				2,064
Service and repair fees – related parties – net		28				28
Management and other fees – net		11,214				11,028
Management and other fees – related medical practices – net		2,693				2,390
Total Revenues – Net		20,979				21,747
COSTS AND EXPENSES
Costs related to patient fee revenue		2,521				2,863
Costs related to product sales		132				330
Costs related to service and repair fees		626				750
Costs related to service and repair fees – related parties		9				10
Costs related to management and other fees		5,550				6,005
Costs related to management and other fees – related medical practices		1,428				1,537
Research and development		400				472
Selling, general and administrative		6,163				4,294
Total Costs and Expenses		16,829				16,261
Income From Operations		4,150				5,486
Other Expenses		(140	)			—
Interest Expense		(22	)			(21	)
Investment Income		112				148
Income Before Provision for Income Taxes and Noncontrolling Interests		4,100				5,613
Provision for Income Taxes		(849	)			(1,107	)
Net Income		3,251				4,506
Net Income – Noncontrolling Interests		(743	)			(1,207	)
Net Income – Controlling Interests	$	2,508			$	3,299
Net Income Available to Common Stockholders	$	2,355			$	3,097
Net Income Available to Class A Non-Voting Preferred Stockholders	$	114			$	151
Net Income Available to Class C Common Stockholders	$	39			$	51
Basic Net Income Per Common Share Available to Common Stockholders	$	0.37			$	0.48
Diluted Net Income Per Common Share Available to Common Stockholders	$	0.36			$	0.47
Basic and Diluted Income Per Share – Class C Common	$	0.10			$	0.13
Weighted Average Basic Shares Outstanding – Common Stockholders		6,447				6,432
Weighted Average Diluted Shares Outstanding – Common Stockholders		6,575				6,560
Weighted Average Basic and Diluted Shares Outstanding – Class C Common		383				383

Contact: Daniel Culver
Director of Communications
E-mail: [email protected]
www.fonar.com

DUBLIN, Ireland, Nov. 12, 2020 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that management will participate in two upcoming investor conferences in November.

• Management will host investor meetings during the Jefferies Virtual London Healthcare Conference on Tuesday and Wednesday, November 17-18, 2020.
• Management will host investor meetings during A.G.P.’s Virtual Healthcare Symposium on Thursday, November 19, 2020.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO^® (tedizolid phosphate) in the United States and certain of its territories.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the distribution and promotion of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO for Complicated Urinary Tract Infections (cUTI), the expansion of its commercial sales force, the clinical utility of XENLETA for CABP, SIVEXTRO for ABSSSI and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP, SIVEXTRO for ABSSSI and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in the European Union, Canada and China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, expectations regarding the impact of the interruptions resulting from COVID-19 on its business, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and SIVEXTRO and whether market demand for XENLETA and SIVEXTRO is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA and SIVEXTRO, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors

Kim Anderson
Nabriva Therapeutics plc
[email protected]

For Media

Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION.

THIS IS AN ANNOUNCEMENT FALLING UNDER RULE 2.4 OF THE CITY CODE ON TAKEOVERS AND MERGERS (THE “CODE”) AND DOES NOT CONSTITUTE AN ANNOUNCEMENT OF A FIRM INTENTION TO MAKE AN OFFER UNDER RULE 2.7 OF THE CODE. THERE CAN BE NO CERTAINTY THAT ANY FIRM OFFER WILL BE MADE NOR AS TO THE TERMS ON WHICH ANY FIRM OFFER MIGHT BE MADE.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION.

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) — Minerals Technologies Inc. (NYSE: MTX) (“MTI” or “the Company”) notes the recent market speculation and movement in the share price of Elementis and confirms that it made an approach on 5 November 2020 to the Board of Elementis regarding a possible all-cash offer for Elementis. The Elementis Board notified Minerals Technologies on 10 November 2020 that this approach had been rejected.

Minerals Technologies’ proposal comprised an all-cash offer of 107 pence per Elementis share, representing a premium of approximately:

• 31% to Elementis’ closing share price of 81.70 pence on 4 November 2020; and
• 47% to Elementis’ 90 trading-day volume weighted average share price of 72.66 pence as of market close on 4 November 2020.

Minerals Technologies is currently considering its position. There can be no certainty that any further proposal or firm offer will be made, nor as to the terms of any further proposal or firm offer. However, any offer would be likely to be solely in cash.

In accordance with Rule 2.6(a) of the Code, Minerals Technologies must, by not later than 5.00 p.m. (London time) on 10 December 2020, either announce a firm intention to make an offer in accordance with Rule 2.7 of the Code or announce that it does not intend to make an offer, in which case the announcement will be treated as a statement to which Rule 2.8 of the Code applies. This deadline may be extended with the consent of the Panel on Takeovers and Mergers in accordance with Rule 2.6(c) of the Code. The deadline shall cease to apply, by virtue of Rule 2.6(b) of the Code, where a firm intention to make an offer for Elementis under Rule 2.7 of the Code is announced by an offeror (other than Minerals Technologies) prior to such deadline.

In accordance with Rule 2.5 of the Code, Minerals Technologies reserves the right to:

1. vary the form and/or mix of the consideration described in this announcement; and
2. make an offer on less favourable terms than those described in this announcement:
   • with the recommendation or consent of the Board of Elementis;
   • if Elementis announces, declares or pays a dividend or any other distribution or return of capital to its shareholders after this announcement (in which case Minerals Technologies reserves the right to make an equivalent reduction to the proposed price);
   • if a third party announces a firm intention to make an offer for Elementis on less favourable terms than those set out in this announcement; or
   • following the announcement by Elementis of a whitewash transaction pursuant to the Code.

A further announcement will be made as appropriate.

Enquiries

Minerals Technologies                                        

Investor Contact
Erik Aldag	+1 (212) 878 1831
Media Contact
Michael Landau	+1 (212) 878 1840
Mark McMaster	+1 (212) 632 6000
Richard Shaw / Edward Earlam	+44 (0) 20 7187 2000

About Minerals Technologies

New York-based Minerals Technologies is a global resource- and technology-based company that develops, produces and markets a broad range of specialty mineral, mineral-based and synthetic mineral products and related systems and services. Minerals Technologies serves the paper, foundry, steel, construction, environmental, energy, polymer and consumer products industries. The Company reported sales of $1.8 billion in 2019. For further information, please visit our website at www.mineralstech.com.

Important notices

Lazard & Co., Limited, which is authorised and regulated by the Financial Conduct Authority in the United Kingdom, is acting exclusively as financial adviser to Minerals Technologies and no one else in connection with the possible transaction described in this announcement, and will not be responsible to anyone other than Minerals Technologies for providing the protections afforded to clients of Lazard & Co., Limited nor for providing advice in relation to the possible transaction referred to in this announcement. Neither Lazard & Co., Limited nor any of its affiliates owes or accepts any duty, liability or responsibility whatsoever (whether direct or indirect, whether in contract, in tort, under statute or otherwise) to any person who is not a client of Lazard & Co., Limited in connection with this announcement, the possible transaction referenced herein, any statement contained herein or otherwise.

This announcement is not intended to, and does not, constitute or form part of any offer, invitation or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of, any securities whether pursuant to this announcement or otherwise.

The release, publication or distribution of this announcement in jurisdictions outside the United Kingdom may be restricted by law or regulation. Any persons into whose possession this announcement comes should inform themselves about, and observe, such restrictions. Any failure to comply with the restrictions may constitute a violation of the securities or other laws of any such jurisdiction.

Disclosure requirements of the Code

Under Rule 8.3(a) of the Code, any person who is interested in 1% or more of any class of relevant securities of an offeree company or of any securities exchange offeror (being any offeror other than an offeror in respect of which it has been announced that its offer is, or is likely to be, solely in cash) must make an Opening Position Disclosure following the commencement of the offer period and, if later, following the announcement in which any securities exchange offeror is first identified. An Opening Position Disclosure must contain details of the person’s interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any securities exchange offeror(s). An Opening Position Disclosure by a person to whom Rule 8.3(a) applies must be made by no later than 3.30 pm (London time) on the 10th business day following the commencement of the offer period and, if appropriate, by no later than 3.30 pm (London time) on the 10th business day following the announcement in which any securities exchange offeror is first identified. Relevant persons who deal in the relevant securities of the offeree company or of a securities exchange offeror prior to the deadline for making an Opening Position Disclosure must instead make a Dealing Disclosure.

Under Rule 8.3(b) of the Code, any person who is, or becomes, interested in 1% or more of any class of relevant securities of the offeree company or of any securities exchange offeror must make a Dealing Disclosure if the person deals in any relevant securities of the offeree company or of any securities exchange offeror. A Dealing Disclosure must contain details of the dealing concerned and of the person’s interests and short positions in, and rights to subscribe for, any relevant securities of each of (i) the offeree company and (ii) any securities exchange offeror(s), save to the extent that these details have previously been disclosed under Rule 8. A Dealing Disclosure by a person to whom Rule 8.3(b) applies must be made by no later than 3.30 pm (London time) on the business day following the date of the relevant dealing.

If two or more persons act together pursuant to an agreement or understanding, whether formal or informal, to acquire or control an interest in relevant securities of an offeree company or a securities exchange offeror, they will be deemed to be a single person for the purpose of Rule 8.3.

Opening Position Disclosures must also be made by the offeree company and by any offeror and Dealing Disclosures must also be made by the offeree company, by any offeror and by any persons acting in concert with any of them (see Rules 8.1, 8.2 and 8.4).

Details of the offeree and offeror companies in respect of whose relevant securities Opening Position Disclosures and Dealing Disclosures must be made can be found in the Disclosure Table on the Takeover Panel’s website at www.thetakeoverpanel.org.uk, including details of the number of relevant securities in issue, when the offer period commenced and when any offeror was first identified. You should contact the Panel’s Market Surveillance Unit on +44 (0)20 7638 0129 if you are in any doubt as to whether you are required to make an Opening Position Disclosure or a Dealing Disclosure.

Forward-looking statements

This announcement (including any information incorporated by reference into it), oral statements made regarding any possible transaction, and any other information published by Minerals Technologies, may contain statements which are, or may be deemed to be, “forward-looking statements”. Forward-looking statements are prospective in nature and are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. The forward-looking statements contained in this announcement, if any, may include statements relating to the expected effects of the possible transaction, the expected timing and scope of any possible transaction and other statements other than historical facts. Often, but not always, forward-looking statements can be identified by the use of forward-looking words and phrases such as “plans”, “expects” or “does not expect”, “is expected”, “is subject to”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “should”, “would”, “might” or “will” be taken, occur or be achieved. Although Minerals Technologies believes that the expectations reflected in such forward-looking statements, if any, are reasonable, it can give no assurance that such expectations will prove to be correct. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by such forward-looking statements. Such forward-looking statements should therefore be construed in the light of such factors. Neither Minerals Technologies, nor any of its shareholders, associates or directors, officers or advisers, provides any representation, assurance or guarantee that the occurrence of the events expressed or implied in any forward-looking statements in this announcement will actually occur. You are cautioned not to place undue reliance on any such forward-looking statements. Other than in accordance with its legal or regulatory obligations, Minerals Technologies is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. No statement in this announcement is intended as a profit forecast or profit estimate.

Publication on website

A copy of this announcement will be available on Minerals Technologies’ website at investors.mineralstech.com promptly, and by no later than 12 noon (London time) on the business day following this announcement in accordance with Rule 26.1(a) of the Code. The content of the website referred to in this announcement is not incorporated into and does not form part of this announcement.