Market Newsdesk

SANTA BARBARA, Calif., Nov. 19, 2020 (GLOBE NEWSWIRE) — LogicMonitor, the leading cloud-based IT infrastructure monitoring and observability platform, today announced it ranked 378 on Deloitte’s 2020 Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences and energy tech companies in North America now in its 26th year. Overall, 2020 Technology Fast 500™ companies achieved revenue growth ranging from 175% to 106,508% from 2016 to 2019. LogicMonitor grew 255% during this period.

LogicMonitor’s chief financial officer, Ziad Fanous, attributes the company’s accelerated growth to an expanded global footprint – including a new Research and Development Center of Excellence in Pune, India and a new regional office in Singapore, as well as investments in product innovation and the expansion of LogicMonitor’s channels and alliances partnerships worldwide.

“It’s an honor to have earned a spot on Deloitte’s Fast 500 list among such like-minded, high growth organizations,” said Fanous. “At LogicMonitor, we are laser-focused on providing the most innovative unified monitoring and observability platform for enterprises today. In the coming year, we will continue to invest in scaling our business to meet the needs of our customers across the globe, giving IT professionals the insights they need to keep their businesses running smoothly.”

Ranking in the Deloitte 2020 Technology Fast 500™ is the latest recognition in an extensive series of honors and awards earned by LogicMonitor in 2020. LogicMonitor was recently recognized as a 2020 CRN Tech Innovator Award winner within the IT Infrastructure Monitoring category. Earlier this year, LogicMonitor ranked No. 1,709 on the 2020 Inc. 5000 List of America’s Fastest-Growing Private Companies, was recognized on JMP Securities’ 2020 Hot 100 List of Best Privately-Held Software Companies, and was honored by the 2020 SaaS Awards Program as the winner of the Best SaaS for Business Management category.

To learn more about LogicMonitor’s global growth and innovative platform, visit www.logicmonitor.com.

About Deloit
te’s 2020 Technology Fast 500™

Now in its 26th year, Deloitte’s Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2016 to 2019.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least $US50,000, and current-year operating revenues of at least $US5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.

About LogicMonitor®

Monitoring unlocks new pathways to growth. At LogicMonitor®, we expand what’s possible for businesses by advancing the technology behind them. LogicMonitor seamlessly monitors infrastructures, empowering companies to focus less on problem solving and more on evolution. We help customers turn on a complete view in minutes, turn the dial from optimization to innovation and turn the corner from sight to vision. For more information, visit www.logicmonitor.com.

Contact

LogicMonitor
Anna Lindsey
Tel: (805) 323-3901
Email: [email protected]

About Deloitte

Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms.

–Strong Growth and Solid Operating Results–

MANCHESTER, N.H., Nov. 19, 2020 (GLOBE NEWSWIRE) —
Allegro MicroSystems, Inc. (“Allegro” or the “Company”) (Nasdaq:ALGM), a global leader in power and sensing semiconductor solutions for motion control and energy efficient systems, today announced financial results for its second fiscal quarter ended September 25, 2020. Total net sales for the three-month period ended September 25, 2020 was $136.6 million, an increase of 18.8% from the prior quarter, demonstrating strong revenue recovery.

“Our business turned a corner in the second fiscal quarter, rebounding off the lows related to the pandemic and showing a quick recovery in our key markets in automotive and industrial where we believe we continue to gain market share,” said Ravi Vig, President and CEO of Allegro MicroSystems. “While uncertainty remains, we have our eye on our long-term opportunities and believe we are in the sweet spot of the convergence of growth trends in automotive, Industry 4.0, data center and green energy, positioning us to take full advantage of a market recovery.”

Business Summary

Automotive revenue was up 17.2% sequentially during the second quarter driven by global auto production growth and also strength in the Company’s xEV business, which nearly doubled from the three-month period ended September 27, 2019. During the second fiscal quarter, the Company completed its strategic acquisition of Voxtel, a privately held company specializing in advanced photonics and 3D imaging technology including components for long-range, eye-safe Light Detection and Ranging (LiDAR). This acquisition brings together Voxtel’s laser and imaging expertise with Allegro’s automotive leadership and scale to enable what the Company believes will be the next generation of Advanced Driver Assistance Systems (ADAS).

Industrial revenue in the second quarter was up 19.7% year-over-year compared to the same prior year fiscal period and 6.1% sequentially due to continued strength in demand for the Company’s three-phase drivers in data centers. The Company’s “Other” business, which represents non-strategic markets, including white goods, desktop computing, printers and peripherals, benefited in part from COVID-related demand for these products.

Business Outlook

For the third fiscal quarter ending December 25, 2020, the Company expects total net sales to be in the range of $147 million to $151 million, with both the Automotive and Industrial businesses growing from the second fiscal quarter. Non-GAAP gross margin is expected to be in the range of 50% – 51%, and non-GAAP earnings per fully-diluted share for the same period is expected to be in the range of $0.11 to $0.12. This guidance is based on an estimated approximate 189.4 million fully-diluted shares outstanding.

Allegro has not provided a reconciliation of its third fiscal quarter outlook for non-GAAP gross margin and non-GAAP earning per fully-diluted share because estimates of all of the reconciling items cannot be provided without unreasonable efforts. It is difficult to reasonably provide a forward-looking estimate between such forward-looking non-GAAP measures and the comparable forward-looking GAAP measures. Certain factors that are materially significant to Allegro’s ability to estimate these items are out of its control and/or cannot be reasonably predicted, including with respect to transaction fees, stock compensation charges, facility closing and consolidation costs, deferred financing costs associated with the repayment of at least 75% of the Company’s $325 million term loan, a pre-IPO $400 million dividend; and the tax consequences of each of these events.

Earnings Webcast

A webcast will be held on Thursday, November 19, at 8:30 a.m. Eastern time. Ravi Vig, Chief Executive Officer and Paul Walsh, Chief Financial Officer, will discuss Allegro’s financial results.

The webcast will be available on the Investor Relations section of the Company’s website at investors.allegromicro.com. A recording of the webcast will be posted in the same location and will be available shortly after the call concludes and will be available for at least 30 days.

About Allegro MicroSystems

Allegro MicroSystems is a leading global designer, developer, fabless manufacturer and marketer of sensor integrated circuits (“ICs”) and application-specific analog power ICs enabling emerging technologies in the automotive and industrial markets. Allegro’s diverse product portfolio provides efficient and reliable solutions for the electrification of vehicles, automotive ADAS safety features, automation for Industry 4.0 and power saving technologies for data centers and green energy applications.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the expected benefits resulting from our acquisition of Voxtel and our expected financial performance for our third fiscal quarter ending December 25, 2020. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,” “should,” “could,” “target,” “potential,” “project,” “predict,” “contemplate,” “potential,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: downturns or volatility in general economic conditions, including as a result of the COVID-19 pandemic, particularly in the automotive market; our ability to compete effectively with intense competition, expand our market share and increase our profitability; our ability to compensate for decreases in average selling prices of our products; the cyclical nature of the analog semiconductor industry; our ability to manage any sustained yield problems or other delays at our third-party wafer fabrication facilities or in the final assembly and test of our products; our ability to fully realize the benefits of past and potential future initiatives designed to improve our competitiveness, growth and profitability; our ability to accurately predict our quarterly net sales and operating results; our ability to adjust our supply chain volume to account for changing market conditions and customer demand; our dependence on manufacturing operations in the Philippines; changes in government trade policies, including the imposition of tariffs and export restrictions; and our ability to protect our proprietary technology and inventions through patents or trade secrets; and other important factors discussed under the caption “Risk Factors” in our final prospectus on Form 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on October 30, 2020, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors & Media page of our website at investors.allegromicro.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

ALLEGRO MICROSYSTEMS, INC.

Consolidated Statements of Income

(in thousands, except share and per share amounts)

(Unaudited)

		Three-Month Period Ended								Six-Month Period Ended
		September 25, 2020				September 27, 2019				September 25, 2020				September 27, 2019
Net sales		$	114,138			$	146,615			$	205,519			$	282,891
Net sales to related party		22,511				16,625				46,131				32,792
Total net sales		136,649				163,240				251,650				315,683
Cost of goods sold		74,879				94,634				134,179				187,690
Gross profit		61,770				68,606				117,471				127,993
Operating expenses:
Research and development		25,130				25,952				49,510				52,080
Selling, general and administrative		24,238				27,593				51,027				53,121
Total operating expenses		49,368				53,545				100,537				105,201
Operating income		12,402				15,061				16,934				22,792
Other income (expense):
Interest income (expense), net		350				(65		)		663				(70		)
Foreign currency transaction (loss) gain		(1,318		)		609				(1,186		)		3,360
Income in earnings of equity investment		246				—				458				—
Other, net		20				(1,189		)		213				(1,096		)
Income before income taxes		11,700				14,416				17,082				24,986
Income tax provision		2,082				2,833				2,610				10,168
Net income		9,618				11,583				14,472				14,818
Net income attributable to non-controlling interests		34				18				68				69
Net income attributable to Allegro MicroSystems, Inc.		$	9,584			$	11,565			$	14,404			$	14,749
Net income attributable to Allegro MicroSystems, Inc. per share:
Basic and diluted		$	0.96			$	1.16			$	1.44			$	1.47
Weighted average shares outstanding:
Basic and diluted		10,000,000				10,000,000				10,000,000				10,000,000

Supplemental Schedule of Total Net Sales

The following table summarizes net sales by core end market and other applications. Other applications include sales of wafer foundry products and from the distribution of Sanken products unrelated to and no longer part of the Company’s business in fiscal year 2021.

		Three-Month Period Ended								Change							Six-Month Period Ended								Change
		September 25, 2020				September 27, 2019				Amount				%			September 25, 2020				September 27, 2019				Amount				%
		(Dollars in thousands)
Core end markets:
Automotive		$	89,479			$	98,209			$	(8,730	)		(8.9	)%		$	165,857			$	190,607			$	(24,750	)		(13.0	)%
Industrial		21,650				18,092				3,558				19.7	%		42,056				34,737				7,319				21.1	%
Other		25,520				20,542				4,978				24.2	%		43,737				38,329				5,408				14.1	%
Total core end markets		136,649				136,843				(194		)		(0.1	)%		251,650				263,673				(12,023		)		(4.6	)%
Other applications:
Wafer foundry products		—				16,698				(16,698		)		(100.0	)%		—				32,988				(32,988		)		(100.0	)%
Distribution of Sanken products		—				9,699				(9,699		)		(100.0	)%		—				19,022				(19,022		)		(100.0	)%
Total net sales		$	136,649			$	163,240			$	(26,591	)		(16.3	)%		$	251,650			$	315,683			$	(64,033	)		(20.3	)%

Supplemental Schedule of Stock-Based Compensation

The Company recorded stock-based compensation expense in the following expense categories of its unaudited consolidated statements of income:

		Three-Month Period Ended								Six-Month Period Ended
(In thousands)		September 25, 2020				September 27, 2019				September 25, 2020				September 27, 2019
Cost of sales		$	53			$	45			$	150			$	90
Research and development		32				26				53				45
Selling, general and administrative		495				303				822				613
Total stock-based compensation		$	580			$	374			$	1,025			$	748

Supplemental Schedule of Acquisition Related Intangible Amortization Costs

The Company recorded intangible amortization expense related to its acquisition of Voxtel in the following expense categories of its unaudited consolidated statements of income:

		Three-Month Period Ended								Six-Month Period Ended
(In thousands)		September 25, 2020				September 27, 2019				September 25, 2020				September 27, 2019
Cost of sales		$	105			$	—				105				—
Selling, general and administrative		9				—				9				—
Total intangible amortization		$	114			$	—			$	114			$	—

ALLEGRO MICROSYSTEMS, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

		September 25, 2020 (Unaudited)				March 27, 2020
Assets
Current assets:
Cash and cash equivalents		$	201,998			$	214,491
Restricted cash		6,354				5,385
Trade accounts receivable, net of allowances of doubtful accounts of $338 and $288 at September 25, 2020 and March 27, 2020, respectively		57,926				59,457
Trade and other accounts receivable due from related party		16,783				30,851
Accounts receivable – other		2,780				1,796
Inventories		104,796				127,227
Prepaid expenses and other current assets		16,585				9,014
Total current assets		407,222				448,221
Property, plant and equipment, net		217,901				332,330
Deferred income tax assets		6,861				7,217
Goodwill		20,257				1,285
Intangible assets, net		36,274				19,958
Related party note receivable		51,377				—
Equity investment in related party		25,028				—
Other assets, net		14,779				8,810
Total assets		$	779,699			$	817,821
Liabilities, Non-Controlling Interest and Stockholders’ Equity
Current liabilities:
Trade accounts payable		$	23,856			$	20,762
Amounts due to related party		1,157				4,494
Accrued expenses and other current liabilities		64,929				56,855
Current portion of related party debt		—				25,000
Bank lines-of-credit		33,000				43,000
Total current liabilities		$	214,491			$	99,743
Related party notes payable, less current portion		5,385				3,514
Other long-term liabilities		$	219,876			$	103,257
Total liabilities		439,752				206,514
Commitments and contingencies
Stockholders’ Equity:
Common stock:
Class A, $.01 par value; 12,500,000 shares authorized; 10,000,000 shares issued and outstanding at September 25, 2020 and March 27, 2020		100				100
Class L, $.01 par value; 1,000,000 shares authorized; 638,298 shares issued and outstanding September 25, 2020; 622,470 shares issued and outstanding at March 27, 2020		6				6
Additional paid-in capital		439,732				458,697
Retained earnings		208,759				194,355
Accumulated other comprehensive loss		(14,133		)		(19,976		)
Equity attributable to Allegro MicroSystems, Inc.		634,464				633,182
Non-controlling interests		1,042				950
Total stockholders’ equity		635,506				634,132
Total liabilities, non-controlling interest and stockholders’ equity		$	779,699			$	817,821

 

ALLEGRO MICROSYSTEMS, INC.

Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

		Six-Month Period Ended
		September 25, 2020				September 27, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income		$	14,472			$	14,818
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		24,026				31,477
Deferred income taxes		1,307				(320		)
Stock-based compensation		1,025				748
Loss on disposal of assets		293				559
Provisions for inventory and bad debt		209				1,941
Changes in operating assets and liabilities:
Trade accounts receivable		6,196				10,294
Accounts receivable – other		(1,292		)		1,148
Inventories		(8,772		)		3,043
Prepaid expenses and other assets		(16,725		)		(3,863		)
Trade accounts payable		2,793				(759		)
Due to/from related parties		10,731				(19,601		)
Accrued expenses and other current and long-term liabilities		(5,623		)		(11,769		)
Net cash provided by operating activities		28,640				27,716
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant and equipment		(18,091		)		(18,199		)
Acquisition of business, net of cash acquired		(8,500		)		—
Proceeds from sales of property, plant and equipment		282				3,920
Contribution of cash balances due to divestiture of subsidiary		(16,335		)		—
Net cash used in investing activities		(42,644		)		(14,279		)
CASH FLOWS FROM FINANCING ACTIVITIES:
Related party note receivable		—				30,000
Net cash provided by financing activities		—				30,000
Effect of exchange rate changes on Cash and cash equivalents and Restricted cash		2,480				(7,157		)
Net (decrease) increase in Cash and cash equivalents and Restricted cash		(11,524		)		36,280
Cash and cash equivalents and Restricted cash at beginning of period		219,876				103,257
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD:		$	208,352			$	139,537
RECONCILIATION OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH:
Cash and cash equivalents at beginning of period		$	214,491			$	99,743
Restricted cash at beginning of period		5,385				3,514
Cash and cash equivalents and Restricted cash at beginning of period		$	219,876			$	103,257
Cash and cash equivalents at end of period		201,998				134,349
Restricted cash at end of period		6,354				5,188
Cash and cash equivalents and Restricted cash at end of period		$	208,352			$	139,537
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid for interest		$	107			$	763
Cash paid for income taxes		$	6,385			$	4,582
Non-cash transactions:
Changes in Trade accounts payable related to Property, plant and equipment, net		$	(4,000	)		$	(2,659	)
Loans to cover purchase of common stock under employee stock plan		$	171			$	—

Non-GAAP Financial Measures

In addition to the measures presented in our consolidated financial statements, we regularly review other metrics, defined as non-GAAP financial measures by the SEC, to evaluate our business, measure our performance, identify trends, prepare financial forecasts and make strategic decisions. The key metrics we consider are non-GAAP Gross Profit, non-GAAP Gross Margin, non-GAAP Operating Expenses, non-GAAP Operating Expenses, non-GAAP Profit before Tax, non-GAAP Provision for Income Tax, non-GAAP Net Income, non-GAAP Net Income per Share, EBITDA, Adjusted EBITDA and Adjusted EBITDA margin (collectively, the “Non-GAAP Financial Measures”). These non-GAAP Financial Measures provide supplemental information regarding our operating performance on a non-GAAP basis that excludes certain gains, losses and charges of a non-cash nature or that occur relatively infrequently and/or that management considers to be unrelated to our core operations, and in the case of non-GAAP Provision for Income Tax, management believes that this non-GAAP measure of income taxes provides it with the ability to evaluate the non-GAAP Provision for Income Taxes across different reporting periods on a consistent basis, independent of special items and discrete items, which may vary in size and frequency. By presenting these Non-GAAP Financial Measures, we provide a basis for comparison of our business operations between periods by excluding items that we do not believe are indicative of our core operating performance, and we believe that investors’ understanding of our performance is enhanced by our presenting these Non-GAAP Financial Measures, as they provide a reasonable basis for comparing our ongoing results of operations. Management believes that tracking and presenting these Non-GAAP Financial Measures provides management and the investment community with valuable insight into matters such as: our ongoing core operations, our ability to generate cash to service our debt and fund our operations; and the underlying business trends that are affecting our performance and evaluating companies in our industry. These Non-GAAP Financial Measures are used by both management and our board of directors, together with the comparable GAAP information, in evaluating our current performance and planning our future business activities. In particular, management finds it useful to exclude non-cash charges in order to better correlate our operating activities with our ability to generate cash from operations and to exclude certain cash charges as a means of more accurately predicting our liquidity requirements. We believe that these Non-GAAP Financial Measures, when used in conjunction with our GAAP financial information, also allow investors to better evaluate our financial performance in comparison to other periods and to other companies in our industry.

These Non-GAAP Financial Measures have significant limitations as analytical tools. Some of these limitations are that:

• such measures do not reflect our cash expenditures, or future requirements for capital expenditures or contractual commitments;
• such measures exclude certain costs which are important in analyzing our GAAP results;
• such measures do not reflect changes in, or cash requirements for, our working capital needs;
• such measures do not reflect the interest expense, or the cash requirements necessary to service interest or principal payments on our debt;
• such measures do not reflect our tax expense or the cash requirements to pay our taxes; although depreciation and amortization are non-cash charges, the assets being depreciated and amortized will often have to be replaced in the future;
• such measures do not reflect any cash requirements for such replacements; and
• other companies in our industry may calculate such measures differently than we do, thereby further limiting their usefulness as comparative measures.

The Non-GAAP Financial Measures are supplemental measures of our performance that are neither required by, nor presented in accordance with, GAAP. These Non-GAAP Financial Measures should not be considered as substitutes for GAAP financial measures such as gross profit, gross margin, net income or any other performance measures derived in accordance with GAAP. Also, in the future we may incur expenses or charges such as those added back in the calculation of these Non-GAAP Financial Measures. Our presentation of these Non-GAAP Financial Measures should not be construed as an inference that future results will be unaffected by unusual or nonrecurring items.

Our prior disclosure referred to non-GAAP Gross Profit and non-GAAP Gross Margin as Adjusted Gross Profit and Adjusted Gross Margin, respectively. No changes have been made to how we calculate these measures.

Non-GAAP Gross Profit and Non-GAAP Gross Margin


We calculate non-GAAP Gross Profit and non-GAAP Gross Margin excluding the items below from cost of revenues in applicable periods and we calculate and non-GAAP Gross Margin as non-GAAP Gross Profit divided by total net sales.

• PSL and Sanken Distribution Agreement – Represents the elimination of inventory cost amortization and foundry service payment related to one-time costs incurred in connection with the disposition of Polar Semiconductor, LLC (“PSL”) during the second fiscal quarter ended September 25, 2020 (the “PSL Divestiture”)
• Stock-based compensation – Represents non-cash expenses arising from the grant of stock awards
• AMTC Facility consolidation one-time costs – Represents one-time costs incurred in connection with closing of our manufacturing facility in Thailand (the “AMTC Facility”) and transitioning of test and assembly functions to the our manufacturing facility in the Philippines (the “AMPI Facility”) announced in fiscal year 2020 consisting of: moving equipment between facilities, contract terminations and other non-recurring charges. The closure and transition of the AMTC Facility is expected to be substantially complete by the end of March 2021. These costs are in addition to, and not duplicative of, the adjustments noted in note (*) below.
• Amortization of acquisition-related intangible assets – Represents non-cash expenses associated with the amortization of intangible assets in connection with the acquisition of Voxtel, Inc., which closed in August 2020.
• COVID-19 related expenses – Represents expenses attributable to the COVID-19 pandemic primarily related to increased purchases of masks, gloves and other protective materials, and overtime premium compensation paid for maintaining 24-hour service at the AMPI Facility.

(*) Non-GAAP Gross Profit and the corresponding calculation of non-GAAP Gross Margin in this release do not include adjustments consisting of:

• Additional AMTC related costs – Represents costs relating to the closing of the AMTC Facility and the transitioning of test and assembly functions to the AMPI Facility in the Philippines announced in fiscal year 2020 consisting of: the net savings expected to result from the movement of work to the AMPI Facility, which facility had duplicative capacity based on the buildouts of the AMPI Facility in fiscal years 2019 and 2018. The elimination of these costs did not reduce our production capacity and therefore did not have direct effects on our ability to generate revenue. The closure and transition of the AMTC Facility is expected to be substantially complete by the end of March 2021.
• Out of period adjustment for depreciation expense of GMR assets – Represents a one-time depreciation expense related to the correction of an immaterial error, related to 2017, for certain manufacturing assets that have reached the end of their useful lives.

Non-GAAP Operating Expenses, non-GAAP Operating


Income


and non-GAAP Operating Margin


We calculate non-GAAP Operating Expenses and non-GAAP Operating Income excluding the same items excluded above to the extent they are classified as operating expenses, and also excluding the items below in applicable periods. We calculate non-GAAP Operating Margin as non-GAAP Operating Income divided by total net sales.

• Transaction fees – Represents transaction-related legal and consulting fees incurred primarily in connection with (i) the unsuccessful acquisition of a competitor in fiscal year 2019, (ii) the acquisition of Voxtel, Inc. in fiscal year 2020, and (iii) the PSL Divestiture and the transfer of the Sanken products distribution business to PSL in fiscal year 2020.
• Severance – Represents severance costs associated with (i) labor savings initiatives to manage overall compensation expense as a result of the declining sales volume during the applicable period, including a voluntary separation incentive payment plan for employees near retirement and a reduction in force and (ii) the closing of the AMTC Facility and the transitioning of test and assembly functions to the AMPI Facility announced and initiated in fiscal year 2020.

(**) Non-GAAP Operating Income in this release does not include adjustments consisting of those set forth in note (*) to the calculation of non-GAAP Gross Profit, and the corresponding calculation of non-GAAP Gross Margin, above or:

• Labor savings – Represents salary and benefit costs related to employees whose positions were eliminated through voluntary separation programs or other reductions in force (not associated with the closure of the AMTC Facility or any other plant or facility) and a restructuring of overhead positions from high-cost to low-cost jurisdictions net of costs for newly hired employees in connection with such restructuring.

EBITDA, Adjusted EBITDA, Adjusted EBITDA Margin and Non-GAAP Profit before Tax


We calculate EBITDA as net income minus interest income (expense), tax provision, and depreciation and amortization expenses. We calculate Adjusted EBITDA as EBITDA excluding the same items excluded above and also excluding the items below in applicable periods, We calculate Adjusted EBITDA Margin as Adjusted EBITDA divided by total net sales. We calculate non-GAAP Profit before Tax as Profit before Tax excluding the same items excluded above and also excluding the items below in applicable periods.

• Non-core loss (gain) on sale of equipment – Represents non-core miscellaneous losses and gains on the sale of equipment
• Foreign currency translation loss (gain) – Represents losses and gains resulting from the remeasurement and settlement of intercompany debt and operational transactions, as well as transactions with external customers or vendors denominated in currencies other than the functional currency of the legal entity in which the transaction is recorded
• Income in earnings of equity investment – Represents our equity method investment in PSL
• Inventory cost amortization – Represents intercompany inventory transactions incurred from purchases made from PSL in fiscal year 2020. Such costs are one-time incurred expenses impacting our operating results during fiscal year 2021 following the PSL Divestiture. Such costs are not expected to have a continuing impact on our operating results after our second fiscal quarter of fiscal year 2021.
• Foundry service payment – Represents foundry service payments incurred under our Price Support Agreement with PSL in respect to the guaranteed capacity at PSL to support our production forecast and are one-time costs incurred impacting our operating results during fiscal year 2021 following the PSL Divestiture. Such costs are not expected to have a continuing impact on our operating results after fiscal year 2021.

Non-GAAP Provision for Income Tax


In calculating non-GAAP Provision for Income Tax, we have added-back the following to GAAP Provision for Income Taxes:

• Tax effect of adjustments to GAAP results – Represents the estimated income tax effect of the adjustments to non-GAAP Profit Before Tax described above and elimination of discrete tax adjustments.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
Reconciliation of Gross Profit
GAAP Gross Profit		$	61,770			$	55,701			$	68,606			$	117,471			$	127,993
PSL and Sanken distribution agreement		2,815				3,383				—				6,198				—
Stock-based compensation		53				97				45				150				90
AMTC facility consolidation one-time costs		408				544				—				952				—
Amortization of acquisition-related intangible assets		105				—				—				105				—
COVID-19 related expenses		73				—				—				73				—
Total		$	3,454			$	4,024			$	45			$	7,478			$	90
Non-GAAP Gross Profit*		$	65,224			$	59,725			$	68,651			$	124,949			$	128,083
Non-GAAP Gross Margin*		47.7		%		51.9		%		42.1		%		49.7		%		40.6		%

* Non-GAAP Gross Profit and the corresponding calculation of non-GAAP Gross Margin do not include adjustments for the following components of our net income: (i) additional AMTC related costs of $2,281, $3,074, and $— for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768, $—, and $— for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and (ii) additional AMTC related costs of $5,355 and $— for the six months ended September 25, 2020 and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768 and $— for the six months ended September 25, 2020 and September 27, 2019, respectively.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
Reconciliation of Operating Expenses
GAAP Operating Expenses		$	49,368			$	51,169			$	53,545			$	100,537			$	105,201
Stock-based compensation		527				348				329				875				658
AMTC facility consolidation one-time costs		1,358				1,161				—				2,519				—
Amortization of acquisition-related intangible assets		9				—				—				9				—
COVID-19 related expenses		398				4,000				—				4,398				—
Transaction fees		1,871				117				1,081				1,988				1,447
Severance		—				337				2,698				337				2,698
Total		$	4,163			$	5,963			$	4,108			$	10,126			$	4,803
Non-GAAP Operating Expenses*		$	45,205			$	45,206			$	49,437			$	90,411			$	100,398

* Non-GAAP Operating Expenses do not include adjustments for the following components of our net income: (i) additional AMTC related costs of $380, $324, and $2,890 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and labor savings costs of $—, $109, and $2,414 for the three months ended September 25, 2020, and June 26, 2020, September 27, 2019, respectively, and (ii) additional AMTC related costs of $704 and $5,664 for the six months ended September 25, 2020 and September 27, 2019, respectively, and labor savings costs of $109 and $4,812 for the six months ended September 25, 2020 and September 27, 2019, respectively.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
Reconciliation of Operating Income
GAAP Operating Income		$	12,402			$	4,532			$	15,061			$	16,934			$	22,792
PSL and Sanken distribution agreement		2,815				3,383				—				6,198				—
Stock-based compensation		580				445				374				1,025				748
AMTC facility consolidation one-time costs		1,766				1,705				—				3,471				—
Amortization of acquisition-related intangible assets		114				—				—				114				—
COVID-19 related expenses		471				4,000				—				4,471				—
Transaction fees		1,871				117				1,081				1,988				1,447
Severance		—				337				2,698				337				2,698
Total		$	7,617			$	9,987			$	4,153			$	17,604			$	4,893
Non-GAAP Operating Income*		$	20,019			$	14,519			$	19,214			$	34,538			$	27,685
Non-GAAP Operating Margin* (% of net sales)		14.6		%		12.6		%		11.8		%		13.7		%		8.8		%

* Non-GAAP Operating Income and the corresponding calculation of non-GAAP Operating Margin do not include adjustments for the following components of our net income: (i) additional AMTC related costs of $2,330, $3,398, and $2,890 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, labor savings costs of $—, $109, and $2,414 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768, $—, and $— for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and (ii) additional AMTC related costs of $5,728 and $5,664 for the six months ended September 25, 2020 and September 27, 2019, respectively, labor savings costs of $109 and $4,812 for the six months ended September 25, 2020 and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768 and $— for the six months ended September 25, 2020 and September 27, 2019, respectively.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
GAAP Net Income		$	9,618			$	4,854			$	11,583			$	14,472			$	14,818
Interest (income) expense		(350		)		(313		)		65				(663		)		70
Tax provision		2,082				528				2,833				2,610				10,168
Depreciation & amortization		12,487				11,539				15,988				24,026				31,477
EBITDA		$	23,837			$	16,608			$	30,469			$	40,445			$	56,533
Adjustments to EBITDA
Non-core loss (gain) on sale of equip.		331				(38		)		604				293				559
Foreign currency translation loss (gain)		1,318				(132		)		(609		)		1,186				(3,360		)
Income in earnings of equity investment		(246		)		(212		)		—				(458		)		—
Stock-based compensation		580				445				374				1,025				748
AMTC facility consolidation one-time costs		1,766				1,705				—				3,471				—
COVID-19 related costs		471				4,000				—				4,471				—
Transaction fees		1,871				117				1,081				1,988				1,447
Severance		—				337				2,698				337				2,698
Inventory cost amortization		1,115				1,583				—				2,698				—
Foundry service payment		1,700				1,800				—				3,500				—
Adjusted EBITDA*		$	32,743			$	26,213			$	34,617			$	58,956			$	58,625
Adjusted EBITDA Margin*		24.0		%		22.8		%		21.2		%		23.4		%		18.6		%

* Adjusted EBITDA and the corresponding calculation of Adjusted EBITDA Margin do not include adjustments for the following components of our net income: (i) additional AMTC related costs of $2,330, $3,398, and $2,890 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and labor savings costs of $—, $109, and $2,414 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively and (ii) AMTC additional costs of $5,728 and $5,664 for the six months ended September 25, 2020 and September 27, 2019, respectively, and labor savings costs of $109 and $4,812 for the six months ended September 25, 2020 and September 27, 2019, respectively.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
Reconciliation of Profit before Tax
GAAP Profit before Tax		$	11,700			$	5,382			$	14,416			$	17,082			$	24,986
Non-core loss (gain) on sale of equip.		331				(38		)		604				293				559
Foreign currency transaction loss (gain)		1,318				(132		)		(609		)		1,186				(3,360		)
Income in earnings of equity investment		(246		)		(212		)		—				(458		)		—
PSL and Sanken distribution agreement		2,815				3,383				—				6,198				—
Stock-based compensation		580				445				374				1,025				748
AMTC facility consolidation one-time costs		1,766				1,705				—				3,471				—
Amortization of acquisition-related intangible assets		114				—				—				114				—
COVID-19 related expenses		471				4,000				—				4,471				—
Transaction fees		1,871				117				1,081				1,988				1,447
Severance		—				337				2,698				337				2,698
Total		$	9,020			$	9,605			$	4,148			$	18,625			$	2,092
Non-GAAP Profit before Tax*		$	20,720			$	14,987			$	18,564			$	35,707			$	27,078

* Non-GAAP Profit before Tax does not include adjustments for the following components of our net income: (i) additional AMTC related costs of $2,661, $3,398, and $2,890 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, labor savings costs of $—, $109, and $2,414 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768, $—, and $— for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and (ii) additional AMTC related costs of $6,059 and $5,664 for the six months ended September 25, 2020 and September 27, 2019, respectively, labor savings costs of $109 and $4,812 for the six months ended September 25, 2020 and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768 and $— for the six months ended September 25, 2020 and September 27, 2019, respectively.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
Reconciliation of Provision for Income Taxes
GAAP Provision for Income Taxes		$	2,082			$	528			$	2,833			$	2,610			$	10,168
GAAP effective tax rate		17.8		%		9.8		%		19.7		%		15.3		%		40.7		%
Tax effect of adjustments to GAAP results		859				1,808				375				2,667				(5,489		)
Non-GAAP Provision for Income Taxes *		$	2,941			$	2,336			$	3,208			$	5,277			$	4,679
Non-GAAP effective tax rate		14.2		%		15.6		%		17.3		%		14.8		%		17.3		%

* Non-GAAP Provision for Income Taxes does not include tax adjustments for the following components of our net income: additional AMTC related costs, labor savings costs, and out of period adjustment for depreciation expense of GMR assets. The related tax effect of those adjustments to GAAP results were $768, $786 and $1,188 for the three months ended September 25, 2020, June 26, 2020, September 27, 2019, respectively, and $1,554 and $2,347 for the six months ended September 25, 2020 and September 27, 2019, respectively.

		Three-Month Period Ended												Six-Month Period Ended
		September 25, 2020				June 26, 2020				September 27, 2019				September 25, 2020				September 27, 2019
		(Dollars in thousands)
Reconciliation of Net Income
GAAP Net Income		$	9,618			$	4,854			$	11,583			$	14,472			$	14,818
Non-core loss (gain) on sale of equip.		331				(38		)		604				293				559
Foreign currency transaction loss (gain)		1,318				(132		)		(609		)		1,186				(3,360		)
Income in earnings of equity investment		(246		)		(212		)		—				(458		)		—
PSL and Sanken distribution agreement		2,815				3,383				—				6,198				—
Stock-based compensation		580				445				374				1,025				748
AMTC facility consolidation one-time costs		1,766				1,705				—				3,471				—
Amortization of acquired-related intangible assets		114				—				—				114				—
COVID-19 related expenses		471				4,000				—				4,471				—
Transaction fees		1,871				117				1,081				1,988				1,447
Severance		—				337				2,698				337				2,698
Tax effect of adjustments to GAAP results		(859		)		(1,808		)		(375		)		(2,667		)		5,489
Non-GAAP Net Income*		$	17,779			$	12,651			$	15,356			$	30,430			$	22,399

* Non-GAAP Net Income does not include adjustments for the following components of our net income: (i) additional AMTC related costs of $2,661, $3,398, and $2,890 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, labor savings costs of $—, $109, and $2,414 for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768, $—, and $— for the three months ended September 25, 2020, June 26, 2020, and September 27, 2019, respectively, (ii) additional AMTC related costs of $6,059 and $5,664 for the six months ended September 25, 2020 and September 27, 2019, respectively, labor savings costs of $109 and $4,812 for the six months ended September 25, 2020 and September 27, 2019, respectively, and out of period adjustment for depreciation expense of GMR assets of $768 and $— for the six months ended September 25, 2020 and September 27, 2019, respectively, and (iii) the related tax effect of adjustments to GAAP results $768, $786 and $1,188 for the three months ended September 25, 2020, June 26, 2020, September 27, 2019, respectively, and $1,554 and $2,347 for the six months ended September 25, 2020 and September 27, 2019, respectively.

Investor Contact:

Katherine Blye
Investor Relations
Phone: (603) 626-2306
[email protected]

CAMBRIDGE, Mass., Nov. 19, 2020 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, announced today that the company has extended the term of the research program under its existing 2017 research collaboration and license agreement with Merck toward developing a clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease.

“We are very pleased with the progress to date in our ongoing strategic collaboration with Merck,” said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. “Extending the research term of our agreement based on promising preclinical data with a goal of identifying a clinical candidate underscores the significant potential of our therapeutic Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform and CUE-300 series in the treatment of debilitating autoimmune diseases.”

Under the terms of the extension, Cue Biopharma will receive additional financial research support to further study and develop promising preclinical biologics with the objective of identifying clinical candidates.

Cue Biopharma entered into an exclusive patent license and research collaboration agreement with Merck in November 2017 to develop biologics for the treatment of selected autoimmune diseases. For further information regarding the amendment, please refer to the Current Report on Form 8-K to be filed by Cue Biopharma with the SEC on November 19, 2020.

About Immuno-STAT

Immuno-STAT™ biologics are being designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drug candidates is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

About Cue Biopharma

Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body to transform the treatment of cancer, infectious diseases and autoimmune diseases. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

Headquartered in Cambridge, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in the design and clinical development of protein biologics, immunology and immuno-oncology.

For more information, visit www.cuebiopharma.com and follow us on Twitter https://twitter.com/CueBiopharma.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the safe harbor created by those sections. Such forward-looking statements include, but are not limited to, those regarding: the goal of identifying a clinical candidate under the Merck collaboration; the potential of the Immuno-STAT platform and CUE-300 series to treat autoimmune diseases; the anticipated results of the company’s drug development efforts, including study results; and the company’s expectations regarding regulatory developments and expected future operating results. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies, its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including possible effects on the company’s operations and clinical trials; negative or inconclusive results from the company’s clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; ; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Contact

George B. Zavoico, Ph.D.
VP, Investor Relations & Corporate Development
Cue Biopharma, Inc.
[email protected]

Media Contact

Alison Chen
LifeSci Communications
[email protected] 

ATLANTA, Nov. 19, 2020 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC)(“DLH” or the “Company”), a leading provider of innovative healthcare services and solutions to federal agencies, today announced that it will participate in the Truist Virtual Industrials & Services Summit on December 8, 2020. The day will consist of one-on-one calls with management, and institutional investors are encouraged to contact Truist directly for time with the Company. A presentation will also be available on the Company’s website.

About DLH

DLH (NASDAQ:DLHC) serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company’s seven core competencies include secure data analytics, clinical trials and laboratory services, case management, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has approximately 2,000 employees serving numerous government agencies. For more information, visit the corporate website at www.dlhcorp.com.

DLH Investor Relations

Contact: Chris Witty
Phone: 646-438-9385
Email: [email protected] 

Investigational drug
RNL
™
d
eliver
s
u
p to
fifteen
t
imes
the
a
bsorbed
d
ose of
r
adiation
c
ompared to
standard
e
xternal
b
eam
r
adiation
t
herapy

RNL was
g
enerally
well-
t
olerated
w
ith
n
o
d
ose-
l
imiting
t
oxicities
o
bserved

Company
m
anagement and
p
rincipal
i
nvestigator
of ReSPECT
to
d
iscuss
i
nterim
d
ata
d
uring
w
ebinar
s
cheduled for
Thursday
,
November
19
, 20
20
at
4
:30
–
5:30 p.m.
ET

AUSTIN, Texas, Nov. 19, 2020 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, today announced positive new interim data from its ongoing ReSPECT™ Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM). These results were presented in an electronic poster entitled, “Safety and Feasibility of Rhenium-186 Nanoliposomes (RNL™) in Recurrent GBM: the ReSPECT Phase 1 Trial,” at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, which is taking place virtually November 19-21, 2020.

The interim data set shows that intratumoral RNL can successfully deliver up to fifteen times the absorbed dose of radiation administered by standard external beam radiation therapy (EBRT) without significant toxicity. These data support progression to the ReSPECT trial’s sixth dose escalation cohort.

“The results we have seen thus far from ReSPECT are encouraging and support the continued development of RNL as a potential new option for recurrent GBM patients,” said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the study. “With limited therapeutic options for these patients, we remain committed to advancing this clinical program to further investigate the therapeutic potential of RNL.”

“Treatment for glioblastoma remains a significant challenge as current therapies have exhibited limited efficacy,” stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “RNL’s novel design allows the drug to be targeted directly into the tumor using a small catheter and enabling greater control of radiation dosing. These encouraging data reinforce RNL’s potential to deliver targeted high-dose radiation in a safe, effective, and convenient manner.”

Key
R
esults from the
I
nterim
A
nalysis

• All 15 patients in the first five of six planned cohorts have completed treatment.
• RNL treatment volume and radiation dose increased successfully from 0.66 milliliter (mL) to 8.8 mL and 1.0 millicurie (mCi) to 22.3 mCi, respectively.
• Cohort 5 patients received an RNL average absorbed radiation dose of 423 Gray (Gy).
• RNL has been well-tolerated, and no dose-limiting toxicity has been observed despite markedly higher absorbed doses of radiation compared to EBRT.
• Most adverse events (AEs) were considered causally unrelated to RNL except scalp discomfort, which was considered related to the surgical procedure. Neither the incidence nor severity of AEs appeared to increase with increasing doses of RNL.
• Four serious adverse events (SAEs) were reported, none of the SAEs were considered causally related to RNL.
• Median survival duration in patients that previously received bevacizumab (n=7) was 4.8 months, while median and mean survival durations in patients that were bevacizumab-naïve (n=8) are currently 11.0 months (range 3.5 – 33) and 15.4 months (95% CI 7.4 – 23.4), respectively, with four patients still alive.
• Two patients survived greater than 30 months after therapy with RNL.

The sixth dose escalation cohort of the ReSPECT trial is underway and one patient has thus far been treated. The sixth cohort is expected to fully enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration (FDA) granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Webinar details

The Company will host a webinar today, Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET discussing these data. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data. In addition, a patient with recurrent GBM from the ReSPECT trial will provide their treatment experience with RNL.

Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.

The live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.

Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.

A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.

Andrew J. Brenner, M.D., Ph.D.

Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.

About Plus Therapeutics, Inc.

Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company’s potential to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers; the Company’s potential to develop drug candidates currently in its product pipeline; and the Company’s potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA’s accelerated regulatory pathways; and the risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
Peter Vozzo
Westwicke/ICR
(443) 377-4767
[email protected]

Media Contact
Terri Clevenger
Westwicke/ICR
(203) 856-4326
[email protected]

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5639e2df-2399-4963-8796-f86e100ffa8e