Market Newsdesk

Exosome Platform


Technology


-Announced Positive Preclinical Data
for Multivalent Exosome-mRNA Vaccine For COVID-19-

–
Novel
Vaccine
Induce
d
Long-Lasting Immunity to Multiple SARS-CoV-2 Proteins
–

-Development of Safe, Non-toxic Exosome Formulation Capable of Delivering Functional mRNA in vitro and in vivo-

–
Platform Expansion Underway Using Engineered Exosomes
–

Duchenne Muscular Dystrophy Program


-In Discussions with FDA on Next Steps in Pathway Forward-

CAP-1002 for COVID-19


–
P
atient
S
creening
U
nderway
in Randomized, Double-Blind, Placebo-Controlled INSPIRE Study-

–
To Host Conference Call and Webcast
Today
at 4:30 p.m. ET
–

LOS ANGELES, Nov. 12, 2020 (GLOBE NEWSWIRE) — Capricor Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today its financial results for the third quarter ending September 30, 2020 and provided a corporate update.

“The Company’s development and achievements in the third quarter have been encouraging on multiple levels. We have continued to build momentum with our exosome platform technology as well as with our CAP-1002 program. The pandemic has provided a unique opportunity for the development of a vaccine candidate but also for the use of CAP-1002 as a potential therapeutic,” said Linda Marbán, Ph.D., Capricor’s president and chief executive officer. 

“We are advancing two separate and novel vaccine programs. Our strategy has evolved from our original plan to use exosomes from our cell as drug delivery vehicles to creating exosomes from multiple cell types that are readily available to build products that can be designed to address targets where delivery has proved to be challenging. We are now leveraging thought leaders and our own expertise to direct the development of exosome-based vaccines and exosome-based therapeutics. We expect significant pipeline expansion and will be seeking partnering opportunities in the months ahead to further cement our rebranding. I have never been more excited at the possibilities for Capricor,” Dr. Marbán added.

The Company continues the development of our late-stage clinical asset, CAP-1002, for the treatment of advanced stages of DMD, and is currently in discussions with potential partners for this program. The FDA has continued to encourage us to conduct a Phase III study, however at this time, Capricor continues to work with FDA to explore alternative pathways forward.

Capricor is currently screening patients for its INSPIRE Phase II study, which is designed to assess the ability of CAP-1002 to modulate the cytokine storm and attenuate the sequelae associated with severe COVID-19. While other therapeutics are in testing for early and much later stage COVID-19, there are very few options for those with severe disease at risk for ventilation. Based on our preclinical data, as well as the data from our emergency use authorization program, CAP-1002 is poised to potentially be an important tool in the toolbox to treat severe COVID-19.

“We are pleased to deliver an update of those accomplishments today focused on our engineered exosome platform, DMD and COVID-19 programs and our anticipated milestones,” added Dr. Marbán.

Third
Quarter
Highlights and Recent Developments

Engineered


Exosome


s


Platform

• Announced positive preclinical data for multivalent exosome-mRNA Vaccine for COVID-19
  • Development of safe, non-toxic exosome formulation capable of delivering functional mRNA in vitro and in vivo
  • Creation of a multiplexed exosome-RNA vaccine that expresses viral antigens engineered to induce cellular immunity and antibody responses to multiple proteins of SARS-CoV-2
    • Demonstrated persistent cellular immune responses to the SARS-CoV-2 N and S proteins
    • Demonstrated moderate but sustained antibody responses to the SARS-CoV-2 N and S proteins
• Generated exosome-based VLPs (virus like particles) with 4 viral antigens expressed on the surface of SARS-CoV-2
• Advanced exosome-based vaccine candidates into animal studies

Duchenne Muscular Dystrophy Program

• Presented positive final 12-month results from the HOPE-2 Phase II study at the International World Muscle Society Virtual Congress 2020
• In discussions with FDA and potential partners to determine next steps and pathway forward

CAP-1002 for


COVID-19

• Initiated patient screening for INSPIRE study
• FDA Acceptance of Capricor’s IND Application for Phase II INSPIRE study

Anticipated Events and
Targeted
Milestones
Into 2021

• Plan to initiate patient enrollment of Phase II INSPIRE study in patients in severe or critical condition with COVID-19
• Plan to meet with FDA in PRE-IND meeting to discuss next steps in exosome mRNA vaccine clinical strategy
• Plan to publish additional preclinical data on exosomes platform
• Plan to announce continued pipeline expansion with exosome platform
• Plan to announce updates on INSPIRE study
• Continue discussions with FDA on DMD program
• Continue to pursue partnership opportunities for pipeline products
• Continue to pursue grant funding opportunities for pipeline products

Third
Quarter Financial Results

The Company reported a net loss of approximately $3.9 million, or $0.20 per share, for the third quarter of 2020, compared to a net loss of approximately $1.6 million, or $0.43 per share, for the third quarter of 2019.

As of September 30, 2020, the Company’s cash, cash equivalents and marketable securities totaled approximately $35.3 million, compared to approximately $9.9 million on December 31, 2019. Additionally, in the third quarter of 2020, Capricor raised approximately $2.0 million in net proceeds at an average price of approximately $5.87 per share under its at-the-market offering program. 

Conference Call and Webcast Details

To participate in the conference call, please dial 877-451-6152 (Domestic/Toll-Free) or 201-389-0879 (International) and reference the conference ID: 13712434        

To participate via a webcast, please visit: http://public.viavid.com/index.php?id=142179

The webcast will be archived for approximately 30 days and will be available at:  http://capricor.com/news/events/.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell and exosome-based therapeutics for the treatment and prevention of diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy and the cytokine storm associated with COVID-19. Capricor is also investigating the field of extracellular vesicles and exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. We are now developing two potential vaccines for COVID-19 as part of our exosome platform. For more information, visit www.capricor.com and follow the Company on Facebook, Instagram and Twitter.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, revenue projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission on March 27, 2020 and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 as filed with the Securities and Exchange Commission on August 10, 2020. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.

For more information, please contact:

Media Contact:

Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
[email protected] / [email protected] 
212.896.1241 / 212.896.1204

Investor Contact:

Joyce Allaire 
LifeSci Advisors, LLC
[email protected] 
617.435.6602

Company Contact:

AJ Bergmann, Chief Financial Officer 
[email protected] 
310.358.3200

CAPRICOR THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
		Three months ended September 30,								Nine months ended September 30,
			2020				2019				2020				2019
REVENUE
Revenue		$	16,863			$	142,071			$	252,420			$	782,928
TOTAL REVENUE			16,863				142,071				252,420				782,928
OPERATING EXPENSES
Research and development			2,629,267				857,764				5,711,896				4,313,056
General and administrative			1,301,673				911,968				4,049,955				2,720,391
TOTAL OPERATING EXPENSES			3,930,940				1,769,732				9,761,851				7,033,447
LOSS FROM OPERATIONS			(3,914,077	)			(1,627,661	)			(9,509,431	)			(6,250,519	)
OTHER INCOME (EXPENSE)
Investment income			3,953				21,061				30,335				80,840
Loss on disposal of fixed asset			–				–				–				(2,720	)
TOTAL OTHER INCOME (EXPENSE)			3,953				21,061				30,335				78,120
NET LOSS			(3,910,124	)			(1,606,600	)			(9,479,096	)			(6,172,399	)
OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain (loss) on marketable securities			–				–				757				(12,393	)
COMPREHENSIVE LOSS		$	(3,910,124	)		$	(1,606,600	)		$	(9,478,339	)		$	(6,184,792	)
Net loss per share, basic and diluted		$	(0.20	)		$	(0.43	)		$	(0.68	)		$	(1.76	)
Weighted average number of shares, basic and diluted			19,801,841				3,746,801				13,958,507				3,500,002

CAPRICOR THERAPEUTICS, INC.
SUMMARY BALANCE SHEETS
		September 30, 2020 (unaudited)			December 31, 2019
Cash, cash equivalents and marketable securities		$	35,300,340		$	9,885,378
Total assets		$	36,187,057		$	11,113,637
Total liabilities		$	5,779,138		$	4,274,251
Total stockholders’ equity – 20,211,602 and 5,227,398 common shares issued and
outstanding at September 30, 2020 and December 31, 2019, respectively			30,407,919			6,839,386
Total liabilities and stockholders’ equity		$	36,187,057		$	11,113,637

• Refinancing reduces debt by $16.0 million and adds $12.5 million to stockholders’ equity, significantly strengthening balance sheet

• $4.0 million in cost reductions align expense structure with lower revenue environment caused by industry downturn and pandemic impact
  
   
• $1.3 million of equity raised in October to support working capital needs for heating season now underway
  
   
• 1-for-15 reverse stock split scheduled for November 20, 2020, expected to meet requirements to maintain NYSE American exchange listing
  
   
• Third quarter revenue of $1.8 million vs. $3.8 million year over year but segment profitability improves due to cost cutting measures
  
   
• Third quarter net income of $8.4 million results from $11.9 million gain on restructured debt

LONGMONT, Colo., Nov. 12, 2020 (GLOBE NEWSWIRE) — Enservco Corporation (NYSE American: ENSV), a diversified national provider of specialized well-site services to the domestic onshore conventional and unconventional oil and gas industries, today reported financial results for its third quarter and nine-month period ended September 30, 2020.

“Before addressing third quarter financial results, I want to highlight a number of important achievements we have accomplished through the first 10 months of 2020 as I believe they set the stage for an improving performance going forward,” said Rich Murphy, executive chairman.  “Early in the year, Enservco faced significant challenges around lower commodity prices and growing impact of the pandemic, burdensome debt, an oversized cost structure, the need for additional capital, and the prospect of losing our NYSE American exchange listing.  Today, I am pleased and proud to say the entire Enservco team came together to answer those challenges with actions that have better positioned the Company to take advantage of profitable growth opportunities as the energy industry recovers.  Enservco today is a leaner, more nimble organization with an expanded blue-chip customer base and a stronger balance sheet.”

Marjorie Hargrave, president and CFO, added, “During the downturn this year we have added to our customer base and optimized the location of our fleet to take advantage of any industry recovery in the near term. The Company is now entering its 2020/21 heating season – typically our most prolific period of the year in terms of revenue and profitability.  Based on customer feedback, we are anticipating an uptick in activity as the heating season progresses and we are excited about long-term prospects for growth and delivering improved shareholder value.”

Management highlighted Enservco’s year-to-date achievements as follows:

Refinancing eliminates $16.0 million in debt and adds $12.5 million to stockholders’ equity.

In September, Enservco closed a refinancing that cut its total debt by $16.0 million, increased stockholders’ equity by $12.5 million and resulted in $8.4 million in net income in the third quarter of 2020.  In return for the lender eliminating $16.0 million in debt, Enservco issued the lender eight million shares of common stock and warrants to purchase an additional 15 million shares at $0.25 per share.  The refinancing not only substantially strengthened the Company’s balance sheet, but it also improved cash flow while adding its senior secured lender as a major shareholder.  Concurrent with the bank refinancing, the investment firm Cross River Partners, which is Enservco’s largest shareholder and is managed by Enservco’s executive chairman Rich Murphy, converted $1.5 million in subordinated debt and accrued interest into Enservco restricted common stock.  The revised bank facility includes a $17.0 million term loan and a $1.0 million working capital revolving line of credit – both of which have October 15, 2021, maturity dates. The term loan is interest only with potential for principal payments in the event Enservco reaches certain profit metrics. 

Right sizing initiatives result in $4.0 million in annualized cost reductions year to date.

When lower commodity prices and the pandemic resulted in a substantial reduction in drilling and completion activity early in 2020, the oilfield services market became more competitive, which led to reduced pricing and gross margins.  Enservco responded by realigning its cost structure to fit these new realities.  The Company has cut more than $4.0 million in annualized costs out of the business, which significantly lowered Enservco’s break-even point and increased the potential to deliver positive financial results in a lower revenue environment. The cost reductions were nearly evenly distributed between costs of providing services (wages and benefits due to headcount reductions and implementation of more strategic hiring practices) and corporate level costs (mainly consolidation of physical locations, reduction of corporate staff from 17 to 9 since the first of the year, and a reduction in the size of the Company’s Board of Directors).

Annualized cost reductions (in $ millions):
Variable operating costs	$	2.57
Administrative costs		1.07
Rent reductions		.22
Utility reductions		.11
Financing costs		.24
Total reductions	$	4.21

Equity cash infusion supports increased activity in Q4/Q1 heating season.

Enservco recently raised $1.3 million in an equity offering to complement its revolving line of credit and support increased activity during the Company’s first- and fourth-quarter heating season, now underway, in which Enservco generates the majority of its annual revenue and profit.  The Company may seek to raise additional equity as the season progresses depending upon its cash needs and the magnitude of increased demand for its services.

Reverse stock split addresses NYSE American exchange continued listing requirement.

Enservco has set a 1-for-15 reverse stock split to be effective after the stock market closes on November 20, 2020.  The reverse split, which was approved by stockholders at the Company’s June 2020 Annual Meeting, is being done with the intent of increasing Enservco’s share price to a level that ensures continued listing on the NYSE American exchange.  Such continued listing is a valuable asset for Enservco and management believes the reverse split can also help attract new investors that may have been prohibited from purchasing Enservco shares due to certain restrictions on trading in lower priced stocks.

Third Quarter Results

Total revenue in the third quarter ended September 30, 2020, was $1.8 million versus $3.8 million in the same quarter last year.  The decline reflected lower commodity prices and the COVID-19 impact.

Production services revenue was $1.4 million compared to $3.3 million year over year and generated a segment profit of $16,000 compared to a segment loss of $17,000 in the third quarter a year ago.  The transition to profitability on significantly lower revenue in the third quarter illustrates the Company’s success in reducing costs. 

Completion services revenue declined to $401,000 from $510,000 year over year and generated a segment loss of $725,000 in the third quarter, a substantial improvement over the prior year segment loss of $1.2 million – again a reflection of cost reduction initiatives.

Sales, general and administrative expense declined to $1.0 million from $1.7 million year over year, reflecting additional cost-cutting measures at the corporate level involving personnel and Board size reductions and consolidation of physical locations.

Total operating expenses in the third quarter declined to $4.8 million from $8.2 million year over year due primarily to the aforementioned cost reductions as well as lower severance and transition costs, lower depreciation and amortization and reduced activity.  In total, the Company has taken more than $4.0 million in annualized costs out of the business since the first of the year.   With a much lower break-even point, the Company is positioned for improved profitability as the industry recovers and the impact of the pandemic subsides.

The Company reported net income of $8.4 million, or $0.14 per share, in the third quarter compared to a net loss of $5.4 million, or $0.10 per share, in the same quarter last year.  The transition to profitability was due to an $11.9 million gain on debt restructuring.
                                                                                                        
Adjusted EBITDA in the third quarter improved to a negative $1.7 million compared to a negative $2.7 million in the same quarter last year.

Nine Month Results

Total revenue for the nine-month period ended September 30, 2020, was $13.3 million versus $35.0 million in the same period a year ago.  The decline reflected lower commodity prices, COVID-19 impact and warmer than normal temperatures during the 2020 first quarter heating season.

Production services revenue declined to $5.9 million from $11.2 million year over year and had a
segment loss of $707,000 in the third quarter compared to a segment profit of $1.2 million in the prior year third quarter.

Completion services revenue through nine months declined to $7.3 million from $23.7 million in the same period last year and generated a segment loss of $270,000 versus a segment profit of $6.9 million year over year.

The segment losses were attributable to a 69% reduction in the Company’s higher margin frac water heating service due to a sharp decline in drilling and completion activity resulting from lower commodity prices and the pandemic.

Total operating expenses in the first nine months of 2020 were reduced to $22.5 million from $36.1 million in the same period last year due to lower costs of providing services combined with lower corporate overhead expense.  Sales, general and administrative expenses improved to $4.1 million from $4.8 million year over year. Depreciation and amortization expense decreased to $4.0 million from $4.2 million due to disposal of assets in the second quarter of 2020.

Net income for the nine-month period, which reflected impact of the third-quarter gain on debt restructuring, was $1.2 million, or $0.02 per diluted share, compared to a net loss of $4.3 million, or $0.04 per diluted share, in the same period a year ago.

Adjusted EBITDA through nine months was a negative $4.3 million versus a positive $3.7 million in the comparable prior year period.

Enservco used $2.3 million in cash from operations through nine months compared to $8.5 million net cash provided by operations in the same period in 2019.

Conference Call Information

Management will hold a conference call today to discuss these results.  The call will begin at 2:30 p.m. Mountain Time (4:30 p.m. Eastern) and will be accessible by dialing 833-492-0064 (973-528-0076 for international callers).  Entry code: 662655.  A telephonic replay will be available through November 19, 2020, by calling 877-481-4010 (919-882-2331 for international callers) and entering the Conference ID #38801. To listen to the webcast, participants should go to the Enservco website at www.enservco.com and link to the “Investors” page at least 15 minutes early to register and download any necessary audio software. A replay of the webcast will be available until December 12, 2020.  The webcast also is available at the following link: https://www.webcaster4.com/Webcast/Page/2228/38801

About Enservco

Through its various operating subsidiaries, Enservco provides a wide range of oilfield services, including hot oiling, acidizing, frac water heating and related services.  The Company has a broad geographic footprint covering seven major domestic oil and gas basins and serves customers in Colorado, Montana, New Mexico, North Dakota, Oklahoma, Pennsylvania, Ohio, Texas, Wyoming and West Virginia. Additional information is available at www.enservco.com

*Note on non-GAAP Financial Measures

This press release and the accompanying tables include a discussion of EBITDA and Adjusted EBITDA, which are non-GAAP financial measures provided as a complement to the results provided in accordance with generally accepted accounting principles (“GAAP”). The term “EBITDA” refers to a financial measure that we define as earnings (net income or loss) plus or minus net interest plus taxes, depreciation and amortization. Adjusted EBITDA excludes from EBITDA stock-based compensation and, when appropriate, other items that management does not utilize in assessing Enservco’s operating performance (as further described in the attached financial schedules). None of these non-GAAP financial measures are recognized terms under GAAP and do not purport to be an alternative to net income as an indicator of operating performance or any other GAAP measure. We have reconciled Adjusted EBITDA to GAAP net income in the Consolidated Statements of Operations table at the end of this release.  We intend to continue to provide these non-GAAP financial measures as part of our future earnings discussions and, therefore, the inclusion of these non-GAAP financial measures will provide consistency in our financial reporting.

Cautionary Note Regarding Forward-Looking Statements

This news release contains information that is “forward-looking” in that it describes events and conditions Enservco reasonably expects to occur in the future. Expectations for the future performance of Enservco are dependent upon a number of factors, and there can be no assurance that Enservco will achieve the results as contemplated herein. Certain statements contained in this release using the terms “may,” “expects to,” and other terms denoting future possibilities, are forward-looking statements. The accuracy of these statements cannot be guaranteed as they are subject to a variety of risks, which are beyond Enservco’s ability to predict, or control and which may cause actual results to differ materially from the projections or estimates contained herein. Among these risks are those set forth in Enservco’s annual report on Form 10-K for the year ended December 31, 2019, and subsequently filed documents with the SEC.  Forward looking statements in this news release that are subject to risk include the Company’s ability to comply with its bank covenants and refinance its bank debt prior to maturity; expectations for an increase in customer activity and an improved financial performance; the ability to deliver improved shareholder value; ability to raise additional capital and attract new investors; the anticipated industry recovery; and the maintenance of the Company’s stock price above exchange de-listing levels.  It is important that each person reviewing this release understand the significant risks attendant to the operations of Enservco.  Enservco disclaims any obligation to update any forward-looking statement made herein.

Contact:

Jay Pfeiffer
Pfeiffer High Investor Relations, Inc.
Phone: 303-880-9000
Email: [email protected]

Marjorie Hargrave
President and CFO
Enservco Corporation
[email protected] 

ENSERVCO CORPORATION
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(in thousands)
	For the Three Months Ended								For the Nine Months Ended
	September 30,								September 30,
		2020				2019				2020				2019
Revenues
Production services	$	1,363			$	3,288			$	5,948			$	11,239
Completion services		401				510				7,343				23,711
		1,764				3,798				13,291				34,950
Expenses
Production services		1,347				3,305				6,655				9,994
Completion services		1,126				1,710				7,613				16,829
Sales, general and administrative expenses		1,049				1,712				4,058				4,772
Patent litigation and defense costs		–				–				–				10
Severance and transition costs		–				83				139				83
Loss (gain) on disposal of assets		21				–				59				(4	)
Impairment loss		–				–				–				127
Depreciation and amortization		1,271				1,404				3,977				4,246
Total operating expenses		4,814				8,214				22,501				36,057
Loss from operations		(3,050	)			(4,416	)			(9,210	)			(1,107	)
Other income (expense)
Interest expense		(477	)			(695	)			(1,665	)			(2,235	)
Gain on restructuring of senior revolving credit facilty		11,916				–				11,916				–
Other income (expense)		29				(67	)			125				1,070
Total other income (expense)		11,468				(762	)			10,376				(1,165	)
Income (loss) from continuing operations before tax expense		8,418				(5,178	)			1,166				(2,272	)
Income tax expense		(6	)			–				(15	)			(32	)
Income (loss) from continuing operations	$	8,412			$	(5,178	)		$	1,151			$	(2,304	)
(Loss) income from discontinued operations		(7	)			(226	)			60				(2,006	)
Net income (loss)	$	8,405			$	(5,404	)		$	1,211			$	(4,310	)
Earnings (loss) from continuing operations per common share – basic	$	0.14			$	(0.09	)		$	0.02			$	(0.04	)
Loss from discontinued operations per common share – basic		–				(0.01	)			–				(0.04	)
Net income (loss) per share – basic	$	0.14			$	(0.10	)		$	0.02			$	(0.08	)
Earnings (loss) from continuing operations per common share – diltued	$	0.14			$	(0.09	)		$	0.02			$	(0.04	)
Loss from discontinued operations per common share – diltued		–				(0.01	)			–				(0.04	)
Net income (loss) per share – diltued	$	0.14			$	(0.10	)		$	0.02			$	(0.08	)
Basic weighted average number of common shares outstanding		58,649				55,457				56,514				54,925
Diluted weighted average number of common shares outstanding		58,649				55,457				56,514				54,925

ENSERVCO CORPORATION AND SUBSIDIARIES
Calculation of Adjusted EBITDA *
	For the Three Months Ended								For the Nine Months Ended
	September 30,								September 30,
		2020				2019				2020				2019
EBITDA*
Net income (loss)	$	8,405			$	(5,404	)		$	1,211			$	(4,310	)
Add back
Interest expense		478				695				1,667				2,235
Provision for income tax expense		6				–				15				32
Depreciation and amortization (including discontinued operations)		1,277				1,703				3,996				5,122
EBITDA*		10,166				(3,006	)			6,889				3,079
Add Back (Deduct)
Stock-based compensation		16				52				377				221
Severance and transition costs		–				83				139				83
Patent litigation and defense costs		–				–				–				10
Loss (gain) on disposal of equipment (including discontinued operations)		20				(14	)			(34	)			(2	)
Gain on debt restructuring		(11,916	)			–				(11,916	)			–
Impairment loss		–				–				–				127
One-time software expense		–				–				–				25
Other expense (income) (including discontinued operations)		1				223				282				(944	)
EBITDA related to discontinued operations		–				(59	)			11				1,133
Adjusted EBITDA*	$	(1,713	)		$	(2,721	)		$	(4,252	)		$	3,732
*Note: See below for discussion of the use of non-GAAP financial measurements.
Use of Non-GAAP Financial Measures: Non-GAAP results are presented only as a supplement to the financial statements and for use within management’s discussion and analysis based on U.S. generally accepted accounting principles (GAAP). The non-GAAP financial information is provided to enhance the reader’s understanding of the Company’s financial performance, but no non-GAAP measure should be considered in isolation or as a substitute for financial measures calculated in accordance with GAAP. Reconciliations of the most directly comparable GAAP measures to non-GAAP measures are provided herein.
EBITDA is defined as net (loss) income (earnings), before interest expense, income taxes, and depreciation and amortization. Adjusted EBITDA excludes stock-based compensation from EBITDA and, when appropriate, other items that management does not utilize in assessing the Company’s ongoing operating performance as set forth in the next paragraph. None of these non-GAAP financial measures are recognized terms under GAAP and do not purport to be an alternative to net income as an indicator of operating performance or any other GAAP measure.
All of the items included in the reconciliation from net income to EBITDA and from EBITDA to Adjusted EBITDA are either (i) non-cash items (e.g., depreciation, amortization of purchased intangibles, stock-based compensation, impairment losses, etc.) or (ii) items that management does not consider to be useful in assessing the Company’s ongoing operating performance (e.g., income taxes,  gain or losses on sale of equipment, severance and transition costs, gain on settlement, expenses to consolidate former Adler facilities, patent litigation and defense costs, other expense (income), EBITDA related to discontinued operations, etc.). In the case of the non-cash items, management believes that investors can better assess the company’s operating performance if the measures are presented without such items because, unlike cash expenses, these adjustments do not affect the Company’s ability to generate free cash flow or invest in its business.
We use, and we believe investors benefit from the presentation of, EBITDA and Adjusted EBITDA in evaluating our operating performance because it provides us and our investors with an additional tool to compare our operating performance on a consistent basis by removing the impact of certain items that management believes do not directly reflect our core operations. We believe that EBITDA is useful to investors and other external users of our financial statements in evaluating our operating performance because EBITDA is widely used by investors to measure a company’s operating performance without regard to items such as interest expense, taxes, and depreciation and amortization, which can vary substantially from company to company depending upon accounting methods and book value of assets, capital structure and the method by which assets were acquired. Additionally, our fixed charge coverage ratio covenant associated with our Loan and Security Agreement with East West Bank require the use of Adjusted EBITDA in specific calculations.
Because not all companies use identical calculations, the Company’s presentation of non-GAAP financial measures may not be comparable to other similarly titled measures of other companies. However, these measures can still be useful in evaluating the Company’s performance against its peer companies because management believes the measures provide users with valuable insight into key components of GAAP financial disclosures.

ENSERVCO CORPORATION
Condensed Consolidated Balance Sheets
(In thousands)
	September 30,				December 31,
ASSETS		2020				2019
Current Assets
Cash and cash equivalents	$	–			$	663
Accounts receivable, net		1,012				6,424
Prepaid expenses and other current assets		1,609				1,016
Inventories		310				398
Income tax receivable, current		57				43
Current assets of discontinued operations		–				187
Total current assets		2,988				8,731
Property and equipment, net		22,590				26,620
Goodwill		546				546
Intangible assets, net		672				828
Income taxes receivable, noncurrent		–				14
Right-of-use asset – financing, net		148				569
Right-of-use asset – operating, net		3,124				3,793
Other assets		349				445
Non-current assets of discontinued operations		809				1,430
TOTAL ASSETS	$	31,226			$	42,976
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current Liabilities
Accounts payable and accrued liabilities	$	2,540			$	4,470
Senior revolving credit facility, related party (including future interest payable of $950 and $0, respectively)		950				33,994
Subordinated debt, related party		–				2,381
Lease liability – financing, current		64				207
Lease liability – operating, current		836				848
Current portion of long-term debt		110				147
Current liabilities of discontinued operations		31				72
Total current liabilities		4,531				42,119
Long-Term Liabilities
Senior revolving credit facility, related party (including future interest payable of $822 and $0, respectively)		17,931				–
Subordinated debt, related party		1,168
Long-term debt, less current portion		2,066				198
Lease liability – Financing		72				259
Lease liability – Operating		2,406				3,009
Other liability		33				33
Long-term liability of discontinued operations		15				34
Total long-term liabilities		23,691				3,533
Total liabilities		28,222				45,652
Commitments and Contingencies
Stockholders’ Equity (Deficit)
Preferred stock, $.005 par value, 10,000,000 shares authorized, no shares issued or outstanding		–				–
Common stock. $.005 par value, 100,000,000 shares authorized, 70,088,783 and 55,642,829 shares issued, respectively; 103,600 shares of treasury stock; and 69,985,183 and 55,539,229 shares outstanding, respectively		352				278
Additional paid-in capital		26,461				22,066
Accumulated deficit		(23,809	)			(25,020	)
Total stockholders’ equity (deficit)		3,004				(2,676	)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)	$	31,226			$	42,976

ENSERVCO CORPORATION
CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED)
	For the Nine Months Ended
	September 30,
		2020				2019
OPERATING ACTIVITIES
Net income (loss)	$	1,211			$	(4,310	)
Net income (loss) from discontinued operations		60				(2,006	)
Net income (loss) from continuing operations		1,151				(2,304	)
Adjustments to reconcile net (loss) income to net cash
used in operating activities
Depreciation and amortization		3,977				4,245
Loss (gain) loss on disposal of equipment		59				(4	)
Gain on Adler settlement		–				(1,252	)
Impairment loss		–				127
Stock-based compensation		377				221
Amortization of debt issuance costs and discount		119				273
Gain on restructuring of senior revolving credit facility		(11,916	)			–
Lease termination expense		–				62
Provision for bad debt expense		362				171
Changes in operating assets and liabilities
Accounts receivable		5,048				7,213
Inventories		88				176
Prepaid expense and other current assets		(593	)			281
Income taxes receivable		(14	)			–
Amortization of operating lease assets		635				599
Other assets		363				239
Accounts payable and accrued liabilities		(1,469	)			(342	)
Operating lease liabilities		(615	)			(546	)
Other liabilities		–				104
Net cash (used in) provided by operating activities – continuing operations		(2,428	)			9,263
Net cash provided by (used in) operating activities – discontinued operations		133				(775	)
Net cash (used in) provided by operating activities		(2,295	)			8,488
INVESTING ACTIVITIES
Purchases of property and equipment		(344	)			(859	)
Proceeds from insurance claims		294				27
Proceeds from disposal of equipment		341				219
Net cash provided by (used in) investing activities – continuing operations		291				(613	)
Net cash provided by investing activities – discontinued operations		675				413
Net cash provided by (used in) investing activities		966				(200	)
FINANCING ACTIVITIES
Gross proceeds from stock issuance		205				–
Stock issuance costs and registration fees		(165	)			–
Net line of credit payments		(855	)			(4,474	)
Proceeds from PPP loan		1,940				–
Repayment of long-term debt		(109	)			(92	)
Payments of finance leases		(350	)			(279	)
Repayment of note		–				(3,700	)
Other financing activities		–				(1	)
Net cash provided by (used in) financing activities – continuing operations		666				(8,546	)
Net cash provided by financing activities – discontinued operations		–				1
Net cash provided by (used in) financing activities		666				(8,545	)
Net Decrease in Cash and Cash Equivalents		(663	)			(257	)
Cash and Cash Equivalents, beginning of period		663				257
Cash and Cash Equivalents, end of period	$	–			$	–
Supplemental Cash Flow Information:
Cash paid for interest	$	1,415			$	1,794
Cash paid for taxes		2				32
Supplemental Disclosure of Non-cash Investing and Financing Activities:
Non-cash reduction of debt in connection with restructuring of senior revolving credit facility	$	16,000			$	–
Non-cash issuance of common stock and warrants in connection with restructuring of senior revolving credit facility		2,532				–
Non-cash conversion of subordinated debt and accrued interest to common stock		1,515				–
Non-cash conversion of accrued interest to senior revolving credit facility		219				–
Non-cash proceeds from revolving credit facilities		–				125

EDINBURGH, United Kingdom, Nov. 12, 2020 (GLOBE NEWSWIRE) — NuCana plc (NASDAQ: NCNA) announced today that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Jefferies Virtual London Healthcare Conference.

Event: Jefferies Virtual London Healthcare Conference
Presentation Date: Wednesday, November 18, 2020
Presentation Time: 11:45 AM GMT

The presentation will be webcast live and available for replay under “Events & Presentations” in the Investors section of the Company’s website at www.nucana.com.

About NuCana plc

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. NuCana’s robust pipeline includes three ProTides in clinical development. Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is currently being evaluated in four clinical studies, including a Phase III study for patients with biliary tract cancer, a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with platinum-resistant ovarian cancer and a Phase III study for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is currently in a Phase I study for the potential treatment of a wide range of advanced solid tumors and a Phase Ib study for patients with metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3’-deoxyadenosine) and is in a Phase I study for patients with advanced solid tumors.

Forward-Looking Statements

This press release may contain “forward‐looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NuCana plc (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning the Company’s planned and ongoing clinical studies for the Company’s product candidates and the
potential advantages of those product candidates, including Acelarin, NUC-3373 and NUC-7738; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies;
the impact of COVID-19 on its preclinical studies, clinical
studies
, business, financial condition and results of operations
;
the Company’s goals with respect to the development and potential use, if approved, of each of its product candidates;
and the utility of prior non-clinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of
the Company’s Annual Report on Form 20-F for the year ended December 31,
2019 filed with the Securities and Exchange Commission (“SEC”) on March 10, 2020, and subsequent repo
rts that the Company files with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward‐looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or
to changes in its expectations.

For more information, please contact:

Hugh S. Griffith
Chief Executive Officer
NuCana plc
Tel: +44 131 357 1111
[email protected]

Westwicke, an ICR Company
Chris Brinzey
Tel: +1 339-970-2843
[email protected]

RooneyPartners
Marion Janic
Tel: +1 212-223-4017
[email protected]

Enrollment
in Phase 1
for Oral COVID-19 Vaccine
Trial
Completed

Significant
viral load reduction and
strong
antibody responses in COVID-19 hamster challenge model

Restarting the Norovirus program

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced financial results for the third quarter of 2020 and provided a corporate update, including updates on its oral COVID-19 vaccine pre-clinical studies and clinical trials.

“To defeat the COVID-19 epidemic, we need not only effective vaccines, but effective vaccines that are easy to administer, store, and distribute. We need a practical global solution,” said Andrei Floroiu, chief executive officer of Vaxart. “The strong pre-clinical data we generated and the clinical progress we have made strengthen our belief that our oral tablet COVID-19 vaccine will emerge as a global solution against the COVID-19 pandemic.”

VXA-CoV2-1 is a single-dose COVID-19 tablet vaccine candidate that we believe can be conveniently distributed and administered without the need for cold-chain storage and distribution.

Unlike injectable vaccines, animal data indicate that VXA-CoV2-1 activates both systemic and mucosal immunity, a broader immune response that has the potential to offer superior protection against SARS-CoV-2. By leveraging over a decade’s worth of work building Vaxart’s platform technology, VXA-CoV2-1 is under investigation to assess its ability to provide durable immunity following a single dose with favorable tolerability.

Recent Business Highlights:

Pre-Clinical and Clinical Developments:

• Completed enrollment in the Company’s Phase 1 study of VXA-CoV2-1, its oral tablet COVID-19 vaccine candidate.
• Reported COVID-19 Hamster Challenge Study data showing protection against COVID-19 in hamsters receiving two oral doses of Vaxart’s oral vaccine. Animals were protected against systemic weight loss, lung weight gain, showed a 4-5 log reduction in lung viral load, and developed IgG titers above 10,000. Both oral and intranasal delivery of VXA-CoV2-1 (rAd-S-N) conferred similar protection against intranasal viral challenge on all these metrics.
• Posted Preclinical studies of a recombinant adenoviral mucosal vaccine to prevent SARS-CoV-2 infection to Biorxiv, which noted immunization with the vaccine candidate induced strong IgA response in the lungs of animals, indicative of a mucosal immune response.
• Restarted its Norovirus vaccine program with a booster study in subjects that were primed in the previously conducted Phase 1b Norovirus trial.

Manufacturing:

• Expanded collaboration with Kindred Biosciences for the manufacturing of our COVID-19 oral vaccine. Kindred’s California plant will be responsible for scaling the COVID-19 clinical trial material into mid-size bioreactors and the Kansas plant will be responsible for manufacturing at 2000L scale in its single use bioreactors.
• Entered into a master services agreement with Attwill Vascular Technologies, LP for processing, lyophilizing, and tableting compounds for the Company’s oral COVID-19 vaccine.

Corporate Developments:

Addition to the Board of Directors: In August, Vaxart appointed Karen J. Wilson to its Board of Directors. Ms. Wilson is a biopharmaceutical finance executive and board member with more than 30 years of industry and leadership experience in life sciences companies with relevant knowledge in finance, strategy, and risk management. She is a certified public accountant and holds a bachelor’s degree in business from the University of California, Berkeley.

Financial Results for the
Fiscal Period
Ended
September
30, 2020

• Vaxart reported a net loss of $8.1 million for the third quarter of 2020 compared to $5.3 million for the third quarter of 2019. The increase was mainly due to an increase in operating expenses. Net loss per share for the third quarter was $0.08 in 2020 compared to $0.32 in 2019, in part due to an increase in the number of shares outstanding.
• Vaxart ended the quarter with cash and cash equivalents of $133.4 million compared to $44.4 million as of June 30, 2020. The increase was primarily due to net proceeds of $97.0 million for the issuance of common stock, partially offset by $9.3 million of cash used in operations.
• Revenue for the third quarter was $265,000 compared to $454,000 in the third quarter of 2019. The decrease was principally due to a reduction in revenue from our contract with Janssen, for which activities were mostly completed between July 2019 and June 2020.
• Research and development expenses were $4.6 million for the third quarter compared to $3.7 million for the third quarter of 2019. The increase was mainly due to manufacturing expenses related to the COVID-19 vaccine candidate and higher stock-based compensation costs, partially offset by reductions in the cost of clinical trials for our norovirus vaccine candidate and in personnel costs after we ceased internal manufacturing as part of our December 2019 restructuring.
• General and administrative expenses were $4.2 million for the third quarter compared to $1.5 million for the third quarter of 2019. The increase was mainly due to higher legal fees and an increase in headcount, with higher stock-based compensation costs.

About Vaxart

Vaxart is a clinical-stage biotechnology company focused on developing oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and have the potential to provide sterilizing immunity for diseases such as COVID-19. Vaxart believes that a room temperature stable tablet is easier to distribute, store and administer than injectable vaccines and may provide a significantly faster response to a pandemic than injectable vaccines, enabling a greater portion of the population to be protected. Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, please visit www.vaxart.com.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from pre-clinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates, and preclinical and clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations relating to Vaxart’s relationship with Emergent, KindredBio and AMS including their ability to produce bulk cGMP vaccines and the timing thereof; and Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and SARS-CoV-2. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Operation Warp Speed may not result in a positive financial impact on Vaxart’s financial results that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to resolve pending legal matters; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Contacts

Investor Relations David R. Holmes LifeSci Advisors, LLC Tel: (646) 970-4995 [email protected]	Media Relations Gloria Gasaatura LifeSci Communications Tel: (646) 970-4688 [email protected]

V
axart, Inc.

Condensed Consolidated Balance Sheets

		September 30, 2020			December 31, 2019
		(Unaudited)			(1 )
		(in thousands)
Assets
Cash and cash equivalents		$	133,438		$	13,526
Accounts receivable			250			3,619
Prepaid and other assets			1,975			594
Property and equipment, net			662			210
Right-of-use assets, net			2,591			1,990
Intangible assets, net			15,794			17,093
Total assets		$	154,710		$	37,032
Liabilities and stockholders’ equity
Accounts payable		$	1,871		$	852
Accrued and other liabilities			3,724			4,583
Liability related to sale of future royalties			14,706			16,332
Operating lease liabilities			2,731			2,313
Total liabilities			23,032			24,080
Stockholders’ equity			131,678			12,952
Total liabilities and stockholders’ equity		$	154,710		$	37,032

(1) Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2019, included on the Form 10-K filed with the Securities and Exchange Commission on March 19, 2020.

Vaxart, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

		Three Months Ended September 30,									Nine  Months Ended September 30,
		2020				2019					2020				2019
		(in thousands, except share and per share amounts)
Revenue		$	265			$	454				$	3,690			$	5,946
Operating expenses:
Research and development			4,616				3,713					11,272				11,249
General and administrative			4,190				1,455					10,076				4,856
Restructuring costs			(952	)			—					(849	)			—
Total operating expenses			7,854				5,168					20,499				16,105
Loss from operations			(7,589	)			(4,714	)				(16,809	)			(10,159	)
Other income and (expenses), net			(470	)			(515	)				(1,345	)			(1,783	)
Provision for income taxes			(26	)			(31	)				(205	)			(294	)
Net loss		$	(8,085	)		$	(5,260	)			$	(18,359	)		$	(12,236	)
Net loss per share, basic and diluted		$	(0.08	)		$	(0.32	)			$	(0.23	)		$	(0.96	)
Shares used in computing net loss per share, basic and diluted			107,718,578				16,249,032					81,121,045				12,748,665

BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that the Company will present at the 2020 Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 11:25 a.m. ET or 4:25 p.m. GMT.

To access the live webcast of Paratek’s presentation, please visit https://wsw.com/webcast/jeff141/paratek/2291400.

Please connect to the web site at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast can be accessed for up to 90 days following the live presentation.

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

The Company’s lead commercial product, NUZYRA^® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA^® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

In 2019, Paratek was awarded a five-year contract from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $285 million, with an option to extend to ten years, to support the development of NUZYRA for the treatment of pulmonary anthrax, FDA post-marketing requirements (PMR) associated with the initial NUZYRA approval, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

Forward Looking Statements 
This press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.  All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “advancing,” “expect,” “look forward,” “anticipate,” “continue,” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties.  We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements.  Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties.  These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 and our other filings with the Securities and Exchange Commission.  We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

CONTACT:

Investor and Media Relations:

Ben Strain

617-807-6688

[email protected]

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced its participation in the following upcoming investor conferences:

• Stifel Healthcare Virtual Conference
   on Tuesday, November 17, 2020 from 4:00-4:30PM ET
• Jefferies Global Healthcare Virtual Conference on Thursday, November 19, 2020 from 9:05-9:35AM ET
• Evercore ISI HealthCONx Virtual Conference on Tuesday, December 1, 2020 from 3:30-3:50PM ET

A live webcast, if recorded, of each presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following each live webcast, an archived replay will be available on the Company’s website for 30 days.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company’s immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Contact:

Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
[email protected]