Market Newsdesk

LATHAM, N.Y., Nov. 16, 2020 (GLOBE NEWSWIRE) — Plug Power Inc. (“Plug Power”) (NASDAQ: PLUG), a leader in providing clean, reliable energy solutions, today announced that it is commencing a registered public offering of $750,000,000 of its common stock. In connection with the offering, Plug Power intends to grant the underwriter a 30-day option to purchase up to $112,500,000 of additional shares of common stock.

Morgan Stanley is acting as sole underwriter in connection with the offering, and may offer the shares of common stock from time to time to purchasers directly or through agents, or through brokers in brokerage transactions on the Nasdaq Capital Market, or to dealers in negotiated transactions or in a combination of such methods of sale, at a fixed price or prices, which may be changed, or at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices.

Plug Power intends to use the net proceeds from the offering for working capital and other general corporate purposes, which may include capital expenditures, potential acquisitions, growth opportunities and strategic transactions.

The securities described are being offered by Plug Power pursuant to an automatic shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC. A preliminary prospectus supplement related to the offering will be filed with the SEC. Before you invest, you should read the preliminary prospectus supplement and the accompanying prospectus in that registration statement and other documents filed with the SEC for more information about Plug Power and this offering. You may obtain these documents free of charge by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and the accompanying prospectus relating to the securities being offered may also be obtained from Morgan Stanley at Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014.

This press release does not and shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Plug Power’s common stock, nor shall there be any offer, solicitation or sale of such shares, in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Plug Power

Plug Power is building the hydrogen economy as the leading provider of comprehensive hydrogen fuel cell (HFC) turnkey solutions. The company’s innovative technology powers electric motors with hydrogen fuel cells amid an ongoing paradigm shift in the power, energy, and transportation industries to address climate change and energy security, while providing efficiency gains and meeting sustainability goals.

Plug Power created the first commercially viable market for HFC technology. As a result, the company has deployed over 38,000 fuel cell systems for e-mobility, more than anyone else in the world, and has become the largest buyer of liquid hydrogen, having built and operated a hydrogen highway across North America. Plug Power delivers a significant value proposition to end-customers, including meaningful environmental benefits, efficiency gains, fast fueling, and lower operational costs.

Plug Power’s vertically-integrated GenKey solution ties together all critical elements to power, fuel, and provide service to customers such as Amazon, BMW, The Southern Company, Carrefour, and Walmart. The company is now leveraging its know-how, modular product architecture and foundational customers to rapidly expand into other key markets including zero-emission on-road vehicles, robotics, and data centers.

Cautionary Language Concerning Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding the offering and the anticipated use of the net proceeds from the offering, are forward-looking statements. These forward-looking statements are made as of the date they were first issued and are based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Plug Power’s control. Plug Power’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including, but not limited to, the risks related to the offering of the shares, market risks and uncertainties and the impact of any natural disasters or public health emergencies, such as the COVID-19 pandemic. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed in Plug Power’s filings and reports with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2019, as amended and supplemented by the Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, as well as other filings and reports that are filed by Plug Power from time to time with the SEC. Plug Power anticipates that subsequent events and developments will cause its views to change and you should consider these factors in evaluating the forward-looking statements and not place undue reliance on such statements. Plug Power undertakes no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Plug Power’s views as of any date subsequent to the date of this press release.

Media Contact

Ian Martorana
The Bulleit Group
‪(415) 237-3681‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
[email protected]

– Cash balance of $370.7 million as of September 30, 2020 bolstered by July IPO –
– Recently expanded ANX005 clinical program into neurodegeneration, with initiation of Phase 2 in Huntington’s Disease –
– Fully enrolled Phase 1b DDI trial in Guillain-Barré Syndrome –

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the brain, body and eye, today announced third quarter 2020 financial results and recent business highlights.

“We continue to make strong progress across our classical complement platform, including expanded development of ANX005 in Huntington’s Disease, and advancement of our subcutaneous formulation, ANX009, into the clinic,” said Douglas Love, Esq., president and chief executive officer of Annexon. “Our unique focus on C1q allows us to address a diverse set of classical complement-mediated autoimmune and neurodegenerative diseases, and we’re well capitalized to conduct several promising near- and mid-term Phase 2 clinical trials in these devastating diseases.”

Program
Highlights

• Initiated Phase
  2 trial evaluating ANX005 in Huntington’s Disease (HD)
  .  Initiated patient dosing in a Phase 2 trial designed to assess safety, tolerability, and biomarkers of target engagement and impact on neurodegeneration
• Initiated Phase 1 first-in-human trial of ANX009. Initiated subcutaneous dosing of healthy volunteers with Annexon’s third clinical-stage drug candidate in a Phase 1 trial designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses
• Completed enrollment of Guillain-Barré Syndrome (GBS) Drug-Drug Interaction (DDI) trial. Fully enrolled global Phase 1b DDI trial assessing safety and potential pharmacokinetic effect of ANX005 co-administered with IVIg in GBS patients. Data are anticipated in early 2021

Anticipated Upcoming Milestones

• ANX005, a clinical-stage investigational monoclonal antibody intended to treat patients with complement-mediated disorders
  — Phase 2 trial in patients with HD is ongoing with initial data anticipated in 2H 2021
  — Phase 2/3 trial in patients with GBS is planned to initiate in early 2021 with data anticipated in 2023
  — Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS) is planned to initiate in early 2021 with initial data anticipated in 2H 2021
  — Phase 2 trial in patients with warm autoimmune hemolytic anemia (wAIHA) is planned to initiate in early 2021 with initial data anticipated in 1H 2022
• ANX007, a clinical-stage investigational monoclonal antibody Fab for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases
  — Phase 2 trial in patients with geographic atrophy (GA) is planned to initiate in early 2021 with data anticipated in 2023 
• ANX009, a clinical-stage investigational, subcutaneous formulation of an antigen-binding fragment (Fab) intended to treat systemic antibody-mediated autoimmune diseases 
  — Phase 1 first-in-human trial is ongoing with data anticipated in 1H 2021 

Third Quarter 2020 Financial Results

• Cash and cash equivalents:  Cash and cash equivalents were $370.7 million as of September 30, 2020 compared to $43.9 million as of December 31, 2019. In July 2020, Annexon completed an upsized IPO of 14,750,000 shares of its common stock, including the exercise of the underwriters’ option to purchase an additional 2,139,403 shares of common stock, resulting in net proceeds of $262.4 million, after deducting underwriting commissions and offering expenses
• Research and development (R&D) expenses: R&D expenses were $11.8 million for the quarter ended September 30, 2020 compared to $7.1 million for the quarter ended September 30, 2019
• General and administrative (G&A) expenses:  G&A expenses were $3.8 million for the quarter ended September 30, 2020 compared to $2.0 million for the quarter ended September 30, 2019
• Net loss:  Net loss was $15.6 million for the quarter ended September 30, 2020 compared to $10.2 million for the quarter ended September 30, 2019. Net loss attributable to common stockholders was $22.0 million or $0.77 per share for the quarter ended September 30, 2020 compared to $10.5 million or $24.14 per share for the quarter ended September 30, 2019

About Annexon, Inc.
Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the brain, body and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended tissue compartments. For more information, visit www.annexonbio.com.

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. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: advancement of the company’s clinical and preclinical programs; the company’s capital position and ability to conduct promising near- and mid-term Phase 2 clinical trials; timing and commencement of future nonclinical studies and clinical trials and research and development programs; and the implementation of the company’s business model and strategic plans for its business and product candidates, including additional indications which the company may pursue. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of COVID-19 or other public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (SEC) on November 16, 2020 pursuant to Rule 424(b) under the Securities Act and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

ANNEXON, INC.

Condensed Consolidated S
tatements of Operations

(in thousands, except share and per share amounts)

(Unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Operating expenses:
Research and development (1)		$	11,775			$	7,089			$	31,279			$	17,729
General and administrative (1)			3,810				1,981				8,999				5,660
Total operating expenses			15,585				9,070				40,278				23,389
Loss from operations			(15,585	)			(9,070	)			(40,278	)			(23,389	)
Loss on remeasurement of redeemable convertible preferred stock liability			—				(1,340	)			—				(5,670	)
Other (expense) income, net			(52	)			224				64				821
Net loss before taxes			(15,637	)			(10,186	)			(40,214	)			(28,238	)
Provision for income taxes			1				2				5				3
Net loss			(15,638	)			(10,188	)			(40,219	)			(28,241	)
Accretion on redeemable convertible preferred stock			(145	)			(281	)			(705	)			(815	)
Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock			(6,219	)			—				(6,219	)			—
Net loss attributable to common stockholders		$	(22,002	)		$	(10,469	)		$	(47,143	)		$	(29,056	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.77	)		$	(24.14	)		$	(4.79	)		$	(67.04	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted			28,465,156				433,749				9,845,754				433,406
(1) Includes the following stock-based compensation expense:
Research and development			624				159				1,284				391
General and administrative			847				451				1,613				1,122

ANNEXON, INC.

Condensed Consolida
ted Balance Sheets

(in thousands)

(Unaudited)

		September 30, 2020				December 31, 2019
Assets
Current assets:
Cash and cash equivalents		$	370,686			$	43,931
Prepaid expenses and other current assets			2,889				1,475
Total current assets			373,575				45,406
Property and equipment, net			2,039				2,138
Other long-term assets			—				2,354
Total assets		$	375,614			$	49,898
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity  (Deficit)
Current liabilities:
Accounts payable		$	3,954			$	2,371
Accrued liabilities			4,649				2,194
Deferred rent, current			385				366
Total current liabilities			8,988				4,931
Deferred rent			1,147				1,437
Total liabilities			10,135				6,368
Redeemable convertible preferred stock			—				143,984
Stockholders’ Equity (Deficit):
Preferred stock			—				—
Common stock			38				4
Additional paid-in capital			508,318				2,202
Accumulated other comprehensive loss			(78	)			(80	)
Accumulated deficit			(142,799	)			(102,580	)
Total stockholders’ equity (deficit)			365,479				(100,454	)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)		$	375,614			$	49,898

Investor Contact:
Sylvia Wheeler
[email protected]

Alexandra Santos
[email protected]

Media Contact:
Caroline Rufo, Ph.D.
[email protected]

SAN JOSE, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, today announced that Professor Jianhua Shao has been appointed as an independent director and a member of the compensation committee, effective November 12, 2020. Professor Shao will succeed to Mr. Jiefeng Gu, who resigned as a director of the Company and as a member of the compensation committee for personal reasons effective on November 12, 2020.

Professor Jianhua Shao has served as a professor of biophysics at Shanghai University of Traditional Chinese Medicine (the “SHUTCM”) since 2012. Before that he successively served as an associate professor from 2003 to 2012 and a lecturer from 1987 to 1992 at SHUTCM. Professor Shao currently serves as the director of the Office of Mathematics and Sciences Teaching and Research at SHUTCM. He is also a member of the council of the Society of Chinese Medical Mathematics and the chief of the Committee of the Society of Chinese Biomedical Engineering (Traditional Chinese Medicine Physics and Engineering). Mr. Shao also serves as the general manager of the project department of SHUTCM Asset Management Company Limited and a director of Shanghai Mingxu Health Management Consulting Co., Ltd. He served as the general manager of Shanghai Traditional Chinese Medicine Technology Co., Ltd. from 2006 to September 2020. Professor Shao has done research and published in the field of biophysics relating to blood vessels, blood fluid dynamics, and the heart. Professor Shao received his bachelor’s degree in physics from Shanghai Normal University in 1982 and his master’s degree in science from the University of the Ryukyus in Japan in 1998.

“I welcome Professor Shao to join the board of directors. His strong academic background and deep medical knowledge will benefit the Company over the long term as we work towards the next phase of our development,” said Dr. Chris Yu, the CEO and Chairman of the board of directors of AnPac Bio. “Also, on behalf of our management team and board of directors, I would like to thank Mr. Gu for his contributions to the Company and I am grateful for all he has done for AnPac Bio during the time he served as our director.”

“AnPac Bio has been recognized in the field of early cancer screening and detection, and I’m excited to be a part of this fantastic organization. I look forward to joining the board and contributing to AnPac Bio’s future success as the Company progresses to the next phase of its strategy,” said Professor Shao, the new independent director and member of the compensation committee of AnPac Bio.

About
AnPac
Bio

AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 128 issued patents as of June 30, 2020. With two certified clinical laboratories in China and one CLIA and CAP accredited clinical laboratory in the United States, AnPac Bio performs a suite of cancer screening and detection tests, including CDA (Cancer Differentiation Analysis), bio-chemical, immunological, and genomics tests. According to Frost & Sullivan, AnPac Bio ranked third worldwide and first in China among companies offering next-generation early cancer screening and detection technologies in terms of the number of clinical samples for cancer screening and detection, based on approximately 41,700 clinical samples as at May 2020. AnPac Bio’s CDA technology platform has been shown in retrospective validation studies to be able to detect the risk of over 20 different cancer types with high sensitivity and specificity.

For more information, please visit: https://www.Anpacbio.com.

For investor and media inquiries, please contact:

Company:

Phil Case, Marketing and Investor Relations
Phone: +1-267-810-6776 (US)
Email: [email protected]

Investor
Relations:

Ascent Investor Relations LLC
Tina Xiao, President
Phone: +1-917-609-0333 (US)
Email: [email protected]   

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. The Company has attempted to identify forward-looking statements by terminologies including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “target,” “aim,” “predict,” “outlook,” “seek,” “goal” “objective,” “assume,” “contemplate,” “continue,” “positioned,” “forecast,” “likely,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the implementation of our business model and growth strategies; trends and competition in the cancer screening and detection market; our expectations regarding demand for and market acceptance of our cancer screening and detection tests and our ability to expand our customer base; our ability to obtain and maintain intellectual property protections for our CDA technology and our continued research and development to keep pace with technology developments; our ability to obtain and maintain regulatory approvals from the NMPA, the FDA and the relevant U.S. states and have our laboratories certified or accredited by authorities including the CLIA; our future business development, financial condition and results of operations and our ability to obtain financing cost-effectively; potential changes of government regulations; general economic and business conditions in China and elsewhere; our ability to hire and maintain key personnel; our relationship with our major business partners and customers; and the duration of the coronavirus outbreaks and their potential adverse impact on the economic conditions and financial markets and our business and financial performance, such as resulting from reduced commercial activities due to quarantines and travel restrictions instituted by China, the U.S. and many other countries around the world to contain the spread of the virus. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

MENLO PARK, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today reported its financial results for the third quarter ended September 30, 2020.

“We are pleased to announce that half of the planned subjects have completed dosing in our Phase 1b study evaluating CB4211 as potential treatments for NASH and obesity,” said Steven Engle, CohBar’s Chief Executive Officer. “We currently expect top line data from the study in the second quarter of 2021, subject to the potential impact of COVID-19. Our preclinical programs are also progressing, with recent data for a CB5138 Analog in combination with the standard of care suggesting additional potential for improved treatments of Idiopathic Pulmonary Fibrosis. Our goal is to identify a clinical candidate for our IPF program early in the first quarter of 2021, subject to successful completion of the remaining required studies. In our CB5064 program for potential use in COVID-19/ARDS, we generated positive preliminary results in a preclinical model of Acute Respiratory Distress Syndrome.”

“In order to finance these exciting programs, we raised $15 million during the quarter to advance our expanded R&D pipeline, added biotech focused institutional investors, and gained additional research analyst coverage,” Mr. Engle continued. “We also expanded awareness and increased investor engagement by presenting at eight industry and healthcare bank conferences, and meeting with family offices and high net worth investors. Going forward, we are continuing to execute on our vision to treat multiple chronic diseases and extend healthy lifespan.”

Third
Quarter 20
20
and Recent
Highlights

• Completed dosing in half of the planned subjects
  in
  the Phase 1b stage of the
  c
  linical
  s
  tudy
  of CB4211
  for NASH and Obesity
  : The ongoing study evaluates CB4211 in subjects with non-alcoholic fatty liver disease (NAFLD) and obesity with at least 10% liver fat. In August, the company announced the first subject had been dosed. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.
• 
  Showed that the combination of a CB5138 Analog antifibrotic peptide and nintedanib produced enhanced effects: In October, the company announced new preclinical data demonstrating that a CB5138 Analog has enhanced effects when combined with nintedanib, the leading treatment for Idiopathic Pulmonary Fibrosis (IPF), suggesting potential utility for combination therapy in IPF. The new data from the therapeutic mouse model of IPF showed that treatment with the combination of CB5138-2 and nintedanib produced greater reductions in fibrosis, inflammation, pro-inflammatory cytokine levels, and collagen deposition compared to either treatment alone. IPF is a chronic, progressive, debilitating, and usually fatal interstitial lung disease that affects approximately 187,000 people worldwide.
• Presented
  a
  ntifibrotic
  r
  esults
  at
  the
  American Thoracic Society
  :
   In August, the company presented new pre-clinical efficacy results in a poster presentation at the American Thoracic Society 2020 International Conference. Antifibrotic and anti-inflammatory effects were demonstrated for MBT2 (CB5138-1) in vitro in human cells and in vivo in prophylactic and therapeutic preclinical models of IPF.

• Generated preliminary efficacy
  in preclinical study of apelin agonists in
  COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and ARDS
  : In August, the company announced preliminary results in an evaluation of its CB5064 Analogs in an ARDS model. These positive results included reduced levels of fluid accumulation, neutrophil infiltration, and cytokine secretion. These are key processes underlying the lethal consequences of severe ARDS and COVID-19 associated ARDS. The company expects the apelin agonists to have potential to treat ARDS patients in general, of which there are approximately three million globally.  CohBar previously presented data at the 2019 ADA Conference showing the activity of its CB5064 Analogs on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of type 2 diabetes.
• Raised $15M in new capital and added biotech focused institutional investors: In August, the company completed a public offering to support its clinical and preclinical programs. The company received aggregate gross proceeds of approximately $15 million before commissions and other estimated offering expenses. The company issued 12.3M units at a price of $1.22 per unit. Each unit consists of one share of the company’s common stock and one warrant to purchase 0.75 of a share of common stock at a per share exercise price of $1.44.
• Gained
  additional
  bank
  research
  c
  overage: Recently, Wall Street banks ROTH Capital Partners and WBB Securities initiated coverage on CohBar. Brookline Capital Markets initiated coverage in May.
• Hosted k
  ey opinion leader webinar
  on IPF and CohBar’s antifibrotic peptides: The company hosted a key opinion leader webinar on the current treatment landscape in IPF, the unmet medical need, and positive findings from preclinical studies of its CB5138 Analogs. This event was led by world-class medical expert Dr. Toby Maher, Director of Interstitial Lung Disease and Professor of Medicine at the Keck School of Medicine, University of Southern California. Dr. Toby Maher provided an authoritative and insightful overview of the IPF situation, emphasizing the urgent need for new treatments. CohBar’s Chief Scientific Officer, Ken Cundy, presented recent results from CohBar’s antifibrotic program.

• Continued investment community outreach and continued partnering efforts: In the third quarter, the company presented and hosted meetings at several healthcare banking conferences: H.C. Wainwright NASH, H.C. Wainwright, and Oppenheimer. CohBar spoke at two COVID-19 conferences: ROTH COVID-19 Therapeutics in Development and Sachs Novel Coronavirus Investment Forum. The company also spoke at Targeting Metabesity, and at the BIO Investor Forum where the company met with prospective investors. Recently, the company presented at the BIO-Europe conference and continues to proactively engage in business development discussions.

Founders
’
Update

During the third quarter and subsequent period, CohBar’s founders, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology, and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to present and publish on the study of mitochondrial science, aging, and age-related diseases.

Dr. Cohen published two papers on how the genomics of mitochondrial DNA are related to diseases of aging, “A Mitochondrial Genome-Wide Association Study of Cataract in a Latino Population” in the Translational Vision Science & Technology Journal and “Mito-Omics and immune function: Applying novel mitochondrial omic techniques to the context of the aging immune system” in the Translation Medicine of Aging Journal.

Dr. Barzilai was a key speaker at the Aging Research & Drug Discovery (ARDD) Meeting. He also was interviewed by the Wall Street Journal, Bloomberg, and The Sun among other publications, and was featured in the Peter Attia Drive and Demystifying Science podcasts.

Third
Quarter 20
20
Financial Highlights

• Cash and Investments: CohBar had cash, cash equivalents and investments of $23.4 million as of September 30, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended September 30, 2020, was approximately $2.9 million.

• R&D Expenses: Research and development expenses were $1.2 million for the three months ended September 30, 2020, compared to $1.9 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower clinical trial and stock-based compensation costs related to the timing of those expenses.

• G&A Expenses: General and administrative expenses were $1.4 million for the three months ended September 30, 2020, compared to $1.3 million in the prior year quarter. The increase in general and administrative expenses was primarily due increased legal costs related to protecting our intellectual property.

• Net Loss: For the three months ended September 30, 2020, net loss, which included $0.9 million of non-cash expenses, was $3.2 million, or $0.06 per basic and diluted share. For the three months ended September 30, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.3 million, or $0.08 per basic and diluted share.

Third
Quarter Investor Call and Slide Presentation:

Date: November 16, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

• Dial-in U.S. and Canada: (877) 451-6152
• Dial-in International: (201) 389-0879
• Conference ID No.: 13711606

Slide Presentation

• Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 312 1885 and password CWBR, or
• Go to www.cohbar.com and click on Q3 2020 Shareholder Presentation at the top of homepage.

For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 16, 2020, through 11:59 p.m. Eastern Time on December 7, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13711606. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

About CohBar

CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics, an emerging class of drugs for the treatment of chronic and age-related diseases. Mitochondria based therapeutics originate from the discovery by CohBar’s founders of a novel group of naturally occurring peptide sequences within the mitochondrial genome, some of which have been shown to have the potential to regulate key processes in multiple systems and organs in the body. To date, the company has discovered more than 100 mitochondrial derived peptides and generated over 1,000 analogs. CohBar’s efforts focus on the development of these peptides into therapeutics that offer the potential to address a broad range of diseases because of the underlying impact of mitochondrial dysfunction. The company’s lead compound, CB4211, is in the Phase 1b stage of a Phase 1a/1b clinical trial for NASH and obesity. In addition, CohBar has four preclinical programs: CB5138 Analogs for fibrotic diseases, CB5064 Analogs for COVID-19 associated ARDS, MBT5 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.

For additional company information, please visit www.cohbar.com.

Forward-Looking Statements

This news release contains forward-looking statements which are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to statements regarding timing and anticipated outcomes of research and clinical trials for our mitochondria based therapeutic (MBT) candidates; expectations regarding the growth of MBTs as a significant future class of drug products; and statements regarding anticipated therapeutic properties and potential of our mitochondrial peptide analogs, MBTs and other potential therapies. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include: our ability to successfully advance drug discovery and development programs, including the delay or termination of ongoing clinical trials; our possible inability to mitigate the prevalence and/or persistence of the injection site reactions, receipt of unfavorable feedback from regulators regarding the safety or tolerability of CB4211 or the possibility of other developments affecting the viability of CB4211 as a clinical candidate or its commercial potential; results that are different from earlier data results including less favorable than and that may not support further clinical development; our ability to raise additional capital when necessary to continue our operations; our ability to recruit and retain key management and scientific personnel; the risk that our intellectual property may not be adequately protected; our ability to establish and maintain partnerships with corporate and industry partners; and risks related to the impact on our business of the COVID-19 pandemic or similar public health crises. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website, and at www.sec.gov or www.sedar.com.

You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Contacts:

Jordyn Tarazi
Director of Investor Relations
CohBar, Inc.
(650) 445-4441
[email protected] 

Joyce Allaire
LifeSci Advisors, LLC
[email protected] 

CohBar, Inc.
Condensed Balance Sheets
	As of
	September 30, 2020				December 31, 2019
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	14,490,941			$	12,563,853
Investments		8,865,992				–
Prepaid expenses and other current assets		620,754				361,311
Total current assets		23,977,687				12,925,164
Property and equipment, net		432,403				523,677
Intangible assets, net		18,344				19,154
Other assets		67,403				64,242
Total assets	$	24,495,837			$	13,532,237
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	472,984			$	444,776
Accrued liabilities		1,039,262				916,692
Accrued payroll and other compensation		353,915				677,755
Current portion of note payable, net of debt discount and offering costs of $34,566 and $0 as of September 30, 2020 and December 31, 2019, respectively		470,434				–
Total current liabilities		2,336,595				2,039,223
Notes payable, net of current portion and net of debt discount and offering costs of $276,486 and $546,312 as of September 30, 2020 and December 31, 2019, respectively		3,121,014				3,356,188
Total liabilities		5,457,609				5,395,411
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value, Authorized 5,000,000 shares;
No shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively		–				–
Common stock, $0.001 par value, Authorized 180,000,000 shares as of September 30, 2020 and 75,000,000 as of December 31, 2019
Issued and outstanding 57,963,409 shares as of September 30, 2020 and 43,069,418 as of December 31, 2019		57,963				43,069
Additional paid-in capital		83,530,601				61,087,082
Accumulated deficit		(64,550,336	)			(52,993,325	)
Total stockholders’ equity		19,038,228				8,136,826
Total liabilities and stockholders’ equity	$	24,495,837			$	13,532,237

CohBar, Inc.
Condensed Statements of Operations
(unaudited)
		For The Three Months Ended September 30,								For The Nine Months Ended September 30,
			2020				2019				2020				2019
Revenues		$	–			$	–			$	–			$	–
Operating expenses:
Research and development			1,245,530				1,943,746				4,240,445				4,734,020
General and administrative			1,372,026				1,283,721				4,594,318				4,279,223
Total operating expenses			2,617,556				3,227,467				8,834,763				9,013,243
Operating loss			(2,617,556	)			(3,227,467	)			(8,834,763	)			(9,013,243	)
Other income (expense):
Interest income			872				66,693				38,064				248,586
Interest expense			(78,691	)			(78,690	)			(234,364	)			(233,508	)
Equity modification expense			(489,645	)			–				(2,290,688	)			–
Amortization of debt discount and offering costs			(51,899	)			(109,963	)			(235,260	)			(329,888	)
Total other expense			(619,363	)			(121,960	)			(2,722,248	)			(314,810	)
Net loss		$	(3,236,919	)		$	(3,349,427	)		$	(11,557,011	)		$	(9,328,053	)
Basic and diluted net loss per share		$	(0.06	)		$	(0.08	)		$	(0.25	)		$	(0.22	)
Weighted average common shares outstanding – basic and diluted			50,201,985				42,861,422				45,569,737				42,766,300

 

 

KENNETT SQUARE, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) — LTC ACO, the first long-term care sponsored Accountable Care Organization (“ACO”) in the United States, today announced it has partnered with Eventus WholeHealth (“Eventus”) for the performance year beginning January 1, 2021. Eventus is a full-service, physician led provider of interdisciplinary holistic care for medically vulnerable adults where they live, including skilled nursing and assisted living facilities as well as private residences. The aligned relationship will allow Eventus practitioners who provide primary care to more than 4,000 Traditional Medicare Fee-For-Service beneficiaries in long-term care facilities in Indiana to participate in the Medicare Shared Savings Program (“MSSP”) through LTC ACO. 

In 2016, LTC ACO began participating in the Medicare Shared Savings Program. In July 2019, LTC ACO entered into its second agreement period with CMS accepting up and downside risk on the Enhanced Track, qualifying it as an Advanced Alternative Payment Model (AAPM). For the most recent reconciled period in 2019, LTC ACO saved the Medicare Program over $32M while realizing a quality score of 94.5%. As a result, LTC ACO received a shared savings distribution of approximately $18.8M, which was shared with participating providers and reinvested in ACO infrastructure to support its further growth and success. In addition to sharing in the shared savings distribution, most participating providers began to qualify to earn a 5% incentive on all of their Medicare Part B billings, both ACO and non-ACO billings, as of July 2019 due to the ACO’s AAPM status.

Through the relationship, LTC ACO and Eventus will take advantage of each other’s industry-leading expertise to deliver extraordinary patient outcomes while improving quality and cost efficiency. Eventus’ 95 physicians and nurse practitioners in Indiana, join nearly 200 others that contracted with LTC ACO in 2020.

“Providing the highest quality of care for medically vulnerable adults is our mission at Eventus and we look forward to utilizing our partnership with LTC ACO to help demonstrate the ability to improve overall patient outcomes while managing episodic and chronic costs,” notes Grace E. Terrell, MD MMM, Chief Executive Officer of Eventus WholeHealth.

Under the partnership, LTC ACO passes along no risk to Eventus and requires no capital outlay. LTC ACO will educate, train and report outcomes with the goal of driving improved patient outcomes, creating healthcare efficiencies and improving quality measures.

“We are excited to welcome Eventus to our ACO,” notes Jason Feuerman, President of LTC ACO. “With several years of experience behind us, along with a successful track record, we are now able to attract and work with providers like Eventus, to significantly expand our resident attribution, designed to improve beneficiary outcomes and create an alternative payment model throughout the long-term care industry.”

For more information on becoming a partner with LTC ACO, please call 1-800-906-8382 or visit us at www.ltcaco.com.

ABOUT LTC ACO

LTC ACO is the first post-acute care sponsored Accountable Care Organization (ACO) in the United States. LTC ACO is a subsidiary of Genesis HealthCare and began participating in the MSSP in 2016. Visit our website at



www.ltcaco.com


.

ABOUT EVENTUS WHOLEHEALTH

Eventus WholeHealth, private equity-backed by


Enhanced Healthcare Partners


, was founded in 2014 to provide physician-led healthcare services for residents and patients of skilled nursing and assisted living facilities. With our highly-trained team of primary care physicians, psychiatrists, nurse practitioners, physician assistants, psychotherapists, podiatrists, and support staff, our comprehensive, evidence-based model provides collaborative interdisciplinary care with the seamless and vital integration of a wide range of specialties. Our holistic approach ensures better outcomes for the most medically vulnerable patients and has enabled our growth into five states. For more information, please visit


www.eventuswholehealth.com


.

Contact:
Lori Mayer
Media Relations
610-283-4995

FAIRFAX, Va., Nov. 16, 2020 (GLOBE NEWSWIRE) — Playa Hotels & Resorts N.V. (NASDAQ: PLYA) (“Playa”) today announced that certain selling shareholders (the “Selling Shareholders”) affiliated with Farallon Capital Management, L.L.C. (collectively, the “Farallon Funds”) have commenced an underwritten secondary offering of 12,500,000 of our Ordinary Shares. The Selling Shareholders expect to grant the underwriter an option to purchase up to 1,875,000 additional Ordinary Shares. Upon consummation of the offering for the proposed number of shares offered, excluding any exercise of the option described above, the Farallon Funds’ aggregate beneficial ownership interest in Playa will be reduced to approximately 13.5%.  

Playa is not offering any Ordinary Shares in the offering and will not receive any proceeds from the sale of Ordinary Shares by the Selling Shareholders in the offering. In addition, none of Playa’s officers or directors is selling any Ordinary Shares in the offering. 

BofA Securities is serving as sole underwriter for the offering.

The offering of these securities is being made pursuant to an effective shelf registration statement. This offering will be made only by means of a prospectus and prospectus supplement. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering and the final prospectus supplement, when available, may be obtained by visiting EDGAR on the SEC’s website at www.sec.gov or by contacting: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC  28255-0001, Attn: Prospectus Department Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Playa Hotels & Resorts N.V.

Playa Hotels & Resorts N.V. is a leading owner, operator and developer of all-inclusive resorts in prime beachfront locations in popular vacation destinations in Mexico and the Caribbean. Playa owns and/or manages a total portfolio consisting of 21 resorts (8,172 rooms) located in Mexico, Jamaica, and the Dominican Republic. In Mexico, Playa owns and manages Hyatt Zilara Cancun, Hyatt Ziva Cancun, Panama Jack Resorts Cancun, Panama Jack Resorts Playa del Carmen, Hilton Playa del Carmen, Hyatt Ziva Puerto Vallarta and Hyatt Ziva Los Cabos. In Jamaica, Playa owns and manages Hyatt Zilara Rose Hall, Hyatt Ziva Rose Hall, Hilton Rose Hall Resort & Spa, Jewel Grande Montego Bay Resort & Spa and Jewel Paradise Cove Beach Resort & Spa. In the Dominican Republic, Playa owns and manages the Hilton La Romana, Hyatt Ziva Cap Cana and Hyatt Zilara Cap Cana. Playa also owns four resorts in Mexico and the Dominican Republic that are managed by a third party and Playa manages the Sanctuary Cap Cana, in the Dominican Republic.  

Forward-Looking Statements


This press release contains “forward-looking statements,” as defined by federal securities laws. Forward-looking statements reflect Playa’s current expectations and projections about future events at the time, and thus involve uncertainty and risk. The words “believe,” “expect,” “anticipate,” “will,” “could,” “would,” “should,” “may,” “plan,” “estimate,” “intend,” “predict,” “potential,” “continue,” and the negatives of these words and other similar expressions generally identify forward looking statements. Such forward-looking statements are subject to various factors that could cause actual outcomes or results to differ materially from those indicated in these statements, including the risks described under the sections entitled “Risk Factors” in Playa’s Annual Report on Form 10-K, filed with the SEC on February 27, 2020 and Quarterly Report on Form 10-Q, filed with the SEC on November 4, 2020, as such factors may be updated from time to time in Playa’s periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and in Playa’s filings with the SEC. Currently, one of the most significant factors that could cause actual outcomes to differ materially from our forward-looking statements is the adverse effects of the current COVID-19 pandemic on the financial condition, operating results and cash flows of Playa, the airlines that service the locations where Playa owns resorts, the short and longer-term demand for travel, the global economy and the local economies where Playa owns its resorts, and the financial markets. While forward-looking statements reflect Playa’s good faith beliefs, they are not guarantees of future performance. Playa disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Playa (or to third parties making the forward-looking statements).

Contact:
Playa Hotels & Resorts N.V.
Pedram Saif, VP, IR & Strategy
571-529-6014
[email protected]

–
Enrollment
and dosing
complete in Phase 1a clinical trial of PT101
;
top-line
results expected
early 2021

–
PT627 s
ystemic PD-1 agonist
development
candidate nominated; IND-enabling studies expected to initiate
4Q
2020

– Presented
preclinical data at FOC
I
S 2020 highlighting
potential of
TALON
platform
in autoimmune disease

WATERTOWN, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — Pandion Therapeutics, Inc. (Nasdaq: PAND), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, today reported financial results for the three and nine months ended September 30, 2020, and provided a recent business update.

“The third quarter was marked by our entrance into the public markets. With the additional proceeds from our IPO, we are well-capitalized to advance our pipeline of engineered proteins that act to restore immune system balance in autoimmunity,” said Rahul Kakkar, M.D., Chief Executive Officer of Pandion Therapeutics. “We’ve made substantial progress in our Phase 1a clinical trial for our lead program, PT101, and now that enrollment and dosing of all cohorts are complete, we expect to announce top-line results in early 2021. In this Phase 1a clinical trial, we are seeking to evaluate the safety and tolerability of PT101 and to demonstrate PT101’s selectivity for activating regulatory T cells, without activating conventional T cells or NK cells. We believe selective expansion of regulatory T cells is important to maximize clinical benefit for patients within this drug class.”

Dr. Kakkar continued, “Following PT101, is our PD-1 agonism program franchise. PD-1 is another control node of the immune system, and we believe activation of PD-1 could help to treat various autoimmune diseases. Work continues on our PD-1 agonists. We plan to initiate investigational new drug (IND)-enabling studies with our systemic PD-1 agonist, PT627, in the fourth quarter of this year and are on-track to enter IND-enabling preclinical studies for our GI/liver-tethered PD-1 agonist, PT001, in the first half of 2021. We are proud of the progress made on each of these molecules as highlighted in our abstracts presented at FOCIS in October of this year.”

Third
Quarter & Recent Business Updates

• C
  omplete
  d enrollment
  in Phase 1a clinical trial of PT101. PT101 is an IL-2 mutein designed to be selective for activation of regulatory T cells, which have the potential to reestablish control of the immune system response in patients with autoimmune disease. The Company completed enrollment and dosing of its Phase 1a double-blind, placebo controlled clinical trial testing the safety and tolerability of single ascending doses of PT101 in healthy volunteers in October 2020.
• Expect
  top-line results from the Phase 1a clinical trial of PT101 in early 2021
  . In addition to safety and tolerability data, the trial is also assessing PT101’s intended mechanism of action. Top-line data are expected to provide information on:
  • Expansion of regulatory T cells (Tregs) and durability of this expansion. Academic literature suggests a two-fold expansion of total Tregs can lead to clinical benefit for autoimmune diseases.
  • Selectivity of PT101 for Tregs over immune–activating conventional T cells (Tconv) and natural killer (NK) T cells. Academic literature associates Tconv and NK cell expansion with loss of clinical benefit and increased risk of adverse events, suggesting selectivity for regulatory T cell expansion may be critical to achieve clinical benefit.
• Nominated PT627 as the Company’s systemic PD-1 agonist
  development candidate
  and plan
  to initiate IND-enabling preclinical studies in 4Q2020
  .
  GI/Liver-tethered PD-1 agonist on
  –
  track to enter IND-enabling studies 1H
  2021. PD-1 is an inhibitory receptor-control node present on activated conventional T cells. By activating the PD-1 receptor, our PD-1 agonist antibodies have the potential to attenuate effector T cell responses, and may have potential for the treatment of autoimmune diseases. Pandion is developing both a systemic PD-1 agonist antibody and a GI/liver-tethered PD-1 agonist bifunctional antibody.
• Presented
  research
  highlighting potential of Pandion’s modular
  pipeline
  in autoimmune diseases at FOC
  I
  S
  and the European Antibody Congress
  . The Company’s drug design and discovery platform allows for the combination of a specific tissue tether with an immune effector molecule within the same bifunctional antibody. Pandion highlighted that two of its tissue tethers, skin and gut, in combination with various effectors demonstrated promising results in animal models of vitiligo and graft vs. host disease, respectively.
• Completed Initial Public Offering (IPO), raising approximately $153 million in gross proceeds
  in July 2020
  .
  

Financial Results for
Third
Quarter
of
2020

• Cash Position: Cash and cash equivalents were $232.3 million as of September 30, 2020, as compared to $16.0 million as of December 31, 2019. The cash balance includes the proceeds from the Company’s IPO in July 2020. The Company expects that its existing cash and cash equivalents will be sufficient to fund its operations through the first half of 2024.
• Research and Development (R&D) Expenses: R&D expenses were $9.3 million for the quarter ended September 30, 2020, compared to $4.4 million for the quarter ended September 30, 2019. The increase was primarily due to higher consulting services and development activities outsourced to Contract Research Organizations.
• General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended September 30, 2020, compared to $1.5 million for the quarter ended September 30, 2019. The increase was primarily due to an increase in professional services, personnel-related costs, including increase in non-cash equity-based compensation, and additional insurance premiums associated with being a public company.
• Net Loss: Net loss attributable to common stockholders was $11.9 million, or a net loss of $0.51 per basic and diluted share, for the quarter ended September 30, 2020, compared to $6.9 million, or a net loss of $6.72 per basic and diluted share, for the quarter ended September 30, 2019.

About
Pandion Therapeutics

Pandion Therapeutics is developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion’s TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format. Pandion’s lead product candidate PT101, a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells, is currently in a Phase 1a clinical trial. Pandion is continuing to develop and expand its library of effector and tether modules as part of its earlier-stage research and discovery pipeline. For more information, please visit www.pandiontx.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy and clinical development plans, timelines and prospects, the timing of availability of clinical trial data and the Company’s ability to fund its operations through the first half of 2024, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with Pandion’s ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; initiate preclinical studies and clinical trials of PT101, PT627, PT001 and its other product candidates; advance PT101, PT627, PT001 and its other product candidates in preclinical research and clinical trials; replicate in clinical trials positive results found in preclinical studies; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; obtain, maintain or protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
	Three Months Ended							Nine Months Ended
	September 30,							September 30,
		2020			2019				2020			2019
Revenue	$	2,632		$	–			$	6,588		$	–
Operating Expenses
Research and development		9,286			4,386				25,088			14,405
General and administrative		4,336			1,522				8,200			3,136
Total operating expenses		13,622			5,908				33,288			17,541
Loss from operations		(10,990	)		(5,908	)			(26,700	)		(17,541	)
Interest income		9			63				54			207
Interest expense		(251	)		–				(333	)		–
Fair value adjustments to convertible note		–			–				89			–
Net Loss		(11,232	)		(5,845	)			(26,890	)		(17,334	)
Change in redemption value of redeemable convertible preferred shares		(664	)		(1,027	)			(4,909	)		(2,963	)
Net loss attributable to common shareholders		(11,896	)		(6,872	)			(31,799	)		(20,297	)
Net loss per common share, basic and diluted	$	(0.51	)	$	(6.72	)		$	(3.71	)	$	(19.91	)
Weighted-average number of shares outstanding used in computing net loss per common share, basic and diluted		23,274,944			1,022,464				8,582,039			1,019,673

Condensed Balance Sheet Data
(in thousands)
	September 30,			December 31,
	2020			2019
	(unaudited)
Cash and cash equivalents	$	232,324		$	15,970
Total assets		240,955			21,019
Total liabilities		16,120			16,841
Total stockholders’/members’ equity(deficit)		224,835			(42,789	)

C
ontact
s

Media:
Kathryn Morris
The Yates Network
914-204-6412
[email protected]

Investors:
Michelle Avery
Pandion Therapeutics
857-273-0444
[email protected]

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Sequential Brands Group, Inc. (“Sequential” or the “Company”) (Nasdaq:SQBG) today announced financial results for the third quarter ended September 30, 2020.

Reverse Stock Split
:

On July 27, 2020, the Company’s previously announced 1 share-for-40 shares (1:40) reverse stock split (the “Reverse Stock Split”) of the Company’s outstanding common stock, par value $0.01 per share became effective. All share and per share amounts in this press release reflect the Reverse Stock Split. Prior periods have been reclassified to reflect the change in the Company’s stated capital attributable to common stock which was reduced proportionately to the Reverse Stock Split ratio, and the additional paid-in capital account which was credited with the amount by which common stock was reduced. As a result of the Reverse Stock Split, the Company regained compliance with the minimum bid price listing rules of The Nasdaq Stock Market.

Third
Quarter 2020 Results from Continuing Operations:

Total revenue from continuing operations for the third quarter ended September 30, 2020 was $24.0 million, compared to $25.4 million in the prior year quarter. On a GAAP basis, income from continuing operations for the third quarter 2020 was $4.5 million or $2.71 per diluted share, compared to loss from continuing operations for the third quarter 2019 of $(18.4) million or $(11.31) per diluted share. Included in income from continuing operations for the third quarter 2020 was a $3.7 million gain on the sale of two non-core brands completed in July 2020. Non-GAAP net income from continuing operations for the third quarter 2020 was $2.1 million, or $1.30 per diluted share, compared to a non-GAAP net loss of $(0.9) million, or $(0.53) per diluted share, in the prior year quarter. See Non-GAAP Financial Measure Reconciliation tables below for a reconciliation of GAAP to non-GAAP measures. Adjusted EBITDA from continuing operations (defined under “Non-GAAP Financial Measures” below) for the third quarter of 2020 was $18.9 million, compared to $13.2 million in the prior year quarter.

Year-to-Date 2020 Results
from Continuing Operations
:

Total revenue from continuing operations for the nine months ended September 30, 2020 was $66.8 million, compared to $77.3 million in the prior year period. On a GAAP basis, loss from continuing operations for the nine months ended September 30, 2020 was $(83.8) million or $(50.96) per diluted share, compared to $(26.4) million or $(16.36) per diluted share for the nine months ended September 30, 2019. Included in the loss from continuing operations for the nine months ended September 30, 2020 were non-cash impairment charges of $85.6 million for indefinite-lived intangible assets related to the trademarks for the Jessica Simpson, Gaiam, Joe’s and Ellen Tracy brands reflecting the financial impacts of COVID-19. Non-GAAP net loss from continuing operations for the nine months ended September 30, 2020 was $(10.0) million, or $(6.08) per diluted share, compared to $(7.7) million, or $(4.74) per diluted share, in the prior year period. Adjusted EBITDA from continuing operations for the nine months ended September 30, 2020 was $43.7 million, compared to $37.7 million in the prior year period.

COVID-19 Update:

The impact of the COVID-19 pandemic and the pace at which there are new developments has created significant uncertainty in the current economic environment. The impacts of COVID-19 have adversely affected our near-term and long-term revenues, earnings, liquidity and cash flows as certain licensees have requested temporary relief or deferred making their scheduled payments. However, the situation is dynamic, and the Company is not currently able to predict the full impact of COVID-19 on its results of operations and cash flows.

Liquidity and Financing Update:

Sequential ended the third quarter with $22.2 million in cash, including restricted cash.

The Company is party to the Third Amendment to the Third Amended and Restated First Lien Credit Agreement (the “Amended BoA Credit Agreement”) with Bank of America, N.A., as administrative agent and collateral agent and the lenders party thereto (the “BoA Facility Loan Parties”) and the Fifth Amendment to its Third Amended and Restated Credit Agreement (as amended, the “Amended Wilmington Credit Agreement”) with Wilmington Trust, National Association as administrative agent and collateral agent (“the Wilmington Agent”) and the lenders party thereto (the “Wilmington Facility Loan Parties”), referred to as its loan agreements (“Loan Agreements”). At September 30, 2020, the Company is in compliance with the covenants included in the Amended BoA Credit Agreement. On November 16, 2020, the Company entered into the Amended Wilmington Credit Agreement with the Wilmington Facility Loan Parties. The amendments modified the covenants in, and obtained a waiver through December 31, 2020 of defaults under, the Amended Wilmington Credit Agreement. However, as a result of the impacts of the COVID-19 pandemic, the Company is not currently forecasted to be able to comply, in the next twelve months, with certain of the financial covenants under the Amended Wilmington Credit Agreement. If the Company fails to comply with such financial covenants, an event of default under the Loan Agreements would be triggered and its obligations under the Loan Agreements may be accelerated. The Company continues to evaluate strategic alternatives, including the divestiture of one or more existing brands or a sale of the Company. The risk of non-compliance creates a material uncertainty that casts substantial doubt with respect to the ability of the Company to continue as a going concern. See our Quarterly Report on Form 10-Q for the period ended September 30, 2020 for additional information.

L
ease Termination
:

On November 13, 2020, the Company signed an agreement to exit its remaining lease obligation from its former office headquarters. See our Quarterly Report on Form 10-Q for the period ended September 30, 2020 for additional information.

Discontinued Operations:

On June 10, 2019, Sequential completed its previously announced sale of 100% of the issued and outstanding equity interests of Martha Stewart Living Omnimedia, Inc. (“MSLO”), a Delaware corporation and a wholly-owned subsidiary of Sequential. The Company had after-tax net loss from discontinued operations of less than $(0.1) million for the third quarter ended September 30, 2020 compared to $(0.3) million in the prior year quarter. The Company’s after-tax net loss from discontinued operations was $(1.2) million for the nine months ended September 30, 2020 compared to $(122.2) million in the prior year period.

Investor Call and Webcast:

Management will provide further commentary today, November 16, 2020, on the Company’s financial results and financial update via a conference call and webcast beginning at approximately 4:15 pm ET. To join the conference call, please dial (877) 407-9208 or visit the investor relations page on the Company’s website www.sequentialbrandsgroup.com. A replay of the conference call is available on the Company’s website.

Non-GAAP Financial Measures:

This press release contains historical and projected measures of Adjusted EBITDA from continuing operations, non-GAAP net income (loss) from continuing operations and non-GAAP earnings (loss) per diluted share from continuing operations. The Company defines Adjusted EBITDA from continuing operations as net income (loss) from continuing operations attributable to Sequential Brands Group, Inc. and Subsidiaries, excluding provision for (benefit from) income taxes, interest income or expense, non-cash compensation, depreciation and amortization, deal advisory costs, debt refinancing costs, non-cash mark-to-market adjustments to equity securities, gain on sale of assets, non-cash impairment of trademarks, net of non-controlling interest, non-cash mark-to-market adjustments on interest rate swaps, and severance. Non-GAAP net income (loss) and non-GAAP earnings (loss) per diluted share from continuing operations are non-GAAP financial measures which represent net income (loss) from continuing operations attributable to Sequential Brands Group, Inc. and Subsidiaries, excluding deal advisory costs, debt refinancing costs, non-cash mark-to-market adjustments to equity securities, gain on sale of assets, non-cash impairment of trademarks, net of non-controlling interest, non-cash mark-to-market adjustments on interest rate swaps, and provision for (benefit from) income taxes. These non-GAAP metrics are an alternative to the information calculated under U.S. generally accepted accounting principles (“GAAP”), as provided in the reports the Company files with the Securities and Exchange Commission, may be inconsistent with similar measures presented by other companies and should only be used in conjunction with the Company’s results reported according to GAAP. Any financial measure other than those prepared in accordance with GAAP should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. We consider these measures to be useful measures of our ongoing financial performance because they adjust for certain costs and other events that the Company believes are not representative of its core licensing business. See below for a reconciliation of these non-GAAP metrics to the most directly comparable GAAP measure.

About Sequential Brands Group, Inc.

Sequential Brands Group, Inc. (Nasdaq: SQBG) owns, promotes, markets, and licenses a portfolio of consumer brands in the active and lifestyle categories. Sequential seeks to ensure that its brands continue to thrive and grow by employing strong brand management, and marketing teams. Sequential has licensed and intends to license its brands in a variety of consumer categories to retailers, wholesalers and distributors in the United States and around the world. For more information, please visit Sequential’s website at: www.sequentialbrandsgroup.com. To inquire about licensing opportunities, please email: [email protected].

Forward-Looking Statements

Certain statements in this press release and oral statements made from time to time by representatives of the Company are forward-looking statements (“forward-looking statements”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date hereof and are based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. The Company’s actual results or actual events could differ materially from those stated or implied in forward-looking statements. Forward-looking statements include statements concerning estimates of GAAP net income, non-GAAP net income, Adjusted EBITDA, revenue (including guaranteed minimum royalties), and margins, guidance, plans, objectives, goals, strategies, expectations, intentions, projections, developments, future events, performance or products, underlying assumptions and other statements that are not historical in nature, including those that include the words “subject to,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “estimates,” “forecasts,” “projects,” “aims,” “targets,” “may,” “will,” “should,” “can,” “future,” “seek,” “could,” “predict,” the negatives thereof, variations thereon and similar expressions. Such forward-looking statements reflect the Company’s current views with respect to future events, based on what the Company believes are reasonable assumptions. Whether actual results will conform to expectations and predictions is subject to known and unknown risks and uncertainties, including: (i) risks and uncertainties discussed in the reports that the Company has filed with the Securities and Exchange Commission (the “SEC”); (ii) general economic, market or business conditions; (iii) the Company’s ability to identify suitable targets for acquisitions and to obtain financing for such acquisitions on commercially reasonable terms; (iv) the Company’s ability to timely achieve the anticipated results of any potential future acquisitions; (v) the Company’s ability to successfully integrate acquisitions into its ongoing business; (vi) the potential impact of the consummation any potential future acquisitions on the Company’s relationships, including with employees, licensees, customers and competitors; (vii) the Company’s ability to achieve and/or manage growth and to meet target metrics associated with such growth; (viii) the Company’s ability to successfully attract new brands and to identify suitable licensees for its existing and newly acquired brands; (ix) the Company’s substantial level of indebtedness, including the possibility that such indebtedness and related restrictive covenants may adversely affect the Company’s future cash flows, results of operations and financial condition and decrease its operating flexibility; (x) the Company’s ability to achieve its guidance; (xi) continued market acceptance of the Company’s brands; (xii) changes in the Company’s competitive position or competitive actions by other companies; (xiii) licensees’ ability to fulfill their financial obligations to the Company; (xiv) concentrations of the Company’s licensing revenues with a limited number of licensees and retail partners; (xv) uncertainties related to the timing, proposals or decisions arising from the Company’s strategic review, including the divestiture of one or more existing brands or a sale of the Company; (xvi) adverse effects on the Company and its licensees due to natural disasters, pandemic disease and other unexpected events; (xvii) uncertainties around the effects of the COVID-19 pandemic, including adverse effects on the Company’s business, financial position, cash flows, ability to comply with its debt covenants and related uncertainty around the Company’s ability to continue as a going concern; and (xviii) other circumstances beyond the Company’s control. Refer to the section entitled “Risk Factors” set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for a discussion of important risks, uncertainties and other factors that may affect the Company’s business, results of operations and financial condition. In addition, the global economic climate and additional or unforeseen effects from the COVID-19 pandemic amplify many of the foregoing risks. The Company’s stockholders are urged to consider such risks, uncertainties and factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Forward-looking statements are not, and should not be relied upon as, a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at or by which any such performance or results will be achieved. As a result, actual outcomes and results may differ materially from those expressed in forward-looking statements. The Company is not under any obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. Readers should understand that it is not possible to predict or identify all risks and uncertainties to which the Company may be subject. Consequently, readers should not consider such disclosures to be a complete discussion of all potential risks or uncertainties. 

For Media and Investor Relations inquiries, contact:

Sequential Brands Group, Inc.

Katherine Nash
T: +1 512-757-2566
E: [email protected]

SEQUENTIAL BRANDS GROUP, INC. AND SUBSIDIARIES

CONDENSED
CONSOLIDATED BALANCE SHEETS

(in thousands)

		September 30,				December 31,
		2020				2019
		(Unaudited)
Assets
Current Assets:
Cash		$	21,937			$	6,264
Restricted cash			294				2,043
Accounts receivable, net			42,921				39,452
Prepaid expenses and other current assets			12,373				4,228
Current assets from discontinued operations			152				6,839
Total current assets			77,677				58,826
Property and equipment, net			1,534				5,349
Intangible assets, net			489,938				599,967
Right-of-use assets – operating leases			52,240				50,320
Other assets			9,900				8,782
Total assets		$	631,289			$	723,244
Liabilities and Equity
Current Liabilities:
Accounts payable and accrued expenses		$	19,225			$	15,721
Current portion of long-term debt			17,000				12,750
Current portion of deferred revenue			5,428				6,977
Current portion of lease liabilities – operating leases			3,267				3,035
Current liabilities from discontinued operations			382				1,959
Total current liabilities			45,302				40,442
Long-term debt, net of current portion			436,388				433,250
Long-term deferred revenue, net of current portion			2,638				4,604
Deferred income taxes			15,728				14,351
Lease liabilities – operating leases			52,222				54,168
Other long-term liabilities			1,828				3,389
Total liabilities			554,106				550,204
Equity:
Preferred stock			–				–
Common stock			17				17
Additional paid-in capital			515,470				515,151
Accumulated other comprehensive loss			(3,227	)			(4,096	)
Accumulated deficit			(479,086	)			(394,126	)
Treasury stock			(3,234	)			(3,230	)
Total Sequential Brands Group, Inc. and Subsidiaries stockholders’ equity			29,940				113,716
Noncontrolling interests			47,243				59,324
Total equity			77,183				173,040
Total liabilities and equity		$	631,289			$	723,244

SEQUENTIAL BRANDS GROUP, INC. AND SUBSIDIARIES

UNAUDITED
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Net revenue		$	24,024			$	25,392			$	66,849			$	77,331
Operating expenses			8,726				12,247				37,576				41,700
Impairment charges			–				33,109				85,590				33,109
Gain on sale of assets			(3,723	)			–				(4,624	)			–
Income (loss) from operations			19,021				(19,964	)			(51,693	)			2,522
Other (income) expense			(72	)			843				3,467				1,270
Interest expense, net			11,925				13,048				36,362				40,794
Income (loss) from continuing operations before income taxes			7,168				(33,855	)			(91,522	)			(39,542	)
Provision for (benefit from) income taxes			1,290				(6,035	)			1,770				(6,655	)
Income (loss) from continuing operations			5,878				(27,820	)			(93,292	)			(32,887	)
Net (income) loss attributable to noncontrolling interest from continuing operations			(1,409	)			9,449				9,535				6,455
Income (loss) from continuing operations attributable to Sequential Brands Group, Inc. and Subsidiaries			4,469				(18,371	)			(83,757	)			(26,432	)
Loss from discontinued operations, net of income taxes			(32	)			(309	)			(1,203	)			(122,192	)
Net Income (loss) attributable to Sequential Brands Group, Inc. and Subsidiaries		$	4,437			$	(18,680	)		$	(84,960	)		$	(148,624	)
Earnings (loss) per share from continuing operations:
Basic and diluted		$	2.71			$	(11.31	)		$	(50.96	)		$	(16.36	)
Loss per share from discontinued operations:
Basic and diluted		$	(0.02	)		$	(0.19	)		$	(0.73	)		$	(75.63	)
Earnings (loss) per share attributable to Sequential Brands Group, Inc. and Subsidiaries:
Basic and diluted		$	2.69			$	(11.50	)		$	(51.69	)		$	(92.00	)
Weighted-average common shares outstanding:
Basic and diluted			1,650,420				1,623,802				1,643,517				1,615,558

SEQUENTIAL BRANDS GROUP, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

		Nine Months Ended September 30,
		2020			2019
Continuing Operations:
Cash Provided By (Used In) Operating Activities		$	4,729		$	(37,887	)
Cash Provided By Investing Activities			4,681			165,780
Cash Provided By (Used In) Financing Activities			607			(180,862	)
Discontinued Operations:
Cash Provided By Operating Activities		$	3,907		$	42,585
Cash Used In Investing Activities			–			(44	)
Cash Used In Financing Activities			–			(574	)
Net Increase (Decrease) In Cash and Restricted Cash			13,924			(11,002	)
Balance — Beginning of period			8,307			16,138
Balance — End of period		$	22,231		$	5,136

Non-GAAP Financial Measure Reconciliation
(in thousands, except earnings per share data)

		(Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Reconciliation of GAAP net income (loss) to non-GAAP net income (loss) from continuing operations:
GAAP net income (loss) attributable to Sequential Brands Group, Inc. and Subsidiaries		$	4,437			$	(18,680	)		$	(84,960	)		$	(148,624	)
Discontinued operations, net of tax			(32	)			(309	)			(1,203	)			(122,192	)
Income (loss) from continuing operations			4,469				(18,371	)			(83,757	)			(26,432	)
Adjustments:
Deal advisory costs (a)			53				255				103				1,535
Debt refinancing costs (b)			59				35				163				37
Non-cash mark-to-market adjustments to equity securities (c)			(191	)			414				(485	)			85
Gain on sale of assets (d)			(3,723	)			–				(4,624	)			–
Non-cash impairment of trademarks, net (e)			–				22,430				73,136				22,430
Non-cash mark-to-market adjustments on interest rate swaps (f)			189				405				3,674				1,276
Provision for (benefit from) income taxes (g)			1,290				(6,035	)			1,770				(6,655	)
Total non-GAAP adjustments			(2,323	)			17,504				73,737				18,708
Non-GAAP net income (loss) from continuing operations (1)		$	2,146			$	(867	)		$	(10,020	)		$	(7,724	)
Non-GAAP weighted-average diluted shares (h)			1,650				1,625				1,647				1,628

		(Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Reconciliation of GAAP Diluted EPS to non-GAAP Diluted EPS from continuing operations:
GAAP earnings (loss) per share attributable to Sequential Brands Group, Inc. and Subsidiaries		$	2.69			$	(11.50	)		$	(51.58	)		$	(91.28	)
GAAP loss per share from discontinued operations			(0.02	)			(0.19	)			(0.73	)			(75.05	)
GAAP earnings (loss) per share from continuing operations		$	2.71			$	(11.31	)		$	(50.85	)		$	(16.23	)
Adjustments:
Deal advisory costs (a)			0.03				0.16				0.06				0.94
Debt refinancing costs (b)			0.04				0.02				0.10				0.02
Non-cash mark-to-market adjustments to equity securities (c)			(0.12	)			0.25				(0.29	)			0.05
Gain on sale of assets (d)			(2.26	)			–				(2.81	)			–
Non-cash impairment of trademarks, net (e)			–				13.81				44.40				13.78
Non-cash mark-to-market adjustments on interest rate swaps (f)			0.11				0.25				2.24				0.79
Provision for (benefit from) income taxes (g)			0.79				(3.71	)			1.07				(4.09	)
Total non-GAAP adjustments			(1.41	)			10.78			$	44.77			$	11.49
Non-GAAP earnings (loss) per diluted share from continuing operations (1)		$	1.30			$	(0.53	)		$	(6.08	)		$	(4.74	)

		(Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Reconciliation of GAAP net income (loss) to Adjusted EBITDA from continuing operations:
GAAP net income (loss) attributable to Sequential Brands Group, Inc. and Subsidiaries		$	4,437			$	(18,680	)		$	(84,960	)		$	(148,624	)
Discontinued operations, net of tax			(32	)			(309	)			(1,203	)			(122,192	)
Income (loss) from continuing operations			4,469				(18,371	)			(83,757	)			(26,432	)
Adjustments:
Provision for (benefit from) income taxes (g)			1,290				(6,035	)			1,770				(6,655	)
Interest expense, net			11,925				13,048				36,362				40,794
Non-cash compensation			31				150				357				1,259
Depreciation and amortization			4,748				823				16,821				2,585
Deal advisory costs (a)			53				255				103				1,535
Debt refinancing costs (b)			59				35				163				37
Non-cash mark-to-market adjustments to equity securities (c)			(191	)			414				(485	)			85
Gain on sale of assets (d)			(3,723	)			–				(4,624	)			–
Non-cash impairment of trademarks, net (e)			–				22,430				73,136				22,430
Non-cash mark-to-market adjustments on interest rate swaps (f)			189				405				3,674				1,276
Severance (i)			–				14				188				834
Total Adjustments			14,381				31,539				127,465				64,180
Adjusted EBITDA from continuing operations (2)		$	18,850			$	13,168			$	43,708			$	37,748

________________________________

(1)   Non-GAAP net income (loss) from continuing operations and non-GAAP earnings (loss) per diluted share from continuing operations are non-GAAP financial measures which represent net income (loss) from continuing operations attributable to Sequential Brands Group, Inc. and Subsidiaries, excluding deal advisory costs, debt refinancing costs, non-cash mark-to-market adjustments to equity securities, gain on sale of assets, non-cash impairment of trademarks, net of non-controlling interest, non-cash mark-to-market adjustments on interest rate swaps, and provision for (benefit from) income taxes. Management uses this information to measure performance over time on a consistent basis and to identify business trends relating to the Company’s financial condition and results of continuing operations. Management believes that these non-GAAP measures are useful measures of ongoing financial performance because they adjust for certain costs and other events that the Company believes are not representative of its core licensing business.

(2)   Adjusted EBITDA from continuing operations is defined as net income (loss) from continuing operations attributable to Sequential Brands Group, Inc. and Subsidiaries, excluding provision for (benefit from) income taxes, interest income or expense, non-cash compensation, depreciation and amortization, deal advisory costs, debt refinancing costs, non-cash mark-to-market adjustments to equity securities, gain on sale of assets, non-cash impairment of trademarks, net of non-controlling interest, non-cash mark-to-market adjustments on interest rate swaps, and severance. Management uses Adjusted EBITDA from continuing operations as a measure of operating performance to assist in comparing performance from period to period on a consistent basis and to identify business trends relating to the Company’s financial condition and results of continuing operations.

(a)   Represents deal advisory costs including legal, financial and accounting services that are not representative of the Company’s day-to-day licensing business.

(b)   Represents expenses for professional fees associated with the Company’s refinancing and amending its debt facilities.

(c)   Represents the non-cash mark-to-market adjustments to equity securities.

(d)   Represents gain on the sale of the Franklin Mint and Linens ‘n Things trademarks of $3.7 million completed in July 2020 for the quarter ended September 30, 2020. Represents gain on the sale of the Franklin Mint and Linens ‘n Things trademarks of $3.7 million completed in July 2020 and of the Nevados trademark of $0.9 million completed in June 2020 for the nine months ended September 30, 2020.

(e)   Represents non-cash impairment charges, net of minority interest, related to the Company’s indefinite-lived intangible assets for certain brands.

(f)   Represents the non-cash mark-to-market adjustment on interest rate swaps.

(g)   Adjustment to remove GAAP provision for (benefit from) income taxes. The Company does not expect to make material cash income tax payments related to continuing operations in 2020 or 2019 because the Company’s net operating losses and other tax benefits are expected to reduce any additional tax obligation.

(h)   Represents weighted-average diluted shares the Company reported or would have reported if the Company had GAAP net income in 2020 and 2019.

(i)   Represents costs and adjustments to previously recorded costs associated with employee terminations not representative of the Company’s day-to-day compensation costs. 

SARATOGA SPRINGS, N.Y., Nov. 16, 2020 (GLOBE NEWSWIRE) — Espey Mfg. & Electronics Corp. (NYSE American: ESP) announces results for its first three months of fiscal year 2021.

Net sales for the first quarter of fiscal year 2021, July 1 to September 30, 2020, were $7,265,515, compared with last year’s first quarter net sales of $5,923,819.  Net income for the quarter increased to $189,824, $0.08 per diluted share, as compared to net income of $81,776, $0.03 per diluted share for the same quarter last year.

The backlog for the Company was $62 million at September 30, 2020, compared with last year’s backlog of $46.6 million at September 30, 2019. New orders in the first three months of fiscal year 2021 were $14.3 million, compared with new orders in the first three months of fiscal year 2020 of approximately $7.0 million.

Mr. Patrick Enright, President and CEO, commented,

Earnings for the quarter are up as we started to see the initial impact of targeted cost reductions which we put in place to offset the anticipated impact from necessary investments in new programs.  An increase in sales, bolstered by strong build to print shipments and robust new sales order bookings, rounded out the quarter. 

While the future of defense spending budgets remain uncertain due to both the administration transition in Washington D.C., and the likely re-assessment of Federal budget appropriations resulting from the effects of the continuing global pandemic, we remain cautiously optimistic that any impact to our anticipated new order bookings for the current fiscal year will be minimal.  The growth strategy we have put in place by investing in new programs and diversifying our customer base, along with introducing targeted cost reductions, should put us in a good position as we navigate through these uncertain times.  In the meantime, our primary focus continues to be on improving liquidity by the turning of inventory into sales.

Espey’s primary business is the development, design, and production of specialized military and industrial power supplies/transformers. The Company can be found on the Internet at www.espey.com.

For further information, contact Mr. David O’Neil (518)245-4400.

This press release may contain certain statements that are “forward-looking statements” and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s current expectations or beliefs concerning future events. The matters covered by these statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. The Company wishes to caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made.

— FDA sets estimated completion review date for the end of February 2021 —

— Targeting launch of VAZALORE for third quarter 2021 –

SPARTA, N.J., Nov. 16, 2020 (GLOBE NEWSWIRE) — PLx Pharma Inc. (NASDAQ: PLXP), a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products, announced today that two chemistry and manufacturing control (“CMC”) supplemental New Drug Applications (“sNDAs”), one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as “VAZALORE”), were submitted to the U.S. Food and Drug Administration (“FDA”) in October for regulatory approval.

The 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and also contains a bioequivalence (“BE”) clinical study report with the required data and analyses from the recently completed BE study. The submission for the 81 mg dose provided for a new product strength of VAZALORE and builds off the information in the original approved NDA (New Drug Application) and the recent sNDA submitted for VAZALORE 325 mg.

The Company received acknowledgement letters from the FDA, officially confirming the receipt of the submissions and setting the estimated completion date for its reviews for VAZALORE 325 mg and VAZALORE 81 mg for the end of February 2021. If approved, the Company plans to bring both doses of VAZALORE to market in the third quarter of 2021.

“We are delighted to have achieved this major milestone for the submissions of our two sNDAs to the FDA earlier than previously announced. This is a significant step for PLx and the millions of patients with vascular disease who can benefit from a novel aspirin therapy. We are highly confident our submissions are supported by strong and compelling data that FDA requires for CMC submissions and we look forward to their review,” stated Natasha Giordano, President and Chief Executive Officer of PLx. “I’d also like to thank our teams and our partners for their extraordinary efforts preparing these filings and our shareholders for their support in advancing VAZALORE to regulatory review,” concluded Giordano.

About VAZAL
ORE

VAZALORE 325 mg is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy with faster, reliable and more predictable platelet inhibition as compared to enteric-coated aspirin, while also reducing the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting. PLx’s supplemental New Drug Applications for VAZALORE 325 mg and VAZALORE 81 mg dose strengths, submitted in October 2020 to the U.S. Food and Drug Administration, are currently under regulatory review.

About PLx Pharma Inc.

PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective and safer products. The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract. PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach erosions and ulcers associated with aspirin and ibuprofen, and potentially other drugs.

To learn more about PLx Pharma Inc. and its pipeline, please visit www.plxpharma.com.

Forward-Looking Statements

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any products or drug candidates are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to PLx may identify forward-looking statements. PLx cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property, risks that PLx may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect PLx’s business, financial conditions and results of operations are contained in PLx’s filings with the U.S. Securities and Exchange Commission (“SEC”), which are available at www.sec.gov. Other risks and uncertainties are more fully described in PLx’s Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020, and in other filings that PLx has made or will make going forward. The forward-looking statements represent PLx’s estimate as of the date hereof only, and PLx specifically disclaims any duty or obligation to update forward-looking statements.

Contact
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

Source: PLx Pharma Inc.