Cyclacel Pharmaceuticals Reviews 2020 Achievements and Announces Key Business Objectives for 2021

– Anticancer Activity of Fadraciclib Monotherapy in Patients with MCL1 Amplified Solid
Tumors



Appointment of Mark Kirschbaum, M.D. as Chief Medical Officer


 $7 Million Strategic Investment by Fundamental Investor Acorn Bioventures

BERKELEY HEIGHTS, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today provided a business update reviewing 2020 achievements and outlining the Company’s key business objectives for 2021. The Company will present at Biotech Showcase™ Digital 2021 taking place virtually from January 11 to 15 with a prerecorded session of the company presentation. Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs. Cyclacel will host one-on-one meetings with investors and industry stakeholders during the event. Registered Biotech Showcase™ Digital 2021 attendees may request one-on-one meetings with Cyclacel through the partneringONE® system.

“With the recent appointment of Dr. Mark Kirschbaum as our CMO and the December 2020 strategic investment from Acorn Bioventures, we are well resourced to progress fadraciclib and CYC140, our two internally discovered molecules,” said Spiro Rombotis, President and Chief Executive Officer. “Fadraciclib, a CDK2/9 inhibitor, has shown promising clinical activity and tolerability in patients with advanced cancers and CYC140, a PLK1 inhibitor, is in a first-in-human study. As the next step in our clinical development program we will evaluate both agents, dosed orally, across a broad spectrum of solid tumors and hematological malignancies as part of our strategy of identifying clinical activity which may lead to registration-enabling studies.”

2020 Key Achievements

  • Data from Phase 1 study of fadraciclib as a single agent reported at the Plenary Session of the 32nd EORTC-NCI-AACR (ENA) Symposium
    • Radiographically confirmed partial response (PR) after a month and a half on i.v. fadraciclib: MCL1-amplified endometrial cancer; failed seven lines of prior therapy; continuing treatment for more than 16 months with 96% reduction in target tumor lesions
    • High bioequivalence observed in 5 patients treated with oral fadraciclib
  • Enrolled 19 patients evaluating i.v. fadraciclib in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL with evidence of antileukemic activity
  • Enrolled five patients evaluating i.v. CYC140 in patients with advanced leukemias
  • Enrolled 12 patients in Phase 1/2 study evaluating an oral regimen of sapacitabine in combination with venetoclax in patients with relapsed or refractory AML/MDS
  • Announced peer-reviewed publication of a fadraciclib review in PLOS ONE. Authored by scientists from Cyclacel and The Institute of Cancer Research, London, the publication describes the discovery of fadraciclib and shows that its targeting of CDK2 and CDK9 leads to broad therapeutic potential
  • Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care
  • Appointed Brian Schwartz, M.D, formerly CMO at ArQule, Inc., and Karin L. Walker, Chief Accounting Officer of Prothena Corporation plc, to the Board of Directors
  • Raised approximately $30 million in net cash in two equity financings and related warrant exercises providing estimated capital to early 2023

In 2021, Cyclacel will commence streamlined Phase 1/2 clinical studies, initially of oral fadraciclib and subsequently of oral CYC140, in a broad range of solid tumors and hematological malignancies. These studies are supported by fadraciclib’s Phase 1 clinical data and its transcriptional mechanism of action enabling apoptosis of cancer cells and the extensive preclinical data of CYC140 demonstrating its antimitotic mechanism and broad therapeutic potential in several solid tumors and hematological malignancies.

The clinical development plan for these studies calls for parallel evaluation of different schedules of the two agents in multiple cohorts defined by cancer histology and collection of biospecimens for translational analysis. The aim of these studies is to identify clinical activity which may lead to registration-enabling studies.

Key Business Objectives for 2021

  • First patient dosed with oral fadraciclib in Phase 1/2 advanced solid tumor study
  • First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor study
  • Manufacture clinical supplies of fadraciclib and CYC140 for registration-enabling studies
  • Data on safety and antileukemic activity from the i.v. fadraciclib-venetoclax Phase 1 study in relapsed/refractory AML and CLL
  • Data from the sapacitabine-venetoclax Phase 1/2 study in relapsed/refractory AML or MDS
  • Initial data from the CYC140 Phase 1 First-in-Human study in patients with advanced leukemias
  • Data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators

About Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, in solid tumors and hematological malignancies. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced cancers. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts  
   
Company: Paul McBarron, (908) 517-7330, [email protected]
Investor Relations: Russo Partners LLC, Jason Assad, (678) 570-6791, [email protected]

© Copyright 2021 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.



Lordstown Motors Surpasses 100,000 Pre-Orders for the Lordstown Endurance, First Full-Size, All-Electric Pickup Truck for Fleets

LORDSTOWN, Ohio, Jan. 11, 2021 (GLOBE NEWSWIRE) — Lordstown Motors Corp. (Nasdaq: RIDE), (“Lordstown Motors”), an emerging OEM producing electric light duty trucks focused on the commercial fleet market, has received more than 100,000 non-binding production reservations from commercial fleets for its Lordstown Endurance™ all-electric pickup truck, with an average order size of nearly 600 vehicles per fleet.

“Receiving 100,000 pre-orders from commercial fleets for a truck like the Endurance is unprecedented in automotive history,” said Steve Burns, CEO of Lordstown Motors. “Adding in the interest we have from federal, state, municipal and military fleets on top of that, I think you can see why we feel that we are about to revolutionize the pickup truck industry.”

The Lordstown Endurance is a full-size, all-electric pickup that has a range of 250 miles, the equivalent of 600hp and can tow up to 7,500lbs. After successful prototype and Alpha builds, Lordstown is now building the first Beta Endurance vehicles and is on track for start of production in September of this year. The initial Endurance is a crew cab configuration with medium bed length, priced at $45,000 after federal rebate.

About Lordstown Motors Corp.

Lordstown Motors Corp. is an Ohio-based original equipment manufacturer of light duty fleet vehicles, founded by CEO Steve Burns with the purpose of transforming Ohio’s Mahoning Valley and Lordstown, Ohio, into the epicenter of electric-vehicle manufacturing. The company owns the 785 acre, 6.2 million square foot Lordstown Assembly Plant where it plans to build the Lordstown Endurance, believed to be the world’s first full-size, all-electric pickup truck designed to serve the commercial fleet market. For additional information visit www.lordstownmotors.com.

Forward Looking Statements

This press release includes forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “feel,” “believes,” expects,” “estimates,” “projects,” “intends,” “should,” “is to be,” or the negative of such terms, or other comparable terminology. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements contained herein due to many factors, including, but not limited to: whether the ATVM Loan will be approved following completion of the due diligence process; our limited operating history and our significant projected funding needs; risks associated with the conversion and retooling of our facility and ramp up of production; our inability to obtain orders from customers and potential customers’ inability to integrate our electric vehicles into their existing fleets; our inability to retain key personnel and to hire additional personnel; competition in the electric pickup truck market; our inability to develop a sales distribution network; and the ability to protect our intellectual property rights. Any forward-looking statements speak only as of the date on which they are made, and Lordstown Motors Corp. undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release.

Contacts:

Investors

Carter Driscoll
[email protected]

Media

Ryan Hallett / Leigh Harmon
[email protected]



Pacific Biosciences of California, Inc. Announces Preliminary Fourth Quarter 2020 Revenue

MENLO PARK, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) — Pacific Biosciences of California, Inc. (the “Company”) (NASDAQ: PACB), a leading provider of high-quality sequencing platforms, today announced unaudited preliminary revenue of approximately $27 million for its fourth quarter ended December 31, 2020. The Company’s full financial results for the fourth quarter and the fiscal year ended December 31, 2020 are not yet available.

Financial and Operational Highlights

  • Preliminary fourth quarter revenue is expected to be approximately $27 million, representing an estimated increase of approximately 41% sequentially compared with $19.1 million for the third quarter of 2020.
  • The Company placed 35 Sequel II/IIe Systems during the fourth quarter, bringing the total installed base of Sequel II/IIe systems up to 203 as of December 31, 2020, compared with 168 as of September 30, 2020.
  • In October 2020, the Company launched the Sequel IIe System, the latest instrument evolution based on the Company’s Single Molecule, Real-Time (SMRT®) Sequencing technology.
  • In November 2020, the Company received approximately $94 million in net proceeds from an underwritten public offering of its common stock and ended the quarter with a balance of over $318 million in unrestricted cash and investments.
  • During the fourth quarter, the Wellcome Sanger Institute committed to purchase seven new Sequel IIe systems to support the Darwin Tree of Life initiative, making it one of the world’s largest SMRT sequencing facilities.
  • The Company expanded its senior management team, naming Mark Van Oene as Chief Operating Officer and Peter Fromen as Chief Commercial Officer.

Preliminary Unaudited Revenue Analysis

The Company expects fourth quarter 2020 revenue of approximately $27 million, an estimated increase of 41% compared with $19.1 million in the third quarter of 2020, and an estimated decrease of 3% compared with $27.9 million in the fourth quarter of 2019.

Preliminary instrument revenue for the fourth quarter of 2020 is expected to be approximately $13.5 million, compared with $7.7 million for the third quarter of 2020, and compared with $15.3 million for the fourth quarter of 2019. Preliminary consumables revenue for the fourth quarter of 2020 is expected to be approximately $10.0 million, compared with $8.0 million for the third quarter of 2020, and compared with $9.3 million for the fourth quarter of 2019. Preliminary service and other revenue for the fourth quarter of 2020 is expected to be approximately $3.5 million, compared with $3.3 million for the third quarter of 2020, and compared with $3.4 million for the fourth quarter of 2019.

Commenting on the announcement, Christian Henry, CEO of Pacific Biosciences stated, “We are pleased with the sales momentum we saw during the fourth quarter, which resulted in strong sequential growth in revenue. We are also pleased with our progress building out the organization including adding Mark and Peter to the Company in order to capitalize on increased customer interest in SMRT Sequencing with HiFi reads.”

The Company’s actual results for the three months ended December 31, 2020 may differ materially from the preliminary estimates above, which are not a comprehensive statement of the Company’s financial results and are not necessarily indicative of the results to be expected for fiscal 2020 or any future period.

Impact of COVID-19 Pandemic
Financial results for the twelve months of 2020 were negatively impacted as many of our customers in multiple regions around the world shut down operations for various periods of time in efforts to curb the spread of the COVID-19 pandemic. This resulted in lower product revenues for the twelve months of 2020 compared to the same period of 2019. Uncertainties associated with the pandemic, including recent resurgences in infection rates, may cause further impacts to our operations and financial results.

The Company is scheduled to present at the 2021 JP Morgan Healthcare Conference on January 14, 2021 at 11:00 am Pacific Time. The Company is scheduled to report its fourth quarter 2020 results during a conference call on February 10, 2021, at which point the Company will discuss its 2020 financial results in more detail.

About Pacific Biosciences
Pacific Biosciences of California, Inc. (NASDAQ:PACB), is empowering life scientists with highly accurate long-read sequencing. The company’s innovative instruments are based on Single Molecule, Real-Time (SMRT®) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio® sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology.

Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, our preliminary financial results for the fourth quarter ended December 31, 2020, including our revenue, instrument revenue, consumable revenue and service and other revenue and our installed instruments during the quarter, customer interest in SMRT Sequencing with HiFi reads, sales momentum, the impact of COVID-19 on our business, and other future events. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, changes in circumstances and other factors that are, in some cases, beyond Pacific Biosciences’ control and could cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Factors that could materially affect actual results can be found in Pacific Biosciences’ most recent filings with the Securities and Exchange Commission, including Pacific Biosciences’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption “Risk Factors.” Pacific Biosciences undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.

Contact:

Trevin Rard
650.521.8450
[email protected] 



Motus GI Expands Intellectual Property Portfolio with U.S. Patent for the Pure-Vu® System’s Universal Method to Mount on the End of Most Commercial Colonoscopes

Receives additional EU Patent for the Pure-Vu® System that protects the design of its fecal waste evacuation channels

FORT LAUDERDALE, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) — Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today announced that the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO) have issued two key new patents that further protect the Company’s flagship product – the Pure-Vu® System – in these key markets.

“We are pleased to announce the strengthening of long-term IP protections in the U.S. and EU for certain innovative technologies that help comprise the backbone of our Pure-Vu System. This includes a U.S. patent for our universal method to mount the Pure-Vu sleeve on nearly all commercial colonoscopes in a manner that creates a secure connection, allowing the scope and the sleeve to work seamlessly together to provide improved visualization during a colonoscopy,” said Tim Moran, chief executive officer of Motus GI. “The commercial potential of our system is more apparent than ever as our U.S. sales program continues to successfully build awareness for the Pure-Vu System among leading U.S. gastroenterologists and hospital systems. In addition, we believe the European market may represent a significant opportunity for the Pure-Vu System if we expand commercialization efforts outside the U.S., either through direct sales or a distribution partnership.”

U.S. Patent

The United States Patent Office issued patent 10,881,277, which is titled “Distal Front End for Coordinated Portioning of an Endoscope with Suction Device.”

European Patent

The EPO issued patent number 3128893, which is titled “Fecal Waste Evacuation Channel.”

About the Pure-Vu System

The Pure-Vu System integrates with standard and slim colonoscopes to improve visualization during a colonoscopy while preserving established procedural workflow by irrigating the colon and evacuating debris to provide a better-quality exam. Challenges with bowel preparation for inpatient colonoscopy, particularly patients who are elderly, with comorbidities, or active bleeds, represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care. Motus GI believes the Pure-Vu System may lead to positive outcomes and lower costs for hospitals by safely and quickly improving visualization of the colon for a quality exam the first time. In multiple clinical studies to date, involving the treatment of challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. Motus GI estimates that approximately four million inpatient colonoscopy procedures take place worldwide each year.

The Pure-Vu System has received a CE Mark in the EU and is cleared by the U.S. Food and Drug Administration to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure.

About Motus GI 

Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions.

For more information, visit www.motusgi.com and connect with the Company on TwitterLinkedIn and Facebook.

Forward-Looking Statements

This press release contains certain forward-looking statements. Forward-looking statements are based on the Company’s current expectations and assumptions. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms, including without limitation, risks inherent in the development and commercialization of potential products, uncertainty in the timing and results of clinical trials or regulatory approvals, maintenance of intellectual property rights or other risks discussed in the Company’s Form 10-K filed on March 30, 2020 and its other filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

Bob Yedid
LifeSci Advisors
(646) 597-6989
[email protected]



Turquoise Hill provides an update on the Tax Arbitration and discussions with the Government of Mongolia and Proposed Class Action

PR Newswire

MONTREAL, Jan. 11, 2021 /PRNewswire/ – Turquoise Hill Resources Ltd. (“Turquoise Hill” or the “Company”) today announced that Oyu Tolgoi LLC (Oyu Tolgoi) has evaluated the Tax Act (“2016-2018 Tax Assessment”) claim for approximately US$228 million from the Mongolian Tax Authority (MTA), as announced on December 23, 2020, including the seeking of a reduction of Oyu Tolgoi’s  carried-forward tax losses by approximately US$1.5 billion.

On February 20, 2020, the Company announced Oyu Tolgoi had been unable to reach resolution of its previously-announced dispute with the MTA with respect to the 2013-2015 Tax Assessment and would be proceeding with the initiation of a formal international arbitration proceeding (Arbitration) in accordance with the dispute resolution provisions within Chapter 14 of the Oyu Tolgoi Investment Agreement (IA) entered into with the Government of Mongolia in 2009 and Chapter 8 of the Oyu Tolgoi Underground Mine Development and Financing Plan (UDP) entered into with the Government of Mongolia in 2015. The dispute resolution provisions call for an UNCITRAL arbitration seated in London before a panel of three arbitrators.

Oyu Tolgoi has given notice of its intention to apply to the Tribunal in the Arbitration for leave to amend its Statement of Claim to include the issues raised in the 2016-2018 Tax Assessment.

As many of the matters raised in the 2016-2018 Tax Assessment are of a similar nature to the matters raised in the 2013-2015 Tax Assessment, Oyu Tolgoi believes amending its Statement of Claim is an efficient and effective means of reaching resolution on both tax assessments. Turquoise Hill remains of the view that Oyu Tolgoi LLC has paid all taxes and charges required under the IA, the Amended and Restated Shareholder Agreement, the UDP and Mongolian law.

In addition, the Government of Mongolia has advised Rio Tinto that it is dissatisfied with the results of the Definitive Estimate, which was completed and delivered by Rio Tinto and publicly announced by the Company on December 18, 2020, and is concerned that the significant increase in the development costs of the Oyu Tolgoi project has eroded the economic benefits it anticipated to receive therefrom. The Government of Mongolia has indicated that if the Oyu Tolgoi project is not economically beneficial to the country, it would be necessary to review and evaluate whether it can proceed. The Government of Mongolia has stressed the importance of achieving a comprehensive solution that addresses both financial issues between the shareholders of Oyu Tolgoi as well as economic and social issues of importance to Mongolia, such as water usage, tax payments, and social issues related to employees, in order to implement the Oyu Tolgoi project successfully. In particular, the Government of Mongolia has expressed its intention to initiate discussions with respect to the termination and replacement of the UDP.

While acknowledging Oyu Tolgoi’s significant contributions to Mongolia, Turquoise Hill is nevertheless committed to engaging immediately with the Government of Mongolia and Rio Tinto to address the UDP and revisit the sharing of economic benefits arising from the Oyu Tolgoi project in the context of agreeing on a comprehensive financing plan as well as addressing the other issues raised.

Proposed Class Action

A legal proceeding in the Superior Court in the District of Montreal has been served initiating a proposed class action against the Company and certain of its current and former officers. The claim alleges that the defendants made material misstatements and material omissions with respect to, among other things, the schedule, cost and progress to completion of the development of Oyu Tolgoi in violation of, among other things, sections 225.8, 225.9 and 225.11 of the Quebec Securities Act. The Company believes that the complaint against it is without merit.

Forward-looking statements and forward-looking information

Certain statements made herein, including statements relating to matters that are not historical facts and statements of the Company’s beliefs, intentions and expectations about developments, results and events which will or may occur in the future, constitute “forward-looking information” within the meaning of applicable Canadian securities legislation and “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements and information relate to future events or future performance, reflect current expectations or beliefs regarding future events and are typically identified by words such as “anticipate”, “could”, “should”, “expect”, “seek”, “may”, “intend”, “likely”, “plan”, “estimate”, “will”, “believe” and similar expressions suggesting future outcomes or statements regarding an outlook. These include, but are not limited to, statements and information regarding: discussions with, and the nature of the Company’s relationship and interaction with, the Government of Mongolia on the continued operation and development of Oyu Tolgoi, including with respect to the definitive estimate and the potential termination, amendment or replacement of the Oyu Tolgoi Underground Mine Development and Financing Plan (the Underground Plan); the willingness and ability of the parties to the Underground Plan to amend or replace the Underground Plan; the arbitration proceedings, including the potential benefits, timing and outcome of the arbitration proceedings; the expectations set out in the OTTR20; the timing and amount of future production and potential production delays; statements in respect of the impacts of any delays on the Company’s cash flows; expected copper and gold grades; the merits of the class action complaint filed against the Company; liquidity, funding sources, funding requirements and planning and the status and nature of the Company’s ongoing discussions with Rio Tinto and its subsidiaries with respect to future funding plans and requirements (including as contemplated by the memorandum of understanding announced on September 10, 2020 (the MOU)); the amount of any funding gap to complete the Oyu Tolgoi Project; the amount and potential sources of additional funding; the Company’s ability to re-profile its existing project debt in line with current cash flow projections; the amount by which a successful re-profiling of the Company’s existing debt would reduce the Company’s currently projected funding requirements; the Company’s and Rio Tinto’s understanding regarding the raising of supplemental senior debt and the Company’s ability to raise supplemental senior debt; the Company’s and Rio Tinto’s understanding regarding the process for identifying and considering other funding options; the Company’s and Rio Tinto’s understanding regarding the scope and timing for an equity offering by the Company to address any remaining funding gap; the Company’s intention to prioritise funding by way of debt and/or hybrid financing over equity funding; the Company’s expectation of the anticipated funding gap; the timing of studies, announcements and analyses; status of underground development; the mine design for Panel 0 of Hugo North Lift 1 and the related cost and production schedule implications; the re-design studies for Panels 1 and 2 of Hugo North Lift 1 and the possible outcomes, content and timing thereof; expectations regarding the possible recovery of ore in the two structural pillars, to the north and south of Panel 0; the possible progression of SOPP and related amendments to the PSFA as well as power purchase agreements; the timing of construction and commissioning of the potential SOPP; sources of interim power; the potential impact of COVID-19 on the Company’s business, operations and financial condition; capital and operating cost estimates, timing of completion of the definitive estimate review and the scope thereof; mill and concentrator throughput; the outcome of formal international arbitration proceedings; anticipated business activities, planned expenditures, corporate strategies, and other statements that are not historical facts.

Forward-looking statements and information are made based upon certain assumptions and other important factors that, if untrue, could cause the actual results, performance or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such statements or information. There can be no assurance that such statements or information will prove to be accurate. Such statements and information are based on numerous assumptions regarding present and future business strategies, local and global economic conditions, and the environment in which the Company will operate in the future, including the price of copper, gold and silver; projected gold, copper and silver grades; anticipated capital and operating costs; anticipated future production and cash flows; the anticipated location of certain infrastructure in Hugo North Lift 1 and sequence of mining within and across panel boundaries; the availability and timing of required governmental and other approvals for the construction of the SOPP; the ability of the Government of Mongolia to finance and procure the SOPP within the timeframes anticipated in the PSFA, as amended; the willingness of third parties to extend existing power arrangements; the status and nature of the Company’s relationship and interaction with the Government of Mongolia on the continued operation and development of Oyu Tolgoi and Oyu Tolgoi LLC internal governance (including the outcome of any such interactions or discussions); the willingness and ability of the parties to the Underground Plan to amend or replace the Underground Plan; the nature and quantum of the current and projected economic benefits to Mongolia resulting from the continued operation of Oyu Tolgoi; the status and nature of the Company’s ongoing discussions with Rio Tinto and its subsidiaries with respect to future funding plans and requirements (including as contemplated by the MOU) as well as the commencement and conclusion of the arbitration proceedings, including the potential benefits, timing and outcome of the arbitration proceedings.

Certain important factors that could cause actual results, performance or achievements to differ materially from those in the forward-looking statements and information include, among others: copper, gold and silver price volatility; discrepancies between actual and estimated production; mineral reserves and resources and metallurgical recoveries; development plans for processing resources; the outcome of the definitive estimate review; public health crises such as COVID-19; matters relating to proposed exploration or expansion; mining operational and development risks, including geotechnical risks and ground conditions; litigation risks, including the outcome of the class action complaints filed against the Company; regulatory restrictions (including environmental regulatory restrictions and liability); Oyu Tolgoi LLC or the Government of Mongolia’s ability to deliver a domestic power source for the Oyu Tolgoi project within the required contractual time frame; communications with local stakeholders and community relations; activities, actions or assessments, including tax assessments, by governmental authorities; events or circumstances (including strikes, blockades or similar events outside of the Company’s control) that may affect the Company’s ability to deliver its products in a timely manner; currency fluctuations; the speculative nature of mineral exploration; the global economic climate; dilution; share price volatility; competition; loss of key employees; cyber security incidents; additional funding requirements, including in respect of the development or construction of a long-term domestic power supply for the Oyu Tolgoi project; capital and operating costs, including with respect to the development of additional deposits and processing facilities; and defective title to mineral claims or property. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. All such forward-looking statements and information are based on certain assumptions and analyses made by the Company’s management in light of their experience and perception of historical trends, current conditions and expected future developments, as well as other factors management believes are reasonable and appropriate in the circumstances. These statements, however, are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements or information.

With respect to specific forward-looking information concerning the continued operation and development of Oyu Tolgoi, the Company has based its assumptions and analyses on certain factors which are inherently uncertain. Uncertainties and assumptions include, among others: the timing and cost of the construction and expansion of mining and processing facilities; the timing and availability of a long-term domestic power source (or the availability of financing for the Company or the Government of Mongolia to construct such a source) for Oyu Tolgoi; the ability to secure and draw down on the supplemental debt under the Oyu Tolgoi project financing facility and the availability of additional financing on terms reasonably acceptable to Oyu Tolgoi LLC, Rio Tinto and the Company to further develop Oyu Tolgoi as well as the status and nature of the Company’s ongoing discussions with Rio Tinto and its subsidiaries with respect to future funding plans and requirements (including as contemplated by the MOU); the status and nature of the Company’s relationship and interaction with the Government of Mongolia on the continued operation and development of Oyu Tolgoi and Oyu Tolgoi LLC internal governance (including the outcome of any such interactions or discussions); the willingness and ability of the parties to the Underground Plan to amend or replace the Underground Plan; the nature and quantum of the current and projected economic benefits to Mongolia resulting from the continued operation of Oyu Tolgoi; the potential impact of COVID-19; the impact of changes in, changes in interpretation to or changes in enforcement of, laws, regulations and government practices in Mongolia; the availability and cost of skilled labour and transportation; the obtaining of (and the terms and timing of obtaining) necessary environmental and other government approvals, consents and permits; delays, and the costs which would result from delays, in the development of the underground mine (which could significantly exceed the costs projected in OTTR20); projected copper, gold and silver prices and their market demand; and production estimates and the anticipated yearly production of copper, gold and silver at Oyu Tolgoi.

The cost, timing and complexities of mine construction and development are increased by the remote location of a property such as Oyu Tolgoi. It is common in mining operations and in the development or expansion of existing facilities to experience unexpected problems and delays during development, construction and mine start-up. Additionally, although Oyu Tolgoi has achieved commercial production, there is no assurance that future development activities will result in profitable mining operations.

Readers are cautioned not to place undue reliance on forward-looking information or statements. By their nature, forward-looking statements involve numerous assumptions, inherent risks and uncertainties, both general and specific, which contribute to the possibility that the predicted outcomes will not occur. Events or circumstances could cause the Company’s actual results to differ materially from those estimated or projected and expressed in, or implied by, these forward-looking statements. Important factors that could cause actual results to differ from these forward-looking statements are included in the “Risk Factors” section in the Company’s AIF, as supplemented by the “Risks and Uncertainties” section of the Q3 2020 MD&A.

Readers are further cautioned that the list of factors enumerated in the “Risk Factors” section of the AIF and in the “Risks and Uncertainties” section of the Q3 2020 MD&A that may affect future results is not exhaustive. When relying on the Company’s forward-looking statements and information to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Furthermore, the forward-looking statements and information contained herein are made as of the date of this document and the Company does not undertake any obligation to update or to revise any of the included forward-looking statements or information, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements and information contained herein are expressly qualified by this cautionary statement.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/turquoise-hill-provides-an-update-on-the-tax-arbitration-and-discussions-with-the-government-of-mongolia-and-proposed-class-action-301205216.html

SOURCE TURQUOISE HILL RESOURCES LTD

Franchise Group, Inc. Announces Offering of Series A Cumulative Perpetual Preferred Stock

ORLANDO, Fla., Jan. 11, 2021 (GLOBE NEWSWIRE) — Franchise Group, Inc. (NASDAQ: FRG) (“Franchise Group” or the “Company”) today announced it has commenced an underwritten registered public offering of shares of its 7.50% Series A Cumulative Perpetual Preferred Stock, par value $0.01 per share and liquidation preference of $25.00 per share (the “Preferred Stock”). The Company expects to grant the underwriters a 30-day option to purchase additional shares of the Preferred Stock in connection with the offering.

The Company expects to use the net proceeds of this offering for general corporate purposes, including funding future acquisitions and investments.

This offering is a reopening of the Company’s original issuance of Preferred Stock, which occurred on September 18, 2020. The additional shares of Preferred Stock sold in this offering will be consolidated, form a single series, and be fully fungible with all outstanding Preferred Stock. The Preferred Stock is listed on The NASDAQ Global Market under the symbol “FRGAP.”

Dividends on the Preferred Stock are paid when declared by the Company’s Board of Directors at a fixed rate of 7.50% of the $25.00 liquidation preference per year, equivalent to $1.875 per year. Dividends on the Preferred Stock are payable quarterly in arrears, on or about the 15th day of January, April, July and October of each year, and the first dividend on the Preferred Stock sold in this offering will be paid on or about April 15, 2021 in an amount equal to $0.46875 per share.

B. Riley Securities, Inc., Incapital LLC, D.A. Davidson & Co., Janney Montgomery Scott LLC, Ladenburg Thalmann & Co. Inc., National Securities Corporation and William Blair & Company, L.L.C. are acting as book-running managers for this offering. Aegis Capital Corp., Boenning & Scattergood, Inc. and Huntington Securities, Inc. are acting as co-managers for this offering.

The offering of these securities is being made pursuant to an effective shelf registration statement on Form S-3, which was initially filed with the Securities and Exchange Commission (the “SEC”) on January 31, 2020, and declared effective by the SEC on June 22, 2020.  The offering will be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to these securities may be obtained, when available, from the website of the SEC at http://www.sec.gov or by contacting:  B. Riley Securities, Inc., 1300 17th Street North, Suite 1300, Arlington, Virginia  22209, Attn: Prospectus Department, Email: [email protected], Telephone: (703) 312-9580. 

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 Franchise Group, Inc.

Franchise Group is an operator of franchised and franchisable businesses that continually looks to grow its portfolio of brands while utilizing its operating and capital allocation philosophy to generate strong cash flow for its shareholders. Franchise Group’s business lines include Liberty Tax Service, Buddy’s Home Furnishings, American Freight and The Vitamin Shoppe. On a combined basis, Franchise Group currently operates over 4,000 locations predominantly located in the U.S. and Canada that are either Company-run or operated pursuant to franchising agreements.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, projections, predictions, expectations, or beliefs about future events or results and are not statements of historical fact, including statements regarding the terms and conditions and timing of the preferred stock offering and the intended use of proceeds. Such forward-looking statements are based on various assumptions as of the time they are made, and are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements are often accompanied by words that convey projected future events or outcomes such as “expect,” “believe,” “estimate,” “plan,” “project,” “anticipate,” “intend,” “will,” “may,” “view,” “opportunity,” “potential,” or words of similar meaning or other statements concerning opinions or judgment of the Company or its management about future events. Although the Company believes that its expectations with respect to forward-looking statements are based upon reasonable assumptions within the bounds of its existing knowledge of its business and operations, there can be no assurance that actual results, performance, or achievements of the Company will not differ materially from any projected future results, performance or achievements expressed or implied by such forward-looking statements. Actual future results, performance or achievements may differ materially from historical results or those anticipated depending on a variety of factors, many of which are beyond the control of the Company.  We refer you to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Transition Report on Form 10-K/T for the transition period ended December 28, 2019, and comparable sections of the Company’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the SEC and are available on the SEC’s website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on the Company or its business or operations. Readers are cautioned not to rely on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date they are made and the Company does not undertake any obligation to update, revise or clarify these forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR RELATIONS CONTACT:

Andrew F. Kaminsky
EVP & Chief Administrative Officer
Franchise Group, Inc.
[email protected]
(914) 939-5161



Starton Therapeutics Selects Formulation for Continuous Subcutaneous Lenalidomide Delivery System for CLL Treatment

Additional patent application filed for novel parenteral formulation in development for Chronic Lymphocytic Leukemia (CLL)

PARAMUS, N.J., Jan. 11, 2021 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company powering continuous delivery of approved drugs in novel indications, announced today that it has selected a subcutaneous lenalidomide formulation as the lead formulation candidate for its continuous subcutaneous delivery system (STAR-LLD SC) for chronic lymphocytic leukemia (CLL) and other hematologic malignancies.

“Lenalidomide is an exceptionally challenging molecule to formulate,” said Andy Rensink, Chief Manufacturing Officer. “By using unique and novel technology we are thrilled to have successfully developed a stable solution for use in the STAR-LLD SC delivery system and are excited to move this product closer to benefitting patients.”

Starton has filed a provisional patent application based on the novelty of the formulation, which is being co-developed and co-manufactured in collaboration with a large international FDA-compliant contract manufacturing partner. Any IP generated from co-development and co-manufacturing will be solely owned by Starton Therapeutics. STAR-LLD SC clinical trial materials are expected to be shipped in Q2 2021 for initiation of Phase 1/2 clinical studies for CLL in the second half of 2021. The studies are expected to use an open-label design with arms in multiple indications in CLL, with each target indication using different sub-population characteristics. Starton believes that this strategy provides multiple shots on goal with at least one indication with the potential for FDA breakthrough therapy designation.

STAR-LLD SC is the first delivery system in the STAR-LLD continuous delivery platform. Starton is also developing a once-weekly transdermal delivery patch system, which is also rapidly progressing in formulation development. STAR-LLD SC will use an ambulatory pump to infuse low-dose lenalidomide continuously, based on Starton research showing that low-dose continuous delivery may have superiority in survival and complete response rates. STAR-LLD is expected to offer a new mode of action for CLL patients and be the first IMiD (immunomodulatory drug) available for this patient population.

About Starton Therapeutics

A clinical-stage biotechnology company focused on transforming standard of care therapeutics. Starton uses proven continuous delivery technology with proprietary drivers to obtain new indications or develop on-label superiority for patients with hematological malignancies. To learn more, visit www.startontx.com   

This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as “may,” “should,” “plan,” “intend,” “potential,” “continue,” “believe,” “expect,” “predict,” “anticipate” and “estimate,” the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the Company’s control and involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the Company’s beliefs, assumptions and expectations of future performance, taking into account information currently available to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, the Company’s business, financial condition, liquidity, results of operations, plans and objectives may vary materially from those expressed in the aforementioned forward-looking statements.


Starton Investor Relations:

[email protected]

+1 551 287 6456



Turning Point Therapeutics Announces 2021 Milestone Targets


  • Present Updated Data from TRIDENT-1 Study in TKI-Naive Patients with ROS1-Positive Non-Small Cell Lung Cancer Jan. 31 at World Conference on Lung Cancer



  • Provide TRIDENT-1 Study Timeline in First Quarter


  • Provide Clinical Data Interim Updates from Multiple Studies, including Phase 1/2 TRIDENT-1, Phase 1 SHIELD-1 and Phase 1 Study of TPX-0046


  • Submit Fourth Drug Candidate IND in First Quarter


  • Initiate Combination Studies for Repotrectinib and TPX-0022


  • Outline Precision Therapy Research Vision in Second Half


  • Company also Updates Cash, Cash Equivalents, and Marketable Securities as of Dec. 31, 2020; Approximately $1.1 Billion Expected to Fund Current Operations into 2024

SAN DIEGO, Jan. 11, 2021 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced 2021 milestone targets for its pipeline of four drug candidates, including data updates from multiple clinical studies and the initiation of new clinical studies. The company also updated its cash position as of Dec. 31, 2020.

“Following a pivotal year in 2020, we believe we have even greater opportunities in 2021 to further advance our pipeline by potentially modifying our SHIELD-1 study to a registrational Phase 1/2 design, adding three new clinical trials, including two anticipated combination studies and a Phase 1 study of our fourth drug candidate, our novel ALK-inhibitor TPX-0131, and reporting initial or updated data from our three clinical stage drug candidates,” said Athena Countouriotis, M.D., president and chief executive officer. “At the same time, we have continued to invest in our discovery engine and look forward to the second half of the year when we plan to outline our focus and goals to further expand the pipeline.”


2020 Achievements and 2021 Milestone Targets

Repotrectinib, ROS1 and TRK Inhibitor

In 2020, repotrectinib was granted breakthrough-therapy designation (BTD) and received its second and third fast-track designations. In addition, the company signed an exclusive license agreement with Zai Lab to develop and commercialize repotrectinib in greater China and reported early interim data from the Phase 2 TRIDENT-1 registrational study.

2021 Milestone Targets:

  • Present updated data from the TRIDENT-1 study in TKI-naive patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) in a mini-oral presentation on Jan. 31 at the World Conference on Lung Cancer
  • Provide an update on the overall Phase 2 TRIDENT-1 registrational study timeline in the first quarter
  • Initiate the Phase 2 TRIDENT-2 combination study in patients with KRAS mutant NSCLC mid-year
  • Provide clinical data updates from certain cohorts of the Phase 2 TRIDENT-1 study in the second half

TPX-0022, MET/SRC/CSF1R Inhibitor

In 2020, Turning Point advanced its clinical development of TPX-0022 and reported initial data from the Phase 1 SHIELD-1 study in an oral presentation during the plenary session at the EORTC-NCI-AACR medical symposium.

Earlier today, the company announced the broadening of its collaboration with Zai Lab to include an exclusive licensing agreement for TPX-0022 in greater China.

2021 Milestone Targets:

  • Initiate the Phase 2 portion of SHIELD-1, pending FDA feedback, in the second half
  • Initiate the Phase 2 SHIELD-2 study of TPX-0022 in combination with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor in the second half
  • Provide a clinical data update from the Phase 1 portion of the SHIELD-1 study in the second half

TPX-0046, RET Inhibitor

In 2020, Turning Point presented preclinical data highlighting the potent inhibition of TPX-0046 against wildtype RET and RET mutations, and continued its ongoing Phase 1 study of TPX-0046.

2021 Milestone Target:

  • Report early interim data from initial patients enrolled in the dose finding portion of the TPX-0046 Phase 1 study in the first half

TPX-0131, ALK Inhibitor

In 2020, Turning Point nominated TPX-0131 as its ALK inhibitor drug candidate, advanced its IND enabling studies, and presented preclinical data highlighting its ability to overcome ALK resistant mutations refractory to approved ALK inhibitors.

2021 Milestone Targets:

  • Submit the IND for TPX-0131 in the first quarter
  • Initiate a Phase 1 clinical study of TPX-0131 in the first half

Early Discovery Pipeline

In 2020, Turning Point named Siegfried Reich as chief scientific officer and made investments to advance its research strategy.

2021 Milestone Target:

  • Outline research strategy, focus and milestones for future development candidates in the second half

Financial

In 2020, Turning Point completed follow-on stock offerings generating gross proceeds of $374 million and $460 million. The company enters 2021 with approximately $1.1 billion in cash, cash equivalents and marketable securities as of Dec. 31, 2020, which is expected to fund operations into 2024.

About Turning Point Therapeutics Inc.

Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study called TRIDENT-1 in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is in a Phase 1 study called SHIELD-1 in patients with advanced or metastatic solid tumors harboring genetic alterations in MET; RET-inhibitor TPX-0046, which is in a Phase 1/2 study of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and ALK-inhibitor TPX-0131, which is in IND-enabling studies. Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidates repotrectinib, TPX-0022, TPX-0046 and TPX-0131, the results, conduct, progress and timing of Turning Point Therapeutics’ research and development programs and clinical trials including the Phase 2 TRIDENT-1 clinical study, the Phase 1 SHIELD-1 clinical study of TPX-0022 and the Phase 1/2 clinical study of TPX-0046, plans regarding future clinical trials and regulatory submissions, the regulatory approval path for repotrectinib, and the strength of Turning Point Therapeutics’ balance sheet and the adequacy of cash on hand. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point’s business and the other risks described in Turning Point Therapeutics’ filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:
Jim Mazzola
[email protected]
858-342-8272 



Tanger Provides Liquidity And Operational Updates

Cash on Hand Grows to More Than $80 Million

Collections Exceed 90% of Fourth Quarter Rents Billed & More Than 40% of Deferred Rents Prepaid in December

Traffic at 90% of Prior Year Levels During Fourth Quarter

PR Newswire

GREENSBORO, N.C., Jan. 11, 2021 /PRNewswire/ — Tanger Factory Outlet Centers, Inc. (NYSE:SKT), a leading operator of upscale open-air outlet centers, today provided liquidity and operational updates.

“Our traffic and strong cash collection metrics clearly demonstrate the importance of our open-air outlet centers to retailers and consumers,” said Stephen Yalof, President and Chief Executive Officer.

The Company’s operations continued to generate positive cash flow throughout the second half of 2020. As of January 6, 2021, Tanger’s total liquidity was more than $680 million, including more than $80 million of cash on hand and $600 million of unused capacity under its unsecured lines of credit. Collections through that date exceeded 90% of fourth quarter 2020 rents billed and more than 40% of the deferred rents due in 2021 had been collected, the majority of which was prepaid by tenants during December.

Consolidated portfolio occupancy was 91.9% as of December 31, 2020. As expected, this reflects approximately 317,000 square feet of space recaptured during the fourth quarter related to tenant bankruptcies and restructuring announcements by retailers for a total of 903,000 square feet during 2020. Traffic during the fourth quarter represented approximately 90% of prior year levels.  

In November, the Company offered a voluntary early retirement plan to certain employees who elected to participate by December 1, 2020. These employees will retire on March 31, 2021 to ensure an orderly transition. Tanger expects to recognize a charge to general and administrative expense of approximately $2.3 million, including approximately $575,000 that was recognized during the fourth quarter of 2020 and $1.7 million to be recognized during the first quarter of 2021. 

The Company will participate in the ICR Conference today at 10:30 a.m. EST. Stephen Yalof will host a fireside chat moderated by Todd Thomas, equity research analyst with KeyBanc Capital Markets. A link to the webcast is available on Tanger’s Investor Relations website, investors.tangeroutlet.com.


About Tanger Factory Outlet Centers, Inc.

Tanger Factory Outlet Centers, Inc. (NYSE: SKT) is a leading operator of open-air upscale outlet shopping centers that owns, or has an ownership interest in, a portfolio of 38 centers. Tanger’s operating properties are located in 20 states and in Canada, totaling approximately 14.1 million square feet, leased to over 2,700 stores operated by more than 500 different brand name companies. The Company has more than 40 years of experience in the outlet industry and is a publicly-traded REIT. For more information on Tanger Outlet Centers, call 1-800-4TANGER or visit the Company’s website at www.tangeroutlets.com


Investor Contact 


Media Contact

Cyndi Holt 

Quentin Pell

VP of Investor Relations 

VP of Corporate Communications and Enterprise Risk


[email protected]

Management


[email protected] 

 

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SOURCE Tanger Factory Outlet Centers, Inc.

Cybin Partners with Kernel to Leverage its Breakthrough Neuroimaging Technology for Psychedelic Therapeutics

Cybin Partners with Kernel to Leverage its Breakthrough Neuroimaging Technology for Psychedelic Therapeutics

HIGHLIGHTS

  • Using Kernel’s technology, Cybin will be able to quantify brain activity in real time during psychedelic experiences. The absence of this data has been a limitation in the progression of new molecules targeting neurological disorders.
  • Kernel’s technology opens new frontier in psychedelic therapeutics by acquiring longitudinal brain activity before, during and after a psychedelic experience, enabling quantification of what was previously subjective self-reporting.
  • Kernel technology is unique among brain scanning technologies and is the first commercially scalable time-domain functional near-infrared spectroscopy system.
  • Cybin aims to build upon its expanded development pipeline gained through the acquisition of Adelia Therapeutics.
  • Kernel, based in Los Angeles, CA, was founded in 2016 and has raised US$104 million to date, including investment from founder Bryan Johnson, General Catalyst and Khosla Ventures.

TORONTO–(BUSINESS WIRE)–Cybin Inc. (NEO:CYBN) (“Cybin”), a life sciences company focused on psychedelic therapeutics, is excited to announce that it has entered into an agreement with neurotech pioneer HI, LLC dba Kernel (“Kernel”) to leverage its innovative technology, Kernel Flow (“Flow”), for its upcoming sponsored clinical work. Click here to view the accompanying film.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210111005430/en/

(Photo: Business Wire)

(Photo: Business Wire)

Flow is a full-head coverage, time-domain functional near-infrared spectroscopy system designed to detect hemodynamic changes in the brain that pulses light through the skull and into the bloodstream in order to measure how much oxygen the blood is carrying at any given time. Flow measurements can be used as analogues of local neural activity during a psychedelic experience. Cybin expects the quantitative measurements enabled by Flow may improve the development, delivery and scaling of its psychedelic therapeutics.

“Access to Kernel’s innovative Flow technology adds another exciting dimension to the investigative work that Cybin is doing to develop breakthrough treatments for mental health disorders such as depression and addiction. Currently, clinical investigators rely on limited subjective information from patients. The ability to collect quantitative data from our sponsored drug development programs is potentially game-changing in terms of our ability to measure where psychedelics work in the brain in real time, and how we ultimately design our future therapeutics. We are delighted to partner with Kernel to study the utility of Flow in sponsored clinical settings. This new cornerstone component of our sponsored clinical programs follows a record-setting capital raise, listing on the NEO Exchange and the acquisition of Adelia Therapeutics Inc., which added significant scientific capabilities, novel molecules, delivery mechanisms and intellectual property,” stated Doug Drysdale, CEO of Cybin.

“Cybin’s visionary approach to understanding and treating mental illness through psychedelic therapeutics opens a new frontier for addressing human health and wellness. This opportunity with Cybin will assist the transition from subjective self-reporting to longitudinal, quantitative measurements and insights, thereby offering the promise of data-driven, personalized treatment protocols that may significantly improve safety and efficacy,” stated Bryan Johnson, Founder and CEO of Kernel.

Cybin intends to take delivery of Flow in the second quarter of 2021. Cybin plans to undertake sponsored studies in a range of clinical conditions and utilize insights gained from the data collected by Flow technology to inform the design of future clinical studies, support regulatory submissions and aid in the design of future molecules to address the needs of mental health patients.

About Cybin

Cybin is a life sciences company advancing psychedelic therapeutics for various psychiatric and neurological conditions. Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. The new delivery systems are expected to be studied through sponsored clinical trials to confirm safety and efficacy.

About Kernel

Kernel is a team of neuroscientists, physicists, engineers, programmers, and experiment and operations experts driven by the belief that exploring and quantifying the human mind is the most important and consequential opportunity of our time. Based in Los Angeles, California, Kernel was founded in 2016 and has raised US$104 million to date including investment from founder Bryan Johnson, General Catalyst and Khosla Ventures. Prior to Kernel, Johnson was the Founder and CEO of Braintree Venmo, which was acquired by eBay for US$800 million in 2013.

About Flow

Flow is a headworn, scalable, non-invasive neuroimaging system. Flow leverages time-domain functional near-infrared spectroscopy, a gold standard optical method for detecting hemodynamics of the cerebral cortex. Time-domain systems acquire richer brain signals than traditional near-infrared spectroscopy devices by applying light in short pulses and precisely capturing the arrival time distribution of scattered photons from each pulse. This “time-of-flight” measurement reveals depth-dependent information and absolute optical properties of the brain. Changes in these measured optical properties allow inference of spatially localized neural activity.

Cautionary Notes and Forward Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this press release include but are not limited to statements regarding the results of Flow technology on Cybin’s sponsored clinical studies, insights to be gained from the data collected by Flow technology, the ability of Flow technology to achieve the stated objectives, the potential success of Cybin’s therapeutics, formulations, delivery mechanisms and therapeutic program. These statements are not historical facts but instead represent only Cybin’s expectations, estimates and projections regarding future events. These statements are not guaranteeing future performance and involve assumptions, risks and uncertainties that are difficult to predict. Therefore, actual results may differ materially from what is expressed, implied or forecasted in such forward-looking statements. The forward-looking information and forward-looking statements included in this press release are made as of the date of this press release. Cybin does not undertake an obligation to update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities law. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, dimethyltryptamine (“DMT”), psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products have not been confirmed by approved research. There is no assurance that the use of psilocybin or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

The NEO Exchange has not approved or disapproved the contents of this news release.

Investor:

Tim Regan/Scott Eckstein

KCSA Strategic Communications

[email protected]

Lisa M. Wilson

In-Site Communications, Inc.

[email protected]

Media:

Jackie Poriadjian

Chief Marketing Officer, Cybin

[email protected]

Annie Graf

KCSA Strategic Communications

[email protected]

Faith Pomeroy-Ward

In-Site Communications, Inc.

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Science Software Biotechnology Research Pharmaceutical Hardware Health Technology

MEDIA:

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Cybin will leverage Kernel’s Flow to quantify brain activity during psychedelic experiences in real time, adding an exciting dimension to its investigative work focused on developing breakthrough therapeutics for mental health disorders. (Photo: Business Wire)
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(Photo: Business Wire)