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Fate Therapeutics Announces Participation in Upcoming Investor Conferences

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

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

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

About Fate Therapeutics, Inc.

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

Contact:

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

 

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Vertex to Present at the Jefferies Virtual London Health Care Conference on November 19

Vertex to Present at the Jefferies Virtual London Health Care Conference on November 19

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the Jefferies Virtual London Health Care Conference on Thursday, November 19, 2020 at 9:05 a.m. ET (2:05 p.m. GMT).

The audio portion of management’s remarks will be available live through Vertex’s website, www.vrtx.com in the “Investors” section under the “News and Events” page. A replay of the conference webcast will be archived on the company’s website.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry’s top places to work, including 11 consecutive years on Science magazine’s Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.(VRTX-WEB)

Vertex Pharmaceuticals Incorporated

Investors:

Michael Partridge, 617-341-6108

Zach Barber, 617-341-6470

Brenda Eustace, 617-341-6187

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Professional Services Health Finance Clinical Trials Pharmaceutical Banking Biotechnology

MEDIA:

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Orchard Therapeutics Unveils Details on New HSC Gene Therapy Research Programs as Part of R&D Investor Event Tomorrow at 9:00 a.m. ET

First look at preclinical data in
f
rontotemporal dementia
with progranulin mutations
(
GRN-
FTD)
and new
amyotrophic lateral sclerosis
(ALS)
program

NOD2
mutation
revealed
as Crohn’s
disease (CD)
genetic target,
associated with 7-10% of
all
CD
cases
in the U.S. and Europe

Deep dive on t
ransduction enhancers
and
stable cell line technology
innovations
that
support manufacturing for larger indications

BOSTON and LONDON, Nov. 12, 2020 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today previewed details on its investigational hematopoietic stem cell (HSC) gene therapy research programs in GRN-FTD and NOD2-CD in advance of an upcoming virtual R&D investor event. The company also disclosed a new research program in ALS. A live webcast of the presentation will be available in the Investors & Media section of the company’s website at www.orchard-tx.com starting Friday, November 13, 2020 at 9:00 a.m. ET.

“We are excited to draw back the curtain at tomorrow’s event on our work in larger indications that form an important part of Orchard’s evolution as a company, including a new program in ALS, in addition to our work in genetic subsets of FTD and Crohn’s disease,” said Bobby Gaspar, M.D., Ph.D., chief executive officer, Orchard Therapeutics. “These research programs have been established using a scientific approach that has resulted in more than 160 patients being treated across multiple rare diseases and a recent positive CHMP opinion in the EU for Libmeldy™. We believe that HSC gene therapy has the power to transform lives, and we are excited about the possibilities for Orchard and patients with its expanded application.”

OTL-204 for GRN-FTD
and
new
ALS
research program

The GRN-FTD and ALS programs are based on the same HSC gene therapy approach that has been clinically validated with Libmeldy (OTL-200), Orchard’s program for metachromatic leukodystrophy, and is under clinical evaluation in the OTL-203 and OTL-201 programs for mucopolysaccharidosis type I and mucopolysaccharidosis type IIIA, respectively. Development work in GRN-FTD and ALS will be undertaken as part of a collaboration with Boston Children’s Hospital (BCH), the University of Padua (UNIPD) and Prof. Alessandra Biffi, chair of the Pediatric Hematology, Oncology and Stem Cell Transplant Division at UNIPD and co-director of the Gene Therapy Program at BCH.

  • OTL-204
    for GRN-FTD: Orchard’s preclinical program in GRN-FTD seeks to introduce a working copy of the GRN gene into HSCs, which can differentiate into microglia and secrete progranulin in the central nervous system, potentially correcting the underlying cause of the disease.

    • Preclinical work completed to date demonstrates that gene-modified HSCs can lead to GRN expression and secretion in the culture medium and uptake by GRN-negative cells.
    • Epidemiological studies suggest the FTD prevalent population in the U.S. and Europe is more than 50,000 patients with approximately 5% caused by mutations in the GRN gene, resulting in up to 2,500 GRN-FTD prevalent patients in the U.S. and Europe, with approximately 800 new patients diagnosed each year.1
  • ALS
    research program: Orchard’s new gene therapy research program in ALS will aim to restore healthy, non-activated microglia with genetically modified HSCs to favorably modulate neuroinflammation, improve symptoms and prolong survival.

    • Preclinical work previously undertaken by Prof. Biffi at BCH is based on exploiting shRNA mediated suppression of NADPH oxidase 2 (NOX2) activity to modulate neuroinflammation and neurodegeneration.
    • Rather than focusing on restoring gene function in patients with specific genetic susceptibility, this approach targets neuroinflammatory responses to support neuronal survival and could be applicable to a broader population of ALS patients.

Prof. Biffi commented, “The ability of HSC gene therapy to restore healthy microglia function supports the use of this technology for the development of treatments for a variety of diseases with central nervous system involvement. In GRN-FTD, initial in vitro data shows progranulin expression and secretion in culture and uptake indicative of cross-correction. My previous work at BCH researching ALS supports the novel approach of treating this severe neurodegenerative condition by targeting the NOX2 pathway.”

OTL-
1
04 for
NOD2-
CD

Orchard’s preclinical program in CD targets mutations in the nucleotide-binding oligomerization domain-containing protein 2 (NOD2) gene, which plays a role in immune cell response to bacterial peptides in the gastrointestinal (GI) tract. The company’s proposed approach leverages this link, using gene modified HSC-derived cells (monocytes) to replace GI resident macrophages, thus potentially correcting the inflammation and colitis associated with NOD2-CD.

  • OTL-104 preclinical work completed to date demonstrates successful restoration of NOD2 expression and functional correction in response to bacterial peptide stimulation, in NOD2 defective murine and human cells.
  • Epidemiological studies suggest the NOD2 genetic subset is associated with 7-10% of all cases of CD, with up to 200,000 patients in the U.S. and Europe with two NOD2 mutated alleles.2

Manufacturing Innovations to Support Work in Larger Indications

Transduction enhancers (TEs
)
and s
table cell line technology (SCL
T
)

Orchard has completed a thorough TE screening process and identified and validated several novel TE compounds, which in combination, facilitate lentiviral vector entry into HSCs and have shown a greater than 50% reduction in vector requirements. The enhancers’ mode of action is expected to be effective in each of Orchard’s HSC gene therapy programs. An evaluation of enhancer-treated HSC engraftment potential in mice is currently underway.

The company has worked extensively with SCLT, including the technology licensed from GSK for certain programs, to both develop processes to efficiently create SCLs for new vectors and scale up the production of SCLs to clinical grade. Results have delivered consistent levels of high-titer lentiviral production comparable to those seen using conventional methods. Selection of single high-titer clones for new vectors using this method has been achieved within three months. Work at Orchard is ongoing to develop upstream and downstream processes to further improve productivity and scalability.

“We have a clear roadmap for Orchard’s future that prioritizes strategic growth and draws on the many synergies across our scientific, manufacturing and emerging commercial platforms,” said Frank Thomas, president and chief operating officer. “Over the next 12 months we have an array of exciting commercial, regulatory and clinical milestones that will continue to showcase the breadth and depth of our advanced HSC gene therapy portfolio.”

Webcast
Information

A live webcast of the presentation “New Horizons in Gene Therapy” will be available under “Events” in the Investors & Media section of the company’s website at www.orchard-tx.com. A replay of the webcast will be archived on the Orchard website following the presentation.

About Orchard’s Research Collaborations

In connection with its previously disclosed collaboration with Prof. Alessandra Biffi, Orchard has signed agreements with Boston Children’s Hospital and the University of Padua to develop and exclusively license new ex vivo HSC gene therapy programs, patents and technologies for the treatment of neurodegenerative disorders. As part of the collaboration, Orchard has initiated sponsored research agreements and obtained exclusive options to license multiple new preclinical programs, including frontotemporal dementia with progranulin mutations (GRN-FTD), amyotrophic lateral sclerosis (ALS) and other rare and less rare indications. Orchard continues to support Professor Biffi’s labs in the development of new proprietary technology focused on enhancing the application of gene-modified HSC therapy for CNS disorders.

About Orchard

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSK’s rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard 

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchard’s investor relations website and may include additional social media channels. The contents of Orchard’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchard’s strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as “anticipates,” “believes,” “expects,” “plans,” “intends,” “projects,” and “future” or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchard’s business strategy and goals, including with respect to its manufacturing strategy, expected future milestones, and its plans and expectations for the development of its product candidates, including the product candidates referred to in this release, and the therapeutic and commercial potential of its product candidates. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchard’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that any one or more of Orchard’s product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials of Orchard’s product candidates will not be repeated or continue in ongoing or future studies or trials involving its product candidates; the risk that the market opportunity for its product candidates may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchard’s business, including on preclinical and clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading “Risk Factors” in Orchard’s quarterly report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchard’s views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

Investors

Renee Leck
Director, Investor Relations
+1 862-242-0764
[email protected]

Media

Christine Harrison
Vice President, Corporate Affairs
+1 202-415-0137
[email protected]

1 Knopman DS, Roberts RO. J Mol Neurosci. 2011, Onyike CU, Diehl-Schmid J. Int Rev Psychiatry. 2013 and Riedl L, et al Neuropsychiatr Dis Treat. 2014
2 Centers for Disease Control and Prevention; European Crohn’s and Colitis Organisation (ECCO); Ashton, James J et al.Clin Transl Gastroenterol. 2020 Feb

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Bicycle Therapeutics to Present at the Jefferies Virtual London Healthcare Conference

Bicycle Therapeutics to Present at the Jefferies Virtual London Healthcare Conference

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that management will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on Thursday, November 19, 2020 at 1:10 p.m. ET.

A live webcast of the fireside chat will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the presentation date.

About Bicycle Therapeutics

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle’s lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com.

Investor and Media Contact:

Bicycle Therapeutics

Maren Killackey

[email protected]

+1-617-203-8300

KEYWORDS: Massachusetts Europe United States United Kingdom North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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Brickell Biotech Reports Third Quarter 2020 Financial Results and Provides Corporate Update

Recently completed capital raise expected to fully fund U.S. pivotal Phase 3 program, with topline results anticipated in Q4 2021

– – –

Initiated the Cardigan I study, the first of two U.S. pivotal Phase 3 clinical studies evaluating sofpironium bromide gel, 15% as a potential treatment for primary axillary hyperhidrosis

– – –

On track to initiate the Cardigan II study, the second U.S. pivotal Phase 3 clinical study, later this year

– – –

Planned commercial launch of ECCLOCK® in Japan by development partner, Kaken, expected by the end of 2020, which follows regulatory approval received in the third quarter

BOULDER, Colo., Nov. 12, 2020 (GLOBE NEWSWIRE) — Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced financial results for the third quarter ended September 30, 2020 and provided a corporate update.

“I am proud of the focus, drive and determination that the Brickell team has shown in 2020, which has allowed us to execute against our corporate goals. As a result, we are now well-positioned to continue executing our strategy to develop sofpironium bromide as a potentially best-in-class treatment option for the more than 10 million people in the U.S. suffering with primary axillary hyperhidrosis,” commented Robert Brown, Chief Executive Officer of Brickell. “Last month, we initiated the Cardigan I registration trial and completed an equity financing, which provided us with additional capital needed to initiate the Cardigan II second registration trial later this year and is expected to allow us to complete the U.S. pivotal Phase 3 program, with topline results anticipated in the fourth quarter of 2021.”

“The third quarter was a productive period for our Japanese development partner, Kaken, who recently received regulatory approval for ECCLOCK® (sofpironium bromide gel, 5%) in Japan for the treatment of primary axillary hyperhidrosis. Japan is the first country to approve sofpironium bromide for any indication and Kaken remains on target for commercial launch later this year. We are thrilled with the progress that both Brickell and Kaken have made and look forward to providing updates on the advancement of our U.S. pivotal Phase 3 program, as well as Kaken’s launch efforts in Japan, over the coming months,” concluded Mr. Brown.

Business and Recent Developments

  • Completed an equity financing in October 2020 resulting in net proceeds of approximately $13.7 million that strengthened the Company’s balance sheet and is expected to fully fund its operations through topline results of the U.S. pivotal Phase 3 program.
  • Initiated the U.S. Phase 3 Cardigan I clinical trial, a multicenter, randomized, double-blinded, vehicle (placebo)-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15% for the treatment of primary axillary (underarm) hyperhidrosis. Subjects will apply sofpironium bromide or vehicle once daily at bedtime to their underarms for six consecutive weeks, with a two-week post-treatment follow-up. The study is expected to enroll up to 350 subjects aged nine years and older with primary axillary hyperhidrosis.
  • Japanese development partner, Kaken Pharmaceutical, Co., Ltd. (“Kaken”), received regulatory approval in Japan to manufacture and market sofpironium bromide gel, 5% for the treatment of primary axillary hyperhidrosis. This approval was based on the results of Kaken’s Japanese pivotal Phase 3 registration study of sofpironium bromide gel, 5% in 281 patients with primary axillary hyperhidrosis, in which all primary and secondary efficacy endpoints demonstrated statistically significant differences between sofpironium bromide gel and vehicle. In addition, sofpironium bromide gel, 5% was observed to be safe and generally well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study with 185 patients in Japan.
  • Kaken and Brickell were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide that is expected to provide additional protection for these newly developed and distinct forms in Japan through 2040. 
  • Completed the 12-month Phase 3 open-label long-term safety study evaluating sofpironium bromide gel, 5% and 15% in 300 subjects nine years and older with primary axillary hyperhidrosis. The study results confirmed that sofpironium bromide gel, at both concentrations, was safe and generally well tolerated, which was consistent with the earlier Phase 2 clinical trial results. No treatment-related serious adverse events were observed. The Company expects to release additional details at an upcoming scientific forum.
  • Entered into a collaboration agreement with AnGes, Inc (“AnGes”) through which the Company has certain rights to develop AnGes’ proprietary investigational adjuvanted plasmid DNA vaccine intended to prevent SARS-CoV-2 (COVID-19) in the U.S., South America and certain other emerging markets. AnGes is currently conducting Phase 1/2 clinical studies with its vaccine candidate in Japan.

Upcoming Milestones

  • Plan to initiate the Cardigan II study, the second U.S. pivotal Phase 3 clinical trial, prior to year end. The Cardigan II study will evaluate the safety and efficacy of sofpironium bromide gel, 15% versus vehicle in approximately 350 subjects aged nine years and older with primary axillary hyperhidrosis.
  • Expect Kaken to launch ECCLOCK® commercially in Japan by the end of 2020. Under our agreement with Kaken, Brickell is entitled to receive commercial milestone payments, as well as tiered royalties based on a percentage of net sales in Japan.
  • Expect to report topline data from both the Cardigan I and II U.S. pivotal Phase 3 clinical studies by the end of 2021.
  • Expect to receive results from the Phase 1/2 clinical studies with AnGes’ COVID-19 vaccine candidate in Japan through the first quarter of 2021. The results from these studies will guide AnGes’ and Brickell’s global development efforts of this novel vaccine candidate.

Financial Results

The Company reported cash and cash equivalents and marketable securities of $20.2 million as of September 30, 2020 compared to $11.7 million as of December 31, 2019. In addition, Brickell has prepaid $4.2 million to third-party clinical research organizations as part of conducting the U.S. pivotal Phase 3 clinical trials of sofpironium bromide. Subsequent to the end of the third quarter, the Company completed a public equity offering resulting in net proceeds of approximately $13.7 million.

Revenue was $0.1 million for the third quarter of 2020 compared to $1.2 million for the third quarter of 2019. Revenue in both periods was driven by research and development activities related to the agreement with Kaken pursuant to which Kaken provided research and development funding to Brickell. The decrease in revenue recognized was attributable to Brickell’s Phase 3 open-label long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were ongoing in 2019 but were concluded or winding down by the end of the first quarter of 2020. Conducting these studies is the basis for revenue recognition of a $15.6 million research and development payment received from Kaken in the second quarter of 2018.

Research and development expenses were $1.3 million for the third quarter of 2020 compared to $3.3 million for the third quarter of 2019. This decrease was primarily due to reduced clinical and other related regulatory and compliance costs of the Phase 3 open-label long-term safety study of sofpironium bromide gel and other ancillary clinical studies that were concluded or winding down by the end of the first quarter of 2020.

General and administrative expenses were $3.2 million for the third quarter of 2020 compared to $3.9 million for the third quarter of 2019. This decrease was primarily due to lower costs of $1.1 million for professional-related fees associated with the merger with Vical Incorporated that occurred in the third quarter of 2019 and $0.4 million for other miscellaneous fees, partially offset by higher costs of $0.6 million for stock and other compensation expense that was driven by increased headcount and $0.2 million for directors’ and officers’ liability insurance due to becoming a public company.

Brickell’s net loss was $4.3 million for the third quarter of 2020 compared to $4.8 million for the third quarter of 2019.

Conference Call and Webcast Information

Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13708850. A live webcast of the conference call can be accessed through the “Investors” tab on the Brickell Biotech website at https://www.brickellbio.com. A replay will be available on this website shortly after conclusion of the event for 90 days.

About Sofpironium Bromide

Sofpironium bromide is a proprietary investigational new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida.

About Hyperhidrosis

Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/.

About Brickell

Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit https://www.brickellbio.com. 

Cautionary Note Regarding Forward-Looking Statements

Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of ongoing and future clinical trials, intellectual property rights, including the validity, term and enforceability of such, the expected timing and/or results of regulatory approvals and prospects for commercializing any of Brickell’s product candidates, or research collaborations with its partners, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. 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,” “potential,” “look forward” and similar expressions and their variants, as they relate to Brickell, Kaken, AnGes or any of Brickell’s partners, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. 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 without limitation, ability to obtain adequate financing to advance product development, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development, regulatory changes, supply chain disruptions, unanticipated demands on cash resources, any disruption to its business caused by the current COVID-19 pandemic, interruptions, disruption or inability by Kaken to supply, launch and commercialize the product in Japan, or obtain adequate pricing, and other risks associated with developing, and obtaining regulatory approval for and commercializing product candidates.

Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at https://www.sec.gov (or at https://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

                                

1 Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.
2 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.

Brickell Investor Contact:

Dan Ferry
LifeSci Advisors
(617) 430-7576
[email protected]

Brickell Biotech, Inc.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

(unaudited)
 
    Three Months Ended

September 30, 		  Nine Months Ended

September 30,
    2020   2019   2020


 		  2019  
Collaboration revenue   $ 142     $ 1,183     $ 1,795     $ 7,248  
                                 
Operating expenses:                                
Research and development   1,281     3,337     6,657     13,585  
General and administrative   3,211     3,901     8,713     7,290  
Total operating expenses   4,492     7,238     15,370     20,875  
Loss from operations   (4,350 )   (6,055 )   (13,575 )   (13,627 )
Investment and other income, net   24     54     27     64  
Gain on extinguishment   —     2,318     —     2,318  
Interest expense   —     (1,098 )   —     (1,982 )
                         
Change in fair value of warrant and derivative liability   —     —     —     212  
Net loss   (4,326 )   (4,781 )   (13,548 )   (13,015 )
Reduction (accretion) of redeemable convertible
preferred stock to redemption value		   —     (82 )   —     10,274  
Net loss attributable to common stockholders   $ (4,326 )   $ (4,863 )   $ (13,548 )   $ (2,741 )
Net loss per common share attributable to common
stockholders, basic and diluted		   $ (0.15 )   $ (1.65 )   $ (0.82 )   $ (1.98 )
Weighted-average shares used to compute net loss per
share attributable to common stockholders, basic and
diluted		   28,107,785     2,943,896     16,475,843     1,382,592  
                         

Brickell Biotech, Inc.

Selected Financial Information

Condensed Consolidated Balance Sheet Data

(amounts in thousands)

(unaudited)
 
  September 30,

2020 		  December 31,
2019
Cash and cash equivalents $ 20,174     $ 7,232  
Marketable securities, available-for-sale —     4,497  
Prepaid expenses and other current assets 6,129     6,240  
Total assets 26,404     18,144  
Total liabilities 7,692     10,570  
Total stockholders’ equity 18,712     7,574  

Posted on

TutorMe Receives National Parenting Product Award

PR Newswire

LOS ANGELES, Nov. 12, 2020 /PRNewswire/ — TutorMe, the online tutoring solution of the future, announced today that it had received a National Parenting Product Award.

“During this time of COVID, many students are away from the traditional school setting where they have direct access to their teachers,” said Elena Epstein, director of the National Parenting Product Awards.

“Unique educational resources and tools can provide a real benefit to families right now. TutorMe is wonderful because it’s available at any time on demand and covers a wide variety of subjects and grade levels. We all know how frustrating it can be trying to figure out chemistry at 10 pm. What a great feeling to know you can call a tutor for some much-needed guidance at the exact time that you need it,” continued Epstein.  

TutorMe is also a recipient of HowtoLearn.com’s 2020 Parent and Teacher Choice™ Award and received the Timmy for Best Tech for Good in LA.

“We are thrilled that the National Parenting Product Awards, in addition to HowtoLearn.com and Tech in Motion Events, have recognized the positive impact of TutorMe on K-12 and higher education students and their families,” said Myles Hunter, co-founder, and CEO of TutorMe. “Ensuring that no student feels left behind in school is why we started TutorMe.”


About the National Parenting Product Awards

Integrity and honesty are at the core of what the National Parenting Product Awards (NAPPA) stands for. For 30 years, NAPPA Awards has been ensuring that parents purchase the highest quality products. NAPPA’s team of evaluators select the best educational tools, books, games, toys, apps, baby gear, and other family-must haves through year-round product testing. For more information on the National Parenting Product Awards, visit NAPPA Awards.


About TutorMe






TutorMe is the online tutor of the future—as a leading provider of online tutoring, the platform connects students with highly qualified tutors in, on average, less than 30 seconds. TutorMe provides instruction via video chat, screen sharing, and virtual whiteboards archived for future reference. They work with learners and parents from K–12 to higher education, either directly or through partnerships with academic institutions or via employer-provided benefits. TutorMe is part of the Zovio network.


About Zovio


Zovio (Nasdaq: ZVO) is an education technology services company that partners with higher education institutions and employers to deliver innovative, personalized solutions to help learners and leaders achieve their aspirations. The Zovio network, which includes Fullstack Academy, TutorMe, and Learn@Forbes, leverages its core strengths and applies its technology and capabilities to priority market needs. Using advanced data and analytics, Zovio identifies the most meaningful ways to enhance the learner experience and deliver strong outcomes for higher education institutions, employers, and learners. Zovio’s purpose is to help everyone be in a class of their own. For more information, visit www.zovio.com.

Alanna Vitucci

[email protected]

858 668 2586 x11636

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/tutorme-receives-national-parenting-product-award-301172357.html

SOURCE TutorMe

Posted on

Q3 2020 Financial Information

  • Cash and cash equivalents at €124.6m as of September 30, 2020, allowing the Company to finance its operating activities through Q4 2022
     
  • Revenues of €0.3m for the first nine months of 2020



Daix (France), November 12, 2020 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today reported its cash position as of September 30, 2020 and its revenues for the first nine months of 2020.




Cash Position

As of September 30, 2020, Inventiva’s cash and cash equivalents stood at €124.6 million, compared to €52.2 million as of June 30, 2020 and €35.8 million as of December 31, 2019.

Inventiva’s net cash flow amounted to €88.8 million (net of (€2.4) million exchange rate effect) for the nine months ended September 30, 2020, compared to (€21.3) million for the first nine months of 2019.

Net cash used in operating activities was (€19.4) million for the first nine months of 2020, compared to (€28.3) million for the same period in 2019. This decrease is mainly due to the halt in the clinical development of lanifibranor for the treatment of systemic sclerosis in February 2019 and the savings generated by the Employment Safeguard Plan subsequently introduced mid-2019, with the first nine months of 2020 recording the full effect of the savings generated. The cash flow from operating activities was also positively impacted by the receipt in January 2020 of €4.2 million in respect of the 2018 Research Tax Credit (CIR – Crédit Impôt Recherche), and the receipt in April and June 2020 of €4.2 million in total in respect of the 2019 CIR.

Net
cash from financing activities amounted to €111.6 million for the first nine months of 2020, driven by: the issuance of €15.0 million (gross proceeds) of ordinary shares in February 2020 to certain existing investors in the Company, the entry into €10.0 million credit agreements, guaranteed by the French State, with a syndicate of French banks in May 2020, and the receipt of €94.9 million2 (gross proceeds) following the successful IPO on the Nasdaq Global Market in July 2020, extending Inventiva’s cash runway through the fourth quarter of 2022.




Revenues

The Company’s revenues for the first nine months of 2020 amounted to €0.3 million, compared to €3.4 million for the same period in 2019.

                                                                                                           
***


Next key milestones expected

  • Regulatory feedback on Phase III development of lanifibranor in NASH from the European Medicines Agency (EMA) – planned for the fourth quarter of 2020
  • AbbVie’s completion of its ongoing Phase I clinical trial with ABBV-157 in psoriasis patients – expectedin the first quarter of 20213 vs fourth quarter of 2020 as initially planned
  • Initiation of Phase III clinical trial evaluating lanifibranor in NASH – planned for the first half of 2021


Upcoming investor conference participation

  • Stifel Virtual Healthcare Conference 2020, November 17-18, 2020
  • Jefferies 11th Virtual Healthcare Conference, November 17-19, 2020
  • Piper Sandler 32nd Annual Virtual Healthcare Conference, November 30 – December 3, 2020


Upcoming scientific conference presentations

  • Presentation of the NATIVE Phase IIb clinical trial results at The Liver Meeting Digital Experience™ 2020 of the AASLD (American Association for the Study of Liver Diseases), November 15, 2020
  • Key Opinion Leader webcast focused on NASH, hosted by Inventiva from The Liver Meeting Digital Experience™ 2020 of the AASLD, November 16, 2020




Next financial results publication

§   Q4 2020 Revenues and cash position: Thursday, February 11, 2021 (after U.S. market close)



About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.

In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (ticker: IVA – ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com



Contacts

Inventiva

Frédéric Cren
Chairman & CEO
[email protected]
+33 3 80 44 75 00

Brunswick Group

Yannick Tetzlaff / Tristan Roquet Montegon / 
Aude Lepreux
Media relations
[email protected]
+33 1 53 96 83 83

Westwicke, an ICR Company


Patricia L. Bank
Investor relations
[email protected]
+1 415 513 1284 



Important Notice

This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva’s clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s clinical trials may not support Inventiva’s product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s control, Inventiva’s product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release.
Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the Universal Registration Document filed with the Autorité des Marchés Financiers on June 19, 2020 under n° D.20-0551 and its amendment filed on July 10, 2020 under n° D. 20-0551-A01 as well as the half-year financial report on June 30, 2020 for additional information in relation to such factors, risks and uncertainties.

Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

1 Non-audited financial information.

2 Based on an exchange rate of $1.1342 per euro, the exchange rate published by the European Central Bank on July 9, 2020.

3 Source: clinicaltrials.gov.

Attachment

Posted on

Blueknight to Participate at Upcoming Investor Conferences

Blueknight to Participate at Upcoming Investor Conferences

TULSA, Okla.–(BUSINESS WIRE)–
Blueknight Energy Partners, L.P. (“Blueknight” or the “Partnership”) (Nasdaq: BKEP and BKEPP) today announced that its Chief Executive Officer, Andrew Woodward, and Chief Financial Officer, Matthew Lewis, are scheduled to participate in the following upcoming virtual investor conferences:

  • RBC Capital Markets Midstream and Energy Infrastructure Conference on Wednesday, November 18, 2020. Blueknight will be hosting one-on-one meetings.
  • Wells Fargo Midstream and Utility Symposium on Tuesday, December 8, 2020. Blueknight will be hosting one-on-one meetings.

Presentation materials used at these conferences will be available through the “Investors” section of the Blueknight website at investor.bkep.com.

About Blueknight Energy Partners, L.P.

Blueknight owns and operates a diversified portfolio of complementary midstream energy assets consisting of:

  • 8.8 million barrels of liquid asphalt storage located at 53 terminals in 26 states;
  • 6.9 million barrels of above-ground crude oil storage capacity located primarily in Oklahoma, approximately 6.6 million barrels of which are located at the Cushing Interchange terminalling facility in Cushing, Oklahoma;
  • 604 miles of crude oil pipeline located primarily in Oklahoma; and
  • 63 crude oil transportation vehicles deployed in Oklahoma and Texas.

Blueknight provides integrated terminalling, gathering and transportation services for companies engaged in the production, distribution and marketing of liquid asphalt and crude oil. Blueknight is headquartered in Tulsa, Oklahoma. For more information, visit the Partnership’s website at www.bkep.com.

Blueknight Investor Relations

Chase Jacobson, (918) 237-4032

[email protected]

KEYWORDS: United States North America Oklahoma

INDUSTRY KEYWORDS: Oil/Gas Energy

MEDIA:

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Posted on

Foresight Announces Third Quarter 2020 Financial Results

Foresight Announces Third Quarter 2020 Financial Results

NESS ZIONA, Israel–(BUSINESS WIRE)–
Foresight Autonomous Holdings Ltd., an innovator in automotive vision systems (Nasdaq and TASE: FRSX), today reported financial results for the third quarter ended September 30, 2020. Foresight ended the third quarter of 2020 with $14.5 million in cash and short-term deposits, GAAP net loss of $11.4 million and non-GAAP net loss for the same period of $10.5 million.

“Foresight continued to demonstrate steady progress in the third quarter, as we established new partnerships with influential players in Europe, Japan and China,” commented Haim Siboni, CEO of Foresight. “We are confident that our new relationships with leading companies such as Elbit Systems and FLIR Systems will lead to stable sales growth, as we continue to refine our products and technology based on feedback from our prototype system sales. I am proud of how Foresight has responded to the market situation posed by the COVID-19 pandemic, as we have worked not only to maintain stable business performance, but also to develop a COVID-19 symptom screening solution which leverages our leading thermal and visible-light camera technology.”

“The third quarter also saw notable progress for our subsidiary Eye-Net Mobile and our affiliated company Rail Vision,” continued Mr. Siboni. “Both companies made impressive strides in new markets, demonstrating the long-term potential of their innovative technologies. Rail Vision has accomplished the first commercial agreement for its shunting yard solution which is currently being evaluated by a major European train operator, while Eye-Net Mobile’s Eye-Net™ Protect solution is undergoing pilot projects with two multi-billion-dollar Japanese companies. We are optimistic that successful evaluation could lead to further collaboration with these impressive partners.”

Third Quarter 2020 Financial Results

  • Research and development (R&D) expenses for the three months ended September 30, 2020 were $2,157,000 compared to $2,547,000 in the three months ended September 30, 2019. The decrease is attributed mainly to a decrease in subcontracted services.
  • General and administrative (G&A) expenses for the three months ended September 30, 2020 were $918,000 compared to $893,000 in the three months ended September 30, 2019. The increase is attributed mainly to an increase in payroll expenses partially offset by a decrease in professional services.
  • GAAP net loss for the three months ended September 30, 2020 was $3,980,000, or $0.02 loss per ordinary share, compared to GAAP net loss of $3,931,000, or $0.03 loss per ordinary share, in the three months ended September 30, 2019. The increase is attributed mainly to an increase in equity in net loss of an affiliated company.
  • Non-GAAP net loss for the three months ended September 30, 2020 was $3,420,000, or $0.02 loss per ordinary share, compared to a non-GAAP net loss of $3,439,000, or $0.01 loss per ordinary share, in the three months ended September 30, 2019. A reconciliation between GAAP net loss and non-GAAP net loss is provided following the financial statements that are part of this release. Non-GAAP results exclude the effect of stock-based compensation expenses, revaluation of other investments and revaluation of derivative warrant liability.

Balance Sheet Highlights

  • Cash and cash equivalents and short-term deposits totaled $14.5 million as of September 30, 2020, compared to $13.1 million on September 30, 2019.
  • Investments in Rail Vision Ltd. totaled $4.7 million as of September 30, 2020, compared to $7.4 million on September 30, 2019. The decrease is attributed mainly to equity in net loss of Rail Vision’s results.
  • GAAP shareholders’ equity totaled $18.8 million as of September 30, 2020, compared to $16.3 million as of December 31, 2019.
  • Non-GAAP shareholders’ equity totaled $18.8 million as of September 30, 2020, compared to $16.6 million as of December 31, 2019.

 

 

As of

September 30,

 

As of

December 31,

(thousands of U.S. dollars)

 

2020

 

2019

 

2019

GAAP Results

 

 

 

 

 

 

Shareholders’ equity

 

$ 18,767

 

$ 20,307

 

$ 16,288

Non-GAAP Results

 

 

 

 

 

 

Shareholders’ equity

 

$ 18,767

 

$ 20,631

 

$ 16,612

A reconciliation between GAAP shareholders’ equity results and non-GAAP shareholders’ equity results is provided following the financial statements that are part of this release. Non-GAAP results exclude revaluation of other investments.

Recent Corporate Highlights:

  • Foresight Received Two Product Orders from Elbit Systems Ltd.: In July, Foresight received two orders for product development and customization from Elbit Systems Land Ltd., a subsidiary of the leading Israeli defense company Elbit Systems. According to the agreement, Foresight will supply a QuadSight® prototype system with wide-angle field-of-view detection capabilities to meet Elbit Systems’ specific requirements. The modified prototype enhances the QuadSight system’s ability to detect objects in a wider area of the road ahead.
  • Foresight Initiated Pilot Project for COVID-19 Screening Solution: Foresight announced in July that its COVID-19 symptom screening solution, which is designed to detect several notable symptoms of the coronavirus, will be tested in a pilot project with Meuhedet, one of Israel’s largest health maintenance organizations. The pilot will take place in Israel in the city of Ashdod, where Meuhedet’s largest clinic serves approx. 50,000 patients. The screening solution, based on Foresight’s extensive experience with thermal and visible light cameras, is designed to detect high body temperature and signs of fatigue.
  • Foresight Received Order for Two Prototype Systems from Multi-Billion-Dollar Chinese Technology Company: Two QuadSight vision system prototypes were ordered in July by the automotive solutions business unit of a multi-billion-dollar global Chinese technology company. The technology company may use Foresight’s technology to improve its autonomous vehicle and safety solutions, and the prototype sales could result in future collaboration.
  • Rail Vision Signed Commercial Agreement to Supply Shunting Yard Systems to Leading European Train Operator: Rail Vision, an affiliate of Foresight, announced in September that it signed a commercial agreement with an affiliate of Knorr-Bremse AG, a $17 billion Europe-based group. According to the agreement, Knorr-Bremse will supply Rail Vision’s Assisted Remote Shunting (ARS) systems to a leading European train operator. As first announced in April, Rail Vision received an initial order from a leading European train operator for an ARS prototype system and to execute an Operational Functional Test. According to the terms of the agreement, the train operator may choose to purchase 30 ARS systems, and may then exercise the option to purchase an additional 45 ARS systems.
  • Eye-Net Mobile Received Patent Approval for Accident Prevention Solution: In late July, Eye-Net Mobile, a wholly-owned subsidiary of Foresight, received a notice of allowance from the U.S. Patent and Trademark Office for its patent application for a “system and method for preventing car accidents and collisions between vehicles and pedestrians.” The patented technology refers to Eye-Net Mobile’s accident prevention system, which predicts collisions between vehicles and pedestrians through a dedicated software application on the mobile devices of pedestrians and vehicle users.
  • Eye-Net Mobile Announced Two Pilot Projects with Global Japanese Technology Companies: In August, Eye-Net Mobile announced two pilot projects for its Eye-Net Protect cellular based V2X (vehicle-to-everything) accident prevention solution. The Eye-Net Protect system will be evaluated by a multi-billion-dollar global Japanese technology company, as well as by a multi-billion-dollar multinational Japanese electronics company. The projects will evaluate the Software Development Kit (SDK) configuration of the Eye-Net Protect solution.
  • Foresight Completed Development of Commercial Version of Automatic Calibration Software: In September, Foresight announced the completion of a commercial version of its groundbreaking automatic calibration software. Foresight’s software solution ensures stereoscopic sensors remain calibrated regardless of their position on the car. These calibration capabilities are essential to create the accurate stereoscopic 3D perception needed for reliable automotive vision systems. Additionally, Foresight submitted two new patent applications related to multiple-sensor camera systems.

     

Use of Non-GAAP Financial Results

In addition to disclosing financial results calculated in accordance with United States generally accepted accounting principles (GAAP), the company’s earnings release contains non-GAAP financial measures of net loss for the period that excludes the effect of stock-based compensation expenses, the revaluation of other investments and revaluation of derivative warrant liability, and non-GAAP financial measures of shareholders’ equity that excludes the effect of derivative warrant liability and the revaluation of other investments. The company’s management believes the non-GAAP financial information provided in this release is useful to investors’ understanding and assessment of the company’s ongoing operations. Management also uses both GAAP and non-GAAP information in evaluating and operating business internally and as such deemed it important to provide all this information to investors. The non-GAAP financial measures disclosed by the company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with GAAP, and the financial results calculated in accordance with GAAP and reconciliations to those financial statements should be carefully evaluated. Reconciliations between GAAP measures and non-GAAP measures are provided later in this press release.

About Foresight

Foresight Autonomous Holdings Ltd. (Nasdaq and TASE: FRSX), founded in 2015, is a technology company engaged in the design, development and commercialization of stereo/quad-camera vision systems for the automotive industry. Through the company’s wholly owned subsidiaries, Foresight Automotive Ltd. and Eye-Net Mobile Ltd., Foresight develops both “in-line-of-sight” vision systems and “beyond-line-of-sight” cellular-based applications. Foresight’s vision sensor is a four-camera system based on 3D video analysis, advanced algorithms for image processing, and sensor fusion. . Eye-Net Mobile’s cellular-based application is a V2X (vehicle-to-everything) accident prevention solution based on real-time spatial analysis of clients’ movement.

The company’s systems are designed to improve driving safety by enabling highly accurate and reliable threat detection while ensuring the lowest rates of false alerts. Foresight is targeting the Advanced Driver Assistance Systems (ADAS), the semi-autonomous and autonomous vehicle markets and predicts that its systems will revolutionize automotive safety by providing an automotive-grade, cost-effective platform and advanced technology.

For more information about Foresight and its wholly owned subsidiary, Foresight Automotive, visit www.foresightauto.com, follow @ForesightAuto1 on Twitter, or join Foresight Automotive on LinkedIn.

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 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Foresight is using forward-looking statements in this press release when it discusses its expected stable sales growth and further collaborations with partners. Because such statements deal with future events and are based on Foresight’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Foresight could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Foresight’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 31, 2020, and in any subsequent filings with the SEC. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: Foresight’s burn rate, its ability to generate revenue, and its ability to continue as a going concern. Based on the projected cash flows and Foresight’s cash balances as of September 30, 2020, Foresight’s management is of the opinion that as of September 30, 2020, without further fund raising it will not have enough resources to enable it to continue advancing its activities for a period of at least 12 months. As a result, there is substantial doubt about Foresight’s ability to continue as a going concern. Except as otherwise required by law, Foresight undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release.

FORESIGHT AUTONOMOUS HOLDINGS LTD.

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

 

As of

September 30, 2020

 

 

As of

September 30, 2019

 

As of

December 31, 2019

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,395

 

$

5,070

 

$

4,827

 

Short Term Deposits

 

 

5,142

 

 

8,068

 

 

5,233

 

Marketable equity securities

 

 

19

 

 

36

 

 

23

 

Other receivables

 

 

446

 

 

773

 

 

613

 

Total current assets

 

 

15,002

 

 

13,947

 

 

10,696

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets:

 

 

 

 

 

 

 

 

 

 

ROU Asset

 

 

1,127

 

 

1,340

 

 

1,278

 

Investment in affiliate company

 

 

4,730

 

 

7,400

 

 

6,729

 

Fixed assets, net

 

 

487

 

 

668

 

 

631

 

 

 

 

6,344

 

 

9,408

 

 

8,638

 

 

 

 

 

 

 

 

 

 

 

 

Total assets

 

$

21,346

 

$

23,355

 

$

19,334

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’

EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

Trade payables

 

$

188

 

$

675

 

$

498

 

Operating Lease Liability

 

 

401

 

 

413

 

 

411

 

Other accounts payables

 

 

1,158

 

 

892

 

 

1,130

 

Total current liabilities

 

 

1,747

 

 

1,980

 

 

2,039

 

 

 

 

 

 

 

 

 

 

 

 

Non-current liabilities:

 

 

 

 

 

 

 

 

 

 

Operating Lease Liability

 

 

832

 

 

1,068

 

 

1,007

 

 

 

 

 

 

 

 

 

 

–

 

Total liabilities

 

 

2,579

 

 

3,048

 

 

3,046

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock of NIS 0 par value;

 

 

–

 

 

–

 

 

–

 

Additional paid-in capital

 

 

79,478

 

 

65,330

 

 

65,681

 

Accumulated deficit

 

 

(60,753

)

 

(45,023

)

 

(49,393

)

Total Foresight autonomous holdings LTD. Shareholders’ equity

 

 

18,725

 

 

20,307

 

 

19,334

 

Non-Controlling Interest

 

 

42

 

 

–

 

 

–

 

Total equity

 

 

18,767

 

 

20,307

 

 

16,288

 

 

 

 

 

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

21,346

 

$

23,355

 

$

 

19,334

 

 

FORESIGHT AUTONOMOUS HOLDINGS LTD.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S. dollars in thousands

 

 

Nine months ended

September 30,

  

Three months ended

September 30,

 

 

2020

  

2019

  

2020

  

2019

Research and development expenses, net

 

(6,374)

 

(7,007)

 

(2,157)

 

(2,547)

 

 

 

 

 

 

 

 

 

Marketing and sales

 

(973)

 

(1,616)

 

(307)

 

(519)

 

 

 

 

 

 

 

 

 

General and administrative expenses

 

(2,212)

 

(2,666)

 

(918)

 

(893)

 

 

 

 

 

 

 

 

 

Operating loss

  

(9,559)

 

(11,289)

 

(3,382)

 

(3,959)

 

 

 

 

 

 

 

 

 

Equity in net gain (loss) of an affiliated company

 

(1,999)

 

(168)

 

(655)

 

(184)

 

 

 

 

 

 

 

 

 

Financing income (expenses), net

 

198

 

388

 

57

 

212

 

 

 

 

 

 

 

 

 

Net loss

  

(11,360)

 

(11,069)

 

(3,980)

 

(3,931)

 

 

 

 

 

 

 

 

 

FORESIGHT AUTONOMOUS HOLDINGS LTD.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

U.S. dollars in thousands

 

 

Nine months ended

September 30,

  

Three months ended

September 30,

 

 

2020

  

2019

  

2020

  

2019

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

  

 

 

 

 

 

 

 

Loss for the Period

 

(11,360)

 

(11,069)

 

(3,980)

 

(3,931)

 

 

 

 

 

 

 

 

 

Adjustments to reconcile profit (loss) to net cash used in operating activities:

 

 

2,852

 

 

2,259

 

 

1,249

 

 

827

 

 

 

 

 

 

 

 

 

Net cash used in operating activities

  

(8,508)

  

(8,810)

  

(2,731)

  

(3,104)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash Flows from Investing Activities

  

 

 

 

 

 

 

 

Changes in short term deposits

 

91

 

4,438

 

1,987

 

4,212

Proceed from other investments

 

–

 

21

 

–

 

–

Proceed from sales marketable securities

 

68

 

–

 

–

 

–

Purchase of fixed assets

 

(48)

 

(73)

 

(39)

 

(34)

 

 

 

 

 

 

 

 

 

Net cash provided by investing activities

  

111

  

4,386

 

1,948

  

4,178

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from Financing Activities:

  

 

 

 

 

 

 

 

Issuance of ordinary shares and warrants, net of issuance expenses

 

 

12,929

 

 

6,521

 

 

(153)

 

–

 

 

 

 

 

 

 

 

 

Net cash provided (used) by financing activities

  

12,929

  

6,521

  

(153)

  

–

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

  

36

  

(185)

  

19

  

(51)

 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

  

4,568

 

1,912

 

(917)

  

1,023

Cash and cash equivalents at the beginning of the period

  

 

4,827

 

 

3,158

 

 

10,312

  

 

4,047

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

  

 

9,395

 

 

5,070

 

 

9,395

  

 

5,070

 

 

 

 

 

 

 

 

 

FORESIGHT AUTONOMOUS HOLDINGS LTD.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW

U.S. dollars in thousands

Adjustments to reconcile profit (loss) to net cash used in operating activities:

  

Nine months

ended

September 30,

  

Three months

ended

September 30,

 

 

2020

  

2019

  

2020

  

2019

Share-based payment

 

910

 

1,286

 

560

 

450

Depreciation

 

192

 

193

 

61

 

65

Revaluation of derivative warrant liability

 

–

 

1

 

–

 

(42)

Equity in loss (gain) of an affiliated company

 

1,999

 

168

 

655

 

184

Revaluation of securities

 

(64)

 

(13)

 

(5)

 

(5)

Revaluation of other investments

 

–

 

324

 

–

 

–

exchange rate changes on cash and cash equivalents

 

(36)

 

185

 

(19)

 

51

 

 

 

 

 

 

 

 

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Decrease (increase) in other receivables

 

167

 

(302)

 

(135)

 

(264)

Increase (decrease) in Trade payables

 

(310)

 

331

 

94

 

368

Change in operating lease liability

 

(15)

 

105

 

2

 

30

Increase (decrease) in other accounts payable

 

9

 

(19)

 

36

 

(10)

 

 

 

 

 

 

 

 

 

Adjustments to reconcile loss to net cash used in operating activities

  

 

2,852

  

 

2,259

 

 

1,249

  

 

827

 

 

 

 

 

 

 

 

 

FORESIGHT AUTONOMOUS HOLDINGS LTD.

SUPPLEMENTAL RECONCILIATION OF GAAP TO NON-GAAP SHAREHOLDERS’ EQUITY

U.S. dollars in thousands

 

 

As of

September 30,

2020

 

 

As of

September 30,

2019

 

 

As of

December 31,

2019

GAAP Shareholders’ equity

 

 

18,767

 

 

20,307

 

16,288

Revaluation of other investments

 

 

—

 

 

324

 

324

Non-GAAP Shareholders’ equity

 

 

18,767

 

 

20,631

 

16,612

 

SUPPLEMENTAL RECONCILIATION OF GAAP TO NON-GAAP RESULTS

U.S. dollars in thousands

 

 

 

Nine months ended

September 30

  

Three months ended

September 30,

 

 

2020

  

2019

  

2020

  

2019

GAAP operating loss

  

(9,559)

  

(11,289)

  

(3,382)

  

(3,959)

Stock-based compensation in research and development

 

 

374

 

 

442

 

 

215

 

 

158

Stock-based compensation in sales and marketing

 

46

 

152

 

14

 

54

Stock-based compensation in general and administrative

 

490

 

692

 

331

 

238

Non-GAAP operating loss

  

(8,649)

  

(10,003)

  

(2,822)

  

(3,509)

 

 

 

 

 

 

 

 

 

GAAP Financing income (expenses), net

  

198

 

388

 

57

  

212

Revaluation of other investments

 

—

 

324

 

—

 

–

Revaluation of derivative warrant liability expenses

 

—

 

1

 

—

 

42

Non-GAAP Financing income, net

  

198

 

713

 

57

  

254

 

 

 

 

 

 

 

 

 

GAAP net loss

  

(11,360)

  

(11,069)

  

(3,980)

  

(3,931)

Stock-based compensation expenses

 

910

 

1,286

 

560

 

450

Revaluation of other investments

 

—

 

324

 

—

 

–

Revaluation of derivative warrant liability

 

—

 

1

 

—

 

42

Non-GAAP net loss

  

(10,450)

  

(9,457)

  

(3,420)

  

(3,439)

 

 

 

 

 

 

 

 

 

 

Investor Relations Contact:

Miri Segal-Scharia

CEO

MS-IR LLC

[email protected]

917-607-8654

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Columbia Care Columbia Care Reports Record Third Quarter 2020 Financial Results, Transitions to Generating Positive EBITDA

Columbia Care Columbia Care Reports Record Third Quarter 2020 Financial Results, Transitions to Generating Positive EBITDA

  • Record 3Q Combined Revenue of $54 Million, an increase of 64% QoQ and 145% YoY.
  • Record 3Q Combined Adjusted Gross Profit of $21 Million, an increase of 78% QoQ and 300% YoY.
  • Record 3Q Combined Adjusted Gross Margin of 39%, an increase of 299 bps QoQ and 1,515 bps YoY.
  • Record 3Q Combined Adjusted EBITDA of over $4 Million, an increase of $9 Million QoQ and $16 Million YoY – marks transition to generating positive Adjusted EBITDA.
  • Closed Acquisition of The Green Solution Solidifying Market Leadership in Colorado; Reaffirms Full Year Guidance.
  • Announced Definitive Agreement to Acquire Project Cannabis, Establishing Leadership Position in California Market.
  • Appointed Consumer Products Veteran Alison Worthington to Board of Directors. Brings Decades of Experience from Starbucks, Coca-Cola, Method Home Products and Microsoft.
  • Completed $20.4 Million Add-on Debt Financing at 170 bps Discount to Prior Offering in 2Q – Increasing Liquidity, Reducing Cost of Capital and Positioning Company for Targeted Capital Expansion and Acquisitions

NEW YORK–(BUSINESS WIRE)–
Columbia Care, Inc. (NEO: CCHW) (CSE: CCHW) (OTCQX: CCHWF) (FSE: 3LP) (“Columbia Care” or the “Company”) is reporting financial and operating results for the third quarter ended September 30, 2020. All financial information is unaudited and provided in US dollars unless otherwise indicated.

“Our growth strategy and operational discipline resulted in Columbia Care generating another quarter of record results,” said Nicholas Vita, CEO of Columbia Care. “While we are delighted to announce significant year-over-year and sequential growth in revenue, gross margin and EBITDA, transitioning to an EBITDA positive business is the milestone we have been eager to surpass. We completed our acquisition of The Green Solution (TGS) in the third quarter, solidifying our leadership position in the world’s second largest cannabis market. TGS adds profitable scale to our national portfolio of brands and brings considerable expertise to ensure our transition to adult use market frameworks is successful in every respect. It opens the door for Columbia Care to further press our leadership position and leverage our know-how and experience across markets nationally. I am extremely proud of the team’s unwavering focus on day to day execution in each market, as well as our continued national focus on quality, innovation, customer care and community service. As we integrate and leverage our pipeline of acquisitions, I expect the power and uniqueness of our operating platform to further distinguish Columbia Care in each of our core functional areas. With strong momentum and political tailwinds, we are reiterating our previously stated revenue, gross margin, and adjusted EBITDA guidance for the full year 2020.”

Third quarter 2020 combined and reported results include one month of contribution from The Green Solution (TGS) in Colorado, which the Company acquired on September 1, 2020. For the month of September, TGS generated approximately $9.5 million of revenue, $4.3 million of gross profit, and $2.4 million of adjusted EBITDA. Through the third quarter, pro forma including the TGS acquisition, Columbia Care had Combined Revenue, Gross Profit and Adjusted EBITDA of $178.6 million, $68.6 million and $1.4 million, respectively.

Third Quarter 2020 Financial Highlights1(in $ thousands, excl. margin items):
 
Q3 2020 Q2 2020 Q3 2019 % QoQ % YoY
Combined Revenue

$

54,162

 

$

33,012

 

$

22,120

 

64%

145%

Combined Adj. Gross Profit (1)

$

21,157

 

$

11,908

 

$

5,290

 

78%

300%

Combined Adj. Gross Margin (1)

 

39

%

 

36

%

 

24

%

299 bps

1515 bps

Combined Adj. EBITDA

$

4,226

 

$

(4,734

)

$

(11,758

)

NM

NM

As Reported (Ex. OH Dispensaries, Includes impact of M&A related inventory write-up) (2):

Revenue

$

48,703

 

$

28,413

 

$

22,120

 

71%

120%

Gross Profit

$

17,231

 

$

10,140

 

$

5,290

 

70%

226%

Gross Margin

 

35

%

 

36

%

 

24

%

-31 bps

1146 bps

Adj. EBITDA

$

3,077

 

$

(5,481

)

$

(11,256

)

NM

NM

Cash

$

42,142

 

$

42,350

 

$

84,506

 

0%

-50%

(1)

 Excludes changes in fair value of biological assets and inventory sold for all periods presented, as well as $1.8 million in Q3 2020 related to write-up of inventory acquired in TGS transaction.

(2)

 Excluding Ohio Dispensaries, Includes Impact of Acquisition Related Fair Market Inventory Write-Ups. OH dispensaries expected to consolidate after 12-month statutory review and approval period. Includes $1.8 million impact to Gross Margin related to FMV write up of TGS inventory at close.

Key State Level Updates:

Arizona:

  • Operational priority is to prepare for the market’s conversion to adult use sales in April 2021 by expanding cultivation, manufacturing and wholesale supply capabilities.
  • Increased plant count by more than 40% in 3Q in anticipation of positive election outcome.
  • Targeting gross margin expansion through new product introductions and improving yield and harvest size.
  • Secured the right to build additional, high-quality indoor cultivation facility co-located with the Tempe dispensary.
  • Accelerating development plans for additional cultivation canopy, manufacturing capacity and introduction of branded edible lines into AZ wholesale market in 2Q 2021.
  • Operationalized boutique bloom room for exotic strains at Tempe dispensary for customers to view plants and enhance consumer engagement and loyalty.
  • Top five market by revenue, generating positive adjusted EBITDA.

California:

  • Signed definitive agreement in 3Q to acquire Los Angeles-based Project Cannabis.
  • Organic revenue growth up more than 2x QoQ with significant gross margin improvement.
  • Extraction and distillation facility commenced operations in July, with 20 liters of extract currently on the shelf and weekly inventory building up for production and wholesale revenue.
  • As part of broader wholesale strategy, launched Amber and Press tablets in San Diego dispensary and secured third-party distribution partner for Amber, Press and Ceeds brands in LA County dispensaries.
  • Pro Forma the close of the Project Cannabis acquisition, CA will be a top five market by revenue, generating positive adjusted EBITDA.

Colorado (pro forma results)2:

  • Completed acquisition of TGS, the state’s largest vertically integrated cannabis operator.
  • Revenue up 19% QoQ, driven by same store sales and significant increase in wholesale revenue.
  • Gross Profit up 19% QoQ.
  • Adjusted EBITDA up 45% QoQ.
  • Trinidad cultivation facility harvest initiated in September, successfully completed in early November – one of the lowest cost, largest cannabis growing facilities in Colorado.
  • Top five market by revenue, generating positive adjusted EBITDA.

Delaware

  • Significant QoQ increases in revenue, gross margin and adjusted EBITDA.
  • Received approval for canopy expansion, adding roughly 20% capacity to meet increasing market demand.
  • Only operator in the state with more than one dispensary and home delivery services.
  • Generating positive adjusted EBITDA.

Florida:

  • Began local marketing initiatives in 3Q which have led to increased foot traffic and sales.
  • Although revenue increased QoQ, new testing requirements and a shortage of approved labs caused a product approval backlog delaying commercial sales of new products.
  • Remain on track to open four additional dispensaries in 2H 2020, with dispensaries in Miami and Brandon now open (October), Longwood opening on November 16th and Delray expected to open in November.

Illinois:

  • Opened adult-use Villa Park dispensary in September; Statewide 3Q revenue up more than 2x QoQ.
  • Canopy in Aurora cultivation facility at full capacity with record flower production; Current average cannabinoid profile stands at a company record 39.8%.
  • Record flower production and wholesale revenue in Q3.
  • Awarded second place for indica flower in Illinois Cannabis Cup.
  • Generating positive adjusted EBITDA.

Massachusetts:

  • Revenue up more than 50% QoQ with strong gross margin and adjusted EBITDA margin expansion.
  • Preparing to expand operational hours at all dispensaries.
  • Expanded dispensary menus to include more internally produced, higher margin products.
  • After delays, approved in Boston by Mayor’s Cannabis Commission for Adult Use Co-Location, scheduled for final zoning board of appeals meeting in December.
  • On track to expand wholesale presence in 4Q.
  • Top five market by revenue, generating positive adjusted EBITDA.

New Jersey:

  • Adult-use sales approved for 2021; Company is materially expanding canopy and manufacturing throughput to prepare for conversion and to supply wholesale medical and adult-use market demand.
  • Completed second harvest in October and on track to complete third by end of November.
  • Established several wholesale partnerships to ensure medical products available for patients.
  • Development of second and third dispensary locations in process.

New York:

  • 3Q revenue up nearly 25% QoQ.
  • Primary driver of growth is continued introduction of new formats and formulations.
  • Wholesale revenue also significant contributor to growth.
  • Company is pursuing additional expansion plans to increase cultivation and manufacturing capacity.
  • Excluding one-time impact of product development costs for new initiatives, New York was adjusted EBITDA positive.

Ohio:

  • Revenue up more than 30% QoQ with significant gross margin and adjusted EBITDA margin expansion.
  • Reached full canopy in Mount Orab cultivation facility at the end of July; Actively pursuing canopy expansion options.
  • Record flower production and wholesale revenue in Q3. Selling products to nearly 80% of dispensaries in Ohio.
  • Began vaporization and tincture commercialization activities in Columbus manufacturing facility.
  • Top five market by revenue, generating positive adjusted EBITDA.

Pennsylvania:

  • Revenue up nearly 20% QoQ.
  • Continued record productivity metrics within our dispensaries.
  • Pursuing retail expansion opportunities to meet increased transaction volumes.
  • Top five market by revenue, generating positive adjusted EBITDA.

Vita continued: “We have executed on our plans to deepen our market footprint and expand our product portfolio. Last month, we were awarded a medical cultivation license in West Virginia. On September 8th, we announced a definitive agreement to acquire Project Cannabis, an integrated, award-winning, California-based cannabis company. The acquisition will enable us to materially increase our scale throughout California and position our wholesale and manufacturing operations as one of the leading suppliers in the state. Project Cannabis will also significantly expand our portfolio of unique products and nationally recognized premium brands. Subsequent to the quarter, we announced the launch of our first internally developed cannabis lifestyle brand, Seed & Strain, which provides customers with potent, high-quality adult use products processed with the same standards and practices we use on our medical products. These developments further position Columbia Care as much more than a medical cannabis company, as we now have premium consumer brands to go alongside our growing adult-use retail and manufacturing footprint.

“As we look ahead, we will continue to focus on driving growth and profitability in our core markets while capitalizing on opportunistic M&A. We will also continue executing on our organic growth strategy, as reflected by our expansion programs in AZ, IL, MA, MO, NJ, NY, UT, and VA along with our recent medical cultivation license award in West Virginia. Our balance sheet remains strong and our recent debt financing continues to reflect the confidence the institutional community has in the operational foundation we have built. We look forward to maintaining significant momentum through the fourth quarter and into 2021 as even more of our markets convert to adult-use sales.”

2020 Outlook

Metric

Stand-alone basis

Pro forma basis

Combined Revenue

$155M – $180M

$234M – $265M

Combined Gross Margin

40%+ in Q4

40%+ in Q4

Break-even Combined Adjusted EBITDA timing

Q4

Q3

Full year CAPEX

$45M – $50M

$45M – $50M

Columbia Care’s 2020 outlook is based on current trends and is consistent with its previously disclosed forecast on August 10, 2020. For Fiscal 2020, the Company is providing guidance to reflect the transition from its 2019 growth strategy of activating licensed jurisdictions to achieving scale in each market. As a practical matter, in providing its 2020 guidance, Columbia Care does not incorporate changes in the regulatory environment, including the potentially positive impact of any future transitions from medical only to medical and adult use programs, despite the Company’s expectations for several markets to convert in the next 12 months. The Company also excludes recent wins in Missouri, Utah and West Virginia as well as any new market openings, the development of additional assets, future M&A and/or license pursuit activities. See “Caution Concerning Forward-Looking Statements” below for further discussion.

Conference Call and Webcast Details

Management will host a conference call today at 4:30 p.m. ET to discuss its third quarter results.

To access the live conference call via telephone, please dial 1-877-407-8914 (US Callers) or 1-201-493-6795 (international callers). A live audio webcast of the call will also be available in the Investor Relations section of the Company’s website at https://ir.col-care.com/ or at https://78449.themediaframe.com/dataconf/productusers/colc/mediaframe/41357/indexl.html

A replay of the audio webcast will be available in the Investor Relations section of the Company’s website approximately 2 hours after completion of the call and will be archived for 30 days.

Non-IFRS Financial Measures

In this press release, Columbia Care refers to certain non-IFRS financial measures, Combined Revenue, Adjusted EBITDA, Combined Adjusted EBITDA, gross profit excluding changes in fair value of biological assets and inventory sold and Combined Gross Profit excluding changes in fair value of biological assets and inventory sold. These measures do not have any standardized meaning prescribed by IFRS and may not be comparable to similar measures presented by other companies. Columbia Care considers certain non-IFRS measures to be meaningful indicators of the performance of its business. A reconciliation of such non-IFRS financial measures to their nearest comparable IFRS measure is included in this press release and a further discussion of some of these items is contained in the Company’s Management, Discussion and Analysis for the three and nine months ended September 30, 2020 dated November 11, 2020.

About Columbia Care Inc.

Columbia Care is one of the largest and most experienced cultivators, manufacturers and providers of medical and adult use cannabis products and related services with licenses in 18 US jurisdictions and the EU. Columbia Care currently operates 100 facilities3 including 76 dispensaries and 24 cultivation and manufacturing facilities. Columbia Care is one of the original providers of medical cannabis in the United States, and continues to deliver an industry-leading, patient-centered medicinal cannabis operation that has quickly expanded into the adult use market as a premier operator. The company currently offers products spanning flower, edibles, oils, and tablets, and manufactures popular brands including Amber and Platinum Label CBD. With more than four million sales transactions since its inception in 2012, Columbia Care is known for setting the standard for compassion, professionalism, quality, care, and innovation in the rapidly expanding cannabis industry. For more information on Columbia Care, please visit www.col-care.com.

_______________

1 Combined metrics for all periods presented include operations from CannAscend in Ohio. The Company purchased an exclusive option to acquire all outstanding membership interests in CannAscend following their twelfth month of operation and is subject to regulatory approval. Combined metrics for Q3 2020 exclude the impact of inventory write-ups related to the acquisition of TGS and include one month of operations from The Green Solution in Colorado, which Columbia Care acquired on September 1, 2020. See table 5 for a reconciliation of reported and combined revenue.

2 Proforma results reflect an entire quarter of contribution from TGS for the periods presented.

3Pro forma facilities either open or under development; includes facilities where Columbia Care provides consultative services pursuant to the terms of a management services arrangement

Caution Concerning Forward-Looking Statements

This press release contains certain statements that constitute forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). Statements concerning Columbia Care’s objectives, goals, strategies, priorities, intentions, plans, beliefs, expectations and estimates, and the business, operations, financial performance and condition of Columbia Care as well as statements under the heading “2020 Outlook” are forward-looking statements. The words “believe”, “expect”, “anticipate”, “estimate”, “intend”, “may”, “will”, “would”, “could”, “should”, “continue”, “plan”, “goal”, “objective”, and similar expressions and the negative of such expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking information involves numerous assumptions, including assumptions on revenue and expected gross margins, capital allocation, EBITDA break even targets and other financial results; growth of its operations via expansion, for the effects of any transactions; expectations for the potential benefits of any transactions including the acquisition of The Green Solution and Project Cannabis; statements relating to the business and future activities of, and developments related to, the Company after the date of this press release, including such things as future business strategy, competitive strengths, goals, expansion and growth of the Company’s business, operations and plans; expectations that planned acquisitions (including the acquisition of Project Cannabis) will be completed as previously announced; expectations regarding cultivation and manufacturing capacity; expectations regarding receipt of regulatory approvals; expectations that licenses applied for will be obtained; potential future legalization of adult-use and/or medical cannabis under U.S. federal law; expectations of market size and growth in the U.S. and the states in which the Company operates; expectations for other economic, business, regulatory and/or competitive factors related to the Company or the cannabis industry generally; and other events or conditions that may occur in the future. Forward-looking statements may relate to future financial conditions, results of operations, plans, objectives, performance or business developments. These statements speak only as at the date they are made and are based on information currently available and on the then current expectations. Holders of securities of the Company are cautioned that forward-looking statements are not based on historical facts but instead are based on reasonable assumptions and estimates of management of the Company at the time they were provided or made and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, as applicable, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: the available funds of the Company and the anticipated use of such funds; the availability of financing opportunities; legal and regulatory risks inherent in the cannabis industry; risks associated with economic conditions, dependence on management and currency risk; risks relating to U.S. regulatory landscape and enforcement related to cannabis, including political risks; risks relating to anti-money laundering laws and regulation; other governmental and environmental regulation; public opinion and perception of the cannabis industry; risks related to contracts with third-party service providers; risks related to the enforceability of contracts; reliance on the expertise and judgment of senior management of the Company, and ability to retain such senior management; risks related to proprietary intellectual property and potential infringement by third parties; risks relating to the management of growth; increasing competition in the industry; risks inherent in an agricultural business; risks relating to energy costs; risks associated to cannabis products manufactured for human consumption including potential product recalls; reliance on key inputs, suppliers and skilled labor; cybersecurity risks; ability and constraints on marketing products; fraudulent activity by employees, contractors and consultants; tax and insurance related risks; risks related to the economy generally; risk of litigation; conflicts of interest; risks relating to certain remedies being limited and the difficulty of enforcement of judgments and effect service outside of Canada; risks related to future acquisitions or dispositions; sales by existing shareholders; limited research and data relating to cannabis; as well as those risk factors discussed under “Risk Factors” in Columbia Care’s Annual Information Form dated March 31, 2020 and filed with the applicable Canadian securities regulatory authorities on SEDAR at www.sedar.com, in the Company’s Annual Information Form, and as described from time to time in documents filed by the Company with Canadian securities regulatory authorities.

The purpose of forward-looking statements is to provide the reader with a description of management’s expectations, and such forward-looking statements may not be appropriate for any other purpose. In particular, but without limiting the foregoing, disclosure in this press release as well as statements regarding the Company’s objectives, plans and goals, including future operating results and economic performance may make reference to or involve forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to have been correct. A number of factors could cause actual events, performance or results to differ materially from what is projected in the forward-looking statements. No undue reliance should be placed on forward-looking statements contained in this press release. Such forward-looking statements are made as of the date of this press release. Columbia Care undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The Company’s forward-looking statements are expressly qualified in their entirety by this cautionary statement.

This news release contains future-oriented financial information and financial outlook information (collectively, “FOFI”) about Columbia Care’s prospective results of operations, production and production efficiency, commercialization, revenue, gross margins and capex, all of which are subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. FOFI contained in this document was approved by management as of the date of this document and was provided for the purpose of providing further information about Columbia Care’s future business operations. Columbia Care disclaims any intention or obligation to update or revise any FOFI contained in this document, whether because of new information, future events or otherwise, unless required pursuant to applicable law. Readers are cautioned that the FOFI contained in this document should not be used for purposes other than for which it is disclosed herein.

 

TABLE 1 – CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in US $ thousands, except share and per share figures, unaudited)
 
Three Months Ended Nine Months Ended
September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019
 
Revenue

$

48,703

 

$

22,120

 

$

103,439

 

$

54,287

 

Production costs

 

(31,472

)

 

(16,830

)

 

(68,035

)

 

(39,167

)

Gross profit before fair value adjustments

 

17,231

 

 

5,290

 

 

35,404

 

 

15,120

 

Fair value adjustments biological assets, net

 

12,060

 

 

10,389

 

 

12,297

 

 

3,590

 

Gross profit

 

29,291

 

 

15,679

 

 

47,701

 

 

18,710

 

Operating expenses

 

(33,648

)

 

(33,819

)

 

(94,796

)

 

(95,013

)

Loss from operations

 

(4,357

)

 

(18,140

)

 

(47,095

)

 

(76,303

)

Other expense, net

 

(6,864

)

 

(458

)

 

(11,477

)

 

(176

)

Income tax expense

 

(315

)

 

(1,264

)

 

(949

)

 

(2,233

)

Net loss

 

(11,536

)

 

(19,862

)

 

(59,521

)

 

(78,712

)

Net loss attributable to non-controlling interests

 

(681

)

 

(1,599

)

 

(4,422

)

 

(1,947

)

Net loss attributable to Columbia Care shareholders

$

(10,855

)

$

(18,263

)

$

(55,099

)

$

(76,765

)

Weighted average common shares outstanding – basic and diluted

 

235,682,767

 

 

216,269,530

 

 

223,461,261

 

 

207,729,060

 

Earnings per common share attributable to Columbia Care shareholders – basic and diluted

$

(0.05

)

$

(0.08

)

$

(0.25

)

$

(0.37

)

 
TABLE 2 – RECONCILIATION OF IFRS TO NON-IFRS MEASURES
(in US $ thousands, unaudited)
 
Three Months Ended Nine Months Ended
September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019
 
Net loss

$

(11,536

)

$

(19,862

)

$

(59,521

)

$

(78,712

)

Income tax expense

 

315

 

 

1,264

 

 

949

 

 

2,233

 

Depreciation and amortization

 

7,895

 

 

4,231

 

 

19,525

 

 

10,260

 

Net interest and debt amortization

 

4,308

 

 

350

 

 

6,789

 

 

1,175

 

EBITDA

$

982

 

$

(14,017

)

$

(32,258

)

$

(65,044

)

 
Share-based compensation

 

7,218

 

 

13,150

 

 

22,341

 

 

24,539

 

Fair value adjustments biological assets, net

 

(12,060

)

 

(10,389

)

 

(12,297

)

 

(3,590

)

Fair value mark-up for acquired inventory

 

1,765

 

 

–

 

 

1,765

 

 

–

 

Adjustments for acquisition and other non-core costs

 

2,616

 

 

–

 

 

3,483

 

 

–

 

Fair value changes on derivative liabilities

 

2,556

 

 

–

 

 

2,556

 

 

–

 

Impairment on disposal group

 

–

 

 

–

 

 

1,969

 

 

–

 

Listing fee expense

 

–

 

 

–

 

 

–

 

 

11,071

 

Adjusted EBITDA

$

3,077

 

$

(11,256

)

$

(12,441

)

$

(33,024

)

 
TABLE 3 – CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(in US $ thousands, unaudited)
 
Three Months Ended Nine Months Ended
September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019
 
Net cash used in operating activities

$

(7,103

)

$

(11,332

)

$

(35,627

)

$

(53,626

)

Net cash provided by (used in) investment activities

 

5,810

 

 

(26,714

)

 

(23,909

)

 

(58,119

)

Net cash provided by (used in) financing activities

 

1,085

 

 

(2,758

)

 

54,214

 

 

150,010

 

Net (decrease) increase in cash

 

(208

)

 

(40,804

)

 

(5,322

)

 

38,265

 

Cash balance – beginning of period

 

42,350

 

 

125,310

 

 

47,464

 

 

46,241

 

Cash balance – end of period

 

42,142

 

 

84,506

 

 

42,142

 

 

84,506

 

 
TABLE 4 – CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (SELECT ITEMS)
(in US $ thousands, unaudited)
 
September 30, 2020 December 31, 2019
 
Cash

$

42,142

$

47,464

Total current assets

 

204,206

 

154,489

Property and equipment, net

 

116,023

 

104,034

Right of use assets

 

185,453

 

79,031

Total assets

 

741,428

 

402,276

Total current liabilities

 

91,665

 

35,402

Total liabilities

 

394,619

 

135,344

Total equity

 

346,809

 

266,932

 
TABLE 5 – COMBINED FINANCIALS AND RECONCILIATIONS
(in US $ thousands, unaudited)
 
Three Months Ended Nine Months Ended
September 30, 2020 September 30, 2019 September 30, 2020 September 30, 2019
 
Revenue, as reported

$

48,703

 

$

22,120

 

$

103,439

 

$

54,287

 

CannAscend revenues

 

5,674

 

 

–

 

 

12,886

 

 

–

 

Eliminations

 

(215

)

 

–

 

 

(215

)

 

–

 

Combined revenue

 

54,162

 

 

22,120

 

 

116,110

 

 

54,287

 

 
Gross profit before fair value adjustments, as reported

$

17,231

 

$

5,290

 

$

35,404

 

$

15,120

 

CannAscend gross profit before fair value adjustments

 

2,300

 

 

–

 

 

5,103

 

 

–

 

Eliminations

 

(139

)

 

–

 

 

(139

)

 

–

 

Combined gross profit before fair value adjustments

 

19,392

 

 

5,290

 

 

40,368

 

 

15,120

 

 
Adjusted EBITDA, as reported

$

3,077

 

$

(11,256

)

$

(12,441

)

$

(33,024

)

CannAscend adjusted EBITDA

 

1,225

 

 

(502

)

 

2,144

 

 

(940

)

Eliminations

 

(76

)

 

–

 

 

(76

)

 

–

 

Combined adjusted EBITDA

 

4,226

 

 

(11,758

)

 

(10,373

)

 

(33,964

)

 

Investor Contact:

Cristina De Tomasi

Investor Relations

+1.212.271.0915

[email protected]

Media Contact:

Gabriella Velez

5WPR

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Agriculture Alternative Medicine Natural Resources Other Health Health

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