Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2021

Appili Therapeutics Reports Financial and Operational Results for Second Quarter of Fiscal Year 2021

HALIFAX, Nova Scotia–(BUSINESS WIRE)–
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced its financial and operational results for the second quarter of its fiscal year 2021, which ended September 30, 2020.

​Second quarter and recent operational highlights include:

“As the world enters the next wave of COVID-19 infections, our antiviral programs are steadily advancing. We were very pleased to sign a global deal with world-class partners to develop Avigan® for the potential treatment and prevention of COVID-19, to dose the first participants in our CONTROL trial, and to file a protocol with the U.S. FDA for Appili’s first Phase 3 study, which is investigating Avigan® for the treatment of early-to-moderate COVID-19 infections,” said Kimberly Stephens, Chief Financial Officer of Appili Therapeutics. “We’ve also staffed key positions, including the appointment of Don Cilla as Chief Development Officer, and graduated to the TSX exchange within 18 months of originally listing on the TSX Venture Exchange. We continue to work diligently to progress our clinical programs, bolster our financial position, expand our team, and drive value for our pipeline portfolio.”

Financial Results

The Company prepares its financial statements in accordance with IFRS as issued by the International Accounting Standard Board and Part I of Chartered Professional Accountants of Canada Handbook –Accounting. All dollar figures are $CAN unless otherwise noted.

The net loss and comprehensive loss of $5.1 million or $0.09 loss per share for the six months ended September 30, 2020 was $2.1 million higher than the net loss and comprehensive loss of $2.9 million or $0.09 loss per share during the six months ended September 30, 2019. This relates mainly to a $1.6 million increase in research and development (R&D) expenses, a $0.8 million increase in general and administrative expenses, offset by a $0.3 million decrease in business development expenses.

As of September 30, 2020, the Company had cash and short-term investments of $22.9 million, compared to $10.5 million on March 31, 2020. As of November 12, 2020, the Company 62,284,216 issued and outstanding Common Shares, 4,548,949 stock options and 15,011,610 warrants outstanding.

This press release should be read in conjunction with the Company’s unaudited interim condensed financial statements for September 30, 2020 and the related management discussion and analysis (MD&A), copies of which are available on SEDAR at www.sedar.com.

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space. Appili has built a pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. Appili’s diverse pipeline aims to address some of the most urgent threats in global public health, including Avigan® tablets, which Appili is evaluating, as part of a consortium with Dr. Reddys Labs, Global Response Aid, and FujiFilm Toyama Chemical for the global treatment and prevention of COVID-19. Appili is also evaluating ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing. In addition, Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may,” “would,” “could,” “should,” “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for,” and similar expressions have been used to identify these forward-looking statements. Forward-looking statements involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, those listed in the annual information form of the Company dated June 24, 2020 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law.

Media Contact:

Andrea Cohen

Sam Brown Inc.

T: 917-209-7163

E: [email protected]

Investor Relations Contact:

Kimberly Stephens, CFO

Appili Therapeutics

TSX: APLI

E: [email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Pharmaceutical Health Infectious Diseases Clinical Trials

MEDIA:

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Camtek Receives Over $20 Million In Orders For Inspection & Metrology Systems From Several Manufacturers

These orders reinforce the outlook for the first half of 2021

PR Newswire

MIGDAL HAEMEK, Israel, Nov. 13, 2020 /PRNewswire/ — Camtek Ltd. (NASDAQ: CAMT); (TASE: CAMT), today announced that in the last ten days it received orders totaling over $20 million for the inspection and metrology of Advanced Packaging, Compound Semiconductors, CMOS Image Sensors and RF devices from several Semiconductors manufacturers.

The orders are expected to be delivered during the first half of 2021.


Rafi Amit, Chief Executive Officer, commented,
“We continue to gain business momentum in the industry’s fastest growing segments, including the Advanced Packaging, Compound Semiconductors, CMOS Image Sensors and RF devices (driven by 5G).  These orders reinforce our outlook for the first half of 2021 which we provided with our third quarter results.”

ABOUT CAMTEK LTD.

Camtek is a leading manufacturer of metrology and inspection equipment and a provider of software solutions serving the Advanced Packaging, Memory, CMOS Image Sensors, MEMS, RF and other segments in the mid end of the semiconductor industry.

Camtek provides dedicated solutions and crucial yield-enhancement data, enabling manufacturers to improve yield and drive down their production costs.

With eight offices around the world, Camtek has best-in-class sales and customer support organization, providing tailor-made solutions in line with customers’ requirements.

This press release is available at www.camtek.com 

This press release contains projections or other forward-looking statements regarding future events or the future
performance of the Company. These statements are only predictions that represent our views only as of the date they are made and may change as time passes. We do not assume any obligation to update that information, except as required by law. These forward-looking statements are subject to risks and uncertainties that may cause actual events or results to differ materially from those projected, including as a result of the effects of general economic conditions; the effect of the COVID-19 crisis on the global markets and on the markets in which we operate, including the risk of a continued disruption to our and our customers’, providers’, business partners and contractors’ business as a result of the outbreak and effects of the COVID-19 pandemic; the risks relating to the concentration of a significant portion of Camtek’s expected business in certain countries, particularly China, from which we expect to generate significant portion of our revenues for the
coming few quarters
, but also Taiwan and Korea, including the risks of deviations from our expectations regarding timing and size of orders from customers in these countries; changing industry and market trends; reduced demand for our products; the timely development of our new products and their adoption by the market; increased competition in the industry; price reductions; as well as due to other risks identified in our Annual Report on Form 20-F and other documents filed by the Company with the SEC.

Although Camtek believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements, including Camtek’s outlook for the first half of 2021 and orders expected to be delivered, will be achieved or will occur. Except as required by law, Camtek undertakes no obligation to update publicly any forward-looking statements for any reason after the date of this press release, to conform these statements to actual results or to changes in its expectations.

CAMTEK LTD.

Moshe Eisenberg, CFO
Tel: +972 4 604 8308
Mobile: +972 54 900 7100
[email protected]

INTERNATIONAL INVESTOR RELATIONS  
GK Investor Relations
Ehud Helft
Tel: (US) 1 646 688 3559
[email protected]

Camtek Ltd.
Tel: +972 (4) 604-8100  
Fax: +972 (4) 644-0523
E-Mail: [email protected] 
Web site: http://www.camtek.com

 

 

 

 

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SOURCE Camtek Ltd

Surface Oncology Announces SRF617 and SRF388 Will Advance to Combination and Expansion Stages of Ongoing Phase 1 Clinical Trials

Both programs have
successfully
escalated to
dose
levels
demonstrating
pharmacodynamic
activity
without dose

limiting toxicities

Detailed
clinical data
for
each
program
to be presented at
a
medical
conference
in the first half of 2021

CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that both of its lead clinical programs, SRF617 (targeting CD39) and SRF388 (targeting IL-27), have achieved predefined criteria for advancement into combination and expansion stages of the ongoing Phase 1 trials. These criteria include safety, successful escalation to a biologically relevant dose, target engagement and meaningful pharmacodynamic activity in the ongoing Phase 1 trials.

“As we initiated the Phase 1 clinical trials just eight months ago, we are extremely pleased with the progress both of our lead product programs have made to date,” said Jeff Goater, chief executive officer. “With the updates announced today, both SRF617 and SRF388 are well-positioned to advance into the key next stages of the ongoing trials in the coming months and ultimately deliver meaningful clinical benefits to patients suffering with cancer.”

“We are very encouraged by these data and our clinical progress to date with SRF617 and SRF388,” said Rob Ross, M.D., chief medical officer. “Both of these programs are highly innovative, next-generation immunotherapies with the potential to provide novel treatment options to patients with cancer. We look forward to advancing each of these programs into the next stage of the ongoing Phase 1 studies and presenting detailed clinical updates at a medical conference in the first half of 2021.”

SRF617
Highlights:

  • The open label, Phase 1/1b clinical trial of SRF617 was initiated in March 2020 and is enrolling patients with a variety of advanced solid tumors. Summary results from nine patients treated across three dose levels (20 mg, 70 mg and 200 mg intravenously every two weeks) include:
    • No dose limiting toxicities have been observed and SRF617 has been well-tolerated.
    • Target occupancy on B cells has increased in a dose-dependent manner, and importantly, within the 200 mg cohort, the goal of meaningful, sustained target occupancy has been achieved. Surface Oncology has already demonstrated that target occupancy is directly correlated with CD39 enzymatic inhibition.
    • Prolonged stable disease (>5 months) has been seen in one patient with NSCLC who had progressed on prior anti-PD-1 treatment.
  • While dose escalation will continue because of the lack of dose-limiting toxicities, SRF617 has achieved a dose that supports advancement of the program into the planned combination expansion cohorts (additional details provided below). We anticipate that the combination cohorts will likely begin enrolling in late 2020.
  • Surface Oncology plans to present detailed initial clinical results from the ongoing Phase 1/1b trial of SRF617 at a medical conference in the first half of 2021.
  • In May 2020, Surface Oncology announced a clinical collaboration with Merck (NYSE: MRK) to evaluate the safety and efficacy of combining SRF617 with Merck’s KEYTRUDA® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a future component of the ongoing first-in-human Phase 1/1b study of SRF617 and will be evaluated in patients with solid tumors, with a focus on patients with gastric cancer and those who have developed resistance to checkpoint inhibition — both areas of high unmet need.
  • In addition, as part of the clinical development plan, Surface Oncology will initiate SRF617 combinations with gemcitabine and abraxane in patients with pancreatic cancer and SRF617 in combination with AB928, an A2A/A2B small molecule inhibitor, in clinical collaboration with Arcus Biosciences (NYSE: RCUS) in patients with prostate cancer.

SRF388
Highlights:

  • The open label, Phase 1 clinical trial of the first-in-class antibody SRF388 was initiated in April 2020 and is enrolling patients with a variety of advanced solid tumors. Summary results from nine patients treated across five dose levels (0.003, 0.03, 0.1, 0.3 and 1 mg/kg intravenously every four weeks) include:
    • No dose limiting toxicities have been observed and SRF388 has been well tolerated.
    • While dose escalation will continue because of the lack of dose-limiting toxicities, SRF388 has already achieved maximal inhibition of the IL-27 signaling pathway at the 0.3mg/kg dose, as measured in whole blood from patients treated on the trial. Planned monotherapy Phase 2 expansion cohorts in liver cancer and kidney cancer are on track to begin enrolling patients in the first half of 2021.
    • Prolonged stable disease (>6 months) has been noted in one patient with kidney cancer, who had progressed on prior anti-PD-1 treatment. Notably, kidney cancer is one of the predefined indications of interest for SRF388 based on clear demonstration of pathway activation in clinical samples. No patients with liver cancer have been enrolled in the dose escalation portion of the trial to date.
  • Surface Oncology plans to present detailed initial clinical results from the ongoing Phase 1 trial of SRF388 at a medical conference in the first half of 2021.
  • The clinical development plan for SRF388 is based on compelling translational research that indicates that IL-27 is upregulated and functional in both kidney cancer and liver cancer. This work is supported in part by a study presented at the 2020 American Association for Cancer Research Annual Meeting demonstrating that high levels of IL-27 correlate strongly with the risk of developing liver cancer. The presentation can be found here.
  • SRF388 recently received Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.

About SRF617
:

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, in gastric cancer, immune cells within the tumor often express high levels of CD39, which may impair an overall anti-cancer immune response even in the presence of an anti-PD-1 antibody. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.

About SRF388
:

SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver and kidney cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies and potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388.

About Surface Oncology:

Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its pipeline includes two wholly-owned lead programs targeting CD39 (SRF617) and IL-27 (SRF388), a clinical-stage collaboration with Novartis targeting CD73 (NZV930), and two preclinical programs, each focused primarily on activating natural killer cells (via targeting PVRIG, also known as CD112R (SRF813)), or depleting regulatory T cells (via targeting CCR8 (SRF114)). Surface’s novel cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. For more information, please visit www.surfaceoncology.com.

Cautionary Note Regarding Forward-Looking Statements:

Certain statements set forth in this press release constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would,” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388, SRF617, SRF813 and its other product candidates through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Surface Oncology’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Surface Oncology’s product candidates, including SRF388, SRF617 and SRF813, will not be successfully developed or commercialized, the risks related to Surface Oncology’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies, and the potential impact of COVID-19 on our clinical and preclinical development timelines and results of operations. Additional risks and uncertainties that could affect Surface Oncology’s future results are included in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ending March 31, 2020, both of which are available on the Security and Exchange Commission’s website at www.sec.gov and Surface Oncology’s website at www.surfaceoncology.com.

Additional information on potential risks will be made available in other filings that Surface Oncology makes from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements contained in this press release are based on assumptions that Surface Oncology believes to be reasonable as of this date. Except as required by law, Surface Oncology assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Contacts:

Investors
Matt Lane
[email protected]
617-901-7698

Media
Matthew Corcoran
mcorcoran@tenbridgecommunications.com
617-866-7350



Promising new data for Ionis’ antisense medicine targeting PCSK9 presented at American Heart Association (AHA) Scientific Sessions 2020

– Single doses resulted in potent, dose-dependent PCSK9 reductions of up to >90%, demonstrating best-in-class potential for the treatment of patients with high cholesterol at risk of cardiovascular disease

PR Newswire

CARLSBAD, Calif., Nov. 13, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that new data for ION449, an investigational antisense medicine designed to reduce plasma levels of proprotein convertase subtilisin/kexin type 9, or PCSK9, were presented today at the American Heart Association (AHA) Scientific Sessions. PCSK9 is integrally involved in the regulation of LDL-cholesterol (LDL-C). Genetic studies have shown that individuals with life-long reduction of LDL-C due to reduced function of PCSK9 have substantially reduced risk of cardiovascular disease.

ION449, also known as AZD8233 for subcutaneous administration and AZD6615 for oral administration, is being developed as part of a collaboration between Ionis and the biopharmaceutical company AstraZeneca. ION449 incorporates Ionis’ advanced Generation 2.5 and LIgand Conjugated Antisense, or LICA, technology. In a Phase 1 study, single subcutaneous doses of ION449 demonstrated dose-dependent reductions in circulating plasma PCSK9 protein and LDL-C levels of up to >90 percent and up to ~70 percent, respectively, in humans with a baseline LDL-C between 100 and 190 mg/dL.Doses of 4, 12, 20, 30, 60, 90 and 120 mg were evaluated. The single 90 mg dose was the minimum dose required to achieve maximum reduction in PCSK9 and LDL-C. ION449 was observed to be safe and well tolerated at all dose levels.

In addition, the feasibility of oral administration of ION449 was established in three in vivo studies:

  • A study in rats demonstrated liver bioavailability of 5 percent with ION449 following intrajejunal administration, mimicking oral administration of tablets not feasible in rodents.
  • A study in dogs demonstrated liver bioavailability of 7 percent following ION449 oral tablet administration for 28 days.
  • A study in healthy monkeys found repeated oral administration of ION449 tablets for 14 days resulted in LDL-cholesterol reductions of 45–50 percent.

An oral formulation of ION449 is currently being evaluated in a Phase 1 study in healthy volunteers.

“Even with existing treatments, cardiovascular disease remains the leading cause of death worldwide, affecting tens of millions of people. Additional treatments are clearly needed for patients still at risk. The data from these studies are very encouraging and demonstrate the best-in-class potential of ION449 for lowering LDL-C via PCSK9 reduction for the treatment of patients with high cholesterol who are at risk of cardiovascular disease,” said Brett P. Monia, Ph.D., chief executive officer at Ionis.

The full poster presentations, “Single Dose Safety, Pharmacokinetics, and Pharmacodynamics of a Potent PCSK9 Synthesis Inhibitor, AZD8233, in Subjects With Elevated LDL Cholesterol” (Poster #MP515) and “An Oral Antisense Oligonucleotide for PCSK9 Inhibition in Humans” (Poster #P244) are available to view on the AHA Scientific Sessions website.

Ionis’ collaboration with AstraZeneca focuses on leveraging Ionis’ pioneering antisense technology to discover and develop antisense therapies and AstraZeneca’s expertise in drug development and commercialization. In addition to cardiovascular programs, the companies are also collaborating to discover and develop antisense drugs to treat cancer, metabolic and other diseases.

About Ionis Pharmaceuticals, Inc.
As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can treat diseases where no other therapeutic approaches have proven effective. Our drug discovery platform has served as a springboard for actionable promise and realized hope for patients with unmet needs. We created the first and only approved treatment for all patients, children and adults with spinal muscular atrophy, as well as the world’s first RNA-targeted therapeutic approved for the treatment of polyneuropathy in adults with hereditary transthyretin amyloidosis. Our sights are set on all the patients we have yet to reach with a pipeline of more than 40 novel medicines designed to potentially treat a broad range of disease, including neurological, cardio-renal, metabolic, infectious, and pulmonary diseases.

To learn more about Ionis visit www.ionispharma.com and follow us on Twitter @ionispharma.

IONIS FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of ION449 (AZD8233 or AZD6615), Ionis’ technologies and products in development. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2019, and the most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticalsä is a trademark of Ionis Pharmaceuticals, Inc.

1 Clinical study (NCT03593785), sponsored by AstraZeneca.

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SOURCE Ionis Pharmaceuticals, Inc.

IMV to Host a Key Opinion Leader Webcast on the Ovarian Cancer Treatment Landscape and Data Highlights from the Phase 2 Trial of a Novel T-Cell Therapy

IMV to Host a Key Opinion Leader Webcast on the Ovarian Cancer Treatment Landscape and Data Highlights from the Phase 2 Trial of a Novel T-Cell Therapy

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today announced that the Company will host a key opinion leader (KOL) webcast on the treatment options in ovarian cancer and competitive landscape within the disease state on Thursday, December 3, 2020 at 8.00am Eastern Time.

The webcast will feature presentations by KOLs Oliver Dorigo, MD, PhD and Jeannine Villella, DO, FACOG, FACS who will discuss the treatment options in ovarian cancer and competitive landscape within the disease state. The KOLs will also provide an update on the ongoing Phase 2 trial with IMV’s novel T cell therapy in patients with advanced ovarian cancer, along with insights about the patients’ experience. Drs. Dorigo and Villella will be available to answer questions from financial analysts following the formal presentation.

IMV management will discuss trial results and their significance to DPX, the company’s delivery platform, as well its outlook on next steps.

To register for the webcast, please click here. A webcast of the presentation will be available under “Events, Webcasts and Presentations” in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, the replay will be available for approximately 30 days. Financial analysts are welcome to ask questions during the live Q&A and are invited to submit their request via email.

About the KOLs

Dr. Oliver Dorigo is the director and associate professor of the division of gynecologic oncology and the director of the gynecologic clinical care program at the Women’s Cancer Center at Stanford University. He is also director of the Mary Lake Polan Gynecologic Oncology Research Laboratory. Dr. Dorigo received his MD from the University of Heidelberg Medical School in Germany. He did a residency in obstetrics and gynecology at the University of Munich, followed by a research fellowship in cancer gene therapy at the Sidney Kimmel Cancer Center in San Diego. He completed his PhD in molecular biology at University of California, Los Angeles, and a clinical fellowship in gynecologic oncology at UCLA/Cedars Sinai Medical Center. Dr. Dorigo was an assistant professor at UCLA until he joined the Stanford faculty in 2013.

Dr. Jeannine Villella obtained her medical degree from New York College of Osteopathic Medicine in Old Westbury, New York and completed her residency training in Obstetrics and Gynecology at Winthrop University Hospital. Thereafter, Dr. Villella was granted a 2-year Henrietta Milstein Fellowship at Columbia University College of Physicians & Surgeons. As part of the division of gynecologic oncology, she performed research in the role of angiogenesis in ovarian cancer and was involved in the care of gynecologic oncology patients. She then completed a 3-year subspecialty fellowship in Gynecologic Oncology at Roswell Park Cancer Institute, where she expanded her research interests into immune response to malignancy and cancer immunotherapy. She has been granted a Winthrop University Hospital Pilot Grant to pursue her research interests in genetic polymorphisms in indoleamine 2, 3- dioxygenase and the effect on ovarian cancer outcomes. Her future goals include having ovarian cancer vaccine clinical trials available at Winthrop University Hospital. She also serves on the Society of Gynecologic Oncologists Clinical Practice Committee and the Gynecologic Oncology Group Vaccine Committee. Dr. Villella is board certified in Obstetrics & Gynecology and Gynecologic Oncology. She currently holds the title Associate Director of Gynecologic Oncology at Winthrop University Hospital and Assistant Professor of Stony Brook School of Medicine. She is the Principal Investigator for the Gynecologic Oncology Group Clinical Trials at Winthrop University Hospital. She also serves on the Society of Gynecologic Oncologists Clinical Practice Committee. She is also an active member of the research organization Society of Gynecologic Investigation.

About the DeCidE Study

“DeCidE” is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. The trial is active but not recruiting. Patients received 2 subcutaneous injections of DPX-Survivac 3 weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off for up to 1 year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with the DPX-Survivac T cell therapy have demonstrated a favorable safety profile across all clinical studies.

IMV’s T cell therapy, DPX-Survivac, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX). IMV’s lead compound is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of cancer-targeted immunotherapies and vaccines based on the Company’s proprietary delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the activation of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a novel cancer target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. IMV is also developing a DPX-based vaccine to fight against COVID-19. Visit www.imv-inc.com and connect with us on Twitter and LinkedIn.

IMV Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, the potential impacts of biomarkers when treating cancer; the potential for using DPX-Survivac to treat different types of cancers; and the results and timing of expected results from the Corporation’s various DPX-Survivac’s studies. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful design and completion of clinical trials and the receipt and timely receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials and studies, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar

Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV Inc.

O: (902) 492-1819 ext : 1042

M: (514) 617-9481 E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors

O: (646) 970-4681

M: (917) 734-7387

E: [email protected]

Media

Delphine Davan, Director of Communications, IMV Inc.

M: (514) 968 1046

E: [email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Oncology Health Infectious Diseases Clinical Trials Pharmaceutical Biotechnology

MEDIA:

OncXerna Therapeutics to Participate at the Piper Sandler Virtual Healthcare Conference

WALTHAM, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-based biomarker platform to predict patient responses for potentially first-in-class targeted oncology therapies, today announced that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will participate at the Piper Sandler Virtual Healthcare Conference taking place November 30-December 3, 2020.

A
bout OncXerna Therapeutics

OncXerna is aiming to deliver next-generation precision medicine for a larger group of cancer patients by leveraging the company’s deep understanding of how to prospectively identify patients based on the dominant, RNA-based biology of their tumor microenvironments. This allows OncXerna to pair those patients with OncXerna’s clinical-stage therapies and known mechanism of action that directly address these biologies, to dramatically improve patient outcomes. For more information on OncXerna, please visit: oncxerna.com/

A
bout OncXerna’s RNA-based Biomarker Platform

Existing precision medicines target only approximately 10% of cancers—those with gene mutations or oncogenic drivers for a small number of genes. Using its proprietary biomarker platform, OncXerna is leveraging the company’s deep understanding of tumor biology at the RNA level to identify the dominant biology underlying a patient’s cancer. OncXerna’s first biomarker panel is specific to the tumor microenvironment (TME Panel-1). Initial results from TME Panel-1 reveal 4 different dominant biologies, demonstrating the presence of specific patient subgroups and their predictive value in responding to treatment. OncXerna is further optimizing the biomarker platform’s tumor microenvironment panel through multiple research collaborations, including a collaboration with Moffitt Cancer Center.

A
bout Bavituximab

Bavituximab is an investigational antibody that reverses immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials to treat a specific subset of patients with advanced gastric cancer to improve their response to anti-PD-1 treatment. The mechanism of action of bavituximab is to block tumor immune suppression signaling from PS to multiple immune cell receptor families (e.g., TIMs and TAMs). The dominant biology targeted by bavituximab may be relevant for patients with many types of solid tumors whose immune systems are too suppressed to benefit from currently available immune oncology therapies. OncXerna’s clinical trials currently combine bavituximab with KEYTRUDA® to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors. Bavituximab is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced gastric cancer.

A
bout Navicixizumab

Navicixizumab is an investigational anti-DLL4/VEGF bispecific antibody that has demonstrated antitumor activity in patients who have progressed on Avastin (bevacizumab) in a Phase 1a/b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with Avastin. OncXerna is targeting patients whose dominant tumor biology is driven by angiogenesis with a focus beyond VEGF to include broader anti-angiogenic pathways. Navicixizumab is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Investor and Media
Contact:

Ashley R. Robinson
LifeSci Partners, LLC
[email protected]

Timbercreek Financial Announces 2020 Third Quarter Results

Company also announces changes to Board of Directors

TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — Timbercreek Financial (TSX: TF) (the “Company”) announced today its financial results for the three months and nine months ended September 30, 2020 (“Q3 2020”).


Q3 2020 Highlights

  • Portfolio continues to perform well through the COVID-19 pandemic with no material increase in delinquencies
     
  • Generated $0.18 in distributable income per share and $0.17 adjusted net income per share as well as delivered a 98.3% distributable income payout ratio and a 102.5% adjusted net income payout ratio.
     
  • Funded $89.4M on new and existing mortgages versus repayments of $145.8M.  This resulted in a reduction of net mortgage investments to $1,153.2M in Q3 2020.  The increase in repayments resulted in a Q3 turnover ratio of 12.3% versus 6.4% in Q2 and is a positive sign of increased market activity that will provide capital for new investment opportunities.  Of note, the majority of these repayments (71%) occurred in September.
     
  • Maintained conservative portfolio risk position focused on income-producing commercial real estate
    ° 90.4% of mortgage investment portfolio are first mortgages
    ° 84.1% of mortgage investment portfolio is invested in cash-flowing properties
    ° 68.2% weighted average loan-to-value
    ° 7.2% quarterly weighted average interest rate on net mortgage investment
     
  • Delivered adjusted net income and comprehensive income of $13.6 million and distributable income of $14.2 million
     
  • Paid $14.0 million in dividends to shareholders

“Our mortgage portfolio continued to perform solidly in the third quarter, with collection rates remaining high and trending in line with historical norms,” said Blair Tamblyn, Chief Executive Officer of Timbercreek Financial. “This performance underscores the benefit of our emphasis on durable, income-generating assets and our conservative portfolio positioning. Importantly, we delivered distributable income in line with our expectations. New investment activity was lower in the quarter as transaction volumes declined across the industry. We had a material volume of repayments, which, when combined with a larger debt facility, will enable us to capitalize on new investment opportunities in the market. We have already seen an uptick in transaction activity in the current quarter.”


Quarterly Comparison


$ millions
Q3 2020     Q3 2019   Q2 2020
             
Net Mortgage Investments $ 1,153.2       $ 1,174.1     $ 1,210.3  
Enhanced Return Portfolio Investments $ 93.6       $ 103.0     $ 82.6  
             
Net Investment Income $ 24.1       $ 24.7     $ 22.0  
Income from Operations $ 20.2       $ 21.3     $ 18.2  
Net Income and comprehensive Income $ 14.4       $ 13.9     $ 11.7  
–Adjusted Net Income and comprehensive Income $ 13.6       $ 13.9     $ 11.5  
Distributable Income $ 14.2       $ 15.9     $ 14.8  
Dividends to Shareholders $ 14.0       $ 14.3     $ 14.2  
             

$ per share
Q3 2020     Q3 2019   Q2 2020
             
Dividends per share $ 0.17       $ 0.17     $ 0.17  
Distributable Income per share $ 0.18       $ 0.19     $ 0.18  
Earnings per share $ 0.18       $ 0.17     $ 0.14  
–Adjusted Earnings per share $ 0.17       $ 0.17     $ 0.14  
             
Payout Ratio on Distributable Income 98.3 %     90.2 %   95.7 %
Payout Ratio on Earnings per share 96.7 %     103.0 %   120.5 %
Payout Ratio on Adjusted Earnings per share 102.5 %     103.0 %   122.6 %
             

Net Mortgage Investments
Q3 2020     Q3 2019   Q2 2020
             
Weighted Average Loan-to-Value 68.2 %     67.8 %   68.7 %
Weighted Average Remaining Term to Maturity 1.1 yr     1.1 yr   1.3 yr
First Mortgages 90.4 %     92.8 %   92.1 %
Cash-Flowing Properties 84.1 %     87.4 %   85.8 %
Rental Apartments 50.0 %     46.5 %   51.6 %
Floating Rate Loans with rate floors (at quarter end) 77.3 %     58.0 %   75.1 %
             
Weighted Average Interest Rate            
For the quarter ended 7.2 %     7.3 %   7.1 %
Weighted Average Lender Fee            
New and Renewed 0.7 %     0.9 %   0.7 %
New Net Mortgage Investment Only 1.2 %     1.2 %   1.1 %




Board of Director Changes


The Company also announced the following changes to its Board of Directors, which reflect the recently announced evolution of Timbercreek Asset Management (“Timbercreek”).

  • Scott Rowland, Chief Investment Officer of Timbercreek, joins the Board as a director. Mr. Rowland is responsible for the development of investment strategies and the overall performance of Timbercreek’s portfolios, and oversees the company’s investment team. Mr. Rowland has over 20 years of industry experience with roles including the Co-Head of Debt Strategies for Fiera Properties and the Managing Director for Blackstone’s debt business in Canada. During a 19-year career at GE Capital, Mr. Rowland held a variety of roles including credit underwriting, Asset Management Leader, Originations Leader and the Managing Director for Real Estate in Canada.   
  • Steven Scott, a long-time independent director of the Company, has reached an agreement in principle to acquire an ownership position in Timbercreek, and will become a non-independent director as a result. To ensure the appropriate ratio of independent directors, Ugo Bizzarri, has agreed to resign from the Board of Directors.    
  • Amar Bhalla joins the Board as an independent director. Mr. Amar Bhalla is a principal at the Amdev Property Group, a private real estate company that owns and manages a portfolio of apartment buildings, commercial sites, and development projects in the GTA. He has over 20 years of experience in the acquisition, repositioning and redevelopment of GTA-based real estate across asset classes. Mr. Bhalla serves on the boards of several TSX and TSX-V listed businesses, including acting as Chair of Dream Impact Trust. Mr. Bhalla is a CFA charterholder and a member of the Institute of Corporate Directors.
  • Cameron Goodnough, who is transitioning the Timbercreek CEO role to Blair Tamblyn, will also no longer serve on the Board.

“We’re thrilled to add Scott and Amar as new directors. Given Scott’s enhanced role with Timbercreek as CIO, we look forward to his direct involvement with the Board. Amar’s extensive experience in value-add real estate strategies make him an ideal addition and an excellent complement to the skill-sets of the existing directors,” added Mr. Tamblyn. “On behalf of the Board, I would like to thank Ugo and Cam for their significant contributions to the success of Timbercreek Financial over many years. We look forward to collaborating with them as they continue to grow their direct real estate and public securities business under the Hazelview brand.” 

Quarterly Conference Call

Interested parties are invited to participate in a conference call with management on Monday, November 16, 2020 1:00 p.m. (EST) which will be followed by a question and answer period with analysts. To join the call:


https://timbercreekfinancial.adobeconnect.com/tfq32020/


Participant Toll Free Dial-In Number: (855) 223-7310
Participant International Dial-In Number: (647) 788-4930
Conference ID Number: 4282428

The playback of the conference call will also be available on www.timbercreekfinancial.com following the call.

About the Company

Timbercreek Financial is a leading non-bank, commercial real estate lender providing shorter-duration, structured financing solutions to commercial real estate professionals. Our sophisticated, service-oriented approach allows us to meet the needs of borrowers, including faster execution and more flexible terms that are not typically provided by Canadian financial institutions. By employing thorough underwriting, active management and strong governance, we are able to meet these needs while generating strong risk-adjusted yields for investors. Further information is available on our website, www.timbercreekfinancial.com.

Non-IFRS Measures

The Company prepares and releases financial statements in accordance with IFRS. As a complement to results provided in accordance with IFRS, the Company discloses certain financial measures not recognized under IFRS and that do not have standard meanings prescribed by IFRS (collectively the “non-IFRS measures”). These non-IFRS measures are further described in Management’s Discussion and Analysis (“MD&A”) available on SEDAR. The Company has presented such non-IFRS measures because the Manager believes they are relevant measures of the Company’s ability to earn and distribute cash dividends to shareholders and to evaluate its performance. The following non-IFRS financial measures should not be construed as alternatives to total net income and comprehensive income or cash flows from operating activities as determined in accordance with IFRS as indicators of the Company’s performance.

Certain statements contained in this news release may contain projections and “forward looking statements” within the meaning of that phrase under Canadian securities laws. When used in this news release, the words “may”, “would”, “should”, “could”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect”, “objective” and similar expressions may be used to identify forward looking statements. By their nature, forward looking statements reflect the Company’s current views, beliefs, assumptions and intentions and are subject to certain risks and uncertainties, known and unknown, including, without limitation, those risks disclosed in the Company’s public filings. Many factors could cause actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by these forward looking statements. The Company does not intend to nor assumes any obligation to update these forward looking statements whether as a result of new information, plans, events or otherwise, unless required by law.

SOURCE: Timbercreek Financial

For further information, please contact:
Timbercreek Financial

Blair Tamblyn
Chief Executive Officer
[email protected]

Tracy Johnston
Chief Financial Officer
[email protected]



BioCryst Presents Data Showing Sustained Attack Rate Reductions, Improved Patient Satisfaction and Quality of Life for HAE Patients Taking Berotralstat in APeX-2 Trial

—Data presented at 2020 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI)—

RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today presented new clinical data that further evaluates the attack rate reductions, patient satisfaction and quality of life of hereditary angioedema (HAE) patients in the APeX-2 trial over 48 weeks. Berotralstat is an investigational treatment for the prevention of attacks in patients with HAE.

The data from three abstracts, including a Distinguished Industry Oral Abstract, are being presented at the 2020 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), which is being conducted virtually from November 13-15.

“Presenting all available treatment options to patients is an important part of HAE clinical management. These data continue to demonstrate the potential of berotralstat as a prophylactic medication, if approved by the FDA, with sustained reduction in attacks and meaningful improvements in quality of life seen over 48 weeks of treatment. With its oral, once-daily administration, berotralstat would offer patients a therapeutic alternative for managing this chronic disease,” said H. James Wedner, M.D., the Dr. Phillip and Arleen Korenblat Professor of Medicine at Washington University School of Medicine in St. Louis, and lead author of the Distinguished Industry Oral Abstract.

Following is a brief description of the clinical data posters being presented at ACAAI.


Berotralstat Reduces Attacks in Patients with Hereditary Angioedema (HAE): APeX-2 Trial 48 Week Results

; Distinguished Industry Oral Abstract, Session A, Friday, November 13, 4:30-5:30 p.m. CT

Patients treated with oral, once-daily berotralstat 150 mg for 48 weeks experienced a sustained reduction in mean investigator confirmed HAE attack rates through month 12.

In patients re-randomized to berotralstat 150 mg after 24 weeks on placebo, there was a marked reduction in investigator-confirmed HAE attack rates over 24 weeks of treatment. These patients had a mean attack rate per month of 2.5 at baseline, 1.7 at month six (while on placebo), 0.6 at month seven (one month after starting berotralstat 150 mg) and 0.6 at month 12 (six months after starting berotralstat 150 mg).  

Berotralstat was generally well-tolerated in APeX-2 through 48 weeks. The safety profile observed from weeks 24 to 48 was consistent with the data observed through the first 24 weeks. The most commonly reported treatment-related adverse events were upper respiratory tract infection, abdominal pain, diarrhea and vomiting.


Berotralstat Positively Impacts Patient-Reported Satisfaction: Results from the Phase 3 APeX-2 trial

; Poster #158

Patient satisfaction with treatment was assessed using the validated Treatment Satisfaction Questionnaire for Medicine (TSQM), which is comprised of three specific scales (side effects, effectiveness and convenience) and is scored on a global satisfaction scale from 0-100.

HAE patients who transitioned from placebo to berotralstat 150 mg at week 24 reported improved overall treatment satisfaction and effectiveness. These patients experienced statistically significant improvements from weeks 24 to 48, with a mean global satisfaction increase of 26 points (p=0.005) and a mean effectiveness increase of 29.6 points (p<0.001).   Convenience scores remained high through week 48, reflecting the positive experiences patients had taking an oral medication.


Berotralstat Improves Patient-Reported Quality of Life Through 48 Weeks in the Phase 3 APeX-2 Trial
; Poster #154

Quality of life was assessed with the Angioedema Quality-of-Life (AE-QoL) questionnaire, a validated tool to measure impairment of QoL based on a total and domain (functioning, fatigue/mood, fear/shame and nutrition) scores. The minimal clinically important difference (MCID) is defined as an improvement of six points.

Clinically meaningful improvements in mean AE-QoL total scores were observed as early as week four, with a mean improvement from baseline of 15 points at week 24. This improvement was sustained through 48 weeks of treatment with berotralstat 150 mg.

Improvements were observed in all four domains (functioning, fatigue/mood, fear/shame, nutrition) through week 48. Notably, 77 percent of patients exceeded the MCID in total AE-QoL total scores at 48 weeks, indicating the reduction in attacks following berotralstat therapy appears to have a positive impact on patients’ quality of life.

About
the
APeX-2
Trial
In APeX-2, 121 eligible HAE type 1 or type 2 patients were randomized 1:1:1 to oral, once daily berotralstat 110 mg or 150 mg or placebo for 24 weeks. At 24 weeks, patients initially randomized to 110 mg or 150 mg of berotralstat continued on that dose. Patients who initially received placebo were re-randomized 1:1 at week 24 to receive either berotralstat 110 mg or 150 mg.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; developing and commercializing ORLADEYO or any HAE product candidate may take longer or may be more expensive than planned; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on product candidates, may impose a clinical hold with respect to such product candidates, or may withhold market approval for product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst’s ability to successfully commercialize its product candidates, manage its growth, and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that 2020 operating expenses and cash usage may not be within management’s expected ranges.  Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements.

BCRXW


Contact:


John Bluth
+1 919 859 7910
[email protected]

Catherine Collier Kyroulis
+1 917 886 5586
[email protected]

ReneSola Power to Release Third Quarter 2020 Financial Results on December 1, 2020

PR Newswire

STAMFORD, Conn., Nov. 13, 2020 /PRNewswire/ — ReneSola Ltd (“ReneSola Power” or the “Company”) (www.renesolapower.com) (NYSE: SOL), a leading fully integrated solar project developer, announced today that it will report its unaudited financial results for the third quarter ended September 30, 2020 after the U.S. stock market close on Tuesday, December 1, 2020. The Company will hold a conference call to discuss the financial results at 4:30 p.m. U.S. Eastern Time on Tuesday, December 1, 2020 (5:30 a.m. China Standard Time on Wednesday, December 2, 2020).

What:              ReneSola Ltd Third Quarter (ended September 30, 2020) Earnings Call
When:             4:30 p.m. U.S. Eastern Time on Tuesday, December 1, 2020 (5:30 a.m. China Standard Time on Wednesday, December 2, 2020)
Webcast:        http://ir.renesolapower.com/webcasts-presentations

Please register in advance to join the conference call using the link provided below and dial in 10 minutes before the call is scheduled to begin. Conference call access information will be provided upon registration.

Participant Online Registration: http://apac.directeventreg.com/registration/event/7488976

A replay of the conference call may be accessed by phone at the following numbers until December 9, 2020. To access the replay, please reference the conference ID 7488976.


Phone Number


Toll-Free Number

United States

+1 (646) 254-3697

+1 (855) 452-5696

Hong Kong

+852 3051-2780

+852 8009-63117

Mainland China

+86 (800) 870-0206

+86 (400) 602-2065

Other International

+61 (2) 8199-0299

A webcast of the conference call will be available on the ReneSola Power website at http://ir.renesolapower.com.

About ReneSola Power

ReneSola Power (NYSE: SOL) is a leading global solar project developer and operator. The Company focuses on solar power project development, construction management and project financing services. With local professional teams in more than 10 countries around the world, the business is spread across a number of regions where the solar power project markets are growing rapidly, and can sustain that growth due to improved clarity around government policies. The Company’s strategy is to pursue high-margin project development opportunities in these profitable and growing markets; specifically, in the U.S. and Europe, where the Company has a market-leading position in several geographies, including Poland, Hungary, Minnesota and New York.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/renesola-power-to-release-third-quarter-2020-financial-results-on-december-1-2020-301172511.html

SOURCE ReneSola Ltd.

Village Farms International Reports Third Quarter 2020 Financial Results – Pure Sunfarms Delivers Seventh Consecutive Profitable Quarter, Nearly Tripling Net Income Sequentially on a 75% Sequential Net Sales Increase as Produce Business Continues Strong Performance

PR Newswire


– Pure Sunfarms Brand Achieves 15.2% Dried Flower Market Share (by Volume) with OSC in October –

VANCOUVER, BC, Nov. 13, 2020 /PRNewswire/ – Village Farms International, Inc. (“Village Farms” or the “Company”) (NASDAQ: VFF) (TSX: VFF) today announced its financial results for the three and nine months ended September 30, 2020.  All figures are in U.S. dollars unless otherwise indicated. 

The Company’s financial statements for the three and nine months ended September 30, 2020, as well as the comparative periods for 2019, have been prepared and presented under United States Generally Accepted Accounting Principals (“GAAP”). On September 30, 2020, Village Farms had a majority (non-controlling) interest of 58.7% of Pure Sunfarms Corp. (“Pure Sunfarms”), as the full acquisition of the remaining interest in Pure Sunfarms did not occur till November 2, 2020. Accordingly, Pure Sunfarms results are not consolidated for the third quarter.

Pure Sunfarms’ Third Quarter and Other Recent Highlights

(Dollar Amounts are Before Village Farms’ Proportionate Share)

  • Achieved significant sequential quarterly growth in key financial metrics for the third quarter of 2020 compared to the second quarter of 2020:
    • Net sales increased 75% to C$22.6 million;
    • Net sales to provincial buyers (retail) increased 30% to C$12.0 million;
    • Gross profit increased 81% to C$7.8 million;
    • Net income increased 200% to C$3.2 million; and
    • Adjusted EBITDA increased 125% to C$5.6 million.
  • Achieved 15.2% brand market share of the dried flower category (by kilograms sold) in October 2020 with the Ontario Cannabis Store (“OCS”)*;
  • Remained the top-selling brand of dried flower products with the OCS (by kilograms sold and dollars sold) for the year-to-date ended October 31, 2020, with a market share of 13.6% (by kilograms sold)*;
  • Launched its first Cannabis 2.0 products, specifically Full Spectrum Vapes in 510 Thread Cartridges and first bottled oil products, in September 2020; and,
  • Received an amendment to its standard cannabis processing license from Health Canada permitting internal extraction operations, which are currently ramping up.

*Data cited has been calculated by Pure Sunfarms from sales information provided by OCS.

Village Farms’ Financial Summary for the Three and Nine Months Ended September 30, 2020 and Corporate Highlights

($US millions except per share metric)


Three Months Ended   
September 30,


Nine Months Ended      
September 30,


2020


2019


Change


2020


2019


Change

Produce Sales

$43.0

$38.3

+12%

$122.7

$111.5

+10%

Net Income (Loss)1

$0.5

($0.7)

+171%

$4.63

$9.52

-52%

Income (Loss) Per Share1

$0.01

($0.01)

+200%

$0.083

$0.202

-60%

Adjusted EBITDA4

$4.6

$2.9

+59%

$7.9

$8.3

-5%

1.

Net income includes the net income contribution from Pure Sunfarms of US$1.4 million and US$3.7 million (Village Farms’ proportionate share) for the three-month periods ended September 30, 2020 and 2019, respectively and US$5.4 million and US$14.5 million (Village Farms’ proportionate share) for the nine-month periods ended September 30, 2020 and 2019, respectively.

2.

Net income for the nine months ended September 30, 2019 includes a one-time gain on the sale of Delta 2 greenhouse facility of $13.6 million.

3.

Net income for the nine months ended September 30, 2020 includes a $4.7 million gain on receipt of Pure Sunfarms shares from Emerald Health Therapeutics as per the Settlement Agreement and Mutual Release, dated March 2, 2020, by and between Village Farms International, Inc., Emerald Health Therapeutics Inc., Emerald Health Therapeutics Canada Inc., and Pure Sunfarms Corp. (the “Settlement Agreement”).

4.

Adjusted EBITDA includes the positive EBITDA contribution from Pure Sunfarms of US$2.5 million and US$5.0 million (Village Farms’ proportionate share) for the three-month periods ended September 30, 2020 and 2019, respectively and US$6.4 million and US$17.7 million (Village Farms’ proportionate share) for the nine-month periods ended September 30, 2020 and 2019, respectively.  Adjusted EBITDA includes the Company’s majority non-controlling interest in Pure Sunfarms and 65% equity interest in Village Fields Hemp USA LLC (“VF Hemp”), (together the “Joint Ventures” or “JVs”). Adjusted EBITDA is not a recognized earnings measure and does not have a standard meaning prescribed in by GAAP. See “Non-GAAP Measures” below.

 

  • On November 2, 2020 (subsequent to quarter end), the Company acquired all issued and outstanding shares of Pure Sunfarms, as a result of which the Company now wholly owns 100% of Pure Sunfarms;
  • In September 2020, the Company completed a registered direct offering of 9,396,226 units at a purchase price of US$5.30 per unit with certain institutional investors for gross proceeds of approximately $49.8 million, of which a portion of the proceeds were used to finance the Pure Sunfarms acquisition;
  • The Company initiated its international cannabis strategy with investments in Australia-based Altum International Pty Ltd, one of Asia-Pacific’s leading cannabinoid platforms, and DutchCanGrow, a Netherlands-based cannabis enterprise pursuing the opportunity to become one of a limited number of licensed cannabis growers when the Dutch government permits the first legal recreational cannabis market in Europe; and
  • Subsequent to quarter end, the Company’s wholly owned subsidiary, Village Farms Clean Energy, Inc. (“VFCE”), renewed and extended its existing contract with the City of Vancouver under which VFCE receives landfill gas captured by the City of Vancouver at the City’s landfill site in Delta, BC, enabling the transition of VFCE to a more attractive long-term business model based on the conversion of landfill gas to high-demand Renewable Natural Gas.

Pure Sunfarms’ Financial Summary for the Three and Nine Months Ended September 30, 2020
(Before Village Farms’ Proportionate Share)
   

(millions except % metrics)


Three Months Ended September 30,


2020


2019


Change of C$


C$


US$


C$


US$

Total Gross Sales

$28.8

$21.7

$24.8

$18.7

+16%

Total Net Sales

$22.6

$17.0

$24.0

$18.1

-6%

Gross Margin

34%

35%

69%

69%

-51%

SG&A

$3.3

$2.4

$3.7

$2.8

-11%

Net income

$3.2

$2.5

$8.9

$6.7

-64%

Adjusted EBITDA5

$5.6

$4.3

$13.4

$10.1

-58%

Adjusted EBITDA Margin

25%

25%

56%

56%

-55%

 

(millions except % metrics)


Nine Months Ended September 30,


2020


2019


Change of C$


C$


US$


C$


US$

Total Gross Sales

$69.6

$51.4

$71.5

$53.8

-2%

Total Net Sales

$53.5

$39.6

$70.7

$53.1

-24%

Gross Margin

40%

40%

75%

75%

-47%

SG&A

$9.1

$6.7

$7.5

$5.6

+21%

Net income6

$12.9

$9.4

$32.1

$24.1

-60%

Adjusted EBITDA5

$14.9

$11.0

$47.1

$35.4

-68%

Adjusted EBITDA Margin

28%

28%

67%

67%

-58%

5.

Adjusted EBITDA is not a recognized earnings measure and does not have a standard meaning prescribed in by GAAP. See “Non-GAAP Measures” below.

6.

Net income includes C$6.0 million of debt forgiveness income as an outcome of the Settlement Agreement.

 

Pure Sunfarms’ Percent of Sales by Product Group


Three months ended
September 30,


Nine months ended
September 30,


Channel


2020


2019


2020


2019

Retail, Flower

48.5%

11.1%

52.3%

3.8%

Retail, 2.0 Product

4.5%

0.0%

1.9%

0.0%

Wholesale, Flower and Trim

47.0%

88.9%

45.8%

96.2%

Management Commentary

“With 75% sequential growth in dollar sales, Pure Sunfarms’ third quarter highlighted its strong sales momentum as its leading brand continues to resonate with consumers,” said Michael DeGiglio, CEO, Village Farms.  “Importantly, this sales momentum was achieved with only a small contribution from Pure Sunfarms’ Cannabis 2.0 and bottled oil products, which were launched late in the quarter.  Pure Sunfarms’ third quarter results are yet further evidence of its earnings power, based on our unique approach to the cannabis industry, with net income nearly tripling from the second quarter of this year, marking Pure Sunfarms seventh consecutive quarter of profitability.  It is an achievement that is unmatched in our industry, and further underscores the significant value in acquiring the entirety of Canada’s premier cannabis company.”

Mr. DeGiglio added, “The deep experience and organizational strength underlying our legacy produce business, which delivered another solid quarter, combined with our proven cannabis capabilities provides Village Farms with a rock-solid foundation as we transform to a vertically integrated, agriculturally-based CPG business to aggressively pursue high-growth opportunities in emerging legal cannabis and related markets in the United States and other targeted markets.  There is no cannabis supplier in Canada or the U.S. with our combination of experience, capabilities and more than ten million square feet of greenhouse assets, and we are encouraged by the evolving regulatory environment in the U.S. and are developing multiple strategies to capitalize on any favourable U.S. regulatory developments in 2021.  We will pursue these opportunities with prudent, disciplined capital allocation and focus on return on invested capital.”

COVID-19 Update

All Village Farms’ production facilities in Texas, British Columbia, and Pure Sunfarms’ facilities in Canada remain open and operational. The Company has experienced a small number of COVID-19 illnesses at its facilities, however, the Company’s protocols were followed and there has been no material disruption to operations. Village Farms and Pure Sunfarms adhere to the highest health and safety standards in their operations and each has put in place heightened hygiene practices and safety protocols, including more stringent cleaning and sanitization, and are taking appropriate precautions throughout all operations as per the recommendations of health authorities.  The Company will continue to enhance and evolve such practices and protocols as the situation warrants.

Summary Statutory Results


(in thousands of U.S. Dollars unless otherwise indicated)


For the three months
ended September 30,


For the nine months
ended September 30,


2020


2019


2020


2019

Sales

$43,037

$38,293

$122,722

$111,512

Cost of sales

(37,418)

(38,904)

(112,809)

(114,418)

Selling, general and administrative expenses

(4,942)

(3,739)

(12,676)

(11,899)

Stock compensation expense

(472)

(666)

(1,329)

(2,663)

Interest expense

(299)

(655)

(1,273)

(2,018)

Interest income

101

304

577

651

Foreign exchange (loss) gain

(484)

(183)

(880)

338

Gain on settlement

4,681

Other income, net

27

69

92

219

(Loss) gain on disposal of assets

(8)

(6)

13,558

(Provision for) recovery of income taxes

(336)

1,266

607

114

Equity earning from unconsolidated entities

1,306

3,519

4,885

14,115

Net income (loss)

$520

($704)

$4,591

$9,509

 

Adjusted EBITDA7

$4,556

$2,881

$7,921

$8,326

Income (loss) per share – basic

$0.01

($0.01)

$0.08

$0.20

Income (loss) per share – diluted

$0.01

($0.01)

$0.08

$0.19

7.

Adjusted EBITDA is not a recognized earnings measure and does not have a standard meaning prescribed in by GAAP. See “Non-GAAP Measures” below.

 

Pure Sunfarms (in C$)


Three months ended September 30, 2020 compared to the three months ended June 30, 2020.

Sales

Sales for three months ended September 30, 2020 increased to $22,627 as compared to $12,902, or a 75% quarter on quarter increase from the three months ended June 30, 2020 sales .  The increase was primarily driven by a 148% increase in sales in the wholesale channel, a 30% quarter on quarter increase in sales to provincial (retail) boards and the September launch of Pure Sunfarms Cannabis 2.0 derivative products, which includes cannabis oil and vape pens. The quarter on quarter growth in retail sales is directly attributable to a 165.7% increase in Pure Sunfarms retail small format, a 29.7% quarter on quarter increase in pre-rolls and a (42.7%) decrease in Pure Sunfarms retail large format, as the large format was launched in the second quarter of 2020 and the third quarter retail large format sales consisted of ongoing replenishment sales.

The channel makeup of the third quarter sales was 53% to the retail channel and 47% to the wholesale channel.  The channel makeup of the second quarter sales was 69% to the retail channel and 31% to the wholesale channel.  Cannabis 2.0 derivative products were 4.5% of third quarter sales, which are included in the retail channel.

The net average selling price for the three months ended September 30, 2020 was higher than the net average selling price for the three months ended June 30, 2020 by 13.3% due to an increase in small format retail sales versus large format retail sales, a quarter on quarter increase in the sales price of retail flower SKUs and a slight increase in wholesale pricing, which is impacted by the makeup of the potency of flower biomass sold to various wholesale customers.

Cost of Sales

Cost of sales for the three months ended September 30, 2020 and three months ended June 30, 2020 was $14,826 and $8,594, respectively, an increase of 73%. The third quarter of 2020 cost of sales includes an inventory write down of ($1,412) for distillate inventory purchased from third party extraction companies for which the market value has dropped since the initial purchase. The quarter on quarter increase in costs excluding the distillate inventory write down was 56%, primarily due to a 143% increase in wholesale kilograms sold, a 120% increase in retail small format kilograms sold which has higher overhead and labor cost compared to retail large format, and the launch of recently approved Cannabis 2.0 products which was co-manufactured by another licensed producer.

Gross Margin

Gross margin for the three months ended September 30, 2020 and three months ended June 30, 2020 was 34.5% and 33.2%, respectively, excluding the distillate inventory write down the third quarter gross margin was 40.7%. The quarter on quarter improvement was due to an increase in wholesale sell price and an increase in small format retail flower sales as compared to higher sales of Pure Sunfarms retail large format products in the second quarter of 2020, which have a lower gross margin.

Net Income

Net income for the three months ended September 30, 2020 and three months ended June 30, 2020 was $3,240 and $1,079 respectively, an increase of 200%. The increase was primarily due to the increase in gross margin.

Adjusted EBITDA

Adjusted EBITDA for the three months ended September 30, 2020 increased 125% to $5,642 from $2,509 for the second quarter.  The third quarter Adjusted EBITDA figure includes the third-party distillate inventory write down of ($1,412).

Pure Sunfarms (in C$)


Three months ended September 30, 2020 compared to the three months ended September 30, 2019.

Sales

Sales for the three months ended September 30, 2020 and 2019 was $22,627 and $23,953, respectively, a decrease of (5.5%). The change was due to 362% increase in provincial (retail) sales and (51.6%) decrease in wholesale selling price for the three months ended September 30, 2020 compared to the three months ended September 30, 2019.  The net average selling price of retail flower for the three months ended September 30, 2020 was lower than the net average selling price for the three months ended September 30, 2019 by (35.8%).

Cost of Sales

Cost of sales for the three months ended September 30, 2020 and 2019 was $14,826 and $7,536, respectively, an increase of 97%. The third quarter 2020 cost of sales includes an inventory write down of ($1,412) for distillate inventory purchased from their third-party extraction companies for which the market value has dropped since the initial purchase. The year on year increase in costs excluding the distillate inventory write down was 78%, primarily due to a 553% increase in retail kilograms sold which require incremental packaging, overhead and logistics expenses compared to product sold through the wholesale channel, as well as higher depreciation expense charge (a year on year increase of 91%).

Gross Margin

Gross margin for the three months ended September 30, 2020 and 2019 was 34.5% and 68.5%, respectively. The decline was due to the ($1,412) inventory write down for distillate inventory in 2020, a lower price environment for the wholesale channel in 2020 as compared to the third quarter of 2019, as well as an increase in costs as a result of Pure Sunfarms’ increase in provincial (retail) sales in 2020, as the majority of sales in the third quarter of 2019 were made through the wholesale channel.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 were $3,261 and $3,741, respectively, a decrease of 12.8%. The decrease was primarily due to wage subsidies received from the Government of Canada as a result of the federal COVID-19 program. Without the subsidy, the year on year selling, general and administrative expenses were essentially flat. 

Net Income

Net income for the three months ended September 30, 2020 and 2019 was $3,240 and $8,860 respectively, a decrease of (63.4%). The decrease was primarily due to the decrease in gross margin.

Adjusted EBITDA

Adjusted EBITDA for the three months ended September 30, 2020 declined (57.7%) to $5,642 from $13,352 for the same prior year period. The decrease was primarily due to the decrease in gross margin.

Produce (in US$)


Three months ended September 30, 2020 compared to the three months ended September 30, 2019

.

Sales

Produce sales for the three months ended September 30, 2020 increased $4,744, or 12.4%, to $43,037 compared to $38,293 for the three months ended September 30, 2019. The improvement in sales is due to an increase in pricing for tomatoes during the three months ended September 30, 2020 compared to the same prior year period. The average net selling price for total tomato pounds sold increased 30% for the three months ended September 30, 2020 compared to the three months ended September 30, 2019, generated primarily from our commodity items, which includes beefsteak tomatoes and tomatoes on the vine (“TOVs”). The increase in net selling price in the commodity items was primarily the result of a supply shortage throughout most of 2020, due to an increase in grocery store traffic, driven by COVID-19 measures, as well as a global tomato virus that is negatively impacting tomato supplies. Pepper prices increased 19% and pepper pounds sold increased 47% when compared to the same prior year period, due to an increase in our third-party pepper contracts. Cucumber prices increased 1% and cucumber pieces sold decreased (12%) for the three months ended September 30, 2020 as compared to the three months ended September 30, 2019.

Cost of Sales

Cost of sales for the three months ended September 30, 2020 decreased ($1,486), or (3.8%), to $37,418 from $38,904 for the three months ended September 30, 2019, as the Company produced less tomatoes at its facilities in the third quarter of 2020 compared to the same period in 2019 due to the transition of the Delta 2 facility, which converted from tomato production in 2019 to cannabis production for Pure Sunfarms in 2020.

Adjusted EBITDA

Adjusted EBITDA for the three months ended September 30, 2020 increased $4,168 to $2,223 from ($1,945) for the three months ended September 30, 2019 due primarily to an increase in gross margin, partially offset by an increase in selling, general and administrative expenses. See the reconciliation of Adjusted EBITDA to net income in “Non-GAAP Measures” below.

Non-GAAP Measures

References in this news release to “Adjusted EBITDA” are to earnings (including the equity in earnings of the Joint Ventures) before interest, taxes, depreciation and amortization (“EBITDA”), as further adjusted to exclude foreign currency exchange gains and losses on translation of long-term debt, unrealized gains on the changes in the value of derivative instruments, stock compensation, and gains and losses on asset sales, and adjusts for the difference in accounting treatment of Pure Sunfarms, which we believe is necessary to reflect the true economic value of our interest in Pure Sunfarms.  Adjusted EBITDA is a cash flow measure that is not recognized under GAAP and does not have a standardized meaning prescribed by GAAP. Therefore, Adjusted EBITDA may not be comparable to similar measures presented by other issuers. Although net income or loss is the most directly comparable financial measure calculated and presented in accordance with GAAP, investors are cautioned that Adjusted EBITDA should not be construed as an alternative to net income or loss determined in accordance with GAAP as an indicator of the Company’s performance or to cash flows from operating, investing and financing activities as measures of liquidity and cash flows. Management believes that Adjusted EBITDA is an important measure in evaluating the historical performance of the Company. 

We also present Adjusted EBITDA, earnings per share and diluted earnings per share on a proportionate segment basis. Each of the components of Adjusted EBITDA, on a proportionate segment basis, are presented in the tables below that present a reconciliation of GAAP results to proportionate results. We believe that the ability of investors to assess our overall performance may be improved by the disclosure of proportionate segment Adjusted EBITDA, earnings per share and diluted earnings per share.

The following table reflects a reconciliation of net income to Adjusted EBITDA, as presented by the Company:


(in thousands of U.S. dollars)


For the three months
ended September 30,


For the nine months
ended September 30,


2020


2019


2020


2019

Net income (loss)

$520

($704)

$4,591

$9,509

Add:

Amortization

1,518

2,360

4,540

5,587

Foreign currency exchange loss (gain)

484

183

880

(338)

Interest expense, net

198

351

696

1,367

Provision for (recovery of) income taxes

336

(1,266)

(607)

(114)

Stock based compensation

472

666

1,329

2,663

Interest expense for JVs

240

276

636

506

Amortization for JVs

598

414

1,276

1,125

Foreign currency exchange loss (gain) for JVs

33

(8)

118

(21)

Income taxes provision from JVs

245

1,355

1,736

5,572

(Gain) loss on disposal of assets

(88)

8

(97)

(13,558)

Gain on settlement agreement

(4,681)

JV gain on settlement of net liabilities

(2,496)

True economic benefit Pure Sunfarms8

(754)

(3,972)

Adjusted EBITDA

$4,556

$2,881

$7,921

$8,326

Adjusted EBITDA for JVs (See table below)

$2,333

$4,826

$6,050

$17,346

Adjusted EBITDA excluding JVs(produce)

$2,223

($1,945)

$1,871

($9,020)

8.

The GAAP treatment of our equity earning of Pure Sunfarms is different than under International Financial Reporting Standards (“IFRS”). Under GAAP the Emerald shares held in escrow are not considered issued until paid for pursuant to the GAAP concept of ‘hypothetical liquidation’. As a result, our ownership percentage for the three and nine months ended September 30, 2019 was 61.4% and 60.8%, respectively, compared to our economic interest under IFRS of 50% for the same periods.

 


Breakout of JV’s Adjusted EBITDA


(in thousands of U.S. dollars)


For the three months
ended September 30,


For the nine months
ended September 30,


2020


2019


2020


2019

Pure Sunfarms Adjusted EBITDA

$2,551

$5,035

$6,365

$17,710

VFH Adjusted EBITDA

(178)

(209)

(315)

(364)

Total JV’s Adjusted EBITDA

$2,333

$4,826

$6,050

$17,346

 

The following tables are a reconciliation of the GAAP results to the proportionate results (which include the Company’s proportionate share of the Pure Sunfarms operations):


For the three months ended September 30, 2020


(in thousands of U.S. dollars)

 

Produce

Pure
Sunfarms9

 

Hemp9

 

Total

Sales

$43,037

$10,007

$-

$53,044

Cost of sales

(37,418)

(6,547)

(43,965)

Gross margin

5,619

3,460

9,079

Selling, general and administrative expenses

(4,942)

(1,436)

(213)

(6,591)

Share-based compensation

(472)

(472)

Interest expense

(299)

(227)

(14)

(540)

Interest income

101

101

Foreign exchange loss

(484)

(33)

(517)

Other income (expense)

27

(76)

1

(48)

Gain on disposal of assets

89

89

(Loss) income before taxes

(450)

1,688

(137)

(1,101)

Recovery of (provision for) income taxes

(336)

(245)

(581)

Net (loss) income

($786)

$1,443

($137)

$520

Adjusted EBITDA10

$2,223

$2,511

($178)

$4,556

(Loss) income per share – basic

($0.01)

$0.02

($0.00)

$0.01

(Loss) income per share – diluted

($0.01)

$0.02

($0.00)

$0.01


For the three months ended September 30, 2019

 (in thousands of U.S. dollars)

 

Produce

Pure
Sunfarms9

 

Hemp9

 

Total

Sales

$38,293

$10,217

$-

$48,510

Cost of sales

(38,904)

(3,211)

(42,115)

Gross margin

(611)

7,006

6,395

Selling, general and administrative expenses

(3,739)

(1,635)

(229)

(5,603)

Share-based compensation

(666)

(666)

Interest expense

(655)

(175)

(830)

Interest income

304

304

Foreign exchange (loss) gain

(183)

8

(175)

Other income

69

5

74

Loss on disposal of assets

(8)

(8)

(Loss) income before taxes

(5,489)

5,209

(229)

(509)

Recovery of (provision for) income taxes

1,266

(1,461)

(195)

Net (loss) income

($4,223)

$3,748

($229)

($704)

Adjusted EBITDA10

($1,945)

$5,035

($209)

$2,881

(Loss) income per share – basic

($0.09)

$0.08

($0.00)

($0.01)

(Loss) income per share – diluted

($0.09)

$0.08

($0.00)

($0.01)


For the nine months ended September 30, 2020


(in thousands of U.S. dollars)

 

Produce

Pure
Sunfarms9

 

Hemp9

 

Total

Sales

$122,722

$22,958

$98

$145,778

Cost of sales

(112,809)

(13,782)

(120)

(126,711)

Gross margin

9,913

9,176

(22)

19,067

Selling, general and administrative expenses

(12,676)

(3,870)

(500)

(17,046)

Share-based compensation

(1,329)

(1,329)

Interest expense

(1,273)

(425)

(211)

(1,909)

Interest income

577

577

Foreign exchange loss

(880)

(117)

(997)

Gain on settlement

4,681

4,681

JV gain on settlement

2,496

2,496

Other income (expense)

92

(92)

82

82

(Loss) gain on disposal of assets

(6)

5

99

98

(Loss) income before taxes

(901)

7,173

(552)

5,720

Recovery of (provision for) income taxes

607

(1,736)

(1,129)

Net (loss) income

($294)

5,437

(552)

4,591

Adjusted EBITDA10

$1,871

6,365

(315)

7,921

(Loss) income per share – basic

($0.01)

$0.10

($0.01)

$0.08

(Loss) income per share – diluted

($0.01)

$0.10

($0.01)

$0.08


For the nine months ended September 30, 2019

 (in thousands of U.S. dollars)

 

Produce

Pure
Sunfarms9

 

Hemp9

 

Total

Sales

$111,512

$32,011

$-

$143,523

Cost of sales

(114,418)

(8,137)

(122,555)

Gross margin

(2,906)

23,874

20,968

Selling, general and administrative expenses

(11,899)

(3,334)

(378)

(15,611)

Share-based compensation

(2,663)

(2,663)

Interest expense

(2,018)

(356)

(2,374)

Interest income

651

651

Foreign exchange gain

338

22

360

Other income

219

12

231

Gain on disposal of assets

13,558

13,558

(Loss) income before taxes

(4,720)

20,218

(378)

15,120

Recovery of (provision for) income taxes

114

(5,725)

(5,611)

Net (loss) income

($4,606)

$14,493

($378)

$9,509

Adjusted EBITDA10

($9,020)

$17,710

($364)

$8,326

(Loss) income per share – basic

($0.09)

$0.30

($0.01)

$0.20

(Loss) income per share – diluted

($0.09)

$0.29

($0.01)

$0.19

9.

The adjusted consolidated financial results have been adjusted to include the Company’s share of revenues and expenses from its Pure Sunfarms and Hemp joint ventures on a proportionate accounting basis, on which management bases its operating decisions and performance evaluation.  GAAP does not allow for the inclusion of the Joint Venture on a proportionate basis.  These results include additional non-GAAP measures such as EBITDA.

10.

Adjusted EBITDA is not a recognized earnings measure and does not have a standard meaning prescribed in by GAAP. See “Non-GAAP Measures” above.

 

Pro Forma Results

The combined pro forma financial information being presented is for informational purposes only and is not necessarily indicative of the results of operations that actually would have been achieved had the transaction occurred as of January 1, 2020, nor do they purport to project the future operating results of the consolidated company. The pro forma financial information also does not reflect the costs of any integration activities or cost savings or synergies expected to be achieved as a result of the transaction and, accordingly, do not attempt to predict or suggest future results.

The combined pro forma financial information being presented is based on preliminary estimates, accounting judgments and currently available information and assumptions that management believes are reasonable. Accordingly, this pro forma financial data is not necessarily indicative of our financial position or results of operations had the Pure Sunfarms acquisition described above for which we are giving pro forma effect actually occurred on the date indicated.

The following tables present pro forma GAAP results as if the Company’s owned 100% of the Pure Sunfarms operations as of January 1, 2020:


For the three months ended September 30, 2020

 


(in thousands of U.S. dollars)

Historical

Village Farms

Historical
Pure Sunfarms

Pro Forma
Adjustments

Pro Forma
Combined

Consolidated sales

$43,037

$17,048

$-

$60,085

Cost of sales

(37,418)

(11,154)

(48,572)

Gross margin

5,619

5,894

11,513

Selling, general and administrative expenses

 

(4,942)

 

(2,447)

 

 

(7,389)

Share-based compensation

(472)

(472)

Interest expense

(299)

(386)

100

(585)

Interest income

101

(100)

1

Foreign exchange loss

(484)

(56)

(540)

Other income (expense)

27

(131)

(104)

(Loss) income before taxes

(450)

2,874

2,424

(Provision for) recovery of income taxes

 

(336)

 

(417)

 

 

(753)

(Loss) gain from consolidated entities after income taxes

 

(786)

 

2,457

 

 

1,671

Equity earnings of unconsolidated entities

 

1,306

 

 

(1,443)

 

(137)

Net income (loss)

$520

$2,457

($1,443)

$1,534

Income per share – basic

$0.01

$0.02

Income per share – diluted

$0.01

$0.02

Weighted average number of common shares – basic

 

58,536

7,354

 

65,890

Weighted average number of common shares – diluted

 

60,440

7,808

 

68,248

Adjusted EBITDA

$4,556

$4,277

($2,511)

$6,322


For the nine months ended September 30, 2020

 


(in thousands of U.S. dollars)

Historical

Village Farms

Historical
Pure Sunfarms

Pro Forma
Adjustments

Pro Forma
Combined

Consolidated sales

$122,722

$39,571

$-

$162,293

Cost of sales

(112,809)

(23,678)

(136,487)

Gross margin

9,913

15,893

25,806

Selling, general and administrative expenses

(12,676)

(6,731)

(19,407)

Share-based compensation

(1,329)

(1,329)

Interest expense

(1,273)

(734)

309

(1,698)

Interest income

577

(309)

268

Foreign exchange loss

(880)

(207)

(1,087)

Gain on settlement

4,681

4,348

9,029

Other income (expense)

92

(146)

(54)

Loss on disposal of assets

(6)

(6)

(Loss) income before taxes

(901)

12,423

11,522

Recovery of (provision for) income taxes

 

607

 

(3,012)

 

(2,405)

Loss from consolidated entities after income taxes

 

(294)

 

9,411

9,117

Equity earnings of unconsolidated entities

 

4,885

 

 

(5,438)

(553)

Net income (loss)

$4,591

$9,411

($5,438)

$8,564

Income per share – basic

$0.08

$0.13

Income per share – diluted

$0.08

$0.13

Weighted average number of common shares – basic

 

55,946

 

8,676

 

64,622

Weighted average number of common shares – diluted

 

57,778

 

9,130

 

66,908

Adjusted EBITDA

$7,921

$10,980

($6,365)

$12,536

 

Within 75 days of November 2, 2020 (the closing date of the Pure Sunfarms acquisition), the Company will file with the U.S. Securities and Exchange Commission, on Form 8-K/A, historical financial statements for Pure Sunfarms, together with unaudited pro forma combined financial statements of the Company as if the Pure Sunfarms Transaction had occurred on January 1, 2020.

This press release is intended to be read in conjunction with the Company’s Consolidated Financial Statements (“Financial Statements”) and Management’s Discussion & Analysis (“MD&A”) for the three and nine month periods ended September 30, 2020 in the Company Form 10-Q, which will be filed on (www.sec.gov/edgar.shtml) and SEDAR (www.sedar.com) and will be available at www.villagefarms.com.

Conference Call

Village Farms’ management team will host a conference call, Friday, November 13, 2020, at 8:30 a.m. ET to discuss its financial results.  Participants can access the conference call by telephone by dialing (647) 427-7450 or (888) 231-8191, or via the Internet at: https://bit.ly/2HoYneE.

For those unable to participate in the conference call at the scheduled time, it will be archived for replay both by telephone and via the Internet beginning approximately one hour following completion of the call. To access the archived conference call by telephone, dial (416) 849-0833 or (855) 859-2056 and enter the passcode 9199257 followed by the pound key. The telephone replay will be available until Friday, November 20, 2020 at midnight (ET).  The conference call will also be archived on Village Farms’ website at http://villagefarms.com/investor-relations/investor-calls.

About Village Farms International, Inc.

Village Farms is one of the largest and longest-operating greenhouse growers in North America, and is leveraging its decades of experience in large-scale, low-cost intensive agriculture and as a vertically integrated produce supplier to pursue high-value, high-growth plant-based Consumer Packaged Goods opportunities in cannabis and CBD in North America and selected markets internationally.

In Canada, British-Columbia-based Pure Sunfarms is one of the single largest cannabis operations in the world, the lowest-cost greenhouse producer, one of the best-selling brands, and has generated profitability for seven consecutive quarters.

In the U.S., subject to compliance with all applicable U.S. federal and state laws, Village Farms is pursuing a strategy to become a leading developer and supplier of branded and white-labeled CBD products targeting “big box” and other major retailers and consumer packaged goods companies, and with one the largest greenhouse operations in country, is well positioned for the potential federal legalization of high-THC cannabis.

Internationally, Village Farms is strategically targeting selected, nascent, legal cannabis and CBD opportunities with significant long-term potential, with an initial focus on the Asia-Pacific region through its investment in Australia-based Altum International.


Cautionary Statement Regarding Forward-Looking Information

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is subject to the safe harbor created by those sections. This press release also contains “forward-looking information” within the meaning of applicable Canadian securities law. We refer to such forward-looking statements and forward-looking information collectively as “forward-looking statements”. Forward-looking statements may relate to the Company’s future outlook or financial position and anticipated events or results and may include statements regarding the financial position, business strategy, budgets, expansion plans, litigation, projected production, projected costs, capital expenditures, financial results, taxes, plans and objectives of or involving the Company. Particularly, statements regarding future results, performance, achievements, prospects or opportunities for the Company, the greenhouse vegetable industry or the cannabis industry are forward-looking statements. In some cases, forward-looking information can be identified by such terms as “outlook”, “may”, “might”, “will”, “could”, “should”, “would”, “occur”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “try”, “estimate”, “predict”, “potential”, “continue”, “likely”, “schedule”, “objectives”, or the negative or grammatical variation thereof or other similar expressions concerning matters that are not historical facts. The forward-looking statements in this press release are subject to risks that may include, but are not limited to: our limited operating history, including that of Pure Sunfarms and our start-up operations of growing hemp in the United States; the legal status of Pure Sunfarms cannabis business; risks relating to obtaining additional financing, including our dependence upon credit facilities; potential difficulties in achieving and/or maintaining profitability; variability of product pricing; risks inherent in the cannabis, hemp and agricultural businesses; the ability of Pure Sunfarms to cultivate and distribute cannabis in Canada; existing and new governmental regulations, including risks related to regulatory compliance and licenses (e.g., Pure Sunfarms’ ability to obtain licenses for its Delta 2 greenhouse facility as well as additional licenses under the Canadian act respecting cannabis to amend to the Controlled Drugs and Substances Act, the Criminal Code and other Acts, S.C. 2018, c. 16 (Canada) for its Delta 3 greenhouse facility), and changes in our regulatory requirements; risks relating to conversion of our greenhouses to cannabis production for Pure Sunfarms; risks related to rules and regulations at the U.S. federal (Food and Drug Administration and United States Department of Agriculture), state and municipal levels with respect to produce and hemp; retail consolidation, technological advances and other forms of competition; transportation disruptions; product liability and other potential litigation; retention of key executives; labor issues; uninsured and underinsured losses; vulnerability to rising energy costs; environmental, health and safety risks, foreign exchange exposure, risks associated with cross-border trade; difficulties in managing our growth; restrictive covenants under our credit facilities; natural catastrophes; the ongoing and developing COVID-19 pandemic; and tax risks.

The Company has based these forward-looking statements on factors and assumptions about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. Although the forward-looking statements contained in this press release are based upon assumptions that management believes are reasonable based on information currently available to management, there can be no assurance that actual results will be consistent with these forward-looking statements. Forward-looking statements necessarily involve known and unknown risks and uncertainties, many of which are beyond the Company’s control, that may cause the Company’s or the industry’s actual results, performance, achievements, prospects and opportunities in future periods to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among other things, the factors contained in the Company’s filings with securities regulators, including this press release. In particular, we caution you that our forward-looking statements are subject to the ongoing and developing circumstances related to the COVID-19 pandemic, which may have a material adverse effect on our business, operations and future financial results.

When relying on forward-looking statements to make decisions, the Company cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties and should not be read as guarantees of future results, performance, achievements, prospects and opportunities. The forward-looking statements made in this press release relate only to events or information as of the date on which the statements are made in this press release. Except as required by law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.


Village Farms International, Inc.


Condensed Consolidated Interim Statements of Financial Position


(In thousands of United States dollars, except share data)


(Unaudited)

September 30, 2020

December 31, 2019


ASSETS


Current assets

Cash and cash equivalents

$

54,666

$

11,989

Trade receivables

10,498

8,997

Inventories

15,301

15,918

Amounts due from joint ventures

10,954

15,418

Other receivables

637

342

Income tax receivable

440

713

Prepaid expenses and deposits

934

1,259

Total current assets

93,430

54,636


Non-current assets

Property, plant and equipment

59,663

63,158

Investment in joint ventures

63,164

41,334

Investment in in minority interests

1,226

Notes receivable – joint ventures

10,713

10,865

Deferred tax asset

9,693

7,999

Right-of-use assets

4,111

3,582

Other assets

1,827

1,834

Total assets

$

243,827

$

183,408


LIABILITIES


Current liabilities

Line of credit

$

3,000

$

2,000

Trade payables

9,667

12,653

Current maturities of long-term debt

2,294

3,423

Accrued liabilities

6,676

3,017

Operating lease liabilities – current

1,711

875

Finance lease liabilities – current

34

61

Total current liabilities

23,382

22,029


Non-current liabilities

Long-term debt

27,793

28,966

Deferred tax liability

2,211

1,873

Operating lease liabilities – non-current

2,465

2,690

Finance lease liabilities – non-current

12

34

Other liabilities

1,437

1,357

Total liabilities

57,300

56,949

Commitments and contingencies (note 15)


SHAREHOLDERS’ EQUITY

Common stock, no par value per share –
unlimited shares authorized; 65,959,810
shares issued and outstanding at September
30, 2020 and 52,656,669 shares issued and
outstanding at December 31, 2019

141,310

98,333

Additional paid in capital

16,892

4,351

Accumulated other comprehensive loss

(516)

(475)

Retained earnings

28,841

24,250

Total shareholders’ equity

186,527

126,459

Total liabilities and shareholders’ equity

$

243,827

$

183,408

 


Village Farms International, Inc.


Condensed Consolidated Interim Statements of Income (Loss) and Comprehensive Income (Loss)


(In thousands of United States dollars, except per share data, unless otherwise noted)


(Unaudited)

Three Months Ended September 30, 

Nine Months Ended September 30, 

2020

2019

2020

2019

Sales

$

43,037

$

38,293

$

122,722

$

111,512

Cost of sales

(37,418)

(38,904)

(112,809)

(114,418)

Gross margin

5,619

(611)

9,913

(2,906)

Selling, general and administrative expenses

(4,942)

(3,739)

(12,676)

(11,899)

Share-based compensation

(472)

(666)

(1,329)

(2,663)

Interest expense

(299)

(655)

(1,273)

(2,018)

Interest income

101

304

577

651

Foreign exchange gain (loss)

(484)

(183)

(880)

338

Gain on settlement agreement

4,681

Other income

27

69

92

219

(Loss) gain on disposal of assets

(8)

(6)

13,558

Loss before taxes and earnings from unconsolidated
   entities

(450)

(5,489)

(901)

(4,720)

(Provision for) recovery of income taxes

(336)

1,266

607

114

Loss from consolidated entities after income taxes

(786)

(4,223)

(294)

(4,606)

Equity earnings from unconsolidated entities

1,306

3,519

4,885

14,115

Net income (loss)

$

520

$

(704)

$

4,591

$

9,509

Basic income (loss) per share

$

0.01

$

(0.01)

$

0.08

$

0.20

Diluted income (loss) per share

$

0.01

$

(0.01)

$

0.08

$

0.19

Weighted average number of common shares used in
the computation of net income (loss) per share (in
thousands):

Basic

58,536

48,845

55,946

48,650

Diluted

60,440

48,845

57,778

50,451

Net income (loss)

$

520

$

(704)

$

4,591

$

9,509

Other comprehensive income (loss):

Foreign currency translation adjustment

31

(22)

(41)

58

Comprehensive income (loss)

$

551

$

(726)

$

4,550

$

9,567

 


Village Farms International, Inc.


Condensed Consolidated Interim Statements of Cash Flows


(In thousands of United States dollars)


(Unaudited)

Nine Months Ended
September 30,

2020

2019


Cash flows provided by (used in) operating activities:

Net income

$

4,591

$

9,509

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

4,540

5,587

Amortization of deferred charges

57

57

Share of income from joint ventures

(4,885)

(14,115)

Interest expense

1,273

2,018

Interest income

(577)

(651)

Interest paid on long-term debt

(1,318)

(2,013)

Gain on settlement agreement

(4,681)

Loss (gain) on disposal of assets

6

(13,558)

Non-cash lease expense

(935)

(778)

Interest paid on finance leases

(3)

(6)

Share-based compensation

1,329

2,663

Deferred income taxes

(321)

(749)

Changes in non-cash working capital items

4,938

4,149

Net cash provided by (used in) operating activities

4,014

(7,887)


Cash flows used in investing activities:

Purchases of property, plant and equipment, net of rebate

(1,076)

(1,630)

Advances to joint ventures

(133)

(9,499)

Proceeds from sale of asset

52

Investment in joint ventures

(11,713)

(13)

Investment in minority interests

(1,226)

Net cash used in investing activities

(14,148)

(11,090)


Cash flows from financing activities:

Proceeds from borrowings

3,000

3,000

Repayments on borrowings

(4,326)

(3,591)

Proceeds from issuance of common stock

46,388

13,868

Issuance costs

(3,819)

Proceeds from exercise of stock options

251

109

Payments on capital lease obligations

(51)

(69)

Proceeds from exercise of warrants

11,369

466

Net cash provided by financing activities

52,812

13,783

Effect of exchange rate changes on cash and cash equivalents

(1)


Net increase (decrease) in cash and cash equivalents

42,677

(5,194)


Cash and cash equivalents, beginning of period

11,989

11,920


Cash and cash equivalents, end of period

$

54,666

$

6,726

 

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SOURCE Village Farms International, Inc.