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StorageVault Reports 2020 Third Quarter Results and Increases Dividend

TORONTO, Nov. 12, 2020 (GLOBE NEWSWIRE) — STORAGEVAULT CANADA INC. (“StorageVault” or the “Corporation”) (SVI-TSX-V) reported the Corporation’s 2020 third quarter results and increases its dividend. Iqbal Khan, Chief Financial Officer, commented:

“Our results continue to show the resiliency of our business – we achieved 3% year over year increase in same store revenue and 4% in NOI. These results place us in a strong position to finish the year and to enter into 2021. We are also very pleased to have announced the acquisition of $220 million of assets that are scheduled to close in Q4 2020.”

2020 Third Quarter Results

Revenue for the third quarter 2020 increased to $40.1 million compared to $37.3 million in Q3 2019 and net operating income (“NOI”), a non IFRS measure, grew to $27.5 million from $24.8 million for the comparative period. Our cash flow from operations increased year over year and when combined with our financing and investing activities resulted in a cash balance of $12.5 million at the end of the quarter. The Q3 2020 net loss of $6.3 million (net loss of $9.4 million for Q3 2019) is after $20.8 million of depreciation and amortization and deferred tax recovery recorded in the quarter of $3.0 million; both amounts are non-cash items.

Revenue and NOI from existing self storage stores increased by 3.1% and 4.0%, compared to the same period last year. Funds from operations (“FFO”), a non IFRS measure, were $11.6 million for Q3 2020 compared to $9.5 million in Q3 2019, a 21.7% increase year over year. Adjusted funds from operations (“AFFO”), a non IFRS measure, were $12.2 million for Q3 2020 compared to $10.8 million in Q3 2019, a 12.5% increase.

For a reconciliation of the above NOI, FFO, and AFFO amounts to IFRS, please see the Corporation’s Management’s Discussion & Analysis for the three and nine months ended September 30, 2020 filed on SEDAR at www.sedar.com.

2020 Nine Months Year to Date Results

Revenue for the nine months ended September 30, 2020 increased to $113.3 million from $97.8 million and NOI, a non-IFRS measure, grew to $75.9 million from $65.4 million, for the comparative period. For the nine months ended September 30, 2020, cash flow from operations was $30.0 million and when combined with our financing and investing activities resulted in a cash balance of $12.5 million. The net loss of $23.3 million for the nine months ended September 30, 2020 (net loss of $34.6 million for 2019) is after $61.5 million in depreciation and amortization, which was offset by a deferred tax recovery of $9.0 million; both non-cash items.

Despite the impacts of COVID-19, the pausing of rent increases, late charges and administrative fees for a significant portion of the year to date, our revenue and NOI from Existing Self Storage, a non-IFRS measure, increased by 4.3% and 4.6%, compared to the same period last year. FFO, a non-IFRS measure, were $29.2 million compared to $21.0 million for the same period in 2019, a 38.9% increase year over year. AFFO, a non-IFRS measure, were $31.5 million compared to $27.3 million for the same period in 2019, a 15.5% increase year over year.

For a reconciliation of the above NOI, FFO, and AFFO amounts to IFRS, please see the Corporation’s Management’s Discussion & Analysis for the three and nine months ended September 30, 2020 filed on SEDAR at www.sedar.com.

Increased Dividend

StorageVault is increasing its quarterly dividend by 0.5% beginning Q4 2020 to $0.002707 per common share.

The COVID-19 Pandemic

To continue to serve the strong demand for our services, we have modified our operations – installed plexiglass partitions, limit the number of customers in our offices to one at a time and continue to improve and offer our no-contact rental processes. Our teams are fully employed and clients are able to safely store and access their valuables. We continue to be extremely proud of our team for continuing to adapt to new processes and for being committed to providing exceptional client and community service.

As the third quarter progressed, we experienced stronger demand, resulting in increased leads, rentals, occupancy and rental rates. These positive trends resulted in the Corporation achieving strong same store revenue and NOI growth. While clients may be further impacted, including through unemployment, which may reduce the ability to pay, the Corporation has experienced no meaningful increases in accounts receivable.

Since the start of the COVID-19, the Corporation continued to execute on our strategies to attract clients through search engine marketing, improving our online presence, virtual community connection programs and the development of a national platform and initiatives to fulfill last mile storage needs. These efforts have allowed us to attract clients who are leveraging our national footprint to offer a complete storage, inventory management and mobilization solution through our self and portable storage and records management infrastructures. 

As at September 30, 2020, we continue to generate significant cash flows from our operations, with $12.5 million in cash on hand. Our balance sheet, along with our strong relationships with our lenders, provide us with sufficient borrowing capacity, refinancing and liquidity options to take advantage of acquisition opportunities that meet our requirements, such as the $220 million in acquisitions announced by the Corporation on November 2, 2020.

Our Strategy

StorageVault is focused on owning and operating storage in the top markets in Canada. Our goal is to have multiple stores in each market, with complementary portable storage units and records management storage services, to take advantage of economies of scale. Our growth strategy is focused on acquisitions, organic growth, expansion of our existing stores and expansion of our portable storage and record management businesses.

Further Information

For comprehensive disclosure of StorageVault’s performance for the three and nine months ended September 30, 2020 and its financial position as at such date, please see StorageVault’s Unaudited Interim Consolidated Financial Statements and Management’s Discussion and Analysis for the three and nine months ended September 30, 2020 filed on SEDAR at www.sedar.com.

Non-IFRS Financial Measures

Management uses both IFRS and Non-IFRS Measures to assess the financial and operating performance of the Corporation’s operations. These Non-IFRS Measures are not recognized measures under IFRS, do not have a standardized meaning under IFRS and are unlikely to be comparable to similar measures presented by other companies. The Non-IFRS Measures referenced in this news release include the following:

  1. Net Operating Income (“NOI”) – NOI is defined as storage and related services revenue less related property operating costs. NOI does not include interest expense or income, depreciation and amortization, corporate administrative costs, stock based compensation costs or taxes. NOI assists management in assessing profitability and valuation from principal business activities.
  2. Funds from Operations (“FFO”) – FFO is defined as net income (loss) excluding gains or losses from the sale of depreciable real estate, plus depreciation and amortization, stock based compensation expenses, and deferred income taxes; and after adjustments for equity accounted entities and non-controlling interests. The Corporation believes that FFO can be a beneficial measure, when combined with primary IFRS measures, to assist in the evaluation of the Corporation’s ability to generate cash and evaluate its return on investments as it excludes the effects of real estate amortization and gains and losses from the sale of real estate, all of which are based on historical cost accounting and which may be of limited significance in evaluating current performance.
  3. Adjusted Funds from Operations (“AFFO”) – AFFO is defined as FFO plus acquisition and integration costs. Acquisition and integration costs are one time in nature to the specific assets purchased in the current period or pending and are expensed under IFRS.
  4. Existing Self Storage – means stores that StorageVault has owned or leased since the beginning of the previous fiscal year.

NOI, FFO, AFFO and Existing Self Storage, should not be viewed as an alternative to, in isolation from, or superior to, net income or cash flow from operations, or results from StorageVault’s comprehensive operations, respectively, or other measures calculated in accordance with IFRS. NOI, FFO and AFFO should not be interpreted as an indicator of cash generated from operating activities and is not indicative of cash available to fund operating expenditures, or for the payment of cash distributions. Existing Self Storage should not be considered a measure of StorageVault’s comprehensive operations. NOI, FFO, AFFO and Existing Self Storage are simply additional measures of operating performance which highlight trends in StorageVault’s core business that may not otherwise be apparent when relying solely on IFRS financial measures. StorageVault’s management also uses these non-IFRS measures in order to facilitate operating performance comparisons from period to period and to prepare operating budgets. In addition, the Corporation’s definitions of NOI, FFO, AFFO and Existing Self Storage may differ from that of other issuers.

About StorageVault Canada Inc.

StorageVault owns and operates 202 storage locations in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec, and Nova Scotia. StorageVault owns 154 of these locations plus over 4,600 portable storage units representing over 8.2 million rentable square feet.

For further information, contact Mr. Steven Scott or Mr. Iqbal Khan:

Tel: 1-877-622-0205
[email protected]

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. In particular, this news release contains forward-looking information regarding: statements regarding StorageVault’s expected future performance; the proposed $220 million of previously announced acquisitions, including the potential closing date of such proposed acquisitions and financing options available to StorageVault to complete such proposed acquisitions; StorageVault’s response to the COVID-19 pandemic, the potential anticipated impact of COVID-19 on StorageVault’s expected future performance, the impact of COVID-19 on its customers’ ability to pay for services provided by StorageVault and StorageVault’s beliefs regarding its ability to navigate the pandemic; positive trends StorageVault is experiencing including stronger demand, resulting in increased leads, rentals, occupancy and rental rates; StorageVault’s ability to attract new clients; statements regarding StorageVault’s liquidity position and its ability to meet liquidity requirements and to take advantage of acquisition opportunities as a result of its liquidity position; and StorageVault’s strategic objectives, goals, growth strategy and focus, including focusing on acquisitions, improving StorageVault’s operational performance, expansion of StorageVault’s existing stores and expansion of StorageVault’s portable storage and records management businesses. There can be no assurance that such forward-looking information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such forward-looking information. This forward-looking information reflects StorageVault’s current beliefs and is based on information currently available to StorageVault and on assumptions StorageVault believes are reasonable. These assumptions include, but are not limited to: the level of activity in the storage business and the economy generally; consumer interest in StorageVault’s services and products; competition and StorageVault’s competitive advantages; trends in the storage industry, including macro-trends in relation to increased growth and growth in the portable storage business; the availability of attractive and financially competitive asset acquisitions in the future; the potential closing of previously announced acquisitions, if any, continuing to proceed as they have progressed to date and StorageVault’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of StorageVault to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; delay or failure to receive board or regulatory approvals; the actual results of StorageVault’s future operations; competition; changes in legislation, including environmental legislation, affecting StorageVault; the timing and availability of external financing on acceptable terms; conclusions of economic evaluations and appraisals; lack of qualified, skilled labour or loss of key individuals; and risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession; the impact that the COVID-19 pandemic may have on StorageVault may include: a short-term delay in payments from customers, an increase in accounts receivable and an increase of losses on accounts receivable; decreased demand for the services that StorageVault offers; and a deterioration of financial markets that could limit StorageVault’s ability to obtain external financing. A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in StorageVault’s disclosure documents on the SEDAR website at www.sedar.com. Although StorageVault has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Forward-looking information contained in this news release is expressly qualified by this cautionary statement. The forward-looking information contained in this news release represents the expectations of StorageVault as of the date of this news release and, accordingly, is subject to change after such date. However, StorageVault expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

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FDA grants a Breakthrough Device Designation for Spiderwort Spinal Cord Technology

Ottawa, Nov. 12, 2020 (GLOBE NEWSWIRE) — Spiderwort Inc., a Canadian medical device company developing innovative biomaterials for regenerative medicine, is pleased to announce that the U.S. Food and Drug Administration (FDA) has designated CelluBridgeTM, Spiderwort’s  Spinal Cord Scaffold Implant, as a “Breakthrough Device”.

The FDA Breakthrough Devices program creates a path for innovators to get their medical devices to market faster. The program targets novel devices that have the potential to provide patients with a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and conditions. This program provides patients and health care providers with timely access to these medical devices by expediting medical devices development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health.

“While this designation is a great achievement for our team, and a validation of our technology, I am most excited for the patients whose lives we will be able to change with our biomaterial,” said Charles M. Cuerrier, CEO and co-founder of Spiderwort. “This designation will enable us to efficiently interact with the FDA in order to increase the speed at which we will initiate our clinical trials”.

Spiderwort’s revolutionary biomaterial uses a plant-based cellulose scaffolding to create a framework that supports the regeneration of healthy tissues. The biomaterial is composed of microchannels which guide regenerating neurons through damaged regions of the spinal cord after a traumatic injury. Preclinical studies are demonstrating the promise of this approach for restoring motor function.

“We are pushing the limits of science every day to bring something remarkable into the world,” said Andrew E. Pelling, Chief Science Officer and co-founder of Spiderwort.  “Spiderwort was born from curiosity-driven exploration, and the results have the potential to significantly improve patients lives.”

Spiderwort also recently announced the closing of its $2.5 million USD Series Seed round of financing, led by Horizons Ventures. The company is preparing for its Series A round of financing in 2021 as it moves closer to clinical testing. 

Daily progress in the Spiderwort labs is moving the company closer to the day when they will revolutionize the bioscience and biotechnology sectors, and improve the lives of millions.

ABOUT SPIDERWORT

Spiderwort Inc. is a biotechnology company with a transformative platform of cellulose-based biomaterials that will serve as the scaffolds for the regenerative medicine of the future. Spiderwort’s biomaterials have shown promise in the treatment of Spinal Cord Injuries and soft tissue regeneration. Spiderwort is led by CEO Charles M. Cuerrier and inspired by the work of TED Fellow Andrew E. Pelling. Learn more at spiderwortbio.com.

Attachments 

Spencer Callaghan
Spiderwort Inc.
[email protected]

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Silo Pharma, Inc. Announces Filing of Three U.S. Provisional Patent Applications


Each Provisional Patent Application Relates to Psilocybin

NEW YORK , Nov. 12, 2020 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO) a developmental stage biopharmaceutical company focused on the use of psilocybin as a therapeutic, today announced the filing of three distinct U.S. Provisional Patent applications with the U.S. Patent and Trademark Office (“USPTO”) pertaining to the central nervous system delivery of unique anti-inflammatory therapeutics coupled with psilocybin.

“Each of these provisional patents relates to the continued research and development of the central nervous system-homing peptides covered by the UMD option agreement to deliver certain compounds,” stated Eric Weisblum, Chairman and CEO of Silo Pharma.” We are excited to have taken this important action with respect to our recently announced collaboration with UMD.”

A provisional patent application is a critical step on the road to commercial viability. As the climate for intellectual property rights becomes more and more competitive, a provisional patent application successfully establishes an early effective filing date and allows the patent applicant or a licensee to ascribe the phrase “patent pending” to any product development and methodologies associated with the patent’s subject matter.

“These patent applications, together with Silo’s efforts to bring scientific talent, resources, and industry leaders together, allows the Company to continue its development of novel therapeutics in the psychedelic category”, stated Mr. Weisblum.

About Silo Pharma 


Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry.  For more information, visit www.silopharma.com.

Safe Harbor and Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.



Investor Relations Contact

:                                      


Hayden IR

Brett Maas
646-536-7331
Email: [email protected]

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Ionis’ pioneering antisense technology to be featured in multiple presentations at American Heart Association (AHA) Scientific Sessions 2020

– Ionis’ novel antisense medicine targeting PCSK9 demonstrates best-in-class potential for the treatment of patients with high cholesterol at risk for cardiovascular disease

PR Newswire

CARLSBAD, Calif., Nov. 12, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), announced today the upcoming presentations of clinical and non-clinical data for several of its investigational antisense medicines for cardiovascular disease at the American Heart Association (AHA) Scientific Sessions 2020, to be held virtually November 13-17, 2020. 

Two of the abstracts accepted for presentation will provide new data from studies of ION449, also known as AZD8233 for subcutaneous administration and AZD6615 for oral administration. ION449 is an investigational antisense medicine targeting PCSK9, which is integrally involved in the regulation of LDL-cholesterol. ION449 is being developed as part of a collaboration between Ionis and the biopharmaceutical company AstraZeneca. Data presented include a study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of ION449 in patients with elevated LDL-cholesterol and a separate pre-clinical study evaluating this investigational medicine for once-daily oral dosing.

Additional presentations by Ionis scientists will include a review of RNA-targeted treatments designed to inhibit the production of apolipoprotein C-III (apoC-III) and lipoprotein(a) or Lp(a). The apoC-III protein is an independent cardiovascular risk factor that regulates triglyceride metabolism in the blood. Ionis’ AKCEA-APOCIII-LRx is an investigational LIgand-Conjugated Antisense (LICA) medicine designed to inhibit the production of apoC-III for patients who are at risk for cardiometabolic disease due to elevated triglyceride levels. AKCEA-APOCIII-LRx is expected to start a Phase 3 study in patients with familial chylomicronemia syndrome (FCS) by year end. Elevated Lp(a) is an independent, genetic risk factor for cardiovascular disease that cannot be well controlled with lifestyle modifications such as diet or exercise or with treatment using existing lipid-lowering therapies. Ionis’ pelacarsen is an investigational LICA medicine designed to reduce the production of apolipoprotein(a) in patients who are at risk for cardiometabolic disease due to high Lp(a). Pelacarsen is currently in a Phase 3 cardiovascular outcomes study.

Following are presentations of Ionis programs and collaborations:

Cardiovascular Seminars:

  • Friday, November 13, 11:10 a.m. CST ‘Experimental Therapy for APOCIII Lowering: ASO, siRNA,’ Rosanne Crooke, Ph.D., senior strategic consultant at Ionis
  • Friday, November 13, 11:20 a.m. CST ‘Experimental Therapy for Lp(a) Lowering,’ Sotirios “Sam” Tsimikas, M.D., Ph.D., senior vice president, clinical development and leader, cardiovascular franchise

Poster Presentations in Collaboration with AstraZeneca:

  • Friday, November 13, 9:00 a.m. CST ‘An Oral Antisense Oligonucleotide for PCSK9 Inhibition in Humans’ (Poster #P244)
  • Friday, November 13, 9:00 a.m. CST ‘Single Dose Safety, Pharmacokinetics, and Pharmacodynamics of a Potent PCSK9 Synthesis Inhibitor, AZD8233, in Subjects With Elevated LDL Cholesterol’ (Poster #MP515)

A full list of presentations can be found on the AHA Scientific Sessions website.

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, the therapeutic and commercial potential of our products, 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, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. 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 Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ionis-pioneering-antisense-technology-to-be-featured-in-multiple-presentations-at-american-heart-association-aha-scientific-sessions-2020-301171533.html

SOURCE Ionis Pharmaceuticals, Inc.

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Sol-Gel Technologies Reports Third Quarter 2020 Financial Results and Corporate Update

  • Epsolay®
    PDUFA goal date set for April 26, 2021

  • Twyneo® New Drug Application
    submitted
    to the
    U.S.
    FDA

  • Top-line generic product revenue of $2.1 million in 3Q 2020

  • In
    October
    2020
    ,
    signed
    an 11th
    generic product
    collaboration agreement with Perrigo

NESS ZIONA, Israel, Nov. 12, 2020 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced financial results for the third quarter ended September 30, 2020 and provided clinical and regulatory updates on its programs.

“The third quarter was highlighted by a major achievement for Sol-Gel, as our first New Drug Application (NDA) for Epsolay for the treatment of inflammatory lesions of rosacea was accepted by the Federal Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date set for April 26, 2021. We now look forward to the NDA acceptance of our second proprietary product, Twyneo, for the treatment of acne vulgaris,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Also, after the close of the third quarter, we expanded our collaboration with Perrigo to develop an eleventh generic product candidate. While we are successfully expanding our partnership with Perrigo, we continue to focus on our own branded product candidates, Epsolay and Twyneo. We are working towards commercializing both treatments, if approved, in 2021, either on our own or with a partner that has a significant U.S. dermatology presence.”

Corporate Highlights and Recent Developments

  • Sol-Gel announced FDA acceptance of NDA for Epsolay (benzoyl peroxide, 5%, cream) with a PDUFA goal date set for April 26, 2021. If approved, Epsolay has the potential to be the first FDA-approved, single-agent benzoyl peroxide prescription drug product for the treatment of inflammatory lesions of rosacea.
  • Sol-Gel submitted an NDA for Twyneo (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) to the FDA in the beginning of October. If approved, Twyneo has the potential to be the first FDA-approved acne treatment that contains fixed-dose combination of benzoyl peroxide and tretinoin.
  • Sol-Gel was informed by its collaboration partner that the launch of an FDA-approved generic drug is expected in the second quarter of 2021. Annual sales of the brand name product exceeded $180 million in the United States in 2019.
  • Bausch Health Companies, Inc. (NYSE:BHC) initiated patent infringement action in the U.S. District Court for the District of New Jersey on August 31, 2020 regarding Perrigo Company plc’s (NYSE; TASE: PRGO) Abbreviated New Drug Application (ANDA) for a generic version of Duobrii® (halobetasol propionate and tazarotene) lotion, a product in which Sol-Gel and Perrigo previously entered into a collaboration agreement. In July 2020, Perrigo filed first-to-file Paragraph IV Certification for Duobrii®.
  • In preparation for commercial launch of proprietary products, and as part of Sol-Gel’s go-to-market strategy, the Company has opened a US headquarters in Whippany, NJ.
  • In October 2020, Sol-Gel signed an additional collaboration agreement with Perrigo for the development, manufacturing and commercialization of a new generic product candidate, the eleventh product collaboration between the companies.
  • The enrollment of patients in the Phase 1 proof-of-concept study with SGT-210, a novel, topical, epidermal growth factor receptor inhibitor in patients with punctate palmoplantar keratoderma has been affected by the COVID-19 pandemic. The Company expects to be able to provide an update regarding the timing of top-line results by year-end.
  • Pre-clinical testing of tapinarof, an aryl hydrocarbon receptor (AhR) agonist, and roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, is progressing for various, new dermatological indications. The Company is also conducting pre-clinical studies in psoriasis to compare the tapinarof/roflumilast combination to each individual active ingredient. A total of 24 provisional patent applications for these projects have been submitted to date. 

Financial Results for the Three Months ended
September
30, 2020

Revenue in the third quarter of 2020 was $2.1 million. The revenue was mainly due to sales of a generic product from a collaboration arrangement with Perrigo. While revenue increased compared to the previous quarter, it is still adversely affected by the COVID-19 pandemic.   In addition, due to the entry of an additional generic version of Zovirax® (acyclovir) cream, 5%, marketed by Amneal Pharmaceuticals Inc., we expect revenue from our generic products to decrease until the expected launch of a second generic drug in the second quarter of 2021 as detailed above.

Research and development expenses were $7.9 million in the third quarter of 2020 compared to $9.9 million during the same period in 2019. The decrease of $2.0 million was mainly attributed to a decrease of $5.9 million in clinical trial expenses for Epsolay and Twyneo partially offset by an increase of $3.4 million in regulatory expenses mainly related to the PDUFA fee for Twyneo.

General and administrative expenses were $3.0 million in the third quarter of 2020 compared to $2.5 million during the same period in 2019. The increase of $0.5 million was mainly attributed to an increase of $0.4 million in commercialization expenses and of $0.1 million in patent-related expenses.

Sol-Gel reported a loss of $8.6 million for the third quarter of 2020 compared to loss of $7.4 million for the same period in 2019.

As of September 30, 2020, Sol-Gel had $27.4 million in cash, cash equivalents and deposits, and $29.9 million in marketable securities for a total balance of $57.3 million. Sol-Gel expects its existing cash resources will enable funding of operational and capital expenditure requirements into the third quarter of 2021.

About Sol-Gel Technologies

Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of Twyneo, under investigation for the treatment of acne vulgaris, and Epsolay, under investigation for the treatment of inflammatory lesions of rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.

About Epsolay®

Epsolay is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules is designed to deliver an effective dose of benzoyl peroxide onto the skin, while reducing the ability of benzoyl peroxide to induce skin irritation, such as erythema, burning and stinging. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. Epsolay is not approved by the FDA and the safety and efficacy has not been established.

About Papulopustular Rosacea

Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. The condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.

About Twyneo®

Twyneo is an investigational, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, it will be the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using Sol-Gel’s proprietary microencapsulation technology. Tretinoin and benzoyl peroxide are widely prescribed separately as a combination treatment for acne; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The silica-based microcapsule is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica-based shell is also designed to release the ingredients slowly over time to provide a favorable efficacy and safety profile. Twyneo is not approved by the FDA and the safety and efficacy has not been established.

About Acne Vulgaris

Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to,
statements regarding the PDUFA goal date for Epsolay (benzoyl peroxide, 5%, cream)
,
the expectation that the FDA will accept the NDA for Twyneo
and
the timing of commercialization of Epsolay and Twyneo
,
expectation that revenue from our generic products will continue
to
decrease until the expected launch
of a second
FDA-approved generic drug in the second quarter of 2021
. These forward-looking statements include information about possible or assumed future results of our business, financial condition,
results
of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important
factors that could cause such differences include, but are not limited to, risks relating to the effects of COVID-19 (coronavirus) as well as the following factors: (
i
) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets
,
the
potential delay in receiving such regula
tory approvals
and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 24, 2020 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.



SOL-GEL TECHNOLOGIES LTD.

CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)

  December 31,


 		  September 30,
  2019


 		  2020 
A s
s
e t s 		          
CURRENT ASSETS:           
Cash and cash equivalents $ 9,412   $ 6,007
Bank deposit   –    21,400
Marketable securities   40,966    29,875
Receivables from collaborative arrangements   4,120    2,180
Prepaid expenses and other current assets   1,293     1,200
TOTAL CURRENT ASSETS   55,791     60,662
           
NON-CURRENT ASSETS:          
Restricted long-term deposits   472    1,285
Property and equipment, net   2,314    2,048
Operating lease right-of-use assets   2,040    1,658
Funds in respect of employee rights upon retirement   684     687
TOTAL NON-CURRENT ASSETS   5,510     5,678
           
TOTAL ASSETS $ 61,301   $ $66,340
Liabilities and shareholders’ equity          
CURRENT LIABILITIES:          
Accounts payable $ 1,710   $  1,121
Other accounts payable           4,123      5,469
Current maturities of operating leases   672      508
TOTAL CURRENT LIABILITIES   6,505      7,098
           
LONG-TERM LIABILITIES –          
Operating leases liabilities    1,373      1,105
Liability for employee rights upon retirement    958      980
TOTAL LONG-TERM LIABILITIES    2,331      2,085
COMMITMENTS                  
TOTAL LIABILITIES    8,836      9,183
           
SHAREHOLDERS’ EQUITY:          
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2019 and September 30, 2020; issued and outstanding: 20,402,800 and 23,000,782 as of December 31, 2019 and September 30, 2020, respectively.   561      635
Additional paid-in capital    203,977      231,397
Accumulated deficit   (152,073)     (174,875)
TOTAL SHAREHOLDERS’ EQUITY    52,465      57,157
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 61,301   $  66,340

(The amounts are stated in U.S. dollars in thousands, except share and per share data)

SOL-GEL TECHNOLOGIES LTD.

CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)

  Nine months ended

September 30


 		  Three months ended

September 30
    2019     2020     2019     2020  
COLLABORATION REVENUES $ 18,884   $ 6,714  

$

   

4,733

   $ 2,116  
RESEARCH AND DEVELOPMENT EXPENSES   32,146     22,248     9,913     7,867  
GENERAL AND ADMINISTRATIVE EXPENSES   5,816     8,014     2,484     3,018  
TOTAL OPERATING LOSS   19,078     23,548     7,664     8,769  
FINANCIAL INCOME, NET   (1,071 )   (746 )   (311 )   (149 )
LOSS FOR THE PERIOD $ 18,007   $ 22,802   $ 7,353   $ 8,620  
BASIC AND DILUTED LOSS PER ORDINARY SHARE $ 0.94     1.02   $ 0.37     0.37  
                         
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE   19,230,070     22,431,096     19,787,194     22,997,708  



For further information, please contact:

Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433

Investor Contact:
Lee M. Stern
Solebury Trout
+1-646-378-2922
[email protected]

Source: Sol-Gel Technologies Ltd. 

Posted on

IMV Inc. Announces Third Quarter 2020 Financial Results and Provides Clinical Update

IMV Inc. Announces Third Quarter 2020 Financial Results and Provides Clinical Update

  • Identification of PD-L1 as a potential Biomarker with 86% of clinical responses in patients with r/r DLBCL in our combination trial with Merck’s Keytruda®
  • Cash and cash equivalents of $54.7M as of September 30th, 2020
  • Expanded Board of Directors and strengthened management team
  • Reviewing data presented at SITC on a conference call and webcast today at 8:00 a.m. ET

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–
IMV Inc. (the “Company” or “IMV”) (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, announces financial results for the third quarter ended September 30, 2020 and provides an update on its clinical and operational progress.

“Biomarkers predictive of responses can be game-changing in the development of new treatments for cancer. We are extremely happy to share our success this week in finding a potential predictive biomarker that is associated with a very high level of clinical efficacy in patients with relapsed/refractory DLBCL. The PD-L1 biomarker is well recognized and already approved for multiple cancer indications and this finding brings us closer to an accelerated path to market for DPX-Survivac in this high unmet medical need patient population.”

“In addition to this significant milestone, we continued to make progress across our pipeline and corporate development objectives steadily advancing development in other cancer indications as well as our vaccine against COVID-19,” said Fred Ors, Chief Executive Officer at IMV.

Third quarter 2020 and Recent Operational Highlights:

DPX-Survivac

Phase 2 SPiReL Study in Relapsed / Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac/CPA in combination with Keytruda® (pembrolizumab) in r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©, ABIM, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario.

As of October 30, 2020, 24 patients have been enrolled across six clinical sites in Canada. As reported in May 2020, the study has already met its primary efficacy endpoint.

On November 11, 2020, Dr. Berinstein delivered a poster presentation at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting. As of the data cut-off date of this presentation, 18 pre-treatment samples from 18 patients enrolled in the SPiReL study were available for biomarker analysis and thirty-nine percent (7/18) of these patients had pre-treatment tumors that were classified as PD-L1 positive.

Key findings for this population include:

  • 6/7 subjects demonstrated a partial response (PR) or complete response (CR), resulting in an Objective Response Rate (ORR) of 86% (3 CR and 3 PR) and no clinical response (PR or CR) has been observed in the PD-L1 negative population (n=11); and
  • Observed 100% Disease Control Rate (DCR) defined as Stable Disease, PR or CR.

On the strength of these results, IMV is working on the design of the next clinical study in r/r DLBCL. The Company plans to engage with the U.S. Food and Drug Administration (FDA) as soon as possible to identify the best path toward registration.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac/CPA. This Phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

IMV intends to present top line data during a virtual key opinion leader meeting on December 3, 2020 at 8:00 am ET.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac/CPA in combination with Keytruda® across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of October 30, 2020, a total of 106 patients out of the planned 184 patients have been enrolled across all five indications at 19 clinical sites in Canada and the US.

As noted previously, the COVID-19 pandemic has impacted data collection and verification from this study. The Company intends to report results in the first quarter of 2021 to coincide with seasonal healthcare industry conferences.

DPX-COVID-19

In October 2020, IMV announced that in consultation with Health Canada, it intends to combine its original Phase 1 and 2 studies into a single trial with the potential to accelerate the clinical development and the timeline of the overall project. The design of this study will incorporate the same two-age strata cohorts (18-55 years old and over 55 years old) as originally planned.

Subject to the approval of Health Canada and after the completion and submission of the preclinical safety, GLP toxicology and challenge studies, the Phase 1/2 trial is expected to be approved and initiated before the end of 2020.

Additional funding and Increased Manufacturing Capacity

In October 2020, IMV announced that the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) will provide advisory services and up to $5.4 million in funding to support the continuation of clinical trials for its DPX-COVID-19 vaccine candidate. This funding is milestone based and will be dependent upon the achievement of certain objectives. To date, IMV has secured more than $10 million to fund its DPX-COVID-19 development efforts and other non-dilutive funding requests are ongoing.

To increase its current manufacturing capacity, IMV has entered a collaboration with a global manufacturing partner and initiated transfer and scale-up activities of DPX-COVID-19. This collaboration has the potential to bring two additional production sites in India and Europe with capacity to produce several hundred million doses of DPX-COVID-19.

Corporate Update

On November 10, 2020, Andrew Hall joined IMV as Chief Business Officer. Mr. Hall was previously Executive Director, Business Development and Global Alliances at Celgene.

In July 2020, Michael P. Bailey was appointed to the board of directors. Mr. Bailey currently serves as President and Chief Executive Officer and a member of the board of directors at AVEO Oncology.

Upcoming Milestones

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

  • DPX-Survivac

    • Additional Phase 2 clinical results from the DLBCL combination at the American Society of Hematology (ASH) annual meeting to be held virtually on December 6, 2020
    • Top line Phase 2 clinical results from the ovarian cancer trial on December 3, 2020
    • Updated Phase 2 clinical results from the basket trial in Q1 2021
  • DPX-COVID-19

    • Initiation of Phase 1/2 clinical trial with DPX-COVID-19 in 2020
    • Preliminary Phase 1/2 results in Q1 2021

Overview of Third quarter 2020 Financial Results

On September 30, 2020, the Company had cash and cash equivalents of $54,700,000 and working capital of $55,875,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This primarily reflects proceeds from the $25,100,000 private placement completed on May 7th, the 6,841,773 common shares issued for gross proceeds of US$30 million (CAD$40.8 million) under its March and June At-The-Market facilities and $2,276,000 from the exercise of 611,888 common share warrants. Based on its current operating plan, IMV expects its current cash position will be sufficient to fund operations for more than the next 12 months.

Research and development expenses increased by $889,000 during the quarter ended September 30, 2020, compared to Q3 2019. These increases are mainly due to pre-clinical development for DPX-COVID-19, which is offset by an increase in government assistance, and to a lesser extent, also attributable to personnel costs due to an increase in headcount. The increase in research and development expenses is partly offset by a decrease in travel, DPX-SurMAGE preclinical development and costs related to the DeCidE1 Phase 2 study of DPX-Survivac/CPA, in patients with advanced recurrent ovarian cancer.

General and administrative expenses increased by $1,064,000 for the quarter ended September 30, 2020 compared to Q3 2019. This increase is explained by an increase in insurance premium and to a lesser extent is also attributable to an increase in foreign exchange loss. This increase is partly offset by a decrease of $223,000 in legal and professional fees and a decrease of $170,000 in travel due to COVID-19 travel restrictions.

The net loss and comprehensive loss of $8,327,000 ($0.13 per share) for the quarter ended September 30, 2020 was $431,000 higher than the net loss and comprehensive loss of $7,896,000 ($0.16 per share) for the quarter ended September 30, 2019.

For the nine-month period ended September 30, 2020, the net loss and comprehensive loss of $25,259,000 was $6,369,000 higher than the net loss and comprehensive loss for the nine-month period ended September 30, 2019. This relates mainly to a $5,161,000 increase in R&D expenses and a $3,000,000 increase in general and administrative expenses partly compensated by a $1,556,000 increase in government assistance mainly towards COVID-19 vaccine development.

For the nine months ended September 30, 2020, IMV’s cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $23,566,000.

As of November 11, 2020, the number of issued and outstanding common shares was 67,093,547 and a total of 4,490,791 stock options, deferred share units and warrants were outstanding.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended September 30, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGARat www.sec.gov/edgar.

Conference Call and Webcast Information

Management will host a conference call and webcast today, November 12, 2020, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 6146758. Other interested parties will be able to access the live audio webcast at this link.

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.

Cautionary Language Regarding 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, statements regarding the Company’s progress in developing a DPX-based vaccine candidate against COVID-19, the Company’s belief that the DPX-based platform creates the opportunity for production of a COVID-19 vaccine, the Company’s belief in the potential efficacy of its DPX-based vaccine against COVID-19, the anticipated timing of the Company’s preclinical assays, studies and clinical trials related to its DPX-based vaccine against COVID-19 and the expected impact of COVID-19 on the Company’s other clinical studies and trials and its operations generally. Such statements 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 and uncertainties affecting the Company and its products.

The Company 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, the Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of preclinical assays, studies and clinical trials, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies and trials, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital, including potentially through grant awards available in Canada, to fund such clinical studies and trials and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale, the ability for the Company to accurately assess and anticipate the impact of COVID-19 on the Company’s other clinical studies and trials and operations generally and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

 

IMV INC.

Unaudited Interim Condensed Consolidated Statements of Loss and Comprehensive Loss

(In thousands of Canadian dollars, except for share and per share amounts)

 

 

Three-months ended

September 30

 

Nine-months ended

September 30

 

2020

$

 

2019

$

 

2020

$

 

2019

$

Income

 

 

 

 

 

 

Subcontract revenue

3

 

13

 

3

 

26

Interest Income

85

 

151

 

209

 

405

Total income

88

 

164

 

212

 

431

Expenses

 

 

 

 

 

 

 

Research and development

6,541

 

5,652

 

18,628

 

13,467

General and administrative

3,699

 

2,635

 

9,778

 

6,778

Government assistance

(1,684)

 

(606)

 

(3,649)

 

(2,093)

Accreted interest and valuation adjustments

(141)

 

379

 

714

 

1,169

Total operating expenses

8,415

 

8,060

 

25,471

 

19,321

Net loss and comprehensive loss

(8,327)

 

(7,896)

 

(25,259)

 

(18,890)

Basic and diluted loss per share

(0.13)

 

(0.16)

 

(0.44)

 

(0.38)

Weighted-average shares outstanding

65,970,269

 

50,615,488

 

58,025,986

 

49,324,232

 

IMV INC.

Unaudited Interim Condensed Consolidated Statements of Financial Position

(In thousands of Canadian dollars, except for share and per share amounts)

 

September 30,

 

December 31,

 

2020

2019

Assets

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

54,700

$

14,066

Accounts receivable

 

1,663

 

845

Prepaid expenses

 

7,191

 

3,032

Investment tax credits receivable

 

1,588

 

1,661

Total current assets

 

65,142

 

19,604

Property and equipment

 

2,833

 

2,830

Total assets

$

67,975

$

22,434

 

Liabilities and Equity

 

 

 

Current liabilities

 

 

 

Accounts payable, accrued and other liabilities

$

8,236

$

6,157

Amounts due to directors

 

62

 

60

Current portion of long-term debt

 

843

 

88

Current portion of lease obligations

 

126

 

100

Total current liabilities

 

9,267

 

6,405

Lease obligation

 

1,234

 

1,208

Long-term debt

 

8,670

 

8,373

Total liabilities

 

19,171

 

15,986

Equity

 

48,804

 

6,448

Total liabilities and equity

$

67,975

$

22,434

 

Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV

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

M: (514) 968-1046 

E: [email protected]

KEYWORDS: United States North America Canada

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

MEDIA:

Posted on

Forma Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

Forma Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update

Strong pipeline progress amid challenging COVID-19 environment

Oral presentation of MAD1 results at upcoming 2020 ASH Virtual Annual Meeting from the randomized, placebo-controlled multi-center Phase 1 trial evaluating FT-4202 in people with sickle cell disease

MAD2 cohort of the Phase 1 trial now enrolling with 600 mg dose

Registrational Phase 2/3 trial of FT-4202 on track to begin enrolling people living with sickle cell disease in the first quarter of 2021

Phase 1 trial evaluating FT-7051 in metastatic castration-resistant prostate cancer on track to begin enrolling patients before end of 2020

WATERTOWN, Mass.–(BUSINESS WIRE)–Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today reported financial results for the third quarter ended September 30, 2020. The company also highlighted recent progress and upcoming milestones for its pipeline programs.

“We are very pleased with our strong pipeline progress during the quarter amid such challenging times,” said Frank Lee, President and Chief Executive Officer of Forma. “We look forward to presenting new data from our ongoing Phase 1 trial of FT-4202 in sickle cell disease at the ASH meeting in December, as well as beginning enrollment of patients for our Phase 1 trial of FT-7051 in men living with metastatic castration-resistant prostate cancer. The recent positive top-line results from the olutasidenib registrational Phase 2 clinical trial in relapsed/refractory acute myeloid leukemia with an IDH1 mutation further underscores our commitment to developing transformative therapies for patients.”

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

  • Both planned dose cohorts enrolling in the multiple ascending dose (MAD) trial. The MAD1 cohort is designed to dose 9-12 SCD patients with 300 mg of FT-4202. Clinical measures being assessed include change in hemoglobin, indirect bilirubin, reticulocytes and lactate dehydrogenase, as well as the monitoring of tolerability and safety during the 14-day dosing and 7-day follow-up period. The MAD2 cohort is assessing a higher 600 mg dose and is now enrolling patients. Patients completing the 600 mg MAD2 cohort may enter the 12-week Open Label Extension (OLE) portion of the trial.
  • FT-4202 abstract selected for oral presentation at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition December 5-8, 2020. The FT-4202 abstract describes blinded data from three patients receiving the 300 mg dose, measuring changes in parameters over the 14-day treatment and 7-day follow-up period including hemoglobin and reticulocytes, as well as tolerability and safety. Updated data will be presented at the ASH annual meeting on December 7, 2020.

CPB/p300 Program in Prostate Cancer:

  • Phase 1 clinical trial of FT-7051 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) on track to start by year end. This trial will enroll patients who have progressed while on standard anti-androgen therapy. Patients’ prostate cancer will be profiled for mutations in the androgen receptor (AR)-signaling pathway that drive resistance to AR-receptor antagonists, such as ARv7 mutations.

IDH1 Program in AML and Glioma:

  • Announced positive data for olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML). In October 2020, Forma announced positive results from the planned interim analysis (IA2) of the Phase 2 registration trial in R/R AML patients with isocitrate dehydrogenase 1 gene mutations (IDH1m). Olutasidenib demonstrated a favorable tolerability profile as a monotherapy, and for the primary efficacy endpoint of composite complete remission (CR+CRh, or complete remission plus complete remission with partial hematologic recovery), achieved a rate of 33.3% (30% CR and 3% CRh). While a median duration of CR/CRh has not been reached, a sensitivity analysis (with a hematopoietic stem cell transplant as the end of a response) indicates the median duration of CR/CRh to be 13.8 months. Safety results are consistent with previously reported Phase 1 clinical trial results.
  • Olutasidenib is also being evaluated in an exploratory Phase 1 trial for glioma as presented at the American Society of Clinical Oncology meeting in June 2020, as well as in other IDH1m solid tumor indications.

Corporate:

  • In September 2020, Forma announced the appointment of industry veteran Thomas G. Wiggans to Forma’s board of directors. Mr. Wiggans has led successful biopharmaceutical companies from start-up stage into the clinic and later global commercialization, served on the boards of numerous public and private companies, and was instrumental in the formation of the Biotechnology Industry Organization, now Biotechnology Innovation Organization (BIO).

Upcoming Milestones

  • Results from the ongoing randomized placebo-controlled multicenter Phase 1 trialevaluating FT-4202 in patients with SCD to be presented at ASH. Clinical data on the safety results, PK/PD and laboratory measurements in 9-12 patients from the 300 mg MAD1 cohort will be presented during an oral presentation at the virtual, 62nd American Society of Hematology (ASH) Annual Meeting and Exposition December 5-8, 2020. Subsequently, results from the MAD2 600 mg cohort are expected in the first quarter of 2021, and 12-week OLE results are anticipated in the second quarter of 2021.
  • Initiation of registrational trial of FT-4202 for people living with SCD: The global pivotal Phase 2/3 trial is expected to initiate in the first quarter of 2021. This adaptive, randomized, placebo-controlled, double-blind, multi-center study will enroll approximately 344 adults and adolescents with SCD. The trial will evaluate FT-4202 doses of 200 mg and 400 mg administered once daily in the Phase 2 portion. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period.
  • Initiation of FT-7051 Clinical Development in mCRPC: Patient enrollment in the Phase 1 trial of FT-7051 in mCRPC patients is expected to begin prior to the end of 2020. Safety and tolerability data from the trial are anticipated in 2021 and clinical activity results in 2022.
  • Non-core Partnering Strategy: Following the recent positive registrational trial results in R/R AML with an IDH1 mutation, Forma remains focused on partnership opportunities for olutasidenib, as well as for the non-core FASN inhibitor for NASH (FT-8225).
  • Possibility of COVID-19 Impact: The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.

Upcoming Investor Events

  • Dec. 7, 2020: Forma will conduct a conference call and webcast on Dec. 7 at 6 p.m. Eastern Standard Time (EST) to discuss updated results from the ongoing Phase 1 trial of FT-4202 in SCD, as well as an overview of the company’s development plans for FT-4202. A live webcast will be available in the “News & Investors” section of Forma’s website www.formatherapeutics.com.

Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities were $384.3 million as of September 30, 2020, as compared to $173.2 million as of December 31, 2019.
  • Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the quarter ended September 30, 2020, compared to $27.6 million for the quarter ended September 30, 2019. The decrease was primarily due to planned reductions in spending on FT-2102, FT-4101, FT-8225, research activities, and internal R&D personnel-related costs, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial, clinical product manufacturing, and preparations for the pivotal Phase 2/3 trial.
  • General and Administrative (G&A) Expenses: G&A expenses were $7.5 million for the quarter ended September 30, 2020, compared to $7.0 million for the quarter ended September 30, 2019. The increase in general and administrative expense was primarily attributable to a $1.3 million increase in equity-based compensation, and a $0.6 million increase in insurance related expense, and a $0.5 million increase in other related general and administrative costs, partially offset by a reduction of $2.0 million related to legal, consulting and other professional fee expenses.
  • Net Income/Loss: Net loss was $27.6 million for the quarter ended September 30, 2020, compared to $31.0 million for the quarter ended September 30, 2019.

About Forma Therapeutics

Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company’s beliefs and expectations regarding its: business plans and objectives; future plans for FT-4202 and FT-7051, including expectations regarding timing and success of the current ongoing clinical trials, therapeutic potential and clinical benefits thereof, and upcoming milestones for the company’s other product candidates; growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2020; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses of capital, expenses and other 2020 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with: the impact of the COVID-19 pandemic on the company’s business, operations, strategy, goals and anticipated milestones; the therapeutic potential of FT-4202, and the timing associated with the initiation or continuation of any of FT-4202 trials; the initiation of our phase I clinical trial of FT-7051; Forma’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Forma’s ability to fund operations; Forma’s ability to identify satisfactory collaboration opportunities, as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in the final prospectus dated June 22, 2020 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and elsewhere in Forma’s filings and reports with the SEC. Forma disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Forma’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Forma explicitly disclaims any obligation to update any forward-looking statements.

Selected Financial Information
(in thousands except share and per share data) 
(unaudited) 
 
Statement of Operations Items: Three Months Ended
September 30,		 Nine Months Ended
September 30,

2020

 

2019

 

2020

 

2019
 
Revenue

 $                –  

 $         3,377

 $                –  

 $       93,113

Operating expenses
Research and development

          24,780

          27,558

          68,501

          84,273

General and administrative

            7,460

            7,025

          22,841

          17,631

Restructuring charges

                   –  

               545

                  63

            5,620

Total operating expenses

          32,240

          35,128

          91,405

        107,524

Loss from operations

        (32,240)

        (31,751)

        (91,405)

        (14,411)

Other income, net

               818

               766

          23,050

            3,057

Loss before taxes

        (31,422)

        (30,985)

        (68,355)

        (11,354)

Income tax benefit

           (3,806)

                   –  

        (26,529)

           (1,217)

Net loss

 $     (27,616)

 $     (30,985)

 $     (41,826)

 $     (10,137)

Preferred return and accretion of preferred return and
cumulative dividends on preferred securities

                   –  

              (607)

           (3,736)

           (2,395)

Distribution to holders of preferred securities in excess of
accrued preferred return

                   –  

                   –  

                   –  

        (11,347)

Tax distribution to holders of Enterprise.1 Incentive Shares

                   –  

                (60)

                   –  

                (60)

Net loss allocable to shares of common stock, basic 

 $     (27,616)

 $     (45,562)

Change in fair value attributable to warrants to purchase
common stock

                  (8)

                   –  

Net loss allocable to shares of common stock, diluted

 $     (27,624)

 $     (45,562)

Net loss allocable to shares of Common 1, basic 

 $     (31,652)

 $     (23,939)

Change in fair value attributable to warrants to purchase
preferred securities

              (198)

              (515)

Net loss allocable to shares of Common 1, diluted

 $     (31,850)

 $     (24,454)

Net loss per share of common stock:
Basic

 $          (0.67)

 $          (2.74)

Diluted

 $          (0.67)

 $          (2.74)

Net loss per share of Common 1:
Basic

 $       (12.42)

 $          (9.40)

Diluted

 $       (12.50)

 $          (9.60)

Weighted-average shares of common stock outstanding:  
Basic

41,088,261

16,616,143

Diluted

41,088,924

16,616,143

Weighted-average shares of Common 1 outstanding, basic
and diluted

2,547,924

2,547,924

Selected Balance Sheet Items:  
September 30,   December 31,

2020

  

2019
     
Cash, cash equivalents, and marketable securities

 $

    384,346

 

 $

    173,180

Total Assets

 $

    447,396

 

 $

    183,035

Accounts payable, accrued expenses, and other
current liabilities

 $

       30,215

 

 $

       23,629

Redeemable convertible and convertible preferred stock outside
of stockholders’ equity

 

 – 

 

 $

    138,131

Total stockholders’ equity

 $

    415,602

 

 $

       18,246

 

Media:

Kari Watson, +1 781-235-3060

MacDougall

[email protected]

Investors:

Mario Corso, +1 781-366-5726

Forma Therapeutics

[email protected]

Stephanie Ascher, +1 212-362-1200

Stern Investor Relations

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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Posted on

SpringWorks Therapeutics Reports Third Quarter 2020 Financial Results and Recent Business Highlights

– Enrollment Complete in the Phase 3
DeFi Trial of Nirogacestat in Adult Patients with Desmoid Tumors –

– Clinical Collaborations Signed with Janssen, Pfizer and Precision Biosciences to Evaluate Nirogacestat in Combination with BCMA-Directed Therapies Across Modalities for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma –

– Entered into Sponsored Research Agreement with Fred Hutchinson Cancer Research Center to Further Evaluate Nirogacestat as a BCMA Potentiator in Multiple Myeloma –

– Completed an Asset Purchase and Exclusive License Agreement of Global Rights to FAAH Inhibitor PF-04457845 to Jazz Pharmaceuticals, Receiving $35 Million Upfront Payment and Potential Future Milestone Payments of Up to $375 Million –

– Raised $269.5 Million in Net Proceeds Through Follow-On Public Offering –

STAMFORD, Conn., Nov. 12, 2020 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2020 and provided an update on recent company developments.

“We are very pleased with our achievements in the third quarter of 2020 across our clinical development, business development and corporate initiatives. We completed enrollment in the Phase 3 DeFi trial, advanced our strategy to develop nirogacestat as a cornerstone of BCMA combination therapy for patients with multiple myeloma by signing additional collaborations with industry and academic leaders, and continued to progress our trials in biomarker defined metastatic solid tumors,” said Saqib Islam, Chief Executive Officer of SpringWorks. “Our ten clinical development programs are progressing as planned and we look forward to providing further updates as we advance our pipeline and continue to execute on our strategy to build a leading targeted oncology company.”


Recent Business Highlights and Upcoming Milestones

Late-Stage Rare Oncology

  • Completed enrollment in the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. SpringWorks expects to report topline data from the DeFi study in the second or third quarter of 2021.
  • Recruiting patients in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
  • Highlighted a publication by investigators at the University of Minnesota and the Dana-Farber Cancer Institute in the Pediatric Cancer & Blood journal reporting data from four pediatric and young adult desmoid tumor patients who received nirogacestat under the SpringWorks Expanded Access Program. In these four patients, the investigators reported one complete response, two partial responses, and one stable disease, with no grade 3 or 4 adverse events.
  • Enrollment is ongoing in the Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. SpringWorks expects to provide an update on the ReNeu trial in the fourth quarter of 2020 or first quarter of 2021.

B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

  • Enrollment is ongoing in a Phase 1b trial evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK’s anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in patients with relapsed or refractory multiple myeloma.
  • Entered into a clinical collaboration with Janssen Biotech, Inc. (Janssen) to evaluate nirogacestat in combination with Janssen’s BCMA CD3 bispecific antibody, teclistamab, in patients with relapsed or refractory multiple myeloma. A Phase 1 study is expected to commence by early 2021, pending discussions with regulators.
  • Entered into a clinical collaboration with Pfizer Inc. (Pfizer) to evaluate nirogacestat in combination with Pfizer’s BCMA CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma. A Phase 1b/2 study is expected to commence in the first half of 2021.
  • An IND application is expected to be filed by the end of 2020 to evaluate nirogacestat in combination with Allogene’s BCMA AlloCAR T therapy, ALLO-715, in patients with relapsed or refractory multiple myeloma.
  • Entered into a clinical collaboration with Precision BioSciences, Inc. (Precision) to evaluate nirogacestat in combination with Precision’s allogeneic CAR T candidate targeting BCMA, PBCAR269A, in patients with relapsed or refractory multiple myeloma. A Phase 1/2a clinical study is expected to commence in the first half of 2021, pending discussions with regulators.
  • Entered into a sponsored research agreement with Fred Hutchinson Cancer Research Center (Fred Hutch) to further explore the ability of nirogacestat to modulate BCMA and potentiate BCMA-targeting therapies in a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch.

Biomarker-Defined Metastatic Solid Tumors

  • Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. SpringWorks and BeiGene expect to report initial clinical data in 2021.
  • Enrollment is ongoing in a Phase 1 trial of BGB-3245 in patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, an entity that is jointly owned by SpringWorks and BeiGene, Ltd. Initial clinical data from the Phase 1 study are expected in 2021.

General Corporate

  • In October 2020, SpringWorks completed a follow-on public offering that raised $269.5 million in net proceeds, which included the underwriters’ full exercise of their option to purchase additional shares of common stock.
  • SpringWorks and Jazz Pharmaceuticals entered into an asset purchase and exclusive license agreement under which Jazz acquired SpringWorks’ fatty acid amide hydrolase (FAAH) inhibitor program, PF-04457845. Under the terms of the agreement, Jazz assumed all milestone and royalty obligations owned by SpringWorks to Pfizer under the 2017 license agreement pursuant to which SpringWorks obtained rights to this asset. In addition, Jazz made an upfront payment of $35 million to SpringWorks, with potential future milestone payments of up to $375 million payable to SpringWorks based upon the achievement of certain clinical development, regulatory and commercial milestones. SpringWorks is also entitled to receive tiered royalties on future net sales of PF-04457845.

Third Quarter and Year to Date 2020 Financial Results

  • Research and Development (R&D) Expenses: R&D expenses were $13.9 million and $36.6 million for the third quarter and year-to-date periods, respectively, compared to $10.7 million and $30.4 million for the comparable periods of 2019, respectively. The increases in R&D expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of R&D personnel, an increase in non-cash share-based compensation expense and increases in external costs related to drug manufacturing and clinical trial costs.
  • General and Administrative (G&A) Expenses: G&A expenses were $7.7 million and $20.9 million for the third quarter and year-to-date periods, respectively, compared to $4.6 million and $11.5 million for the comparable periods of 2019, respectively. The increases in G&A expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of G&A personnel supporting the growth of the organization, and an increase in non-cash share-based compensation expenses, as well as increases in expenses related to the expansion of business activities.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported net losses of $21.7 million, or $0.51 loss per share, and $56.8 million, or $1.35 loss per share, for the third quarter and year-to-date periods ended September 30, 2020, respectively. This compares to net losses of $16.8 million, or $1.77 loss per share, and $34.4 million, or $9.24 loss per share, for the comparable periods of 2019, respectively.
  • Cash Position: Cash, cash equivalents and marketable securities were $276.8 million as of September 30, 2020. This does not include the net proceeds of $269.5 million from the Company’s follow-on public offering completed in October 2020 or the $35 million upfront payment Jazz Pharmaceuticals made to SpringWorks in October 2020.

COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2020 and refer to the Forward-Looking Statements section in this press release.

About SpringWorks Therapeutics

SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio. For more information, visit www.springworkstx.com and follow @SpringWorksTx on Twitter and LinkedIn.

SpringWorks
uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company’s website in the ‘Investors & Media’ section. Accordingly, investors should monitor such portions of the SpringWorks website, in addition to following press releases, SEC filings and public conference calls and webcasts.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding SpringWorks’ clinical trials and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to SpringWorks’ financial results, the timing for completion of SpringWorks’ clinical trials of its product candidates, whether and when, if at all, SpringWorks’ product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in SpringWorks’ SEC filings. SpringWorks cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. SpringWorks disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent SpringWorks’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.


SpringWorks Therapeutics, Inc.



Condensed Consolidated Statements of Operations



(Unaudited)

                         
    Three Months Ended September 30,    Nine Months Ended September 30, 
(in thousands, except share and per-share data)   2020     2019     2020     2019  
Operating expenses:                        
Research and development   $ 13,923     $ 10,745     $ 36,597     $ 30,373  
General and administrative     7,669       4,584       20,946       11,495  
Total operating expenses     21,592       15,329       57,543       41,868  
                         
Loss from operations     (21,592 )     (15,329 )     (57,543 )     (41,868 )
Other income:                        
Interest income, net     63       997       1,156       2,280  
Total other income     63       997       1,156       2,280  
Equity investment loss     (130 )     (2,501 )     (459 )     (2,501 )
Net loss   $ (21,659 )   $ (16,833 )   $ (56,846 )   $ (42,089 )
                         
Reconciliation of net loss to net loss attributable to common stockholders:                        
Net loss   $ (21,659 )   $ (16,833 )   $ (56,846 )   $ (42,089 )
Net gain attributable to extinguishment of Series A convertible preferred and Junior Series A convertible preferred units     —       —       —       7,729  
Net loss attributable to common stockholders   $ (21,659 )   $ (16,833 )   $ (56,846 )   $ (34,360 )
                         
                         
Net loss per share, basic and diluted   $ (0.51 )   $ (1.77 )   $ (1.35 )   $ (9.24 )
Weighted average common shares outstanding, basic and diluted     42,148,837       9,487,329       41,961,691       3,716,877  










SpringWorks Therapeutics, Inc.



Selected Balance Sheet Data



(Unaudited)

 
    September 30, 2020   December 31, 2019
         
(In thousands)    
Cash, cash equivalents and marketable securities   $ 276,819     $ 327,652  
Working Capital (1)     266,150       319,391  
Total Assets     286,100       334,831  
Total liabilities     13,345       12,759  
Accumulated deficit     (129,875 )     (73,029 )
Total stockholders’ (deficit) equity     272,755       322,072  
             
             

(1) We define working capital as current assets less current liabilities.

Contact:

Kim Diamond
Phone: 203-561-1646
Email: [email protected]

Posted on

RetailMeNot Compiles the List of Stores Staying Closed on Thanksgiving

PR Newswire

AUSTIN, Texas, Nov. 12, 2020 /PRNewswire/ — RetailMeNot, a J2 Global business within its Ziff Davis division and leading savings destination that brings shoppers incredible offers, promo codes and sales every day, has compiled a comprehensive list of stores staying closed on Thanksgiving.

Stores staying open on Thanksgiving evening has been a heated topic for years, but this year, it’s especially divisive, with the continuation of the COVID-19 pandemic. Due to social distancing guidelines, shoppers have made a big shift to online shopping. In fact, according to recent research by RetailMeNot, 88% of shoppers do not plan to shop doorbuster sales in-store this holiday season.

With Black Friday right around the corner—a historically chaotic in-store shopping moment—many major retailers have announced that for the first time in years, they will keep their doors closed on Thanksgiving in response to the COVID-19 pandemic.

Walmart was the early bird in terms of its announcement to close on Thanksgiving. For more than 30 years, Walmart kicked off Black Friday sales early, allowing customers to save more on Thanksgiving Day. But this year, the megastore announced it would close doors to all 4,000+ stores in the U.S. Other major retailers that followed suit include Best Buy, Target, Kohl’s, The Home Depot and Dick’s Sporting Goods.

For more tips and details about how to shop smart, safely and save big this holiday season, visit RetailMeNot’s blog, The Real Deal.

Stores Officially Closed on Thanksgiving Day 2020

  • Academy Sports + Outdoors
  • Bath & Body Works
  • Bed Bath & Beyond
  • Best Buy
  • BJ’s
  • Boscov’s
  • Costco
  • Dick’s Sporting Goods
  • Foot Locker
  • GameStop
  • The Home Depot
  • JCPenney
  • Kohl’s
  •  Lamps Plus
  • Macy’s
  • Office Depot/OfficeMax
  • REI
  • Simon Property Group
  • Target
  • Ulta
  • Under Armour
  • The Outlet Resource Group
  • Walmart
  • Williams-Sonoma

About RetailMeNot
RetailMeNot is a leading savings destination bringing people and the things they love together through savings with retailers, brands and restaurants. RetailMeNot makes everyday life more affordable through online and in-store coupon codes, cash back offers, and the RetailMeNot Deal Finder™ browser extension. To learn more, visit http://www.retailmenot.com/corp or follow @RetailMeNot on social media.

About J2 Global
J2 Global, Inc. (NASDAQ: JCOM) is a leading Internet information and services company consisting of a portfolio of brands including IGN, Mashable, Humble Bundle, Speedtest, PCMag, RetailMeNot, Offers.com, Spiceworks Ziff Davis, Everyday Health, BabyCenter and What To Expect in its Digital Media segment and eFax, eVoice, iContact, Campaigner, Vipre, IPVanish and KeepItSafe in its Cloud Services segment. J2 Global reaches over 230 million people per month across its brands. As of December 31, 2019, J2 Global had achieved 24 consecutive fiscal years of revenue growth. For more information, visit: www.j2global.com

Media Contact:
Hillary White
[email protected] 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/retailmenot-compiles-the-list-of-stores-staying-closed-on-thanksgiving-301171472.html

SOURCE RetailMeNot

Posted on

Xunlei Announces Unaudited Financial Results for the Third Quarter Ended September 30, 2020

Shenzhen, China, Nov. 12, 2020 (GLOBE NEWSWIRE) — Xunlei Limited (“Xunlei” or the “Company”) (Nasdaq: XNET), a leading innovator in shared cloud computing and blockchain technology in China, today announced its unaudited financial results for the third quarter ended September 30, 2020.

Third Quarter 2020 Financial Highlights:

  • Total revenues were US$43.7 million, representing a decrease of 1.4% from the previous quarter.
  • Cloud computing and other internet value-added services (“Cloud computing and other IVAS”) revenues were US$21.2 million, representing an increase of 1.1% from the previous quarter.
  • Subscription revenues were US$19.6 million, representing a decrease of 5.5% on a sequential basis.
  • Online advertising revenues (consisting primarily of revenues from mobile advertising) were approximately US$3.0 million, representing an increase of 10.8% from the previous quarter.
  • Gross profit was US$22.7 million, representing an increase of 11.3% on a sequential basis. Gross margin was 51.9% in the third quarter of 2020, compared with 46.0% in the previous quarter.
  • Net loss was US$1.5 million in the third quarter of 2020, compared with a net loss of US$11.8 million in the previous quarter.
  • Diluted loss per ADS was US$0.02 as compared with a diluted loss of US$0.17 in the previous quarter.

Recent developments

  • Collaborated with e-Surfing Cloud Storage, the cloud storage product run by Shijilong Information Network Co., Ltd, a wholly-owned subsidiary of China Telecom, to develop joint cloud storage services and explore other consumer-related products to achieve resource sharing and mutual benefits.
  • Launched a BaaS (Blockchain as a Service) platform to free enterprises and developers from dealing with complex technical issues in blockchain infrastructure and to drive innovation and productivity.

Mr. Jinbo Li, Chairman and Chief Executive Officer of Xunlei, stated that “Xunlei delivered a quarter of solid execution. We are encouraged by meaningful improvements across several financial and operating metrics, including an 87% sequential improvement in our bottom-line. Through our relentless focus on reinforcing our core competitiveness, optimizing operating efficiencies, and placing more control on cost and expenses, we are seeing our strengths bolstered and profitability improved across our major product lines. And we are optimistic that the positive momentum would be carried into the fourth quarter of 2020. ”

“We remain committed to uncovering Xunlei’s value by offering our users reliable and secured digital experience. In the third quarter of 2020, we expanded service capabilities in our cloud computing business, explored new partnership and launched the BaaS platform for our blockchain services. Looking forward, we will continue to optimize operating metrics and drive product innovation to deliver value to our users, partners and shareholders,” concluded Mr. Jinbo Li.

Third
Quarter
2020
Financial Results

Total Revenues

Total revenues were US$43.7 million, representing a decrease of 1.4% from the previous quarter.

Revenues from cloud computing and other IVAS combined were US$21.2 million, representing an increase of 1.1% from the previous quarter.

Revenues from subscriptions were US$19.6 million, representing a decrease of 5.5% from the previous quarter. The number of subscribers was 3.8 million as of September 30, 2020, compared with 3.9 million as of June 30, 2020. The average revenue per subscriber for the third quarter of 2020 was RMB35.9, compared with RMB37.5 for the second quarter of 2020. The decrease in subscription revenues was attributable to the decline in pricing and subscriber base compared with the previous quarter.

Revenues from online advertising were US$3.0 million, representing an increase of 10.8% from the previous quarter. The increase in the third quarter was mainly due to the application of precision targeting algorithm to achieve better advertising placement and improve monetization efficiency.

Cost of Revenues

Total cost of revenues was US$21.0 million in the third quarter of 2020, representing 48.1% of our total revenues, compared with US$23.9 million, or 54.0% of our total revenues, in the second quarter. The decrease was mainly due to decreased cost associated with a write-down of our inventory for Onething Cloud hardware products of US$2.5 million in the second quarter.

Bandwidth costs were US$15.4 million, representing 35.1% of our total revenues, compared with US$13.9 million, or 31.4% of our total revenues in the previous quarter, the increased bandwidth cost was primarily due to increased demand for our cloud computing service, which was consistent with the increase of our cloud computing revenues.

The remaining cost of revenues mainly included revenue-sharing costs for our live streaming products.

Gross Profit and Gross Margin

Gross profit for the third quarter of 2020 was US$22.7 million, representing an increase of 11.3% from the previous quarter. Gross margin was 51.9% in the third quarter, compared with 46.0% in the previous quarter. The increase in gross profit was mainly due to (i) an increase in revenue from online advertising services, which have a higher gross margin compared with other businesses, and (ii) a decrease in cost associated with a write-down of our inventory discussed above.

Research and Development Expenses

Research and development expenses for the third quarter of 2020 were US$12.1 million, representing 27.6% of our total revenues, compared with US$14.5 million or 32.8% of our total revenues in the previous quarter. The decrease was mainly due to decreased labor cost as a result of optimization of our organizational structure during the past quarters.

Sales and Marketing Expenses

Sales and marketing expenses for the third quarter of 2020 were US$4.2 million, representing 9.6% of our total revenues, compared with US$4.4 million or 9.9% of our total revenues in the previous quarter.

General and Administrative Expenses

General and administrative expenses for the third quarter of 2020 were US$7.5 million, representing 17.1% of our total revenues, compared with US$10.1 million or 22.8% of our total revenues in the previous quarter. The decrease was mainly due to decreased employee and rental expenses as there were more employee severance compensation as a result of organizational optimization in the previous quarter and the incurrence of a one-time expense associated with terminating several office leases in the second quarter.

Impairment of Assets, Net of
R
ecoveries

No impairment of assets was accrued in the third quarter. The amount for the second quarter was approximately US$5.1 million, which represented a one-time write-off of certain receivables and prepayments in connection with our cloud computing business as we determined that those receivables and prepayments were not recoverable.

Operating Loss

Operating loss was US$1.0 million, compared with US$13.7 million in the previous quarter. The decrease was mainly due to higher gross profit and less operating expenses incurred this quarter as discussed above.

Net
Loss
and
Loss Per
ADS

Net loss was US$1.5 million in the third quarter of 2020, compared with a net loss of US$11.8 million in the previous quarter. Non-GAAP net loss was US$0.9 million in the third quarter of 2020, compared with a Non-GAAP net loss of US$11.2 million in the previous quarter.

Diluted loss per ADS in the third quarter of 2020 was US$0.02, compared with a diluted loss per ADS of US$0.17 in the previous quarter.

Cash Balance
and Short-Term Investments

As of September 30, 2020, the Company had net current assets of approximately US$195.3 million. With cash, cash equivalents and short-term investments of US$246.0 million, compared with US$257.1 million as of June 30, 2020. The Company anticipates adequate liquidity to meet its current obligations.

Share Repurchase Program

The Company approved a share repurchase program to repurchase up to US$20 million of its outstanding shares before June 30, 2021. As of September 30,2020, the Company has repurchased 1,191,392 ADSs using cash of US$4.47 million.

Guidance for
Fourth
Quarter
2020

For the fourth quarter of 2020, Xunlei estimates total revenues to be between US$45 million and US$49 million, and the midpoint of the range represents a quarter-over-quarter increase of approximately 8.0%. This estimate represents management’s preliminary view as of the date of this release, which is subject to change and any changes could be material.

Conference Call Details         

Xunlei’s management will host a conference call at 8:00 a.m. U.S. Eastern Time on November 12, 2020 (9:00 p.m. Beijing/Hong Kong Time), to discuss its quarterly results and recent business activities.

Conference Call Preregistration

Due to the outbreak of COVID-19, operator assisted conference calls are not available at the moment. All participants wishing to attend the call must preregister online before they can receive the dial-in numbers. Preregistration may require a few minutes to complete. The Company would like to apologize for any inconvenience caused by not having an operator as a result of COVID-19.

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

Participant Online Registration: http://apac.directeventreg.com/registration/event/8999108

Once preregistration has been completed, participants will receive dial-in numbers, an event passcode, and a unique registrant ID.

To join the conference, please dial the number you receive, enter the event passcode followed by your unique registrant ID, and you will be joined to the conference instantly.

The Company will also broadcast a live audio webcast of the conference call. The webcast will be available at http://ir.xunlei.com.

Following the earnings conference call, an archive of the call will be available by dialing:

China (Mandarin): 400-602-2065
Hong Kong: 800-963-117
United States: 1-855-452-5696
International: 61-2-8199-0299
Replay Passcode: 8999108
Replay End Date: November 20, 2020
   

About
Xunlei

Founded in 2003, Xunlei Limited (NASDAQ: XNET) is a leading innovator in shared cloud computing and blockchain technology in China. Xunlei provides a wide range of products and services across cloud acceleration, blockchain, shared cloud computing and digital entertainment to deliver an efficient, smart and safe internet experience.

Safe Harbor Statement

This press release contains statements of a forward-looking nature. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by terminology such as “will,” “expects,” “believes,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the management’s quotations, the “Outlook” and “Guidance” sections in this press release, as well as the Company’s strategic, operational and acquisition plans, contain forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company and the industry. Forward-looking statements involve inherent risks and uncertainties, including but not limited to: (i) the Company’s ability to continue to innovate and provide attractive products and services to retain and grow its user base; (ii) the Company’s ability to keep up with technological developments and users’ changing demands in the internet industry; (iii) the Company’s ability to convert its users into subscribers of its premium services; (iv) the Company’s ability to deal with existing and potential copyright infringement claims and other related claims; (v) the risk that Covid-19 or other health risks in China or globally could adversely affect the Company’s operations or financial results; (vi) the Company’s ability to react to the governmental actions for its scrutiny of internet content in China and the Company’s ability to compete effectively. Additionally, these forward‑looking statements, particularly our guidance, involve risk, uncertainties and assumptions, including those related to the impacts of COVID‑19 on our business and global economic conditions. Many of these assumptions relate to matters that are beyond our control and changing rapidly, including, but not limited to, the timeframes for and severity of social distancing and other mitigation requirements, the impact of COVID‑19 on our customers’ purchasing decisions and the length of our sales cycles, particularly for customers in certain industries highly affected by COVID‑19. Significant variation from the assumptions underlying our forward‑looking statements could cause our actual results to vary, and the impact could be significant. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results. Further information regarding risks and uncertainties faced by the Company is included in the Company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of the press release, and the Company undertakes no obligation to update any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

About Non-GAAP Financial Measures

To supplement Xunlei’s consolidated financial results presented in accordance with United States Generally Accepted Accounting Principles (“GAAP”), Xunlei uses the following measures defined as non-GAAP financial measures by the United States Securities and Exchange Commission: (1) non-GAAP operating income/(loss), (2) non-GAAP net income/(loss) from continuing operations, (3) non-GAAP basic and diluted earnings per share for common shares attributable to continuing operations, and (4) non-GAAP basic and diluted earnings per ADS attributable to continuing operations. The presentation of the non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP.

Xunlei believes that these non-GAAP financial measures provide meaningful supplemental information to investors regarding the Company’s operating performance by excluding share-based compensation expenses, which is not expected to result in future cash payments. These non-GAAP financial measures also facilitate management’s internal comparisons to Xunlei’s historical performance and assist the Company’s financial and operational decision making. A limitation of using these non-GAAP financial measures is that these non-GAAP measures exclude share-based compensation charge that has been and will continue to be for the foreseeable future a significant recurring expense in Xunlei’s results of operations. Management compensates for these limitations by providing specific information regarding the GAAP amounts excluded from each non-GAAP measure. The accompanying reconciliation tables at the end of this release include details on the reconciliations between GAAP financial measures that are most directly comparable to the non-GAAP financial measures the Company has presented.

     
XUNLEI LIMITED    
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS    
(Amounts expressed in thousands of USD, except for share, per share (or ADS) data)    
     
  September 30,   December 31,  
  2020   2019  
         
Assets        
         
Current assets:        
Cash and cash equivalents 123,835   162,465  
Short-term investments 122,176   102,847  
Accounts receivable, net 23,623   27,533  
Inventories 1,748   5,537  
Due from related parties 6,304   1,658  
Prepayments and other current assets 12,762   16,543  
Total current assets 290,448   316,583  
         
Non-current assets:        
Restricted cash 1,588   2,983  
Long-term investments 26,495   26,365  
Deferred tax assets 165   1,118  
Property and equipment, net 42,962   38,770  
Intangible assets, net 8,758   9,426  
Goodwill 21,660   20,382  
Other long-term prepayments and receivables 213   313  
Right-of-use assets 1,999   8,747  
Total assets 394,288   424,687  
         
Liabilities        
Current liabilities:        
Accounts payable 20,260   24,213  
Due to related parties 5,002   5,002  
Contract liabilities and deferred income, current portion 32,901   31,988  
Lease liabilities 2,084   4,693  
Income tax payable 2,807   2,550  
Accrued liabilities and other payables 32,117   42,840  
Total current liabilities 95,171   111,286  
         
Non-current liabilities:        
Contract liabilities and deferred income, non-current portion 932   1,223  
Lease liabilities, non-current portion 19   4,132  
Deferred tax liabilities, non-current portion 1,082   1,179  
Interest-bearing bank borrowing 19,089   11,324  
Total liabilities 116,293   129,144  
         
Equity        
Common shares (US$0.00025 par value, 1,000,000,000 shares authorized, 368,877,205 shares issued and 339,165,241 shares outstanding as at December 31, 2019; 368,877,205 issued and 334,401,981shares outstanding as at September30, 2020) 84   85  
Additional paid-in-capital 469,687   472,052  
Accumulated other comprehensive loss (9,798 ) (13,425 )
Statutory reserves 5,132   5,132  
Treasury shares (29,711,964 shares and 29,056,264 shares as at December 31, 2019 and June 30, 2020, respectively) 9   7  
Accumulated deficits (185,459 ) (166,973 )
Total Xunlei Limited’s shareholders’ equity 279,655   296,878  
Non-controlling interests (1,660 ) (1,335 )
Total liabilities and shareholders’ equity 394,288   424,687  
         

       
XUNLEI LIMITED
 
Unaudited Condensed Consolidated Statements of Income
 
(Amounts expressed in thousands of USD, except for share, per share (or ADS) data)
       
  Three months ended
  Sep 30,   Jun 30,   Sep30,  
  2020   2020   2019  
       
Revenues, net of rebates and discounts 43,722   44,328   43,839  
Business taxes and surcharges (34 ) (8 ) (77 )
Net revenues 43,688   44,320   43,762  
Cost of revenues (21,004 ) (23,931 ) (24,450 )
Gross profit 22,684   20,389   19,312  
       
Operating expenses      
Research and development expenses (12,069 ) (14,548 ) (17,593 )
Sales and marketing expenses (4,185 ) (4,382 ) (6,241 )
General and administrative expenses (7,463 ) (10,100 ) (9,113 )
Assets impairment loss, net of recoveries –   (5,060 ) 427  
Total operating expenses (23,717 ) (34,090 ) (32,520 )
       
Operating loss (1,033 ) (13,701 ) (13,208 )
Interest income 404   408   801  
Interest expense –   –   –  
Other income, net (335 ) 1,772   (11,761 )
Loss before income taxes (964 ) (11,521 ) (24,168 )
Income tax expenses (498 ) (254 ) (448 )
Net loss (1,462 ) (11,775 ) (24,616 )
Less: net loss attributable to non-controlling interest (3 ) (247 ) (59 )
Net loss attributable to common shareholders (1,459 ) (11,528 ) (24,557 )
       
   
  Three months ended
   
  Sep 30,   Jun 30,   Sep 30,  
  2020   2020   2019  
       
Loss per share for common shares      
Basic (0.0043 ) (0.0339 ) (0.0726 )
Diluted (0.0043 ) (0.0339 ) (0.0726 )
       
Loss per ADS      
Basic (0.0215 ) (0.1695 ) (0.3630 )
Diluted (0.0215 ) (0.1695 ) (0.3630 )
       
Weighted average number of common shares used in calculating :      
Basic 336,371,957   339,816,984   338,473,633  
Diluted 336,371,957   339,816,984   338,473,633  
       
Weighted average number of ADSs used in calculating :      
Basic 67,274,391   67,963,397   67,694,727  
Diluted 67,274,391   67,963,397   67,694,727  

XUNLEI LIMITED
 
Reconciliation of GAAP and Non-GAAP Results (Excluding discontinued operations)
 
(Amounts expressed in thousands of USD, except for share, per share (or ADS) data)
 
  Three months ended
  Sep 30,   Jun 30,   Sep 30,  
  2020   2020   2019  
       
       
GAAP operating loss (1,033 ) (13,701 ) (13,208 )
Share-based compensation expenses 548   547   1,508  
Non-GAAP operating loss (485 ) (13,154 ) (11,700 )
       
GAAP net loss from continuing operations (1,462 ) (11,775 ) (24,616 )
Share-based compensation expenses 548   547   1,508  
Non-GAAP net loss (914 ) (11,228 ) (23,108 )
       
GAAP loss per share for common shares:      
Basic (0.0043 ) (0.0339 ) (0.0726 )
Diluted (0.0043 ) (0.0339 ) (0.0726 )
       
GAAP loss per ADS:      
Basic (0.0215 ) (0.1695 ) (0.3630 )
Diluted (0.0215 ) (0.1695 ) (0.3630 )
       
Non-GAAP loss per share for common shares:      
Basic (0.0027 ) (0.0323 ) (0.0681 )
Diluted (0.0027 ) (0.0323 ) (0.0681 )
       
Non-GAAP loss per ADS:      
Basic (0.0135 ) (0.1615 ) (0.3405 )
Diluted (0.0135 ) (0.1615 ) (0.3405 )
       
Weighted average number of common shares used in calculating:      
Basic 336,371,957   339,816,984   338,473,633  
Diluted 336,371,957   339,816,984   338,473,633  
       
Weighted average number of ADSs used in calculating:      
Basic 67,274,391   67,963,397   67,694,727  
Diluted 67,274,391   67,963,397   67,694,727  


CONTACT:
Investor Relations
Xunlei Limited
Email: [email protected]
Tel: +86 755 86338443
Website: http://ir.xunlei.com