Market Newsdesk

SALT LAKE CITY, Nov. 16, 2020 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced today the expansion of Myriad myChoice^® tumor testing in several European markets and China.

Myriad myChoice CDx is the industry’s most clinically-validated genomic instability test. The test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors, including Lynparza (olaparib). A biomarker subgroup analysis of the PAOLA-1 Phase III trial (Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer, 2019) of Lynparza included patients with advanced ovarian cancer and homologous recombination deficient (HRD)-positive tumors as detected by the myChoice test, including those with BRCA gene mutations. The trial showed that Lynparza in combination with bevacizumab maintenance treatment improved progression-free survival to a median of 37.2 months versus 17.7 months for bevacizumab alone in patients with HRD-positive advanced ovarian cancer. Recently, the European Commission authorized use of Lynparza for the first-line maintenance treatment with bevacizumab of patients with HRD-positive advanced ovarian cancer. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck.

As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the company’s global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriad’s myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC). 

Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology. The partnership with Burning Rock expands global access to myChoice and positions the test as a preferred developmental companion diagnostic in this important drug development category.

“These new strategic partnerships with leading companies dedicated to advancing the power of precision medicine, reinforce Myriad’s commitment to expanding access to genetic insights for more patients than ever before,” said Nicole Lambert, president of Myriad Genetic Laboratories. “Through close collaboration with innovative laboratories in Europe and with Burning Rock in China, we are bringing the clinical benefits of myChoice testing to additional markets and patients, advancing personalized treatment for patients around the world.”

In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.

About Myriad myChoice

Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: https://myriad-oncology.com/mychoice-cdx/

About Myriad Genetics

Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Company’s new international collaborations on the myChoice^® CDx test, including offering the test to European patients, and partnering with pathology institutes in Europe and Burning Rock in China; and the Company’s strategic directives under the caption “About Myriad Genetics.”  These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements.  These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements;  the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.  All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Media Contact:
Jared Maxwell          
(801) 505-5027        
[email protected]

Investor Contact:
Scott Gleason
(801) 584-1143
[email protected] 

ALPHARETTA, Ga., Nov. 16, 2020 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that two presentations of Clearside preclinical and clinical data were given at the virtual American Academy Ophthalmology (AAO) 2020 Annual Meeting.

Clearside also announced a clinical characterization of the suprachoroidal injection procedure across three retinal disorders was published in the Association for Research in Vision and Ophthalmology (ARVO) peer-reviewed, Medline-indexed journal, Translational Vision Science and Technology, which can be accessed here. The data described in this paper demonstrate that suprachoroidal injection was well accepted by physician-investigators, and that the device and procedure may accommodate a wide range of anatomic and demographic variables. These data suggest that suprachoroidal injection could be readily adopted in clinical practice for targeted, compartmentalized delivery of ocular therapies.

“Reflecting on the past year, I am grateful to our team and the numerous physicians and researchers who have delivered 33 presentations on our assets and suprachoroidal space (SCS^®) injection platform during 2020,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “In addition to our conference presentations, we have placed four publications in peer reviewed journals to further educate the medical community on our clinical progress. This coverage and attention on our programs have established Clearside as the leader in suprachoroidal delivery. We look forward to continuing to advance our suprachoroidal delivery programs with data expected in 2021 from our CLS-AX (axitinib injectable suspension) Phase 1/2a clinical trial, and our integrin inhibitor preclinical studies.”

Dr. Ciulla continued, “In addition to our internal progress, we are pleased with the advancements of our clinical development partners. This weekend at the AAO conference, suprachoroidal delivery was featured by our gene therapy partner, REGENXBIO, as well as in a late breaking presentation from Aura Biosciences in choroidal melanoma. Both of these companies are using our SCS Microinjector^® to deliver their assets into the suprachoroidal space.”

Title: Suprachoroidal
CLS-AX (axitinib injectable suspension),
as a Potential Long-Acting Therapy for Neovascular Age-Related Macular Degeneration (
nAMD
)

Authors: Robert Bhisitkul; Viral Kansara; Thomas Ciulla
Conclusions:
CLS-AX is intended to be a targeted therapy to affected tissue layers via suprachoroidal injection. Axitinib has intrinsic high potency and pan-VEGF inhibition through receptor blockade. In pharmacokinetic studies, CLS-AX demonstrated prolonged duration. The U.S. Food and Drug Administration has accepted Clearside’s Investigational New Drug Application and a Phase 1/2a clinical trial in wet age-related macular degeneration (wet AMD) is expected to initiate by the end of 2020.

Title:
Systemic Therapy and Efficacy of CLS-TA
:
Results from the Phase 3 PEACHTREE Clinical Trial

Authors: Quan Nguyen; Thomas Ciulla
Conclusions: These post hoc results corroborate the pre-specified study analyses in the PEACHTREE trial. The visual acuity and macular edema improvements associated with suprachoroidally injected CLS-TA versus the control in treating macular edema associated with noninfectious uveitis, was noted regardless of administration of systemic therapy at baseline.

About Clearside’s Suprachoroidal Space (SCS

^®

) Injection Platform

Clearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector^® can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. Clearside’s unique platform is inherently flexible and intended to work with established medications, new formulations of medicines, as well as future innovations such as gene therapy.

About
CLS-AX (axitinib injectable suspension)

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved to treat renal cell cancer that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade, and may benefit patients who sub-optimally respond to current more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species. Preclinical results from Clearside and independent investigators have shown pharmacodynamic effect with reduced growth of experimental neovascularization and decreased fluorescein leakage. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of wet AMD.

About
XIPERE
™
(triamcinolone acetonide suprachoroidal injectable suspension)

XIPERE^TM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye and being investigated for the treatment of macular edema associated with non-infectious uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for the commercialization and development of XIPERE in the United States and Canada and exclusive options for the right to commercialize and develop XIPERE in Europe and the United Kingdom, Australia and New Zealand, and South America and Mexico (through a license agreement between Clearside and Bausch Health’s affiliate). Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE in Greater China and South Korea.

About Clearside Biomedical

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector^® targets the suprachoroidal space (SCS^®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. Clearside’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit www.clearsidebio.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the development and potential benefits of CLS-AX and XIPERE, including the timing of initiation of and data from the Phase 1/2a clinical trial for CLS-AX in wet AMD, as well as the timing of data from preclinical studies in Clearside’s integrin inhibitor program. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 10, 2020 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor and Media
Contact
s
:

Jenny Kobin
Remy Bernarda
[email protected]
(678) 430-8206

Source: Clearside Biomedical, Inc.

BARRIE, Ontario, Nov. 16, 2020 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized, research-driven cannabis extraction, distillation and derivative products today announced its financial results for the three and nine months ended September 30, 2020 and outlined its plan to accelerate growth and improve profitability.

“MediPharm Labs has created a strong and capable platform to pursue global leadership of medical, wellness and adult-use markets for cannabis,” said Pat McCutcheon, CEO, MediPharm Labs. “We have identified business strengths that can be exploited including significant technical depth, global GMP supply-chain capabilities, high-potential customer agreements including a significant exclusive multi-year contract with European pharmaceutical leader STADA, and a strong cash position.”

“Economic conditions including the oversupply in the Canadian bulk crude resin and distillate markets, along with the impact of COVID 19, continue to challenge the industry,” added Mr. McCutcheon. “We are now focused on doing more to drive profitable revenue and address weaknesses including reducing our cost structure. We have taken immediate steps to improve our costs and organizational alignment against which we have put an action plan in place that will create value and enable us to achieve our potential.”

The immediate action plan to create value consists of the following elements:

• Improve financial management to reduce and better align costs with the timing of sales generation
• Enhance marketing and sales with focus on accelerating research and development and new product commercialization for B2B and B2C operations
• Transition from B2B wholesale concentrate market, due to oversupply in Canada, to white label contract manufacturing
• Reduced headcount for an annualized savings of $3 million to meet needs of current environment
• Undertook an independent operational review to identify areas for improvement and opportunities to restore growth to help drive significant improvement in cash flows and margins

These actions, some of which were taken late in the third quarter, and others subsequent to the quarter end, will prepare MediPharm Labs for significant performance improvements in 2021 as revenue under new customer agreements ramps up.

Q3
2020
FINANCIAL SUMMARY

• Cash and equivalents balance at September 30, 2020, was $36.5 million; finalized settlement of the second tranche of the convertible debenture.

• Revenue was $4.9 million, compared to $13.9 million in Q2 2020. Reflects lower bulk extract volumes and average selling prices, partially offset by growth in formulated finished goods sales, up 30% to provincial distributors throughout Canada, and sales from MediPharm Labs Australia.
• Finished product shipments grew to comprise 57% of Q3 revenue up from 16% in Q2 2020.
• Commercialized SKUs grew 13% from Q2. Increased development activities for continued growth.
• International revenue grew to $0.7 million as sales of GMP-certified formulated products under agreements with customers in Australia, New Zealand and the U.K. ramped up.
• Gross profit was ($10.6 million) and gross margin was (214%) compared to gross profit of $2.2 million and gross margin of 16% in Q2 2020, primarily due to a $6.3 million non-cash write down of inventory to net realizable value and a $1.5 million write down of non-current deposits given to vendors for capital expenditures.
• Negative Adjusted EBITDA⁽¹⁾ was $7.3 million.
• Net loss before tax was $15.4 million, compared to a net loss of $3.8 million in Q2 2020.

Q3 2020 FINANCIAL SUMMARY TABLE

	Three months ended
	September 30, 2020	June 30, 2020	March 31, 2020	December 31, 2019	September 30, 2019
Revenue	4,947	13,918	11,089	32,444	43,386
Gross profit	( 10,588 )	2,212	(10,882)	9,987	14,754
Gross margin %	( 214 %)	16 %	(98 %)	31 %	34 %
Net (loss)/income before tax	( 15,422 )	(3,775)	(22,029)	(2,401)	5,395
Adjusted EBITDA (1)	(7,26 2 )	(2,180)	(5,657)	2,661	10,066
Adjusted EBITDA margin %	(147 %)	(16 %)	(51 %)	8%	23 %
(1)   See Non-IFRS Measures section of this news release.

LOOKING FORWARD: GROWTH AND IMPROVEMENT CATALYSTS

Refining Processes,
Leveraging SAP and
Reducing Costs: During and subsequent to the third quarter, production processes were refined, the workforce was streamlined by 20% representing $3 million annualized cost reductions, and strict spending disciplines were implemented. Along with other cost containment measures in Q4, these actions will provide benefits as revenue ramps up. The Company is also realizing increasing advantages from the recent implementation of its SAP resource planning system.

STADA
Pharmaceutical Partnership
and
30 Supply Contracts
to
Drive
Revenue
: The Company now has more than 30 supply agreements with customers in eight countries, including its first major collaboration with a leading European consumer healthcare and generics company. Under its agreement with STADA, MediPharm Labs will export GMP-certified finished product and cannabis API for Germany with a plan to expand to other promising European markets over time. This agreement, the first of its kind in the cannabis industry, further strengthened the Company’s reputation as a specialist pharmaceutical manufacturer of cannabis API and finished products. In addition, the Company has formed its first alliances in the large and growing Latin American market for medical cannabis and has continued to build out its MediPharm Labs Australia customer base.

Gathering Speed with Finished Goods Production
and

LABS Cannabis

Brand
: In Q3, MediPharm Labs finished goods sales to provincial retailers grew 30% despite modest month over month sales growth of adult-use cannabis channels in Canada. To enhance its prospects domestically, the Company continues to shift its focus toward white label contract manufacturing and producing finished goods gaining market share with its growing product line up. In late October, MediPharm Labs was first to market with a consumer sized 99% Pure CBD Isolate Crystal on the launch of LABS Cannabis CBD Isolate, which serves a broad range of wellness consumers and patients. More new products will follow.

Expanding Production Capabilities: The Company remains focused on global medical and wellness markets and to enhance and diversify its channels. As such, the Company continues to expand its production capabilities and contract manufacturing operations. During the quarter, SKUs increased 10% from Q2, and included tincture bottles, topicals, isolate, sublingual sprays and various formulations for edibles and beverages.

Contributing to Clinical Research: Subsequent to quarter end, the Company initiated a clinical trial to research and evaluate the effectiveness of MediPharm Labs’ proprietary cannabis-derived medical products and formulations on the treatment of end-stage renal disease or chronic kidney disease. The Company expects to expand its portfolio of clinical trials in the coming quarters.

REVENUE EXPECTATIONS

Based on agreed customer production schedules, the Company expects revenue from its portfolio of domestic and international sales agreements will grow beginning early in 2021 and will be complemented by new sales of LABS Cannabis products.

GOVERNANCE AND LEADERSHIP CHANGES

Subsequent to quarter end, the Company announced the departures of Robert Kwon, Chief Financial Officer and the Company’s Chief Marketing Officer. A search process has been initiated for a new CFO while the role of Chief Marketing Officer will not be directly filled and but will be covered by the Company’s new VP of Sales.

As part of a broader plan to strengthen the skills and independence of the Company’s Board of Directors, MediPharm Labs welcomed Shelley Martin, the retired President and Chief Executive Officer of Nestlé Canada Inc., Chris Taves, the COO of BMO Capital Markets, and Chris Halyk, the former President of Janssen Inc. (Canada) as Directors this year. The Company’s Board of Directors is now comprised of 7 Directors, 5 of whom are independent.

Q3 2020 FINANCIAL RESULTS CONFERENCE CALL DETAILS

MediPharm Labs executive management team will host a conference call and audio webcast to discuss the results and outlook for its third quarter ended September 30, 2020 on Monday November 16, 2020, at 8:30 a.m. eastern time.

Audio Conference Call Dial
In
Details:

Date:	Monday, November 16, 2020
Time:	8:30 a.m. Eastern Time
Dial In:	Toll-free number: +1-833-502-0471 / International number: +1-236-714-2179
Conference ID:	7656805
Audio Webcast:	WEBCAST or https://ir.medipharmlabs.com/news-events in the Events section
Replay:	+1-800-585-8367/ International +1-416-621-4642 Conference ID: 7656805
	until November 23, 2020 11:59 p.m.

NON-IFRS MEASURES

Adjusted EBITDA is not a recognized performance measure under IFRS, does not have a standardized meaning and therefore may not be comparable to similar measures presented by other issuers. Adjusted EBITDA is included as a supplemental disclosure because Management believes that such measurement provides a better assessment of the Company’s operations on a continuing basis by eliminating certain non-cash charges and charges or gains that are nonrecurring. Adjusted EBITDA is defined as net loss excluding interest, taxes, depreciation and amortization, share-based compensation, non-cash, non-recurring expense and one-time inventory write downs. Adjusted EBITDA has limitations as an analytical tool as it does not include depreciation and amortization expense, interest income and expense, taxes, share-based compensation and transaction fees. Because of these limitations, Adjusted EBITDA should not be considered as the sole measure of the Company’s performance and should not be considered in isolation from, or as a substitute for, analysis of the Company’s results as reported under IFRS. The most directly comparable measure to Adjusted EBITDA calculated in accordance with IFRS is operating income (loss). The above is a reconciliation of the Company’s operating loss to Adjusted EBITDA. See “Reconciliation of non-IFRS measures” in the Company’s Management’s Discussion and Analysis for the period ended September 30, 2020 for additional information.

About MediPharm Labs

Founded in 2015, MediPharm Labs specializes in the production of purified, pharmaceutical-quality cannabis oil and concentrates and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm Labs has completed commercial exports to Australia and has fully commercialized its wholly-owned Australian extraction facility. MediPharm Labs Australia was established in 2017.

For further information, please contact:

Laura Lepore, VP, Investor Relations
Telephone: 705-719-7425 ext 1525
Email: [email protected]     
Website: www.medipharmlabs.com    

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, doing more to drive profitable revenue and reduce costs; exploiting business strengths; putting an action plan in place that will create value and will enable the Company to achieve its potential; improving financial management; accelerating research and development and new product commercialization for B2B and B2C operation; enhancing marketing and sales; exiting the B2B wholesale concentrate market; significant performance improvements in 2021 as revenue under new customer agreements ramps up; revenues ramping up; the launch of new products; and revenue growth beginning in early 2021 and being complemented by new sales of LABS Cannabis products. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

 

• Filed Form S-4 with the SEC
• Regained Nasdaq Compliance

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Hudson Capital Inc. (NASDAQ: HUSN) (Hudson Capital) and FreightHub, Inc. (Fr8Hub), a North American transportation logistics platform company focused on US-Mexico cross-border shipping, have continued to make progress in their plans to merge. On November 12, 2020, Hudson Capital filed with the Securities and Exchange Commission (SEC), a Registration Statement on Form S-4, including a preliminary joint proxy statement relating to the planned merger between Hudson Capital and Fr8Hub.  In addition, on November 12, 2020, Hudson Capital received a notice from NASDAQ Regulation informing Hudson Capital that for the last 10 consecutive business days, from October 29 to November 11, 2020, the closing bid price of Hudson Capital’s ordinary shares had been $1.00 or greater per share and accordingly, Hudson Capital had regained compliance with Listing Rule 5550(a)(2) and the issue with maintaining a minimum bid price of its shares was now closed.

About FreightHub, Inc.

FreightHub, Inc. (Fr8Hub) makes shipping simple, transparent, and efficient. A transportation logistics platform company, Fr8Hub focuses on truckload freight for US-Mexico cross-border, domestic Mexico and domestic US. As an established digital freight marketplace, broker, transportation management system (TMS) and public API, Fr8Hub uses its proprietary technology platform to connect carriers and shippers and significantly improve matching and operation efficiency via innovative technologies such as live pricing and real-time tracking.

About Hudson Capital Inc.

Incorporated in 2014, Hudson Capital Inc. (formerly known as China Internet Nationwide Financial Services Inc. (NASDAQ: HUSN)) commenced its business by providing financial advisory services to small and medium size companies. The traditional business segments include commercial payment advisory, intermediary bank loan advisory and international corporate financing advisory services which help clients to meet their commercial payment and investment needs. For more information, about Hudson Capital, please see the documents filed by Hudson Capital with the SEC at www.sec.gov.

Important Information About the Proposed
Merger Transaction
and Where to Find It

In connection with the proposed merger, Hudson Capital intends to file relevant materials with the Securities and Exchange Commission (the “SEC”), including a Registration Statement on Form S-4 (the “Form S-4”), which includes and serves as a proxy statement/prospectus for Hudson Capital’s shareholders and a prospectus for Fr8Hub’s stockholders. Promptly after the Form S-4 is declared effective by the SEC, Hudson Capital will mail the definitive proxy statement/prospectus and a proxy card to each shareholder entitled to vote at the special meeting on the merger and the other proposals set forth in the proxy statement. SHAREHOLDERS OF HUDSON CAPITAL ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE MERGER THAT HUDSON CAPITAL WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT HUDSON CAPITAL, FREIGHTHUB AND THE MERGER. The definitive proxy statement/prospectus and other relevant materials in connection with the merger (when they become available), and any other documents filed by Hudson Capital with the SEC, may be obtained free of charge at the SEC’s website (www.sec.gov).

Participants in the Solicitation

Hudson Capital and its directors and executive officers may be deemed participants in the solicitation of proxies from Hudson Capital’s shareholders with respect to the merger. A list of the names of those directors and executive officers and a description of their interests in Hudson Capital will be included in the prospectus/proxy statement for the proposed merger and be available at www.sec.gov. Additional information regarding the interests of such participants will be contained in the prospectus/proxy statement for the proposed merger when available. Information about Hudson Capital’s directors and executive officers and their ownership of ordinary shares of Hudson Capital is set forth in Hudson Capital’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on June 15, 2020, These documents can be obtained free of charge from the sources indicated above.

Fr8Hub and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of Hudson Capital in connection with the proposed merger. A list of the names of such directors and executive officers and information regarding their interests in the proposed merger will be included in the prospectus/proxy statement for the proposed merger.

Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Hudson Capital’s and Fr8Hub’s actual results may differ from their expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, Hudson Capital’s and Fr8Hub’s expectations with respect to future performance and anticipated financial impacts of the proposed acquisition, the satisfaction of the closing conditions to the proposed acquisition, and the timing of the completion of the proposed acquisition.

These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Most of these factors are outside Hudson Capital’s and Fr8Hub’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the occurrence of any event, change, or other circumstances that could give rise to the termination of the definitive merger agreement (the “Agreement”); (2) the outcome of any legal proceedings that may be instituted against Hudson Capital or Fr8Hub following the announcement of the Agreement and the transactions contemplated therein; (3) the inability to complete the proposed acquisition, including due to failure to obtain approval of the shareholders of Hudson Capital and stockholders of Fr8Hub, certain regulatory approvals, or satisfy other conditions to closing in the Agreement; (4) the occurrence of any event, change, or other circumstance that could give rise to the termination of the Agreement or could otherwise cause the transaction to fail to close; (5) the impact of COVID-19 pandemic on Fr8Hub’s business and/or the ability of the parties to complete the proposed acquisition; (6) the inability to obtain or maintain the listing of Hudson Capital’s shares of common stock on Nasdaq following the proposed merger; (7) the risk that the proposed acquisition disrupts current plans and operations as a result of the announcement and consummation of the proposed merger; (8) the ability to recognize the anticipated benefits of the proposed merger, which may be affected by, among other things, competition, the ability of Fr8Hub to grow and manage growth profitably, and retain its key employees; (9) costs related to the proposed merger; (10) changes in applicable laws or regulations; (11) the possibility that Hudson Capital or Fr8Hub may be adversely affected by other economic, business, and/or competitive factors; (12) risks relating to the uncertainty of the projected financial information with respect to Fr8Hub; (13) risks related to the organic and inorganic growth of Fr8Hub’s business and the timing of expected business milestones; and (14) other risks and uncertainties indicated from time to time in the prospectus/proxy statement on the Form S-4, relating to the proposed merger, including those under “Risk Factors” therein, to be filed by Hudson Capital and in Hudson Capital’s other filings with the SEC. Hudson Capital cautions that the foregoing list of factors is not exclusive. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. Hudson Capital and Fr8Hub caution readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Hudson Capital and Fr8Hub do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions, or circumstances on which any such statement is based.

No Offer or Solicitation

This press release shall not constitute a solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the proposed merger. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Fr8Hub
Contact
:

Moriah Shilton or Kirsten Chapman, LHA Investor Relations, [email protected], 415.433.3777

Hudson Capital
Contact
:

Hon Man Yun, Chief Financial Officer, [email protected], (852) 98047102

~ The Company Continues to Work with
the FDA and
Its
Third-Party
Drug Product Manufacturer to Fully Address CRL and Prepare NDA Resubmission for PEDMARK™
 ~

~ No Clinical Safety or Efficacy Issues Identified
;
No Additional Studies Required
for PEDMARK™
 ~

~
The Company Has Approximately $33 Million in Cash and No Outstanding Debt ~

RESEARCH TRIANGLE PARK, N.C., Nov. 16, 2020 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (Nasdaq:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the third quarter ended September 30, 2020 and provided a business update.

“We are pleased with the recent constructive and collaborative Type A meeting with the FDA to discuss the path forward for resubmission of the New Drug Application (NDA) for PEDMARK™ for the prevention of life-long hearing loss for children receiving cisplatin chemotherapy,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “Importantly, there were no clinical or safety issues identified in the complete response letter (CRL) and there are no requirements for additional clinical data within the CRL. We are working closely with the FDA and our third-party drug product manufacturer to fully address the CRL and plan to resubmit the NDA for PEDMARK™ with the goal of achieving regulatory approval and making PEDMARK™ commercially available to patients in need as quickly as possible.”

Financial


Results for the


Third


Quarter


2020

• Cash Position
  – Cash and cash equivalents were $33.2 million as of September 30, 2020. The reduction in cash balance is the result of cash used for operating activities including regulatory activities of PEDMARK™ and expenses associated with commercial and operational launch preparation during the quarter. As of September 30, 2020, the Company has no funded debt.
• R
  esearch and
  D
  evelopment (R&D)
  Expenses – R&D expenses were $1.4 million for the third quarter ended September 30, 2020, compared to $0.8 million for the same period in 2019. The increase in R&D in the quarter was due to an increase in R&D expenses after the Complete Response Letter (CRL).
• G
  eneral
  and
  A
  dministrative
  (G&A)
  Expenses
  – G&A expenses for the third quarter ended September 30, 2020, increased by $3.4 million over the same period in 2019, reflecting the Company’s focus on commercialization readiness of PEDMARK™. The increase in G&A during the quarter was primarily due to commercialization readiness activities during the quarter leading up to the PDUFA date of PEDMARK in August 2020.
• Net Loss
  – Net loss for the quarter ended September 30, 2020 was $6.2 million ($0.24 per share), compared to $1.8 million ($0.09 per share) for the same period in 2019.

Financial Update

The selected financial data presented below are derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended September 30, 2020 and management’s discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

Unaudited Condensed Consolidated
Statements of Operations:
(U.S. Dollars in thousands except per share amounts)

	Three Months Ended
	September 30,				September 30 ,
	20 20				201 9
Revenue	$	–			$	–
Operating expenses:
Research and development		1,368				795
General and administrative		4,491				1,068
Loss from operations		(5,859	)			(1,863	)
Other (expense)/income
Amortization expense		(355	)			(17	)
Other loss		(8	)			1
Net interest income		22				70
Total other income, net		(341	)			54
Net (loss)	$	(6,200	)		$	(1,809	)
Basic net (loss) per common share	$	(0.24	)		$	(0.09	)
Diluted net (loss) per common share	$	(0.24	)		$	(0.09	)

Fennec Pharmaceuticals Inc.
Balance Sheets
(U.S. Dollars in thousands)
		Unaudited September 30, 2020			Audited December 31, 2019
Assets
Cash and cash equivalents	$	33,166		$	13,650
Other current assets		904			234
Non-current assets, net		–			262
Total Assets	$	34,070		$	14,146
Liabilities and stockholders’ equity
Current liabilities	$	2,885		$	2,271
Total stockholders’ equity		31,185			11,875
Total liabilities and stockholders’ equity	$	34,070		$	14,146

Working Capital		Fiscal Year Ended
Selected Asset and Liability Data:		September 30, 2020				December 31, 2019
(U.S. Dollars in thousands)
Cash and cash equivalents		$	33,166			$	13,650
Other current assets			904				234
Current liabilities			(2,885	)			(2,271	)
Working capital		$	31,185			$	11,613
Selected Equity:
Common stock & APIC		$	188,844			$	154,663
Accumulated deficit			(158,902	)			(144,031	)
Stockholders’ equity			31,185				11,875

About PEDMARK™ 

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies.  Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and particularly harmful to the survivors of pediatric cancer.

In the U.S. and Europe, it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy.  The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.  SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).  PEDMARK has received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018. 

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK™ for the prevention of platinum-induced ototoxicity in pediatric patients.   Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans.  For more information, please visit www.fennecpharma.com

Forward Looking Statements

Except for historical information described in this press release, all other statements are forward-looking. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL and the Company’s plans to address them.  Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, Fennec’s reliance on third party manufacturing, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. Fennec disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

For further information, please contact:

Investors:

Rosty Raykov
Chief Executive Officer
Fennec Pharmaceuticals Inc.
(919) 636-5144

Media:

Elixir Health Public Relations
Lindsay Rocco
(862) 596-1304
[email protected]