Monthly Archives: May 2020

Intellipharmaceutics Announces First Quarter 2020 Results

TORONTO, ON / ACCESSWIRE / May 29, 2020 / Intellipharmaceutics International Inc. (OTCQB:IPCIF)(TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the three months ended February 29, 2020. All dollar amounts referenced herein are in United States dollars unless otherwise noted.

On April 9, 2020, we announced an update on timing of the release of our first quarter financial results for the three months ended February 29, 2020. The Canadian Securities Administrators had announced temporary relief from certain regulatory filings required to be made on or before June 1, 2020 by reporting issuers in Canada, in view of the recent COVID-19 developments and the impact on market participants.The blanket relief provided a 45-day extension for periodic filings, including financial statements and management's discussion and analysis. We are relying on this 45-day extension period provided under the blanket relief for the filing of our interim financial statements for the three months ended February 29, 2020 and this related MD&A.

On February 5, 2020, we announced the resignation of Greg Powell, our Chief Financial Officer, for personal and family reasons Pending the hiring of a replacement for Mr. Powell, the functions of Chief Financial Officer for us are being carried out by our President and former Chief Financial Officer, Dr. Amina Odidi. Fazayill Shaideen, who has been our Controller for the past 8 years, will continue to handle accounting activities.

On January 15, 2020, at a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee ("Advisory Committees") of the FDA to discuss our New Drug Application ("NDA") for Aximris XR™, abuse-deterrent oxycodone hydrochloride extended-release tablets, the Advisory Committees voted 24 to 2 against the approval of our NDA for Aximris XR™ for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. We expect the FDA to take action on our application, on completion of their review of the NDA.

Results of Operations

The Company recorded net loss for the three months ended February 29, 2020 of $1,747,373 or $0.08 per common share, compared with a net loss of $3,224,449 or $0.16 per common share for the three months ended February 28, 2019. In the three months ended February 29, 2020, the net loss is attributed to the increase in licensing revenues from commercial sales of generic Focalin XR®, offset by a decrease in up-front fees recognized in revenue, combined with decreased administrative expenses related to professional and legal fees and R&D expenses related to the decrease in third party consulting fees, decrease in expenses related to biostudies and the reduction in R&D staff. In the three months ended February 28, 2019, the net loss was attributed to the lower licensing revenues from commercial sales of generic Focalin XR® and to a lesser extent, sales of generic Seroquel XR® shipped to Mallinckrodt, combined with increased administrative expense related to professional and legal fees.

The Company recorded revenues of $377,554 for the three months ended February 29, 2020 versus $343,536 for the three months ended February 28, 2019. Such revenues consisted primarily of licensing revenues from commercial sales of the 15, 25, 30 and 35 mg strengths of our generic Focalin XR® under the Par agreement. The increase in revenues in the three months ended February 29, 2020 compared to the three months ended February 28, 2019 is primarily due to higher profit share payments from sales of generic Focalin XR® capsules in the U.S. Beginning in early 2018, we began to see a significant impact from aggressive pricing by competitors, resulting in a marked increase in gross-to-net deductions such as wholesaler rebates, chargebacks and pricing adjustments. While the gross-to-net deductions fluctuate on a quarter over quarter basis, profit share payments for the first quarter of 2020 have improved in comparison to the same period in 2019, offset partially by a decrease in up-front fees recognized after the termination of the Mallinckrodt agreement in August 2019.

Expenditures for R&D for the three months ended February 29, 2020 were lower by $1,184,416 compared to the three months ended February 28, 2019. The decrease is primarily due to significantly reduced third party consulting fees, decrease in expenses related to biostudies and the reduction in R&D staff.

Selling, general and administrative expenses were $523,231 for the three months ended February 29, 2020 in comparison to $1,207,243 for the three months ended February 28, 2019, resulting in a decrease of $684,012. The decrease is namely due to a decrease in administrative costs and a decrease in wages and marketing costs.

The Company had cash of $6,052 as at February 29, 2020 compared to $2,821,669 as at February 28, 2019. The decrease in cash was mainly due to expenditures for R&D and selling, general, and administrative expenses which are partially offset by cash receipt from Par.

As of February 29, 2020, our cash balance was $6,052. We currently expect to meet our short-term cash requirements from quarterly profit share payments from Par and by cost savings associated with managing operating expense levels. If we are able to supply products to our marketing and distribution partner, Tris Pharma, and it achieves sales of our generic Seroquel XR®, generic Pristiq and generic Effexor XR at anticipated rates, then we may satisfy our cash needs with reduced staff and cost-saving measures. We will need to obtain additional funding to further product commercialization activities and the development of our product candidates. Potential sources of capital may include payments from licensing agreements, and/or debt financings and/or new strategic partnership agreements which the Company is actively exploring. The Company has funded its business activities principally through the issuance of securities, loans from related parties and funds from development agreements. There is no certainty that such funding will be available going forward. If conditions permit, we intend to utilize the equity markets and/or debt financing to bridge any funding shortfall. Our future operations are highly dependent upon our ability to source additional capital to support advancing our product pipeline through continued R&D activities and to fund any significant expansion of our operations. Our ultimate success will depend on whether our product candidates receive approval by the FDA or Health Canada or the regulatory authorities of other countries in which our products are proposed to be sold and on and whether we are able to successfully market our approved products. We cannot be certain that we will receive FDA or Health Canada or such other regulatory approval for any of our current or future product candidates, that we will reach the level of sales and revenues necessary to achieve and sustain profitability, or that we can secure other capital sources on terms or in amounts sufficient to meet our needs or at all.

There can be no assurance that we will not be required to conduct further studies for our Aximris XR product candidate, that the FDA will approve any of our requested abuse-deterrence label claims, that the FDA will meet its deadline for review or that the FDA will ultimately approve the NDA for the sale of product candidate in the U.S. market or that the product will ever be successfully commercialized and produce significant revenue for us.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company's Oxycodone ER based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).

Cautionary Statement Regarding Forward-Looking Information

Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our expectations , plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, and statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs and market penetration and risks or uncertainties arising from the delisting of our shares from Nasdaq and our ability to comply with OTCQB and TSX requirements. In some cases, you can identify forward-looking statements by terminology such as "appear", "unlikely", "target", "may", "will", "should", "expects", "plans", "plans to", "anticipates", "believes", "estimates", "predicts", "confident", "prospects", "potential", "continue", "intends", "look forward", "could", "would", "projected", "goals" ,"set to", "seeking" or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, , the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, capital availability, the estimated proceeds (and the expected use of any proceeds) we may receive from any offering of our securities, the potential dilutive effects of any future financing, potential liability from and costs of defending pending or future litigation, risks associated with the novel coronavirus (COVID-19) including its impact on our business and operations, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates and the difficulty in predicting the timing and results of any product launches, the timing and amount of profit-share payments from our commercial partners, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property rights for our drug delivery technologies, products and product candidates, recent and future legal developments in the United States and elsewhere that could make it more difficult and costly for us to obtain regulatory approvals for our product candidates and negatively affect the prices we may charge, increased public awareness and government scrutiny of the problems associated with the potential for abuse of opioid based medications, pursuing growth through international operations could strain our resources, our limited manufacturing, sales, marketing and distribution capability and our reliance on third parties for such, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and/or commercial partners with the ability to fund patent litigation and with acceptable product development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and commercial partners, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, delays in product approvals that may be caused by changing regulatory requirements, the difficulty in predicting the timing of regulatory approval and launch of competitive products, the difficulty in predicting the impact of competitive products on sales volume, pricing, rebates and other allowances, the number of competitive product entries, and the nature and extent of any aggressive pricing and rebate activities that may follow, the inability to forecast wholesaler demand and/or wholesaler buying patterns, seasonal fluctuations in the number of prescriptions written for our generic Focalin XR® capsules which may produce substantial fluctuations in revenue, the timing and amount of insurance reimbursement regarding our products, changes in laws and regulations affecting the conditions required by the FDA for approval, testing and labeling of drugs including abuse or overdose deterrent properties, and changes affecting how opioids are regulated and prescribed by physicians, changes in laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the effect of recent changes in U.S. federal income tax laws, including but not limited to, limitations on the deductibility of business interest, limitations on the use of net operating losses and application of the base erosion minimum tax, on our U.S. corporate income tax burden, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third-party sourced products and materials, challenges related to the development, commercialization, technology transfer, scale-up, and/or process validation of manufacturing processes for our products or product candidates, the manufacturing capacity of third-party manufacturers that we may use for our products, potential product liability risks, the recoverability of the cost of any pre-launch inventory, should a planned product launch encounter a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential issues, the successful compliance with FDA, Health Canada and other governmental regulations applicable to us and our third party manufacturers' facilities, products and/or businesses, our reliance on commercial partners, and any future commercial partners, to market and commercialize our products and, if approved, our product candidates, difficulties, delays or changes in the FDA approval process or test criteria for ANDAs and NDAs, challenges in securing final FDA approval for our product candidates, including our oxycodone hydrochloride extended release tablets product candidate, in particular, if a patent infringement suit is filed against us with respect to any particular product candidates (such as in the case of Oxycodone ER), which could delay the FDA's final approval of such product candidates, healthcare reform measures that could hinder or prevent the commercial success of our products and product candidates, the risk that the FDA may not approve requested product labeling for our product candidate(s) having abuse-deterrent properties and targeting common forms of abuse (oral, intra-nasal and intravenous), risks associated with cyber-security and the potential for vulnerability of our digital information or the digital information of a current and/or future drug development or commercialization partner of ours, and risks arising from the ability and willingness of our third-party commercialization partners to provide documentation that may be required to support information on revenues earned by us from those commercialization partners. Additional risks and uncertainties relating to us and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-1 and F-3 registration statements (including any documents forming a part thereof or incorporated by reference therein), as amended, as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Trademarks used herein are the property of their respective holders.

Unless the context otherwise requires, all references (i) to "we," "us," "our," "Intellipharmaceutics," and the "Company" refer to Intellipharmaceutics International Inc. and its subsidiaries and (ii) in this document to share amounts, per share data, share prices, exercise prices and conversion rates have been adjusted to reflect the effect of the 1-for-10 reverse split which became effective on each of Nasdaq and TSX at the open of market on September 14, 2018. The common shares of the Company are currently traded on the OTCQB and the TSX.

Nothing contained in this document should be construed to imply that the results discussed herein will necessarily continue into the future or that any conclusion reached herein will necessarily be indicative of our actual operating results.

The condensed unaudited interim consolidated financial statements, accompanying notes to the condensed unaudited interim consolidated financial statements, and Management Discussion and Analysis for the three months ended February 28, 2019 will be accessible on Intellipharmaceutics' website at www.intellipharmaceutics.com and will be available on SEDAR and EDGAR.

Summary financial tables are provided below.

Intellipharmaceutics International Inc.
Condensed unaudited interim consolidated balance sheets
As at

(Stated in U.S. dollars)

 
 
 
 
 
 

 

 
February 29,
 
 
November 30,
 

 

 
2020
 
 
2019
 

 

 
$
 
 
$
 

 

 
 
 
 
 
 

Assets

 
 
 
 
 
 

Current

 
 
 
 
 
 

Cash

 
 
6,052
 
 
 
64,622
 

Accounts receivable, net

 
 
264,237
 
 
 
177,202
 

Investment tax credits

 
 
775,736
 
 
 
775,736
 

Prepaid expenses, sundry and other assets

 
 
172,312
 
 
 
156,616
 

Inventory

 
 
246,756
 
 
 
349,131
 

 

 
 
1,465,093
 
 
 
1,523,307
 

 

 
 
 
 
 
 
 
 

Property and equipment, net

 
 
2,138,438
 
 
 
2,273,406
 

 

 
 
3,603,531
 
 
 
3,796,713
 

 

 
 
 
 
 
 
 
 

Liabilities

 
 
 
 
 
 
 
 

Current

 
 
 
 
 
 
 
 

Accounts payable

 
 
3,977,117
 
 
 
3,757,018
 

Accrued liabilities

 
 
1,136,971
 
 
 
927,698
 

Employee costs payable

 
 
1,450,497
 
 
 
893,864
 

Income tax payable

 
 
5,678
 
 
 
5,678
 

Promissory notes payable

 
 
159,863
 
 
 
159,863
 

Convertible debentures

 
 
1,707,131
 
 
 
1,744,813
 

 

 
 
8,437,257
 
 
 
7,488,934
 

 

 
 
 
 
 
 
 
 

 

 
 
 
 
 
 
 
 

Shareholders' equity (deficiency)

 
 
 
 
 
 
 
 

Capital stock

 
 
 
 
 
 
 
 

Authorized

 
 
 
 
 
 
 
 

Unlimited common shares without par value

 
 
 
 
 
 
 
 

Unlimited preference shares

 
 
 
 
 
 
 
 

Issued and outstanding

 
 
 
 
 
 
 
 

23,678,105 common shares

 
 
46,144,402
 
 
 
45,561,222
 

(November 30, 2019 – 22,085,856)

 
 
 
 
 
 
 
 

Additional paid-in capital

 
 
44,190,409
 
 
 
44,167,721
 

Accumulated other comprehensive income

 
 
284,421
 
 
 
284,421
 

Accumulated deficit

 
 
(95,452,958
)
 
 
(93,705,585
)

 

 
 
(4,833,726
)
 
 
(3,692,221
)

Contingencies

 
 
 
 
 
 
 
 

 

 
 
3,603,531
 
 
 
3,796,713
 

 
 
 
 
 
 
 
 
 

Intellipharmaceutics International Inc.
Condensed unaudited interim consolidated statements of operations
and comprehensive loss
For the three months ended February 29, 2020 and February 28, 2019
(Stated in U.S. dollars)

 
 
 
 
 
 
 

 

 
2020
 
 
2019
 

 

 
$
 
 
$
 

Revenues

 
 
 
 
 
 

Licensing

 
 
377,554
 
 
 
264,551
 

Up-front fees

 
 

 
 
 
78,985
 

 

 
 
377,554
 
 
 
343,536
 

 

 
 
 
 
 
 
 
 

Cost of goods sold

 
 

 
 
 
33,068
 

Gross Margin

 
 
377,554
 
 
 
310,468
 

 

 
 
 
 
 
 
 
 

Expenses

 
 
 
 
 
 
 
 

Research and development

 
 
947,845
 
 
 
2,132,261
 

Selling, general and administrative

 
 
523,231
 
 
 
1,207,243
 

Depreciation

 
 
102,699
 
 
 
125,284
 

 

 
 
1,573,775
 
 
 
3,464,788
 

 

 
 
 
 
 
 
 
 

Loss from operations

 
 
(1,196,221
)
 
 
(3,154,320
)

 

 
 
 
 
 
 
 
 

Net foreign exchange gain (loss)

 
 
22,788
 
 
 
(11,332
)

Interest income

 
 

 
 
 
11
 

Interest expense

 
 
(573,940
)
 
 
(58,808
)

Net loss and comprehensive loss

 
 
(1,747,373
)
 
 
(3,224,449
)

 

 
 
 
 
 
 
 
 

Loss per common share, basic and diluted

 
 
(0.08
)
 
 
(0.16
)

 

 
 
 
 
 
 
 
 

Weighted average number of common

 
 
 
 
 
 
 
 

shares outstanding, basic and diluted

 
 
23,210,927
 
 
 
20,058,207
 

 
 
 
 
 
 
 
 
 

Intellipharmaceutics International Inc.
Condensed unaudited interim consolidated statements of cash flows
For the three months ended February 29, 2020 and February 28, 2019
(Stated in U.S. dollars)

 
 
 
 
 
 
 

 

 
2020
 
 
2019
 

 

 
$
 
 
$
 

 

 
 
 
 
 
 

Net loss

 
 
(1,747,373
)
 
 
(3,224,449
)

Items not affecting cash

 
 
 
 
 
 
 
 

Depreciation

 
 
102,699
 
 
 
126,165
 

Stock-based compensation

 
 
53,749
 
 
 
2,274
 

Accreted interest

 
 
514,437
 
 
 
7,937
 

 

 
 
 
 
 
 
 
 

Change in non-cash operating assets & liabilities

 
 
 
 
 
 
 
 

Accounts receivable

 
 
(87,035
)
 
 
24,084
 

Investment tax credits

 
 

 
 
 
(45,000
)

Prepaid expenses, sundry and other assets

 
 
(15,696
)
 
 
(31,683
)

Inventory

 
 
102,375
 
 
 
31,723
 

Accounts payable, accrued liabilities and employee costs payable

 
 
1,018,274
 
 
 
(358,923
)

Deferred revenue

 
 

 
 
 
(75,000
)

Cash flows used in operating activities

 
 
(58,570
)
 
 
(3,542,872
)

 

 
 
 
 
 
 
 
 

Financing activities

 
 
 
 
 
 
 
 

Repayment of 2013 Debenture

 
 

 
 
 
(300,000
)

Proceeds from issuance of shares on exercise of 2018 Pre-Funded Warrants

 
 

 
 
 
26,454
 

Cash flows used in financing activities

 
 

 
 
 
(273,546
)

 

 
 
 
 
 
 
 
 

Investing activity

 
 
 
 
 
 
 
 

Purchase of property and equipment

 
 

 
 
 
(3,790
)

Cash flows used in investing activities

 
 

 
 
 
(3,790
)

 

 
 
 
 
 
 
 
 

Decrease in cash

 
 
(58,570
)
 
 
(3,820,208
)

Cash, beginning of period

 
 
64,622
 
 
 
6,641,877
 

Cash, end of period

 
 
(6,052
)
 
 
2,821,669
 

 

 
 
 
 
 
 
 
 

Supplemental cash flow information

 
 
 
 
 
 
 
 

Interest paid

 
 

 
 
 
63,836
 

Taxes paid

 
 

 
 
 

 

 
 
 
 
 
 
 
 
 

CONTACT INFORMATION

Company Contact:
Intellipharmaceutics International Inc.
Isa Odidi
Chief executive Officer
416.798.3001 ext. 102
investors@intellipharmaceutics.com

SOURCE: Intellipharmaceutics International Inc.

ReleaseID: 591961

Trilogy International Partners Inc. Announces Results of Annual General Shareholders’ Meeting

BELLEVUE, WA / ACCESSWIRE / May 29, 2020 / Trilogy International Partners Inc. (TSX:TRL) (the "Corporation" or "TIP Inc.") an international wireless and fixed broadband telecommunications operator, is pleased to announce the results from its Annual General Meeting of Shareholders (the "Meeting") held on May 29, 2020.

By resolution passed by ballot vote, all of the seven nominees proposed by management for election to the Board of Directors at the Meeting and listed in the Corporation's Management Information Circular dated April 14, 2020, were elected. The Directors will remain in office until the next annual meeting of shareholders, or until their successors are elected or appointed.

The results of the vote on the election of the Board of Directors are as follows:

Board of Directors

Votes in Favour

Votes Withheld

 

Number of Votes

Percentage (%)

Number of Votes

Percentage (%)

John W. Stanton

46,610,830

99.31%

324,582

0.69%

Bradley J. Horwitz

44,643,344

95.12%

2,292,068

4.88%

Theresa E. Gillespie

46,597,787

99.28%

337,625

0.72%

Mark Kroloff

44,953,826

95.78%

1,981,586

4.22%

Alan D. Horn

46,808,462

99.73%

126,950

0.27%

Nadir Mohamed

46,835,672

99.79%

99,740

0.21%

Reza Satchu

46,525,190

99.13%

410,222

0.87%

The other item of business at the Meeting was to appoint Grant Thornton LLP, Chartered Accountants, as auditors of the Company for the ensuing year and to authorize the directors to fix the remuneration of the auditors.

By resolution passed by ballot vote, Grant Thornton LLP, Chartered Accountants, were appointed as auditors of the Company for the ensuing year. Votes by securityholders and proxyholders received with respect to the reappointment of Grant Thornton LLP, Chartered Accountants, were voted as follows:

Votes For

Votes Withheld

Number of Votes

Percentage (%)

Number of Votes

Percentage (%)

48,530,994

99.80%

98,976

0.20%

About Trilogy International Partners Inc.

Trilogy International Partners Inc. is the parent company of Trilogy International Partners LLC ("Trilogy LLC"), a wireless and fixed broadband telecommunications operator formed by wireless industry veterans John Stanton, Theresa Gillespie and Brad Horwitz. Trilogy LLC's founders have an exceptional track record of successfully buying, building, launching and operating communications businesses in 15 international markets and the United States.

Trilogy LLC currently provides wireless communications services through its operating subsidiaries in New Zealand and Bolivia. Its head office is located at 155 108th Avenue NE, Suite 400, Bellevue, Washington, 98004.

For more information, visit www.trilogy-international.com.

Contact:

Ann Saxton
425-458-5900
Ann.Saxton@trilogy-international.com
Vice President, Investor Relations & Corporate Development

SOURCE: Trilogy International Partners Inc.

ReleaseID: 591987

Theralase Release 1Q2020 Financial Statements

TORONTO, ON / ACCESSWIRE / May 29, 2020 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated PhotoDynamic Compounds ("PDC") and their associated drug formulations intended to safely and effectively destroy various cancers released its audited annual consolidated 1Q2020 financial statements.

Financial Highlights:

Total revenue for the three-month period ended March 31, 2020, decreased to $111,542 from $121,179 for the same period in 2019, an 8% decrease.

In Canada, revenue remained relatively constant at $70,506 from $70,617 in 2019. In the US, revenue decreased 100% to $Nil from $5,075 and international revenue remained constant at $Nil for 2020 and 2019, during the three-month period ended March 31, 2019. The decrease in total revenue in 2020 is due to the COVID-19 pandemic as most health care practitioners elected to put their practices on quarantine and any purchasing decisions on hold in March 2020.

Cost of sales for the three-month period ended March 31, 2020, was $99,447 (89% of sales) resulting in a gross margin of $12,096 or 11% of revenue, compared to a cost of sales of $84,251 (70% of revenue) in 2019, resulting in a gross margin of $36,928 or 70% of revenue. Cost of sales is represented by the following costs: raw materials, subcontracting, direct and indirect labour and the applicable share of manufacturing overhead. The gross margin as a percentage of sales decrease, year over year, is attributed to decreased sales and fixed production salaries for the TLC-1000 and TLC-2000 product lines.

For the three-month period ended March 31, 2020, selling expenses decreased to $136,894, from $178,807 in 2019, a 23% decrease.The decrease in selling and marketing expenses is primarily due to the restructuring of the Canadian and US sales and marketing departments, resulting in the termination of certain sales and marketing personnel.

Administrative expenses for the three-month period ended March 31, 2020, increased slightly to $533,329 from $531,557 in 2019, representing a 0.3% increase. The increase in administrative expenses is primarily attributed to increased spending on director and advisory fees (38%) and stock based compensation (331%).

Net research and development expenses for the three-month period ended March 31, 2020, increased to $1,047,282 from $447,751 in 2019, a 134% increase.

Research and development expenses for the three-month period ended March 31, 2020, increased primarily due to increased expenses for commencing the Phase II NMIBC Clinical Study ("Study II"). Research and development expenses represented 63% of the Company's operating expenses for the three-month period ended March 31, 2020, and represent an investment into the research and development of the Company's PDT technology.

The net loss for the three-month period ended March 31, 2020, was $1,643,856 which included $327,921 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss for the same period in 2019 of $1,125,471, which included $327,921 of net non-cash expenses.

The PDT division represented $1,099,045 of this loss (67%) for the three-month period ended March 31, 2020.

The increase in net loss is primarily attributed to the following:

Increased investment in research, development and clinical expense of Study II.
Decreased sales of TLC-1000 and TLC-2000 due to market uncertainty directly attributable to the COVID-19 pandemic.

Operational Highlights:

FDA IND Authorization. On May 19, 2020, the Company received FDA Investigational New Drug ("IND") authorization to commence enrolling and treating patients in Study II in the United States, a key milestone and achievement for the Company.
FDA Fast Track. In June 2019, a conference call between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval ("FTA") post receipt of the FDA IND authorization, based on the clinical study data collected to date. As stated by the FDA, fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Breakthrough Therapy Designation. Continuing the FDA conference call, it was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation ("BTD") and / or Accelerated Approval ("AA"), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated. To date, 12 patients have been enrolled and treated in Study II, representing approximately 50% of the interim milestone to submit an analysis to the FDA in support of a BTD.
Covid-19 Update. Due to the current COVID-19 pandemic, the Canadian clinical study sites are currently on clinical hold for patient enrolment and treatment until the federal government, respective provincial governments and executive committees of the respective hospitals deem the clinical study sites able to re-commence Study II. Theralase is in constant communication with all clinical sites for any update on re-starting the enrollment and treatment activities of Study II.
Clinical study site status. Theralase has successfully launched 4 Canadian study sites (with 1 additional clinical study site in advanced negotiation) and with FDA IND approval, the Company can now move forward with onboarding 15 clinical study sites in the US. In 2019, Theralase signed an agreement with a Trial Management Organization ("TMO") to provide 4 to 6 US based urology study sites for Study II which will considerably advance the US onboarding process.

Theralase has successfully treated a total of 12 patients (8 patients at University Health Network ("UHN"), Toronto, Canada and 4 patients at McGill University Health Centre ("MUHC") in Montreal, Canada).

All Canadian study sites are currently on hold however, UHN is slowly transitioning to patient treatment and follow-up and will proceed with second treatment of one patient on May 29, 2020.

Additional cancer indications. Extensive preclinical research has been conducted with Rutherrin®, a patented formulation of the Company's lead PDC (TLD-1433) combined with transferrin. The Company has demonstrated significant anti-cancer efficacy of Rutherrin®, across numerous preclinical models; including: GlioBlastoma Multiforme ("GBM") and Non-Small Cell Lung Cancer ("NSCLC"). When Study II is well underway with the majority of the approximately 20 study sites open and recruiting patients, the Company expects to expand the breadth of oncological indications as Theralase has now developed significant expertise and intellectual property of its patented PDCs, in the area of photopharmacology and anti-cancer therapy, with data acquired from preclinical models of human disease.

About Phase II Study

Study II will utilize the Therapeutic Dose (0.70 mg/cm2) of TLD-1433 and will focus on the treatment of approximately 100 to 125 BCG-Unresponsive NMIBC patients presenting with Carcinoma In-Situ ("CIS") in approximately 20 clinical study sites located in Canada and the US, with a primary endpoint of efficacy (measured by Complete Response ("CR")) and a secondary endpoint of duration of CR at approximately 360 days post-initial CR and a tertiary endpoint of safety measured by incidence and severity of adverse events.

The primary and secondary endpoints will be evaluated by:

CR in patients with CIS with or without resected papillary disease at 90 days post-treatment with a duration of CR evaluated at 360 days post-treatment.

Patient CR is defined as at least one of the following:

1) Negative cystoscopy and negative (including atypical) urine cytology
2) Positive cystoscopy with biopsy-proven benign or low-grade NMIBC
3) Negative cystoscopy with malignant urine cytology, if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative

The tertiary endpoint will be evaluated by:

Incidence and severity of Adverse Events ("AEs") Grade 4 or higher that do not resolve within 360 days post-treatment; whereby:

Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening or disabling, Grade 5 = Death

About Theralase® Technologies Inc.

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers.

Additional information is available at www.theralase.com and www.sedar.com

This news release contains "forward-looking statements" which reflect the current expectations of management of the Company's future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as "may", "would", "could", "should", "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions have been used to identify these forward-looking statements. These statements reflect management's current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Many factors could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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

For More Information:

1.866.THE.LASE (843-5273) x 304
416.699.LASE (5273) x 304
Kristina Hachey, Chief Financial Officer
khachey@theralase.com
www.theralase.com

SOURCE: Theralase® Technologies Inc.

ReleaseID: 592019

IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Phoenix Tree Holdings Limited and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / May 29, 2020 / The Schall Law Firm, a national shareholder rights litigation firm, announces the filing of a class-action lawsuit against Phoenix Tree Holdings Limited ("Phoenix Tree" or "the Company") (NYSE:DNK) for violations of the federal securities laws.

Investors who purchased the Company's American Depositary Shares ("ADSs") pursuant and/or traceable to prospectuses and registration statements issued in connection with the Company's January 22, 2020 initial public offering ("IPO"), are encouraged to contact the firm before June 26, 2020.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 1880 Century Park East, Suite 404, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at brian@schallfirm.com.

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. Phoenix Tree misrepresented the number and nature of renter complaints before its IPO. The Company also misrepresented its exposure to adverse effects on the rental market in China due to the Wuhan coronavirus. Following its IPO, reports exposed that Phoenix Tree experienced significant financial problems based on the coronavirus outbreak. Based on these facts, the Company's public statements and Registration Statements were false and materially misleading. When the market learned the truth about Phoenix Tree, investors suffered damages.

Join the case to recover your losses.

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
Cell: 424-303-1964
info@schallfirm.com

SOURCE: The Schall Law Firm

ReleaseID: 592026

Dr. Amir Bajoghli’s Article on Shiitake Mushroom Dermatitis Featured in Premier Immunology Publication

MCLEAN, VA / ACCESSWIRE / May 29, 2020 / The shiitake is an edible mushroom native to East Asia. The popularity of these mushrooms has increased over the years in the United States and with it has been a rise in allergic skin reactions to this relatively new ingredient on the American culinary landscape.

Shiitake flagellate dermatitis, also known as toxicoderma, is an allergic reaction related to the ingestion of raw or undercooked shiitake mushrooms. Signs of this dermatologic condition include skin eruptions resembling scratch or whiplash marks. This skin reaction occurs in approximately 2-3% of people who eat undercooked or raw shiitake mushrooms.

Various theories exist as to how and why this type reaction occurs with some people who eat the undercooked forms of the edible fungus.

When Dr. Amir Bajoghli of Skin & Laser Dermatology Center recently treated such a case in his practice, he realized it was of importance to share his medical findings regarding the patient with the scientific community. He wrote up the details of this Shiitake mushroom dermatitis. These findings were published in the Annals of Allergy, Asthma & Immunology, the premier publication for allergic and immunologic diseases.

Dr. Bajoghli is honored to publish the case with his father, Dr. Mehdi Bajoghli, a practicing allergist in Northern Virginia.

Dr. Amir Bajoghli has been active in the practice of dermatology and laser surgery since the completion of his training at the combined Tufts University and Boston University. He regularly presents lectures to other physicians regionally and internationally, and teaches medical students and dermatology residents at Georgetown University.

Dr. Amir Bajoghli can be reached at either of his Virginia offices:

McLean:
1359 Beverly Rd., 2nd Floor
McLean, VA 22101
(703) 893-1114

Woodbridge:
2200 Opitz Blvd., Suite 100
Woodbridge, VA 22191
(703) 492-4140

SOURCE: Skin and Laser Dermatology Center

ReleaseID: 591993

Leaf Provides Update Regarding RTO Financial Statements for The Period Ending March 31, 2020 (“Q1”) and Caprice Business Development Canada Inc. Pre-RTO Q1 Financial Statements

VANCOUVER, BC / ACCESSWIRE / May 29, 2020 / Leaf Mobile Inc. (TSX Venture:LEAF) ("Leaf" or the "Company") announces that due to the COVID-19 pandemic, the Company intends to postpone the filing of the unaudited interim financial statements with respect to predecessor entities 1182533 B.C. Ltd. and subsidiary LDRLY (Technologies) Inc. ("LDRLY") for their respective interim periods ended March 31, 2020 (collectively the "RTO Q1 Filings"), which were originally required to be filed on June 1, 2020 under Sections 4.10(2) of National Instrument 51-102 – Continuous Disclosure Obligations.

The Company relies on the extension for filings in accordance with BC Instrument 51-515 – Temporary Exemption from Certain Corporate Finance Requirements and analogous exemptions provided in Alberta and Ontario (collectively, the "Extension").

This announcement is further to the Company's announcement on May 1, 2020 regarding the Company's intention, due to the COVID-19 pandemic, to postpone the filing of 1182533 B.C. Ltd. and LDRLY's audited annual financial statements for the year ended December 31, 2019 (the "RTO 2019 Filings") The Company continues to rely on such exemptions for the filing of the RTO 2019 Filings.

The Company is continuing to work diligently and expeditiously to file the RTO Filings and currently expects them to be filed on or prior to the extended filing deadline of June 21, 2020. Until such time as the RTO Filings are filed, management and other insiders of the Company are subject to a trading black-out that reflects the principles in section 9 of National Policy 11-207.

Since the Company's news release on May 1, 2020 with respect to the RTO 2019 Filings, the following material business developments have occurred:

the granting of stock options to directors, management and consultants (see the Company's news releases dated April 20, 2020 and May 19, 2020);
the launch of the "Cheech & Chong Bud Farm" mobile game (see the Company's news release dated May 21, 2020); and
the Company's disclosure of April 2020 monthly results, and retainer of services from New Era Publishing Inc., OGIB Corporate Bulletin Ltd., KIN Communications Inc. and Mobcast Ltd. UK (see the Company's news release dated May 26, 2020).

Other than the foregoing, the Company confirms there have been no undisclosed material business developments since April 1, 2020, the date of filing the Company's audited annual financial statements for the year ended December 31, 2019.

The Company also advises that it will be filing unaudited interim financial statements for the period ending March 31, 2020 for Caprice Business Development Canada Inc. (as the Company was then known) on or before June 1, 2020. The statements relate to the period ending prior to the completion of the Company's qualifying transaction, which involved the amalgamation of Caprice Business Development Canada Inc. and 1182533 B.C. Ltd. (see the Company's news release dated April 17, 2020).

ON BEHALF OF THE BOARD

Darcy Taylor
CEO
Telephone (604) 633-1418

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.

SOURCE: LEAF Mobile Inc.

ReleaseID: 592007

NHI to Participate in the NAREIT REITWeek 2020 Conference

MURFREESBORO, TN / ACCESSWIRE / May 29, 2020 / National Health Investors (NYSE:NHI) announced that members of senior management will participate in the NAREIT REITWeek 2020 Investor Conference on Tuesday, June 2 and Wednesday, June 3.

About NHI

Incorporated in 1991, National Health Investors, Inc. (NYSE: NHI) is a real estate investment trust specializing in sale-leaseback, joint-venture, mortgage and mezzanine financing of need-driven and discretionary senior housing and medical investments. NHI's portfolio consists of independent, assisted and memory care communities, entrance-fee retirement communities, skilled nursing facilities, medical office buildings and specialty hospitals. For more information, visit www.nhireit.com.

Contact:

Dana Hambly
Director, Investor Relations
Phone: (615) 890-9100

SOURCE: National Health Investors

ReleaseID: 591994

INVESTOR ALERT: Monteverde & Associates PC Reminds Investors of an Ongoing Inquiry Regarding the Merger

NEW YORK, NY / ACCESSWIRE / May 29, 2020 / Juan Monteverde, founder and managing partner at Monteverde & Associates PC, a national securities firm headquartered at the Empire State Building in New York City, is investigating:

Willis Towers Watson Public Limited Company (WLTW) relating to its combination with Aon plc. Under the terms of the agreement, Willis Towers stockholders will be entitled to receive 1.08 newly issued Class A ordinary Aon share for each share of Willis Towers common stock owned. Click here for more information: https://www.monteverdelaw.com/case/willis-towers-watson-plc. It is free, and there is no cost or obligation to you.

Mobile Mini, Inc. (MINI) relating to its combination with WillScot Corporation. Under the terms of the agreement, Mobile Mini stockholders will receive 2.4050 shares of WillScot common stock for each share of Mobile Mini common stock owned. Click here for more information: https://www.monteverdelaw.com/case/mobile-mini-inc. It is free, and there is no cost or obligation to you.

Taubman Centers, Inc. (TCO), relating to its sale to Simon Property Group, Inc. Under the terms of the sale, each share of Taubman common stock will be converted into the right to receive $52.50 in cash for each share of Taubman common stock owned. Click here for more information: https://www.monteverdelaw.com/case/taubman-centers-inc. It is free, and there is no cost obligation to you.

About Monteverde & Associates PC

We are a national class action securities litigation law firm that has recovered millions of dollars and is committed to protecting shareholders from corporate wrongdoing. Our lawyers have significant experience litigating Mergers & Acquisitions and Securities Class Actions. Mr. Monteverde is recognized by Super Lawyers as a Rising Star in Securities Litigation in 2013, 2017-2019, an award given to less than 2.5% of attorneys in a particular field. He has also been selected by Martindale-Hubbell as a 2017-2019 Top Rated Lawyer. Our firm's recent successes include changing the law in a significant victory that lowered the standard of liability under Section 14(e) of the Exchange Act in the Ninth Circuit. Thereafter, our firm successfully preserved this victory by obtaining dismissal of a writ of certiorari as improvidently granted at the United States Supreme Court. Emulex Corp. v. Varjabedian, 139 S. Ct. 1407 (2019). Also, in 2019 we recovered or secured six cash common funds for shareholders in mergers & acquisitions class action cases.

If you own common stock in any of the above-listed companies and wish to obtain additional information and protect your investments free of charge, please visit our website or contact Juan E. Monteverde, Esq. either via e-mail at jmonteverde@monteverdelaw.com or by telephone at (212) 971-1341.

CONTACT:

Juan E. Monteverde, Esq.
MONTEVERDE & ASSOCIATES PC
The Empire State Building
350 Fifth Ave. Suite 4405
New York, NY 10118
United States of America
jmonteverde@monteverdelaw.com
Tel: (212) 971-1341

Attorney Advertising. (C) 2020 Monteverde & Associates PC. The law firm responsible for this advertisement is Monteverde & Associates PC (www.monteverdelaw.com). Prior results do not guarantee a similar outcome with respect to any future matter.

SOURCE: Monteverde & Associates PC

ReleaseID: 591996

Tikvah Calls on Gain Capital Board to Change its Recommendation

CHARLOTTE, NC / ACCESSWIRE / May 29, 2020 / Tikvah Management LLC ("Tikvah") acts as investment manager to clients owning 1,697,331 shares of Gain Capital Holdings, Inc. representing approximately 4.5% of shares outstanding. In a letter dated May 29, 2020 (attached), Tikvah notes its support of JB Capital Partners L.P.'s ("JB Capital") proposal outlined in its May 28 Schedule 13D Amendment filing for the company to purchase the 14,657,089 shares owned by holders party to voting agreement for $6.25.

Tikvah also calls on the board of Gain Capital Holdings Inc. to act in the best interests of its shareholders and change its recommendation that stockholders adopt the merger agreement with INTL FCStone Inc. Tikvah believes the merger is no longer in the best interests of shareholders and undervalues the company for the reasons set forth in JB Capital's 13D filing.

Contact:

John Short,
Tikvah Management
js@simcah.com
704-879-2230

SOURCE: Tikvah Management LLC

ReleaseID: 591982

Kairos Metals Corp. Provides Update on Delay in Filing Annual Financial Statements Due to COVID-19 Related Delays

CALGARY, AB / ACCESSWIRE / May 29, 2020 / Kairos Metals Corp. ("Kairos" or the "Company") provides an update with respect to the postponed filing of the following continuous disclosure documents (collectively the "Documents"):

the Company's Annual Audited Financial Statements for the twelve-month period ended December 31, 2019 as required by section 4.2 of National Instrument 51-102 – Continuous Disclosure Obligations ("NI 51-102");

the Company's Management Discussion & Analysis for the twelve-month period ended December 31, 2019 as required by section 5.1(2) of NI 51-102;

The Company previously announced that the Company expected the Documents to be filed on or prior to June 15, 2020. The Company expects to meet that deadline.

The Company further announces that filing of its unaudited interim quarterly financial statements and accompanying management's discussion and analysis for the quarter ended March 31, 2020 (collectively the "Interim Documents") will be postponed due to delays caused by the COVID-19 pandemic. The Interim Documents would ordinarily have been filed on or before June 1, 2020, the required deadline set by NI 51-102. The Company is relying on the exemption provided in Alberta Instrument 51-517 – Temporary Exemption from Certain Corporate Finance Requirements (the "Alberta Instrument") of the Alberta Securities Commission (and similar exemptions provided by the securities commission in British Columbia), which provides the Company with an additional 45 days to complete its Interim Documents, which includes the following continuous disclosure documents:

the Company's unaudited financial statements for the quarter ended March 31, 2020 as required by section 4.4 of NI 51-102; and

the Company's Management's discussion and analysis for the quarter ended March 31, 2020 as required by section 5.1(2) of NI 51-102.

The Company expects to file the Interim Documents no later than July 15, 2020.

Until the Company has filed the required Documents, members of the Company's management and other insiders are subject to a trading blackout reflecting the principles contained in section 9 of National Policy 11-207 – Failure to File Cease Trade Orders and Revocations in Multiple Jurisdictions.

Since April 30, 2020, when the Company announced that it would rely on the Alberta Instrument, there have been no material business developments except in relation to the closing of the Property Retransfer that was announced by the Company's press release dated May 6, 2020 (further particulars may be viewed under the Company's profile at SEDAR.com).

For additional information regarding this news release please contact Al Kroontje, Director, at (403) 607 4009 or e-mail al@kasten.ca.

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 news release.

This news release may contain certain forward-looking information and statements. All statements included herein, other than statements of historical fact, are forward-looking information and such information involves various risks and uncertainties. There can be no assurance that such information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such information. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in Kairos's disclosure documents on the SEDAR website at www.sedar.com. Kairos does not undertake to update any forward-looking information except in accordance with applicable securities laws.

SOURCE: Kairos Metals Corp.

ReleaseID: 591999