Cocrystal Pharma (COCP) – Influenza Trial Continues With New Clinical Trials Planned For COVID-19

Thursday, May 12, 2022

Cocrystal Pharma (COCP)
Influenza Trial Continues With New Clinical Trials Planned For COVID-19

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Cocrystal Reported 1Q22 With Pipeline Updates.  Cocrystal reported a 1Q22 loss of $4.2 million or $(0.04) per share.  The company reviewed its recent clinical progress, including its ongoing Phase 1 study of CC-42344 in influenza and plans to initiate two Phase 1 studies of CC-45205 in COVID-19.  Cash at the end of 1Q22 was $54.8 million.

Influenza programs.  Cocrystal reported Phase 1 data from the CC-42344, its oral PB2 inhibitor for pandemic and seasonal influenza A.  The first two cohorts of healthy adults receiving escalating doses of 100 mg and 200 mg, reported positive safety and pharmacokinetic data.  This Phase 1 dose escalation trial began in March 2022 in Australia, with additional cohorts continuing enrollment.  Additional data is expected during 2022….

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Direct Digital Holdings Reports First Quarter 2022 Financial Results



Direct Digital Holdings Reports First Quarter 2022 Financial Results

Research, News, and Market Data on Direct Digital Holdings

First Quarter 2022 Revenue Up 100% Year-Over-Year to $11.4
Million

HOUSTON, May 12, 2022 /PRNewswire/ — Direct Digital Holdings, Inc. (Nasdaq: DRCT) (“Direct Digital”), a leading advertising and marketing technology platform, announced financial results for the first quarter ended March 31, 2022.

Chairman and Chief Executive Officer Mark Walker said, “We are pleased to report record revenue for the first quarter of 2022, which demonstrates the increasing value of Direct Digital’s world-class buy- and sell-side advertising platform for middle-market clients. Our quarterly growth was primarily driven by our sell-side advertising segment, and we are excited about the prospect of maintaining this momentum throughout 2022 by continuing to innovate our programmatic advertising offerings for the middle market segment, enhance our publisher partner engagement and monetization strategies, and further extend our reach into the underserved and underrepresented publisher communities.”

Keith Smith, President, added, “Our recent IPO, strategic debt refinance, and successful repurchase of equity from one of Direct Digital’s pre-IPO owners have optimally positioned Direct Digital to achieve its ambitious goals for 2022 and beyond.”

First Quarter 2022
Financial Highlights:

  • Revenue increased to $11.4 million in the first quarter of 2022, an increase of $5.7 million, or 100% over the $5.7 million in the same period of 2021.
    • Our sell-side advertising segment grew to $5.6 million, or 540% over the $0.9 million in the same period of 2021, and contributed $4.7 million of the increase in overall revenue.
    • Our buy-side advertising segment grew to $5.8 million, or 21% over the $4.8 million in the same period of 2021, and contributed $1.0 million of the increase in overall revenue.
  • Operating income increased to $0.6 million for the first quarter of 2022 compared to an operating loss of approximately ($26,000) in the same period of 2021.
  • Net loss was $(0.7) million in the first quarter of 2022, compared to $(0.8) million in the same period of 2021.
  • Adjusted EBITDA(1) increased 113% to $1.1 million in the first quarter 2022, compared to $0.5 million in the same period of 2021.
  • Net operating cash used in the first quarter was ($0.9) million compared to a net operating cash of $3.6 million generated in the same period of 2021.

Business Highlights

  • For the first quarter ended March 31, 2022, we processed approximately 90 billion monthly impressions through our sell-side advertising segment, an increase of 93% growth in the same period of 2021, with over 570 billion bid requests for the quarter.
  • In addition, our sell-side advertising platforms received over 3 billion bid responses, an increase of over 849% over the same period in 2021, through 69,000 buyers for the quarter.
  • Our buy-side advertising segment served over 128 customers, an increase of 41% in comparison to the same period of 2021.

Financial Outlook

Our guidance assumes that the U.S. economy continues to recover, and we do not have any major COVID-19-related setbacks or other major shocks that may cause economic conditions to deteriorate or otherwise significantly reduce advertiser demand. We plan to offer annual guidance and update it throughout the year, accordingly, we estimate the following:

  • For fiscal year 2022, we continue to expect revenue to be in the range of $48.0 million to $52.0 million, or 31% year-over-year growth at the mid-point.

“We are happy to report such a strong first quarter, which is a testament to our strategic post-IPO operating plan. We believe we are poised to continue to deliver significant growth, and favorable conditions in the advertising industry will also drive our business as we take advantage of these tailwinds to execute on both our organic and inorganic growth strategies, ultimately providing long-term shareholder value,” commented Mark Walker.

Conference Call and
Webcast Details

Direct Digital will host a conference call on Thursday, May 12, 2022 at 5:00 p.m. Eastern Time to discuss the Company’s quarterly results. The live webcast, dial-in information and replay can be accessed at https://ir.directdigitalholdings.com/.  Please access the website at least fifteen minutes prior to the call to register, download and install any necessary audio software. For those who cannot access the webcast, a replay will be available at https://ir.directdigitalholdings.com/ for a period of twelve months.

(1)

“Adjusted EBITDA” is a non-GAAP financial measure. The section titled “Non-GAAP Financial Measures” below describes our usage of non-GAAP financial measures and provides reconciliations between historical GAAP and non-GAAP information contained in this press release.

 Forward
Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and which are subject to certain risks, trends and uncertainties. As used below, “we,” “us,” and “our” refer to Direct Digital. We use words such as “could,” “would,” “may,” “might,” “will,” “expect,” “likely,” “believe,” “continue,” “anticipate,” “estimate,” “intend,” “plan,” “prospect,” “project” and other similar expressions to identify forward-looking statements, but not all forward-looking statements include these words. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements. All of our forward-looking statements involve estimates and uncertainties that could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. Our forward-looking statements are based on assumptions that we have made in light of our industry experience and our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. Although we believe that these forward-looking statements are based on reasonable assumptions, many factors could affect our actual operating and financial performance and cause our performance to differ materially from the performance expressed in or implied by the forward-looking statements, including, but not limited to: our dependence on the overall demand for advertising, which could be influenced by economic downturns; any slow-down or unanticipated development in the market for programmatic advertising campaigns; the effects of health epidemics, such as the ongoing global COVID-19 pandemic; operational and performance issues with our platform, whether real or perceived, including a failure to respond to technological changes or to upgrade our technology systems; any significant inadvertent disclosure or breach of confidential and/or personal information we hold, or of the security of our or our customers’, suppliers’ or other partners’ computer systems; any unavailability or non-performance of the non-proprietary technology, software, products and services that we use; unfavorable publicity and negative public perception about our industry, particularly concerns regarding data privacy and security relating to our industry’s technology and practices, and any perceived failure to comply with laws and industry self-regulation; restrictions on the use of third-party “cookies,” mobile device IDs or other tracking technologies, which could diminish our platform’s effectiveness; any inability to compete in our intensely competitive market; any significant fluctuations caused by our high customer concentration; our limited operating history, which could result in our past results not being indicative of future operating performance; any violation of legal and regulatory requirements or any misconduct by our employees, subcontractors, agents or business partners; any strain on our resources, diversion of our management’s attention or impact on our ability to attract and retain qualified board members as a result of being a public company; our dependence, as a holding company, on receiving distributions from Direct Digital Holdings, LLC to pay our taxes, expenses and dividends; and other factors and assumptions discussed in the “Risk Factors,” “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” and other sections of our filings with the SEC that we make from time to time. Should one or more of these risks or uncertainties materialize or should any of these assumptions prove to be incorrect, our actual operating and financial performance may vary in material respects from the performance projected in or implied by these forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as required by law, we undertake no obligation to update any forward-looking statement contained in this release to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated or unanticipated events or circumstances, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

About Direct Digital
Holdings

Direct Digital Holdings (Nasdaq: DRCT) brings state-of-the-art supply- and demand-side advertising platforms together under one umbrella company. The holding group’s supply-side platform Colossus SSP offers advertisers of all sizes extensive reach within general market and multicultural media properties. Its operating companies Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare and travel to financial services. Direct Digital Holdings’ buy-side solutions manages over 200 clients daily, and the sell-side solution serves over 80,000 advertisers generating over 70+ billion impressions per month across display, CTV, in-app, and other media channels.

 

CONSOLIDATED BALANCE SHEETS

March 31, 2022

December 31, 2021

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

4,406,800

$

4,684,431

Accounts receivable, net

7,754,091

7,871,181

Prepaid expenses and other current assets

875,928

1,225,447

Total current assets

13,036,819

13,781,059

Goodwill

6,519,636

6,519,636

Intangible assets, net (Note 3)

15,103,123

15,591,578

Deferred financing costs, net (Note 2)

66,869

96,152

Operating lease – right-of-use assets

917,877

Other long-term assets

56,602

11,508

Total assets

$

35,700,926

$

35,999,933

LIABILITIES AND MEMBERS’ EQUITY

CURRENT LIABILITIES:

Accounts payable

$

5,920,459

$

6,710,015

Accrued liabilities

6,087,173

1,044,907

Notes payable, current portion

687,500

550,000

Deferred revenues

431,432

1,348,093

Operating lease liabilities, current portion

209,914

Related party payables (Note 7)

70,801

Total current liabilities

13,336,478

9,723,816

Notes payable, net of short-term portion and $2,153,821 and $2,091,732, deferred financing cost, respectively

19,021,179

19,358,268

Mandatorily redeemable non-participating preferred units

6,455,562

Line of credit

400,000

400,000

Paycheck Protection Program loan

287,143

287,143

Economic Injury Disaster Loan

150,000

150,000

Operating lease liabilities, net of current portion

708,262

Total liabilities

33,903,062

36,374,789

COMMITMENTS AND CONTINGENCIES (Note 8)

STOCKHOLDERS’ / MEMBERS’ EQUITY (DEFICIT)

Units, 1,000,000 units authorized at December 31, 2021; 34,182 units issued and outstanding as of December 31, 2021

4,294,241

Class A common stock, $0.001 par value per share, 160,000,000 shares authorized, 2,800,000 shares issued and outstanding as of March 31, 2022

2,800

Class B common stock, $0.001 par value per share, 20,000,000 shares authorized, 11,378,000 shares issued and outstanding as of March 31, 2022

11,378

Additional paid-in capital

7,272,856

Accumulated deficit

(5,489,170)

(4,669,097)

Total stockholders’ / members’ equity (deficit)

1,797,864

(374,856)

Total liabilities and stockholders’ / members’ equity

$

35,700,926

$

35,999,933

 

CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)

Three Months Ended
March 31,

2022

2021

Revenues

Buy-side advertising

$

5,831,041

$

4,828,048

Sell-side advertising

5,539,296

865,686

      Total revenues

11,370,337

5,693,734

Cost of revenues

Buy-side advertising

2,069,346

1,954,640

Sell-side advertising

4,520,192

741,693

      Total cost of revenues

6,589,538

2,696,333

Gross Profit

4,780,799

3,482,420

Operating expenses

Compensation, taxes and benefits

2,555,036

1,773,081

General and administrative

1,640,892

1,250,515

      Total operating expenses

4,195,928

3,023,596

Income (loss) from operations

584,871

(26,195)

Other (expense) income

(1,256,494)

(783,098)

      Tax expense (benefit)

Net loss

$

(671,623)

$

(809,293)

Net loss per share of common stock / common unit:

      Basic and diluted

$

(0.09)

$

(23.68)

Weighted-average number of shares / common units outstanding:

      Basic and diluted

7,089,000

34,182

 

CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

For the Three Months Ended

March 31,

2022

2021

Cash Flows Provided By (Used In) Operating Activities:

Net loss

$

(671,623)

$

(809,293)

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

Amortization of deferred financing costs

152,287

84,629

Amortization of intangible assets

488,455

488,455

Amortization of right-of-use assets

17,602

Forgiveness of Paycheck Protection Program loan

(10,000)

Paid-in-kind interest

95,344

Loss on redemption of non-participating preferred units

590,689

Bad debt expense

(2,425)

Changes in operating assets and liabilities:

Accounts receivable

119,515

1,508,681

Prepaid expenses and other current assets

304,423

(84,211)

Accounts payable

(926,581)

(717,036)

Accrued liabilities

62,803

46,148

Deferred revenues

(916,661)

2,966,693

Related party payable

(70,801)

                       Net cash provided by (used in) operating activities

(852,317)

3,569,410

Cash Flows Provided By (Used In) Financing Activities:

Proceeds from issuance of Class A common shares, net of transaction costs

11,329,818

Payments on term loan

(137,500)

(77,801)

Payment of deferred financing costs

(185,093)

Redemption of non-participating preferred shares

(7,046,251)

Redemption of common units

(3,237,838)

Distributions to members

(148,450)

(144)

                     Net cash provided used in financing activities

574,686

(77,945)

                     Net (decrease) increase in cash and cash equivalents

(277,631)

3,491,465

Cash and cash equivalents, beginning of the period

4,684,431

1,611,998

Cash and cash equivalents, end of the year

$

4,406,800

$

5,103,463

NON-GAAP FINANCIAL
MEASURES

In addition to our results determined in accordance with U.S. generally accepted accounting principles (“GAAP”), including, in particular operating income, net cash provided by operating activities, and net income, we believe that earnings before interest, taxes, depreciation and amortization (“EBITDA”), as adjusted for acquisition transaction costs, forgiveness of Paycheck Protection Program loans, gain from revaluation and settlement of seller notes and earnout liability, loss on early extinguishment of debt, and loss on early redemption of non-participating preferred units, (“Adjusted EBITDA”), a non-GAAP measure, is useful in evaluating our operating performance. The most directly comparable GAAP measure to Adjusted EBITDA is net loss.

In addition to operating income and net income, we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-GAAP financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons:

  • Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as depreciation and amortization, interest expense, provision for income taxes, and certain one-time items such as acquisition transaction costs and gains from settlements or loan forgiveness that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired;
  • Our management uses Adjusted EBITDA in conjunction with GAAP financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and
  • Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-GAAP financial measures to supplement their GAAP results.

Our use of this non-GAAP financial measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our financial results as reported under GAAP. The following table presents a reconciliation of Adjusted EBITDA to net loss for each of the periods presented:

RECONCILIATION OF NON-GAAP FINANCIAL METRICS
(Unaudited)

For the Three Months
Ended March 31,

2022

2021

Net loss

$

(671,676)

$

(890,293)

Add back (deduct):

    Amortization of intangible assets

488,455

488,455

    Interest expense

713,787

811,757

    Forgiveness of Paycheck Protection Program loan

(10,000)

    Loss on early redemption of non-participating preferred units

590,689

Adjusted EBITDA

$

1,121,305

$

480,919

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/direct-digital-holdings-reports-first-quarter-2022-financial-results-301546560.html

SOURCE Direct Digital Holdings


What is a Small-Cap Stock (In 500 Words or Less)



Small-Cap Stocks and How They’re Different

Shares of public companies with a total market capitalization between $300 million to $2 billion are categorized as small-cap.

Market capitalization is determined by taking a stock’s share price and multiplying it by all of the outstanding shares. If the product comes to between $300 million and $2 billion, it fits the definition of small-cap.

Example

ABC Company Share Price: $4.25

Shares Outstanding: 400 Million

Market Capitalization: $4.25 x 400,00,00 =

$1.7 Billion

The above example shows ABC Company trading at $4.25 per share. There are $400 million shares outstanding – by multiplying $4.25 by 400 million, it reveals the company has a market cap of $1.7 billion –  $1.7 billion is between $200 million and $2 billion, so it is categorized as a small-cap company.

Market-cap data is available for small-cap stocks on Channelchek and other websites that provide investor information on companies.

Why is it Important?

Investors generally view stocks in three size categories: large, mid, and small-cap. Some even add two other categories they call microcap and megacap.

Knowing a company’s size, measured by market capitalization, is useful information for investors, here’s why:

Small-cap companies can exist in any industry. The difference between the smaller company and those with larger capitalization in the same business is that smaller companies have an increased potential for growth. Smaller companies are also more prone to being acquired. A company that gets acquired usually does at a share price above market levels.  

Another possible benefit is small companies usually have a more focused business line which allows investors the ability to fine-tune their concentration. To understand this, take a small one-product company that gets FDA approval for the only drug it has been working on for years. Its share price would likely skyrocket. If a large-cap company like Johnson and Johnson got approval for a drug that is just as effective, the impact on J&J’s earnings would not be as impactful for the stock price.

This is because the larger J&J also sells many other products. The stock price of the small company typically would show a much greater impact. This is true of growth, earnings, profit, and market-cap which is watered down when you’re larger.

There are unique risks to small-cap companies as well. Take the company I just mentioned that has just one drug that received FDA approval. What if the drug was turned down? They don’t have other products they can sell to offset costs.

 Most larger company stocks were at one time small-cap stocks.

Performance

Small-cap stocks can also experience larger than average price swings. But, if you’re a long-term investor, it may be worth it.

In the past 20 years, the S&P SmallCap 600 index, a leading benchmark for small-cap stocks, has outperformed the S&P indexes for large- and mid-caps on an average yearly basis. During that period, the S&P’s benchmark small-cap index returned an average of *8.3% annually, compared to 8% and 6.3% from its mid- and large-cap indexes.

Because of their size, small-cap stocks have different risks and rewards for investors when compared to their larger counterparts.

Paul Hoffman

Managing Editor, Channelchek

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Release – Avivagen Announces Approval in China, the World’s Largest Commercial Feed Production Market



Avivagen Announces Approval in China, the World’s Largest Commercial Feed Production Market

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ May 12, 2022 /– Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that Avivagen’s oxidized carotenoid-based feed additive product has received approval for use in China.

“Core to our success to date has been the strong inroads we’ve made across key Asian feed markets, and we’re thrilled to now have regulatory approval to bring OxC-betaTM to feed producers and commercial operations across China,” says Kym Anthony, Chief Executive Officer, Avivagen. “Having direct access to the world’s largest feed market at a time of continued growth has the potential to be transformative for Avivagen and help drive greater adoption and growth in Asia and worldwide.”

The approval comes as a result of Avivagen working closely with COFCO Biotech, a state-owned multi-billion-dollar company, and follows successful trials across numerous species.

China was ranked as the number one feed-producing country in the world in the 2022 Alltech Agri-Food Outlook, producing 261.4mmt in 2021. The country also experienced the largest increase in feed production by tonnage during the year, as the country’s feed industry continues to consolidate and modernize . The country has been a leader in efforts to reduce antibiotic use with livestock nationwide, in an effort to reduce antimicrobial-resistance in the region.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™
Technology and OxC-beta™ Livestock

Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking
Statements

This
news release includes certain forward-looking statements that are based upon
the current expectations of management. Forward-looking statements involve
risks and uncertainties associated with the business of Avivagen Inc. and the
environment in which the business operates. Any statements contained herein
that are not statements of historical facts may be deemed to be
forward-looking, including those identified by the expressions “aim”,
“anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”,
“if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”,
“potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and
similar expressions.

Statements set out in
this news release relating to the potential impacts on Avivagen from this
regulatory approval, future growth and prospects for Avivagen and the
possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds
as growth promoters are forward-looking statements. These forward-looking
statements are subject to a number of risks and uncertainties that could cause
actual results or events to differ materially from current expectations. For
instance, Avivagen’s products may not gain market acceptance or regulatory
approval in new jurisdictions or for new applications and may not be widely
accepted as a replacement for antibiotics as growth promoters in livestock
feeds due to many factors, many of which are outside of Avivagen’s control.
Readers are referred to the risk factors associated with the business of
Avivagen set out in Avivagen’s most recent management’s discussion and analysis
of financial condition available at www.SEDAR.com. Except as required by law,
Avivagen assumes no obligation to update the forward-looking statements, or to
update the reasons why actual results could differ from those reflected in the
forward-looking statements.

Neither 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.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164

Website: www.avivagen.com
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Release – The Big Tomato, Hydroponic Division of Schwazze, Receives Westword Best of Denver Award for the Best Home Cultivation Store



The Big Tomato, Hydroponic Division of Schwazze, Receives Westword Best of Denver Award for the Best Home Cultivation Store

Research, News, and Market Data on Schwazze


DENVER, May 9, 2022 /PRNewswire/ – 
Schwazze, (OTCQX: SHWZ) (NEO: SHWZ), a premier vertically integrated, multi-state operating cannabis company with assets in Colorado and New Mexico is proud to announce that its hydroponic and indoor gardening brand, The Big Tomato has been named the Best Home Cultivation Store in the city of Denver by Westword magazine.

Westword magazine states, “The Big Tomato was helping home growers long before the dispensary boom, selling indoor gardening supplies for over two decades. Now owned by Schwazze, a Denver-based cannabis corporation, the Big Tomato still offers the same friendly service for newbies and regulars, but now has even more of a cannabis focus — and an online shopping option, to boot. For beginning green thumbs, finding a trustworthy growing store is like searching for a new mechanic; more cynical shops can take advantage of that lack of experience by suggesting unnecessary lighting equipment and nutrients. That’s not the case at the Big Tomato, so don’t be afraid to ask questions.”

“We are honored to receive the Westword award for Best Home Cultivation Store in Denver,” said Jeremy Bullock, Vice President – Commercial Sales. “We are proud to serve our community and provide expert advice to an industry that has historically lacked access to information and education about the best practices for cultivating cannabis.”

The Big Tomato (Big Tomato) has served the indoor, hydroponic and community of Colorado for over 20 years. Big Tomato predates the hydroponics boom, and offers competitive prices and an extensive selection of expertly curated supplies. The experienced growers at Big Tomato offer superior product knowledge to hobbyists and commercial growers alike. From propagation to harvest, Big Tomato has developed a reputation as the go-to source for all garden supply needs.

695 Billing St.,
Aurora, Colorado
303-364-4769

thebigtomato.com

About Schwazze

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,”, “predicts,” or similar words. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to consummate the acquisition described in this press release or to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and * out ability to satisfy the closing conditions for the private finding described in this press release. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

Cision View original content:https://www.prnewswire.com/news-releases/the-big-tomato-hydroponic-division-of-schwazze-receives-westword-best-of-denver-award-for-the-best-home-cultivation-store-301541846.html

SOURCE Schwazze


Useful Information on Where CPI Numbers Come From


Image Credit: Brett Jordan (Flickr)


How the Bureau of Labor Statistics Confirms Your Sticker Shock by Measuring CPI

As purchases of pretty much everything cost more than they did a year ago, a correct accounting of average cost per household has recently taken the spotlight. The methods the federal government uses to track changes in prices each month on a hundred thousand goods and services were given little thought during non-inflationary periods. But now, as more consumers are asking whether the 8.3% inflation rate corresponds with their anecdotal 23% increase in groceries or the change in prices they’re experiencing with cars, understanding where the government gets the statistics from is useful information.

Bureau of Labor Statistics

Quantifying the magnitude and pace of inflation is among the Bureau of Labor Statistics (BLS) official jobs.

There are 477 workers that work for the BLS that track price changes. Many of these are “on-the-ground” economists whose job it is to confirm that you just paid $1.37 for a can of tuna and that it isn’t a fluke. Their work literally moves markets, including all those tied to interest rates, the stock market, COLA raises for Social Security recipients, and other prices tied to one of the CPI indices.

After a two-year pandemic-related shift away from in-person confirmation, many price checkers have returned and are back out in stores and visiting service businesses in person to collect data. This could include visiting a reception hall, checking prices on a manicure, asking accountants what they charge for a basic tax return, oil change, etc.

Under the Spotlight

For decades there was little attention paid to inflation. For most of the years, the risk of deflation was the most spoken about concern. Retirees would complain that their COLA was more than eaten up by rising Medicaid deductions, and many of us were amazed each time we decided to buy electronics like a new TV. Not only did it cost less than the last one we purchased, but it had better features.

A recent story in the Wall Street Journal about one of these BLS price-checking economists explains she spends more time than ever at each location. Not because she has more business there, but because business owners want to complain to her about rising prices. The story in the Journal says this checker has six children and lately she’s been called upon by her husband and friends to suggest ways to avoid higher bills. This advice she can share. What she cannot help with is sharing any information she has that is confidential, as it could be market moving and considered insider information.

The job of a price-checker has been described as a treasure hunt. As you might imagine, they have very strict price collection rules. Shop owners are not at all counted on to know any of the rules because there is no financial incentive or accountability for them to care enough to treat the task with the importance required.

The job is exacting. To price an item, BLS workers go through up to an 11-page list of data points to make sure they are pricing the same item as they did the prior month. As an example of how exacting, a can of soup will have 12 different specifications, including flavor, size, brand, organic labeling, material of the packaging and dietary features, such as sodium content.

Challenge of Monthly Measurement

The BLS tracks prices on their list of goods and services, along with 8,000 housing units each month. The bureau determines which items to include using census-collected data on buying habits. This makes sure the measurements reflect the way Americans spend their money and captures new buying habits as they emerge using a four-year cycle.

Business participation in the monthly CPI price gathering is voluntary. Businesses can’t be required to participate.  

One challenge they have recently run into is supply-chain shortages. It has made it more difficult to check prices from month to month over the pandemic since goods are often out of stock.

And what about shrinkflation? The price checkers are challenged with watching for quantity changes. If a container of ice cream or can of Pringles has an unchanged price, but the package has shrunk, the price checker has to account for it as a price increase.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content



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Inflation is No Baloney

Sources

https://newscorp.com/business/dow-jones/

https://www.dowjones.com/

https://www.marketwatch.com/

https://www.wsj.com/articles/inflation-bls-price-checkers-who-determine-cpi-11652132333?mod=hp_lead_pos8

https://bigcharts.marketwatch.com/

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Release – Onconova Therapeutics Reports First Quarter 2022 Financial Results And Provides Business Update



Onconova Therapeutics Reports First Quarter 2022 Financial Results And Provides Business Update

News and Market Data on Onconova Therapeutics


Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., May 11, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2022, and provided a business update.

Highlights for the first quarter of 2022 and recent weeks include:

  • The ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to generate encouraging safety data with the maximum tolerated dose not yet reached in either trial. The trial in the United States is currently enrolling into its fourth dose cohort, which is evaluating a 160 mg dose administered orally each day (i.e. continuous daily dosing). The trial in China is enrolling into its fifth dose cohort, which is evaluating a 200 mg dose administered orally once a day on days 1-21 of 28-day cycles. A protocol amendment is being prepared to enable further dose escalation in the trial in China.
  • An abstract titled “Narazaciclib’s kinase inhibitory activity is differentiated from approved CDK4/6 inhibitors in preclinical models,” has been accepted for publication at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting.
  • Rigosertib’s investigator-sponsored program has seen progress across multiple ongoing and planned trials. The expansion cohort of the Phase 1/2a study of oral rigosertib plus nivolumab in patients with KRAS+ non-small cell lung cancer (NSCLC) continues to enroll patients, as does the Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa (RDEB-associated SCC). A planned Phase 2 trial of rigosertib plus pembrolizumab in patients with metastatic melanoma was recently cleared to proceed by the United States Food and Drug Administration (FDA) following a review of its protocol.

Management
Commentary

“We are pleased to be advancing two highly differentiated therapeutic candidates towards near-term milestones with cash runway expected to extend for at least eighteen months,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We remain on track to identify narazaciclib’s recommended Phase 2 dose later this year, which will enable us to move forward into later-stage studies designed to evaluate its safety and efficacy in monotherapy and combination settings. As we finalize the specifics of these upcoming trials, we will continue to be informed by the results of our ongoing Phase 1 program and preclinical studies. The results of these studies to-date set narazaciclib apart from currently approved CDK4/6 inhibitors, and we look forward to building on these data in future trials.”

Dr. Fruchtman continued, “Rigosertib’s investigator sponsored study program is also moving towards key catalysts. Later this quarter, our collaborators expect to initiate a Phase 2 study evaluating rigosertib plus anti-PD-1 therapy in metastatic melanoma patients refractory to checkpoint blockade. This trial is supported both by preclinical data that demonstrate rigosertib’s immunotherapeutic effects, and prior clinical results from the ongoing investigator sponsored study of the rigosertib-anti-PD-1 combination therapy in KRAS-mutated NSCLC. These initial results showed the studied doublet generating responses in refractory patients who previously failed therapy with a checkpoint inhibitor, a finding we hope to replicate in melanoma. We have continued to amass data in NSCLC since this initial readout, and look forward to providing updated results from the ongoing Phase 1/2a trial by the end of the year. The advancement of this and rigosertib’s other investigator-sponsored studies is expected to serve as a valuable complement to our narazaciclib program, which remains our core focus.”

First
Quarter Financial Results

Cash and cash equivalents as of March 31, 2022, were $50.8 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the first quarter of 2022, compared with $1.9 million for the first quarter of 2021.

General and administrative expenses were $2.2 million for the first quarter of 2022, compared with $2.2 million for the first quarter of 2021.

Net loss for the first quarter of 2022 was $4.1 million, or $0.20 per share on 20.9 million weighted average shares outstanding, compared with a net loss of $4.7 million, or $0.32 per share for the first quarter of 2021 on 14.6 million weighted average shares outstanding.

Conference
Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the first quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 7369861.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About
Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Forward-Looking
Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company
Contact:

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680

ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200


bmackle@lifesciadvisors.com


Townsquare Media (TSQ) – The Engine That Could

Wednesday, May 11, 2022

Townsquare Media (TSQ)
The Engine That Could

Townsquare is a community-focused digital media and digital marketing solutions company with market leading local radio stations, principally focused outside the top 50 markets in the U.S. Our assets include a subscription digital marketing services business, Townsquare Interactive, providing website design, creation and hosting, search engine optimization, social media and online reputation management as well as other digital monthly services for approximately 26,800 SMBs; a robust digital advertising division, Townsquare IGNITE, a powerful combination of a) an owned and operated portfolio of more than 330 local news and entertainment websites and mobile apps along with a network of leading national music and entertainment brands, collecting valuable first party data, and b) a proprietary digital programmatic advertising technology stack with an in-house demand and data management platform; and a portfolio of 321 local terrestrial radio stations in 67 U.S. markets strategically situated outside the Top 50 markets in the United States. Our portfolio includes local media brands such as WYRK.com, WJON.com, and NJ101.5.com and premier national music brands such as XXLmag.com, TasteofCountry.com, UltimateClassicRock.com and Loudwire.com.

Michael Kupinski, Director of Research, Noble Capital Markets, Inc.

Patrick McCann, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Exceeds Q1 expectations, above guidance. The company reported Q1 revenue of $100.2 million, above our estimate of $99.4 million and management’s previous guidance. Adj. EBITDA in the quarter was $22.1 million, exceeding our estimate of $21.4 million.

Digital inflection point. Total Digital revenue grew an attractive 15.9% year-over-year to $51.1 million. Notably, after accounting for 48% of total revenue in Q4 of 2021, Digital eclipsed the 50%-mark, accounting for 51% of total revenue in Q1. In our view, this milestone emphasizes that Townsquare truly has become a digital-first media company.  …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Award-Winning NBC reporter Michele Tafoya joins the Salem Podcast Network



Award-Winning NBC reporter Michele Tafoya joins the Salem Podcast Network

Research, News, and Market Data on Salem Media


IRVING, Texas–(BUSINESS WIRE)– Salem
Media Group
, Inc. (NASDAQ: SALM) announced today that Salem Podcast Network has signed former NBC Sideline Reporter Michele Tafoya to host a new podcast called “Sideline Sanity”. The podcast, which will air four episodes a week beginning Monday, May 23rd, will focus on life, politics, and world news.

“I’m thrilled to launch my first podcast with the Salem Podcast Network,” Michele said. “It’s exciting to join the chorus of talented Salem voices discussing the historic issues facing America and the world.”

The Salem Podcast network launched in January 2021 and is already ranked as the 11th most listened to podcast network on the Triton Digital platform, with 17 million average downloads per month.

“I cannot wait for the rest of the country to get to know Minnesota’s own Michele Tafoya beyond her successful years of reporting from the sidelines,” said Salem Twin Cities General Manager Nic Anderson. “She’s full of insight, passionate about her platform and she’s ready to speak her mind. And Salem Media-Twin Cities is eager to help as we produce her podcast for a national audience and look forward to working with her locally as opportunities arise,” added Anderson.

Michele Tafoya is an award-winning sportscaster and political commentator. Michele recently announced her retirement as the longtime sideline reporter for NBC’s Sunday Night Football. Since her start with the network in 2011, Michele has won four Emmys for her work on the field in the Outstanding Sports Personality –Sports Reporter category and has recently been nominated a tenth time for the 2021-2022 season. Michele is the only reporter nominated every year of the award’s existence. After her last game at Superbowl LVI in 2022, she announced her involvement as co-chair for Republican candidate Kendall Qualls’ campaign for governor of Minnesota. She also recently appeared as a guest host on THE VIEW as well, holding her own and speaking her truth alongside the panel.

With a career spanning over 30 years, Michele is a versatile talent who has covered nearly every sport, from the Super Bowl LII (2018) to the 2016 Olympic Summer Games in Rio, Brazil. She has helped pave the way for the younger generation of women sportscasters and cares deeply about making a difference in this country. Tafoya received a Bachelor of Arts degree in Mass Communications from the University of California, Berkeley in 1988, and a Master’s degree in Business Administration from the University of Southern California in 1991. She currently resides in Minnesota with her family.

ABOUT SALEM MEDIA GROUP:

Salem Media Group is America’s leading multimedia company specializing in Christian and conservative content, with media properties comprising radio, digital media and book and newsletter publishing. Each day Salem serves a loyal and dedicated audience of listeners and readers numbering in the millions nationally. With its unique programming focus, Salem provides compelling content, fresh commentary and relevant information from some of the most respected figures across the Christian and conservative media landscape. Learn more about Salem Media Group, Inc. at www.salemmedia.comFacebook and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220428006200/en/

Evan D. Masyr
Executive Vice President and Chief Financial Officer
(805) 384-4512
evan@salemmedia.com

Source: Salem Media Group, Inc.


Release – BioSig Technologies, Inc. Issues Shareholder Letter with Corporate Update on Recent Achievements



BioSig Technologies, Inc. Issues Shareholder Letter with Corporate Update on Recent Achievements

News and Market Data on BioSig Technologies

Westport, CT, May 11, 2022 (GLOBE NEWSWIRE) —

  • To date,
    Company’s FDA 510(k) cleared PURE EP(TM) system has completed over
    2,200 patient cases with 75 physicians at 17 hospitals across the United
    States
  • The Company adds
    new executives to accelerate sustained commercial momentum developing
    a national installed base of the PURE EP systems

BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today issued a Letter to Shareholders providing highlights on the Company’s recent developments and updates.

Recent Company highlights include:

  • The growth of its PURE EP(TM) System from its first-in-human surgical procedures in 2019 to completing over 2,200 patient cases with 75 physicians at 17 hospitals across the United States.
  • BioSig strengthened its management with a new commercialization team led by industry veteran Gray Fleming, Chief Commercial Officer, who spent 18 years with St. Jude Medical.
  • The rollout of a two-phase approach for purchase, lease, or rental options for PURE EP and a new go-to-market strategy for commercialization.
  • Launch of its new NOVA-5 software at the Heart Rhythm Society Convention on April 29, 2022. NOVA-5 offers greater customization and smarter workflows with the aim of further driving clinical adoption.
  • Recapped the successful completion of its first blinded clinical trial in 2021 and published those results in a leading peer-reviewed journal. Titled “Evaluation
    of a novel cardiac signal processing system for electrophysiology
    procedures: The PURE EP 2.0 study
    ,” the study was conducted at three leading medical centers across the United States: St. David’s Medical Center (TCAI), Mayo Clinic, and Massachusetts General Hospital.
  • A snapshot into Biosig’s financing included no debt and positioning in a global electrophysiology device market which, according to Grand View Research, could reach $12.2 billion by 2026 and expand at a growth rate of approximately 12%.

“We have made great strides on multiple fronts and felt it was an important time to communicate to our shareholders the strength of our business and the initiatives we are executing that have served as the foundation for our growth trajectory,” said Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. “We strongly believe in the value of our technology and are now supported with both peer-reviewed clinical data and third-party economic data, proving the value of what we have built. We are eager to continue working on our new commercialization strategy, seeing the impact of our new NOVA-5 software has, and all our initiatives we are undertaking to drive shareholder value and expand PURE EP.”

To view the Company’s Shareholder Letter in its entirety, please visit: Presentations :: BioSig
Technologies, Inc. (BSGM)
.

The PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2,200 patient cases with the PURE EP(TM) System.

Clinical data acquired by the PURE EP(TM) System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(TM) signals over conventional sources.

About
BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP(TM) System, is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking
Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social, and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise.


Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Greens Farms Road

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

Release – PDS Biotech Provides Business Update and Reports First Quarter 2022 Financial Results



PDS Biotech Provides Business Update and Reports First Quarter 2022 Financial Results

Research, News, and Market Data on PDS Biotech

Company to host
conference call and webcast today, May 11, 2022, at 8:00 AM EDT

FLORHAM PARK, N.J., May 11, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, will discuss its financial results for the quarter ended March 31, 2022, and provide a business update on its conference call today.

“2022 is shaping up to be an incredibly productive year for PDS Biotech,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. “As we continue to make significant clinical progress on our lead oncology candidate, PDS0101, we’re looking ahead to presentations of preliminary data from our two most advanced Phase 2 clinical trials at this year’s ASCO meeting in early June. We believe ASCO’s selection of the preliminary data from both trials for presentation at the June meeting is a testament to the quality of work being done by our team and our partners, as well as the potential demonstrated by PDS0101 in treating advanced HPV-associated cancers. We look forward to sharing these efficacy and safety data in the near term. In addition, we continue to leverage our proprietary platforms to advance our pre-clinical pipeline into clinical studies, focused on a variety of cancer targets and infectious diseases. Lastly, due to our partnering model and our financial discipline, we finished the quarter with a strong cash balance which we project to fund our current operations into 2024.”

Recent Business Highlights:

  • Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7 in Chicago:
    • The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
    • The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2 clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.
  • In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.
  • Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.

First Quarter 2022
Financial Results

PDS Biotech reported a net loss of approximately $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022 compared to a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021.

Research and development (R&D) expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributable to an increase of $1.8 million in manufacturing services and quality costs, $1.04 million in clinical study and regulatory costs, $0.8 million in personnel costs and $0.06 million in facilities.

General and administrative expenses increased to approximately $3.3 million for the three months ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributable to an increase of $1.0 million in personnel costs, $0.6 million in legal fees and $0.1 in marketing expenses.

Total operating expenses increased to approximately $8.5 million for the three months ended March 31, 2022 from approximately $3.0 million for the three months ended March 31, 2021 for the reasons described above. 

PDS Biotech’s cash balance as of March 31, 2022 was approximately $58.9 million.

Conference Call and
Webcast

The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, May 11, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13728184. To access the webcast, please use the following link PDS Biotech Earnings Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking
Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

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

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: 
pdsb@cg.capital


PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY

Condensed Consolidated Statements of Operations and
Comprehensive Loss

(Unaudited)

 

March 31, 2022

 

December 31, 2021

ASSETS

(unaudited)

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

58,881,101

 

 

$

65,242,622

 

Prepaid expenses and other

 

1,849,406

 

 

 

1,597,569

 

Total current assets

 

60,730,507

 

 

 

66,840,191

 

 

 

 

 

 

 

Property and equipment, net

 

 

 

 

86

 

Operating lease right-to-use asset

 

308,327

 

 

 

357,611

 

 

 

 

 

 

 

Total assets

$

61,038,834

 

 

$

67,197,888

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

2,745,709

 

 

$

1,309,403

 

Accrued expenses

 

1,961,468

 

 

 

2,187,704

 

Operating lease obligation-short term

 

311,311

 

 

 

258,924

 

Total current liabilities

 

5,018,488

 

 

 

3,756,031

 

 

 

 

 

 

 

Noncurrent liability:

 

 

 

 

 

Operating lease obligation-long term

 

146,980

 

 

 

231,430

 

Total Liabilities:

$

5,165,468

 

 

$

3,987,461

 

     

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

Common stock, $0.00033 par value, 75,000,000 shares authorized at March 31, 2022 and December 31, 2021, 28,450,894 shares and 28,448,612 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

 

9,388

 

 

 

9,387

 

Additional paid-in capital

 

125,041,062

 

 

 

123,904,602

 

Accumulated deficit

 

(69,177,084

)

 

 

(60,703,562

)

Total stockholders’ equity

 

55,873,366

 

 

 

63,210,427

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

$

61,038,834

 

 

$

67,197,888

 

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and
Comprehensive Loss

(Unaudited)

 

Three Months Ended March 31,

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

Research and development expenses

$

5,161,315

 

 

$

1,413,057

 

General and administrative expenses

 

3,317,907

 

 

 

1,636,216

 

 

 

 

 

 

 

Total operating expenses

 

8,479,222

 

 

 

3,049,273

 

 

 

 

 

 

 

Loss from operations

 

(8,479,222

)

 

 

(3,049,273

)

 

 

 

 

 

 

Other income

 

 

 

 

 

Interest income

 

5,700

 

 

 

655

 

 

 

 

 

 

 

Net loss and comprehensive loss

$

(8,473,522

)

 

$

(3,048,618

)

 

 

 

 

 

 

Per share information:

 

 

 

 

 

Net loss per share, basic

$

(0.32

)

 

$

(0.14

)

Net loss per share, diluted

$

(0.32

)

 

$

(0.14

)

 

 

 

 

 

 

Weighted average common shares outstanding, basic

 

26,161,156

 

 

 

22,263,838

 

Weighted average common shares outstanding, diluted

 

26,161,156

 

 

 

22,263,838

 

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements
of Cash Flows

(Unaudited)

 

Three Months Ended March 31,

 

2022

 

 

2021

 

Cash flows from
operating activities:

 

 

 

Net loss

$

(8,473,522

)

 

$

(3,048,618

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Stock-based compensation expense

 

1,128,973

 

 

 

257,622

 

Stock-based 401K company common match

 

 

 

 

35,747

 

Depreciation expense

 

86

 

 

 

1,860

 

Operating lease expense

 

60,257

 

 

 

60,257

 

Changes in assets and liabilities:

 

 

 

 

 

Prepaid expenses and other assets

 

(251,837

)

 

 

(721,849

)

Accounts payable

 

1,436,306

 

 

 

(464,626

)

Accrued expenses

 

(226,236

)

 

 

119,473

 

Operating lease liabilities

 

(43,036

)

 

 

(42,057

)

 

 

 

 

 

 

Net cash used in operating activities

 

(6,369,009

)

 

 

(3,802,191

)

 

 

 

 

 

 

Cash flow from
financing activities:

 

 

 

 

 

Proceeds from exercise of stock options

 

7,488

 

 

 

 

Net cash provided by financing activities

 

7,488

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net decrease in cash
and cash equivalents

 

(6,361,521

)

 

 

(3,802,191

)

Cash and cash equivalents at beginning of period

 

65,242,622

 

 

 

28,839,565

 

 

 

 

 

 

 

Cash and cash
equivalents at end of period

$

58,881,101

 

 

$

25,037,374

 

Release – Direct Digital Holdings to Report First Quarter 2022 Financial Results



Direct Digital Holdings to Report First Quarter 2022 Financial Results

Research, News, and Market Data on Direct Digital Holdings

HOUSTON, May 11, 2022 /PRNewswire/ — Direct Digital Holdings (Nasdaq: DRCT) (“Direct Digital”), a leading advertising and marketing technology holding group, will report financial results for the first quarter ended March 31, 2022, on Thursday, May 12, 2022 after the U.S. stock market closes. Management will host a conference call and webcast on the same day at 5:00 p.m. ET to discuss the results.

The live webcast and replay can be accessed at https://ir.directdigitalholdings.com/

About Direct Digital
Holdings
Direct Digital Holdings (Nasdaq: DRCT) brings state-of-the-art supply- and demand-side advertising platforms together under one umbrella company. The holding group’s supply-side platform Colossus SSP offers advertisers of all sizes extensive reach within general market and multicultural media properties. Its operating companies Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare and travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage 17,500 clients daily, generating over 30 billion impressions per month across display, CTV, in-app, and other media channels.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/reminder-direct-digital-holdings-to-report-first-quarter-2022-financial-results-301545448.html

SOURCE Direct Digital Holdings

Released May 11, 2022

Finding Tomorrow’s Best Stocks Beneath a Cloak of Invisibility


Image Credit: Mob Mob (Flickr)


Reinventing Your Trading as the Market Transforms Yet Again

Momentum traders were big gainers from the Summer of 2020 until January of 2022. Only a year ago, jumping onboard the Globalstar (GSAT), Gamestop (GME), or other meme stock freight train helped turn many accounts extremely green. That trade seems to be over for now, and traders and investors may now have to pivot. Just as they pivoted after the March 2020 selloff to find opportunity investing in FAANG stocks or following r/wallstreetbets conversations – the recent economic upheaval suggests another pivot may be required for investors to survive and thrive.

About the Market Selloff

While the activities of many retail investors quickly become running for cover when the market sells off, time should be dedicated to calmly looking at the big picture while remembering which products and services will have global appeal when the downward trend ends.

Lining up opportunities uncovered in the current carnage will prepare you to jump when the time is right.

This isn’t simple, it involves experiencing the anxiety of red days and recognizing the potential for future green. Some of the red stocks have become “on-sale” and should be further analyzed; others are approaching where they should have been valued all along. Work to determine which is which.

The markets have changed for now, going forward they will require the work they always used to require, and the rewards may not come as quickly or easily. But interesting companies still exist.

What I  Mean by “Interesting”

One company that seems to have its hand in everything that will be hot tomorrow, or maybe the day after, is Meta Materials (Nasdaq: MMAT). I’ll use it as an example as their earnings came out yesterday (May 10), and first quarter revenue was up 299%. This year the stock price has tumbled. Like most young tech companies, MMAT still operates at a loss; this example is not a recommendation one way or another.

Meta Materials was a company that flew under my radar until I learned about them at NobleCon18. They are involved in products that will help the builders of everything that we expect to see more of in the future. This includes:

  • Making 5G work substantially better
  • Resolving weather-related issues with automotive sensors
  • Medical imaging and sensing enhancement
  • Eliminating the need for expensive rare earth materials in touch screens
  • And a lot more

Ken Rice, the COO and CFO of Meta Materials, said at NobleCon, “we didn’t leave the Stone Age because we ran out of rocks, we left the Stone Age because somebody invented bronze and figured out it was better…” The company is providing better materials to growing industries and is doing it with greater speed, lower cost, and improved scale. 

They have over 269 active or pending patents from which to benefit; it is not a patent portfolio held to trade, this was made clear when during the NobleCon presentation, the COO said they exist to “keep everybody out of our sandbox.”

Meta materials is an interesting company with the promise of trumping yesterday’s amazing high-tech building materials with better ones. Watch the NobleCon18 video to understand how Meta Materials can essentially produce the “cloak of invisibility.”

What to Look For

History has shown us a few things about the stock market. First, it has always come back and hit new highs. Second, it confounds those that require certainty, investors are better served by placing probabilities in their corner, and third, there is always a rotation, while money is leaving one industry or sector, it is moving to another.

Technology has been a sector where a product or invention that was incredible when released, becomes replaced by something even better in a dozen years or so years. Pay no more attention to old technology then new. Look at what tomorrow is likely to demand to be better, this is one smart place theme to start a search.

Take-Away

Markets go up and markets go down. If it were predictable, it would already be where it’s going. What is highly probable is tomorrow’s technologies are going to be replacements for today’s. And, tomorrow is coming, there’s nothing we can do about it.

For investors and traders that are seeing more red in their portfolio than they have since March 2020, look with a level head at the possibilities still around, read up on some of the 6000+ small companies available on Channelchek, subscribe to Channelchek’s YouTube channel and don’t rush into anything until you’ve got a handle on your odds of success.

Paul Hoffman

Managing Editor, Channelchek

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Meta Materials (MMAT) NobleCon18 Presentation Replay

Sources

https://feeds.issuerdirect.com/news-release.html?newsid=8330648170070524

https://channelchek.com/news-channel/Meta_Materials__MMAT__NobleCon18_Presentation_Replay

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