The Trend Away from Opioids Provides Investors with Many Opportunities

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The Growing Field of Non-Opioid Pain Alleviation

Is there money to be made for investors in the business of controlling pain? There is a decreased willingness or ability of doctors to prescribe opioids because of the risk of addiction. This is just one reason the companies making breakthroughs in controlling or alleviating pain are set to get a bigger chunk of the growing industry. The other driver is an aging populous with increased longevity. The non-opioid pain management developments include novel medicines and medical devices to treat, prevent, or assess causes. Investors could benefit from growing their awareness in this healthcare space, particularly some of the smaller companies concentrating on the pain management sector.

The pain management (PM) industry is rapidly growing. Estimates on the potential for the industry were captured in a report by Zion Market Research. The report shows the trajectory of the pain management therapeutics industry is likely to amass earnings of about $81.9 billion by 2026. This is an increase of $16.3 billion over 2019 earnings. Reduced opioid use has opened a path for inventive new therapeutics to become the new go-to where an opioid would have been prescribed previously. This provides investors with an even broader spectrum of publicly traded opportunities to review.

Segments in Pain Management

Treatment of chronic pain has a large base as a major healthcare service. This base provides a solid footing for the business of pain management therapeutics. Pain-relieving drugs such as opioids have been the “go to” medication for patients with severe pain. But their usage needs to be short-term or limited to treat pain in the terminally ill. The reduced and safer use of opioids leave many sufferers needing new alternatives.

As with any other investment space there is a wide swath of segmentation and sectors within the business. The primary pharmaceutical segments in pain management include:

Anesthetics

NSAIDS

Anticonvulsants

Anti-migraine agents

Antidepressants

Non-narcotic analgesics

Neuropathic Pain

Arthritic Pain

Cancer pain

Post-operative Pain

Chronic Back Pain

Fibromyalgia

Migraines

The anticipated growth of pain management therapeutics within North American healthcare is expected to happen on several fronts. Players include the nimble, creative small growth companies as well as the huge established names. Large companies involved in the segment include Novartis AG, Purdue Pharma L.P., AstraZeneca Plc., Mallinckrodt Pharmaceuticals, GlaxoSmithKline Plc., Teva Pharmaceutical Industries Ltd., Pfizer Inc., Depomed, Inc., Johnson & Johnson Services, Inc., Endo International Plc., Merck & Co., Inc., and Abbott Laboratories. These are big corporations where successful individual products aren’t as impactful to the bottom line or stock price movement.

The smaller, more nimble prospects, where developments have a greater impact on value could be worth learning about. There are a number of them that have developed solutions that are just now becoming adopted and substituted for old methods of treatment. Below is a list of five companies in this space that may be worth becoming familiar with:

Baudax Bio Inc.

(BXRX) is a pharmaceutical company. It is focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs.

BXRX is currently trading at $3.45 and has a market cap of $1.73 million.

PainReform Ltd

PRFX is a clinical-stage specialty pharmaceutical company. It is focused on the reformulation of established therapeutics. The company’s product PRF-110 is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended post-operative analgesia.

PRFX is currently trading at $0.41 and has a market cap of $4.36 million.

NanoVibronix

NAOV is engaged in manufacturing of noninvasive biological response-activating devices which target wound healing and pain therapy, without the assistance of medical professionals. The primary products of the company include WoundShield which is patch-based therapeutic ultrasound device to help regenerate tissue and healing by using ultrasound to increase local capillary perfusion and tissue oxygenation; PainShield which is a disposable patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures; and UroShield which is an ultrasound-based product designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain. Most of the company’s revenue comes from the U.S.

NAOV is currently trading at $0.37 with a market cap of $12.14 million.

electroCore Inc.

ECOR is a commercial-stage bioelectronic medicine company with a platform for non-invasive vagus nerve stimulation therapy initially focused on neurology and rheumatology. The company’s product gammaCore is FDA-cleared for adjunctive use for the preventive treatment of cluster headache and for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

ECOR is trading at $0.28 and has a market cap of $20.27 million.

Bioelectronics Corp.

BIEL is an electroceutical company. It develops wearable, neuromodulation devices to safely mitigate neurological diseases. Its product line includes Actipatch Musculoskeletal Pain Therapy, Allay menstrual pain therapy, Smart insole heel pain therapy and Recovery RX post-operative and Chronic wounds therapy. The company sells its products to wholesale distributors, directly to hospitals and clinics, and consumers.

BIEL tades for under $0.01 a share, but has a market cap of $59.36 million and average trading volume of 13.4 million shares.

Take Away

Investing based on trends that are building is one method to develop a longer-term investment portfolio. One trend that is likely to continue is the move away from addictive opioids used for pain management and towards both pharmaceutical and device-based solutions. As with many sectors this year, stock valuations are down. Does this make one or more of them a smart buy?

Small and microcap investing come with its challenges. Help sort through the plusses and minuses of life sciences companies, both in biotech and medical devices, as two top equity analysts discuss what they look for when evaluating the fundamentals of a company’s prospects. The free event held online on December 15th will also include analysts with expertise in other industries sharing what they deem important in the industries they cover. All in all, it will help small, and microcap investors in the life sciences and other sectors better understand what the seasoned veterans look at.

Paul Hoffman

Managing Editor, Channelchek

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Sources:

https://www.zionmarketresearch.com/news/pain-management-therapeutics-market

https://www.channelchek.com

https://channelchek.vercel.app/news-channel/New_Developments_in_Pain_Management___a_NobleCon_Online_Investor_Event___Presenting_Companies

Release – Onconova Therapeutics to Present At The Upcoming Medinvest Oncology Investor Conference

Research, News, and Market Data on ONTX

PDF Version

NEWTOWN, Pa., Dec. 07, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that it will participate in the MedInvest Oncology Investor Conference being held in New York, NY on December 14-15, 2022.

Steven M. Fruchtman, M.D., President and Chief Executive Officer, will present a corporate overview at the conference on Wednesday, December 14th at 9:40 a.m. ET. Dr. Fruchtman and other members of the Onconova management team will also be available for one-on-one meetings at the conference on December 14th.

Those interested in requesting a one-on-one meeting can submit a registration request using the conference website: https://www.medinvestconferences.com/register.

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.

Company Contact:
Mark Guerin
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

Release – Vera Bradley Announces Third Quarter Fiscal Year 2023 Results

Research, News, and Market Data on VRA

Dec 7, 2022

Consolidated third quarter net revenues totaled $124.0 million

Third quarter net income totaled $5.2 million, or $0.17 per diluted share, vs. $0.17 per diluted share last year; excluding certain items, non-GAAP net income totaled $6.3 million, or $0.20 per diluted share, vs. $0.18 per diluted share last year

Balance sheet remains solid, with cash and cash equivalents of $25.2 million and no debt

Jackie Ardrey named President and CEO effective November 1, 2022, replacing retiring President and CEO Rob Wallstrom

FORT WAYNE, Ind., Dec. 07, 2022 (GLOBE NEWSWIRE) — Vera Bradley, Inc. (Nasdaq: VRA) today announced its financial results for the third quarter ended October 29, 2022.

In this release, Vera Bradley, Inc. or “the Company” refers to the entire enterprise and includes both the Vera Bradley and Pura Vida brands. Vera Bradley on a stand-alone basis refers to the Vera Bradley brand.

Third Quarter Comments

Rob Wallstrom, outgoing Chief Executive Officer of the Company, commented, “We are pleased with our year-over-year improvement in third quarter non-GAAP EPS, largely driven by implementation of our targeted expense reductions. Total Company third quarter revenues of $124.0 million were modestly above overall expectations, and we began to experience some stabilization in our gross margin rate as supply chain challenges moderated and strategic price increases helped offset increased raw material and freight costs.

“As in past quarters, we are continuing to experience bifurcation in the spending of our customer base. Vera Bradley’s Direct Full-Price Channel customers with higher household incomes remained more engaged and continued to spend more than customers with lower household incomes, especially in our Vera Bradley Factory Channel, where inflationary pressures impacted traffic and discretionary spending. However, our Vera Bradley Indirect Channel experienced its third consecutive quarter of year-over-year growth.”

“We opened two additional Pura Vida Full-Price retail stores in the quarter, and they are performing ahead of our expectations,” Wallstrom continued. “As with many direct-to-consumer companies, we have seen a shift from a pure-digital-play model to an integrated multi-channel platform. Our four Full-Price retail stores are not only profitable but have driven improved ecommerce traffic and revenue in their trade areas. However, overall Pura Vida revenues continued to be negatively impacted by the shift in social and digital media effectiveness and rising digital media costs, and we experienced a decline in sales to wholesale accounts.”

Jackie Ardrey Named President and CEO

Jackie Ardrey joined the Company as President and CEO effective November 1, 2022, replacing retiring President and CEO Wallstrom. Wallstrom will continue to work closely with Ardrey through the end of December 2022 to ensure a smooth transition. Ardrey also replaced Wallstrom on the Company’s Board of Directors.

Ardrey is an accomplished, results-oriented leader with over 25 years of experience in multi-channel retail enterprises. Between 2018 and October 2022, she held the post of President at home furnishings and seasonal décor catalog and online retailer Grandin Road, part of the Qurate Retail Group. Previously, Ardrey was CEO of Trading Company Holdings and Senior Vice President of Merchandising and Supply Chain for iconic omnichannel gourmet food and gifting brand Harry and David. Prior to that, she spent 14 years at multi-channel high-end children’s retailer Hanna Andersson in various roles of increasing responsibility, including Senior Vice President of Merchandising, Design, and Wholesale.

“Although I have just been with the Company a few short weeks, I am convinced that both our Vera Bradley and Pura Vida brands have untapped potential in the marketplace,” Ardrey commented. “While I expect the macro environment to remain unpredictable, our teams are focused, and our cash position and balance sheet remain solid. I look forward to working closely with our leadership teams to develop and execute solid growth plans; leverage our many opportunities, especially in merchandising and marketing; and deliver consistent, sustainable growth and value to our stakeholders over the long term.”

Summary of Financial Performance for the Third Quarter

Consolidated net revenues totaled $124.0 million compared to $134.7 million in the prior year third quarter ended October 30, 2021.

For the current year third quarter, Vera Bradley, Inc.’s consolidated net income totaled $5.2 million, or $0.17 per diluted share. These results included $1.1 million of net after tax charges, comprised of $0.6 million of consulting and professional fees primarily associated with cost savings initiatives and the CEO search, $0.4 million for the amortization of definite-lived intangible assets, and $0.3 million of severance and stock-based retirement compensation charges, partially offset by a benefit of $0.2 million for the reversal of certain purchase order cancellation fees. On a non-GAAP basis, Vera Bradley, Inc.’s consolidated third quarter net income totaled $6.3 million, or $0.20 per diluted share.

For the prior year third quarter, Vera Bradley, Inc.’s consolidated net income totaled $5.8 million, or $0.17 per diluted share. These results included $0.4 million of net after tax charges related to intangible asset amortization. On a non-GAAP basis, Vera Bradley, Inc.’s consolidated third quarter net income totaled $6.2 million, or $0.18 per diluted share.

Summary of Financial Performance for the Nine Months

Consolidated net revenues totaled $352.9 million for the current year nine months ended October 29, 2022, compared to $390.9 million in the prior year nine month period ended October 30, 2021.

For the current year nine months, Vera Bradley, Inc.’s consolidated net loss totaled ($31.6) million, or ($1.00) per diluted share. These results included $34.2 million of net after tax charges, comprised of $18.2 million of Pura Vida goodwill and intangible asset impairment charges, $5.0 million of severance and stock-based retirement compensation retirement charges and other employee costs, $4.7 million of inventory adjustments associated with the exit of certain technology products and the write-off of excess mask inventory, $3.0 million of consulting and professional fees primarily associated with cost savings initiatives and the CEO search, $1.3 million of intangible asset amortization, $1.0 million of store and right-of-use asset impairment charges, $0.7 million of purchase order cancellation fees for spring 2023 goods, and $0.3 million of goodMRKT exit costs. On a non-GAAP basis, Vera Bradley, Inc.’s consolidated net income for the nine months totaled $2.6 million, or $0.08 per diluted share.

For the prior year nine months, Vera Bradley, Inc’s consolidated net income totaled $12.7 million, or $0.37 per diluted share. These results included $1.3 million of net after tax charges related to intangible asset amortization. On a non-GAAP basis, Vera Bradley, Inc.’s consolidated net income totaled $14.0 million, or $0.41 per diluted share, for the nine months.

Non-GAAP Numbers

The current year non-GAAP third quarter income statement numbers referenced below exclude the previously outlined consulting and professional fees primarily associated with cost savings initiatives and the CEO search, amortization of definite-lived intangible assets, severance and stock-based retirement compensation charges, and a benefit for the reversal of certain purchase order cancellation fees. The current year non-GAAP income statement numbers for the nine months referenced below exclude the previously outlined goodwill and intangible asset impairment charges, severance and stock-based retirement compensation retirement charges and other employee costs, inventory adjustments, consulting and professional fees, intangible asset amortization, store and right-of-use asset impairment charges, purchase order cancellation fees, and goodMRKT exit costs.

The prior year non-GAAP third quarter and nine-month income statement numbers referenced below exclude the previously outlined intangible asset amortization.

Third Quarter Details

Current year third quarter Vera Bradley Direct segment revenues totaled $80.1 million, a 7.6% decrease from $86.6 million in the prior year third quarter. Comparable sales decreased 9.6% in the third quarter. The Company permanently closed 12 full-line stores and opened 5 factory outlet stores in the last twelve months.

Vera Bradley Indirect segment revenues totaled $22.3 million, a 6.7% increase over $20.9 million in the prior year third quarter, reflecting an increase in certain key account orders, partially offset by a decline in specialty account orders.

Pura Vida segment revenues totaled $21.7 million, a 20.3% decrease from $27.2 million in the prior year.

Third quarter consolidated gross profit totaled $65.9 million, or 53.1% of net revenues, compared to $72.3 million, or 53.6% of net revenues, in the prior year. On a non-GAAP basis, current year gross profit totaled $65.6 million, or 52.9% of net revenues. The current year gross profit rate was negatively affected by higher inbound and outbound freight expense, deleverage of overhead costs, and channel mix changes, partially offset by price increases.

Third quarter consolidated SG&A expense totaled $60.1 million, or 48.4% of net revenues, compared to $64.5 million, or 47.8% of net revenues, in the prior year. On a non-GAAP basis, consolidated SG&A expense totaled $57.6 million, or 46.4% of net revenues for the current year third quarter, compared to $63.7 million, or 47.3% of net revenues, in the prior year. As expected, Vera Bradley’s SG&A current year expenses were lower than the prior year primarily due to cost reduction initiatives and a reduction in variable-related expenses due to the lower sales volume.

The Company’s third quarter consolidated operating income totaled $6.0 million, or 4.8% of net revenues, compared to $8.0 million, or 5.9% of net revenues, in the prior year third quarter. On a non-GAAP basis, the Company’s current year consolidated operating income totaled $8.2 million, or 6.6% of net revenues, compared to $8.7 million, or 6.5%, of net revenues, in the prior year.

By segment:

  • Vera Bradley Direct operating income was $17.1 million, or 21.3% of Direct net revenues, for the third quarter, compared to $17.8 million, or 20.6% of Direct net revenues, in the prior year. On a non-GAAP basis, current year Direct operating income totaled $16.8 million, or 21.0% of Direct revenues.
  • Vera Bradley Indirect operating income was $9.0 million, or 40.4% of Indirect net revenues, for the third quarter, compared to $7.3 million, or 35.1% of Indirect net revenues, in the prior year. On a non-GAAP basis, current year Indirect operating income totaled $9.0 million, or 40.2% of Indirect net revenues.
  • Pura Vida’s operating loss was ($1.4) million, or (6.2%) of Pura Vida net revenues, in the current year, compared to operating income of $1.8 million, or 6.6% of Pura Vida net revenues, in the prior year. On a non-GAAP basis, Pura Vida’s operating loss was ($0.1) million, or (0.3%) of Pura Vida net revenues, compared to operating income of $2.6 million, or 9.4% of Pura Vida net revenues, in the prior year.

Details for the Nine Months

Vera Bradley Direct segment revenues for the current year nine-month period totaled $228.7 million, an 8.7% decrease from $250.5 million in the prior year. Comparable sales declined 11.6% for the nine months.

Vera Bradley Indirect segment revenues for the nine months totaled $56.6 million, a 6.8% increase over $53.0 million in the prior year, reflecting an increase in certain key account orders, partially offset by a decline in specialty account orders.

Pura Vida segment revenues for the nine months totaled $67.5 million, a 22.7% decrease from $87.4 million in the prior year.

Consolidated gross profit for the nine months totaled $178.9 million, or 50.7% of net revenues, compared to $211.8 million, or 54.2% of net revenues, in the prior year. On a non-GAAP basis, current year gross profit totaled $185.9 million, or 52.7% of net revenues. The current year gross profit rate was negatively affected by higher inbound and outbound freight expense, deleverage of overhead costs, and channel mix changes, partially offset by price increases.

For the nine months, consolidated SG&A expense totaled $195.0 million, or 55.3% of net revenues, compared to $194.1 million, or 49.7% of net revenues, in the prior year. On a non-GAAP basis, current year consolidated SG&A expense totaled $181.0 million, or 51.3% of net revenues, compared to $191.8 million, or 49.1% of net revenues, in the prior year. As expected, Vera Bradley’s non-GAAP SG&A current year expenses were lower than the prior year primarily due to cost reduction initiatives and a reduction in variable-related expenses due to the lower sales volume.

For the nine months, the Company’s consolidated operating loss totaled ($45.1) million, or (12.8%) of net revenues, compared to consolidated operating income of $18.6 million, or 4.8% of net revenues, in the prior year nine-month period. On a non-GAAP basis, the Company’s current year consolidated operating income was $5.3 million, or 1.5% or net revenues, compared to $20.9 million, or 5.4% of net revenues, in the prior year.

By segment:

  • Vera Bradley Direct operating income was $32.6 million, or 14.3% of net revenues, compared to $51.9 million, or 20.7% of Direct net revenues, in the prior year. On a non-GAAP basis, current year Direct operating income was $38.6 million, or 16.9% of Direct net revenues.
  • Vera Bradley Indirect operating income was $18.4 million, or 32.5% of Indirect net revenues, compared to $17.4 million, or 32.8% of Indirect net revenues, in the prior year. On a non-GAAP basis, current year Indirect operating income totaled $19.4 million, or 34.2% of Indirect net revenues.
  • Pura Vida’s operating loss was ($28.8) million, or (42.7%) of Pura Vida net revenues, for the current year, compared to operating income of $7.5 million, or 8.6% of Pura Vida net revenues, in the prior year. On a non-GAAP basis, Pura Vida’s operating income was $4.3 million, or 6.4% of Pura Vida net revenues, for the current year, compared to $9.8 million, or 11.3% of Pura Vida net revenues, for the prior year.

Balance Sheet

Net capital spending for the third quarter and nine months totaled $2.6 million and $7.0 million, respectively.

Cash, cash equivalents, and investments as of October 29, 2022 totaled $25.2 million compared to $75.3 million at the end of last year’s third quarter. The Company had no borrowings on its $75 million ABL credit facility at quarter end.

Total quarter-end inventory was $178.3 million, compared to $148.3 million at the end of the third quarter last year. Total current year inventory was higher than the prior year primarily due to approximately $17 million in incremental logistics costs burdening overall inventory as well as incremental Vera Bradley Factory inventory related to lower than expected revenues.

During the third quarter, the Company repurchased approximately $0.8 million of its common stock (approximately 0.2 million shares at an average price of $3.56), bringing year-to-date purchases through the end of the third quarter to approximately $17.3 million (approximately 2.6 million shares at an average price of $6.56). The Company has $28.5 million of remaining availability under its $50.0 million repurchase authorization that expires in December 2024.

Forward Outlook

Ardrey noted, “We expect the fourth quarter macroeconomic environment to continue to be unpredictable; the Pura Vida business will continue to be challenging; inflationary pressures will continue to impact Vera Bradley customers with lower household incomes, particularly in the Factory Channel; and there will be continued pressure on gross margin.”

Excluding net revenues, all forward-looking guidance numbers referenced below are non-GAAP. The prior year SG&A and earnings per diluted share numbers exclude the previously disclosed net charges related to intangible asset amortization. Current year guidance excludes previously disclosed goodwill and intangible asset impairment charges, severance and stock-based retirement compensation retirement charges and other employee costs, inventory adjustments, consulting and professional fees, intangible asset amortization, store and right-of-use asset impairment charges, purchase order cancellation fees, and goodMRKT exit costs.

For the fourth quarter of Fiscal 2023, the Company’s expectations are as follows:

  • Consolidated net revenues of $136 to $141 million. Net revenues totaled $149.6 million in the prior year fourth quarter.
  • A consolidated gross profit percentage of 49.5% to 50.5% compared to 50.9% in the prior year fourth quarter. The expected decrease is primarily associated with incremental targeted promotional activity and deleverage on overhead costs, partially offset by price increases and lower year-over-year freight expense. 
  • Consolidated SG&A expense of $61 to $63 million compared to $67.1 million in the prior year fourth quarter. The reduction in SG&A expense is being driven by cost reduction initiatives and a reduction in compensation expense, marketing, and other variable-related expenses due to the expected sales decline from the prior year.
  • Consolidated diluted EPS of $0.16 to $0.20 based on diluted weighted-average shares outstanding of 31.1 million and an effective tax rate of approximately 25%. Diluted EPS totaled $0.17 in last year’s fourth quarter.

For Fiscal 2023, the Company’s updated expectations are as follows:

  • Consolidated net revenues of $489 to $494 million. Net revenues totaled $540.5 million in Fiscal 2022. Year-over-year Vera Bradley revenues are expected to decline between 6% and 7%, and Pura Vida revenues are expected to decline between 20% and 21%.
  • A consolidated gross profit percentage of 51.9% to 52.1% compared to 53.3% in Fiscal 2022. The expected year-over-year decrease is primarily related to incremental inbound and outbound freight expense, incremental targeted promotional activity, and deleverage on overhead costs, partially offset by price increases.
  • Consolidated SG&A expense of $242 to $244 million compared to $258.8 million in Fiscal 2022. The reduction in SG&A expense is being driven by cost reduction initiatives and a reduction in compensation expense, marketing, and other variable-related expenses due to the expected sales decline from the prior year.
  • Consolidated operating income of $11.6 to $13.5 million compared to $30.1 million in Fiscal 2022.
  • Consolidated diluted EPS of $0.22 to $0.26 based on diluted weighted-average shares outstanding of 31.6 million and an effective tax rate of between 24.0 and 25.0%. Diluted EPS totaled $0.57 last year.
  • Net capital spending of approximately $10 million compared to $5.5 million in the prior year, reflecting investments associated with new Vera Bradley factory and Pura Vida store locations and technology and logistics enhancements.

Disclosure Regarding Non-GAAP Measures

The Company’s management does not, nor does it suggest that investors should, consider the supplemental non-GAAP financial measures in isolation from, or as a substitute for, financial information prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Further, the non-GAAP measures utilized by the Company may be unique to the Company, as they may be different from non-GAAP measures used by other companies.

The Company believes that the non-GAAP measures presented in this earnings release, including cost of sales; gross profit; selling, general, and administrative expenses; impairment of goodwill and intangible assets; operating income (loss); net income (loss); net (loss) income attributable and available to Vera Bradley, Inc.; and diluted net income (loss) per share available to Vera Bradley, Inc. common shareholders, along with the associated percentages of net revenues, are helpful to investors because they allow for a more direct comparison of the Company’s year-over-year performance and are consistent with management’s evaluation of business performance. A reconciliation of the non-GAAP measures to the most directly comparable GAAP measures can be found in the Company’s supplemental schedules included in this earnings release.

Call Information

A conference call to discuss results for the third quarter is scheduled for today, Wednesday, December 7, 2022, at 9:30 a.m. Eastern Time. A broadcast of the call will be available via Vera Bradley’s Investor Relations section of its website, www.verabradley.com. Alternatively, interested parties may dial into the call at (800) 437-2398, and enter the access code 6836290. A replay will be available shortly after the conclusion of the call and remain available through December 21, 2022. To access the recording, listeners should dial (844) 512-2921, and enter the access code 6836290.

About Vera Bradley, Inc.

Vera Bradley, Inc. operates two unique lifestyle brands – Vera Bradley and Pura Vida. Vera Bradley and Pura Vida are complementary businesses, both with devoted, emotionally-connected, and multi-generational female customer bases; alignment as casual, comfortable, affordable, and fun brands; positioning as “gifting” and socially-connected brands; strong, entrepreneurial cultures; a keen focus on community, charity, and social consciousness; multi-channel distribution strategies; and talented leadership teams aligned and committed to the long-term success of their brands.

Vera Bradley, based in Fort Wayne, Indiana, is a leading designer of women’s handbags, luggage and other travel items, fashion and home accessories, and unique gifts.  Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand is known for its innovative designs, iconic patterns, and brilliant colors that inspire and connect women unlike any other brand in the global marketplace.

In July 2019, Vera Bradley, Inc. acquired a 75% interest in Creative Genius, Inc., which also operates under the name Pura Vida Bracelets (“Pura Vida”). Pura Vida, based in La Jolla, California, is a digitally native, highly-engaging lifestyle brand founded in 2010 by friends Paul Goodman and Griffin Thall. Pura Vida has a differentiated and expanding offering of bracelets, jewelry, and other lifestyle accessories.

The Company has three reportable segments: Vera Bradley Direct (“VB Direct”), Vera Bradley Indirect (“VB Indirect”), and Pura Vida. The VB Direct business consists of sales of Vera Bradley products through Vera Bradley full-line and factory outlet stores in the United States, verabradley.com, verabradley.ca, Vera Bradley’s online outlet site, and the Vera Bradley annual outlet sale in Fort Wayne, Indiana. The VB Indirect business consists of sales of Vera Bradley products to approximately 1,700 specialty retail locations throughout the United States, as well as select department stores, national accounts, third party e-commerce sites, and third-party inventory liquidators, and royalties recognized through licensing agreements related to the Vera Bradley brand. The Pura Vida segment consists of sales of Pura Vida products through the Pura Vida websites, www.puravidabracelets.comwww.puravidabracelets.eu, and www.puravidabracelets.ca; through the distribution of its products to wholesale retailers and department stores; and through its Pura Vida retail stores.

Website Information

We routinely post important information for investors on our website www.verabradley.com in the “Investor Relations” section. We intend to use this webpage as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, our webpage is not incorporated by reference into, and is not a part of, this document.

Investors and other interested parties may also access the Company’s most recent Corporate Responsibility and Sustainability Report outlining its ESG (Environmental, Social, and Governance) initiatives at https://verabradley.com/pages/corporate-responsibility.

Vera Bradley Safe Harbor Statement

Certain statements in this release are “forward-looking statements” made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the Company’s current expectations or beliefs concerning future events and are subject to various risks and uncertainties that may cause actual results to differ materially from those that we expected, including: possible adverse changes in general economic conditions and their impact on consumer confidence and spending; possible inability to predict and respond in a timely manner to changes in consumer demand; possible loss of key management or design associates or inability to attract and retain the talent required for our business; possible inability to maintain and enhance our brands; possible inability to successfully implement the Company’s long-term strategic plan; possible inability to successfully open new stores, close targeted stores, and/or operate current stores as planned; incremental tariffs or adverse changes in the cost of raw materials and labor used to manufacture our products; possible adverse effects resulting from a significant disruption in our distribution facilities; or business disruption caused by COVID-19 or other pandemics. Risks, uncertainties, and assumptions also include the possibility that Pura Vida acquisition benefits may not materialize as expected and that Pura Vida’s business may not perform as expected. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s public reports filed with the SEC, including the Company’s Form 10-K for the fiscal year ended January 29, 2022. We undertake no obligation to publicly update or revise any forward-looking statement. Financial schedules are attached to this release.

CONTACTS:
Investors:
Julia Bentley, VP of Investor Relations and Communications
jbentley@verabradley.com
(260) 207-5116

Media:        
mediacontact@verabradley.com
877-708-VERA (8372)

Release – Ocugen Announces Update on Ocu400 Phase 1/2 Clinical Trial Targeting Retinitis Pigmentosa and Leber Congenital Amaurosis

Research, News, and Market Data on OCGN

December 7, 2022

Continued Positive Safety Data for OCU400

Established High Dose as the Maximum Tolerable Dose in Current OCU400
Clinical Trial

MALVERN, Pa., Dec. 07, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data Safety and Monitoring Board (DSMB) for the OCU400 clinical trial recently convened and established high dose as the maximum tolerable dose (MTD) in the dose-escalation phase of the study.

“The DSMB has recommended moving forward to dose subsequent subjects with NR2E3 and RHO gene mutations associated with Retinitis Pigmentosa (RP) and CEP290 gene mutations associated with Leber Congenital Amaurosis (LCA) at the targeted dose in the expansion phase of the study,” said Dr. Peter Y. Chang, MD, FACS, Massachusetts Eye Research & Surgery Institution, DSMB Chair for the OCU400 clinical trial. “No serious adverse events (SAEs) related to OCU400 have been reported to date.”

10 patients with NR2E3 and RHO gene mutations associated with RP have been dosed in the Phase 1/2 clinical trial to date. An additional eight patients with these RP gene mutations, along with three patients with CEP290 gene mutations associated with LCA, will be dosed at MTD and enrollment is expected to be complete by the end of Q1 2023.

Data from the MTD has the potential to navigate strategy for the planned Phase 3 study in the U.S. and other major markets. The Company plans to file a Biologics License Application (BLA) for OCU400 in 2025.

Ocugen is committed to finding solutions for people with inherited retinal disease for whom no effective treatment options exist. Currently, RP is associated with mutations in more than 100 genes, affecting more than 2.5 million people globally. LCA is a rare eye disease associated with mutations in more than 25 genes, affecting more than 150,000 people globally.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

Release – CoreCivic Receives Lease Termination Notice for the California City Correctional Center from the State of California

Research, News, and Market Data on CXW

December 6, 2022

BRENTWOOD, Tenn., Dec. 06, 2022 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (CoreCivic or the Company) announced today it received notice from the California Department of Corrections and Rehabilitation (CDCR) of its intent to terminate the lease agreement for the company-owned, 2,560-bed California City Correctional Center (CCCC) by March 31, 2024, due to the state’s declining inmate population.

The lease agreement is fully funded through the current fiscal year ending June 30, 2023. Funding for the lease of the CCCC for the 2024 fiscal year, beginning July 1, 2023, will be determined in the California legislature in the first half of 2023 as part of the annual budget process. As part of this process the Company plans to engage with the state of California regarding the continued utilization of the CCCC by the CDCR due to its modern infrastructure, efficient design, and comprehensive maintenance program.

Since the lease of the CCCC commenced in 2013, the Company has continually invested in facility enhancements to ensure the CCCC is operating at its optimum performance to the benefit of the facility’s residents, the correctional professionals employed at the CCCC and CDCR. In order to support the Company’s environmental sustainability commitments, the Company recently procured a 100% renewable electricity supply for the facility. The Company believes these factors, along with the advanced age of many of the state of California’s other correctional facilities, support the continued lease of the CCCC by the CDCR.

Rental revenue generated from the CDCR at the CCCC for year ended December 31, 2021, and nine months ended September 30, 2022, was $33.3 million and $25.7 million, respectively, and is reported in the CoreCivic Properties business segment. CoreCivic is very proud of its opportunity over the past nine years to help the state of California successfully manage through its historic challenges with prison overcrowding. The Company believes its relationship with the state of California has demonstrated the value and flexibility it provides to governments across its full range of solutions, including through innovative lease agreements like the one at CCCC.

About CoreCivic

CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. CoreCivic provides a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. CoreCivic is the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and believes it is the largest private owner of real estate used by government agencies in the United States. CoreCivic has been a flexible and dependable partner for government for nearly 40 years. CoreCivic’s employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.

Forward-Looking Statements

This press release contains statements as to CoreCivic’s beliefs and expectations of the outcome of future events that are “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. These include, but are not limited to, the risks and uncertainties associated with the timing of the lease termination, which could potentially occur prior to March 31, 2024, and the Company’s intention to engage with the state of California regarding the continued utilization of the CCCC by the CDCR.

CoreCivic takes no responsibility for updating the information contained in this press release following the date hereof to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events or for any changes or modifications made to this press release or the information contained herein by any third-parties, including, but not limited to, any wire or internet services.

Contact:Investors: Cameron Hopewell – Managing Director, Investor Relations – (615) 263-3024
Financial Media: David Gutierrez, Dresner Corporate Services – (312) 780-7204
  

Cathie Wood Expands on Her Expectations of Deflation

Image Credit: Singularity University (YouTube)

An Alternative View of Today’s Economy by Cathie Wood

Cathie Wood made the argument that investors comparing the current economic crosscurrents to the 1970s are developing forecasts based on the wrong data-set. Speaking at the Finimize Modern Investor Summit via video, the ARK Invest funds founder instead suggested the current economy and inputs are similar to a different period – she then made a case for her reasoning.

“If you go back to the 19-teens (1912-1922), then the period was very similar to the period we’re in today,” she said at the Investor Summit. That period featured a war, a pandemic (Spanish flu), and supply-chain problems. “It was the most prolific period for innovation in history,” she said, pointing to the disruptive impact of electricity, the telephone, and the car.

Wood explained that inflation went from 24% in June 1920 to -15% in June 2021. She made clear she isn’t forecasting deflation this severe; however, she is expecting year-over-year inflation to swing into negative territory, with prices going down. “What has happened during the last few years is going to flip, and we think that the market will flip back to a preference for growth stocks and our innovation strategy,” she said.

Wood also elaborated on a tweet she issued earlier about how deep the inversion was of the yield curve.

Twitter @CathieDWood

“That’s the bond market saying, ‘hello, Fed, are you watching?'” She said Federal Reserve Chair Jerome Powell is trying to be the reincarnation of Paul Volcker at a time when it’s not appropriate. “I think that’s a mistake because this is not a 15-year problem; it’s a 15-month one,” said Wood. She highlighted that commodity prices are tumbling, supply chains are improving, and companies are

Ark Invest funds have been positioned in a more concentrated waiting pattern while Wood waits for inflation dynamics to be supportive of innovation. She gave an example; the innovation fund, for instance, has been narrowed to 32 companies from 58, Wood said, as she highlighted that the firm has become less convinced China is supportive of innovation.

Take Away

It’s worth reviewing the differing opinions of several investors that have made above-average returns in their careers. While almost no one is always correct, there are many different right ways to make money in any market.

The Ark flagship fund is down 63% this year; in the past, Wood has indicated her funds’ time period to measure return is five years, not one. Perhaps investors with a longer holding period can garner useful ideas from her pounding the deflation drum, while investors with a shorter time horizon are concerned about inflation.

Paul Hoffman

Managing Editor, Channelchek

Great Lakes Dredge & Dock (GLDD) – Fleet Renewal Program Moving Forward


Wednesday, December 07, 2022

Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Fleet Renewal. Great Lakes announced the Galveston Island is in the water and is scheduled to be in operation in the first half of 2023. The Galveston Island provides Great Lakes with additional capacity and improved efficiencies. The new vessel will  have a positive impact on Great Lakes’ competitiveness in the coastal protection and maintenance markets as well as address the specific needs in the growing offshore wind market, in our view. Next step is to undergo sea trials, which we expect will happen shortly.

Introducing the Galveston Island. Originally announced in June 2020, the Galveston Island is a 6,500-cubic-yard-capacity Trailing Suction Hopper Dredge. The dredge will be equipped with a direct high-power pump-ashore installation, dredging system automation, dynamic positioning and tracking, U.S. EPA Tier IV compliant engines, and have capabilities of running on biofuel to minimize the environmental impact. Cost to build was around $100 million.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Baudax Bio (BXRX) – Closing of $5 million Public Offering is Announced


Wednesday, December 07, 2022

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Gross proceeds of nearly $5 million or net proceeds around $4.2 million.  The offering consisted of 1,042,087 shares of common stock (or Series C pre-funded warrants) combined with both a Series A-3 warrant to purchase 1,042,087 common shares and a Series A-4 warrant to purchase 1,042,787 common shares.  The combined unit was publicly offered at $4.795 per unit. The pre-funded warrants were offered to purchasers where the offering would result in beneficial ownership greater than 4.99% (or, at the election of the purchaser, 9.99%).

Warrants exercisable at $4.50 per share.  The Series C pre-funded warrants are exercisable at $0.01 per share. The Series A-3 warrants are exercisable immediately and will expire 5 years from date of issuance.  The Series A-4 warrants are exercisable immediately and expire 13 months from date of issuance.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Demand for Tankers Causes Shipping Rates to Explode

Oil Tanker Day Rates To Be Supported By The EU’s Ban On Russian Crude

Over the past 12 months, global container shipping rates have steadily declined to their long-term averages as supply chain snarls have receded and backups at ports have disappeared.

Now, another segment of the cargo shipping industry is seeing day rates explode to record highs.

So-called dirty tankers, those that carry crude oil, are charging over $100,000 a day for their services as international sanctions against Russia force ships—including Suezmaxes, Aframaxes and very large crude carriers (VLCCs)—to take longer, more circuitous routes. Carriers that once made deliveries to the North Sea port of Rotterdam via the Baltic Sea are now having to sail to China, India and Turkey, which are twice or three times the distance. All three Asian countries have said they will continue to buy Russian oil.

The Baltic Exchange Dirty Tanker Index, which measures shipping rates on 12 international routes, rose as much as 243% for the 12-month period through the end of November.

So how high could rates go? According to Omar Nokta, a shipping analyst at Jefferies, they could potentially climb to between $150,000 and $200,000 a day.

We’re almost there now. The Aframax day rate to ship oil from the Black Sea to the Mediterranean hit an astronomical $145,000 a day during the week ended November 18, according to Compass Maritime.

Russia Oil Turmoil To Drive Tanker Market Higher

This week, the 27 countries of the European Union (EU) officially banned crude imports from Russia, the world’s number two producer, and on February 5, 2023, all Russian oil products will be banned. This will have the effect of disrupting global trade routes further, driving up rates even more.

As you can see below, Europe’s imports of Russian oil were already down dramatically from the beginning of 2022, when the country invaded Ukraine. Before the ban, the Netherlands was the only remaining European destination for deliveries outside of the Mediterranean and Black Sea basin. To help offset the loss of Russian supply, Norway will ship a record volume of North Sea oil in January, Bloomberg reports.

Oil Tankers Generating Record Revenues, Stocks Hitting New Highs

Due to changes in shipping routes, demand for oil tankers is expected to surge to levels not seen in three decades, according to Clarkson Research. The U.K.-based group is forecasting that the number of ton-miles, defined as one ton of freight shipped one mile, could increase 9.5% next year. That would mark the largest annual increase since 1993.

Volumes are already at pre-pandemic levels, with VLCCs and Aframaxes having exceeded 2019 volumes for the first time since the second quarter of 2020.

Oil Tankers Generating Record Revenues, Stocks Hitting New Highs

Also supporting rates is the fact that oil carriers are replacing vessels at a historically low pace.

In July, Clarksons reported that new shipbuilding orders for container vessels had surpassed those for tankers for the first time ever. Whereas the global order book for containerships stood at 72.5 million deadweight tonnage (dwt)—a measure for how much weight a ship can carrier—the orderbook for crude oil and oil product tankers was 34 million dwt, a new record low.

This has contributed to massive revenues and net income, which should keep carriers in a strong position even as container rates have dried up. Last week, Mitsui O.S.K. Lines president Takeshi Hashimoto told JPMorgan analysts that he believes profits will remain strong due to the company’s liquified natural gas (LNG) business as well as dry bulkers and tankers.

Frontline, the fourth largest oil tanker company, just reported net income of $154.4 million in the third quarter, compared to $108.5 million estimated.

Below you can see how revenues have surged for companies such as International Seaways, Ardmore Shipping and Scorpio Tankers.

With the S&P 500 still down more than 14% for the year, shares of a number of oil tankers have hit new all-time highs in recent days. Among those are Ardmore, International Seaways and Euronav. Teekay Tankers was up 226% year-to-date, while Scorpio was up 323% over the same period.

Will these returns continue? I can’t say, of course, but the structural support doesn’t appear to be going away anytime soon.

The Baltic Dirty Tanker Index is made up from 12 routes taken from the Baltic International Tanker Routes. The S&P 500 is widely regarded as the best single gauge of large-cap U.S. equities and serves as the foundation for a wide range of investment products. The index includes 500 leading companies and captures approximately 80% coverage of available market capitalization.

Holdings may change daily. Holdings are reported as of the most recent quarter-end. The following securities mentioned in the article were held by one or more accounts managed by U.S. Global Investors as of (09/30/22): Mitsui OSK Lines Ltd.

This article was republished with permission from Frank Talk, a CEO Blog by Frank Holmes of U.S. Global Investors (GROW). Find more of Frank’s articles here – Originally published October 21, 2021

US Global Investors Disclaimer

All opinions expressed and data provided are subject to change without notice. Some of these opinions may not be appropriate to every investor. By clicking the link(s) above, you will be directed to a third-party website(s). U.S. Global Investors does not endorse all information supplied by this/these website(s)  and is not responsible for its/their content.

The Baltic Dirty Tanker Index is made up from 12 routes taken from the Baltic International Tanker Routes. The S&P 500 is widely regarded as the best single gauge of large-cap U.S. equities and serves as the foundation for a wide range of investment products. The index includes 500 leading companies and captures approximately 80% coverage of available market capitalization.

Holdings may change daily. Holdings are reported as of the most recent quarter-end. The following securities mentioned in the article were held by one or more accounts managed by U.S. Global Investors as of (09/30/22): Mitsui OSK Lines Ltd.

Release – Comstock To Present at The Money, Metals & Mining Virtual Expo

Research, News, and Market Data on LODE

Gold Assays as high as 2.95 ounces per ton and silver assays as high as 6.68 ounces per ton

VIRGINIA CITY, NEVADA, December 6, 2022 – Comstock Inc. (NYSE: LODE) (“Comstock” or the “Company”) today announced Corrado De Gasperis, Executive Chairman and CEO, will present a company update, including recent developments in advanced technologies for mineral discoveries, during the Money, Metals & Mining Virtual Expo. Mr. De Gasperis is also a member of the moderated panel, “Energy and Precious Metals: Three Ways to Win” on Wednesday, December 7, at 2:45 pm EST. Following this panel, Mr. De Gasperis will present, “How Advanced Technologies will Transform Discovery and Extraction in All Mining Districts” at 4:00 pm EST. Please register if you want to attend:
https://online.moneyshow.com/2022/december/money-metals-mining-virtual-expo/registration/

Last week, Comstock announced the publication of the initial technical report for the Company’s Dayton Consolidated Project detailing an estimated mineral resource constrained within an open pit economic shell based on a gold price of $1,800 per ounce. The estimate includes Measured and Indicated resources containing 293,000 ounces of gold and 2,120,000 ounces of silver, plus an additional Inferred resource containing 90,000 ounces of gold and 480,000 ounces of silver.

The Dayton project has long been known for high grade assays, with gold assays as high as 2.95 ounces per ton, and silver assays as high as 6.68 ounces per ton. Drilling by Comstock has also encountered significant thicknesses of mineralization, including 135 feet averaging 0.218 ounces per ton Au and 0.685 ounces per ton Ag (hole D11-21), 145 feet averaging 0.056 ounces per ton Au and 0.352 ounces per ton Ag (hole D11-33), 50 feet averaging 0.030 ounces per ton Au and 1.072 ounces per ton Ag (hole D94-17), 295 feet averaging 0.027 ounces per ton Au and 0.087 ounces per ton Ag (hole D10-01), and 235 feet averaging 0.031 ounces per ton Au and 0.102 ounces per ton Ag (hole SV12-05).

Behre Dolbear authored the independent, initial assessment of the Dayton Consolidated Project mineral resources, as of November 1, 2022, compliant with current SEC S-K 1300 guidelines.

The full report is available on the Company’s website, at www.comstock.inc/investors.

This morning, Channelchek published a report by Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc. Mr. Reichman’s report is entitled, “Recent Technical Reports Highlight Value of Comstock’s Mineral Properties.” Please register here if you would like to access this report: https://www.channelchek.com/news-channel/comstock-inc-lode-recent-technical-reports-highlight-value-of-comstocks-mineral-properties

About Comstock

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complementary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.


About Behre Dolbear

Behre Dolbear is a one of the oldest mineral industry advisory firms in the world, continuously operating since 1911. Behre Dolbear authored the Technical Report Summary, Dayton Consolidated Project, Lyon County, Nevada as an independent third-party, following the United States Security and Exchange Commission’s mining rules under subpart 1300 of Regulation S-K.

Forward-Looking Statements 

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future industry market conditions; future explorations or acquisitions; future changes in our exploration activities; future prices and sales of, and demand for, our products; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; and future working capital, costs, revenues, business opportunities, debt levels, cash flows, margins, taxes, earnings and growth. These statements are based on assumptions and assessments made by our management considering their experience and their perception of historical and current trends, current conditions, possible future developments, and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; ability to achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology, quantum computing and advanced materials development, and development of cellulosic technology in bio-fuels and related carbon-based material production; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.

Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

Contact information:  
Comstock Inc.
P.O. Box 1118
Virginia City, NV 89440
www.comstock.inc
Corrado De Gasperis
Executive Chairman & CEO
Tel (775) 847-4755
degasperis@comstockinc.com
Zach Spencer
Director of External Relations
Tel (775) 847-5272 Ext.151
questions@comstockinc.com

Release – Baudax Bio Announces Closing of $5 Million Public Offering

Research, News, and Market Data on BXRX

December 06, 2022 4:11pm EST

MALVERN, Pa., Dec. 06, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on innovative products for hospital and related settings, today announced the closing of its previously announced public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-4 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and will expire thirteen months from the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $5 million. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-268251), which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 2, 2022. The offering was made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 374,114 shares of common stock of the Company that were previously issued to an investor in November 2020, January 2021, June 2021, December 2021, March 2022, May 2022 and September 2022, at exercise prices ranging from $21.00 to $43.60 per share and expiration dates ranging from October 2023 to September 2027, were amended effective upon the closing of the offering so that the amended warrants have a reduced exercise price of $4.50 per share and will expire five years following the closing of the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one in a Phase II study and an additional unique NMB in a dose escalation Phase I study, as well as a proprietary chemical reversal agent specific to these NMBs. Baudax Bio has received approval for and marketed ANJESO®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-opioid, non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including Baudax Bio’s ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to comply with all listing requirements of the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com 

Source: Baudax Bio, Inc.

Released December 6, 2022

Release – Bowlero Corp. Completes Latest Acquisition

Research, News, and Market Data on BOWL

12/06/2022

Adds Great Escape in Pleasant Hill, Iowa to Growing Portfolio

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp., (NYSE: BOWL) the global leader in bowling entertainment, announced today that it has completed the acquisition of Great Escape in Iowa. This is the Company’s 15th completed acquisition in calendar year 2022, bringing the Company’s total center count to 326.

Great Escape, located in Pleasant Hill, a suburb of Des Moines, is a 24-lane bowling center featuring laser tag, over 50 arcade games, virtual reality, and a full-service restaurant. Great Escape marks the Company’s second acquisition in Iowa this calendar year, the first being Thunderbowl located in Council Bluffs.

Brett Parker, President & Chief Financial Officer of Bowlero Corp. stated, “The addition of Great Escape is another exciting acquisition for Bowlero. We remain committed to bringing our guests a world-class entertainment experience, and furthering our presence nationwide.”

Great Escape is expected to open under Bowlero Corp. management on December 9th.

About Bowlero Corp
Bowlero Corp. is the global leader in bowling entertainment, media, and events. With more than 300 bowling centers across North America, Bowlero Corp. serves more than 27 million guests each year through a family of brands that includes Bowlero, Bowlmor Lanes, and AMF. In 2019, Bowlero Corp. acquired the Professional Bowlers Association, the major league of bowling, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com

For Media:
Bowlero Corp. Public Relations
PR@BowleroCorp.com

For Investors:
Bowlero Corp. Investor Relations
IRSupport@BowleroCorp.com

Source: Bowlero Corp.

Release – BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology

Research, News, and Market Data on BSGM

December 06, 2022

Clinical abstract focuses on value of PURE EP™’s and its groundbreaking High Frequency Algorithm (HFA) during pulmonary vein isolation

Westport, CT, Dec. 06, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that a peer-reviewed case report titled, “Confirmation of Acute Pulmonary Vein Reconnection with The Utilization of PURE EP’s High-Frequency Algorithm (HFA)” has been published in the Journal of Atrial Fibrillation & Electrophysiology. The publication is available electronically via the JAFIB-EP open access digital journal.

Co-authored by Roy Chung, MD, Clinical Cardiac Electrophysiologist at Cleveland Clinic and Zachary Koch, CCDS, CEPS, Clinical Director at BioSig Technologies, Inc., the case report describes a 65-year-old patient with a medical history of symptomatic and persistent atrial fibrillation undergoing pulmonary vein isolation (PVI). PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logotation produced by a 3D mapping system. PURE EP™’s real-time HFA identified early local activation, providing a clear and precise location that served as the primary target for ablation therapy during the procedure. Results from the case study support the efficacy of PURE EP™’s HFA in identification of the pulmonary vein gap compared to the inferior annotation produced by the 3D mapping system.

“This case study adds to the growing pipeline of clinical evidence validating the PURE EP™ System as an essential and valuable technology for today’s EP lab—particularly for challenging cases,” commented Gray Fleming, Chief Commercial Officer, BioSig Technologies, Inc. “We believe that these findings, along with other clinical applications we continue to explore in collaboration with the Cleveland Clinic, demonstrate PURE EP™’s ability to set new standards in the field of electrophysiology.”

In October, the Company signed a master research agreement with Cleveland Clinic to explore expanded applications for its digital signal processing technology.

The proprietary High Frequency Algorithm (HFA)—a proprietary feature found only in the PURE EP™ System—reclaims the specificity lost within the blended data of the traditional bipolar wave. HFA enables electrophysiologists to apply specific near-field frequency data to the treatment of even the most complex arrhythmias. By removing unnecessary distractions, the PURE EP™ System with HFA preserves the value of cardiac signals and delivers clear, actionable insights to today’s electrophysiologist.

About BioSig Technologies
BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.2

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.

1 Koch W. Zachary; Chung, Roy (2022), Confirmation of Acute Pulmonary Vein Reconnection with Case Report: The Utilization of PURE EP’s High-Frequency Algorithm (HFA), Journal of Atrial Fibrillation & Electrophysiology, Volume 15, Issue 6, Nov 2022. https://jafib-ep.com/journal/volume-15-issue-6-nov-2022/confirmation-of-acute-pulmonary-vein-reconnection-with-the-utilization-of-pure-eps-high-frequency-algorithm-hfa/

2 Global Market Insights Inc. March 08, 2022.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
 
 

Source: BioSig Technologies, Inc.

Released December 6, 2022