Austria’s Raiffeisen faces US wrath over Russian business By Reuters

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LONDON/FRANKFURT (Reuters) -The U.S. Treasury has warned Austria’s Raiffeisen Bank International (RBI) that its access to the U.S. financial system could be restricted because of its Russian dealings, according to a person who has seen a letter detailing the threat.

The May 6 letter is the strongest warning yet to the biggest Western bank in Russia and follows months of pressure from Washington, and Europe, as they try to toughen up sanctions against Russia and further squeeze it financially.

RBI this month abandoned a $1.5 billion deal linked with a sanctioned Russian tycoon that the U.S. opposed. But the bank’s ties to Russia run much deeper. Restrictions on its access to the dollar system would have potentially deeply damaging consequences.

WHY IS THE U.S. CONCERNED?

After Russia launched its full-scale invasion of Ukraine in February 2022, the U.S. responded with wide-ranging sanctions on Russia and its companies. Many Western companies, including banks, made a rush to exit.

But several Western banks with a big presence in Russia including RBI and Italy’s UniCredit have remained. Both have been in Russia since the collapse of the Soviet Union more than three decades ago.

RBI’s reluctance to pull back has increasingly frustrated U.S. officials aware that their sanctions have not been as effective as hoped. Sanctions enforcement agency OFAC launched an inquiry into RBI at the start of 2023.

The bank has been delaying plans to leave Russia.

To unlock funds frozen in Russia, RBI had planned to buy a stake in construction group Strabag from a company the Vienna-based group identified as being controlled by Russian tycoon Oleg Deripaska.

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The move was opposed by the U.S. Treasury because Deripaska is sanctioned.

After repeated U.S. warnings not to proceed, this month the bank dropped the bid.

The European Central Bank is also stepping up pressure on RBI, and is expected to tell it to reduce business in Russia.

Remaining in Russia has proven very profitable for banks, a disincentive to exit.

WHAT DOES RBI SAY?

An RBI spokesperson said on Wednesday the bank had significantly reduced activities in Russia and was working towards “de-consolidation” of its subsidiary there.

Banks including RBI also say that exiting Russia is a complicated process, and that they cannot just sell up.

For an international bank to spin off local operations, it would require the approval of Russia’s central bank, finance ministry and even Russian President Vladimir Putin.

Russian authorities last year made it clear to RBI, which has around 4 million local account holders and 10,000 staff, that they wish it to stay because it enables international payments, one source previously told Reuters.

U.S. sanctions denied Russian banks access to the SWIFT global payment system. That has made lenders like RBI a payment lifeline to hundreds of Russian companies.

RBI has also received support from Austria, where officials have pushed back against pressure on the bank.

Austria and Russia maintain close ties going back decades and Vienna has long acted as a hub for cash from Russia and its former Soviet neighbours.

WHAT COULD THE U.S. DO?

In short, a lot.

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The dollar is the cornerstone of international finance and the United States is the world’s most powerful regulator chiefly because it can end a bank’s access to the currency.

In its letter to RBI, Deputy Treasury Secretary Wally Adeyemo made reference to President Joe Biden’s executive order authorising U.S. secondary sanctions on foreign financial institutions that conduct significant transactions involving Russia’s military-industrial base.

Losing access to the dollar would be likely to plunge any bank into a crisis.

Richard Portes, a professor of economics at the London Business School who has studied sanctions, said curbing RBI’s access would be “hugely damaging”.

Critics of sanctions say that the U.S. is accelerating the use of alternatives to the dollar, such as the Chinese buying Russian oil with payments in yuan.

Yet the dollar remains the pre-eminent currency for international trade and is the dominant reserve currency – a status likely to endure, analysts say.

WILL THE TREASURY DO IT?

Washington has so far held back from using the new executive order to sanction foreign financial institutions.

Secondary sanctions target foreign people or companies doing business with those already under U.S. sanctions.

Washington’s threat to hit foreign financial institutions with sanctions has made a significant difference in financial flows between Russia and countries such as Turkey, the United Arab Emirates, and Kazakhstan, Adeyemo said in February.

HAS THE U.S. CURBED DOLLAR ACCESS BEFORE?

Curbing a Western bank’s access to the dollar system is extremely rare.

French bank BNP Paribas (OTC:) in 2014 was banned for a year from conducting certain dollar transactions as part of a settlement to resolve accusations it contravened U.S. sanctions against Sudan, Cuba and Iran.

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In 2018, the U.S. accused Latvia’s third-biggest bank, ABLV, of money laundering and breaching sanctions on North Korea. This effectively froze the banks out of dollar financial markets and triggered its closure.



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Siemens misses profit forecast as industrial business struggles By Reuters

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ZURICH (Reuters) – Siemens reported a drop in second quarter earnings at its industrial business, the German engineering group said on Thursday, after suffering a slowdown at its flagship factory automation division.

The trains to industrial software maker said industrial profit fell 2% to 2.51 billion euros ($2.73 billion) during the three months to the end of March. The figure missed analyst forecasts for 2.68 billion euros in a company gathered consensus of analysts.

Sales fell 1% to 19.16 billion euros, below the 19.28 billion euros expected, while net profit fell to 2.19 billion euros.

Digital Industries – the company’s factory software and automation division – struggled with lower orders, sales and profit, during the period, the company said.

In contrast, Siemens’s buildings and transport division both posted increases in revenues during the quarter.

“Siemens proved its resilience with strong revenue performance in Smart Infrastructure, Mobility and industrial software; this nearly offset currently muted demand in Digital Industries’ automation business,” said Chief Executive Roland Busch in a statement.

($1 = 0.9188 euros)



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374Water Releases First Quarter 2024 Results and Provides Business Update By Investing.com

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New CEO Chris Gannon unveils Product Development, Commercialization and Go-to-Market Objectives

DURHAM, NC / ACCESSWIRE / May 15, 2024 / 374Water Inc. (NASDAQ:SCWO), a global leader in cutting-edge, sustainable waste management technologies, today provides a business update and reports its financial results for the first quarter ended March 31, 2024.

“In just under a month, we have hit the ground running developing a strategic plan to unlock the value inherent in this enterprise. I have immersed myself in our technology and our market opportunities to chart the best path forward in our product development, commercialization, and go-to-market approach,” said Chris Gannon, CEO of 374Water. “We have a massive opportunity in front of us to take advantage of regulatory tailwinds driving demand for technologies like our AirSCWO system. Over the ensuing months, we will provide more detail and clarity on our go forward strategy, with a focus on four key areas: (1) executing on our municipal biosolid/sludge and federal/DOD contractual obligations which is an important proof point; (2) expanding the application of our AirSCWO systems to industrial and other waste streams; (3) securing new manufacturing and engineering facilities; and (4) expanding our compliment of talented engineers and field personnel, as well as our leadership team.”

Financial Highlights

  • For the three-month period ended March 31, 2024, the Company generated revenue of $315,000 which compares to $801,000 for the three months ending March 31, 2023, a 61% decrease.
    • Our revenue is primarily based on progress toward completion of our sold unit and also includes the sale of treatability services. Costs associated with our sold unit have started to decline as we reach the end of our fabrication and testing, which have had a direct correlation to the reduced revenue recognized this year. This has had a direct impact on our change in revenue year-over-year.
  • Total Operating Expenses for the quarter ended March 31, 2024, increased marginally to $1.9 million from $1.8 million in the prior year quarter driven primarily by an increase in R&D expense.

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Capital Structure

  • As of March 31, 2024, the Company had working capital of $11.7 million. We are actively working on optimizing our operational efficiencies and exploring new market opportunities, all aimed at long-term value creation while remaining steadfast in our commitment to innovation and excellence. A primary financial goal for the Company is to extend its runway while scaling the business.

Business Highlights

  • On April 23, 2024 the Company announced the appointment of Chris Gannon as its new President and Chief Executive Officer. Mr. Gannon brings deep executive leadership experience in multiple disciplines and industries, including environmental technology development, highly engineered product, advanced manufacturing, and global customer support and service with customers in the municipal, industrial, commercial, defense, and medical spaces.
  • In March 2024, the Company announced a new contract with the City of Orlando, highlighted by the deployment of an AirSCWO 6 service unit, which will be integrated into Orlando’s Iron Bridge Water Pollution Control Facility. This AirSCWO 6 unit is expected to deploy in 2024.
  • 374Water continued its progress on an expected 2024 deployment to Orange County Sanitation District. The Company is underway with factory acceptance testing and once achieved, will begin mobilizing the unit to Orange County.
  • The Company continues to focus on executing demonstrations and securing demonstration partners within the municipal biosolids, federal and military PFAS, and industrial markets.
  • The Company is in active discussions with major TSDF operators to not only serve as technology development and commercialization partners, focused initially on PFAS intensive waste streams, but also serve as long-term waste destruction partners. The Company places a priority these partnerships as we continue to scale our commercial grade technology to meet growing demand for AirSCWO technology.

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Earnings Conference Call

Management will hold a conference call at 10:00 am Pacific Time (1:00 pm Eastern Time) on Friday, May 17, 2024, to provide a more detailed business update and discussion of quarterly results. Participants who wish to join the conference by telephone can access the call by dialing (Toll Free) 888-506-0062 or (International) 973-528-0011. Participants may join the live webcast by accessing it at the webcast registration link here: https://www.webcaster4.com/Webcast/Page/3040/50613.

A webcast replay will be available through May 31, 2024 on the Investors Section of the Company’s website at https://374water.com/investor-relations/.

For more on AirSCWO or about our team, visit 374Water.com or follow us on LinkedIn.

About 374Water

374Water Inc. (NASDAQ:SCWO) is a global cleantech company with innovative solutions to wastewater treatment and waste management issues. 374Water’s AirSCWO technology transforms organic “wastes” into minimal impact, value-added products, effectively shifting the waste management paradigm from disposal to resource recovery. 374Water is leading a new era of creating value in sustainability, eliminating PFAS and protecting our communities. Follow us on LinkedIn.

Cautionary Language

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning.

Investor Contact:
Heather Crowell
ir@374water.com

Media Contact:
Christian Rizzo
media@374water.com

374Water Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
March 31, 2024 (Unaudited) and December 31, 2023

March 31,

2024

December 31,

2023

Assets

Current Assets:

Cash

$ 7,936,161 $ 10,445,404

Accounts receivable, net of allowance

84,324 64,792

Unbilled accounts receivable

1,771,609 1,494,553

Other accounts receivable

34,161 39,749

Inventory, net

2,601,658 2,276,677

Prepaid expenses

921,365 581,085

Total Current Assets

13,349,278 14,902,260

Long-Term Assets:

Property, and Equipment, net

223,339 230,971

Intangible asset, net

971,691 988,029

Total Long-Term Assets

1,195,030 1,219,000

Total Assets

$ 14,544,308 $ 16,121,260

Liabilities and Stockholders’ Equity

Current Liabilities:

Accounts payable and accrued expenses

$ 755,721 $ 572,297

Accrued contract loss provision

600,000 500,000

Accrued legal settlement

135,000 135,000

Unearned revenue

132,768 130,000

Other liabilities

10,408 36,787

Total Current Liabilities

1,633,897 1,374,084

Total Liabilities

1,633,897 1,374,084

Commitments and contingencies (Note 9)

Stockholders’ Equity

Preferred stock: 50,000,000 convertible Series D preferred shares authorized; par value $0.0001 per share, nil issued and

outstanding at March 31, 2024 and December 31, 2023

Common stock: 200,000,000 common shares authorized, par value $0.0001 per share, 132,670,446 and 132,667,107 shares

outstanding at March 31, 2024 and December 31, 2023, respectively

13,266 13,266

Additional paid-in capital

30,872,643 30,684,943

Accumulated deficit

(17,977,969 ) (15,953,504 )

Accumulated other comprehensive loss

2,471 2,471

Total Stockholders’ Equity

12,910,411 14,747,176

Total Liabilities and Stockholders’ Equity

$ 14,544,308 $ 16,121,260

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374Water, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
For the three months ended March 31, 2024 and 2023 (Unaudited)

2024 2023

Revenue

$ 315,278 $ 801,458

Cost of goods sold

617,298 720,146

Gross margin

(302,020 ) 81,312

Operating Expenses

Research and development

535,147 355,905

Compensation and related expenses

651,604 718,760

Professional fees

252,705 99,572

General and administrative

459,727 585,659

Total Operating Expenses

1,899,183 1,759,896

Loss from Operations

(2,201,203 ) (1,678,584 )

Other Income

Interest income

104,620 37,859

Other income

72,118 382

Total Other Income

176,738 38,241

Net Loss before Income Taxes

(2,024,465 ) (1,640,343 )

Provision for Income Taxes

Net Loss

$ (2,024,465 ) $ (1,640,343 )

Other comprehensive income

Foreign currency translation gain

824

Unrealized gain on marketable securities

18,967

Total other comprehensive loss

19,791

Total comprehensive loss

(2,024,465 ) (1,620,552 )

Net Loss per Share – Basic and Diluted

$ (0.02 ) $ (0.01 )

Weighted Average Common Shares Outstanding – Basic and Diluted

132,668,777 127,146,695

374Water Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
For the three months ended March 31, 2024 and 2023 (Unaudited)

Cash Flows from Operating Activities

2024 2023

Net loss

$ (2,024,465 ) $ (1,640,343 )

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

Depreciation and amortization expense

24,560 29,105

Issuance of common stock for services

4,500

Stock-based compensation

183,200 214,924

Gain on foreign currency translation

824

Increase in inventory reserve

50,000

Changes in operating assets and liabilities:

Accounts receivable

(19,532 ) (26,188 )

Unbilled accounts receivable

(277,056 ) (754,290 )

Other receivables

5,588 (308,374 )

Inventory

(374,981 ) (127,309 )

Prepaid expenses

(340,280 ) 23,285

Accounts payable and accrued expenses

183,424 (581,582 )

Accrued contract loss provision

100,000

Unearned revenue

2,768 5,000

Other liabilities

(26,379 ) (13,528 )

Net Cash Used In Operating Activities

(2,508,653 ) (3,178,176 )

Cash Flows from Investing Activities

Purchase of equipment

(7,303 )

Increase in intangible assets

(590 ) (2,705 )

Cash Used In Investing Activities

(590 ) (10,008 )

Cash Flowfrom Financing Activities

Proceeds from the sale of common stock

8,294,708

Cash Provided by Financing Activities

8,294,708

Net (Decrease) Increase in Cash

(2,509,243 ) 5,106,224

Cash, Beginning of the Period

10,445,404 4,046,937

Cash, End of the Period

$ 7,936,161 $ 9,153,161

SUPPLEMENTAL CASH FLOW DISCLOSURES:

Cash paid for interest

$ $

Cash paid for taxes

$ $

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SOURCE: 374Water Inc.



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Panbela Provides Business Update and Reports Q1 2024 Financial Results By Investing.com

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MINNEAPOLIS, May 15, 2024 (GLOBE NEWSWIRE) — Panbela  Therapeutics, Inc.  (OTCQB: PBLA),  a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended March 31, 2024. As previously announced, management is hosting earnings call today at 4:30 p.m. ET.

Q1 2024 and recent Highlights:

Clinical

  • Announced revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests high potential for improved survival outcomes for patients in the trial.
  • Poster presentation of Ivospemin (SBP-101) at AACR highlighting the efficacy of SBP-101 in combination with doxorubicin to treat platinum-resistant ovarian cancer
  • ASPIRE trial has exceeded 50% enrollment; complete enrollment of approximately 600 patients anticipated by Q1 2025
  • Publication of Clinical Data:  Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial. Br J Cancer  130, 788“797 (2024)

Financial / Business

  • Gained eligibility for quotation of common stock on the OTCQB
  • Closed $9.0 million public offering of common stock and warrants
  • Issuance of a New Patent in the US and Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac

“We were thrilled to announce that our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma, or mPDAC, is now expected to reach its interim data analysis in the first quarter of 2025, due to a lower-than-anticipated event rate, suggesting improved survival outcomes for patients in the trial. This gives us hope for meaningful advancements in mPDAC treatment beyond the incremental benefits seen with recently approved therapies,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela.

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“In addition to the progress in our ASPIRE trial, which has now exceeded 50% enrollment with complete enrollment of approximately 600 patients anticipated by Q1 2025, we were pleased to present a poster highlighting the efficacy of SBP-101 in combination with doxorubicin for treating platinum-resistant ovarian cancer at AACR. We also welcomed the publication of clinical data from our Phase I study of high-dose DFMO, celecoxib, cyclophosphamide, and topotecan for patients with relapsed neuroblastoma in the British Journal of Cancer. On the financial and business front, we announced the transfer of our common stock to the OTCQB market and successfully closed a $9.0 million public offering. As we look ahead, Panbela remains steadfast in its commitment to improving patient outcomes and driving value for our stockholders, with several key catalysts on the horizon, including the highly anticipated overall survival interim analysis in our Phase III ASPIRE Trial.”

First Quarter ended March 31, 2024 Financial Results

General and administrative expenses were approximately $1.2 million in the quarter, compared to $1.4 million in the same period last year. The decrease is due primarily to reduced legal and other professional services.

Research and development expenses were approximately $5.5 million, compared to $3.5 million in the same period last year. This increase is primarily due to significant growth in the number of active sites and enrollment in project ASPIRE.

Net loss in the quarter was approximately $7.1 million, or $2.28 per diluted share, compared to a net loss of $5.1 million, or $392.76 per diluted share, in the same period last year. This increased loss is due to the incremental research and development expenses.

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Total cash was $262,000 as of March 31, 2024. Total current assets were $1.8 million and current liabilities were $10.5 million as of the same date. In April the Company’s partner in Pediatric Neuroblastoma, US WorldMeds ®, provided a nondilutive payment of approximately $0.8 million in exchange for a reduction in the potential future milestone payments.

Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $4.2 million. The current portion of the notes payable plus accrued interest totaled approximately $1.3 million and was paid to the noteholder in the first quarter of 2024.

During the first quarter, the Company completed a registered public offering. Net proceeds from the raise, which closed on January 31, 2024, were approximately $8.1 million.

Conference Call Information

May 15, 2024 at 4:30PM EST

Toll Free: 877-545-0523International: 973-528-0016Participant Access Code: 234396Webcast Link:  https://www.webcaster4.com/Webcast/Page/2556/50531

Conference Call Replay Information

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 50531Webcast Replay:  https://www.webcaster4.com/Webcast/Page/2556/50531

About our PipelineThe pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer and diabetes. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101  IvospeminIvospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit  https://clinicaltrials.gov/study/NCT03412799  .

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Flynpovi™Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase III trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p ‰¤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X EflornithineCPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.

About PanbelaPanbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at  www.panbela.com.  Panbela’s common stock is eligible for quotation on the OTCQB under the symbol PBLA.

Cautionary Statement Regarding Forward-Looking StatementsThis  press  release contains forward-looking statements, which can be identified by words such as:  anticipate, design, hope, may, plan, and will. Examples of forward-looking statements include statements we make  regarding timing of trials and results of collaborations with third parties and future studies. All statements other than statements of historical fact are statements that should be deemed forward-looking statements.  Forward-looking statements are neither historical facts nor assurances of future performance.  Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements  relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.  Our actual results and financial condition may differ materially and adversely from the forward-looking statements.  Therefore, you should not rely on any of these forward-looking statements.  Important factors that could cause our actual results and financial condition to differ materially from those indicated in the  forward-looking statements include, among others, the following:  (i) our ability to obtain additional capital, on acceptable terms or at all, required to implement our business plan; (ii) our lack of diversification and the corresponding risk of an investment in our Company; (iii) our ability to maintain our listing on a national securities exchange; (iv) progress and success of our randomized Phase II/III clinical trial; (v) our ability to demonstrate the safety and effectiveness of our product candidates:  ivospemin  (  SBP-101  ), Flynpovi, and eflornithine  (CPP-1X)   (v) our ability to obtain regulatory approvals for our product candidates, SBP-101, Flynpovi and  CPP-1X  in the United States, the European Union or other international markets; (vii) the market acceptance and level of future sales of our product candidates, SBP-101, Flynpovi and  CPP-1X  ; (viii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101, Flynpovi and  CPP-1X  ; (ix) the rate of progress in establishing reimbursement arrangements with third-party payors; (x) the effect of competing technological and market developments; (xi) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xii) such other factors as discussed in Part I, Item  1A under the caption Risk Factors in our most recent Annual Report on Form 10-K , any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made.  We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement,  whether written or oral, whether  as  a result of  new information, future developments or otherwise.

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Contact Information:Investors:James CarbonaraHayden IR(646) 755-7412james@haydenir.com  

Media:Tammy GroenePanbela Therapeutics, Inc.(952) 479-1196

Panbela Therapeutics, Inc.Consolidated Statements of Operations and Comprehensive Loss (unaudited)(In thousands, except share and per share amounts)

             
    Three months ended March 31,
      2024       2023     Percent Change
Operating expenses:            
General and administrative   $ 1,204     $ 1,352     -10.9 %
Research and development     5,522       3,508     57.4 %
Operating loss     (6,726 )     (4,860 )   38.4 %
             
Other income (expense):            
Interest income     0       16      
Interest expense     (63 )     (102 )   -38.2 %
Other income (expense)     (469 )     (167 )   180.8 %
Total other income (expense)     (532 )     (253 )   110.3 %
             
Loss before income tax benefit     (7,258 )     (5,113 )   42.0 %
             
Income tax benefit     138            
             
Net loss     (7,120 )     (5,113 )   39.3 %
Foreign currency translation adjustment     459       163     181.6 %
Comprehensive Loss   $ (6,661 )   $ (4,950 )   34.6 %
             
Basic and diluted net loss per share   $ (2.28 )   $ (392.76 )   -99.4 %
Weighted average shares outstanding – basic and diluted     3,125,835       13,018     23911.6 %
             

Panbela Therapeutics, Inc.Consolidated Balance Sheets (unaudited)(In thousands, except share amounts)

  March 31, 2024   December 31, 2023
ASSETS (Unaudited)    
Current assets:      
Cash and cash equivalents $ 262     $ 2,578  
Prepaid expenses and other current assets   1,210       299  
Income tax receivable   313       183  
Total current assets   1,785       3,060  
Other non-current assets   8,742       8,742  
Total assets $ 10,527     $ 11,802  
       
LIABILITIES AND STOCKHOLDERS’ DEFICIT      
Current liabilities:      
Accounts payable $ 8,506     $ 9,939  
Accrued expenses   979       1,141  
Accrued interest payable   34       238  
Debt, current portion   1,000       1,000  
Total current liabilities   10,519       12,318  
       
Debt, net of current portion   3,194       4,194  
Total non-current liabilities   3,194       4,194  
       
Total liabilities   13,713       16,512  
       
Stockholders’ deficit:      
Preferred stock, $0.001 par value; 10,000,000 authorized; no shares issued or outstanding as of March 31, 2024 and December 31, 2023          
Common stock, $0.001 par value; 100,000,000 authorized; 4,854,931 and 480,095 issued as of March 31, 2024 and December 31, 2023 respectively; 4,854,861 and 480,025 shares outstanding as of March 31, 2024 and December 31, 2023, respectively   5        
Treasury Stock at cost; 70 shares at both of March 31, 2024 and December 31, 2023   (1 )     (1 )
Additional paid-in capital   128,223       120,043  
Accumulated deficit   (132,617 )     (125,497 )
Accumulated comprehensive income   1,204       745  
Total stockholders’ deficit   (3,186 )     (4,710 )
Total liabilities and stockholders’ deficit $ 10,527     $ 11,802  
       

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Panbela Therapeutics, Inc.Consolidated Statements of Cash Flows (unaudited)(In thousands)

  Three Months Ended March 31,
    2024       2023  
Cash flows from operating activities:      
Net loss $ (7,120 )   $ (5,113 )
Adjustments to reconcile net loss to net cash used in operating activities:      
Stock-based compensation   103       180  
Non-cash interest expense   34       42  
Changes in operating assets and liabilities:      
Income tax receivable   (140 )      
Prepaid expenses and other current assets   (912 )     (2,108 )
Other non-current assets         (5,441 )
Accounts payable   (957 )     4,644  
Accrued liabilities   (400 )     (1,955 )
Net cash used in operating activities   (9,392 )     (9,751 )
       
Cash flows from financing activities:      
Proceeds from public offering of common stock and warrants net of underwriters discount and offering costs of $926 and $1,302 respectively   8,082       15,358  
Cash paid for fractional shares         (4 )
Principal payments on notes   (1,000 )     (1,650 )
Net cash provided by financing activities   7,082       13,704  
       
Effect of exchange rate changes on cash   (6 )     (3 )
       
Net change in cash   (2,316 )     3,950  
Cash and cash equivalents at beginning of period   2,578       1,285  
Cash and cash equivalents at end of period $ 262     $ 5,235  
       
Supplemental disclosure of cash flow information:      
Cash paid during period for interest $ 266     $ 386  
       
Supplemental disclosure of non-cash transactions:      
Cashless exercise of warrants $     $ (8 )
       



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Female Executives Prioritize Market Expansion to Drive Business Growth, Show High Preparedness for M&A By Investing.com

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BOSTON, May 15, 2024 /PRNewswire/ — Capstone Partnersa leading middle market investment banking firm, released its inaugural 2024 Women Entrepreneurs Study, which analyzes the responses of more than 200 female business owners across the U.S. for key findings related to business decisions, growth strategies, and legacy expectations. By comparing the survey results to Capstone’s annual Middle Market (MM) Business Owners Surveythe report seeks to identify and elevate key differences and challenges that female founders face.

Women entrepreneurs’ current growth strategies have largely included organic initiatives, with more than half increasing market penetration (59%) and expanding product or service portfolios (53.8%). Of note, market penetration tactics have been more pertinent to women CEOs compared to the broader MM business owner audience, of which only 47.5% have increased market penetration.

Regarding current growth strategies, only 18.1% of women entrepreneurs have enacted inorganic initiatives through M&A. However, M&A as an exit strategy is likely to be more prevalent, with 36.7% considering a merger or acquisition. This is especially true for women CEOs aged 18-34, as many plan to participate in multiple business ventures throughout their careers. Among female CEOs in this age group, 48% have considered M&A as an exit strategy compared to 33.6% of 35 to 54-year-olds and 17.9% of 55+ year-olds. Elevated private equity interest in businesses owned by Gen Z founders may have also contributed to 18 to 34-year-olds’ M&A exit considerations. Nearly two-thirds (64%) of women CEOs ages 18-34 have been contacted by a sponsor looking to buy their company.

According to our results, women entrepreneurs are more prepared for an exit than they perceive. When prompted directly, 43.3% of female CEOs noted they have started to plan a business exit. However, when provided a list of exit preparation steps, 74.8% identified that they have completed at least one step. Many women entrepreneurs have built a strong executive leadership team (37.1%), determined financial needs (34.3%), and maximized growth strategies (31.9%) in 2023 to prepare for a future exit.

When it came to top concerns for the future growth of their company, inflation headlined the chart, comprising 55% of responses. Customer retention was the next highest concern at 35%. These figures mirrored the top two concerns in Capstone’s MM Business Owner Survey. At the same time, increased workload or stress appeared third on female founders’ list compared to seventh for overall MM business owners. Funding for growth and credit availability were also more heavily weighted.

Nearly one in four respondents to Capstone’s WE Survey indicated that they required help raising debt and equity capital. The absence of growth funds allocated to female founders and the lack of sizeable loans approved for women-owned businesses are known hurdles for women entrepreneurs seeking to expand their business operations. Access to early-stage, or venture capital (VC), funding has been historically low for women, with incremental gains over the past 15 years. In 2008, 3.4% of VC deals went to female-founded companies compared to 6.1% in 2023, according to PitchBook. In addition to limited deal volume for female founders, the average deal size remains far below those awarded to male counterparts. In 2023, the average VC deal value for male-founders was $9.4 million compared to $3.1 million for female-founders.

Also included in this report:

  • An overview of the current size and growth of women-owned businesses in the  U.S.
  • Key findings on female executive’s business operations and strategies.
  • Commentary on the challenges women face around credit availability and fundraising.
  • Commentary and  Q&A from select Capstone advisors on key service areas that women business owners identified as areas of interest or demand.

To access to full report, click here.

ABOUT CAPSTONE PARTNERS

For over 20 years, the firm has been a trusted advisor to leading middle market companies, offering a fully integrated range of investment banking and financial advisory services uniquely tailored to help owners, investors, and creditors through each stage of the company’s lifecycle. Capstone’s services include  M&A advisory, debt and equity placement, corporate restructuring, special situations, valuation and fairness opinions and financial advisory services. Headquartered in Boston, the firm has 175+ professionals in multiple offices across the  U.S. With 12 dedicated industry groups, Capstone delivers sector-specific expertise through large, cross-functional teams. Capstone is a subsidiary of Huntington  Bancshares Incorporated (NASDAQ:HBAN). For more information, visit  www.capstonepartners.com.

For More Information Contact:
Sarah Doherty
Director of Market Intelligence
sdoherty@capstonepartners.com
617-619-3310

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BTN Group to Launch Business Travel Show Asia Pacific

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BTN Group announced today it will launch Business Travel Show Asia Pacific next April, co-locating the inaugural event with the new Meetings Show Asia Pacific Apr. 16-17, 2025, at the Sands Expo and Convention Center at Marina Bay Sands in Singapore.

The Meetings Show held its first event last month with more than 1,000 meetings, incentives, congress and exhibition professionals in attendance. Both events are part of the Northstar Travel Group portfolio, which is reaching deeper into the region.

“We are excited to launch another one of our market-leading event brands in the
Singapore and Asia Pacific market,” said Northstar Travel Group CEO Jason Young. “The Business Travel Show, following the successful recent launch of The
Meetings Show, highlights our ability to connect buyers and sellers in the
travel industry, strengthening relationships and delivering exceptional value
to our partners and attendees.”

The Business Travel Show Asia Pacific will mirror the format of the BTN Group’s Business Travel Show
Europe, which marks its 30th anniversary this year. The Asia Pacific iteration will feature the group’s unique hosted buyer program, which has been a pillar of the
show’s ongoing success in Europe since 2012.

“We are thrilled about this opportunity as it marks a
natural evolution and expansion of the Business Travel Show brand into the
vibrant APAC region,” said BTN Group EVP and group publisher Louis Magliaro. “The strength of corporate travel market in this
region is undeniable, and we are eager to extend our current reach to connect
with key industry players and foster new collaborations.”

The Business Travel Show Asia Pacific and The Meeting Show Asia Pacific are
supported by the Singapore Tourism Board. Business Travel Show Asia Pacific joins Northstar’s portfolio of Asia Pacific-located events including Hotel Investment Conference Asia Pacific on
Aug. 28-30, 2024, WiT Singapore on Oct. 14-16, 2024, and CruiseWorld Asia in
October 2024.



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GenAI Adds Speed to ServiceNow Business Transformations By Investing.com

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Brazilian enterprises are increasingly looking for ServiceNow (NYSE:) providers that can demonstrate industry-specific expertise, ISG Provider Lens™ report says

SÃO PAULO–(BUSINESS WIRE)–In a rapidly changing business environment, the addition of GenAI to the latest version of ServiceNow will enable Brazilian enterprises to dramatically speed up their business transformations, according to a new research report published today by Information Services Group (ISG) (Nasdaq: NASDAQ:), a leading global technology research and advisory firm.

The 2024 ISG Provider Lens™ ServiceNow Ecosystem Partners report for Brazil finds the GenAI-enhanced version of ServiceNow could lead to faster business transformations for enterprises in Brazil. When assisted by structured agents, cycle times for ServiceNow solutions can now, in some cases, be cut in half, the ISG report says.

Enterprises in Brazil are becoming increasingly aware of the importance of choosing service providers that understand the nature of their business, the ISG report says. Key sectors of the Brazilian economy, such as agribusiness, financial services, government and healthcare, are driving demand for ServiceNow integrations with industry-specific solutions, the report says.

Providers that combine GenAI capabilities with a solid knowledge of industry-specific needs will be able to differentiate themselves from competitors, said Bill Huber, partner, digital platforms and solutions, for ISG. The convergence of IT and business processes on platforms like ServiceNow will accelerate business transformation in Brazil over the next few years.

Recently, there has been a marked increase in Brazilian enterprises seeking ServiceNow partners that not only demonstrate a deep understanding of ServiceNow technologies but also have knowledge of business processes, the ISG report says. According to the report, these enterprises prefer providers that have already invested in industry-specific reference models and evaluation methodologies, data and benchmarking capabilities and that can point to verifiable platform results.

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ServiceNow’s partners are responding by specializing in specific industry sectors, further enhancing their ability to provide customized solutions that meet the unique demands of each sector, the ISG report says. With this approach, known as business transformation management, service providers combine vertical-specific expertise with knowledge of platforms and advanced technologies, including GenAI, the report says.

Enterprises need to be able to consolidate focused content and effectively use evolving information and knowledge bases, said Jan Erik Aase, partner and global leader, ISG Provider Lens Research. Effectively leveraging industry knowledge to accelerate specific business solutions in a structured manner will be fundamental to the productivity of Brazilian enterprises.

The report also examines how newer and more strategic functionalities on the ServiceNow platform, including those in non-IT workflows, are quickly becoming top priorities for enterprises in Brazil.

For more insights into the ServiceNow ecosystem challenges facing enterprises in Brazil, such as an increased emphasis on speed and a heightened focus on transformation, along with ISG’s advice for addressing them, see the ISG Provider Lens™ Focal Points briefing here.

The 2024 ISG Provider Lens™ ServiceNow Ecosystem Partners report for Brazil evaluates the capabilities of 27 providers across three quadrants: ServiceNow Consulting Services, ServiceNow Implementation and Integration Services and ServiceNow Managed Services Providers.

The report names Accenture (NYSE:), Alparservice, AOOP, Capgemini, Deloitte and Extreme Group as Leaders in all three quadrants, while The Cloud People and Wipro (NYSE:) are named as Leaders in two quadrants each. Digisystem is named as a Leader in one quadrant.

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In addition, Cask and YSSY are named as Rising Stars ” companies with a promising portfolio and high future potential by ISG’s definition ” in two quadrants each.

In the area of customer experience, KPMG is named the global ISG CX Star Performer for 2024 among ServiceNow Ecosystem providers. KPMG earned the highest customer satisfaction scores in ISG’s Voice of the Customer survey, part of the ISG Star of Excellence™ program, the premier quality recognition for the technology and business services industry.

Customized versions of the report are available from AOOP and Extreme Group.

The 2024 ISG Provider Lens™ ServiceNow Ecosystem Partners report for Brazil is available to subscribers or for one-time purchase on this webpage.

About ISG Provider Lens™ Research

The ISG Provider Lens™ Quadrant research series is the only service provider evaluation of its kind to combine empirical, data-driven research and market analysis with the real-world experience and observations of ISG’s global advisory team. Enterprises will find a wealth of detailed data and market analysis to help guide their selection of appropriate sourcing partners, while ISG advisors use the reports to validate their own market knowledge and make recommendations to ISG’s enterprise clients. The research currently covers providers offering their services globally, across Europe, as well as in the U.S., Canada, Brazil, the U.K., France, Benelux, Germany, Switzerland, the Nordics, Australia and Singapore/Malaysia, with additional markets to be added in the future. For more information about ISG Provider Lens research, please visit this webpage.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including AI and automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs 1,600 digital-ready professionals operating in more than 20 countries”a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

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Will Thoretz, ISG
+1 203 517 3119
will.thoretz@isg-one.com

Thábata Mondoni, Mondoni Press for ISG
Mobile: +55 11 98671 5652
thabata@mondonipress.com.br

Source: Information Services Group, Inc.



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Best Restaurants in Provincetown – Eater Boston

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Much more than a brewery (and the city’s first on-site brewery to boot), Provincetown Brewing Company is a popular gathering place for beers, inexpensive bites, and fun trivia and other events that continue into the off-season. Bring the crew and hang out on the patio or in the taproom, decorated with strange art and perfectly kitschy, and enjoy dishes like nachos piled high with melted cheddar, pico de gallo and verde sauce, and lemongrass chicken wings and poutine. Add jerk chicken to a salad or, better yet, order a jerk chicken sandwich from the heartier menu offerings and enjoy the smoky, slow-cooked flavor.

IO Biotech Reports First Quarter 2024 Financial Results and Provides Business Highlights By Investing.com

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  • Outcome of interim analysis for the overall response rate (ORR) for the first 225 patients randomized in the pivotal Phase 3 trial (IOB-013/KN-D18) of lead investigational therapeutic cancer vaccine, IO102-IO103, in combination with pembrolizumab still expected in Q3 2024; outcome of primary endpoint of progression free survival (PFS) is now projected to occur in first half of 2025
  • Completed enrollment in Phase 2 basket trial IOB-022/KN-D38 and in first cohort of Phase 2 neoadjuvant/adjuvant basket trial IOB-032/PN-E40, which has been expanded to include a randomized melanoma cohort
  • Presented poster at the American Association for Cancer Research (AACR) Annual Meeting 2024; non-clinical data presented further support the dual mechanism of action of IO102-IO103
  • Strengthened executive team with key hires to business and commercial development positions
  • Ended first quarter with approximately $118.0 million in cash and cash equivalents, maintaining expected cash runway into the fourth quarter of 2025

NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win ® platform, today reported financial results for the first quarter ended March 31, 2024.

This will be a transformative year for IO Biotech as we approach the interim analysis of our pivotal Phase 3 study in first-line advanced melanoma, which, if supportive, could allow for a submission of a Biologics License Application (BLA) to the United States (US) Food and Drug Administration (FDA) this year, said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. Last year, we expanded our Phase 3 study to potentially bring in the time to reach the primary endpoint of progression free survival and we concluded enrollment in the fourth quarter of 2023 with 407 patients. As we prepare for the interim analysis, we now have greater visibility to estimate the timing of reaching 226 events needed for the PFS analysis, which we now project will occur in the first half of 2025.

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Dr. Zocca continued, With continued execution of our Phase 3 study and its planned interim analysis as our main priorities this year, we also continue both of our Phase 2 basket studies: completing enrollment in our IOB-022 study; and rapidly enrolling and expanding our newest basket study, IOB-032, in the neo-adjuvant/adjuvant settings of melanoma and squamous cell carcinoma of the head and neck (SCCHN). Finally, as we prepare for potential commercialization and partnering, I am very pleased with the strength of expertise we have added to our leadership team with the additions of Marjan Shamsaei as Senior Vice President, Commercial and Portfolio Lead, and Faiçal Miyara as Chief Business Officer. I founded IO Biotech 10 years ago and couldn’t be more proud of all that we have accomplished, and, with such a strong team in place, confident in what lies ahead.

Recent Business Highlights

  • The company recently completed enrollment of 407 patients in its pivotal Phase 3 trial (IOB-013/KN-D18) of IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) in advanced melanoma. The primary endpoint of the Phase 3 trial is PFS. The PFS analysis will be conducted when 226 events have occurred in the trial, which, based on the expanded trial size, reaching full enrollment ahead of schedule and the events to date in the study, the company now projects will occur in the first half of 2025. Additionally, a planned interim analysis of ORR will be conducted when the first 225 randomized patients reach one year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024 and, if supportive, we believe could allow for submission of a BLA for accelerated approval in the US.
  • The independent data monitoring committee (IDMC) for the company’s IOB-013/KN-D18 Phase 3 trial convened its fourth meeting in March 2024 and recommended that the trial continue without modifications.
  • The company’s Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) or recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) completed enrollment; the company plans to submit abstracts with updates from this study to medical meetings in the fall of 2024.
  • The company’s Phase 2 solid tumor basket trial (IOB-032/PN-E40) studying treatment with IO102-IO103 in combination with pembrolizumab given before (neo-adjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or SCCHN has been enrolling patients since December 2023 in cohorts A (melanoma) and B (SCCHN) in the US, European Union (EU) and Australia. Cohort A is now fully enrolled and the company recently expanded the study to include a randomized cohort C in melanoma, in which patients are randomized either to IO102-IO103 in combination with pembrolizumab or to pembrolizumab alone.
  • In April, a poster presentation of new non-clinical data further supporting the dual mechanism of action of the company’s lead cancer vaccine, IO102-IO103, was delivered at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. While further studies are needed to fully discern the relationship between IDO1+/PD-L1+ target populations within the ™E and the impact of IDO1/PD-L1 targeted vaccination, we believe the data presented support the use of a dual antigen approach to reduce the immunosuppression and enhance anti-tumor effect.
  • In April, the company strengthened its executive team with the appointments of Faiçal Miyara, Ph.D., as Chief Business Officer, and Marjan Shamsaei, Pharm.D., as Senior Vice President, Commercial and Portfolio Lead.

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First Quarter 2024 Financial Results

  • Net loss for the three months ended March 31, 2024, was $19.5 million, compared to $17.0 million for the three months ended March 31, 2023.
  • Research and development expenses were $14.3 million for the three months ended March 31, 2024, compared to $11.9 million for the three months ended March 31, 2023. The increase was primarily related to clinical trial-related activities for the company’s IO102-IO103 therapeutic cancer vaccine candidate, including the continued execution of the company’s pivotal Phase 3 clinical trial. The company recognized $0.6 million in research and development equity-based compensation for the three months ended March 31, 2024, compared to $0.7 million for the three months ended March 31, 2023.
  • General and administrative expenses were $5.9 million for the three months ended March 31, 2024, compared to $6.0 million for the three months ended March 31, 2023. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended March 31, 2024, compared to $1.2 million for the three months ended March 31, 2023.
  • Cash and cash equivalents as of March 31, 2024 were $118.0 million, compared to $143.2 million at December 31, 2023. During the three months ended March 31, 2024, the company used cash, cash equivalents and restricted cash of $24.9 million. The increase in cash use was primarily driven by milestone payments and payment of other accrued expenses associated with clinical trials, as well as the payment of year-end bonuses. The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 2025.

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About IO102-IO103

IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (™E) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA ® is a registered trademark of Merck Sharp (OTC:) & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Patients have been enrolled from centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

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About the IOB-013/KN-D18 Clinical Trial Endpoints

The primary endpoint of the IOB-013/KN-D18 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the first half of 2025. Additionally, there is a planned per-protocol interim analysis of overall response rate when the first 225 randomized patients reach one year of treatment in mid-2024. The outcome of this analysis is expected in the third quarter of 2024. There is a high statistical bar for the Phase 3 interim analysis (p ‰¤0.005), which was set to preserve most of the alpha for the primary endpoint of PFS. Regardless of the outcome of the interim analysis, the trial is designed to continue to the primary PFS endpoint.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in first-line advanced cancers in non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial

IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket trial investigating the IO102-IO103 therapeutic cancer vaccine in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The study will enroll approximately 15 patients with melanoma and 15 patients with SCCHN in cohort A and cohort B respectively as single arm cohorts receiving combination of IO102-IO103 with pembrolizumab, whereas in cohort C ‰¥30 melanoma patients will be randomized 1:1 to neo-adjuvant treatment with either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery ( ‰¤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

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About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win ® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York.

For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech).

Forward-Looking Statement

This press release contains 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. Forward-looking statements, including regarding the timing of the interim and primary analyses of the company’s Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

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Contact:Maryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com

 
IO BIOTECH, INC. Consolidated Statements of Operations and Comprehensive Loss (Unaudited in thousands, except share and per share amounts)
 
    Three Months EndedMarch  31,  
    2024     2023  
Operating expenses            
Research and development   $ 14,311     $ 11,900  
General and administrative     5,886       6,024  
Total operating expenses     20,197       17,924  
Loss from operations     (20,197 )     (17,924 )
Other income (expense)            
Currency exchange (loss) gain, net     (462 )     258  
Interest income     1,617       1,028  
Total other income (expense)     1,155       1,286  
Loss before income tax expense     (19,042 )     (16,638 )
Income tax expense     415       406  
Net loss     (19,457 )     (17,044 )
Net loss attributable to common shareholders     (19,457 )     (17,044 )
Net loss per common share, basic and diluted   $ (0.30 )   $ (0.59 )
Weighted-average number of shares used in computing net loss per common share, basic and diluted     65,880,914       28,815,267  
Other comprehensive loss            
Net loss   $ (19,457 )   $ (17,044 )
Foreign currency translation     194       517  
Total comprehensive loss   $ (19,263 )   $ (16,527 )
 
IO BIOTECH, INC.Consolidated Balance Sheets (Unaudited in thousands, except share and per share amounts)
 
    March  31,2024     December  31,2023  
Assets            
Current assets            
Cash and cash equivalents   $ 117,982     $ 143,193  
Prepaid expenses and other current assets     6,146       4,062  
Total current assets     124,128       147,255  
Restricted cash     268       268  
Property and equipment, net     788       847  
Right of use lease asset     2,092       2,259  
Other non-current assets     883       89  
Total non-current assets     4,031       3,463  
Total assets   $ 128,159     $ 150,718  
Liabilities and stockholders’ equity            
Current liabilities            
Accounts payable   $ 3,840     $ 3,878  
Lease liability – current     666       655  
Accrued expenses and other current liabilities     6,537       11,184  
Total current liabilities     11,043       15,717  
Lease liability – non-current     1,650       1,839  
      Total non-current liabilities     1,650       1,839  
Total liabilities     12,693       17,556  
Commitments and contingencies (Note 9)            
Stockholders’ equity            
Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of March 31, 2024 and December 31, 2023            
Common stock, par value of $0.001 per share; 300,000,000 shares authorized at March 31, 2024 and December 31, 2023; 65,880,914 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively     66       66  
Additional paid-in capital     408,154       406,587  
Accumulated deficit     (283,279 )     (263,822 )
Accumulated other comprehensive loss     (9,475 )     (9,669 )
Total stockholders’ equity     115,466       133,162  
Total liabilities and stockholders’ equity   $ 128,159     $ 150,718  

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Innate Pharma Reports First Quarter 2024 Business Update and Financial Results By Investing.com

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  • First preclinical data set for IPH45, a pre-IND anti-Nectin-4 Antibody Drug Conjugate, presented as an oral presentation at AACR 2024
  • Progression of Sanofi-developed NK Cell Engager SAR443579/IPH6101 to Phase 2 in blood cancers
  • Five ASCO Annual Meeting 2024 abstracts:
    • Final TELLOMAK Phase 2 data for lacutamab in Mycosis Fungoides
    • Two posters on IPH6501, Innate’s second generation ANKET ® in B‘cell Non-Hodgkin’s Lymphoma
    • AstraZeneca (NASDAQ:) to present poster on updated results for monalizumab from Phase 2 stage III unresectable NSCLC trial
    • Monalizumab SCLC Phase 2 MOZART trial poster
  • Cash position of €113.9 million1 as of March 31, 2024 (not including the €4.0 million payment to be received from Sanofi (NASDAQ:)), anticipated cash runway into end 2025
  • Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. EDT

MARSEILLE, France–(BUSINESS WIRE)–Regulatory News:

Innate Pharma SA (OTC:) (Euronext Paris: IPH; Nasdaq: IPHA) (Innate or the Company) today reported its consolidated financial results for the quarter ending March 31, 2024.

We are executing our strategy of building on our partnered drug candidates while advancing our next generation of proprietary medicines, said Hervé Brailly, Chief Executive Officer ad interim of Innate Pharma. Our second generation ANKET ®, IPH6501 began clinical development for NHL. We presented preclinical data for IPH45, our Nectin-4 ADC, at the recently held AACR Annual Meeting. Our partner Sanofi also advanced SAR443579, a tri-functional NK Cell Engager targeting CD123, to Phase 2 in blood cancer. We expect to have several data presentations at ASCO, including data from the TELLOMAK Phase 2 trial with lacutamab in mycosis fungoides, as we prepare to submit an IND for IPH45 later this year.

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Webcast and conference call will be held today at 2:00pm CEST (8:00am EDT)

The live webcast will be available at the following link: https://events.q4inc.com/attendee/244650312

Participants may also join via telephone using the following registration link:

https://registrations.events/direct/Q4I9730892

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com. A replay of the webcast will be available on the Company website for 90 days following the event.

1 Including short term investments ( €21.3 million) and non-current financial instruments ( €10.1 million).

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T Cell lymphoma

TELLOMAK is a global, open-label, multi-cohort Phase 2 clinical trial evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides (MF).

  • Top-line results in MF patients will be presented at the ASCO Annual Meeting 2024 being held May 31 “ June 4 in Chicago. Title of the abstract is: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: results from the TELLOMAK Phase 2 trial. The full abstract will be released at 5:00 PM ET on Thursday, May 23, 2024 on the ASCO Annual Meeting website.
  • In January 2024, Innate announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold previously placed on the lacutamab IND on October 2023 following a patient death in the TELLOMAK study. The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated.

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Peripheral T Cell lymphoma (PTCL)

  • The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial led by the Lymphoma Study Association (LYSA) to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL is ongoing and continues to recruit patients.

ANKET ® (Antibody-based NK cell Engager Therapeutics):

ANKET ® is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer. Innate’s pipeline includes five public drug candidates born from the ANKET ® platform: SAR443579 (SAR’579/IPH6101) (CD123-targeted), SAR445514 (SAR’514/IPH6401) (BCMA-targeted), IPH62 (B7-H3-targeted), IPH67 (target undisclosed, solid tumors) and tetra-specific IPH6501 (CD20-targeted with IL‘2v). Several other undisclosed proprietary preclinical targets are being explored.

IPH6501 (proprietary)

IPH6501 is Innate’s proprietary CD20-targeted IL-2v bearing second-generation ANKET ®.

  • Innate will present 2 posters on IPH6501 at the upcoming ASCO Annual Meeting 2024, being held from May 31 to June 4 in Chicago. Titles of the abstract are:
    • A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma
    • Preclinical assessment of IPH6501, a first-in-class IL2v-armed tetraspecific NK Cell Engager directed against CD20 for R/R B-NHL, in comparison to a CD20-targeting T Cell Engager
  • The full abstracts will be released at 5:00 PM ET on Thursday, May 23, 2024 on the ASCO Annual Meeting website.
  • In March 2024 the first patient was dosed in the Phase 1/2 clinical trial evaluating IPH6501 in B cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients.

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SAR443579, SAR445514, IPH62 and IPH67 (under development by Sanofi)

SAR443579/IPH6101

The Phase 1/2 clinical trial, currently under development, by Sanofi is progressing well, evaluating SAR443579 / IPH6101, a trifunctional anti-CD123 NKp46×CD16 NK cell engager and ANKET ® platform lead asset, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).

  • In April 2024, Sanofi advanced SAR443579 / IPH6101, to the Phase 2 dose expansion of the trial. Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m (which has been booked as revenue in the first quarter but had not been received from Sanofi in the quarter, and has therefore not been included in the cash position).

SAR445514/IPH6401

The Sanofi led Phase 1/2 clinical trial with SAR’514 / IPH6401, a trifunctional anti-BCMA Nkp46xCD16 NK cell engager, in patients with Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Light-chain Amyloidosis is ongoing.

IPH62

IPH62 is a NK cell engager program targeting B7-H3 from Innate’s ANKET ® platform under development. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.

IPH67

IPH67 is a NK cell engager program in solid tumors from Innate’s ANKET ® platform under development. Following a research collaboration period, Sanofi will be responsible for all development, manufacturing and commercialization.

Sanofi still retains the option of one additional ANKET ® target under the terms of the 2022 research collaboration and license agreement.

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Antibody Drug Conjugates:

Innate develops different approaches for the treatment of cancer utilizing its antibody engineering capabilities to deliver novel assets, with its innovative ANKET ® platform and is also exploring Antibody Drug Conjugates (ADC) formats.

Beyond its proprietary programs, Innate has an ongoing agreement with Takeda on ADCs.

IPH45 (Nectin-4 ADC):

IPH45 is Innate’s proprietary and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4.

  • First preclinical data were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024. In preclinical studies, IPH45 shows anti-tumor efficacy in vivo, in Nectin-4 expressing tumors including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma patient-derived xenografted (PDX) mice models, across Nectin-4 high and Nectin-4 low expression levels. In addition, IPH45 has anti-tumor activity in combination with anti-PD1 treatment in PD-1 resistant model in vivo and has a favorable safety profile in relevant animal toxicology models.
  • IPH45 continues towards IND filing in 2024.

Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing.

AstraZeneca will present a poster at ASCO titled: Updated results from COAST, a phase 2 study of durvalumab (D) ± oleclumab (O) or monalizumab (M) in patients (pts) with stage III unresectable non-small cell lung cancer (uNSCLC).

A poster at ASCO will also be presented titled A phase II trial of monalizumab in combination with durvalumab (MEDI4736) plus platinum-based chemotherapy for first-line treatment of extensive stage small cell lung cancer (MOZART): Hoosier Cancer Research Network LUN21-530 study.

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IPH5201 (anti-CD39), partnered with AstraZeneca:

The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing and recruitment is on track.

IPH5301 (anti-CD73):

The investigator-sponsored CHANCES Phase 1 trial of IPH5301 by Institut Paoli-Calmettes is ongoing.

Corporate Update:

  • Early January 2024, two new Executive Board members were appointed. Arvind Sood, Executive Vice President (EVP), President of US Operations, Dr Sonia Quaratino, EVP, Chief Medical Officer, joining Hervé Brailly, interim Chief Executive Officer and Yannis Morel, EVP, appointed Chief Operating Officer.
  • In connection with Innate’s previous announcement that it had established an at-the-market (A™) program, on January 16, 2024 Innate filed a new Registration Statement on Form F-3 (Registration No. 333-276164). On February 6, 2024, Innate filed a prospectus supplement relating to its previously established A™ program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million of American Depositary Shares (ADS). Each ADS represents one ordinary share of Innate. As of March 31, 2024, no sales have been made under the program.

Financial Results:

Cash, cash equivalents and financial assets of the Company amounted to €113.9 million as of March 31, 2024. At the same date, financial liabilities amounted to €37.7 million. Cash, cash equivalents and financial assets as of March 31, 2024 do not include the €4.0 million payment to be received from Sanofi.

Revenues for the first three months of 2024 amounted to €6.6 million ( €26.0 million for the same period in 2023). For the three-month period, ended March 31, 2024, revenue from collaboration and licensing agreements mainly results from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

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About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform.

Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET ® multi-specific NK cell engagers to address multiple tumor types.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code
Ticker code
LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including believe, potential, expect and will and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties which could cause the company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (AMF), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

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This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Investors
Innate Pharma
Henry Wheeler
Tel.: +33 (0)4 84 90 32 88
Henry.wheeler@innate-pharma.fr

Media Relations
NewCap
Arthur Rouillé
Tel.: +33 (0)1 44 71 00 15
innate@newcap.eu

Source: Innate Pharma SA



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Uber to buy Delivery Hero’s Taiwan business for $950 mln By Investing.com

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Investing.com– Uber Technologies Inc (NYSE:) said on Tuesday it had reached an agreement with German food delivery firm Delivery Hero AG (ETR:) to take over the latter’s foodpanda business in Taiwan for $950 million in cash.

The deal will see foodpanda being folded into the Uber Eats platform, and is subject to regulatory approval. Uber said it expects the deal to close in the first half of 2025, until which Delivery Hero will continue operating foodpanda.

Separately, Uber and Delivery Hero also reached an agreement where Uber will buy $300 million in newly issued ordinary shares of Delivery Hero.

Tuesday’s deal comes after reports earlier this year said the two companies had stopped negotiations over the sale of Delivery Hero’s Asian operations. It was not immediately clear whether the sale included foodpanda’s operations in Southeast Asia.

The German firm has been courting buyers for its Asian units as it moves to streamline its operations and better focus on its core European market.

The deal also gives Uber more headway in the food delivery business, particularly in Asia, where Uber Eats faces stiff competition from local players.



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PAVmed Provides Business Update and First Quarter 2024 Financial Results By Investing.com

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Lucid (NASDAQ:) strengthens balance sheet and secures a July 17, 2024 MolDX pre-submission meeting date

Veris Health completes MOU with The Ohio State’s James Cancer Hospital

Conference call and webcast to be held tomorrow, May 14th at 8:30 AM EDT

NEW YORK, May 13, 2024 /PRNewswire/ — PAVmed (NASDAQ:) Inc. (NASDAQ: PAVM, PAVMZ) (“PAVmed” or the “Company”), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) (“Lucid”) and Veris Health Inc. (“Veris”), and presented financial results for the Company for the three months ended March 31, 2024.

Conference Call and Webcast

The webcast will take place on Tuesday, May 14, 2024, at 8:30 AM and is accessible in the investor relations section of the Company’s website at pavmed.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name “PAVmed Business Update” to join.

Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at pavmed.com.

Business Update Highlights

“I am very pleased with the strong progress PAVmed’s subsidiaries have made on multiple fronts during the first quarter and recent weeks,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “Lucid, PAVmed’s strongest and most advanced asset, is making great commercial progress and continues to successfully finance its operations through long-term fundamental investors. Lucid now has the runway to advance through key reimbursement milestones on the pathway to profitability. As discussed last quarter, we updated the PAVmed overall strategy to drive shareholder value through independently-financed subsidiaries that leverage PAVmed’s shared infrastructure. Veris and the PMX Incubator are progressing well in furtherance of this revised strategy.”

Highlights from the first quarter and recent weeks include:

  • Yesterday, Lucid reported that 1Q24 EsoGuard ® revenue was $1.0 million, which was flat compared to 4Q23 and represents a 124 percent increase from 1Q23.
  • Strengthened balance sheet by Lucid’s completion of a $29.8 million Series B Preferred Stock Offering.
  • Peer-reviewed publication of positive data from landmark National Cancer Institute (NCI)-sponsored clinical validation study, strengthening EsoGuard’s clinical data supporting ongoing payor engagement.
  • Secured July 17, 2024 MolDX pre-submission meeting to review data for technical assessment (TA) under its foundational Local Coverage Determination (LCD).
  • Completed Memorandum of Understanding (MOU) with The Ohio State’s James Cancer Hospital to implement pilot program enrolling their patients onto Veris Cancer Care Platform.
  • Clear path to FDA clearance for Veris implantable monitor pending financing.
  • Actively seeking to raise capital for PortIO Corp. as part of the PMX incubator initiative, which will also include other technologies such as EsoCure and CarpX.

Financial Results:

  • For the three months ended March 31, 2024, EsoGuard related revenues were $1.0 million. Operating expenses were approximately $15.0 million which include stock-based compensation expenses of $1.9 million. GAAP net loss attributable to common stockholders was approximately $22.8 million, or $(2.62) per common share.
  • As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s non-GAAP adjusted loss was approximately $8.6 million or $(0.99) per common share.
  • PAVmed had cash and cash equivalents of $25.5 million as of March 31, 2024, compared to $19.6 million as of December 31, 2023.
  • The unaudited financial results for the three months ended March 31, 2024 were filed with the SEC on Form 10-Q on May 13, 2024, and are available at www.pavmed.com or www.sec.gov.

PAVmed Non-GAAP Measures

  • To supplement our financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA) and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.
  • Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures.
  • Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.
  • A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three months ended March 31, 2024 and 2023 are as follows:

Condensed Consolidated Statement of Operations (Unaudited)

For the three months ended

March 31,

2024

2023

(in thousands except per-share amounts)

Revenue

$ 1,010

$ 446

Operating expenses

15,046

20,847

Other (Income) Expense

4,476

1,813

Net Loss

18,512

22,214

Net income (loss) per common share, basic and diluted

$ (2.62)

$ (2.78)

Net loss attributable to common stockholders

(22,788)

(18,005)

Preferred Stock dividends and deemed dividends

7,576

74

Net income (loss) as reported

(15,212)

(17,931)

Adjustments:

Depreciation and amortization expense1

586

727

Interest expense (income), net2

(56)

62

NCI ownership share of Interest and Depreciation adjustments

(131)

(168)

EBITDA

(14,813)

(17,310)

Other non-cash or financing related expenses:

Stock-based compensation expense3

1,882

4,419

ResearchDx acquisition/settlement paid in stock1

713

Change in FV convertible debt2

2,163

1,040

Offering costs convertible debt2

1,186

Loss on debt extinguishment2

369

525

Debt modification expense

2,000

Other non-cash charges

NCI ownership share of non-GAAP adjustments

(239)

(1,742)

Non-GAAP adjusted (loss)

$ (8,638)

$ (11,169)

Basic and Diluted shares outstanding

8,695

6,473

Non-GAAP adjusted (loss) income per share

$(0.99)

$(1.73)

1 Included in general and administrative expenses in the financial statements.

2 Included in other income and expenses.

3 Stock-based compensation (“SBC”) expense included in operating expenses is detailed as follows in the table below by category within operating expenses for the non-GAAP Net operating expenses:

Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses

(in thousands except per-share amounts)

For the three months ended

March 31,

2024

2023

Cost of revenue

$ 1,744

$ 1,346

Stock-based compensation expense3

(36)

(23)

Net cost of revenue

1,708

1,323

Amortization of acquired intangible assets

372

505

Sales and marketing

4,311

4,539

Stock-based compensation expense3

(403)

(444)

Net sales and marketing

3,908

4,095

General and administrative

6,678

10,407

Depreciation expense

(214)

(222)

ResearchDx acquisition/settlement paid in stock

(713)

Stock-based compensation expense3

(1,078)

(3,588)

Net general and administrative

5,386

5,884

Research and development

1,941

4,050

Stock-based compensation expense3

(365)

(364)

Net research and development

1,576

3,686

Total operating expenses

15,046

20,847

Depreciation and amortization expense

(586)

(727)

ResearchDx acquisition/settlement paid in stock

(713)

Stock-based compensation expense3

(1,882)

(4,419)

Net operating expenses

$ 12,578

$ 14,988

About PAVmed and its Subsidiaries

PAVmed Inc . is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its majority-owned subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard ® Esophageal DNA Test and EsoCheck ® Esophageal Cell Collection Device”the first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths. Its other majority-owned subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform.

For more and for more information about PAVmed, please visit pavmed.com.

For more information about Lucid Diagnostics, please visit luciddx.com.

For more information about Veris Health, please visit verishealth.com.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of PAVmed’s and Lucid’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s and Lucid’s common stock; PAVmed’s Series Z warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance PAVmed’s and Lucid’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s and Lucid’s clinical and preclinical studies; whether and when PAVmed’s and Lucid’s products are cleared by regulatory authorities; market acceptance of PAVmed’s and Lucid’s products once cleared and commercialized; PAVmed’s and Lucid’s ability to raise additional funding as needed; and other competitive developments. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s and Lucid’s future operations, see Part I, Item 1A, “Risk Factors,” in PAVmed’s and Lucid’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed or Lucid after its most recent Annual Report. PAVmed and Lucid disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

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Real Estate Showdown: A Back Bay Brownstone vs. a Belmont Farmhouse

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Listing Agents: CS LUXURY GROUP, KELLER WILLIAMS REALTY (BOSTON); MARTHA DELANEY, COLDWELL BANKER REALTY (BELMONT)

Photos courtesy of MADORE PHOTOGRAPHY (BOSTON); DRONE HOME MEDIA (BELMONT)

195 Marlborough St., No. 2, Boston Sales Price: ~$2,250,000 5 Chilton St., Belmont
$2,250,000
6
1,404 square meters
2
2 full
Asking price
days on the market
Size
bedroom
bathroom
$2,900,000
170
3,500 square meters
4
2 full, 1 half

No matter your design sense, natural light is at the top of almost every home buyer’s wish list. The sun-filled living room in this stunning Back Bay home features a beautiful 12-over-12 bay window that offers magnificent views of Marlborough Street. Large windows in the kitchen and bedrooms add to the spacious atmosphere of the townhouse. Built in 1880 but renovated in 1974, the home is also full of classic design elements, including a wood-burning fireplace, stately 10-foot ceilings, and built-in closets. Chic accents in the kitchen and bathroom—hello, marble-tiled showers—add a little regal elegance.

As for sunlight, this Belmont farmhouse built in 1883 also has large windows, but its design is airier and more modern than its Boston counterpart. The property was recently renovated from the ground up to suit the modern lifestyle – think oak-wrapped beams, a custom gas fireplace and quartz countertops, all in an open floor plan. The home also features an extensive, professionally landscaped yard and a finished basement. It was two thousand square meters larger than the city residence and sold for exactly the same price. A larger space and lots of sun? At least in this showdown, the suburbs have the upper hand.

First published in the May 2024 print edition with the headline “Real Estate Showdown: A Back Bay Brownstone vs. a Belmont Farmhouse.”

FT/Schroders Business Book of the Year contest accepting entries

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The Financial Times & Schroders Business Book of the Year Award is now accepting entries.

It invites authors and publishers to fill in the form band present their works that delve into critical business themes such as economics, finance, management, climate change, and the future of work. Remember, you have the opportunity to win a £30,000 top prize!

The award’s panel of judges will be led by FT editor Roula Khalaf. Publishers are encouraged to submit their works digitally, adhering to the specified submission deadlines.

Two-part submission deadline:

  • For books published between 16 November 2023, and 31 May 2024, the deadline is 31 May 2024
  • For titles released between 1 June 2024, and 15 November 2024, submissions must be made by 30 June 2024

Eligibility and Submission Guidelines:

Who Can Submit: The competition is open to all authors and publishers. Whether you’re a seasoned author or a newcomer, we welcome your entries.
Language: Submissions must be in English or translated into English. Formats Accepted: Both physical books and digital copies are accepted. However, a final PDF of the book must be included with your submission.
Multiple Submissions: Publishers are allowed to submit multiple titles provided they align with the award’s objectives.

How to Submit:

Entry Form: Complete the entry form with details about the book and the author(s).
Attach Your Book: Upload a final PDF of your book through the form. Instructions for submitting physical copies are also provided.
Update Submission: You can update details or replace the PDF file anytime before the deadline using the same form.

To apply, go here.



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Best Real Estate Articles May 2024

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Der Frühlingsmarkt ist in weiten Teilen des Landes in vollem Gange. Es ist eine großartige Zeit, sich über Immobilien zu informieren! Dieser Monat enttäuscht nicht mit mehreren großartigen Immobilienartikeln.

Entdecken Sie den Schlüssel zum Eigenheim, indem Sie die richtige Hypothek finden

Entdecken Sie die Geheimnisse, wie Sie die ideale Hypothek für Ihre Bedürfnisse finden. Als Immobilienexperten in Zentral-Maryland weisen Chris und Karen Highland ihre Kunden darauf hin, dass der Weg zum Eigenheim mit einem klaren Verständnis davon beginnt, was man sich leisten kann. Am häufigsten finanzieren Hauskäufer ihr Haus; Das bedeutet, den richtigen Kreditgeber zu finden.

Vom Kreditgebervergleich über das Verständnis der Kreditbedingungen bis hin zur Beurteilung Ihrer finanziellen Bereitschaft behandelt dieser Artikel alle wesentlichen Schritte zur Sicherung der richtigen Hypothek für Ihr Traumhaus. Egal, ob Sie ein Erstkäufer oder ein erfahrener Eigenheimbesitzer sind, Sie können sich das Wissen aneignen, um fundierte Entscheidungen zu treffen und sich sicher auf dem Hypothekenmarkt zurechtzufinden.

Entdecken Sie Expertentipps und praktische Ratschläge, um Ihren Weg zum Hauskauf zu optimieren. Mit Einblicken in zu berücksichtigende Faktoren, für die Beantragung erforderliche Dokumente und die Vorteile einer Hypotheken-Vorabgenehmigung ist dieser Leitfaden Ihre Anlaufstelle für die Bewältigung des Hypothekenprozesses.

Lassen Sie sich nicht von der Unsicherheit aufhalten – machen Sie den ersten Schritt in Richtung Eigenheim.

Beste Immobilienblogs Mai 2024

Sehen Sie sich einige der besten Immobilienartikel an, die im Mai 2024 veröffentlicht wurden.

Kauf eines Hauses mit Abwassersystem

Bill Gassett, Immobilienprofi aus Massachusetts, veröffentlicht einen informativen Artikel über die Überlegungen und Verantwortlichkeiten, die mit dem Besitz eines Hauses mit Klärgrube in Massachusetts verbunden sind. Es wird betont, wie wichtig es ist, die örtlichen Vorschriften zu verstehen und einzuhalten, insbesondere die Anforderungen von Titel V, die Inspektionen vor dem Abschluss eines Immobilienverkaufs vorschreiben.

Aus der Sicht eines erfahrenen Maklers aus Massachusetts unterstreicht der Artikel die Notwendigkeit, die Funktionalität von Abwassersystemen zu verstehen und die Bedeutung regelmäßiger Wartung zur Gewährleistung ihrer Langlebigkeit. Dies unterstreicht die entscheidende Rolle der Einholung eines Inspektionsberichts gemäß Titel V, um den Zustand des Systems zu beurteilen und potenzielle zukünftige Kosten vorherzusagen.

Darüber hinaus bietet der Artikel einen detaillierten Überblick über den Inspektionsprozess für Abwassersysteme und vergleicht ihn mit häuslichen Gesundheitsuntersuchungen. Der Schwerpunkt liegt auf der Beseitigung etwaiger Warnsignale, um teure Überraschungen nach dem Kauf zu vermeiden.

Außerdem werden verschiedene Aspekte des Eigenheims mit einer Klärgrube untersucht, darunter Installationskosten, langfristige Wartungskosten und mögliche Anzeichen von Systemproblemen.

Mir gefiel, wie der Artikel eine ausgewogene Perspektive auf die Vor- und Nachteile des Besitzes einer Immobilie mit einer Klärgrube bietet und neben den Wartungsherausforderungen und Bedenken hinsichtlich der Einhaltung gesetzlicher Vorschriften auch Kosteneffizienz und Umweltvorteile hervorhebt.

Ich liebe dieses, weil so viele Menschen, die über öffentliche Abwasserkanäle verfügen, die erforderliche Wartung von Abwassersystemen nicht verstehen.

Hauskäufer: Geschenkgeld verstehen

In diesem Artikel schreibt Kevin Vitali einen umfassenden Leitfaden für die oft schwierige Aufgabe der Finanzierung eines Hauskaufs, insbesondere für Erstkäufer, die Schwierigkeiten haben, für eine Anzahlung zu sparen und die Abschlusskosten zu decken. Es unterstreicht die Rolle von Schenkungsgeldern, finanziellen Geschenken von Familienmitgliedern oder anderen berechtigten Spendern, um Wohneigentum realisierbarer zu machen.

Diese Mittel können entscheidend sein, um einen Teil oder die gesamte Anzahlung zu decken, wodurch die finanzielle Belastung des Käufers verringert und der Weg zum Eigenheim beschleunigt wird. Um Schenkungsgelder effektiv nutzen zu können, ist es jedoch erforderlich, die Richtlinien der Kreditgeber und IRS-Vorschriften zu verstehen, um die Einhaltung sicherzustellen. Dazu gehört die Vorlage eines Schenkungsschreibens des Spenders, in dem die Art der Mittel bestätigt wird und bestimmte Regeln eingehalten werden, die in verschiedenen Hypothekenprogrammen wie FHA, VA oder herkömmlichen Darlehen festgelegt sind.

Der Artikel beschreibt die Vorteile der Verwendung von Schenkungsgeldern für den Hauskauf, einschließlich potenziell besserer Hypothekenkonditionen und niedrigerer monatlicher Zahlungen aufgrund einer höheren Anzahlung. Darin werden die Zulassungskriterien für Spender erörtert und betont, dass sie mit keiner an der Transaktion beteiligten Partei verbunden sein dürfen.

Darüber hinaus bietet der Artikel praktische Ratschläge zur Dokumentation und Beschaffung von Schenkungsgeldern, einschließlich der Bedeutung bewährter Mittel und der Aufrechterhaltung einer klaren Papierspur. Der Artikel schließt mit Einblicken in steuerliche Auswirkungen, Anzahlungshilfeprogramme und die Notwendigkeit einer proaktiven Kommunikation mit Hypothekenmaklern, um eine reibungslose Transaktion sicherzustellen.

Durch umfassende Anleitungen und Beispiele aus der Praxis ist der Artikel eine wertvolle Ressource für Einzelpersonen, die sich mit der Komplexität der Finanzierung eines Hauskaufs mit Schenkungsgeldern auseinandersetzen müssen.

Ein fertiger Keller ist ein Mehrwert

Aber wieviel? Joe Boylan deckt die Feinheiten der Fertigstellung eines Kellers auf und untersucht seine möglichen Auswirkungen auf den Wert und die Lebensqualität eines Hauses. Joe bietet umfassende Beratung für Hausbesitzer, die eine Kellerrenovierung in Betracht ziehen. Zunächst wird die Notwendigkeit einer sorgfältigen Planung vor Beginn eines solchen Projekts betont. Es verdeutlicht die zu erwartende Wertsteigerung der Immobilie, den persönlichen Bedarf an zusätzlichem Raum und die erforderliche finanzielle Investition.

Der Artikel beleuchtet den Bewertungsprozess und die Unterscheidung zwischen über- und untergelegener Quadratmeterzahl. Darin wird betont, dass fertiggestellte Keller zwar zu Bewertungszwecken nicht in die Gesamtquadratfläche einbezogen werden, aber dennoch zum Gesamtwert eines Hauses beitragen.

Bedenken wie Überschwemmungen und Radon werden angesprochen und die Bedeutung einer ordnungsgemäßen Planung und Schadensbegrenzungsmaßnahmen hervorgehoben.

So funktionieren FHA-Geschenkfonds

Der Artikel von Luke Skar untersucht eingehend die Verwendung von FHA-Schenkgeldern zur Erleichterung des Eigenheimbesitzes, insbesondere für Personen, die vor der Herausforderung stehen, ausreichende Ersparnisse für Anzahlungen und andere Ausgaben anzusammeln.

FHA-Darlehen, die auf Käufer mit mittlerem bis niedrigem Einkommen zugeschnitten sind, bieten Flexibilität bei den Anforderungen an die Kreditwürdigkeit und ermöglichen so vielen Käufern, denen herkömmliche Kredite sonst möglicherweise verweigert würden, eine Genehmigung zu erhalten. Die Einführung von Schenkungsfonds ermöglicht es Verwandten und ausgewählten Organisationen, sich an diesen Ausgaben zu beteiligen, wodurch der Zugang zu Wohneigentum für Familien mit mittlerem und niedrigem Einkommen erweitert wird.

Das Verständnis der FHA-Richtlinien für Geschenkfonds ist von entscheidender Bedeutung, da Kreditnehmer bestimmte Kriterien erfüllen müssen, um sich zu qualifizieren. Dazu gehört die Verwendung der Mittel für Hauptwohnsitze, die Einhaltung der FHA-Immobilienstandards und die Erfüllung der Hypothekenversicherungspflichten.

Darüber hinaus müssen sich Kreditnehmer mit den Feinheiten der Dokumentation, einschließlich eines FHA-Geschenkbriefs, auseinandersetzen, um Transparenz und Compliance während des Underwriting-Prozesses sicherzustellen.

Der Artikel betont auch, wie wichtig es ist, die Schenkungssteuergrenzen einzuhalten, und beschreibt alternative Methoden, wie etwa Schenkungen von Eigenkapital, um Hauskäufe zu unterstützen. Durch umfassende Einblicke unterstreicht der Artikel die Bedeutung von FHA-Geschenkfonds für die Förderung umfassenderer Wohneigentumsmöglichkeiten.

Renovierungsprojekte mit hohem ROI

Verbesserungen mit hohem ROIVerbesserungen mit hohem ROI

Welche Heimwerkerarbeiten haben eine hohe Kapitalrendite?

Weiter zum Thema Renovierungen schreibt Vicki Moore darüber, welche Hausrenovierungen den größten Return on Investment (ROI) für Hausbesitzer in Pacifica, Kalifornien, bringen, insbesondere für diejenigen, die verkaufen möchten. Sie bietet wertvolle Einblicke und betont, wie wichtig es ist, sich auf Verbesserungen zu konzentrieren, die sowohl den ROI als auch die Verkaufsfähigkeit der Immobilie steigern.

Der Artikel beleuchtet Schlüsselbereiche wie die Attraktivität von Bordsteinen, Malerarbeiten, Küchen- und Badezimmerrenovierungen, energieeffiziente Modernisierungen und Verbesserungen des Wohnens im Freien. Es bietet umsetzbare Ratschläge, die auf Markttrends und Expertenmeinungen basieren.

Vicki betont die Bedeutung des ersten Eindrucks und schlägt kostengünstige Möglichkeiten vor, die Attraktivität des Bordsteins zu verbessern, beispielsweise das Streichen der Haustür mit kräftigen Farben und das Hinzufügen bunter Topfpflanzen.

Sie unterstreicht die transformative Kraft von Farbe bei der Erfrischung von Wohnräumen und der Schaffung einer sauberen, einladenden Atmosphäre für potenzielle Käufer.

Darüber hinaus wird die Bedeutung von Wohnräumen im Freien im milden Klima von Pacifica hervorgehoben, mit Vorschlägen zur Schaffung einladender Außenbereiche, die den Wohnraum des Hauses erweitern und seine Gesamtattraktivität steigern.

Durch die Konzentration auf Renovierungen mit hohem ROI, die auf den Pacifica-Markt zugeschnitten sind, können Hausbesitzer den Wert ihrer Immobilie optimieren, ernsthafte Käufer anlocken und letztendlich ihre Kapitalrendite maximieren. Die richtige Inszenierung maximiert den Erfolg beim Hausverkauf.

Kapitalertragsteuer und Hausverkauf

Paul Sian entwirrt die Feinheiten der Kapitalertragssteuer beim Verkauf von Häusern und als Finanzinvestition gehaltenen Immobilien. Hausbesitzer und Immobilieninvestoren haben je nach Gewinnhöhe, Familienstand und Wohnsitzdauer unterschiedliche steuerliche Auswirkungen.

Hausbesitzer können beispielsweise Anspruch auf erhebliche Steuerbefreiungen haben, wenn sie die Immobilie eine bestimmte Zeit lang bewohnt haben. Die Steuerlandschaft kann jedoch komplex sein und erfordert die Konsultation von Steuerexperten, um mögliche Ausnahmen zu erkennen und individuelle Umstände zu verstehen.

Ebenso profitieren Immobilieninvestoren von Abschreibungen und Abschreibungen für die Immobilieninstandhaltung, verfügen jedoch nicht über die gleichen Befreiungen wie Eigenheimbesitzer, was die Bedeutung einer fachkundigen Beratung zur Optimierung der Steuerergebnisse unterstreicht.

Insgesamt plädiert der Artikel für eine proaktive Steuerplanung und regelmäßige Konsultationen mit Steuerexperten, um optimale Steuerergebnisse im dynamischen Bereich von Immobilientransaktionen sicherzustellen.

Was ist die 3x-Miete-Regel?

Alex Capozzolo erklärt die 3x-Mietenregel. Manche halten diesen goldenen Standard für viele Mieter für ein Hindernis, sodass potenzielle Mieter mindestens das Dreifache der Monatsmiete verdienen müssen, um sich ihre Wunschmiete zu sichern. Entstanden aus dem Streben der Vermieter nach finanzieller Sicherheit, stellt diese Regel sicher, dass Mieter nach der Mietzahlung über ausreichende Ressourcen für andere Notwendigkeiten verfügen.

Alex bietet eine Schritt-für-Schritt-Anleitung zur Beurteilung der eigenen finanziellen Bereitschaft, betont die Bedeutung des Bruttoeinkommens und untersucht alternative Ansätze für diejenigen, die diese Schwelle nicht erreichen. Von der Aushandlung niedrigerer Mieten bis hin zur Gewinnung von Mitunterzeichnern verfügen Mieter über eine Reihe von Taktiken, um Einkommensbarrieren zu überwinden und sich die gewünschte Unterkunft zu sichern.

Darüber hinaus beleuchtet der Artikel Unterschiede in den staatlichen Vorschriften und sich abzeichnende Trends und bietet Einblicke in mögliche Änderungen, die die Belastung für Mieter in Zukunft verringern könnten.

FRÜHERE IMMOBILIEN-ROUNDUPS

Wenn Ihnen diese Zusammenfassung gefallen hat, schauen Sie sich einige der Rezensionen der letzten Monate an.

Karen HighlandKaren HighlandKaren und Chris Highland von der Highland Group mit eXp Realty in Central Maryland helfen seit über 32 Jahren Menschen beim Kauf und Verkauf von Wohnimmobilien in und um Frederick, Maryland.

„Es liegt uns am Herzen, Verbraucher über die Besonderheiten von Wohnimmobilien und den lokalen Markt aufzuklären und ihnen realistische Erwartungen an den Kauf und Verkauf eines Hauses zu vermitteln.“

Milestone Scientific Schedules First Quarter 2024 Financial Results and Business Update Conference Call By Investing.com

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ROSELAND, N.J., May 13, 2024 (GLOBE NEWSWIRE) — Milestone Scientific Inc. (NYSE:), a leading developer of computerized drug delivery instruments, that provide painless and precise injections, today announced that it will host a conference call at 8:30 AM Eastern Time on Thursday, May 16th, 2024, to discuss the company’s financial results for the first quarter ended March 31, 2024, as well as the company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and by entering the access code: 525731. A webcast and replay of the call may be accessed at Webcast URL: https://www.webcaster4.com/Webcast/Page/2306/50619.

An audio replay of the call will be available through May 30, 2024, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 50619.

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS), a technology-focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical, dental and cosmetic applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise, efficient and increase the overall patient comfort and safety. Their proprietary DPS Dynamic Pressure Sensing Technology ® instruments is the platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions of subcutaneous drug delivery, including local anesthetic. To learn more, view the MLSS brand video or visit milestonescientific.com.

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Contact:Crescendo Communications, LLCEmail: mlss@crescendo-ir.comTel: 212-671-1020



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Tourmaline Bio Reports First Quarter 2024 Financial Results and Recent Business Highlights By Investing.com

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“ Initiated Phase 2 TRANQUILITY trial in April 2024 following U.S. FDA clearance of Investigational New Drug application (IND) for clinical development program in Atherosclerotic Cardiovascular Disease (ASCVD) “

“ Expanded Thyroid Eye Disease (TED) clinical development plan, including accelerating the planned initiation of a pivotal Phase 3 trial into 2024 “

“ Completed underwritten follow-on public offering in January 2024, raising gross proceeds of $172.5 million “

“ Ended the quarter with $350.3 million of cash, cash equivalents and investments, providing cash runway into 2027 “

NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) — Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced its financial results for the first quarter ended March 31, 2024 and outlined recent business highlights.

During the first quarter of 2024, we continued to execute on our two strategic paths for TOUR006, including the initiation of our Phase 2 TRANQUILITY trial in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD). We believe TOUR006 offers multiple pipelines in a single product with the potential to address significant unmet medical needs in TED, ASCVD, and other autoantibody and inflammation-driven diseases, said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. We are excited about the ongoing progress of our clinical programs as well as the opportunity to expand into additional indications in 2024 and beyond.

Clinical Highlights and Upcoming Milestones:

Tourmaline is currently pursuing the development of TOUR006 in two areas of high unmet need: FcRn+ and cardiovascular inflammation.

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FcRn+

  • Tourmaline believes that TOUR006, a long-acting, fully-human, anti-IL-6 monoclonal antibody, can potentially deliver substantial therapeutic benefit to address a wide range of autoantibody-driven disorders, including by providing a more durable response and patient-friendly administration compared to therapies currently on the market or in clinical development.
  • The pivotal spiriTED Phase 2b trial in TED is currently enrolling, and Tourmaline expects topline data in 2025.
  • Tourmaline plans to initiate a pivotal Phase 3 trial evaluating TOUR006 delivered subcutaneously every 8 weeks as first-line treatment for TED in the second half of 2024, with topline data expected in 2026.

Cardiovascular Inflammation

  • In 2023, Tourmaline reached alignment with the U.S. Food and Drug Administration (FDA) on the clinical development program of TOUR006 in ASCVD, and Tourmaline received clearance for the related IND in March 2024.
  • In April 2024, Tourmaline initiated the Phase 2 TRANQUILITY trial, which evaluates quarterly subcutaneous dosing of TOUR006 in patients with elevated hs-CRP and CKD. Topline data from this trial are expected in the first half of 2025.
  • If successful, results from the Phase 2 TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready in 2025 for TOUR006 in cardiovascular disease.

Other Corporate Highlights:

  • In January 2024, Tourmaline completed an underwritten follow-on public offering of its common stock, which included the full exercise of the underwriters’ option to purchase additional shares, resulting in gross proceeds of $172.5 million. Net proceeds were $161.3 million after deducting underwriting discounts and offering expenses.

First Quarter 2024 Financial Results:

Cash Position

  • Cash, cash equivalents and investments were $350.3 million as of March  31, 2024, as compared to $203.0 million as of December  31, 2023. Tourmaline anticipates that its current cash, cash equivalents and investments will provide cash runway into 2027, funding key TOUR006 data readouts in TED and cardiovascular disease and the opportunity to expand development efforts into additional indications.

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Research and Development Expenses

  • Research and development expenses were $11.4 million for the first quarter of 2024, as compared to $6.1 million for the first quarter of 2023.
  • The increase in research and development expenses was primarily driven by employee compensation costs attributable to increased headcount and clinical trial costs related to the spiriTED and TRANQUILITY trials.

General and Administrative Expenses

  • General and administrative expenses were $6.1 million for the first quarter of 2024, as compared to $1.4 million for the first quarter of 2023.
  • The increase in general and administrative expenses was primarily driven by employee compensation costs attributable to increased headcount, increased consulting expenses, including recruiting, commercial planning and other services, and increased professional service fees.

Net Loss

  • Net loss was $13.3 million for the first quarter of 2024 and $7.5 million for the first quarter of 2023, resulting in basic and diluted net loss per share of $0.55 and $8.28, respectively.
  • The increase in net loss was attributable to increased operating expenses and the overall growth of Tourmaline throughout 2023 and into 2024. The decrease in net loss per share was attributable to the issuance of additional shares of common stock in conjunction with the reverse merger and private placement that were completed in October 2023 as well as the January 2024 underwritten follow-on public offering.

About Tourmaline Bio:

Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is TOUR006.

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About TOUR006:

TOUR006 is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. TOUR006 has been previously studied in 448 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is developing TOUR006 in TED and ASCVD as its first two indications, with additional diseases under consideration.

Cautionary Note Regarding Forward-Looking Statements:

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as believe, designed to, expect, may, plan, potential, will and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of TOUR006; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for TOUR006, including reporting of data therefrom; the timing and potential of preclinical research and development activities; market opportunities; the timing and potential to expand TOUR006 into additional indications; and Tourmaline’s anticipated cash runway. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on or about May 13, 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Tourmaline Bio, Inc.
Condensed Consolidated Statements of Operations (unaudited)
(amounts in thousands, except per share data)
Three Months Ended
March 31,
2024 2023
Operating expenses:
Research and development $ 11,376 $ 6,137
General and administrative 6,141 1,365
Total operating expenses 17,517 7,502
Loss from operations (17,517 ) (7,502 )
Other income, net 4,206
Net loss $ (13,311 ) $ (7,502 )
Net loss per share, basic and diluted $ (0.55 ) $ (8.28 )
Weighted-average common shares outstanding, basic and diluted 24,082 906
Tourmaline Bio, Inc.
Selected Condensed Consolidated Balance Sheet Data (unaudited)
(amounts in thousands)

March 31, December 31,
2024 2023
Cash, cash equivalents and investments $ 350,296 $ 202,951
Working capital $ 295,272 $ 203,872
Total assets $ 359,169 $ 210,295
Total stockholders’ equity $ 354,139 $ 205,042

Media Contact:
Scientific PR
Sarah Mishek
SMishek@ScientPR.com

Investor Contact:
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com



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Almirall Delivers Strong Start of 2024 “ Q1 Net Sales Growth of 6.6% Overall and 18% in the European Dermatology Business, Driven by Biologics and Solid Performance of Broad Product Portfolio

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  • Positive trajectory with Net Sales increase by 6.6% to a total of €247.4 MM, EBITDA increase of 1.4% YoY to a total of €52.5 MM driven by higher overall sales
  • Performance driven by biologics as key growth engines, with Ilumetri ® showing 30% increase in sales vs Q1 2023, and Ebglyss ® in Germany ranking second in intention to make future prescriptions among first-line advanced therapies for patients with moderate-to-severe atopic dermatitis
  • Broad product portfolio growing steadily – including the strong quarterly performance by Wynzora ® and Klisyri ® – further building a strong foundation for leadership in medical dermatology in Europe
  • Achievement of significant R&D milestones including licensing the anti-IL-21 monoclonal antibody NN-8828 from Novo Nordisk (NYSE:) and signing the collaboration with Eloxx on ZKN-013 for the treatment of rare diseases based on nonsense mutations. Both, anti-IL-1RAP mAb and IL-2muFc compounds are now in phase I
  • Full year guidance confirmed based on the strong sales performance in Q1 2024

BARCELONA, Spain–(BUSINESS WIRE)–Almirall, S.A. (ALM) a global biopharmaceutical company based in Barcelona, today announced its financial results from the first quarter 2024. Almirall delivered strong sales growth in the first quarter of 2024 which continues to be driven by the dermatology business in Europe. Net Sales increased by 6.6% to a total of €247.4 MM, EBITDA was €52.5 MM (increase of 1.4% YoY) driven by higher sales growth, with a gross margin of 63.5%. Dermatology sales in Europe increased by 18.1% to a total of €113MM. Continued strong investments in supporting the Ebglyss launch and our R&D efforts (10.7% of Net Sales).

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This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240512974045/en/

Almirall R&D Center in Barcelona (Photo: Business Wire)

Ilumetri ® continues to show very strong results with sales of €49MM in Q1, which is a 30% increase YoY. The encouraging initial data from our launch of Ebglyss ® in Germany ( €3.6 MM sales in Germany in Q1 2024) in addition to high product awareness and strong qualitative feedback from HCPs and their patients fuel confidence in the market potential of this potentially game-changing product indicated for patients with moderate to severe Atopic Dermatitis. Recently launched in Norway, preparations in additional European markets (UK, Austria, Denmark, and Spain) are on track for 2024. Wynzora and Klisyri continue to grow and strongly contribute to the increase of the dermatology business overall with 80% and 40% increases YoY respectively in Europe.

We started the year with a strong business performance and therefore confirm our guidance for 2024. We continue to deliver very strong results in the European Dermatology business, driven by the combination of the performance of Ilumetri ®, our new biologic for Atopic Dermatitis, Ebglyss ®, and the consistent growth of our other dermatology products such as Klisyri ®, and Wynzora ® that build the foundation of our leadership in medical dermatology in Europe. We continue to advance our exciting early and late-stage pipeline through licensing deals and consistent investment in our R&D capabilities. As we are continuing our close partnerships with the dermatology community, and further establishing our leadership in Medical Dermatology, we are set to deliver sustained success and growth in the years to come. Carlos Gallardo, Almirall Chairman and CEO

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Financial highlights ( € rounded million)

Q1 2024

Q1 2023

Variation

Total Revenue

248.8

232.5

7.0%

Net Sales

247.4

232.0

6.6%

Other Income

1.4

0.5

180%

Gross Profit

157.2

151.7

3.6%

% of sales

63.5%

65.4%

Total EBITDA

52.5

51.8

1.4%

Net Income

7.4

7.7

(3.9%)

2024 Full Year Guidance

Guidance reiterated: Net Sales growth of high-single digit net sales growth and EBITDA between €175 MM – €190 MM.

R&D pipeline

Almirall’s continued focus on R&D and the medical dermatology pipeline and its consistent investment in creating leading R&D capabilities aim to unlock further value from product innovation in the future “ in line with the company’s long-term view on its contributions and commitment to positively impacting patients and society. The early and late-stage pipeline achievements in Q1 2024 include licensing of the anti-IL-21 monoclonal antibody NN-8828 which is involved in a variety of immune-mediated diseases from Novo Nordisk. A new collaboration with Eloxx was announced to progress the asset ZKN-013 for the treatment of rare dermatological and other diseases associated with nonsense mutations. Furthermore, both, anti-IL-1RAP mAb and IL-2muFc compounds are now in phase I. The initiation of phase II clinical trial of the Anti-IL-1RAP mAb is on preparation.

Partnership with the dermatology community

Our close collaborations with dermatologists and life-science experts continue to be a key cornerstone for our dedication to and success in medical dermatology. In April we held the 15th Skin Academy in Barcelona, with over 800 international dermatologists in attendance. With leading experts presenting updates and featuring discussions on key topics like atopic dermatitis, psoriasis, actinic keratosis amongst other, this forum continues to play a central role in advancing skin science, insights on new treatment options, and fostering collaborations amongst the international dermatology community.

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Dividend and Investor Calendar 2024

On 10th May, the General Shareholders’ Meeting approved the distribution of a dividend charged to unrestricted reserves, for the amount of €0.19 per share. For the purposes of this dividend distribution, it was approved to use the scrip dividend shareholder remuneration system, which has already been applied in previous years.

Investor calendar 2024

H1 2024 Financial Results “ 22nd July 2024

Q3 2024 Financial Results “ 11th November 2024

About Almirall

Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs.

Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Almirall (total revenue in 2023: €898.8 MM, 1900 employees globally) has a direct presence in 21 countries and affiliates in over 70 others.

For more information, please visit almirall.com

Legal notice

This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are “forward-looking statements”. These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.

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Corporate Communications:

corporate.communication@almirall.com
Phone: (+34) 659 614 173

Investor Relations

investors@almirall.com
Phone: (+34) 93 291 30 87

Source: Almirall, S.A.



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Acri Capital Acquisition Corporation Announces Extension of the Deadline for an Initial Business Combination By Investing.com

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Austin, Texas, May 10, 2024 (GLOBE NEWSWIRE) — Acri Capital Acquisition Corporation (the Company) (Nasdaq: ACAC), a special purpose acquisition company, today announced that, in order to extend the date by which the Company must complete its initial business combination from May 14, 2024 to June 14, 2024, Acri Capital Sponsor LLC, the sponsor of the Company, has deposited into its trust account (the Trust Account) an aggregate of $50,000 (the New Monthly Extension Payment).

Pursuant to the Company’s Amended and Restated Certificate of Incorporate currently in effect, the Company may extend on monthly basis from April 14, 2024 until January 14, 2025 or such an earlier date as may be determined by its board to complete a business combination by depositing the New Monthly Extension Payment for each month into the Trust Account.

About Acri Capital Acquisition Corporation

Acri Capital Acquisition Corporation is a blank check company, also commonly referred to as a special purpose acquisition company, or SPAC, formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses with one or more businesses or entities.

Cautionary Statement Regarding Forward-Looking Statements

This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as will likely result, are expected to, will continue, is anticipated, estimated, believe, intend, plan, projection, outlook or words of similar meaning. Such forward-looking statements are based upon the current beliefs and expectations of our management and are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are difficult to predict and generally beyond our control. Actual results and the timing of events may differ materially from the results anticipated in these forward-looking statements.

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Contact Information

Company Contact:

Acri Capital Acquisition Corporation
Ms. Joy Yi Hua, Chairwoman
Email: acri.capital@gmail.com

Investor Relations Contact:

International Elite Capital
Annabelle Zhang
Telephone: +1(646) 866-7989
Email: acri@iecapitalusa.com



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New to The Street Airs Corporate Interviews, Televised Episodes 573 and 574 as Sponsored Programming on Bloomberg TV and The FOX Business Network

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NEW YORK, May 10, 2024 (GLOBE NEWSWIRE) — New to The Street, an FMW Media business show production, will air its corporate interviews, episodes 573 and 574, as Sponsored Programming on Bloomberg TV and FOX Business Network.

Episode 573 airs on Bloomberg TV as sponsored programming on Saturday, May 11, 2024, at 6:30 PM ET, featuring the following Six (6) Corporate Guests:

1). Two-Wheel Electric Vehicle (EV) – Zapp Electric Vehicles Group Limited’s  (NASDAQ: ZAPP) ($ZAPP) interview with Swin Chatsuwan, Chief Executive Officer.

2). Digital Marketing – Banzai International, Inc.’s  (NASDAQ: BNZI) ($BNZI) interview with Joe Davy, Founder, Chairman and CEO.

3). Financial Product “ Gondola’s MySaftTank™ interview with Brian Dumont, Co-Founder, CEO and President.

4). Real Estate “ La Rosa Holdings Corp.’s (NASDAQ: LRHC) ($LRHC) interviews with Joe La Rosa, Founder and CEO, and Peter Goldstein, CEO of Exchange Listings, LLC., the Founder of Emmis Capital IPO Fund, and Author: “The Entrepreneur’s IPO.”

5). Sustainable Solutions “ Sustainable Green Team, Ltd.’s (OTCQX: SG™) ($SG™) interview with Tony Raynor, CEO and Founder.

6). “Sekur Privacy & Sekur Security “ Weekly Hack segment with internet privacy expert Mr. Alain Ghiai, CEO, Sekur Private Data, Ltd. (OTCQB: SWISF) (CSE: SKUR) (FRA: GDT0) (Sekur ®).

Episode 574 airs on the FOX Business Network as sponsored programming on Monday, May 13, 2024, at 10:30 PM PT, featuring the following four (4) Corporate Guests:

1). Financial Product “ Gondola’s MySaftTank™ interview with Brian Dumont, Co-Founder, CEO and President.

2). “All Things Capital” segment, TV Co-Hosts Kortney Murray and Jane King interview with The Motion of Gratitude’s Shannon Missimer, Co-Founder/Chief Gratitude Officer and Matthew Missimer, Co-Founder.

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3). Sports Watches – Game Time  Watches’ (“Game Time”) interview with Adam Pennington, President.

4). “Sekur Privacy & Sekur Security “ Weekly Hack segment with internet privacy expert Mr. Alain Ghiai, CEO, Sekur Private Data, Ltd. (OTCQB: SWISF) (CSE: SKUR) (FRA: GDT0) (Sekur ®).

New to The Street’s TV Host Jane King talks with Swin Chatsuwan, Chief Executive Officer of Zapp Electric Vehicles Group Limited  (NASDAQ: ZAPP) ($ZAPP) (“Zapp EV”), about the company’s first product, the i300 electric urban motorcycle, and its competitive positioning in the approximately $130 billion global powered two-wheeler total addressable market. Zapp EV is led by a team of motorcycle experts with years of experience in the automotive industry. Together, they saw an opportunity with electrification in the two-wheeler sector and designed the  i300 as a high-performance, technologically advanced, and easy to ride electric two-wheeler that combines superbike specifications in a step-through form factor. Swin highlights for viewers that i300 has introduced what they believe is the two-wheeler sector’s first significant innovation in the last 50 years, which will set the standard for potentially the next 50 years. Consumers in emerging markets, including in Southeast Asia and India, are some of the biggest buyers of two-wheelers. And since demand for two-wheelers is forecast to increase, the i300 is well-positioned as an award-winning and patented design that people want to buy. This approach to design also benefits both Zapp EV and the environment, as the low-component architecture lowers cost, reduces materials, and streamlines assembly to make the process more sustainable. The on-screen QR code is available during the show; download or visit Zapp Electric Vehicles Group Limited  – https://zappev.com/. The interview will air as a sponsored program on Bloomberg TV, episode 573, on Saturday, May 11, 2024, at 6:30 PM ET.

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From the New York Stock Exchange studio, New to The Street’s TV Host Jane King talks about Banzai International, Inc.  (NASDAQ: BNZI) ($BNZI) (“Banzai”) with Joe Davy, Founder, Chairman and Chief Executive Officer. Banzai is a marketing technology company that produces data-driving sales/marketing solutions for clients in the USA, Middle East, Africa, and Asia Pacific. Joe Davy explains that the Company’s mission is to provide unique turn-key marketing solutions for its clients to assist them in meeting sales goals. Banzai believes direct customer engagement with real people can effectively and efficiently outperform AI marketing platforms. Joe sees that customers want to engage with others in real time, either personally or virtually. With Banzai International, Inc.’s product platforms, “Boost,” “Demio,” and “Reach,” clients can effectively engage their customers, creating unique market-driven campaigns that result in higher sales. Forbes magazine rated “Demio” the No. 1 webinar platform for marketing. Every industry has more competition than ever, and Banzai’s digital marketing technology platforms focus on “Engagement Marketing,” giving its customers unique and effective sales and marketing solutions. Throughout 2024, Banzai will seek potential acquisition targets that will be accretive to the Company’s current operations to increase BNZI’s sales upwardly and faster. Current clients using Banzai’s data management solutions manage and connect with buyers, offering real-time products and services. The on-screen QR code is available during the show; download or visit Banzai International, Inc.  (NASDAQ: BNZI) ($BNZI) (“Banzai”) – https://www.banzai.io/. The interview will air as a sponsored program on Bloomberg TV, episode 573, on Saturday, May 11, 2024, at 6:30 PM ET.

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From the New York Stock Exchange studio, Brian Dumont, Co-Founder, Chief Executive Officer and President of Gondola, talks with New to The Street’s TV Host Jane King about the Company’s MySafeTank™, a No /Low Volatility financial product. MySafeTank™ provides retail investors with a financial product with built-in guarantees to minimize risks and taxes. The No Volatility product provides a steady growth rate, while the Low Volatility product tends to follow the . The rate of returns can change over time, but with MySafeTank™, the returns are never less than zero. Each product option safeguards the client’s investment dollars to grow net values. Brian explains that many investors are always concerned about taxes, volatility, and liquidity when they make an investment decision. MySafeTank™ offers a safe and secure solution for those seeking a low-risk investment strategy. Anyone can visit https://www.mysafetank.com/contact-us to request an online personal finance questionnaire. Gondola will send back an estimate of a possible No/low-risk, No-tax investment return strategy. MySafeTank™ uses an AI component to interact with clients, but when a client decides to move forward with an investment, a live representative will help the client open accounts. The Company’s name, Gondola, means a vehicle or vessel that carries or ferries someone or something safely. Ski Gondolas carry skiers safely to mountain tops, and the Company’s MySafeTank wants to manage retail investors’ money safely for the best returns and tax outcomes. The on-screen QR code is available during the show; download or visit Gondola’s MySafeTank™ – https://www.mysafetank.com/. The interview will air as a sponsored program on Bloomberg TV, episode 573, on Saturday, May 11, 2024, at 6:30 PM ET, and on the FOX Business Network, episode 574, on Monday, May 13, 2024, at 10:30 PM PT.

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New to The Street’s TV Host Jane King is at the Nasdaq MarketSite Studio with Joe La Rosa, the Founder and CEO of La Rosa Holdings Corp. (NASDAQ: LRHC) ($LRHC), and Peter Goldstein, the CEO of Exchange Listings, LLC, the Founder of Emmis Capital IPO Fund and Author: “The Entrepreneur’s IPO.” La Rosa Holdings Corp. has five agent-centric, technology-integrated, cloud-based, multi-service real estate segments as a holding Company. Peter Goldstein starts the segment with his business history, with 35 years of experience in investment banking and capital markets. Many entrepreneurs and small and medium-sized businesses believe they are too small to become publicly traded entities. Peter explains the misnomer, the need to be the next “Unicorn,” is not an accurate perception for micro and small cap entities to become public and access to the equity markets. His book: “The Entrepreneur’s IPO,” thoroughly explains and educates entrepreneurs interested in going public. Joe La Rosa talks about LRHC and its business model that can assist realtors with creating multiple revenue streams. Many traditional real-estate offices have complex revenue share models with time limitations and aggregate sales numbers before sharing can commence. La Rosa Realty has an immediate turn-key revenue share model with no restrictions, wait periods or sales requirements. A single agent can take immediate advantage of LRHC’s revenue share program. Using the Company’s AI platform, JAEME, encouraged agents to embrace AI technology to be more efficient and effective in their real-estate professions. Joe wants his professionals not to be afraid of AI but to use it to be more productive and successful. La Rosa Holdings Corp. is averaging about two real-estate agency acquisitions per month and expects further growth. LRHC went public in October 2023, and its shares now trade on the Nasdaq Exchange, symbol LRHC. The on-screen QR code is available during the show; download or visit La Rosa Holdings Corp. – https://larosaholdings.com/. The interview will air as a sponsored program on Bloomberg TV, episode 573, on Saturday, May 11, 2024, at 6:30 PM ET.

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On New to The Street, Sustainable Green Team, Ltd.’s (OTCQX: SG™) ($SG™) Tony Raynor, CEO and Founder, talks with TV Host Jane King from the Nasdaq MarketSite Studio. SG™ is revolutionizing sustainability using cutting-edge technology, converting waste into viable products. Agricultural companies can meet their sustainability goals using SG™’s products and services. The Company diversified itself from making mulch products by introducing cutting-edge, disruptive technologies that address the world’s agricultural problems. Tony explains that in addition to groundbreaking technologies, the Company has a global team of experts and consultants with experience in finance, governmental agencies, and sustainability methodologies. The adage: “Wisdom comes through the multitude of counsel” explains Tony’s team of global personnel committed to spearheading projects with the vision for immediate objectives and sustainable solutions. With personnel in the Middle East, Australia, and the USA, Tony has the right team to launch all SG™’s products and services globally. SG™’s technology converts waste into nutrient-rich soil, diminishing food insecurities while sequestering carbon, reducing odors, and limiting diseases. SG™’s team and technologically advanced products are genuinely revolutionary, and they have a global mission to scale upward to increase agricultural outputs dramatically. The Company has a YouTube channel with many informative videos about the Company and its sustainable initiatives. The on-screen QR code is available during the shows: The Sustainable Green Team, Ltd. – https://www.thesustainablegreenteam.com/. The interview will air as a sponsored program on Bloomberg TV, episode 573, on Saturday, May 11, 2024, at 6:30 PM ET.

Internationally acclaimed internet privacy expert Alain Ghiai, CEO, Sekur Private Data Ltd. (OTCQX: SWISF) (CSE: SKUR) (FRA: GDT0) (Sekur ®) and New to The Street TV Host / Multi-media Journalist Ana Berry present the “Sekur Privacy & Sekur Security “ The Weekly Hack” segment. Ana and Alain discuss the FBI, NSA, and US State Department issuing a joint cybersecurity advisory on foreign state-sponsored email hackings and attacks. The US Government agencies believe North Korea’s military intelligence agency is behind the cybersecurity attacks. Businesses, individuals, organizations, and governmental offices are all vulnerable. 91% of cybersecurity breaches occur from a compromised email. The best solution to minimize a possible cybersecurity hack is subscribing to one of Sekur’s closed-loop encrypted platforms.  The SekurMail service  with the SekurSend/SekurReply feature provides private email communication. The recipient must not be a Sekur subscriber to enjoy the security and privacy features of the product. Subscribers can send emails with time limits, password protection, and other time-out features to enhance privacy for themselves and the recipient. The whole email chain is on the Company’s private and secure servers in Switzerland, which has the strictest privacy law in the world. To further one’s privacy, Alain recommends the Company’s SekurVPN service, which masks a subscriber’s internet footprint and shows an IP address as Switzerland. Alain again informs viewers that Sekur Private Data Ltd. never sells data, never data mines, never ask for phone numbers, never uses 3rd party providers, and never tracks internet traffic. The Company is offering PROMO CODE: PRIVACY, which gives 15% savings toward monthly and yearly subscriptions to any of its services. Viewers, please tune in next time for the newest cybersecurity topic on the “Sekur Privacy & Sekur Security“ Weekly Hacksegment. The on-screen QR code is available during the shows to download more info or visit Sekur Private Data, Ltd. “ https://sekurprivatedata.com/, http:/sekur.com/ and https://sekur.com/en/vpn. Privacy has arrived! The interview will air as a sponsored program on Bloomberg TV, episode 573, on Saturday, May 11, 2024, at 6:30 PM ET, and on the FOX Business Network, episode 574, on Monday, May 13, 2024, at 10:30 PM PT.

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From the Nasdaq MarketSite Studio, on New to The Street’s “All Things Capital” segment, TV Co-Hosts Kortney Murray, CEO/Founder of Coastal Kapital, LLC, and New to The Street’s Jane King introduce The Motion of Gratitude. Shannon Missimer, Co-Founder/Chief Gratitude Officer and Matthew Missimer, Co-Founder, explain the Company’s business in the science of gratitude, creating programs, tools, and training that can promote positivity in individuals, organizations, and businesses. Many focus on negative emotions and thoughts, usually creating negative situations and outcomes. The Motion of Gratitude works to help their clients find positive thoughts through expressing practices of gratitude. Shannon’s experiences as a stay-at-home mother enabled her to seek the simplest gratitude and grounded her in happiness and enjoyment in caring for her children and husband. She sees that all caregivers can become overwhelmed, whereas self-care and well-being become out of reach. Giving caregivers the tools to find and practice gratitude can create a productive, positive environment, reduce stress, and find a path to happiness. Matt talks about his 18 years of experience as a financial advisor assisting people in meeting their financial goals. During his past career, he often saw clients who never embraced gratitude and focused only on the money or the lack thereof. He is now working with others, teaching them the 28 Days of Gratitude, and seeks to install a practice of gratitude, tools to achieve emotional happiness. The Motion of Gratitude is the first Company to develop the “Corporate Gratitude Initiative,” a business-based program that can help employers and their employees find common ground on positive ongoings. With a corporate mindset and culture set in intentional gratitude, positivity arises, making for more productive and safe work environments. The Motion of Gratitude makes money from its physical products, apps, and consultations to help entities become full of gratitude and the ensuing positive outcomes. The on-screen QR code is available during the show; download or visit The Motion of Gratitude – https://themotionofgratitude.com/. The interview will air as a sponsored program on the FOX Business Network, episode 574, on Monday, May 13, 2024, at 10:30 PM PT.

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From the New York Stock Exchange studio, TV Host Jane King sits with Adam Pennington, President of Game Time  Watches (“Game Time”). As the leader in licensed sports watches, Game Time features  timepieces  with official NFL, NHL, MLB, and more team logos. The Company has a wide range of watch products for children and adults, including custom-made one-of-a-kind watches. Game Time has the official JETS teams license, offering unique watch products that use the new JETS logo. JETS’ players will also appear on social media and in digital ads to promote its Game Time Watches. Reebok International Limited’s (“Reebok”) North American division signed a 4-year deal to work with Game Time Watches to create a line of workout watches ranging in price from $29.99 to $199.99. Reebok has sales agreements with Walmart (NYSE:) and others worldwide, generating $billions in sales revenues. Game Time believes the deal is a fantastic opportunity to expand its watch product lines throughout Reebok’s online and retail outlets. The Company now offers wall clocks featuring sports teams and has an agreement with the US Army to make an Army logo wall clock. The top 20-30 colleges have engaged with the Company that will offer college logo sports watches. The Company is raising money with the hopes of going public and looking to continue to expand its unique specialty timepiece product lines. The on-screen QR code is available during the show; download or visit Game Time  Watches – https://gametimewatch.com/. The interview will air as a sponsored program on the FOX Business Network, episode 574, on Monday, May 13, 2024, at 10:30 PM PT.

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About Zapp Electric Vehicles Group Limited (NASDAQ: ZAPP) ($ZAPP):

Zapp EV  (NASDAQ: ZAPP) ($ZAPP) and its operating subsidiaries are run by a team of experts from the mobility industry on a mission to redefine the electric two-wheeler segment. Zapp’s debut product, the i300, is an urban electric high-performance two-wheeler capable of traditional motorcycle levels of performance in a step-through format, combining ease of use with exhilaration and fun. The i300 is the first in a suite of high-performance electric two-wheelers that Zapp plans to bring to market. Zapp will offer a high-quality direct-to-customer experience known as DSDTC (drop-ship-direct-to-customer). Customers ordering the i300 online will have their bikes conveniently delivered to their homes by authorized “Zappers,” who will provide at-home inspection, service, and support throughout the vehicle ownership lifecycle. Zapp is a registered trademark of Zapp Electric Vehicles Limited in the United Kingdom and other countries. For more information, visit  www.zappev.com.

About Banzai International, Inc.  (NASDAQ: BNZI) ($BNZI) (Banzai): Banzai International, Inc.  (NASDAQ: BNZI) ($BNZI) (“Banzai”) is a marketing technology company that provides essential marketing and sales solutions for businesses of all sizes. On a mission to help their customers achieve their mission, Banzai enables companies of all sizes to target, engage, and measure both new and existing customers more effectively. Banzai customers include Square, Hewlett Packard Enterprise (NYSE:), Thermo Fisher Scientific (NYSE:), Thinkific, Doodle, and ActiveCampaign, among thousands of others – www.banzai.io.

About  Gondola:

Gondola is the culmination of Brian and Kevin Dumonts’ combined 40 years as financial advisors. Realizing that their unique approach to financial planning could help more people than their clients, Brian and Kevin started Gondola to provide tax-free, liquid, and non-volatile solutions to help as many people as possible. With Gondola’s MySafeTank™, your financial earnings are safeguarded and tax-free. Access your money whenever you want without penalty – https://www.mysafetank.com/.

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About La Rosa Holdings Corp. (NASDAQ: LRHC) ($LRHC):

La Rosa Holdings Corp. (NASDAQ: LRHC) ($LRHC) is a holding company for five agent-centric, technology-integrated, cloud-based, multi-service real estate segments. In addition to providing person-to-person residential and commercial real estate brokerage services to the public, the Company cross-sells ancillary technology-based products and services primarily to its sales agents and the sales agents associated with their franchisees. La Rosa’s business is organized based on the services they provide internally to their agents and the public, which are residential and commercial real estate brokerage, franchising, real estate brokerage education and coaching, and property management – https://larosaholdings.com/.

About Peter Goldstein:

Peter Goldstein is a seasoned entrepreneur, capital markets expert, and investor with over 35 years of diverse international business experience. Throughout his career, he’s held pivotal roles, including CEO, chairman, investment banker, founder, board member, investor, and advisor to public, private, and emerging growth companies. Peter’s achievements span capital markets, specializing in equity financing, strategic planning, and transaction structuring. These include numerous successful IPOs, M&A, uplisting, reverse merger transactions, private placements, and crowdfunding campaigns. He’s the founder of Exchange Listing, LLC, dedicated to facilitating growth companies’ listings on esteemed exchanges like NASDAQ and the NYSE, and Emmis Capital, a specialized boutique fund investing in global small and microcap pre-IPO growth  companies – https://exchangelistingllc.com/ & https://emmiscap.com/.

About Sustainable Green Team, Ltd. (OTCQX: SG™) ($SG™):

Sustainable Green Team, Ltd. (OTCQX: SG™) ($SG™) is a leading Company in climate reversing technologies, a provider of sustainable solutions to improve environmental health, promote sustainable practices, and deliver eco-friendly products and services. SG™ aims to make significant contributions to global sustainability; learn more by visiting the Company website, https://thesustainablegreenteam.com/, SG™’s  YouTube Channel, corporate commercial –  https://www.youtube.com/watch?v=d_0rLESvJJ0, corporate video – https://www.youtube.com/watch?v=xJ7Dp9Coi88&t=1s and SG™’s Blogs – https://thesustainablegreenteam.com/sgtm-blog.

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About Sekur Private Data Ltd.  (OTCQB: SWISF) (CSE: SKUR) (FRA: GDT0) ($SWISF):

Sekur Private Data, Ltd.  (OTCQB: SWISF) (CSE: SKUR) (FRA: GDT0) ($SWISF) is a cybersecurity and internet privacy provider of Swiss-hosted solutions for secure communications and secure data management. The Company distributes a suite of secure cloud-based storage, disaster recovery, document management, encrypted emails, and secure communication tools. It sells its products through its websites, www.sekur.com, approved distributors, and telecommunication companies worldwide. Sekur Private Data, Ltd. serves consumers, businesses, and governments worldwide – https:/sekurprivatedata.com  and  https://sekur.com; Twitter: @sekurprivate.

About The Motion of Gratitude:

Driven by a newfound appreciation for gratitude, The Motion of Gratitude’s Co-Founders Shannon and Matthew Missimer spent three years developing resources and tools, resulting in “The Experience,” The Company’s  digital 28-day Gratitude Initiative, guiding individuals in developing intentional practices around gratitude and presence.  Rooted in scientific research & stories on gratitude’s impact, The Experience aims to remind you to Feel The Impact that daily Gratitude has in our lives. It provides the tools to set a new foundation in your life rooted in a perspective of Gratitude & Intention. Through a combined physical product and digital experience, The Motion of Gratitude creates a structure for individuals and businesses to practice intentional gratitude and be present while navigating the intense responsibility of their lives and businesses. Take 28 days to refocus, rediscover gratitude, and set a new direction for a purposeful, present life – https://themotionofgratitude.com/.

About Game Time Watches:

Game Time  Watches (“Game Time”) is the leader in licensed sports watches, having active, ongoing license agreements with the NFL, MLB, NHL, NASCAR, and WWE, along with several iconic athletes and brands. In 2017, Game Time launched the first official licensed Smart Watch for the NFL. Over the last 20 years, Game Time Watch has become the number-one-selling watch licensee in the NFL, NHL, and MLB history. Its watch line includes dozens of styles from kid’s digital watches to high-end limited-edition watches – https://gametimewatch.com/.

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About Coastal Kapital, LLC:

Coastal Kapital, LLC provides businesses with the capital needed to get a competitive edge, maximizing a company’s profits. Helping companies succeed since 2007, Coastal Kapital account executives have over 14 years of experience and relationships with over 150 different programs.  Their clients understand that time equals money, and Coastal Kapital is the one-stop shop for all your financial needs and offers its clients the most innovative programs. They offer equipment leasing, business loans, working capital, merchant Processing, collateral assets, and real estate-backed funding, regardless of credit type. Coastal Kapital is a dedicated financial service leader in commercial equipment and asset-based lending and maintains relationships with business owners, vendors, and manufacturers across the US who value partnerships and integrity – https://coastalkapital.com/.

About  New to The Street:

New to The Street is an FMW Media production that operates one of the longest-running US and International sponsored and syndicated Nielsen-rated programming television brands, “New to The Street.” Since 2009, New to The Street has run biographical interview segment shows across major U.S. television networks. The Nielsen-rated and sponsored broadcast programming platform reaches millions of homes in the US and international markets. FMW’s New to The Street show appears on Bloomberg and the FOX Business Network as sponsored programming. FMW is also one of the nation’s largest buyers of linear television, long and short-form paid programming – https://newtothestreet.com/.

Forward-Looking Statements Disclaimer US/Canada:

This press release contains forward-looking statements within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology. However, not all forward-looking statements contain these words. Forward-looking statements do not guarantee future performance or results and will not necessarily be accurate indications of when such performance or results are achieved. This press release should be considered in all filings of the Companies contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

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This press release contains forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking information is often, but not always, identified by the use of words such as “seek,” “anticipate,” “believe,” “plan,” “estimate,” “expect,” “likely,” and “intend” and statements that an event or result “may,” “will,” “should,” “could” or “might” occur or be achieved and other similar expressions. These statements reflect management’s current beliefs and are based on information currently available to management as of the date hereof. Forward-looking information in this press release includes, without limiting, the foregoing expectations. 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.

CONTACT:

New to The Street Monica Brennan monica@NewtoTheStreet.com https://newtothestreet.com/ 1-917-330-2564

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/de08aa08-363e-4612-a5cd-53d3ab73c7eb

 

New to The Street Airs Corporate Interviews, Televised Episodes 573 and 574 as Sponsored Programming on Bloomberg TV and The FOX Business Network

Shows 573/574: 1). Zapp Electric Vehicles Group Limited (NASDAQ: ZAPP) ($ZAPP) 2). Banzai International, Inc. (NASDAQ: BNZI) ($BNZI) 3). Gondola’s MySaftTank™ 4). La Rosa Holdings Corp.’s (NASDAQ: LRHC) ($LRHC) 5). Sustainable Green Team, Ltd. (OTCQX: SG™) ($SG™) 6). Sekur Private Data, Ltd. (OTCQB: SWISF) (CSE: SKUR) (FRA: GDT0) (Sekur ®). 7). The Motion of Gratitude 8). Game Time Watches (“Game Time”) -www.newtothestreet.com



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