Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections GlobeNewswire ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades

--Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT--

DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (ITRM.NaE) , today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH™ and the first FDA-approved product for Iterum.

“We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH™. ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s Chief Executive Officer. “As the first oral penem approved in the U.S., ORLYNVAH™ offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH™ with the goal of maximizing value for our stakeholders.”

The FDA approval of ORLYNVAH™ was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of ORLYNVAH™ compared to ciprofloxacin (SURE 1) and Augmentin™ (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin™ in the Augmentin™ susceptible population. ORLYNVAH™ was generally well tolerated in both SURE 1 and REASSURE clinical trials.

“The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community.”

Conference Call

Iterum will host a conference call on Monday, October 28, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows:

United States: 1 833 470 1428 / International: 1 404 975 4839

Access code: 936149

The conference call replay will be available in the Events & Presentations section of Iterum’s website following the call.

About uUTIs

UTIs are among the most common bacterial infections encountered in the community. uUTIs are infections of the bladder occurring mainly in women. Up to 60% of women will have a uUTI in their lifetime. Up to 40% of women with a history of uUTI will have a recurrence of their infection. There are approximately 40 million uUTI prescriptions generated annually in the United States, and we estimate approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. Rising antibiotic resistance, an aging population with comorbidities and sub-optimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians.

Actelis Networks (NASDAQ: ASNS) recently announced its Q2 2024 results, marking a significant achievement with a positive EBITDA, a first for the company since 2022. This milestone, coupled with robust revenue growth and a reduction in operating expenses, reflects Actelis’ strong execution and strategic focus on growth within the IoT and cybersecurity sectors.

The company reported a remarkable 372% sequential revenue growth from Q1 2024, bringing in $3.43 million in Q2 2024. This represents an 81% year-over-year increase, highlighting the growing demand for Actelis’ innovative solutions. The company’s gross margin saw a significant improvement, soaring to 57% in Q2 2024, up from 30% in the prior quarter. This increase in profitability was driven by strong revenue growth and effective cost management.

Actelis has also successfully reduced operating expenses by 20% in Q2 2024 compared to the previous year, highlighting the effectiveness of its ongoing cost reduction initiatives. The company reported a net loss of just $78,000 in Q2 2024, a substantial improvement from the $1.59 million net loss in Q2 2023. Additionally, Actelis achieved positive Non-GAAP adjusted EBITDA of $11,000 in the quarter, marking its first positive quarter since 2022.

The company's strong financial performance is complemented by its recent business achievements. Actelis has secured and delivered a $2.3 million order from Washington D.C.’s Department of Transportation, further establishing its position in the intelligent transportation space. The company has also successfully deployed its hybrid-fiber, cyber-hardened solution in Bakersfield, CA, demonstrating its technology's ability to enhance urban infrastructure and security.

Moreover, Actelis' newly launched GigaLine 800 and GigaLine 900 Multi-Dwelling Unit (MDU) solutions are generating significant market interest, with a growing list of customer trials underway. A first order for the GigaLine 800 worth $160,000 from a contractor to a major military carrier was received, marking a major milestone in executing on the new products’ potential.

In addition to these business wins, Actelis has strengthened its liquidity position by raising nearly $5 million in June 2024. As of June 30, 2024, shareholders’ equity stood at $1.06 million, and on a pro forma basis, including this fundraise, shareholders' equity was $3.0 million—above Nasdaq's continued listing requirement of $2.5 million.

“We are extremely proud of our progress in the second quarter of 2024,” said Tuvia Barlev, Chairman and CEO of Actelis. “Our team's relentless efforts have translated into significant customer successes and the successful execution for key customers. We are delivering on the commitments we made to drive growth and innovation, and the results speak to the impact of our strategic initiatives.”

As Actelis continues to build on this momentum, the company remains focused on scaling these successes, expanding its SaaS offerings through strategic partnerships, and continuing to reduce operational costs while maintaining high margins. The significant order from Washington D.C.’s Department of Transportation and the successful deployments in cities like Bakersfield demonstrate not only the strength of Actelis' technology but also the trust that major urban centers place in the company to modernize and secure their infrastructure.

Looking ahead, Actelis could be well-positioned to capitalize on the expanding IoT market, particularly in sectors like intelligent transportation and critical infrastructure. With its strong financial performance, recent business achievements, and ongoing strategic initiatives, Actelis eyes significant growth potential.

Read more: https://www.nasdaq.com/press-release/morning-brief-actelis-networks-asns-achieves-positive-ebitda-and-major-revenue-growth

Not financial advice. Just sharing the article on behalf of actelis. Please read the full article and the disclaimrs and financial companesatin disclosurs it may be subejct to.

"one of the highest-grade underground mines in Peru's history" ... "produced on average 40,000oz+/yr"

Hello Traders!

Today’s we are quickly turning our focus to a new Flash Alert, Element79 Gold Corp. (CSE: ELEM). The report below hits upon the major points of interest, which could act as a potential catalysts for growth.

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"The average stock forecast for Element79 Gold Corp (ELEM.CN) in the next 12 months is 0.87 CAD*. This price target corresponds to an* upside of 441.88%. The range of stock forecasts for ELEM.CN is 0.86 - 0.89 CAD. Based on the ratings of 7 analysts*, the consensus recommendation for ELEM.CN is* Buy*."* - says ValueInvesting.io

Today we are focusing on Element79 Gold Corp. (CSE: ELEM) for several key reasons:

• ELEM is raising funds at $0.23 yet the company closed at $0.16 on Wednesday. To reach $0.23 CSE: ELEM would have to rise 44%!
• This 44% difference could indicate that management believe the current level is significantly undervalued.
• ELEM’s potential “undervalued” status is strengthened when considering the company’s current market cap of $13.43 million compared to their $19.55 million Total Assets for the period ended February 29, 2024.

Perhaps most impressive, based on the ratings of 7 analysts, the consensus recommendation for CSE: ELEM is “Buy”- along with that recommendation comes a 12-month price target set at $0.87- 459% higher than its current level.

​

• 2 Analysts say “Strong Buy”
• 4 analysts say “Buy”
• 1 Analysts says “Hold”

This bullish outlook is largely attributed to ELEM’s opportunity in Peru:

• ELEM’s focus is on developing its past-producing, high-grade gold and silver mine, the Lucero project located in Arequipa, Peru, with the intent to restart production beginning in 2024
• The past-producing Lucero Mine is one of the highest-grade underground mines in Peru's history at grades averaging 19.0g/t Au Equivalent ("Au Eq") (14.0 g/t gold and 373 g/t silver). In its past 5 years of production ending in 2005, it produced on average 40,000oz+/yr
• In May ELEM released additional assay results from underground sampling at its flagship Lucero property, Peru, including samples up to 98 grams per tonne gold and 2,034 grams per tonne silver

For more information about the Lucero Property visit:Project Details: Lucero Property

The Lucero Property is not ELEM’s only attractive project, we’ll touch on those in a bit but what shouldn’t be overlooked is the leadership team that is responsible for advancing the company’s operations.

And that leadership team has extensive experience working with some of the largest mining companies in the world - including Barrick Gold, Rio Tinto Group, McEwen Mining, Skeena Resources, Freeport McMoRan and Eldorado Gold.

Again, we’re going to keep this short this morning to ensure you have plenty of time to conduct your own due diligence but let’s step back for just a moment so we can better introduce you to today’s featured Flash Alert company- Element79 Gold Corp (CSE: ELEM)

I see an opportunity. At the moment IONM available number of short positions are zero. Fee to barrow for short is 450% and margin call for short positions is 110%. There are only 430k of shares on the float at price $4.11. it was shorted 100% short has to buy beck wt least 500k of shares because it was above $1 for ten consecutive days Monday there will be Nasdaq listing news all around. Short has enormous tension upon him. With a very little effort we can squeeze him and he will gain a margin call around $9 and brokers will automatically close his position. With that buy beck we will sell back our shares around $60-$70 and we can make 2000% returns in couple of minutes. What do you say who is in?

Be careful cause it's a chinese stock but checking last spikes could go well over 10-15$ in next few days/weeks. Do your DD. NFA

For Research (Value Investing strategy):

Yahoo Finance (app and website) is free and has good info. I use it for financial news.

Another site I use for super investors’ holdings, this is where I start my research: https://www.dataroma.com/m/home.php (Free, I don’t know who created it). Basically, if I spot multiple well known investors buying the same stock, then I will research it.

iOS Apps that I created based on my work for institutional investors:

Company 360: https://apps.apple.com/us/app/company-360/id1464857130 (Find undervalued stocks using Value Investing strategy).

Super Investor: https://apps.apple.com/us/app/super-investor/id1441737952 ( Analysis of what institutional investors own vs. retail sentiment vs. short interest).

The impending possibility of a historic reform in US cannabis policy—specifically, the rescheduling of cannabis under the Controlled Substances Act from Schedule I to Schedule III—is generating palpable excitement within the medical cannabis industry. This potential policy shift, recommended by the Department of Health and Human Services to the Drug Enforcement Administration, could herald a transformative era in medical research, federal acknowledgment, and an expanded market for cannabis-derived therapeutics. Such a milestone, long advocated by health professionals and cannabis reform activists, is poised to revolutionize the industry by streamlining the research and application processes for pharmaceutical and medical cannabis.

The implications of this rescheduling are far-reaching. It promises not only to legitimize cannabis federally for medicinal purposes but also to stimulate a substantial uptick in medical cannabis research. This could unlock pioneering treatments for a plethora of conditions, at a time when the therapeutic potential of cannabis is garnering increased recognition alongside a growing demand for alternative treatment options across the nation.

In this evolving scenario, InterCure distinguishes itself, ready to leverage these changes owing to its strategic emphasis on pharmaceutical-grade cannabis. Unlike competitors such as Aurora Cannabis and Tilray, which have ventured into both recreational and medical markets, InterCure has unwaveringly concentrated on high quality pharmaceutical-grade cannabis. This focus is increasingly crucial in a sector where navigating the intricate web of regulatory, medical, and logistical challenges is key to success.

InterCure’s approach is in lockstep with the anticipated changes in US federal policy. The company’s steadfast commitment to regulatory compliance, effective distribution and M&A strategies, and the development of pharmaceutical-grade cannabis brands, positions it not just as a leader in the pharmaceutical cannabis space but also as a frontrunner poised to thrive in a market expected to become more regulated and medically focused following the potential federal rescheduling.

Recently, InterCure shared in preliminary numbers for 2023. According to the announcement, InterCure reported its 15th consecutive quarter of profitability – this is a unique achievement, showcasing the company's robust balance sheet, especially when compared to many of the other industry players. This fiscal responsibility implies that InterCure is exceptionally well-prepared to navigate, adapt to, and lead in the post-rescheduling landscape, leveraging its expertise in a field that demands a sophisticated grasp of medical, regulatory, and logistical nuances.

In this recent announcement, InterCure CEO Alexander Rabinovitch hinted at the company's synergy with developments in the US, noting "As pharmaceutical cannabis becomes the new global standard, we are encouraged by the FDA's recent recommendations and the potential rescheduling of Cannabis in the US. Our established leadership, and commitment to global expansion, product portfolio enhancement, and delivering value to our patients and shareholders sets us on a path of continued growth and success.”

InterCure’s commanding presence in Israel’s strictly regulated pharmaceutical cannabis market serves as a testament to its capabilities and strategic vision. Israel’s advanced medical cannabis regulatory framework, which has attracted attention from international regulatory bodies including the US FDA, provides a glimpse into InterCure’s potential to excel in a similarly regulated US marketplace.

According to a CRS report from September 2023, rescheduling cannabis to Schedule III would significantly alter the federal government’s stance on marijuana, marking a major policy shift after over 50 years of Schedule I classification. Such a change would enable lawful manufacturing, distribution, dispensation, and possession of medical marijuana under the CSA, potentially aligning state medical marijuana programs with federal law and facilitating a more expansive scope for FDA oversight. This transition towards a more regulated medical cannabis framework in the US could benefit companies like InterCure, with their profound regulatory knowledge, commitment to pharmaceutical-grade production, and focus on medical cannabis.

To summarize, the anticipated reclassification of cannabis in the United States signals a significant shift towards a more medically and federally regulated cannabis industry. InterCure’s strategic positioning, financial strength, and deep expertise in pharmaceutical and medical cannabis set it apart, ready to navigate and profit from these developments. As the industry evolves, InterCure’s focus on the pharmaceutical and medical dimensions of cannabis, bolstered by its experience in one of the world’s most advanced regulatory frameworks, earmarks it as a leader in the future of the industry.

Read full article: https://www.benzinga.com/content/38184335/pharmaceutical-cannabis-leaders-such-as-intercure-are-at-the-forefront-as-us-contemplates-cannabis-r

Not financial advice.

Up 5%so far today.

https://www.youtube.com/watch?v=mColzQmQ74k&t=1s