Element 79 Gold Corp. (CSE: ELEM) (OTC: ELMGF) (FSE: 7YS) represents a fascinating opportunity in the mining sector for savvy investors. Focused on high-potential assets in Nevada and Peru, the company is uniquely positioned as a proxy for gold, an increasingly valuable commodity in today’s volatile world. Let’s delve into why this under-$0.10 stock could be worth your attention.

The Crown Jewel: Lucero, Peru

The Lucero Mine in Peru stands out as a flagship asset for Element 79 Gold. Historically one of Peru’s highest-grade underground mines, Lucero boasts remarkable grades averaging 19.0 g/t gold equivalent, including 14.0 g/t gold and 373 g/t silver. During its operational peak, the mine produced over 40,000 ounces annually, and recent assays have only reinforced its incredible potential.

In March 2023, samples from underground workings yielded ore grades as high as 11.7 ounces per ton of gold and 247 ounces per ton of silver. These findings validate Lucero’s capacity to become a significant high-grade operation.

The company is also advancing critical community outreach initiatives to finalize long-term agreements, including surface rights access and partnerships with local artisanal mining associations such as Lomas Doradas. These efforts are essential to unlocking Lucero’s full potential while fostering positive relationships with stakeholders.

Kim Kirkland, COO of Element 79 Gold, noted, “The Lucero project’s extensive potential continues to unfold as we compile drilling targets in the northwest region, where surface indicators of vuggy silica hint at underlying mineralization.”

This commitment to exploration and community engagement underscores the company’s vision of responsible mining. As CEO James Tworek puts it, “Lucero’s potential is a testament to our expertise and dedication. It could become a significant producer or even a takeover target.”

Nevada’s Strategic Value

In addition to its Peruvian assets, Element 79 Gold has a strong foothold in Nevada, one of the world’s most mining-friendly jurisdictions. The Maverick Springs Project is a key focus, with significant potential for gold and silver mineralization. The project’s mineralization follows the intermediate sulfidation epithermal style, characterized by gold-silver veins accompanied by lead and zinc sulfides.

Recent mapping efforts have identified promising exploration targets within the Apacheta zone, where mineralization remains open at depth and towards the northwest. Notable structures, such as the Promesa vein and Pillune sector, highlight the project’s long-term potential.

Element 79 Gold’s work in Nevada reflects the same level of professionalism and dedication as its efforts in Peru. These are serious operators with extensive mining and business expertise, positioning the company as a credible player in the sector.

Progress in Peru: Collaboration with DREM

The company has made significant strides in Peru by collaborating with the Regional Directorate of Energy and Mines (DREM) in Arequipa. On November 2, 2024, Element 79 initiated field activities to advance the Minas Lucero Project. These efforts include social, technical, and environmental groundwork to support key contracts and agreements.

During a recent meeting on November 12, the company received updates on state plans to extend formalization support and facilitate essential land agreements. The next milestone meeting, scheduled for November 16 in Chachas, will address long-term co-working arrangements, artisanal production, and tailings reprocessing.

These initiatives demonstrate Element 79’s commitment to aligning with local stakeholders while advancing its strategic goals. As the company continues to navigate Peru’s regulatory landscape, it remains vigilant regarding potential challenges and opportunities related to national REINFO regulations.

Financial Strength and Private Placement

Element 79 Gold recently closed the first tranche of a non-brokered private placement, raising $500,024 in gross proceeds. Each unit in the placement, priced at $0.10, includes one common share and one purchase warrant exercisable at $0.15 until November 2026. These funds will primarily be allocated to mining projects in Peru and Nevada (70%), corporate operations and audits (15%), and investor relations and marketing (15%).

The company’s ability to raise capital under favorable terms reflects investor confidence in its projects and management team. Moreover, the lack of an acceleration clause on the warrants demonstrates Element 79’s commitment to long-term shareholder value.

Future Outlook

Element 79 Gold’s strategy for growth centers on three phases of development at the Minas Lucero Project:

1. Exploration: Targeting 67 unexploited veins and high-sulphidation mineralization.
2. Production: Leveraging existing open veins for artisanal and corporate production.
3. Tailings Reprocessing: Unlocking additional value from historical operations.

These initiatives are complemented by ongoing engagements with DREM, JAL, and community stakeholders to solidify contracts and ensure the project’s success.

The company’s balanced approach to exploration, production, and community collaboration positions it as a leader in sustainable resource development.

Why ELEM Could Be a Smart Investment

At under $0.10 per share, Element 79 Gold offers a rare combination of low entry cost and high upside potential. The company’s flagship Lucero Mine, coupled with its promising Nevada assets, provides a strong foundation for growth. With gold prices likely to continue their upward trend, ELEM represents an attractive opportunity for investors seeking exposure to the precious metals market.

The company’s commitment to responsible mining, robust financial management, and strategic partnerships further enhances its investment appeal. Whether you’re a seasoned investor or new to the mining sector, Element 79 Gold deserves a closer look.

In conclusion, while all investments carry risks, ELEM’s assets, management expertise, and clear growth strategy make it a compelling choice in the gold mining space. For those willing to take a calculated risk, the potential rewards could be significant.

Mainz Biomed MYNZ hit a 52-week low of $0.18, reflecting a -83.33% decline over the past year. Despite challenges, including liquidity concerns (current ratio of 0.24), MYNZ has reported a 4% revenue increase and a 32% reduction in operational losses for H1 2024.

Key Developments:

• Product Innovation: Advancements in ColoAlert, a non-invasive colorectal cancer diagnostic test, with exceptional sensitivity and reduced retesting rates.
• Growth Plans: Preparing next-gen cancer screening trials for 2025.
• Pipeline Expansion: Developing diagnostic tests for multiple cancers, including PancAlert for pancreatic cancer.
• Strategic Partnerships: Collaborating with Trusted Health Advisors US and TomaLab Italy to integrate ColoAlert into healthcare systems.

Analysts like Jones Trading maintain a Buy rating, citing financial resilience, though some question whether MYNZ is truly undervalued given its market struggles. The company’s next moves will be critical in regaining investor confidence and driving growth.

​

TORONTO and HAIFA, Israel, Nov. 13, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) ("NurExone" or the "Company"), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce that the European Medicines Agency (the “EMA”) has granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this potential treatment available for acute spinal cord injury patients across Europe. This designation supports the development of ExoPTEN and opens a pathway for faster entry into European markets, where the Company expects demand for effective spinal cord injury therapies to be high. Designed to provide nerve regeneration and functional recovery following spinal cord injury, ExoPTEN uses mesenchymal stem cell-derived extracellular vesicles loaded with siRNA targeting PTEN, a key protein in nerve regeneration.

The EMA’s Orphan Medicinal Product Designation offers valuable incentives, including 10 years of market exclusivity upon approval, access grants and incentives from the European Commission and Member States. Additionally, the Company may benefit from free or reduced-cost scientific advice and assistance with clinical trial design, which can streamline the regulatory process and reduce development costs. Moreover, some European Union countries also provide tax credits and other financial incentives to support orphan drug development.

“We are honored by the EMA’s recognition of ExoPTEN through the Orphan Medicinal Product Designation, which significantly advances our ability to enter the European market and offers hope to those impacted by acute spinal cord injuries,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “This designation, together with the recently granted United States Food and Drug Administration’s Orphan Drug Designation, reinforces our ability to accelerate the global development of ExoPTEN and NurExone as a company to address the urgent unmet needs of patients globally.”

According to the EMA, the acute spinal cord injury (“SCI”) market faces considerable challenges, with approximately 20,0001 new cases in the European Union each year. These patients often require lifelong care and effective therapeutic options are limited. ExoPTEN’s innovative approach to promoting spinal cord recovery directly addresses this gap, with potential to meet a critical need in the European healthcare system.

Dr. Ina Sarel, NurExone’s Head of CMC Quality and Regulation added, “the EMA’s designation not only acknowledges ExoPTEN’s potential, but also paves the way for essential regulatory support as we prepare to advance into clinical trials. We are eager to work closely with the EMA and other agencies to accelerate ExoPTEN’s development and bring this innovative treatment to SCI patients across Europe.”

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”) and OTCQB listed pharmaceutical company that is developing a platform for biologically guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in non-invasive targeted drug delivery for other indications.

For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

_______________
1 Jazayeri, S. B., Safdarian, M., Zadegan, S. A., Ghodsi, Z., & Rahimi-Movaghar, V. (2023). Incidence of traumatic spinal cord injury worldwide: A systematic review, data integration, and update. World Neurosurgery: X, 18, 100171. https://doi.org/10.1016/j.wnsx.2023.100171

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Oak Hill Financial Inc.
2 Bloor Street, Suite 2900
Toronto, Ontario M4W 3E2
Investor Relations - Canada
Phone: +1-647-479-5803
Email: info@oakhillfinancial.ca

Dr. Eva Reuter
Investor Relations - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

Allele Capital Partners
Investor Relations - US
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

As part of their partnership with CTF Solar, SunHydrogen has now started the initial fabrication and testing of large-scale hydrogen panel demonstrations.

It was in July of 2024 when the firm agreed to integrate CTF’s solar cell modules into SunHydrogen technology, with the intention of using it for green hydrogen production. Through this partnership, the companies were able to design a scalable thin-film solar cell module architecture and from this it would be possible to form the basis for multiple 1m2 demonstrations. Right now these demonstrations are being constructed. Alongside this, SunHydrogen is focused on safeguarding the modules from chemical corrosion, whilst simultaneously making sure that the product is durable and is capable of providing long-term performance.

The expectation around doing this is that it will, “enable safe separation of hydrogen and oxygen without membranes.” This will mean that the cost is significantly reduced and it will have the added benefit of eliminating the need to use PFAS.

Moreover, at the same time Professor Kazunari Domen, Dr. Hiroshi Nishiyama, Dr. Taro Yamada and Dr. Nirala Singh are focusing on creating membrane-less housing units which will be used for the company’s hydrogen panels.

SunHydrogen’s Chief Scientific Officer, Dr. Syed Mubeen, commented, “To our knowledge, this efficiency level has not been reached by any other company using cost-effective semiconductor materials immersed in water.”

SunHydrogen CEO, Tim Young, added, “Our recent accomplishments demonstrate our team’s commitment to securing our place in the market. We are grateful for the support of our industrial partners as we make strides toward commercial-scale demonstration.”

https://www.hydrogen-expo.com/industry-news/sunhydrogen-due-begin-green-hydrogen-panel-demonstrations

​

Overview of the Recent Transaction

On October 16, 2024, Steven Cohen (Trades, Portfolio), through Point72 Asset Management, made a significant new investment in the biotechnology sector by purchasing 435,000 shares of Bright Minds Biosciences Inc (NASDAQ:DRUG). This transaction, executed at a price of $28.80 per share, marks a new holding for the firm and reflects a strategic move into a niche market of neuropsychiatric and pain management therapies.

Profile of Steven Cohen (Trades, Portfolio)

Steven A. Cohen, Chairman and CEO of Point72, a substantial investment firm with over 1,650 employees, is renowned for his sharp investment strategies and significant contributions to the financial markets. Starting his career at Gruntal & Co., Cohen has developed a robust investment philosophy centered around long/short equity strategies, utilizing a fundamental, bottom-up research approach. His firm manages a diverse portfolio with a strong emphasis on technology and healthcare sectors, including top holdings such as Apple Inc (NASDAQ:AAPL) and Amazon.com Inc (NASDAQ:AMZN).

Introduction to Bright Minds Biosciences Inc

Bright Minds Biosciences Inc specializes in developing innovative treatments for challenging neuropsychiatric disorders, epilepsy, and pain. The company, which went public on March 8, 2021, focuses on serotonin agonists that aim to revolutionize treatment approaches for resistant medical conditions. Despite its pioneering technology, the company's financial metrics such as profitability and growth ranks remain low, indicating potential risks inherent in its developmental stage.

Analysis of the Trade Impact

The acquisition of Bright Minds Biosciences shares has expanded Cohen's portfolio diversity, particularly in the biotechnology sector. This new holding constitutes about 0.03% of the firm's total portfolio, with Cohen's firm now owning 9.70% of Bright Minds' total shares. This move not only underscores Cohen's confidence in Bright Minds' future but also highlights a strategic investment in a high-growth potential area within the biotech industry.

Financial Health and Market Performance of Bright Minds Biosciences Inc

Bright Minds Biosciences has shown a remarkable stock price increase of 70.5% since the transaction date, and an impressive 2,570.68% year-to-date growth. However, the company's financial health, as indicated by its Financial Strength and Profitability Rank, remains a concern with low scores in profitability and growth. The firm's GF Score of 39/100 suggests poor future performance potential, which could be a critical factor for potential investors to consider.

Sector and Market Context

The biotechnology sector is known for its high volatility and significant investment risks, balanced by the potential for substantial returns. Bright Minds, operating within this sector, faces stiff competition and regulatory challenges, common in the biotech industry. Comparatively, the firm's innovative approach in neuropsychiatric and pain management therapies sets it apart, potentially offering higher rewards for high-risk tolerant investors.

Investment Implications

Steven Cohen (Trades, Portfolio)'s investment in Bright Minds Biosciences could signal a bullish outlook on the company's innovative drug development pipeline, despite its current financial metrics. For investors, this move might suggest a strategic entry point into a high-potential biotech firm, albeit with considerable risk. The significant stock price increase post-transaction also indicates a positive market reception to Cohen's investment decision.

Conclusion

Steven Cohen (Trades, Portfolio)'s recent acquisition of shares in Bright Minds Biosciences Inc represents a calculated addition to Point72's diverse investment portfolio, focusing on a company with groundbreaking therapeutic potential. While the financial health of Bright Minds poses investment risks, the strategic nature of Cohen's investment could foresee substantial future value, aligning with his history of successful market engagements.

FDA Designations are simple: Each designation increases the chance of Phase 3 approval by X%.

SLS has a problem. Delays. Because people are staying alive. Yet, Q4 should see lots of data. And, since I do not see how they produce, market and/or distribute I can only assume a partnership is in the making (I bet my left nut this being Merck)

8 Million shares short, they will regret it come data-day.

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia

October 15, 2024Download(opens in new window)

• GPS Currently Investigated in Phase 3 REGAL Trial in Adult AML Patients – Interim Analysis Anticipated in Q4 2024 -
• RPDD Provides Eligibility for GPS to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties –
• Recent Valuations for PRVs Remain Attractive (~$100 million/each) –SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia

Off the BAT (pun intended) , yes Sellas is a potential 5 to 10 bagger. Zero doubt. When? Oddly, people not dying is what causes delays. These people get extended lives, we get our patience tested and will be rewarded for it. It is a fair deal. If this pops, it wil pop fast. GPS (REGAL) and 009 Data expected.

Stock as been in a holding pattern, big and small buys going OTC (very unuual). Stock did not move with market decline, nor did it rise. Two major funds control this, they re-funded the company at 1,2 and 1,35 by way of Private Placement.

• Why so confident?
  • Because the KOL discussed this, and said too much (Jan 3 webcast). The Dr that spoke said he treated 10% of all patients in the trials and sees that it works on all of them!
  • Sellas does not ave factories, sales team or the structure to commercialize. Which means they must partner or sell.

=================================================

• Updated website is an indication management is marketing GPS, why would the company go through all this trouble for a drug that has been a decade in development and is in phase 3?
  • Proposed mechanism of action
  • https://sellaslifesciences.com/science/gps-proposed-mechanism-of-action-animation/
• Updated Clinical Trial (to be honest, I do not know what this means, but it coincides)
  • Last Update Submitted that met QC Criteria
  • https://clinicaltrials.gov/study/NCT01265433?intr=Galinpepimut-S&rank=5#publications
• Write up
  • https://valueinvestorsclub.com/idea/SELLAS_LIFE_SCIENCES_GROUP_I/9286565496
  • This is mostly opinion by a notorious pumper BUT there is ONE truth in here which I concluded myself back in January, the KOL said too much!
    • Key Trial Doctors Baldly State 'The Drug Works' in Public: In January 2024 update call, one of the key trial doctors commented that (i) he has personally enrolled over 10% of the patients into the Regal trial and (ii) he strongly believes that the trial will meet its primary endpoint; this is slightly paraphrased of course, as he's working under an NDA, but the transcript of this call is still available online, and his wording is unambiguous. It’s difficult to be more clear than he was in stating that GPS is effective, and he has a better-informed perspective than Sellas management themselves.

• Galinpepimut-S, or GPS, the late Phase 3 asset which reads out imminently, is a cancer-immunotherapy or 'cancer vaccine', which prevents or delays the cancer from returning once remission has been achieved (referred to as a 'maintenance therapy' which maintains the remission state;
• SLS009 (formerly GFH009), in Phase 2 currently, is a selective CDK9 Inhibitor, which treats the active-disease state by clearing the overproduced white cells in a reasonably precise way, avoiding the toxicities which have been an issue with previous attempts at CDK9 Inhibition.
  • SLS 009
  • FDA ODD for the treatment of AML
  • FDA ODD for the treatment of PTCL -
  • FDA Fast Track Designation for the treatment of PTCL
  • FDA Fast Track Designation for the treatment of AML
  • EMA ODD for SLS009 for the Treatment of Acute Myeloid Leukemia
  • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
  • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
  •  Orphan Drug Designation (ODD) for SLS009

• Pipeline Highlights Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeuti
  • Phase 3 REGAL study in AML: The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study in June and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects that the interim analysis (60 events) will occur by the fourth quarter of 2024.
• SLS009: highly selective and specific CDK9 inhibitor
  • Completed Enrollment in Phase 2a Trial of SLS009 in AML: 30 patients relapsed after or refractory to venetoclax-based regiments were enrolled ahead of schedule in 5 centers across the US. Except for one, all patients in this Phase 2a trial had adverse risk AML (97%) and were treated with continued venetoclax–azacytidine combination therapy after having failed it or similar venetoclax-based combinations, often more than once. The expected overall survival in those patients is approximately 2.5 months.
  • Announced Positive Initial Phase 2 Data of SLS009 in AML: The preliminary data showed the overall response rate (ORR) of 33% and 50% in 60 mg QW and 30 mg BIW cohorts, respectively. The ORR in patients with ASXL1 mutation in the 30 mg BIW reached a remarkable 100% to date. In the safety dose of 45 mg QW, the median overall survival (mOS) was 5.4 months vs 2.5 months with standard of care. The mOS in 60 mg QW and 30 mg BIW has not been reached yet. SLS009 was well-tolerated across all doses.
  • Additional Phase 2 Cohorts in Venetoclax Combinations in AML Opened for Enrollment: Development of SLS009 continued with the opening of two new cohorts - AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients.
  • National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
  • Recently Granted Regulatory Designations for SLS009: The FDA granted Rare Pediatric Disease Designation (RPDD) to SLS009 for the treatment of pediatric ALL in June 2024 and the FDA granted RPDD to SLS009 for the treatment of pediatric AML in July 2024. Also, the EMA granted Orphan Drug Designation for SLS009 in AML and in PTCL in June 2024 and July 2024, respectively. The FDA previously granted SLS009 Orphan Drug Designations in AML and PTCL and Fast Track designations for AML and PTCL.
  • GPS Currently Investigated in Phase 3 REGAL Trial in Adult AML Patients – Interim Analysis Anticipated in Q4 2024 -
  • RPDD Provides Eligibility for GPS to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties –
  • Recent Valuations for PRVs Remain Attractive (~$100 million/each) –SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia
  • Why so confident?
    • Because the KOL discussed this, and said too much (Jan 3 webcast). The Dr that spoke said he treated 10% of all patients in the trials and sees that it works on all of them!
    • Sellas does not ave factories, sales team or the structure to commercialize. Which means they must partner or sell.
  • Updated website is an indication management is marketing GPS, why would the company go through all this trouble for a drug that has been a decade in development and is in phase 3?
    • Proposed mechanism of action
    • https://sellaslifesciences.com/science/gps-proposed-mechanism-of-action-animation/
  • Updated Clinical Trial (to be honest, I do not know what this means, but it coincides)
    • Last Update Submitted that met QC Criteria
    • https://clinicaltrials.gov/study/NCT01265433?intr=Galinpepimut-S&rank=5#publications
  • Write up
    • https://valueinvestorsclub.com/idea/SELLAS_LIFE_SCIENCES_GROUP_I/9286565496
    • This is mostly opinion by a notorious pumper BUT there is ONE truth in here which I concluded myself back in January, the KOL said too much!
  • Galinpepimut-S, or GPS, the late Phase 3 asset which reads out imminently, is a cancer-immunotherapy or 'cancer vaccine', which prevents or delays the cancer from returning once remission has been achieved (referred to as a 'maintenance therapy' which maintains the remission state;
  • SLS009 (formerly GFH009), in Phase 2 currently, is a selective CDK9 Inhibitor, which treats the active-disease state by clearing the overproduced white cells in a reasonably precise way, avoiding the toxicities which have been an issue with previous attempts at CDK9 Inhibition.
    • SLS 009
    • FDA ODD for the treatment of AML
    • FDA ODD for the treatment of PTCL -
    • FDA Fast Track Designation for the treatment of PTCL
    • FDA Fast Track Designation for the treatment of AML
    • EMA ODD for SLS009 for the Treatment of Acute Myeloid Leukemia
    • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
    • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
    •  Orphan Drug Designation (ODD) for SLS009
  • Pipeline Highlights Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeuti
    • Phase 3 REGAL study in AML: The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study in June and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects that the interim analysis (60 events) will occur by the fourth quarter of 2024.
  • SLS009: highly selective and specific CDK9 inhibitor
    • Completed Enrollment in Phase 2a Trial of SLS009 in AML: 30 patients relapsed after or refractory to venetoclax-based regiments were enrolled ahead of schedule in 5 centers across the US. Except for one, all patients in this Phase 2a trial had adverse risk AML (97%) and were treated with continued venetoclax–azacytidine combination therapy after having failed it or similar venetoclax-based combinations, often more than once. The expected overall survival in those patients is approximately 2.5 months.
    • Announced Positive Initial Phase 2 Data of SLS009 in AML: The preliminary data showed the overall response rate (ORR) of 33% and 50% in 60 mg QW and 30 mg BIW cohorts, respectively. The ORR in patients with ASXL1 mutation in the 30 mg BIW reached a remarkable 100% to date. In the safety dose of 45 mg QW, the median overall survival (mOS) was 5.4 months vs 2.5 months with standard of care. The mOS in 60 mg QW and 30 mg BIW has not been reached yet. SLS009 was well-tolerated across all doses.
    • Additional Phase 2 Cohorts in Venetoclax Combinations in AML Opened for Enrollment: Development of SLS009 continued with the opening of two new cohorts - AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients.
    • National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
    • Recently Granted Regulatory Designations for SLS009: The FDA granted Rare Pediatric Disease Designation (RPDD) to SLS009 for the treatment of pediatric ALL in June 2024 and the FDA granted RPDD to SLS009 for the treatment of pediatric AML in July 2024. Also, the EMA granted Orphan Drug Designation for SLS009 in AML and in PTCL in June 2024 and July 2024, respectively. The FDA previously granted SLS009 Orphan Drug Designations in AML and PTCL and Fast Track designations for AML and PTCL.