Gold Shines Bright: Outperforming Indexes in Uncertain Times

As global markets continue to navigate choppy waters, one asset class has emerged as a beacon of stability and growth: gold. The precious metal has been on a remarkable upward trajectory, consistently making new highs and outperforming major stock market indexes. This trend has caught the attention of investors, particularly those interested in small-cap opportunities in the gold mining sector.

In recent months, gold prices have surged to record levels, breaking through previous resistance points and establishing new benchmarks. This impressive performance comes against a backdrop of economic uncertainty, inflationary pressures, and geopolitical tensions – factors that have historically driven investors towards safe-haven assets like gold.

The numbers speak for themselves: While the NASDAQ has posted a respectable year-to-date (YTD) gain of 12%, gold has outpaced it with a YTD increase of 16%. Looking at the year-over-year (YOY) performance, the NASDAQ is up 22%, but gold is not far behind with a 21% increase. These figures underscore gold’s resilience and its ability to keep pace with, and even outperform, one of the most dynamic stock market indexes.

Several key drivers are fueling gold’s ascent:

  1. Inflation concerns: With central banks around the world implementing accommodative monetary policies to combat economic slowdowns, fears of inflation have intensified. Gold, long considered a hedge against inflation, has naturally attracted increased investor interest.
  2. Weakening dollar: The US dollar’s relative weakness has made gold more attractive to international investors, as the metal becomes cheaper in other currencies.
  3. Geopolitical tensions: Ongoing conflicts and trade disputes have heightened global uncertainty, prompting investors to seek refuge in gold’s perceived stability.
  4. Low interest rates: With rates remaining at historically low levels, the opportunity cost of holding non-yielding assets like gold has decreased, making it more appealing to investors.

While major indexes like the S&P 500 and Dow Jones Industrial Average have experienced volatility, gold has steadily climbed. Its ability to outpace the NASDAQ’s YTD performance is particularly noteworthy, given the tech-heavy index’s reputation for growth.

This outperformance has significant implications for the small-cap investing landscape, particularly in the gold mining sector. Junior gold miners and exploration companies often exhibit a leveraged relationship to gold prices, meaning their stock prices can move more dramatically than the price of gold itself.

As gold prices rise, many of these smaller companies become increasingly viable, with previously marginal projects suddenly becoming profitable. This dynamic creates exciting opportunities for small-cap investors who are willing to do their due diligence and identify promising junior miners with solid fundamentals and strong growth potential.

However, it’s crucial for investors to approach this sector with caution. While the potential rewards can be substantial, junior gold stocks are known for their volatility. Thorough research, diversification, and a long-term perspective are essential when considering investments in this space.

Looking ahead, many analysts remain bullish on gold’s prospects. The combination of ongoing economic uncertainties, potential inflationary pressures, and the metal’s historical role as a store of value suggest that gold may continue its upward trajectory. This outlook bodes well for both direct investments in gold and strategic positions in carefully selected gold mining stocks.

In conclusion, gold’s stellar performance amidst current market conditions presents a compelling narrative for investors. Its ability to outshine major indexes while providing a hedge against economic uncertainties makes it an attractive option for portfolio diversification. For small-cap investors, the gold mining sector offers intriguing opportunities to capitalize on this trend, provided they approach it with the necessary research and risk management strategies.

As always, investors should consult with financial advisors and conduct thorough research before making investment decisions, especially in the dynamic and potentially volatile world of small-cap gold stocks.

Mars Acquires Pringles Parent Kellanova for $36 Billion in 2024’s Mega Deal

Key Points:
– Mars acquires Kellanova for $36 billion, creating a snacking powerhouse
– Deal combines iconic brands like M&M’s, Snickers, Pringles, and Pop-Tarts
– Merger aims to boost market share and navigate changing consumer trends

Mars Inc. has announced its acquisition of Kellanova for a staggering $36 billion, sending shockwaves through the global snack industry. This landmark deal, the largest of 2024, is set to reshape the landscape of the packaged food sector and create a snacking behemoth that combines some of the world’s most beloved brands.

The all-cash transaction, which values Kellanova at $83.50 per share, represents a significant 33% premium over the company’s recent stock price. This bold move by Mars, the family-owned confectionery giant, signals a strategic push to expand its snacking platform and strengthen its position in an increasingly competitive market.

As consumers continue to reach for convenient, branded snacks despite economic pressures, this merger capitalizes on the enduring appeal of household names. The deal brings together Mars’ iconic candies like M&M’s and Snickers with Kellanova’s popular offerings such as Pringles, Cheez-It, and Pop-Tarts. This diverse portfolio positions the combined entity to cater to a wide range of snacking preferences and occasions.

Mars CEO Poul Weihrauch emphasized the company’s commitment to maintaining price stability, stating, “We hope to be able to absorb more costs in our structure and help alleviate the issues we have in an inflationary environment.” This consumer-friendly approach could help the newly formed snacking powerhouse navigate the challenges of price-sensitive shoppers and increased competition from private label brands.

The merger also presents exciting opportunities for global expansion. Kellanova’s strong presence in Africa opens new doors for Mars to introduce its confectionery products to the continent. Conversely, Mars’ established foothold in China could pave the way for Pringles to significantly expand its reach in the world’s most populous market.

Industry analysts view this deal as a potential catalyst for further consolidation in the packaged food sector. As companies seek to achieve economies of scale and enhance their competitive edge, we may see more strategic acquisitions and mergers in the near future.

However, the road ahead is not without challenges. The combined company will need to navigate changing consumer preferences, including a growing demand for healthier snack options. Mars has indicated that about half of its portfolio will consist of “wholesome” snacks, such as low-calorie Special K, Kind bars, and Nutri-grain, addressing this trend.

Another potential hurdle is the impact of weight loss drugs like Ozempic and Wegovy on snack consumption. While Mars currently has no plans to develop products specifically for users of these medications, the company’s diverse portfolio may help mitigate any potential downturn in certain product categories.

As the deal moves forward, subject to regulatory approvals, the snack industry watches with bated breath. The creation of this new snacking giant is poised to reshape market dynamics, influence product innovation, and potentially redefine the way we indulge in our favorite treats.

With the transaction expected to close in the first half of 2025, consumers and investors alike are eager to see how this sweet merger will transform the future of snacking. As Mars and Kellanova join forces, one thing is certain: the snack aisle will never be the same again.

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Release – LakeShore Biopharma Announces Financial Results for Fiscal Year 2024

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Gross margin increased to 79.5%; product pipeline continues to advance

Company anticipates double-digit year-over-year revenue growth and bottom line breakeven for Fiscal Year 2025

GAITHERSBURG, Md., Aug. 15, 2024 /PRNewswire/ — LakeShore Biopharma Co., Ltd. (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced its financial results for the fiscal year ended March 31, 2024 (“Fiscal Year 2024”).

   

Mr. Dave Chenn, Chairman and Interim Chief Executive Officer of the Company, commented, “In Fiscal Year 2024, our revenue was affected by a shortage of finished product inventory, resulting from earlier supply chain disruptions at our YSJA rabies vaccine production facilities. Despite these difficulties, we have successfully implemented operational improvements that have normalized production, and our inventory challenges are now resolved as we enter Fiscal Year 2025. We have maintained our position as a leading rabies vaccine producer in China, and continued to improve our gross margin by emphasizing operational efficiency. We also made significant advancements in our product pipeline during Fiscal Year 2024, progressing our next-generation PIKA rabies vaccine through its ongoing Phase III clinical trial and meeting significant developmental milestones for other pipeline products.”

Mr. Dave Chenn continued, “Looking ahead, our Fiscal Year 2025 strategy will focus on driving revenue growth, controlling expenses, and enhancing profit margins. We are implementing a comprehensive plan that includes cost reductions, organizational restructuring, strengthened internal controls, and strategic resource allocation to key growth areas. Our goal will be to foster innovation, efficiency, stability, and sustainable profitability as we work to build value for our shareholders.”

Ms. Rachel Yu, Interim Chief Financial Officer of the Company, added, “For Fiscal Year 2024, we recorded revenues of RMB573.4 million (US$80.8 million), representing a decrease compared to Fiscal Year 2023 due to persistent supply chain issues affecting raw material availability, manufacturing processes, and overall output capacity which impacted our topline. We recorded a gross profit of RMB455.7 million (US$64.2 million), and our gross margin increased by 1.8 percentage points to 79.5% compared to Fiscal Year 2023. With cash and cash equivalents of RMB246.6 million (US$34.7 million), we will maintain our focus on maximizing long-term shareholder returns by refining our business strategies and leveraging new market opportunities. Looking ahead to Fiscal Year 2025, we anticipate double-digit year-over-year growth in revenues, and expect to achieve breakeven on our bottom line by the time our fiscal year concludes on March 31, 2025.”

Business Updates

YSJATM Rabies Vaccine

LakeShore Biopharma’s marketed vaccine product, YSJATM rabies vaccine, is the first aluminum-free lyophilized rabies vaccine launched in China. Since the Company commenced production at its current GMP-compliant facilities in February 2020, and commercialization of the product in late 2020, market intake of the Company’s YSJA rabies vaccine has been consistent and strong. As of March 31, 2024, LakeShore Biopharma maintained its leadership position as one of the top rabies vaccine producers in China and has sold more than 27.3 million doses of YSJATM rabies vaccines to approximately 1,767 Chinese Center(s) for Disease Control and Prevention (“CDC”) customers, which represents 61.3% of CDC customers in China since October 2020.

Clinical Pipeline

LakeShore Biopharma continues to prioritize and advance its portfolio of innovative product candidates under various clinical development stages, including PIKA rabies vaccine, PIKA YS-ON-001, and PIKA YS-HBV-002.

PIKA Rabies Vaccine

  • In April 2024, the Company announced positive interim results from the ongoing Phase III clinical trial of its next-generation PIKA rabies vaccine in the Philippines and Pakistan. The interim results indicate that the PIKA rabies vaccine has successfully met the primary endpoints of the trial and has the potential to achieve best-in-class accelerated protection and meet the World Health Organization’s goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. Subject to successful completion of the Phase III clinical trial, the Company plans to submit the New Drug Applications/Biologics License Applications to relevant regulatory authorities throughout Asia, Africa, Europe, and the Americas.

PIKA YS-ON-001

  • PIKA YS-ON-001 is designed as an immunological therapeutical agent against cancers. In 2023, the Company completed the Phase I clinical trial of PIKA YS-ON-001 in China.

PIKA YS-HBV-002

  • In April 2024, the Company announced that its YS-HBV-002, the second generation of immunotherapeutic vaccine designed to treat patients suffering from chronic hepatitis B virus infection, had been granted clinical trial approval by the Philippine Food and Drug Administration. In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-002 in the Philippines.

Fiscal Year 2024 Financial Results

Total Revenue

Total revenue was RMB573.4 million (US$80.8 million) in Fiscal Year 2024, compared to RMB687.2 million in the same period of 2023, representing a decrease of 16.6%. This was primarily due to COVID-related disruptions affecting the Company’s manufacturing operations and production, which reduced batch approvals and doses available for sale. This impact was partially offset by an increase in the product price of the YSJA rabies vaccine of approximately RMB2.9 per dose.

Gross Profit

Gross profit in Fiscal Year 2024 was RMB455.7 million (US$64.2 million), representing a 79.5% gross margin, compared to RMB533.8 million, or a 77.7% gross margin, in the same period of 2023. The improvement in gross margin was primarily due to the increase in unit price of the YSJA rabies vaccine, and a decrease in unit cost resulting from lowered delivery costs and an increase in production batches.

Selling and Marketing Expenses

Selling and marketing expenses in Fiscal Year 2024 were RMB301.3 million (US$42.5 million), compared to RMB272.9 million in the same period of 2023. This change was primarily due to an increase in promoting and marketing service fees to continuously promote the YSJA rabies vaccine.

General and Administrative Expenses

General and administrative expenses in Fiscal Year 2024 were RMB140.1 million (US$19.7 million), compared to RMB72.9 million in the same period of 2023. This change was primarily attributable to increases in legal fees, auditing fees, directors & officers liability insurance costs, and employee benefits.

Research and Development Expenses

Research and development expenses in Fiscal Year 2024 were RMB302.8 million (US$42.7 million), compared to RMB318.7 million in the same period of 2023. The change was primarily driven by decreases in testing fees, clinical trial fees, and consulting service fees related to the development of the Company’s COVID-19 vaccine, and decreases in employee benefits as a result of staffing optimizations.

Impairment Loss on Inventory, Property, Plant and Equipment, and Other Assets

Impairment loss on inventory, property, plant and equipment (“PP&E”), and other assets in Fiscal Year 2024 was RMB157.4 million (US$22.2 million), compared to RMB8.7 million in the same period of 2023. The change was primarily attributable to 1) impairment loss on inventory impacted by COVID-related disruptions affecting the Company’s manufacturing operations and production and raw materials used in the research and development of the Company’s COVID-19 vaccine, and 2) impairment loss on PP&E related to COVID-19 vaccine equipment.

Net Loss

Net loss for Fiscal Year 2024 was RMB433.5 million (US$61.1 million), compared with RMB145.5 million in the same period of 2023.

Balance Sheet

As of March 31, 2024, the Company had cash and cash equivalents of RMB246.6 million (US$34.7 million), compared with RMB370.4 million as of March 31, 2023.

Business Outlook

The Company anticipates double-digit year-over-year revenue growth and expects to achieve breakeven in Fiscal Year 2025.

The above outlook is based on information available as of the date of this press release and reflects the Company’s current and preliminary expectations regarding its business situation and market conditions. The outlook is subject to changes, especially given uncertainties and situations related to market competitive dynamics and regulatory policies, etc.

About LakeShore Biopharma 

LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit https://investor.lakeshorebio.com/.

Exchange Rate Information

This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to U.S. dollars are made at a rate of RMB7.095 to US$1.00, the exchange rate set forth in the central parity rate release of the People’s Bank of China on March 31, 2024.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma’s ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “potential,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “goal,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of LakeShore Biopharma’s management and are not predictions of actual performance.

LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, and other risks described in documents subsequently filed by the company from time to time with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: LakeShoreBiopharma.IR@icrinc.com 

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Release – Traws Pharma Reports Q2 2024 Financial Results, Provides Recent Business Highlights

Research News and Market Data on TRAW

Merger with Trawsfynydd Therapeutics, Inc (“Trawsfynydd”) and concurrent private placement of $14 million (cash runway to support planned operations through year end), with recently achieved clinical milestones, put Traws on track to achieve key readouts for the clinical pipeline in H2 2024 and beyond

  • Lead antiviral program, tivoxavir marboxil, for influenza, including avian flu, is dosing the first cohort in the Phase 1 dose extension study in Australia
  • COVID-19 program, ratutrelvir, completed the Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) study in Australia
  • Oncology strategy includes investigator-sponsored trials (ISTs), planned to begin in H2 2024, adding a new dimension to the narazaciclib program, with continued investigator support for rigosertib
  • Corporate update call planned for August 15, 2024 at 8:00 AM ET

NEWTOWN, Pa., Aug. 15, 2024 (GLOBE NEWSWIRE) — Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today outlined recent business highlights and reported unaudited financial results for the second quarter ended June 30, 2024. The Company intends to host a conference call and live webcast on Thursday, August 15, 2024 at 8:00 AM ET.

“The last several months have been transformational for Traws Pharma, with strategic and product development progress and an increase in capital,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “Completion of the merger agreement that created Traws Pharma expanded our investor base to include recognized healthcare investors, Orbimed and Torrey Pines, while broadening our portfolio to include compounds that we believe have best-in-class potential for influenza (flu), including bird flu, and COVID-19. In addition, ISTs are enhancing our multi-kinase inhibitors for cancer, narazaciclib and rigosertib.”

“We expect the antiviral program to advance over the next 6+ months as we complete preparations to report Phase 1 results and initiate Phase 2 studies in flu and COVID-19. Preclinical data and topline data from SAD studies from our influenza candidate, tivoxavir marboxil, suggest that it has the potential to achieve our target product profile as a single dose treatment that is active against pandemic-potential viruses as well as oseltamivir and baloxavir resistant viruses,” continued Dr. Cautreels. “In addition, clinical-trial enabling studies for our COVID-19 candidate, ratutrelvir, suggest that it has the potential to be effective without the requirement for co-administration of a CYP-inhibitor, and active against virus strains that may be resistant to other approved agents such as nirmatrelvir. In the coming months, we look forward to completing the Phase 1 studies, finalizing the dosing plan and initiating the Phase 2 program for both tivoxavir marboxil and ratutrelvir. We believe these data could pave the way for key readouts in 2025.”

Upcoming Milestones

Tivoxavir marboxil — Targets the influenza cap-dependent endonuclease, which is highly conserved across flu strains, including avian flu. The compound is intended to be administered as a single dose per treatment

  • Q4 2024: Announcement of topline Phase 1 dose extension results from Australia
  • Q4 2024/Q1 2025: Initiation of Phase 2 efficacy study

Ratutrelvir – Targets Mpro (3CL protease). The compound does not require combination use of a CYP-inhibitor such as ritonavir

  • Q4 2024: Announcement of topline results from Phase 1 SAD and MAD studies
  • Q4 2024/Q1 2025: Initiation of Phase 2 efficacy study

Narazaciclib – our multi-kinase inhibitor, including CKD4+, with potential for use in multiple solid tumors

  • H2 2024: Release topline results from our Phase 1/2 study at an upcoming medical meeting. In addition, we plan to announce the recommended Phase 2 dose (RP2D) and initiate ISTs in multiple myeloma, breast cancer and other indications

Rigosertib – our multi-kinase inhibitor targeting cell cycle proteins including PLK-1, with potential for use in the ultra-rare disease, advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC, RDEB)

  • Continue to support the IST-led program, including compassionate use for patients with RDEB

Recent Developments

  • Start of dosing in Phase 1 dose extension study for tivoaxavir marboxil, a placebo-controlled trial designed to evaluate three doses, including two doses from the successful Phase 1 dose escalation study (80 and 120 mg) and one new, increased dose (240 mg) in healthy volunteers. The study was designed to assess pharmacokinetics, pharmacodynamics and safety, to define the dosing plan for the upcoming Phase 2 efficacy study. The expected dosing schedule will be one single oral dose.
  • Completion of a Phase 1 dose escalation study for ratutrelvir in Australia, a SAD/MAD study conducted in healthy volunteers. The study was designed to assess SAD (5 doses ranging from 15 mg to 600 mg) and MAD (2 doses, 150 mg, and 600 mg, daily for 10 days) and provide pharmacokinetics, pharmacodynamics and safety data to guide the dosing plan for the upcoming Phase 2 efficacy study. The expected dosing schedule will be one oral dose per day for 10 days.
  • Completion of Phase 1/2 dose escalation studies for narazaciclib, evaluated as a monotherapy and in combination with letrozole in patients with recurrent metastatic low-grade endometrioid endometrial cancer and other gynecologic malignancies. The studies were designed to define the dose limiting toxicity (DLT) and maximally tolerated dose (MTD) of the combination, and the RP2D for further clinical trials. Topline data are are being analyzed.
  • Presentation of further data from ongoing ISTs for rigosertib, shared at the Society for Investigative Dermatology (SID) held in July, 2024 which highlighted ongoing studies for RDEB-associated SCC, conducted at the University Hospital in Salzburg, Austria and Thomas Jefferson University, Philadelphia, PA.
  • Completion of the merger with Trawsfynydd and concurrent $14 million private placement in April expanded the clinical portfolio of the combined entity to include two potentially best-in-class oral small molecule programs, for influenza and COVID-19, as well as oral two agents for solid tumor cancers. The transaction also enhanced the Company’s investor base, with the addition of Orbimed and Torrey Pines.

Financial Results:

Traws financial results for the quarter ended June 30, 2024 represent the first post-transaction quarterly report of the combined company. The financial results for the comparable period in 2023 represent a consolidated summary of the combined entity. For simplicity, the explanatory statements below provide a high-level summary of expenses for the quarter ended June 30, 2024.

Cash, cash equivalents and short-term investments: As of June 30, 2024, the Company had cash, cash equivalents, and short-term investments of approximately $16.9 million, compared to cash, cash equivalents, and short-term investments of approximately $20.8 million at December 31, 2023. The company believes its cash balance is adequate to support planned operations through year end 2024.

Acquired in-process R&D related to our transaction early in the second quarter resulted in a non-cash charge of $117.5 million.

Research and development (R&D) expense for the three months ended June 30, 2024, totaled $4.0 million, compared to $2.5 million for the comparable period in 2023. Q2 2024 R&D expenses mainly reflect the cost of the Phase 1 SAD/MAD COVID-19 study, the Phase 1 extension study in flu, completion of the narazaciclib Phase 1/2 dose escalation study, regulatory expenses to support planned upcoming studies, and expenses related to stock-based compensation and restructuring costs related to the recent transaction.

General and administrative (G&A) expense for the three months ended June 30, 2024, totaled $2.0 million compared to $2.2 million for the comparable period in 2023. Q2 2024 G&A expenses include stock-based compensation and restructuring costs related to the merger.

Net loss: The net loss for the three months ended June 30, 2024 was $123.1 million, or $4.87 per basic and diluted common share, which reflects a non-cash charge of $117.5 million related to in-process R&D from Onconova’s April 2024 acquisition of Trawsfynydd. This compares with a net loss of $4.3 million, or $0.20 per basic and diluted common share, for the same period in 2023.

Conference Call and Webcast Information

Traws Pharma will host a conference call and webcast today, August 15, 2024, at 8:00 AM ET to discuss recent business progress and second quarter financial results. To access the call, please dial: 
1 (877) 407-0789 (United States) or 1 (201) 689-8562 (International) and reference the conference ID “13748066”. To access the webcast, please click: Traws Pharma Corporate Update Call. The live and archived webcast can also be accessed by visiting the “Corporate Events & Presentations” tab of the Events and Presentations section of the Investor Relations page. A replay of the webcast will be archived for 90 days.

About Traws Pharma, Inc.

Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two potentially best-in-class oral small molecules in Phase 1 studies: tivoxavir marboxil, a novel oral antiviral drug candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease).

In the cancer program, Traws is developing the novel, proprietary multi-kinase CDK4-plus inhibitor narazaciclib, with potential for refractory endometrial cancer and potentially other solid tumor cancers, and rigosertib, multi-kinase inhibitor targeting cell cycle proteins including PLK-1, with potential for use in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC, RDEB).

Traws Pharma is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections and cancer.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding Traws Pharma, its respective businesses, the merger agreement with Trawsfynydd Therapeutics, Inc. and concurrent private placement and the use of proceeds from such financing and the Company’s financing strategies, as well as statements regarding the milestones, preclinical studies and clinical studies for its four product candidates, tivoxavir marboxil for influenza including avian flu, ratutrelvir for COVID-19, and narazaciclib and rigosertib for cancer, related to the design, timing and potential results and the timing of next steps. Traws has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, merger integration, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Traws Pharma Contact:
Mark Guerin
Traws Pharma, Inc.
267-759-3680
www.trawspharma.com

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

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Release – Eledon Pharmaceuticals Reports Preliminary Second Quarter 2024 Operating Results

Research News and Market Data on ELDN

Presented updated data on 13 participants from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

80 participants (two-thirds of projected recruitment) enrolled in Phase 2 BESTOW trial

Completed an oversubscribed $50 million private placement; Company expects sufficient liquidity through December 2025

IRVINE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported recent business highlights for its second quarter 2024.

“We have entered the second half of the year with a strong balance sheet following our oversubscribed $50 million private placement and we are highly encouraged by the progress and reception from the transplant community for our Phase 2 BESTOW trial, which remains on track to complete enrollment by the end of this year,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking at this progress and the data we presented in June, we continue to believe that tegoprubart has the potential to displace calcineurin inhibitors, the current standard of care, as a first-line immunosuppression agent for patients undergoing kidney transplant.”

Second Quarter 2024 and Recent Corporate Developments

  • Enrolled the 80th participant in July 2024 in the ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of organ rejection in kidney transplantation.
  • Presented updated data at the American Transplant Congress (ATC) in June 2024 from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 13 participants demonstrated that tegoprubart was generally safe and well tolerated, with an overall mean estimated glomerular filtration rate (eGFR) of all reported time points after day 30 post-transplant of 70.5 mL/min/1.73m2. Two participants completed over 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one-year post-transplant.
  • Completed an oversubscribed private placement financing for total gross proceeds of $50.0 million, before deducting any offering related expenses.

Anticipated Upcoming Milestones

  • End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • Mid-2025: Report updated interim clinical data from the ongoing Phase 1b and long-term safety and efficacy extension studies of tegoprubart in kidney transplantation.

Financial Results

In the course of preparing the Company’s financial statements as of and for the three and six months ended June 30, 2024, the Company, in consultation with Crowe LLP, the Company’s independent registered public accounting firm, determined that a reclassification was necessary with respect to the Company’s reporting and recording of the fair value of certain common stock warrants and pre-funded warrants associated with the Company’s Securities Purchase Agreement dated as of April 28, 2023 (and the potential second and third closings thereof), resulting in a reclassification of these warrants as liabilities on the Company’s balance sheet, on a mark-to-market basis.

The Company expects to restate its audited consolidated financial statements that appeared in its Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 28, 2024, as amended on April 26, 2024, and its unaudited condensed consolidated financial statements that appeared in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024 (together, the “Impacted Reports”). As previously disclosed on the Company’s Form 12b-25 Notification of Late Filing filed with the SEC today, the Company also expects to delay the filing of its Form 10-Q for the three and six months ended June 30, 2024 in light of the time and resources needed to prepare a complete and accurate Form 10-Q in light of the restatement process . See also the Company’s Current Report on Form 8-K filed today for additional information.

This accounting reclassification is non-cash and is not expected to have an economic impact on the Company’s operations or on the Company’s cash, cash equivalents and short-term investments, or cash runway.

Eledon ended the second quarter with approximately $83.6 million in cash and cash equivalents, which includes the $50.0 million received in the private placement financing transaction during the second quarter.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand (CD40L), a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in allogeneic kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedInTwitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about enrollment in our clinical trials, the development and future success of product candidates, the company’s capital resources and ability to finance operations through December 2025, our filing of amendments to the Impacted Reports and our Form 10-Q for the three and six months ended June 30, 2024, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the completion of our financial closing procedures; final adjustments; completion of the review by our independent registered public accounting firm; the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Qs, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Noble Capital Markets Investor Events

Noble Capital Markets, a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving emerging growth companies, hosts a wide range of investor events throughout the year, including in-person non-deal roadshows around the United States, sector specific virtual equity conferences, and Noble’s flagship in-person equity conference, NobleCon.

Noble Capital Markets 20th Annual Emerging Growth Equity Conference

NobleCon has become the preeminent showcase of emerging growth companies. It’s about unfettered access to 200+ public company c-suite executives. Attendees ranging from high-net-worth individuals through to institutional portfolio managers. Panels of key opinion leaders covering topics that matter. Scheduled 1×1 meetings for qualified attendees. Past headliners ranging from Larry King to President George W. Bush. Networking and wind-down events designed to both entertain and keep productivity going. Organizational excellence in a technologically advanced environment. NobleCon20 at Florida Atlantic this December. If you’re looking for the next apple, this is your orchard. Presenting company and investor / attendee registration is now open! Click below to learn more.

In-Person Non-Deal Roadshows

Noble hosts in-person meetings with executives from companies listed on Channelchek throughout the United States. Qualified Investors, at all levels, as well as registered representatives, are welcome to attend these breakfasts, lunches, cocktail receptions, and 1×1 days at no cost, with no obligation to invest. Seating for these events is limited. Click below to view the calendar to request attendance.

Virtual Equity Conferences

In 2024, Noble hosted 3 sector specific virtual equity conferences, featuring emerging growth public company executive presentations from a variety of sectors, Q&A sessions moderated by Noble’s Analysts and Bankers, and scheduled 1×1 meetings with qualified investors.

If you missed out on any of the virtual conferences this year, replays of the corporate presentations and moderated Q&A sessions are available to registered Channelchek members, at the links below.

Noble Capital Markets Emerging Growth Basic Industries Conference Presentation Replays

Noble Capital Markets Emerging Growth TMT / Consumer Conference Presentation Replays

Noble Capital Markets Emerging Growth Virtual Healthcare Conference Presentation Replays

Xcel Brands (XELB) – Its Transformation Appears To Be Working


Thursday, August 15, 2024

Xcel Brands, Inc. 1333 Broadway 10th Floor New York, NY 10018 United States https:/Sector(s): Consumer Cyclical Industry: Apparel Manufacturing Full Time Employees: 84 Key Executives Name Title Pay Exercised Year Born Mr. Robert W. D’Loren Chairman, Pres & CEO 1.27M N/A 1958 Mr. James F. Haran CFO, Principal Financial & Accou

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

In line Q2. Total company revenues of $2.95 million was in line with our $3.0 million estimate. Adj. EBITDA, which was essentially flat at a loss of $40,000 was in line with our loss estimate of $44,000. See Figure #1 Q2 Results for highlights. Q2 reflected sequential quarterly improvement from the Q1 adj. EBITDA loss of $1.6 million. 

Behind the numbers. In our view, the recent results reflect the company’s progress toward its high margin licensing model. But, the quarter also reflected the revenue from Lori Goldstein, which was sold on June 30. As such, Q3 will reflect the absence of revenue from that brand. Notably, the company’s developing brands, Christie Brinkley and C. Wonder, appear to be performing well and may offset a large portion of the anticipate revenue impact. 


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

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

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

Unicycive Therapeutics (UNCY) – 2Q24 Reported With Guidance For NDA Submission By End Of August


Thursday, August 15, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

OLC Data and NDA Dominated 2Q24. Unicycive reported 2Q24 income of $3.0 million or $0.08 per share and a loss of $(0.15) on a fully diluted basis. Loss from operations for 2Q24 was $7.4 million, with a gain of $16.8 million from the change in fair value of warrant conversion. This offsets a charge of $11.8 million in 1Q24, bringing the six-month total for fair value of warrant conversion to $5.0 million. Cash on June 30 was $41.8 million, which we expect to fund operations into 2H25.

Pivotal Study Met Its Endpoints and Showed Patients Reaching Target Levels. As discussed in our Research Note on June 26, Unicycive reported results from its OLC pivotal study met its tolerability and safety endpoints with data that compares favorably with Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. We believe these results could make OLC highly competitive in the marketplace.


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

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

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

SKYX Platforms (SKYX) – Setting the Table for Future Revenue Growth


Thursday, August 15, 2024

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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

Execution on target. The company reported a solid quarter, in line with our revenue estimate and better than our adj. EBITDA loss estimate. Q2 revenue was $21.4 million, roughly in line with our estimate of $22.0 million, while an adj. EBITDA loss of $2.1 million was better than our forecast of a loss of $4.0 million. In our view, the sequential revenue growth, coupled with a diminishing cash burn should serve as a favorable indicator of the company’s ability to execute its growth strategy, while targeting a swing towards profitability in 2025.  

Expanding distribution channels. Recently, the company announced that its products would become available at Home Depot. Products are already live on Home Depot’s website and various products are expected to arrive in a select number of stores in the coming months. We view this as a significant expansion that furthers the company’s ability to reach both the retail and professional channels at scale. As such, we believe the inclusion of SKYX products at Home Depot could accelerate revenue growth in both customer verticals.


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

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

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

Snail (SNAL) – Looking Beyond The Noise


Thursday, August 15, 2024

Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Q2 results. The company reported Q2 revenue of $21.6 million, and adj. EBITDA of $3.1 million, both of which were lower than our forecasts of $27.8 million and $7.4 million, respectively. In our view, there were multiple factors contributing to the shortfall, such as deferred revenue in the quarter, as well as lower than expected revenue from ARK: Survival Ascended (ASA) on Microsoft Game Pass.

Deferred revenue. Notably, deferred revenue is largely related to the five DLC packages included in the sale of ASA, of which four have not been released yet. Furthermore, as DLC packages included in ASA are released, the company will defer less revenue from future ASA sales. In our view, reducing deferred revenue will provide investors with a clearer picture of company operating results.


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

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

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

Schwazze (SHWZ) – Post Call Notes and Updated Model


Thursday, August 15, 2024

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

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

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

Audit. Schwazze and its auditor are working diligently to complete the necessary re-audit of the 2023 financials. While management did not provide a timetable, we believe the process will be completed in the near-term. No material misstatements have been uncovered to date. Once audited financials are filed, we expect the Company to apply for re-listing of its shares.

Re-Scheduling. We continue to expect re-scheduling to occur in the near-term, which will have a positive impact on the entire industry. Schwazze continues to believe the elimination of 280e taxes will have a significant impact on cash flows for the Company. The Company also will seek to refile past tax returns to capture prior excess taxes paid under 280e.


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

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

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

QuoteMedia Inc. (QMCI) – Revenue Remains Lackluster


Thursday, August 15, 2024

QuoteMedia is a leading software developer and cloud-based syndicator of financial market information and streaming financial data solutions to media, corporations, online brokerages, and financial services companies. The Company licenses interactive stock research tools such as streaming real-time quotes, market research, news, charting, option chains, filings, corporate financials, insider reports, market indices, portfolio management systems, and data feeds. QuoteMedia provides industry leading market data solutions and financial services for companies such as the Nasdaq Stock Exchange, TMX Group (TSX Stock Exchange), Canadian Securities Exchange (CSE), London Stock Exchange Group, FIS, U.S. Bank, Broadridge Financial Systems, JPMorgan Chase, CI Financial, Canaccord Genuity Corp., Hilltop Securities, HD Vest, Stockhouse, Zacks Investment Research, General Electric, Boeing, Bombardier, Telus International, Business Wire, PR Newswire, FolioFN, Regal Securities, ChoiceTrade, Cetera Financial Group, Dynamic Trend, Inc., Qtrade Financial, CNW Group, IA Private Wealth, Ally Invest, Inc., Suncor, Virtual Brokers, Leede Jones Gable, Firstrade Securities, Charles Schwab, First Financial, Cirano, Equisolve, Stock-Trak, Mergent, Cision, Day Trade Dash and others. Quotestream®, QModTM and Quotestream ConnectTM are trademarks of QuoteMedia. For more information, please visit www.quotemedia.com.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Hans Baldau, Research Associate, Noble Capital Markets, Inc.

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

Weak Q2 Results. The company reported revenue of $4.7 million and adjusted EBITDA of $0.5 million, lighter than our estimates of $5.0 million and $0.9 million, respectively. Figure #1 Q2 Variance highlights the company’s results against our expectations. Revenues stayed flat from the first quarter and decreased by 6.0% from the year earlier Q2 2023.

Slow start to the year. Management indicated following its first quarter results that client churn at the tail end of 2023 contributed to the slow start in 2024. As of the first quarter, the company anticipated a strong finish to the year as its pipeline was expected to improve. We expect more details on the second half following its investor call at 2pm ET, call number is 800.274.8461.


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

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

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