Latest news with #clinicalstage
Yahoo
2 days ago
- Business
- Yahoo
1 Stock Down 34% This Year to Buy and Hold
Investors are withdrawing their money from stocks like Viking Therapeutics due to the current uncertainty. However, the biotech has a duo of mid-stage candidates that look incredibly promising. Though it carries above-average risk, Viking has significant upside potential. 10 stocks we like better than Viking Therapeutics › Shares of Viking Therapeutics (NASDAQ: VKTX), a mid-cap biotech, are down by 34% this year. This poor performance may suggest that recent company-specific developments have rendered the stock less attractive or that it is being affected by broader market issues. The latter is true, at least to some extent, but Viking Therapeutics' thesis has not changed significantly this year. The drugmaker remains attractive compared to most of its similarly sized peers. Here is why. Viking Therapeutics is a clinical-stage biotech. That means the company has no product on the market, generates no revenue, and is consistently unprofitable. Investors aren't too keen on buying shares of companies that fit this profile when broader equities are experiencing significant volatility due to potential macroeconomic issues. In fairness, that makes sense. Clinical-stage biotechs carry above-average risk. Their products may never see the light of day outside the clinic, and even when they do, many do not generate substantial revenue. However, Viking Therapeutics is a bit different. The company is developing medicines across several areas with high unmet needs. First, there is the drugmaker's work in the weight management space. The anti-obesity drug market has experienced significant growth in recent years. Yet, analysts continue to predict that the best is yet to come. Viking Therapeutics' leading candidate in this area, VK2735, is a dual GLP-1/GIP agonist. The only approved medicine of this kind on the market is Eli Lilly's Zepbound, an undisputed leader. Being in the same class as Zepbound doesn't guarantee VK2735's success, but it's still worth pointing out that a similar mechanism of action that led to Zepbound's breakthrough and efficacy could also prove successful for Viking Therapeutics' crown jewel. And more importantly, the investigational medicine has produced better results than almost any other mid-stage candidate in weight management, outside of those being developed by Eli Lilly and Novo Nordisk. That's impressive for a mid-cap biotech, considering significantly larger drugmakers with far more resources are trying to dominate this market. Viking Therapeutics' other mid-stage program, VK2809, performed well in patients with metabolic dysfunction-associated steatohepatitis (MASH), a disease with obesity as one of the main risk factors and whose prevalence is on the rise. However, the U.S. Food and Drug Administration approved just the first MASH medicine last year, although that will likely change soon. The point, though, is that VK2809 could join a relatively young market in a few years and generate massive sales down the road. These two candidates set Viking Therapeutics apart from other clinical-stage biotech companies. It's also worth noting that Viking Therapeutics recently signed a multiyear manufacturing agreement with privately held CordenPharma for VK2735. Per the terms of the deal, CordenPharma will manufacture more than a billion oral formulations of the medicine annually, as well as over 100 million autoinjectors and another 100 million syringes per year. Viking Therapeutics will make payments to CordenPharma, totaling $150 million through 2028. This deal highlights that Viking Therapeutics is already planning some post-commercial activity for its leading candidate. That's a great sign for investors. Viking Therapeutics is developing other candidates, including another weight management product that is still in preclinical studies. Following a similar blueprint, this product is a dual agonist that mimics the action of not just one but two gut hormones: amylin, which helps regulate blood sugar, and calcitonin, which regulates calcium levels. There is slow progress on that front, but Viking Therapeutics' commitment to innovation is impressive for such a small biotech. Now, Viking Therapeutics' most advanced programs could fail in phase 3 studies. If that happens, especially with VK2735, the stock price is likely to plummet. That's a significant risk to consider. That's why the stock is probably not suitable for risk-averse investors. However, those who are comfortable with volatility should strongly consider initiating a small position in the stock. If the business goes under, which isn't that rare for smaller biotech companies, your losses will be relatively small so long as the company makes a tiny portion of your overall portfolio. But there is significant upside potential that those who invest in Viking Therapeutics today could enjoy over the long run. Before you buy stock in Viking Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Viking Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $669,517!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $868,615!* Now, it's worth noting Stock Advisor's total average return is 792% — a market-crushing outperformance compared to 171% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 2, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Novo Nordisk, and Viking Therapeutics. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. 1 Stock Down 34% This Year to Buy and Hold was originally published by The Motley Fool
Yahoo
2 days ago
- Business
- Yahoo
1 Stock Down 34% This Year to Buy and Hold
Investors are withdrawing their money from stocks like Viking Therapeutics due to the current uncertainty. However, the biotech has a duo of mid-stage candidates that look incredibly promising. Though it carries above-average risk, Viking has significant upside potential. 10 stocks we like better than Viking Therapeutics › Shares of Viking Therapeutics (NASDAQ: VKTX), a mid-cap biotech, are down by 34% this year. This poor performance may suggest that recent company-specific developments have rendered the stock less attractive or that it is being affected by broader market issues. The latter is true, at least to some extent, but Viking Therapeutics' thesis has not changed significantly this year. The drugmaker remains attractive compared to most of its similarly sized peers. Here is why. Viking Therapeutics is a clinical-stage biotech. That means the company has no product on the market, generates no revenue, and is consistently unprofitable. Investors aren't too keen on buying shares of companies that fit this profile when broader equities are experiencing significant volatility due to potential macroeconomic issues. In fairness, that makes sense. Clinical-stage biotechs carry above-average risk. Their products may never see the light of day outside the clinic, and even when they do, many do not generate substantial revenue. However, Viking Therapeutics is a bit different. The company is developing medicines across several areas with high unmet needs. First, there is the drugmaker's work in the weight management space. The anti-obesity drug market has experienced significant growth in recent years. Yet, analysts continue to predict that the best is yet to come. Viking Therapeutics' leading candidate in this area, VK2735, is a dual GLP-1/GIP agonist. The only approved medicine of this kind on the market is Eli Lilly's Zepbound, an undisputed leader. Being in the same class as Zepbound doesn't guarantee VK2735's success, but it's still worth pointing out that a similar mechanism of action that led to Zepbound's breakthrough and efficacy could also prove successful for Viking Therapeutics' crown jewel. And more importantly, the investigational medicine has produced better results than almost any other mid-stage candidate in weight management, outside of those being developed by Eli Lilly and Novo Nordisk. That's impressive for a mid-cap biotech, considering significantly larger drugmakers with far more resources are trying to dominate this market. Viking Therapeutics' other mid-stage program, VK2809, performed well in patients with metabolic dysfunction-associated steatohepatitis (MASH), a disease with obesity as one of the main risk factors and whose prevalence is on the rise. However, the U.S. Food and Drug Administration approved just the first MASH medicine last year, although that will likely change soon. The point, though, is that VK2809 could join a relatively young market in a few years and generate massive sales down the road. These two candidates set Viking Therapeutics apart from other clinical-stage biotech companies. It's also worth noting that Viking Therapeutics recently signed a multiyear manufacturing agreement with privately held CordenPharma for VK2735. Per the terms of the deal, CordenPharma will manufacture more than a billion oral formulations of the medicine annually, as well as over 100 million autoinjectors and another 100 million syringes per year. Viking Therapeutics will make payments to CordenPharma, totaling $150 million through 2028. This deal highlights that Viking Therapeutics is already planning some post-commercial activity for its leading candidate. That's a great sign for investors. Viking Therapeutics is developing other candidates, including another weight management product that is still in preclinical studies. Following a similar blueprint, this product is a dual agonist that mimics the action of not just one but two gut hormones: amylin, which helps regulate blood sugar, and calcitonin, which regulates calcium levels. There is slow progress on that front, but Viking Therapeutics' commitment to innovation is impressive for such a small biotech. Now, Viking Therapeutics' most advanced programs could fail in phase 3 studies. If that happens, especially with VK2735, the stock price is likely to plummet. That's a significant risk to consider. That's why the stock is probably not suitable for risk-averse investors. However, those who are comfortable with volatility should strongly consider initiating a small position in the stock. If the business goes under, which isn't that rare for smaller biotech companies, your losses will be relatively small so long as the company makes a tiny portion of your overall portfolio. But there is significant upside potential that those who invest in Viking Therapeutics today could enjoy over the long run. Before you buy stock in Viking Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Viking Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $669,517!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $868,615!* Now, it's worth noting Stock Advisor's total average return is 792% — a market-crushing outperformance compared to 171% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of June 2, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Novo Nordisk, and Viking Therapeutics. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. 1 Stock Down 34% This Year to Buy and Hold was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
24-05-2025
- Business
- Associated Press
IMUNON Announces Up To $9.75 Million Private Placement Priced At-The-Market Under Nasdaq Rules
$3.25 million upfront with up to an additional $6.5 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants LAWRENCEVILLE, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 7,222,223 shares of its common stock (or pre-funded warrants in lieu therof) and short-term warrants to purchase up to an aggregate of 14,444,446 shares of common stock at a purchase price of $0.45 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrants in a private placement priced at-the-market under Nasdaq rules. The warrants will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants at an exercise price of $0.45 per share and will expire three years from the date of stockholder approval. The offering is expected to close on or about May 27, 2025, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the the exclusive placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as financial advisor. The aggregate gross proceeds to the Company from the private placement is expected to be approximately $3.25 million, before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $6.5 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The shares of common stock, pre-funded warrants and short-term warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the 'Act') and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and short-term warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the short-term warrants and the shares of common stock underlying the pre-funded warrants and short-term warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ('SEC') or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the shares of common stock and the shares issuable upon exercise of the pre-funded warrants and short-term warrants. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed multiple clinical trials including one Phase 2 clinical trial (OVATION 2). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit Forward-Looking StatementsContacts:
Yahoo
23-05-2025
- Business
- Yahoo
Sol-Gel Reports First Quarter 2025 Results
NESS ZIONA, Israel, May 23, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced financial results for the first quarter ended March 31, 2025. Financial Results for the First Quarter Year Ended March 31st, 2025 Total revenue in the first quarter was $1 million compared to $0.5 million revenues for the same period in 2024. Research and development expenses were $8.8 million compared to $5.3 million in the same period in 2024. The increase of $3.5 million was primarily attributed to an increase of $3.6 million due to expenses associated with supplier-led manufacturing development to support future commercialization of SGT-610, an increase of $0.5 million related to the commercialization of EPSOLAY and TWYNEO in territories outside of the U.S., offset by a decrease of $0.5 million in clinical trial expenses related to SGT-610. General and administrative expenses were $1.3 million compared to $1.8 million for the same period in 2024. The decrease of $0.5 million was mainly attributed to a decrease in payroll and stock-based compensation expenses due to cost measures being taken in 2024. Sol-Gel reported a net loss of $8.8 million for the first quarter of 2025 and of $3.2 basic and diluted loss per share, compared to a net loss of $6.3 million and a loss of $2.3 per basic and diluted share for the same period in 2024. As of March 31, 2025, Sol-Gel had $16.9 million in cash, cash equivalents, and deposits and no marketable securities for a total balance of $16.9 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About Sol-Gel Technologies Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products for the treatment of skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The Company's pipeline includes Orphan Drug candidate, SGT-610 under investigation for the prevention of new basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas. For additional information, please visit Forward Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to our expected cash runway. In some cases, you can identify forward-looking statements by terminology such as 'believe,' 'may,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' 'expect,' 'predict,' 'potential,' or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management's current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations, a delay in the timing of our clinical trials, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators' ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators' ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators' ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ('SEC') on April 29, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. SOL-GEL TECHNOLOGIES LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) (Unaudited) December 31, March 31, 2024 2025 Assets CURRENT ASSETS: Cash and cash equivalents $ 19,489 $ 16,890 Bank deposits 12 12 Marketable securities 4,425 - Accounts receivables 3,595 3,883 Prepaid expenses and other current assets 3,774 2,647 TOTAL CURRENT ASSETS 31,295 23,432 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,291 1,293 Long-term receivables 1,024 518 Property and equipment, net 202 183 Operating lease right-of-use assets 1,426 1,332 Other long-term assets 13 - Funds in respect of employee rights upon retirement 595 305 TOTAL NON-CURRENT ASSETS 4,551 3,631 TOTAL ASSETS $ 35,846 $ 27,063 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable $ 1,265 $ 438 Other accounts payable 3,590 3,702 Current maturities of operating leases 430 433 TOTAL CURRENT LIABILITIES 5,285 4,573 LONG-TERM LIABILITIES: Operating leases liabilities 878 746 Liability for employee rights upon retirement 833 363 Other long-term Liability 1,209 TOTAL LONG-TERM LIABILITIES 1,711 2,318 TOTAL LIABILITIES 6,996 6,891 SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 5,000,000 as of December 31, 2024 and March 31, 2025, respectively; issued and outstanding: 2,785,762 as of December 31, 2024 and March 31, 2025, respectively (*) 774 774 Additional paid-in capital 258,959 259,089 Accumulated deficit (230,883) (239,691) TOTAL SHAREHOLDERS' EQUITY 28,850 20,172 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 35,846 $ 27,063 (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. SOL-GEL TECHNOLOGIES LTD. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands) (Unaudited) Three months endedMarch 31 2024 2025 LICENSE REVENUES $ 466 $ 1,031 RESEARCH AND DEVELOPMENT EXPENSES 5,345 8,843 GENERAL AND ADMINISTRATIVE EXPENSES 1,833 1,257 OPERATING LOSS 6,712 9,069 FINANCIAL INCOME,net (368) (261) LOSS FOR THE PERIOD 6,344 8,808 BASIC AND DILUTED LOSS PER ORDINARY SHARE 2.3 3.2 WEIGHTED AVERAGE NUMBER OF SHARES*OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE (*) 2,785,762 2,785,762 (*)All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. Sol-Gel Contact:Eyal Ben-OrChief Financial Officerir@ Sol-Gel Technologies in to access your portfolio
