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benjaminec/iStock via Getty Images Hercules Capital ( NYSE: HTGC ) is a business development company concentrating on (mostly) US businesses operating within a few key sectors: Technology. Life sciences. SaaS. Sustainable and renewable technology. It offers attractive income to its shareholders (~10% yield Analyst’s Disclosure: I/we have a beneficial long position in the shares of HTGC either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. The information, opinions, and thoughts included in this article do not constitute an investment recommendation or any form of investment advice. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.WARRINGTON, Pa., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or "the Company") WINT , a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the third quarter ended September 30, 2024 and provided key business updates. "The third quarter of 2024 was marked with significant progress. We were very pleased with the SEISMiC B study results in early cardiogenic shock showing significant improvement in many measures of cardiac function and blood pressure along with a favorable safety profile in patients with heart failure and cardiogenic shock. There have been four positive Phase 2 studies with over 300 patients treated with istaroxime resulting in a consistent, unique and attractive drug profile across a wide range of severities," said Craig Fraser, Chairman and CEO. "With trial execution and active operations comes the need for capital and we successfully completed transactions providing resources for our near-term needs as well as secured an equity line of credit to potentially support future requirements," Mr. Fraser added. "Looking forward, we plan to accelerate enrollments in the istaroxime SCAI Stage C cardiogenic shock study with a planned interim data read out in early Q2 2025 as well as providing guidance on our strategy and planned activities with our oncology preclinical aPKCi inhibitor assets. Given what we believe to be strong data and market need, the Company is turning attention to business development activities to secure additional licenses and partnerships for our multi-asset cardiovascular platform with the objective to secure non-dilutive capital and partner resources to advance the assets to potential commercialization." Key Business Updates Announced positive Phase 2b topline clinical results with istaroxime significantly improving cardiac function and blood pressure in heart failure patients with early cardiogenic shock. The study met its primary endpoint in significantly improving systolic blood pressure over six hours (SBP AUC) for the combined Part A and Part B SEISMiC istaroxime group compared to placebo as well as for SEISMiC Part B alone. The improvements in SBP AUC at 24 hours were also significantly increased by istaroxime and the improvements were sustained through 96 hours of measurement. Cardiac output (the amount of blood pumped by the heart over a minute) and filling pressures in the heart significantly improved as did measured kidney function. Heart failure severity as assessed by the NYHA classification decreased significantly up to 72 hours compared to placebo. A favorable safety and tolerability profile, including risk for cardiac arrythmias, was also observed. The clinical study data was presented in a late-breaker session at the Heart Failure Society of America conference and the Company reviewed the clinical results along with the program strategy and plans at a virtual Investor Meeting which has been posted to the Company website. Completed two private placements in July 2024 for aggregate proceeds of approximately $13.9 million, which consisted of approximately $4.4 million of new funding (with $2.3 million of net proceeds) and a $9.5 million payment through the full cancellation and extinguishment of certain holders outstanding senior notes, including secured notes, and shares of the Company's Series B Convertible Preferred Stock. Entered into a Common Stock Purchase Agreement with an equity line investor, whereby the Company has the right, but not the obligation, to sell such investor, and, subject to limited exceptions, the investor is obligated to purchase for up to $35 million of newly issued shares of the Company's common stock. Announced initiation of the SEISMiC C study of istaroxime in SCAI Stage C cardiogenic shock to complete Phase 2b and advance the transition to Phase 3. This is a global trial including sites in the U.S., Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care with inotropes and/or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for 6 hours and based on the patient's condition, the ability to remove standard of care therapies while on istaroxime will also be assessed. The primary endpoint of the study is assessment of systolic blood pressure (SBP) profile over the first 6 hours of treatment. Expanded patent estate with new patents with istaroxime in cardiogenic shock and acute heart failure. Cardiogenic shock national phase filings were completed for patent applications around the world, including in the United States, Germany, France, Italy, Japan and China. A patent was issued for istaroxime for Japan entitled, "Istaroxime-containing intravenous formulation for the treatment of heart failure and it has been accorded Patent No. 7560134. A patent was issued for istaroxime for Hong Kong, and it is entitled, "Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF)." The claims are directed formulations comprising istaroxime, pharmaceutically acceptable salts thereof, and methods of use, alone, or in combination with other agents useful for the treatment and management of acute heart failure. Select Third Quarter 2024 Financial Results For the third quarter ended September 30, 2024, the Company reported an operating loss of $4.7 million, which was comparable to an operating loss of $4.7 million in the third quarter of 2023. Included in our operating loss for the third quarter of 2024 is $2.2 million related to the change in fair value of our common stock warrant liability and $0.7 million in expenses related to the two private placements completed in July 2024 which were allocated to the warrants issued in those transactions and expensed immediately. Research and development expenses were $2.0 million for the third quarter of 2024, compared to $2.1 million for the third quarter of 2023. Research and development expenses for both periods primarily relate to the SEISMiC Extension trial of istaroxime for the treatment of early cardiogenic shock which completed enrollment during the third quarter of 2024. General and administrative expenses for the third quarter of 2024 were $2.8 million, compared to $2.6 million for the third quarter of 2023. For the third quarter of 2024, general and administrative expenses include $0.7 million in expenses related to the two private placements completed in July 2024 which were allocated to the warrants issued in those transactions and expensed immediately. The Company reported a net loss attributable to common stockholders of $3.8 million ($4.23 per basic share) on 0.9 million weighted-average common shares outstanding for the quarter ended September 30, 2024, compared to a net loss of $4.4 million ($15.47 per basic share) on 0.3 million weighted average common shares outstanding for the comparable period in 2023. As of September 30, 2024, the Company reported cash and cash equivalents of $2.3 million and current liabilities of $14.4 million, which includes an $8.6 million warrant liability. Included in prepaid expenses and other assets as of September 30, 2024 is $0.7 million in receivables related to ELOC Purchase Agreement gross proceeds for sales made during the quarter for which we had not yet received the cash payment. The related net proceeds after the redemption of the Series C Preferred Stock was $0.5 million. In addition, subsequent to September 30, 2024 and through November 22, 2024, we sold an additional 4.3 million shares of Common Stock under the ELOC Purchase Agreement for net proceeds of $2.4 million following mandatory redemption payments on our Series C Preferred Stock. Following these financings, we believe that we have sufficient resources available to fund our business operations through January 2025. Readers are referred to, and encouraged to read in its entirety, the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which was filed with the Securities and Exchange Commission on November 26, 2024, and includes detailed discussions about the Company's business plans and operations, financial condition, and results of operations. Nasdaq Update On November 21, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff ("Staff") of The Nasdaq Stock Market LLC stating that it was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of it not having timely filed its Quarterly Report on Form 10-Q ("Form 10-Q") for the quarter ended September 30, 2024 with the Securities and Exchange Commission. Based on the November 26, 2024 filing of the Company's Form 10-Q and a subsequent letter received from Nasdaq on November 27, 2024 stating the Staff has determined that the Company complies with Nasdaq Listing Rule 5250(c)(1), this matter is now closed. About Windtree Therapeutics, Inc. Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree's portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. Examples of such risks and uncertainties include, among other things: the Company's ability to secure significant additional capital as and when needed; the Company's ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company's risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company's other product candidates, including preclinical oncology candidates; the Company's ability to access the debt or equity markets; the Company's ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company's clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company's product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company's efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company's product candidates, and the Company's ability to service those markets; the Company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company's product candidates, if approved; the Company's ability to maintain compliance with the continued listing requirements of Nasdaq; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People's Republic of China and the Republic of China (Taiwan), and the evolving events in the Middle East, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company's operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company's ability to access the capital markets. These and other risks are described in the Company's periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov . Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information: Eric Curtis ecurtis@windtreetx.com WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Balance Sheets (in thousands, except share and per share data) September 30, 2024 December 31, 2023 (Unaudited) ASSETS Current Assets: Cash and cash equivalents $ 2,300 $ 4,319 Prepaid expenses and other current assets 1,628 1,060 Total current assets 3,928 5,379 Property and equipment, net 128 183 Restricted cash 9 150 Operating lease right-of-use assets 1,133 1,444 Intangible assets 25,250 25,250 Total assets $ 30,448 $ 32,406 LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $ 2,054 $ 809 Accrued expenses 1,650 1,618 Operating lease liabilities - current portion 468 436 ELOC commitment note payable 317 - Derivative liability - ELOC commitment note 347 - Common stock warrant liability 8,621 - Loans payable 444 233 Other current liabilities 525 900 Total current liabilities 14,426 3,996 Operating lease liabilities - non-current portion 784 1,161 Restructured debt liability - contingent milestone payments - 15,000 Other liabilities 3,800 3,800 Deferred tax liabilities 4,887 5,058 Total liabilities 23,897 29,015 Mezzanine Equity: Series C redeemable preferred stock, $0.001 par value; 18,820 and 0 shares authorized; 15,719 and 0 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 2,142 - Series B redeemable preferred stock, $0.001 par value; 5,500 and 0 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively - - Total mezzanine equity 2,142 - Stockholders' Equity: Preferred stock, $0.001 par value; 4,975,680 and 5,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively - - Common stock, $0.001 par value; 120,000,000 shares authorized; 2,340,429 and 333,145 shares issued at September 30, 2024 and December 31, 2023, respectively; 2,340,428 and 333,144 shares outstanding at September 30, 2024 and December 31, 2023, respectively 2 - Additional paid-in capital 856,267 851,268 Accumulated deficit (848,806 ) (844,823 ) Treasury stock (at cost); 1 share (3,054 ) (3,054 ) Total stockholders' equity 4,409 3,391 Total liabilities, mezzanine equity & stockholders' equity $ 30,448 $ 32,406 WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations (in thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Expenses: Research and development $ 1,968 $ 2,110 $ 14,084 $ 5,288 General and administrative 2,773 2,580 6,514 7,292 Loss on impairment of goodwill - - - 3,058 Total operating expenses 4,741 4,690 20,598 15,638 Operating loss (4,741 ) (4,690 ) (20,598 ) (15,638 ) Other income (expense): Gain on debt extinguishment 71 - 14,591 - Change in fair value of common stock warrant liability 2,166 - 2,166 - Interest income 12 112 62 264 Interest expense (51 ) (13 ) (174 ) (38 ) Other (expense) income, net (446 ) 166 (530 ) 275 Total other income, net 1,752 265 16,115 501 Loss before income taxes (2,989 ) (4,425 ) (4,483 ) (15,137 ) Income tax benefit (expense) 240 - (71 ) - Net loss $ (2,749 ) $ (4,425 ) $ (4,554 ) $ (15,137 ) Extinguishment of Series B Preferred Stock 572 - 572 - Deemed dividend on Series C Preferred Stock (1,573 ) - (1,573 ) - Net loss attributable to common stockholders $ (3,750 ) $ (4,425 ) $ (5,555 ) $ (15,137 ) Net loss per share attributable to common stockholders Basic and diluted $ (4.23 ) $ (15.47 ) $ (8.64 ) $ (80.95 ) Weighted average number of common shares outstanding Basic and diluted 887 286 643 187 © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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San Francisco (5-5) at Green Bay (7-3) Sunday, 4:25 p.m. EST, FOX BetMGM NFL odds: Packers by 2 1/2. Against the spread: 49ers 4-6; Packers 4-6 Series record: Packers lead 38-34-1 Last meeting: 49ers beat Packers 24-21 in NFC divisional playoff game Jan. 20, 2024, in Santa Clara, California. Last week: 49ers lost 20-17 at home to Seattle; Packers won 20-19 at Chicago 49ers offense: overall (2), rush (7), pass (4), scoring (T-8) Packers offense: overall (4), rush (4), pass (9), scoring (T-8) 49ers defense: overall (6), rush (8), pass (8), scoring (T-16) Packers defense: overall (12), rush (14), pass (13), scoring (10) Turnover differential: 49ers plus-3; Packers plus-5 QB Brandon Allen: With Brock Purdy unavailable due to a sore right shoulder, Allen will make his first start in three years. The 32-year-old Allen has made nine career starts, and his teams have gone 2-7 in those games. His last start came with Cincinnati in the 2021 regular-season finale when the Bengals rested usual starter Joe Burrow to get ready for the playoffs. Allen has thrown three passes in the last three seasons, including none since joining San Francisco in 2023. Allen was a member of the Los Angeles Rams in 2017, when Packers coach Matt LaFleur was that team’s offensive coordinator. RB Josh Jacobs has 838 yards rushing this season to rank third in the NFL entering Week 12. He ran for 76 yards and a touchdown while also catching five passes for 58 yards against the Bears. Jacobs has scored four touchdowns (three rushing, one receiving) over his past four games. He has at least 90 yards from scrimmage over his past six games, matching Houston’s Joe Mixon for the NFL’s longest such active streak. 49ers RB Christian McCaffrey vs. Packers run defense: McCaffrey rushed for 98 yards and two touchdowns — including the game-winner with 1:07 left — in the 49ers’ playoff victory over the Packers last season. Green Bay is coming off a performance in which it allowed a season-high 179 yards rushing to the Bears. Purdy isn't playing due to a sore throwing shoulder. ... The 49ers also won't have Nick Bosa after he injured his left hip and oblique against the Seahawks. ... Niners CB Charvarius Ward will miss a third straight game following the death of his 1-year-old daughter. ... Niners LT Trent Williams (ankle) is questionable. ... Niners TE George Kittle is expected back after missing last week’s game with a hamstring injury. ... Packers CB Jaire Alexander (knee) and LB Edgerrin Cooper (hamstring) have been ruled out. ... Packers guard Jordan Morgan (shoulder) is on injured reserve. The 49ers have beaten the Packers in the playoffs three of the past five years. That includes a 37-19 victory in the 2019 NFC championship, a 13-10 upset at Lambeau Field in the 2021 divisional round and the 24-21 thriller last season. The past three matchups between these teams — including a Packers 30-28 road victory on Sept. 26, 2021 — have been decided by a total of eight points. This marks the first time these teams have faced off at Lambeau Field during the regular season since a Packers 33-30 triumph on Oct. 15, 2018. Each of the past three Packers-49ers games at Green Bay have been decided by three points. 49ers coach Kyle Shanahan and Packers coach Matt LaFleur worked together as assistants at Houston (2008-09), Washington (2010-13) and Atlanta (2015-16). A loss would give the 49ers a losing record more than 10 games into a season for the first time since going 6-10 in 2020. ... San Francisco has lost a league-worst three games this season after leading in the final two minutes of regulation. ... The 49ers have allowed 36 points in the final two minutes of regulation, second most in the NFL. ... The Niners had only one play from scrimmage go for at least 20 yards last week, tied for the fewest in any game in eight seasons under Shanahan. ... San Francisco is outgaining the opposition through the air by an NFL-best 53.9 yards per game. ... McCaffrey has topped 100 yards from scrimmage in his first two games back from Achilles tendinitis and has five straight games with at least 100 yards from scrimmage going back to last postseason. ... McCaffrey’s 57 games with at least 100 yards from scrimmage are the most for any active player. ... The 49ers are 1-5 this season when Purdy turns the ball over and 4-0 when he doesn’t. ... Purdy’s four rushing TDs are the most in a season for a Niners QB since Colin Kaepernick had four in 2013. ... This is the first of three games the Packers are playing in a 12-day stretch. They host the Miami Dolphins on Thanksgiving night and visit the NFC North-leading Detroit Lions on Dec. 5. ... The Packers are tied for fourth in the league with 19 takeaways, but they don’t have any over their past two games. ... Packers S Xavier McKinney has six interceptions this season to rank second in the league, behind Detroit’s Kerby Joseph (seven). McKinney has seven total takeaways, putting him in a tie for first with Joseph. ... Jacobs’ 838 yards rushing and 1,024 scrimmage yards this season are the most any Packer has had in his first 10 games with the team. Jacobs’ 1,024 scrimmage yards are the most for any Packer through the first 10 games of a season since Ahman Green had 1,057 at this point in 2004. ... Packers DL Rashan Gary had his 35th sack against Chicago to overtake teammate Kenny Clark for ninth place in franchise history. Clark, a three-time Pro Bowl selection, is still seeking his first sack of the season. ... The Packers and 49ers have the NFC’s best regular-season winning percentage since 2019. The Packers are 63-30 and the 49ers 59-34 during that stretch. ... San Francisco’s George Kittle has seven touchdown catches to lead all NFL tight ends. Green Bay’s Tucker Kraft has five touchdown receptions to match Baltimore’s Mark Andrews for the second-highest total among tight ends. ... The 49ers rank 26th in the league with TDs on 48.8% of their red zone drives. Green Bay is 27th in that category and has scored TDs on 48.7% of its drives. Packers WR Christian Watson’s slow start to the season means he might have been stashed on someone’s bench or perhaps even became available on some fantasy football waiver wires. Now would be a good time to try to acquire him. Watson had four catches for a career-high 150 yards against the Bears. After getting targeted just 14 times over his first six games, Watson’s had 17 targets in his past three. He had a catch each of the four times Jordan Love targeted him in Chicago. AP NFL: https://apnews.com/hub/NFL