
Child safety and privacy are paramount concerns for all parents, and incidents like this serve as a stark reminder of the need for constant vigilance and oversight. It is crucial that schools and childcare facilities have robust safeguards in place to protect the children in their care and prevent any breaches of trust or violations of privacy.The recent announcement by Tencent Video regarding the limitation of the number of devices on which members can log in has sparked controversy and debate among users. This move, aimed at preventing account sharing and ensuring fair usage of the platform, has also caught the attention of its competitor, iQIYI, which is now considering similar measures to combat account abuse.Should the U.S. increase immigration levels for highly skilled workers?
( MENAFN - GlobeNewsWire - Nasdaq) . 630 Patients Enrolled To Date; Enrollment Completion Now Expected in Q1 2025 with Top-line Results Anticipated in Q2 2025; . Upon Potential Positive Phase 3 Data the Company Expects to Submit a New Drug Application (“NDA”) for D-PLEX100 under Fast Track and Breakthrough Therapy Designations, Previously Granted to D-PLEX100 by the FDA; . Proceeds from this Financing and Exercise of Data-Triggered Warrant Expected to Extend Cash Runway Beyond Potential NDA Approval PETACH TIKVA, Israel, Dec. 24, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD ) (“PolyPid” or the“Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today that following the independent Data Safety Monitoring Board's (“DSMB”) review of unblinded efficacy data from the first 430 enrolled patients in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections (“SSIs”) in patients undergoing abdominal colorectal surgery with large incisions, the DSMB's recommendation was to conclude the study upon enrollment of 800 patients, which is the lowest sample size reassessment stop after the minimum planned number of 624 patients. At this interim analysis, the DSMB also had the option to recommend stopping SHIELD II due to futility or overwhelming efficacy or to reassess the trial's sample size to a maximum of 1,100 patients. In addition, the DSMB's confirmed the good safety profile of D-PLEX100 in SHIELD II to date. “We view the DSMB's recommendation to conclude SHIELD II upon the enrollment of 800 patients as a favorable outcome, as it is suggestive of positive efficacy signals from D-PLEX100,” said Dikla Czaczkes Akselbrad, PolyPid's Chief Executive Officer.“The sample size reassessment is an opportunity to ensure the study has sufficient power to conclusively confirm D-PLEX100's treatment benefit, and we believe this increases the trial's overall probability of success. We are now focused on completing the trial, while advancing our planned NDA and Marketing Authorization Application (“MAA”) submissions, preparing pre-launch activities, and expediting partnership discussions in and outside of the United States.” The study has enrolled 630 patients to date and enrollment of the last 170 patients is expected to occur in the first quarter of 2025. The Company anticipates reporting top-line results in the second quarter of 2025. Upon potential positive Phase 3 data, the Company expects to submit an NDA with the advantages of the Fast Track and Breakthrough Therapy designations, which were granted to D-PLEX100 in 2020. PolyPid also announced that it has entered into a securities purchase agreement for a private placement financing (the“PIPE”) led by existing institutional shareholders for $14.5 million in gross proceeds priced at $3.22 per share, the closing price on December 20, 2024. In connection with the PIPE financing, the Company has agreed to consider Yitzchak Jacobovitz, CFA, partner and lead healthcare analyst at AIGH Capital Management, for appointment to the Company's board of directors. Under the securities purchase agreement, the investors have agreed to purchase 4,493,830 of the Company's ordinary shares, no par value per share (the“Ordinary Shares”), or pre-funded warrants in lieu thereof, at a purchase price of $3.22 per share (or pre-funded warrant). The investors will also receive warrants to purchase up to 6,740,745 Ordinary Shares at an exercise price of $4.00 per share. The warrants expire upon the earlier of nine months from the date of issuance and 10 trading days following PolyPid's announcement of top-line results from its SHIELD II Phase 3 trial. Exercise of the warrants in full would result in an additional $27.0 million in gross proceeds to the Company. The PIPE is expected to close on December 26, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the sale of the securities for its ongoing SHIELD II Phase 3 clinical trial, working capital and general corporate purposes. The gross proceeds from the financing extend PolyPid's cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II. Proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval. Citizens JMP is acting as exclusive placement agent in the offering. The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the“Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the PIPE investors, the Company has agreed to file within 30 calendar days of closing one or more registration statements with the Securities and Exchange Commission (the "SEC") covering the resale of the Ordinary Shares and Ordinary Shares issuable upon exercise of the warrants and pre-funded warrants. This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction. About SHIELD II SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (“SoC”), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (“SSI”) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial enrolls patients in centers in the United States, Europe and Israel. About D-PLEX 100 D-PLEX100, PolyPid's lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions. About PolyPid PolyPid Ltd. (Nasdaq: PYPD ) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma. For additional Company information, please visit and follow us on Twitter and LinkedIn . Forward-looking Statements This press release contains“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as“expects,”“anticipates,”“intends,”“plans,”“believes,”“seeks,”“estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected timing for completion of enrollment of the SHIELD II trial, expected timing for top-line results from the SHIELD II trial, potential NDA and MAA submissions, potential clinical benefits of D-PLEX100, including safety and efficacy, pre-launch activities and partnership discussions, the gross proceeds to be received from the PIPE, intended use of proceeds from the PIPE, the anticipated closing date for the PIPE, the anticipated gross proceeds from the exercise of warrants issued in the PIPE if such warrants are exercised in full, that the gross proceeds from the financing extend the Company's cash runway into the third quarter of 2025, that proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval, and the potential addition of Mr. Jacobovitz to the Company's board of directors. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 6, 2024. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites. Contacts: PolyPid Ltd. Ori Warshavsky COO – US 908-858-5995 ... Investors: Brian Ritchie LifeSci Advisors 212-915-2578 ... MENAFN23122024004107003653ID1109025499 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.In recent times, the world has witnessed escalating tensions between nations, with conflicts and disputes dominating global headlines. Amidst this charged political atmosphere, one unlikely figure has emerged as a potential beacon for peace – the hair ambassador. Tasked with promoting dialogue and understanding through the universal language of beauty, these individuals possess the unique ability to bridge divides and foster camaraderie.
Manmohan Singh, India’s reluctant prime minister, dies aged 92By LOLITA C. BALDOR and MATTHEW LEE WASHINGTON (AP) — The United States is expected to announce that it will send $1.25 billion in military assistance to Ukraine, U.S. officials said Friday, as the Biden administration pushes to get as much aid to Kyiv as possible before leaving office on Jan. 20. The large package of aid includes a significant amount of munitions, including for the National Advanced Surface-to-Air Missile Systems and the HAWK air defense system. It also will provide Stinger missiles and 155 mm- and 105 mm artillery rounds, officials said. The officials, who said they expect the announcement to be made on Monday, spoke on condition of anonymity to provide details not yet made public. The new aid comes as Russia has launched a barrage of attacks against Ukraine’s power facilities in recent days, although Ukraine has said it intercepted a significant number of the missiles and drones. Russian and Ukrainian forces are also still in a bitter battle around the Russian border region of Kursk, where Moscow has sent thousands of North Korean troops to help reclaim territory taken by Ukraine. Earlier this month, senior defense officials acknowledged that that the Defense Department may not be able to send all of the remaining $5.6 billion in Pentagon weapons and equipment stocks passed by Congress for Ukraine before President-elect Donald Trump is sworn in. Related Articles National News | Bird flu virus likely mutated within a Louisiana patient, CDC says National News | A 9th telecoms firm has been hit by a massive Chinese espionage campaign, the White House says National News | Court rules Georgia lawmakers can subpoena Fani Willis for information related to her Trump case National News | US homelessness up 18% as affordable housing remains out of reach for many people National News | Most Americans blame insurance profits and denials alongside the killer in UHC CEO death, poll finds Trump has talked about getting some type of negotiated settlement between Ukraine and Russia, and spoken about his relationship with Russian President Vladimir Putin . Many U.S. and European leaders are concerned that it might result in a poor deal for Ukraine and they worry that he won’t provide Ukraine with all the weapons funding approved by Congress. The aid in the new package is in presidential drawdown authority, which allows the Pentagon to take weapons off the shelves and send them quickly to Ukraine. This latest assistance would reduce the remaining amount to about $4.35 billion. Officials have said they hope that an influx of aid will help strengthen Ukraine’s hand, should Zelenskyy decide it’s time to negotiate. One senior defense official said that while the U.S. will continue to provide weapons to Ukraine until Jan. 20, there may well be funds remaining that will be available for the incoming Trump administration to spend. According to the Pentagon, there is also about $1.2 billion remaining in longer-term funding through the Ukraine Security Assistance Initiative, which is used to pay for weapons contracts that would not be delivered for a year or more. Officials have said the administration anticipates releasing all of that money before the end of the calendar year. If the new package is included, the U.S. has provided more than $64 billion in security assistance to Ukraine since Russia invaded in February 2022.John Swinney and Gordon Brown at Alex Salmond memorial service
Cenk Uygur, founder of the left-wing media outlet The Young Turks, said Friday that he is “optimistic” as President-elect Donald Trump gears up for his second term in office. Uygur, previously extremely critical of Trump, shared his realization that the Make America Great Again (MAGA) movement is not his “mortal enemy” like he once believed. He identified the political establishment as his true foe in a series of posts on social media. I’ve been trying to figure out why I’m more optimistic now than I was before the election, even though I was so against the guy who won. I know now. MAGA is not my mortal enemy (and neither is the extreme left). My mortal enemy is the establishment. And they have been defeated! — Cenk Uygur (@cenkuygur) November 29, 2024 “I’ve been trying to figure out why I’m more optimistic now than I was before the election, even though I was so against the guy who won. I know now. MAGA is not my mortal enemy (and neither is the extreme left). My mortal enemy is the establishment. And they have been defeated!” Uygur wrote on X. Uygur said Trump’s win was a result of more than “establishment candidate” Vice President Kamala Harris falling short at the ballot box, pointing to the decline of legacy media “propaganda.” “It’s not just that the establishment candidate lost, it’s that their media is mortally wounded. The source of their strength was not insipid politicians like Mitch McConnell and Joe Biden. The source of their strength was their propaganda machine — the mainstream media,” he wrote. The Young Turks founder reveled in the rise of independent journalism on social media, declaring his love for the unrestrained media ecosystem online. (RELATED: Dana White Says He’s ‘Never F*cking Doing’ Politics Again) Now, online media is strong enough that their oppressive monopoly on the American mind has been broken. Now, we’re in the jungle. They hate that! I love it! This uncontrolled marketplace of ideas is where I’m home. I’d rather be in the populist woods than an establishment prison. — Cenk Uygur (@cenkuygur) November 29, 2024 “Now, online media is strong enough that their oppressive monopoly on the American mind has been broken. Now, we’re in the jungle. They hate that! I love it! This uncontrolled marketplace of ideas is where I’m home. I’d rather be in the populist woods than an establishment prison,” Uygur wrote. Ugyur has garnered attention on X for giving Trump and his allies “ credit where credit is due ” on a variety of issues including his post-election interactions with “Morning Joe” co-hosts and Republican South Carolina Sen. Lindsey Graham. He slammed the hoax surrounding Trump’s out-of-context “ bloodbath ” comment and praised the president-elect’s heroism after being shot in Butler, Pennsylvania in July. The Young Turks founder also spoke fondly of X owner Elon Musk, a close ally of Trump, for inviting open dialogue about plans for cutting the Pentagon’s budget. “I asked @elonmusk to put me in charge of cutting the Pentagon. And he said – what are your suggestions? I run the largest left-wing network online and a Democratic leader has NEVER asked me that question. The idea that they would take advice from a populist is disdainful to them,” Ugyur wrote on Nov. 19. “You’re SO deluded.” Cenk Uygur clashes with pollster Allan Lichtman over the downfall of the Democrats. Allan: “Who taught you manners?!” 📺 https://t.co/YmVwKQEiTI @piersmorgan | @cenkuygur | @AllanLichtman pic.twitter.com/CmW4gsFZUt — Piers Morgan Uncensored (@PiersUncensored) November 19, 2024 During a recent panel discussion on “Piers Morgan Uncensored,” Ugyur delivered a fiery response to the “deluded” Allan Lichtman , who he said “deserve[s] a tall glass of shut up juice” for incorrectly predicting Harris’s victory.
Lai Lifuge, known for his versatility and basketball IQ, has been a consistent performer for his team throughout the season. His ability to contribute both offensively and defensively has made him a valuable asset, and his inclusion in the best lineup for the 15th round comes as no surprise to fans and analysts alike.The Assad regime, led by President Bashar al-Assad, has long been a key ally of Iran in the region. Iran has provided significant military and financial support to the Assad government in its ongoing efforts to crush a nearly decade-long rebellion against its rule. The potential collapse of the Assad regime, therefore, would represent a significant blow to Iran's strategic interests in the region.
In conclusion, the controversy over South Korea's "emergency martial law" declaration has raised concerns about its impact on China-South Korea relations. The response from the Chinese Ministry of Foreign Affairs highlights the importance of diplomacy and dialogue in addressing disputes and maintaining peace and stability in the region. Both China and South Korea must work together to overcome their differences and strengthen their bilateral relations for the benefit of both countries and the region as a whole.
Another factor that could impact the political situation in Syria is the changing dynamics among the external powers involved in the conflict. The shifting alliances and interests of these powers could create opportunities for new political arrangements in the country. For example, a reconciliation between Russia and the United States, or a change in Turkey's stance towards the Assad regime, could potentially pave the way for a political transition in Syria.Friday’s High School Football Playoff Scores
In conclusion, the European Football Association's decision to remove Coot from its list of referees sets a precedent for accountability and transparency in the world of football officiating. It sends a clear message that unethical behavior will not be condoned, and that those who fail to uphold the standards of the game will face consequences for their actions. By taking a proactive stance against misconduct, the European Football Association is taking a step in the right direction towards ensuring the integrity and fairness of European football for players, clubs, and fans alike.The resolution to arrest President Yoon was proposed by the opposition party, which holds a majority in the National Assembly. The lawmakers argued that swift action was necessary to prevent any further damage to the country's reputation and restore the rule of law. The resolution was passed with overwhelming support, signalling a growing consensus among political leaders that Yoon must be held accountable for his actions.