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When President Donald Trump was searching for a new FBI Director after firing James Comey in 2017, he wanted among other things someone who looked the part of America’s top law enforcement official. Christopher Wray, a 50-year-old Yale-trained lawyer, was at the top of the list thanks to his conservative credentials as a leading partner at one of the nation’s biggest law firms and experience running the criminal division in George W. Bush’s Justice Department. For Trump, who has always placed emphasis on people looking the part for their jobs, Wray’s square-jawed serious demeanor helped seal the deal, people close to the process told CNN at the time. Soon after he became director, however, Trump began grousing that Wray wasn’t doing enough TV, people briefed on the matter said. Trump’s view was that the FBI director should be seen publicly supporting the president, who was in the middle of the Russia investigation into his campaign. Years later, in the spring of 2022, Trump sent Wray a handwritten letter, according to one person familiar with the note, congratulating him on his recent appearance on “60 Minutes” in which Wray discussed Chinese espionage efforts directed at the US. What Trump didn’t know at the time was that the FBI was beginning a criminal investigation, based on a referral from the National Archives, into his decision to hoard classified documents at Mar-a-Lago. The FBI court-authorized search of Mar-a-Lago that August led to a grand jury indictment against Trump — and ended any chance of Wray keeping his job in Trump’s second term. “He invaded my home,” Trump said on NBC’s “Meet the Press” this week, lambasting the director he chose . “He invaded Mar-a-Lago.” As Trump prepares to replace Wray with Kash Patel, a MAGA acolyte who has joined the president-elect in vowing to use the Justice Department to target political adversaries, Wray’s departure marks a clear end to a decadeslong era of independence for the FBI. When he first hired Wray, Trump’s expectations of unbridled fealty, a loyalty standard that Comey has said Trump also asked him to meet, were a sharp departure from the culture of the modern FBI, which has assiduously cultivated its independence since the Watergate scandal and the abuses of the 48-year reign of J. Edgar Hoover. It’s an independence that has irritated almost every president through the years. A tenure filled with tension Compared to Comey, whose frequent media appearances caused some of the bureau’s problems, Wray preferred to keep a lower profile and avoided the press. That was not the type of director Trump was anticipating, according to senior administration officials. That mismatch in expectations helped create a tightrope Wray tried to walk during Trump’s first term, as he limited his direct interactions with Trump while focusing on priorities that were important to the administration. Wray is “an ideal person to run the FBI because he recognizes it’s a non-partisan job and he has the respect of the troops,” said a former Justice Department official who helped push for Wray’s hiring. While Trump and Republicans rail against the so-called weaponization of the bureau, the former official said, “Kash Patel is exactly what Trump says he doesn’t want in an FBI director: someone who is going to weaponize the FBI.” Wray’s tenure under Trump was punctuated by periods of significant tension. Unhappy about the investigation into Russian meddling in the 2016 election, and eventually their failure to support his claims of fraud in the 2020 election, Trump would often lash out at Justice officials, including at times at Wray. At least twice, Wray told aides that he was prepared to resign over Trump’s demands, according to a former US official briefed on the matter. “A couple times, it got to where he said ‘I’m not going to do that,’ and he was persuaded to stay,” the former US official said. A current senior FBI official said that employees are frustrated that some of the attacks against the bureau and Wray were for decisions by their bosses at the Justice Department, which the FBI sometimes disagreed with. Early in the Biden administration, for example, the Justice Department issued a memo suggesting parents protesting at school boards over Covid measures could be investigated if they made threats. The FBI distanced itself from the memo, which never produced any actual investigations. But the damage was done, and Republican lawmakers continue to cite the issue as an example of overreach. FBI command center in 2020 The pressures on Wray came into clear view in June 2020, days after riots erupted across the country following the police killing of George Floyd. Wray, along with Vice President Mike Pence and Attorney General Bill Barr, stood in the FBI’s command center in downtown Washington, DC. After riots swelled around the city, a few blocks away a fire was set in the basement of historic St. John’s Church as protesters gathered in Lafayette Square outside the White House. Barr took charge of the law enforcement response and ordered 150 FBI agents into the square to clear protestors that night, according to a person present, despite some agents raising concerns that FBI agents aren’t trained to do crowd control, noting the risk that an agent or a protester could be killed. The decision was made and agents were deployed to patrol the streets of Washington. Wray later apologized to agents, noting that orders weren’t coming from him or even Barr, but from Trump, according to the person present at the command post. Days later Wray spoke at a press conference alongside Barr and for the first time appeared to endorse the idea that Antifa was behind the violence, something Trump had been insistent on despite a lack of evidence to support his claims. “We’re seeing people who are exploiting this situation to pursue violent extremist agendas,” Wray said. “Anarchists like Antifa and other agitators. These individuals have set out to sow discord and upheaval rather than join in the righteous pursuit of equality and justice.” Inside the bureau, some officials were surprised that Wray had come to echo Trump and Barr’s claims about Antifa. But Wray’s words, temporarily at least, served to help bolster Trump’s confidence that Wray and the FBI were doing what he wanted. Months later at a congressional hearing, Wray told lawmakers that Antifa was an ideology, not a group, prompting criticism from Republicans. A more understated director At the bureau, where Comey was well-liked as director, Wray’s arrival in 2017 was a sharp turn. But it was a welcome one for employees who hoped that a more understated director would lower the political heat on the bureau and refocus attention on its national security and criminal enforcement missions. Visibly uncomfortable in large crowds, Wray has a political gift in smaller gatherings, particularly rank-and-file employees who rarely get face time with the director, current and former FBI officials said. When he spoke to graduating classes of new agents at the FBI academy in Quantico, Virginia, Wray often compared the teamwork aspect of being an FBI agent to being on a rowing team, invoking his own time as a Yale crew team member. For each graduating class, Wray would eat lunch at the cafeteria with six to eight students who were viewed as leaders of their class, a former FBI agent who admires Wray told CNN. Like he did for all his meetings or when he was a trial attorney, Wray was known to prepare before even small gatherings at the academy. “He’s not a guy who works on emotion, he is very tactical, very prepared,” the former agent said. Former senior FBI officials said that while Wray didn’t like to speak publicly in the media, he was good at building relationships with local law enforcement agencies and with private sector companies that the FBI needs for its national security and counter-terrorism efforts. He often insisted to speak directly to current and former employees struggling with bereavement or health issues, notably former FBI employees suffering from post-9-11 illnesses. Every time a police officer was killed on duty anywhere in the US, Wray made calls to their family or police chiefs. “I cannot tell you how many deathbed calls he has made,” the former US official said. Decision to step down After Trump announced his intention last month to replace Wray with Patel, Wray wrestled with how to leave the bureau he had helmed for nearly eight years. He struggled with whether it was better for the FBI and its tradition of independence to stay and be fired, or to leave before Trump’s arrival to save the bureau from further attacks, people close to his thinking said. Ultimately Wray decided to announce his plans to resign to hundreds of FBI employees at the Washington, DC, headquarters, saying he would leave before Trump took office. His speech tacitly acknowledged the political headwinds the FBI will face under the new presidency. Wray also took the time during the speech to highlight the accomplishments by his agents throughout his years there, from thwarting terror plots to stopping cyber-attacks on US infrastructure and hospitals, fentanyl seizures and rescuing children from predators. “An awful lot of people are alive today because of your tireless efforts ,” Way told the audience. “As daunting as all that may sound, I’ve got enormous confidence in you and your ability to continue to meet the threats coming over the horizon.” Under Wray, the FBI stopped numerous foreign hacking operations from countries like China and Russia, alleged Iranian plots to kill current and former government officials, and opened up the largest investigation in FBI history, charging more than 1500 people in connection to the January 6, 2021, US Capitol attack. Still, none of it was enough to save Wray, whose tenure ends the same way as Comey’s – with Trump angry about being investigated by what he sees as his own FBI.Rudy Giuliani in a courtroom outburst accuses judge in assets case of being unfair, drawing a rebuke
By Clarissa-Jan Lim Days after Daniel Penny was acquitted in the chokehold death of Jordan Neely , he is set to attend an Army-Navy football game Saturday as a guest of Vice President-elect JD Vance. Vance said that Penny had accepted his invite to the game in a post on X on Friday morning. “Daniel’s a good guy, and New York’s mob district attorney tried to ruin his life for having a backbone,” Vance wrote. “I’m grateful he accepted my invitation and hope he’s able to have fun and appreciate how much his fellow citizens admire his courage.” Like others on the political right , Vance hailed Penny as a good Samaritan who helped his fellow citizens by confronting a potentially dangerous situation. Neely, a former Michael Jackson impersonator with a history of mental illness, died after Penny restrained him by the neck for an extended period of time during an encounter on the New York City subway in 2023. Penny argued that he meant to restrain Neely only until police arrived and did not intend to harm him. A New York City medical examiner ruled that Neely died from compression to his neck as a result of the chokehold. A jury cleared Penny of criminally negligent homicide in Neely’s death Monday after failing to come to an agreement on a charge of second-degree manslaughter , which a judge then dismissed. Penny’s ascension to folk hero status on the right is not unlike the support that Kyle Rittenhouse gained among conservatives after fatally shooting two people during a Black Lives Matter protest in Kenosha, Wisconsin, in 2020. Rittenhouse was acquitted of homicide charges in the case, and Donald Trump met with Rittenhouse afterward, praising him as “really a nice young man.” There are vast differences in the details of each case, but the lionization of Penny on the right coincides with the narrative about rising crime across the country, especially in urban areas like New York City. National data crime data , however, indicates the opposite . Clarissa-Jan Lim is a breaking/trending news blogger for MSNBC Digital. She was previously a senior reporter and editor at BuzzFeed News.NEW YORK — After missing last weekend’s loss to the Dolphins, Jets running back Breece Hall could return in Week 15. Hall (knee) is listed as questionable for Sunday’s game against the Jaguars. “He looks good right now,” Jets interim coach Jeff Ulbrich said on Friday afternoon. “So, it looks promising.” Hall injured his knee during the Jets’ Week 11 loss to the Colts. However, Hall played in the team’s next game against the Seahawks following the Jets’ bye week. While Hall could play on Sunday, the Jets will be without returner and running back Kene Nwangwu. After breaking his hand, Nwangwu will be placed on injured reserve and miss the rest of the season. Nwangwu was named the AFC Special Teams Player of the Week after the Jets’ Week 13 loss to the Seahawks. In that game, after being elevated from the practice squad, Nwangwu registered a 99-yard kick-return touchdown and forced a fumble on a separate kickoff return. “He brought such value as a returner,” Ulbrich said about Nwangwu. “To put him out there with a broken hand, that would be counterproductive for him and us as a team. “Unfortunately, it cuts the season short and what a bright light he was and what an amazing future I think he has in this league.” The Jets’ secondary could be limited against the Jaguars. Brandin Echols (shoulder) is doubtful, and D.J. Reed (groin) is questionable. Ulbrich is “hopeful” Reed can play against Jacksonville. “It’s something that’s lingered here and there,” Ulbrich said about Reed’s groin injury. “It got aggravated and it went away and it got aggravated again. “We are hopeful, but we will see how it goes. He has been a guy that, it has been sore on a Friday and been able to play on a Sunday multiple times this year. We will see how that goes.” Sauce Gardner, who missed last week’s game due to a hamstring injury, will play against the Jaguars. If Echols and Reed do not play, rookie Qwan’tez Stiggers will likely receive more playing time opposite Gardner. “I’m excited for him,” Ulbrich said about Stiggers. “If he gets an opportunity to play, I’m excited about what he can do. He has demonstrated great growth this season and he has elite ball skills. “If we gotta roll with Qwan’tez Stiggers, we are excited about that opportunity for him and for us.” ©2024 New York Daily News. Visit nydailynews.com . Distributed by Tribune Content Agency, LLC.None
TOM HARRIS: The SNP is chronically addicted to spending on the bloated public sector - as services get ever worse. But without seismic reform, this tartan gravy train is doomed to hit the buffersGenesis Bryant scores 27 and No. 19 Illinois women beat UMES 75-55 in Music City ClassicDAMASCUS (AP) — Exuberant Syrians observed the first Friday prayers since the ouster of President Bashar Assad , gathering in the capital's historic main mosque, its largest square and around the country to celebrate the end of half a century of authoritarian rule. The gatherings illustrated the dramatic changes that have swept over Syria less than a week after insurgents marched into Damascus and toppled Assad. Amid the jubilation, U.S. Secretary of State Antony Blinken met with allies around the region and called for an “inclusive and non-sectarian” interim government. Blinken arrived in Iraq on a previously unannounced stop after talks in Jordan and Turkey, which backs some of the Syrian insurgent factions. So far, U.S. officials have not talked of direct meetings with Syria's new rulers. The main insurgent force, Hayat Tahrir al-Sham, has worked to establish security and start a political transition after seizing Damascus early Sunday. The group has tried to reassure a public both stunned by Assad's fall and concerned about extremist jihadis among the rebels. Insurgent leaders say the group has broken with its extremist past, though HTS is still labeled a terrorist group by the United States and European countries. HTS's leader, Ahmad al-Sharaa, formerly known as Abu Mohammed al-Golani, appeared in a video message Friday congratulating “the great Syrian people for the victory of the blessed revolution.” “I invite them to head to the squares to show their happiness without shooting bullets and scaring people,” he said. “And then after, we will work to build this country, and as I said in the beginning, we will be victorious by the help of God.” Syrians celebrate in the historic heart of Damascus Huge crowds, including some insurgents, packed Damascus' historic Umayyad Mosque in the capital's old city, many waving the rebel opposition flag — with its three red stars — which has swiftly replaced the Assad-era flag with with its two green stars. According to Arab television stations, the Friday sermon was delivered by Mohammed al-Bashir, the interim prime minister installed by HTS this week. The scene resonated on multiple levels. The mosque, one of the world's oldest dating back some 1,200 years, is a beloved symbol of Syria, and sermons there like all mosque sermons across Syria had been tightly controlled under Assad's rule. Also, in the early days of the anti-government uprising in 2011, protesters would leave Friday prayers to march in rallies against Assad before he launched a brutal crackdown that turned the uprising into a long and bloody civil war. “I didn’t step foot in Umayyad Mosque since 2011," because of the tight security controls around it, said one worshipper, Ibrahim al-Araby. “Since 11 or 12 years, I haven’t been this happy.” Another worshipper, Khair Taha, said there was “fear and trepidation for what’s to come. But there is also a lot of hope that now we have a say and we can try to build.” Blocks away in Damascus' biggest roundabout, named Umayyad Square, thousands gathered, including many families with small children — a sign of how, so far at least, the country's transformation has not seen violent instability. “Unified Syria to build Syria,” the crowd chanted. Some shouted slurs against Assad and his late father, calling them pigs, an insult that would have previously led to offenders being hauled off to one of the feared detention centers of Assad’s security forces. One man in the crowd, 51-year-old Khaled Abu Chahine — originally from the southern province of Daraa, where the 2011 uprising first erupted — said he hoped for “freedom and coexistence between all Syrians, Alawites, Sunnis, Shiites and Druze.” The interim prime minister, al-Bashir, had been the head of a de facto administration created by HTS in Idlib, the opposition's enclave in northwest Syria. The rebels were bottled up in Idlib for years before fighters broke out in a shock offensive and marched across Syria in 10 days. Similar scenes of joy unfolded in other major cities, including in Aleppo, Homs, Hama, Latakia and Raqqa. US and its allies try to shape a rapidly changing Syria Al-Sharaa, HTS' leader, has promised to bring a pluralistic government to Syria, seeking to dispel fears among many Syrians — especially its many minority communities — that the insurgents will impose a hard-line, extremist rule. Another key factor will be winning international recognition for a new government in a country where multiple foreign powers have their hands in the mix. The Sunni Arab insurgents who overthrew Assad did so with vital help from Turkey, a longtime foe of the U.S.-backed Kurds . Turkey controls a strip of Syrian territory along the shared border and backs an insurgent faction uneasily allied to HTS — and is deeply opposed to any gains by Syria's Kurds. In other developments, Turkish Foreign Minister Hakan Fidan said Turkey’s Embassy in Damascus would reopen Saturday for the first time since 2012, when it closed due to the Syrian civil war. The U.S. has troops in eastern Syria to combat remnants of the Islamic State group and supports Kurdish-led fighters who rule most of the east. Since Assad's fall, Israel has bombed sites all over Syria, saying it is trying to prevent weapons from falling into extremist hands, and has seized a swath of southern Syria along the border with the Israeli-occupied Golan Heights, calling it a buffer zone. After talks with Fidan, Blinken said there was “broad agreement” between Turkey and the U.S. on what they would like to see in Syria. That starts with an "interim government in Syria, one that is inclusive and non-sectarian and one that protects the rights of minorities and women” and does not “pose any kind of threat to any of Syria’s neighbors,” Blinken said. Fidan said the priority was “establishing stability in Syria as soon as possible, preventing terrorism from gaining ground, and ensuring that IS and the PKK aren’t dominant” — referring to the Islamic State group and the Kurdistan Workers Party. Ankara considers the PKK within Turkey's borders a terrorist group, as it does the Kurdish-backed forces in Syria backed by the U.S. A U.S. official said that in Ankara, President Recep Tayyip Erdogan and Fidan both told Blinken that Kurdish attacks on Turkish positions would have to be responded to. The official spoke to reporters on condition of anonymity to discuss private diplomatic talks. The U.S. has been trying to limit such incidents in recent days and had helped organize an agreement to prevent confrontations around the northern Syrian town of Manbij, which was taken by Turkey-backed opposition fighters from the U.S.-backed Kurdish forces earlier this week. In Baghdad, Blinken met with Iraqi Prime Minister Mohammed al-Sudani, saying both countries wanted to ensure the Islamic State group — also known by its Arabic acronym Daesh — doesn't exploit Syria's transition to re-emerge. “Having put Daesh back in its box, we can’t let it out, and we’re determined to make sure that that doesn’t happen," Blinken said. The U.S. official who briefed reporters said that Blinken had impressed upon al-Sudani the importance of Iraq exercising its full sovereignty over its territory and airspace to stop Iran from transporting weapons and equipment to Syria, either for Assad supporters or onward to the militant Hezbollah group in Lebanon. Lee reported from Ankara, Turkey. Associated Press Writer Suzan Fraser in Ankara contributed to this report.
Bronson Reed has been receiving a significant push within WWE in recent weeks. His feuds with Seth Rollins and Braun Strowman both drew high ratings on television and across social media. He was rewarded by being placed into the New Bloodline's roster for its War Games match at Survivor Series. Unfortunately for Reed, he suffered an injury to his ankle and foot after hitting a Tsunami off the top of the cage at Survivor Series. According to Mike Johnson of Pro Wrestling Insiders, Reed is set to undergo surgery at some point next week. "The word making the rounds among WWE talents is that Bronson Reed will undergo surgery sometime next week for his ankle/foot injury suffered at WWE Survivor Series," Johnson reported. "Reed was injured hitting a Tsunami off the top of the cage through a table...Reed was slated to wrestle Seth Rollins in steel cage matches as part of the company's past-holiday live event week, so those lineups will change in the days to come." This injury couldn't have come at a worse time for Reed. He had finally generated some momentum within the company and had multiple big matches and angles lined up. His role alongside Solo Sikoa and the rest of the new bloodline would have helped increase his popularity with the fans, too. Now, Reed will be sidelined indefinitely. Once he returns, he must begin working his way back into a strong position. That could take months if it happens at all. Professional wrestling moves quickly. Fans will forget about his feuds while he's off television, and new storylines will take their place. There's no guarantee Rollins or Strowman will be available for new creative angles when he returns. And nobody knows where the Bloodline story will go next. Considering Reed's injury occurred during a dangerous spot within a match, which was undoubtedly part of the creative process, the hope is that WWE will do right by him once he returns. However, he may need to show some patience. Reed had earned this moment. Hopefully, when he's back and healthy, he will have opportunities to earn another big spot and can use that to springboard himself back toward the top of the "Monday Night RAW" card.Jim Harbaugh and Chargers focused on accomplishing more after wrapping up playoff berthFACT FOCUS: Inspector general’s Jan. 6 report misrepresented as proof of FBI setupSpeculation vs. Investing – How Hype Can Cause Memecoin Traders to Confuse the Two
Palvella Therapeutics to debut on Nasdaq under the ticker symbol “PVLA” as a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic diseases Strong balance sheet with approximately $80.0 million of cash and cash equivalents, including proceeds from a PIPE financing co-led by BVF Partners, L.P. and Frazier Life Sciences Cash expected to fund operations into the second half of 2027, including through Phase 3 SELVA clinical trial of QTORINTM 3.9% rapamycin anhydrous gel (QTORINTM rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) and Phase 2 clinical trial in cutaneous venous malformations (cutaneous VMs) Microcystic LMs is a chronically debilitating and lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S. QTORINTM rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs and cutaneous VMs WAYNE, Pa., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the completion of its previously announced merger with Pieris Pharmaceuticals, Inc. (Pieris). The combined company will operate under the name Palvella Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Capital Market on December 16, 2024, under the ticker symbol "PVLA". Palvella will continue to be led by Wes Kaupinen, its Founder and Chief Executive Officer, and other members of the Palvella management team. The transaction was approved by Pieris stockholders at a special meeting held on December 11, 2024, and the transaction had been previously approved by Palvella stockholders. "With strong support from leading healthcare-dedicated investors, Palvella is well positioned to enter the public markets and pursue our vision of becoming the leading rare disease company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases," said Mr. Kaupinen. “This transaction will enable us to accelerate late-stage development of QTORINTM rapamycin, our lead product candidate, for microcystic LMs and cutaneous VMs while also further advancing additional novel product candidates from our QTORINTM platform." Concurrent with the merger, Palvella completed a previously announced oversubscribed $78.9 million private placement co-led by BVF Partners, L.P., an existing investor, and Frazier Life Sciences, a new investor, and with participation from a syndicate of leading healthcare-dedicated investors. Additional new investors include Blue Owl Healthcare Opportunities, Nantahala Capital, DAFNA Capital Management, ADAR1 Capital Management, and a healthcare dedicated fund. Existing investors Samsara BioCapital, Petrichor, CAM Capital, Ligand Pharmaceuticals, Integrated Finance Group (an AscellaHealth partner company), BioAdvance, and Gore Range Capital also participated in the financing. Palvella's cash and cash equivalents of approximately $80.0 million is expected to fund operations into the second half of 2027, including through results from the SELVA Phase 3 clinical trial of QTORINTM rapamycin for the treatment of microcystic LMs and Phase 2 clinical trial of QTORINTM rapamycin in cutaneous VMs. Palvella’s research team developed QTORINTM, a patented and versatile platform designed to generate novel topical therapies that penetrate the deep layers of the skin to locally treat a broad spectrum of serious, rare genetic skin diseases. Well-accepted mechanisms of action of rapamycin and other therapeutic agents represent potential therapies for rare genetic skin diseases. However, the adverse event profile of those agents through systemic exposure poses significant barriers to patient adoption. Palvella’s QTORINTM product candidates are designed for targeted, localized delivery of therapeutic agents to pathogenic tissue of interest while minimizing systemic absorption and thereby reducing the risk of unwanted adverse events associated with systemic therapy. Palvella's lead product candidate QTORINTM rapamycin is a novel, patented 3.9% rapamycin anhydrous gel currently under development for the treatment of microcystic LMs, cutaneous VMs, and other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway. QTORINTM rapamycin has received FDA Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation for microcystic LMs and is the recent recipient of up to a $2.6 million FDA Orphan Products Grant. QTORINTM rapamycin has also received Fast Track Designation for venous malformations. QTORINTM rapamycin is protected by issued composition patents covering anhydrous gel formulations of rapamycin, as well as methods of use, in the U.S., Japan, Australia, China and Israel and pending patent applications broadly covering anhydrous gel formulations of rapamycin, as well as methods of use, in the U.S. and other countries. In the third quarter of 2024, Palvella initiated SELVA, a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORINTM rapamycin administered once daily for the treatment of microcystic LMs. The primary efficacy endpoint is the change from baseline in the overall microcystic LM Investigator Global Assessment (mLM-IGA) at week 24. The Phase 3 study is enrolling approximately 40 subjects, age six or older, at leading vascular anomaly centers across the U.S. Transaction Details Based on the final exchange ratio of approximately 0.30946 shares of Pieris common stock for each share of Palvella common stock, at the closing of the merger, there are approximately 13.95 million shares of the combined company's common stock outstanding on a diluted basis, with prior Pieris stockholders owning approximately 11% on a diluted basis and prior Palvella stockholders (including investors in the private placement) holding approximately 89% of the combined company's outstanding common stock on a diluted basis. In connection with the closing of the merger, Pieris issued a non-transferable contingent value right (CVR) to Pieris shareholders of record immediately prior to the closing, which does not include the former holders of shares of Palvella or the private financing investors. Holders of the CVR will be entitled to receive payments from proceeds received by the combined company, if any, under Pieris' existing partnership agreements with Pfizer and Boston Pharmaceuticals, in addition to other potential licensing agreements involving certain of Pieris' legacy assets, as well as certain potential payments related to historical research and development tax credits, which may or may not be realized. TD Cowen served as lead placement agent and Cantor served as a placement agent for Palvella's concurrent financing. Troutman Pepper Hamilton Sanders LLP served as legal counsel to Palvella. Cooley LLP served as legal counsel to the placement agents. Stifel served as the exclusive financial advisor to Pieris and Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C. served as legal counsel to Pieris. About Microcystic Lymphatic Malformations Microcystic LMs are a rare, chronically debilitating genetic disease caused by dysregulation of the phosphatidylinositol 3-kinase (PI3K)/mTOR pathway. The disease is characterized by malformed lymphatic vessels that protrude through the skin and persistently leak lymph fluid (lymphorrhea) and bleed, often leading to recurrent serious infections and cellulitis that can cause hospitalization. The natural history of microcystic LMs are persistent and progressive without spontaneous resolution, with symptoms generally worsening during life, including increases in the number and size of malformed vessels that lead to complications and lifetime morbidity. There are currently no FDA-approved treatments for the estimated more than 30,000 diagnosed patients with microcystic LMs in the United States. About Palvella Therapeutics Founded and led by rare drug disease drug development veterans, Palvella Therapeutics (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORINTM platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORINTM 3.9% rapamycin anhydrous gel (QTORINTM rapamycin), is currently in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations (microcystic LMs) and a Phase 2 trial in cutaneous venous malformations. For more information, please visit www.palvellatx.com or follow the Company on LinkedIn. QTORINTM rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency. This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella and Pieris, as well as assumptions made by, and information currently available to, management of Palvella and Pieris. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, the sufficiency of the combined company’s capital resources; the combined company’s cash runway; the expected timing of the closing of the proposed transactions; statements regarding the potential of, and expectations regarding, Palvella’s programs, including QTORINTM rapamycin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity; the expected timing of initiating, as well as the design of Palvella’s Phase 2 clinical trial of QTORINTM rapamycin in cutaneous venous malformations. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the limited operating history of each company; the significant net losses incurred since inception; the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORINTM rapamycin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of the global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella and Pieris to protect their respective intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Pieris’ most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC, as well as the registration statement on Form S-4 filed with the SEC by Pieris in connection with the merger. Palvella and Pieris can give no assurance that the conditions to the proposed transactions will be satisfied. Except as required by applicable law, Palvella and Pieris undertake no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. Palvella Therapeutics Contact Information Investors Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media Stephanie Jacobson Managing Director, Argot Partners palvella@argotpartners.com
EMPOLI, Italy (AP) — Scotland international Che Adams scored from almost the halfway line as Torino ended a run of poor form to win at Empoli 1-0 in Serie A on Friday. Adams replaced Antonio Sanabria in the 64th minute and made his mark almost immediately. With 70 gone, he spotted the Empoli goalkeeper off his line and lobbed the ball over his head from inside the center circle. The goal ended his personal eight-game drought in spectacular fashion, and will ease pressure on coach Paolo Vanoli. The Turin club was unbeaten in its first five league games and topped the table for a time. But it has won only one of 10 games since, back in late October. Friday's win lifted Torino into 12th place, two places and three points behind Empoli. AP soccer: https://apnews.com/hub/soccerMAA Announces Regular Quarterly Preferred DividendNone
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