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NoneIf you purchase an independently reviewed product or service through a link on our website, Rolling Stone may receive an affiliate commission. As we watched acrobats twirl and twist across the air, committing to gravity-defying feats amidst the backdrop of elaborate sets — a full-sized pirate ship, two story-tall books opening their pages — all I can think back to is the pre-show of this performance of Cirque du Soleil ‘s JOYÁ : three seasoned musicians, humbly spotlit on the stage, simply performing the son cubano classic, “Chan-Chan”. One of the most underrated aspects of Cirque du Soleil performances are the soundtracks, unless of course, you’re attending one of their more popular jukebox musical-style residencies ( Love , Viva Elvis , and Michael Jackson: The Immortal World Tour , specifically). It’s easy to understand why — I was captivated at first sight by the lush Mayan jungle environment of VidantaWorld Riviera Maya’s theater , where JOYÁ enjoys its residency. Ambient bird calls play over the speakers, blue jellyfish-shaped lights hung from the ceiling, while vines twist and encroach on an old professor’s expansive study on stage. But as the official show started after dinner, it would be hard not to note the musicians who become almost part of the story’s set themselves, stepping in the background, yet visible at all times. Shows like JOYÁ are a shot of pure, concentrated energy, and worthy traveling miles to witness — the live music is a part of that. From original compositions, to “world” beats (a nebulous genre, yet given CdS’s international presence and influence, feels like an apt descriptor), the conception of the score is almost as important as crafting the narrative of the show itself, according to Executive Vice Chairman and former Cirque du Soleil CEO, Daniel Lamarre. “It’s very important, and I would say that it’s one of the elements that make our shows unique. We think of the music almost like a movie, but even more so, because the performers are part of the cast of characters, playing live.” This brings new creative challenges when producing a fresh concept — continuing a decade-long partnership with Grupo Vidanta, their latest show LUDÕ is set to premiere next year solely at VidantaWorld’s BON in Nuevo Vallarta, Mexico (which will also house the world’s first luxury theme park, opening in 2026). LUDÕ (from the Latin word for “I play”) is more than just a show — it’s an ambitious fusion of live music, acrobatics, and gourmet dinner theater. Set in a cutting-edge, 696-seat custom theater, we’re told that “water flows through every aspect of the story”, similar to their long-running show O in Las Vegas . However this aquatic-themed theater will feature a wrap-around aquarium, with advanced acoustics that were made to compliment the “dreamlike” score and fill the unique space. Editor’s picks The 100 Best TV Episodes of All Time The 250 Greatest Guitarists of All Time “The score was written with the idea in mind to envelop the performers, as if you, yourself, were underwater,” explains Lamarre. “The only element that we had to be careful about when it came to the music was how it complimented the human performing acts. It was very important that we built some good, basic energy, because there are some comedic acts. The pacing is something that is very important, and we accentuate pacing here because the music is there to sustain the narrative.” The process of choreographing the show was also different due to the nature of the circular, aquarium-esque element of the show. “It took some guts [Laughs]. Just as an example, we’ve seen a lot of aquariums, right? And they’re all flat, right? So here, we will have a glass wall that is surrounding the theater, so just the technology to make sure that would work and that the water won’t leak was a challenge.” However, he says their experience with producing the water elements in O did make a difference. “If you go below the stage basin [at O in Las Vegas ], you can see what’s happening in the pool. It’s a show in and of itself. But we always said to each other, maybe one day we should do something that the public can appreciate. And it’s different skills you have to look for in performers, but it’s worth it.” Related Content Sabrina Carpenter's Espresso Martini Kit Is Back in Stock, Just in Time for Her New 'Nonsense Christmas' Special I Never Regretted Buying This Espresso Machine — Until It Went On Sale Monday Night Football Livestream: How to Watch Bengals vs. Cowboys Game Online Five Holiday Outfit Ideas for Men, Starting At Less Than $150 While that doesn’t mean we expect to see, say, a violin quartet playing underwater (or will we? Specific show details are being kept heavily under wraps), Lamarre does make it clear that similar to other former Cirque du Soleil productions, live music will be another integral part of LUDÕ. “We are probably one of the largest companies in term of hiring musicians, because all of our musical performances are live. You know, a lot of circus shows play with a [soundtrack] tape, and we’ve never done that. We didn’t want to anyways, because we like the idea that the musicians are part of the show. You can feel their energy, and they become part of the room. In our new show, we integrate our musicians in a unique way because, again, that’s something unique to Cirque.” Opening in Nov. 2025, LUDÕ will officially kick off with over 300 planned shows per year, and the only way you’ll be able to see it is at VidantaWorld’s Nuevo Vallarta resort. Whether you’re a Cirque enthusiast, or just see it as an added entertainment bonus to staying at one of the best luxury travel destinations in Mexico, it’s definitely set to become a must-see attraction. VidantaWorld is even offering exclusive vacation packages early next year for LUDÕ so guests can get a closer look into the artistry and technical innovations behind the scenes (package info will become available in early 2025, with priority access for VidantaWorld newsletter subscribers starting in February). Pre-sale sign-ups for dinner show tickets are now live on cirquedusoleil.com/ludo , so be sure to snag those seats before your next trip.Taylor Swift makes surprise visit to Kansas City children's hospital
LOS ANGELES — The locker room after the Rams’ 37-20 loss to the Philadelphia Eagles was as quiet as any this season. Players shouldered blame in quiet, shorts responses to reporters’ questions before filing out and into the night. As they dissected what had just happened, the Rams (5-6) also looked ahead and stated they could not afford for this game to spiral into the next game, which is Sunday’s matchup with the New Orleans Saints (4-7). “Just make sure you turn the page. Obviously, there are things that we want to correct from the game and find ways to be better moving forward, but make sure that we come out with great energy today. It starts today,” Rams quarterback Matthew Stafford said before Wednesday’s practice. “There are going to be things we want to clean up from practice, make sure we do that and move on day-to-day with the right attitude and the right spirit.” As the Rams have gone about making those corrections, a consistent word has come to mind: Consistency. Asked what he’s looking for from the defense Sunday after its worst performance since the early weeks of the season, head coach Sean McVay used that word. He spoke about playing as a unit, sticking to assignments, coverage and pass rush complementing each other. Then he added with a smile, “Same things I’m looking for on the defense would be exactly how I would answer your offensive question as well.” Even 11 games into the season, we still haven’t seen the Rams offense perform with the type of consistency you would expect from a group with this much talent. Against the Eagles, the Rams moved the ball well in the first quarter, reaching the red zone twice without needing a third down. But any momentum was quickly lost with a 10-play second quarter that resulted in a loss of six yards. It was the same story a week before, with the offense blazing in the second and third quarters against the Patriots while going nowhere in the first and fourth quarters. “It’s kind of the word ‘consistency’ right now,” Rams offensive coordinator Mike LaFleur said. “There are times where it feels like we go right down the field and put it in, and there are other times where it just feels a little bit harder than it should. I think that’s the biggest key right now.” The defense is facing a similar obstacle. The Rams are among the best in the NFL at holding teams without a touchdown in the red zone, limiting opponents to a 48.8% success rate. That ranks eighth in the league, but the flip side is that the Rams allow teams 3.7 trips into the red zone per game, which is tied for 28th. Defensive tackle and captain Kobie Turner raised the issue of allowing too many long drives following the Eagles loss, and defensive coordinator Chris Shula agreed with the assessment. “Some of that, especially the other night, they were in third downs a decent amount of time and it was a third and favorable,” Shula said. “Then, finding a way to get stops, finding a way to play, get them off track, get them into 2nd-and-longs where you get those 3rd-longs, and you can earn the right to rush the passer.” Entering Week 13, it’s not encouraging that the Rams are still struggling to find consistency in their execution. But to this point, it hasn’t upended their season. The wild card might be out of reach, but the NFC West title is still up for grabs. But that starts with a road win against a Saints team playing with nothing to lose. “We know that it’s going to be a great challenge, especially at their place. It’ll be rocking atmosphere and environment with the holidays and the momentum they have,” McVay said. “We’ve a lot of guys that are experiencing things for the first time. I have seen the resolve of this group show itself. Now, we’ve to do it.” When: 1:05 p.m. Sunday Where: Superdome, New Orleans TV/radio: FOX (Ch. 11)/710 AM; 93.1 FM; 1330 AM (Spanish); Sirius 382, 226
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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 [email protected] Media Stephanie Jacobson Managing Director, Argot Partners [email protected]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 [email protected] Media Stephanie Jacobson Managing Director, Argot Partners [email protected]Gwyneth Paltrow and Chris Martin’s Daughter Apple Wears Valentino Dress That Took 750 Hours to Make for Le Bal Debut
Police arrested a 26-year-old man on Monday in the Manhattan killing of UnitedHealthcare’s CEO after they say a Pennsylvania McDonald's worker alerted authorities to a customer who resembled the suspected gunman. The suspect, identified by police as Luigi Nicholas Mangione, had a gun believed to be the one used in Wednesday’s attack on Brian Thompson , as well as writings expressing anger at corporate America, police said. Here are some of the latest developments in the investigation: Where was the man captured? Mangione was taken into custody at around 9:15 a.m. after police received a tip that he was eating at a McDonald’s in Altoona, Pennsylvania, about 85 miles (137 kilometers) east of Pittsburgh, police said. Mangione was being held in Pennsylvania on gun charges and will eventually be extradited to New York to face charges in connection with Thompson’s death , said NYPD Chief of Detectives Joseph Kenny. What evidence did police find? In addition to a three-page, handwritten document that suggests he harbored “ill will toward corporate America,” Kenny said Mangione also had a ghost gun, a type of weapon that can be assembled at home and is difficult to trace. Officers questioned Mangione, who was acting suspiciously and carrying multiple fraudulent IDs, as well as a U.S. passport, New York Police Commissioner Jessica Tisch said at a news conference. Officers also found a sound suppressor, or silencer, “consistent with the weapon used in the murder,” the commissioner said. He had clothing and a mask similar to those worn by the shooter and a fraudulent New Jersey ID matching one the suspect used to check into a New York City hostel before the shooting, Tisch said. What do we know about Mangione? Kenny said Mangione was born and raised in Maryland, has ties to San Francisco and that his last known address is in Honolulu. Mangione, who was valedictorian of his Maryland prep school, earned undergraduate and graduate degrees in computer science in 2020 from the University of Pennsylvania, a university spokesman told The Associated Press on Monday. He learned to code in high school and helped start a club at Penn for people interested in gaming and game design, according to a 2018 story in Penn Today, a campus publication. His social media posts also suggest that he belonged to the fraternity Phi Kappa Psi. They also show him taking part in a 2019 program at Stanford University, and in photos with family and friends at the Jersey Shore and in Hawaii, San Diego, Puerto Rico, and other destinations. The Gilman School, from which Mangione graduated in 2016, is one of Baltimore’s elite prep schools. Some of the city’s wealthiest and most prominent people, including Orioles legend Cal Ripken Jr., have had children attend the school. Its alumni include sportswriter Frank Deford and former Arizona Gov. Fife Symington. In his valedictory speech, Luigi Mangione described his classmates’ “incredible courage to explore the unknown and try new things,” according to a post on the school website. He praised their collective inventiveness and pioneering mindset. Mangione took a software programming internship after high school at Maryland-based video game studio Firaxis, where he fixed bugs on the hit strategy game Civilization 6, according to a LinkedIn profile. Firaxis parent company Take-Two Interactive said Monday it would not comment on former employees. He more recently worked at the car-buying website TrueCar, according to the head of the Santa Monica, California-based company. “While we generally don’t comment on personnel matters, we confirm that Luigi Mangione has not been an employee of our company since 2023,” TrueCar CEO Jantoon Reigersman said by email. Mangione comes from a prominent Maryland family. His grandfather Nick Mangione, who died in 2008, was a successful real estate developer. One of his best-known projects was Turf Valley Resort, a sprawling luxury retreat and conference center outside Baltimore that he purchased in 1978. The father of 10 children, Nick Mangione prepared his five sons — including Luigi Mangione’s father, Louis Mangione — to help manage the family business, according to a 2003 Washington Post report. The Mangione family also purchased Hayfields Country Club north of Baltimore in 1986. On Monday, Baltimore County police officers blocked off an entrance to the property, which public records link to Luigi Mangione’s parents. Reporters and photographers gathered outside the entrance. Luigi Mangione is one of 37 grandchildren of Nick Mangione, according to the grandfather's obituary. Luigi Mangione's grandparents donated to charities through the Mangione Family Foundation, according to a statement from Loyola University commemorating Nick Mangione’s wife’s death in 2023. They donated to various causes ranging from Catholic organizations to colleges and the arts. One of Luigi Mangione’s cousins is Republican Maryland state legislator Nino Mangione, a spokesman for the lawmaker's office confirmed Monday. The shooting and a quick escape Police said the person who killed Thompson left a hostel on Manhattan's Upper West Side at 5:41 a.m. on Wednesday. Just 11 minutes later, he was seen on surveillance video walking back and forth in front of the New York Hilton Midtown, wearing a distinctive backpack. At 6:44 a.m., he shot Thompson at a side entrance to the hotel, fled on foot, then climbed aboard a bicycle and within four minutes had entered Central Park. Another security camera recorded the gunman leaving the park near the American Museum of Natural History at 6:56 a.m. still on the bicycle but without the backpack. After getting in a taxi, he headed north to a bus terminal near the George Washington Bridge, arriving at around 7:30 a.m. From there, the trail of video evidence runs cold. Police have not located video of the suspect exiting the building, leading them to believe he likely took a bus out of town. Police said they are still investigating the path the suspect took to Pennsylvania. “This just happened this morning," Kenny said. "We’ll be working, backtracking his steps from New York to Altoona, Pennsylvania,” Kenny said. Associated Press reporters Lea Skene in Baltimore, Matt O'Brien in Providence, Rhode Island, and Cedar Attanasio in New York contributed to this report. Copyright 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission. The business news you need Get the latest local business news delivered FREE to your inbox weekly.Gemini – (21st May to 20th June) Monthly Horoscope Prediction says, discover New Horizons and Fresh Opportunities This month promises excitement and transformation for Gemini. Harness your curiosity to explore new relationships and professional endeavors. December brings Gemini a wave of fresh energy and opportunity. It's a perfect time for you to connect with others, innovate at work, and manage your finances wisely. Stay attentive to your health by balancing activity and rest, ensuring you remain vibrant throughout the month. Gemini Love Horoscope This Month This month, your social skills shine brightly, making it an excellent time for deepening existing relationships or meeting new potential partners. Single Geminis might find someone intriguing, while those in relationships will feel a renewed sense of intimacy. Communication is key, so express your feelings openly and listen attentively. Social gatherings and festive events could present exciting opportunities to connect on a deeper level. Keep your heart open to the possibilities that December holds. Gemini Career Horoscope This Month Your career takes a dynamic turn this December. You're likely to encounter opportunities that require quick thinking and adaptability. Colleagues may seek your insights, as your innovative ideas are in high demand. Networking can open doors to new ventures, so engage actively with peers and superiors. This month, showcase your skills and take initiative in projects, as it could lead to promising advancements. Stay focused and maintain a positive attitude to navigate challenges successfully. Gemini Money Horoscope This Month Financially, December encourages prudent decision-making for Geminis. Consider reviewing your budget and identifying areas where you can save. Investments may yield positive results, but it's important to research thoroughly before committing. Avoid impulsive spending and prioritize your long-term financial goals. Collaboration with a financial advisor or trusted friends could provide valuable insights. By staying disciplined and organized, you'll ensure a stable and secure financial footing for the months to come. Gemini Health Horoscope This Month Your health is generally strong this month, but it's essential to find a balance between work and relaxation. Incorporate regular physical activity into your routine, whether through exercise or leisurely walks. Be mindful of your diet and stay hydrated, especially during holiday gatherings. Stress management techniques, like meditation or yoga, can help maintain mental well-being. Remember to listen to your body and get adequate rest. Prioritizing self-care will keep your energy levels high and spirits lifted. Gemini Sign Attributes Strength: Insightful, Wise, Smart, Pleasant, Quick-witted, Charming Weakness: Inconsistent, Gossipy, Lazy Symbol: Twins Element: Air Body Part: Arms & Lungs Sign Ruler: Mercury Lucky Day: Wednesday Lucky Color: Silver Lucky Number: 7 Lucky Stone: Emerald Gemini Sign Compatibility Chart Natural affinity: Aries, Leo, Libra, Aquarius Good compatibility: Gemini, Sagittarius Fair compatibility: Taurus, Cancer, Scorpio, Capricorn Less compatibility: Virgo, Pisces By: Dr. J. N. Pandey Vedic Astrology & Vastu Expert Website: www.astrologerjnpandey.com E-mail: djnpandey@gmail.com Phone: 91-9811107060 (WhatsApp Only)
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