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2025-01-25
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jili games apk latest version The State Board of Education has the use of lessons in public elementary schools. Officials voted 8-7 on the measure during a hearing in Austin on Friday. The new curriculum, developed by Bluebonnet Learning and the Texas Education Agency, pertains to reading and language arts lessons for kids in grades K-5 and math lessons for kids in grades K-8. The teachings call into question the constitutionally of such tax-payer-funded instruction. It remains unclear if the curriculum would violate the Establishment Clause in the First Amendment, which prohibits the government from establishing a or providing official support for a religion. The instruction includes lessons on Biblical beliefs, including the stories of Moses, the Good Samaritan, the Golden Rule and readings from the Book of Genesis. The curriculum is optional but schools could get additional funding if they implement the teachings, set to be available to educators in August 2025. Its approval is the latest development in a series of GOP efforts to bring Christianity into public school systems across the country. In Oklahoma, the state’s top educator, Ryan Walters, has ordered teachers to keep a copy of the Bible in classrooms. In Louisiana, officials hope to post the Ten Commandments in classrooms starting next year. Critics of the new Texas instruction raised concerns about how the lessons could inappropriately promote the Christian faith in classrooms, whether the materials are age-appropriate or will be effective. Those who support it, say the lessons could help develop students’ writing and reading skills. Following the vote, the Texas American Federation of Teachers said in a that the new teachings violate the state’s Code of Ethics by “infusing lessons with Bible-based references more appropriate for Sunday Schools than public schools.” The group argues the new teachings come from idealogues instead of educational experts and is asking districts not to use them. “At a moment of profound political division, this curriculum is a concerted effort to ‘other’ and exclude students of differing cultures and religions through state-sponsored instructional materials. “It is the latest evidence that Christian nationalists have bought their way into every governing body of the state, including the state Board of Education... We can anticipate what will come next, whether that’s the erasure of contributions of marginalized populations in social studies or the minimalization of climate change in science.” President-elect has called for the disbandment of the federal Department of Education, for a more conservative agenda in public schools and for banning educators from teaching on critical race theory. In 2023, Governor Greg Abbott asked the Texas Education Agency to develop a new curriculum pending approval from the state Board of Education. Abbott has praised the materials and they would help students “better understand the connection of history, art, community, literature, and religion on pivotal events like the signing of the US Constitution, the Civil Rights Movement, and the American Revolution.”Leak Suggests Switch 2 Will Finally Fix The Original’s Most Notorious Problem

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



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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 wes.kaupinen@palvellatx.com Media Stephanie Jacobson Managing Director, Argot Partners palvella@argotpartners.com

Remarry, Not ‘Marry Again’

Thirteen community organizations in Montreal's Ahuntsic-Cartierville borough had until 5 p.m. Friday to vacate their long-time home, but they refuse to pack up. Instead, they're fighting the eviction, which was ordered by the building's owner, the (CSSDM). The school service centre has been renting the space to the organizations for about 20 years, but now plans to use the property for a French-language learning centre Among the groups being evicted is (SNAC), which offered food assistance to 1,970 households over the last year, feeding nearly 4,000 people from their location in the C on Laverdure Street There is also an organization that supports people dealing with addiction, homelessness and mental health issues. There's a daycare and , a youth advocacy group, as well. There's even a francisation centre already on site, offering French-language classes. There are services for seniors, a meals-on-wheels program and educational services, too, said Rémy Robitaille, head of , the council representing the groups getting evicted "We won't move from here, even if they told us to move at 5 p.m. tonight," he said, noting the community groups are challenging the eviction in court. The organizations say they have nowhere to relocate after months of struggling to find something affordable. Rémy Robitalle, head of Solidarité Ahuntsic, said the eviction saga has dragged on since 2022, beginning with a 200 per cent rent increase. (Gabriel Guindi/CBC) The landlord, the CSSDM, said in a statement Friday that it is facing a sustained increase in educational needs in the Ahuntsic-Cartierville sector, particularly for francisation programs offered in adult education. At the same time, the , which houses the CSSDM's current francisation centre, is being renovated and the the programming there needs to be relocated to the , the statement said "To fulfil our primary mission of providing education and to avoid a service disruption in the absence of any other facility capable of accommodating all our students, we are compelled to reclaim full possession of the building," it said. Given Solidarité Ahuntsic's repeated refusals, since 2018, to sign a lease with the CSSDM, the organizations are currently occupying the premises under a month-to-month tolerance lease, the statement added. The eviction is a lawful step, the CSSDM said, and legal proceedings are ongoing. The council has refused rent increases for six years while the school service centre continues to pay electricity, heat and maintenance, it said. Several politicians have condemned the decision to force the groups out, including MNA Haroun Bouazzi, who represents the Maurice-Richard riding, which includes parts of Ahuntsic-Cartierville and Montréal-Nord. Bouazzi has called the eviction a disaster for the neighbourhood's social and community safety net, noting that 25,000 people rely on the organizations' services each year. Bouazzi is urging the (CAQ) government to intervene and grant a reprieve. He has been lobbying for the government to delay the eviction since the spring. Along with a petition, he submitted a detailed demand to the government, explaining the urgency of the situation, but said the only response he got was one deferring responsibility to the CSSDM. The CSSDM argues the eviction is necessary to provide French courses, but Bouazzi points out that French-language programming is already available there. Efforts to delay the eviction for three years have been supported by Ahuntsic-Cartierville borough mayor Émilie Thuillier and federal MP Mélanie Joly, who represents the riding of Ahuntsic-Cartierville. The three-year reprieve would allow the organizations to relocate to a new facility in the Écoquartier Louvain, a social development planned for the borough but for which construction has not begun. The development, which will include 800 to 1,000 housing units, is expected to accommodate co-operatives and a shared space for community groups as well. "All the community organizations will have a place together in the new centre, but we need time to build it," Thuillier said. In the meantime, officials are urging the Quebec government to give the CSSDM more funds so it can find more suitable premises for the francisation centre it wants to create. Bouazzi said the building is very old and that, before it can be used as a learning centre, it would need extensive renovations that would take four years — longer than the community groups need to relocate. The Centre communautaire d'Ahuntsic houses 13 community organizations, all of which are facing eviction. (Julie Marceau/Radio-Canada) "I have a hard time thinking that this government will destroy the social mesh we have here," he said. "I am sure that what they want is noble and positive, but now that we understand the consequences, we have to stop this madness." Robitaille noted that the groups' trouble with their landlord began in 2022, when the CSSDM increased their rent by 200 per cent. The organizations attempted to refuse the rent increase, but the CSSDM threatened to sell the building. When the organizations offered to buy it, the service centre instead opted to retake it for educational purposes. Robitaille said it's not clear to him why the CSSDM wants to evict the organizations so soon. "It's strange they want to remove the francisation courses that we already give to around 400 people a year," he said, noting the renovations to get the building up to code will be costly, but the government has been cutting back on subsidies for . The Ministry of Education issued a statement Friday afternoon, saying the CSSDM owns the building and is responsible for its use, including surplus properties. "If the CSSDM needs the space for students, the educational mission must always take priority," the ministry said.Stock market today: Wall Street slips as technology stocks drag on the market

President-elect Donald Trump announced Friday he would work to end the "inconvenient" custom of moving clocks forward one hour every spring, which he said was imposing an unnecessary financial burden on the United States. "The Republican Party will use its best efforts to eliminate Daylight Saving Time, which has a small but strong constituency, but shouldn't! Daylight Saving Time (DST) is inconvenient, and very costly to our Nation," Trump posted on his website, Truth Social. DST was adopted by the federal government during World War I but was unpopular with farmers rushing to get produce to morning markets, and was quickly abolished. Many states experimented with their own versions but it wasn't reintroduced nationwide until 1967. The Democratic-controlled US Senate advanced a bill in 2022 that, like Trump's plan, would bring an end to the twice-yearly changing of clocks, in favor of a "new, permanent standard time." But The Sunshine Protection Act called for the opposite switch -- moving permanently to DST rather than eliminating it -- to usher in brighter evenings, and fewer journeys home in the dark for school children and office workers. The bill never made it to President Joe Biden's desk, as it was not taken up in the Republican-led House. It had been introduced in 2021 by a Republican, Florida Senator Marco Rubio, who is about to join the incoming Trump administration as secretary of state. He said studies had shown a permanent DST could benefit the economy. Either way, changing to one permanent time would put an end to Americans pushing their clocks forward in the spring, then setting them back an hour in the fall. Colloquially the practice is referred to as "springing" forward and "falling" back. The clamor has increased in recent years to make DST permanent especially among politicians and lobbyists from the Northeast, where frigid conditions are normal in the early winter mornings. "It's really straightforward. Cutting back on the sun during the fall and winter is a drain on the American people and does little to nothing to help them," Rubio said in a statement ahead of the vote. "It's time we retire this tired tradition." Rubio said the United States sees an increase in heart attacks and road accidents in the week that follows the changing of the clocks. Any changes would be unlikely to affect Hawaii and most of Arizona, the Navajo Nation, American Samoa, Guam, the Northern Mariana Islands, Puerto Rico and the US Virgin Islands, which do not spring forward in summer. ft/nro

VST Tillers Tractors targets ₹2,000 crore revenue by FY26; eyes 20% growth in FY25

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