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MIAMI--(BUSINESS WIRE)--Dec 13, 2024-- FAIRHOLME FUNDS, INC. THE FAIRHOLME FUND (FAIRX) On December 13, 2024, the Fairholme Fund (NASDAQ: FAIRX) distributed an Ordinary Income dividend of $0.21078 per share to shareholders of record as of December 12, 2024. The Fairholme Fund’s Net Asset Value (“NAV”) was reduced by the total amount of the distribution. The Record Date, Ex-Dividend Date, Payable Date, and Cents-Per-Share are as follows: Distribution Type Record Date Ex-Dividend Date Payable Date Cents-Per-Share Ordinary Income December 12, 2024 December 13, 2024 December 13, 2024 $0.21078 Total $0.21078 THE FAIRHOLME FOCUSED INCOME FUND (FOCIX) On December 13, 2024, the Fairholme Focused Income Fund (NASDAQ: FOCIX) distributed an Ordinary Income dividend of $0.06767 per share to shareholders of record as of December 12, 2024. The Fairholme Focused Income Fund’s Net Asset Value (“NAV”) was reduced by the total amount of the distribution. The Record Date, Ex-Dividend Date, Payable Date, and Cents-Per-Share are as follows: Distribution Type Record Date Ex-Dividend Date Payable Date Cents-Per-Share Ordinary Income December 12, 2024 December 13, 2024 December 13, 2024 $0.06767 Total $0.06767 Past performance is not a guarantee of future results. Investing in the Funds involves risks including loss of principal. The Funds’ investment objectives, risks, charges, and expenses should be considered carefully before investing. The prospectus contains this and other important information about the Funds, and it may be obtained by calling Shareholder Services at (866) 202-2263 or visiting our website www.fairholmefunds.com . Read it carefully before investing. The Fairholme Fund is non-diversified, which means that The Fairholme Fund invests in a smaller number of securities when compared to more diversified funds. Therefore, The Fairholme Fund is exposed to greater individual stock volatility than a diversified fund. The Fairholme Fund also invests in foreign securities which involve greater volatility and political, economic and currency risks and differences in accounting methods. The Fairholme Fund may also invest in “special situations” to achieve its objectives. These strategies may involve greater risks than other fund strategies. The Fairholme Focused Income Fund (the “Income Fund”) is a non-diversified mutual fund, which means that the Income Fund invests in a smaller number of securities when compared to more diversified funds. This strategy exposes the Income Fund and its shareholders to greater risk of loss from adverse developments affecting portfolio companies. The Income Fund’s investments are also subject to interest rate risk, which is the risk that the value of a security will decline because of a change in general interest rates. Investments subject to interest rate risk will usually decrease in value when interest rates rise and rise in value when interest rates decline. Also, securities with long maturities typically experience a more pronounced change in value when interest rates change. Debt securities are subject to credit risk (potential default by the issuer). The Income Fund may invest without limit in lower-rated securities. Compared to higher-rated fixed income securities, lower-rated debt may entail greater risk of default and market volatility. Foreside Funds Distributors LLC (12/24) View source version on businesswire.com : https://www.businesswire.com/news/home/20241213557386/en/ CONTACT: Fairholme Funds, Inc. Jodi Lin, 305-358-3000 KEYWORD: FLORIDA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: COMMUNICATIONS PROFESSIONAL SERVICES PUBLIC RELATIONS/INVESTOR RELATIONS FINANCE SOURCE: Fairholme Funds, Inc. Copyright Business Wire 2024. PUB: 12/13/2024 05:30 PM/DISC: 12/13/2024 05:32 PM http://www.businesswire.com/news/home/20241213557386/en
The International Criminal Court issued arrest warrants on Thursday for Israeli Prime Minister Benjamin Netanyahu, his former defense minister and a Hamas military leader, accusing them of war crimes and crimes against humanity. The announcement came as health officials in the Gaza Strip said the death toll from the 13-month-old war between Israel and Hamas has surpassed 44,000. The warrant marked the first time that a sitting leader of a major Western ally has been accused of war crimes and crimes against humanity by a global court of justice. The ICC panel said there were reasonable grounds to believe that both Netanyahu and his ex-defense minister bear responsibility for the war crime of starvation and the crimes against humanity of murder, persecution and other inhumane acts. Israel’s war has caused heavy destruction across Gaza, decimated parts of the territory and driven almost the entire population of 2.3 million people from their homes, leaving most dependent on aid to survive. Israel launched its war in Gaza after Hamas-led militants stormed into southern Israel on Oct. 7, 2023, killing some 1,200 people, mostly civilians, and abducting another 250 . Around 100 hostages are still inside Gaza, at least a third of whom are believed to be dead. Here’s the Latest: UNITED NATIONS -- The U.N. humanitarian chief for Gaza is warning that the delivery of critical food, water, fuel and medical supplies is grinding to a halt throughout the territory and “the survival of two million people hangs in the balance.” Muhannad Hadi said in a statement Thursday that Israeli authorities have been banning commercial imports for more than six weeks and at the same time thefts from humanitarian convoys by armed individuals have surged. “In 2024, U.N. trucks have been looted 75 times –- including 15 such attacks since Nov. 4 alone –- and armed people have broken into U.N. facilities on 34 occasions,” he said. Last week, one driver was shot in the head and hospitalized along with another truck driver, Hadi said. And on Saturday 98 trucks were looted in a single attack which saw the vehicles damaged or stolen. The Gaza humanitarian coordinator said bakeries are closing because of lack of flour or fuel to operate generators. “Palestinian civilians are struggling to survive under unlivable conditions, amid relentless hostilities,” Hadi said. He demanded the immediate improvement of security and conditions throughout Gaza to allow the safe and unimpeded delivery of humanitarian aid “through lawful means.” Israel says it puts no limit on the supplies permitted into Gaza, and it blames the U.N. distribution system. But Israel’s official figures show the amount of aid it has let in has plunged since the beginning of October. The U.N has blamed Israeli military restrictions, along with widespread lawlessness that has led to theft of aid shipments. WASHINGTON — The White House fundamentally rejects the International Criminal Court’s decision to issue arrest warrants for senior Israeli officials, press secretary Karine Jean-Pierre said Thursday. She said the Biden administration was “deeply concerned by the prosecutor’s rush to seek arrest warrants and the troubling process errors that led to this decision.” The Biden administration has increased its warnings and appeals to Israeli Prime Minister Benjamin Netanyahu to do more to spare civilians in airstrikes and other attacks, and to allow more aid to reach Gaza. However, a 30-day Biden administration deadline came and went earlier this month for Israel to meet specific U.S. targets to improve its treatment of Palestinian civilians in Gaza trapped in the war. U.S. demands included that Israel lift a near-total ban on delivery of aid to hard-hit north Gaza for starving civilians there. KHAN YOUNIS, Gaza Strip — The three children were playing outside a cluster of tents housing displaced people in the Gaza Strip when an Israeli airstrike killed them, along with six other people. It’s become a grim, near-daily ritual more than 13 months into the Israel-Hamas war, which local health authorities said Thursday has killed over 44,000 Palestinians. Israel carries out frequent strikes against what it says are militants hiding in civilian areas, and women and children are nearly always among the dead. Wednesday’s strike killed Hamza al-Qadi, 7, his brother Abdulaziz, 5, and their sister Laila, 4, in a tent camp in the southern city of Khan Younis. Areej al-Qadi, their mother, says they were playing outside when they were killed. “All that’s left of them are their notebooks, their books and a blood-stained jacket,” she said as she broke into tears. “They were children who did nothing.” The Israeli military did not respond to a request for comment on the strike. Gaza’s Health Ministry said Thursday that 44,056 Palestinians have been killed and 104,268 wounded since the start of the war, which was ignited by Hamas’ Oct. 7 attack into Israel. Palestinian militants killed some 1,200 people that day, mostly civilians, and abducted around 250 people. The Health Ministry does not say how many of those killed in Gaza were fighters but says women and children make up more than half the fatalities. Israel, which rarely comments on individual strikes, says it has killed over 17,000 militants, without providing evidence. Hours after the ministry announced the latest toll, the International Criminal Court issued arrest warrants against Israeli Prime Minister Benjamin Netanyahu, his former defense minister and a Hamas military leader. Mahmoud bin Hassan, the children’s father, said he buried them on Thursday. He asked when the international community would take action to stop the war. “When the entire Palestinian population has been killed?” he said. NEW YORK — Human Rights Watch applauded the International Criminal Court's arrest warrants issued Thursday against both Israeli and Hamas officials. The warrants “break through the perception that certain individuals are beyond the reach of the law,” the associate international justice director at Human Rights Watch, Balkees Jarrah, said in a statement. The New York-based rights group earlier this month released a report saying Israel has committed war crimes and crimes against humanity in the Gaza Strip, including massive forced displacements that amount to ethnic cleansing. JERUSALEM — Israeli prosecutors have charged a former aide to Prime Minister Benjamin Netanyahu with leaking classified documents to international media, apparently to protect the Israeli leader from criticism as a hostage deal was collapsing. Eli Feldstein, a former media adviser to Netanyahu, was charged Thursday with leaking classified information with the intent of harming state security and obstruction of justice. The leaked documents are said to have formed the basis of a widely discredited article in the London-based Jewish Chronicle — which was later withdrawn — suggesting Hamas planned to spirit hostages out of Gaza through Egypt, and an article in Germany’s Bild newspaper that said Hamas was drawing out the hostage talks as a form of psychological warfare on Israel. Critics say the leaks were aimed at giving Netanyahu political cover as the case-fire talks ground to a halt. Some have accused Netanyahu of resisting a deal in to preserve his governing coalition, which includes hard-line members who have threatened to bring down the government if he makes concessions to Hamas. The leaks came at a time of public uproar over the deaths of six hostages who were killed by their Hamas captors as Israeli soldiers were closing in. The indictment said the leaks were meant “to create media influence on the public discourse in Israel in regards to the handling of the hostage situation, after the news of the murder of six hostages.” The indictment identified two other Netanyahu aides as being connected to the scheme, but only Feldstein and an unidentified reservist in Israeli military intelligence were charged. Netanyahu, who denies the accusations, has not been identified as a suspect in the burgeoning investigation. Israeli media say if convicted, Feldstein could potentially face life in prison. JERUSALEM -- The Israeli military has launched an investigation into the death of a 70-year-old Israeli man who entered Lebanon with Israeli forces and was killed in a Hezbollah ambush. Investigators are trying to determine, among other things, who allowed Zeev Erlich into the combat zone with the forces and why he was permitted to enter. According to Israeli media reports, Erlich was not on active duty when he was shot, but was wearing a military uniform and had a weapon. The army said he was a reservist with the rank of major and identified him as a “fallen soldier” when it announced his death. Erlich was a well-known West Bank settler and researcher of Jewish history. Media reports said Erlich was permitted to enter Lebanon to explore a local archaeological site. The army said a 20-year-old soldier was killed in the same incident, while an officer was badly wounded. The army announced Thursday that the chief of staff, Lt. Gen. Herzi Halevi, has appointed a team of experts “to examine and strengthen operational discipline and military culture” following the incident. It said its commander for northern Israel, Maj. Gen. Ori Gordin, would launch a separate “command inquiry,” while Israeli military police conduct a separate probe. Such investigations can lead to criminal charges. BEIRUT — At least 29 people were killed Thursday in Israeli strikes on different towns and villages across Lebanon, according to Lebanon’s Health Ministry and state-run media. In eastern Lebanon, Israeli airstrikes killed 26 people in six different towns in Baalbek province, the health ministry and the National News Agency said. In Tyre province, southern Lebanon, three people were killed in an Israeli strike, the health ministry said. The health ministry Wednesday said that over 3,550 people have been killed in the 13-month war between Hezbollah and Israel, the majority following Israel’s escalation in late September. The European Union's foreign policy chief has underlined that the arrest warrants issued by the International Criminal Court against Israeli Prime Minister Benjamin Netanyahu and Hamas officials are a legal and not political matter, and that they are binding on all 27 EU member countries and other signatories to the ICC to implement. “The tragedy in Gaza has to stop," Josep Borrell told reporters during a visit to Jordan. “It is not a political decision. It is the decision of an international court of justice, and the decision of the court has to be respected, and implemented.” “This decision is a binding decision on all state parties of the court, which include all members of the European Union," he added. ANKARA — Turkish President Recep Tayyip Erdogan’s ruling partyhas welcomed the decision by the International Criminal Court to issue arrest warrants against Israeli Prime Minister Benjamn Netanyahu and former Defense Minister Yoav Gallant, calling it a judgement made for the sake of “humanity.” Omer Celik, spokesman for the Erdogan’s party, said on the social media platform X that Netanyahu and Gallant would “eventually be held accountable for genocide.” Celik also criticised Israeli officials who described the ICC decision as antisemitic. Turkey is among the most vocal critics of Israel’s military actions in Gaza and has submitted a formal request to join a genocide case that South Africa has filed against Israel at the U.N.’s International Court of Justice. Dutch foreign minister Caspar Veldkamp, whose country hosts the International Criminal Court, has confirmed The Netherlands would arrest Israeli Prime Minister Benjamin Netanyahu if he arrived on Dutch soil. “The line from the government is clear. We are obliged to cooperate with the ICC ... we abide 100% by the Rome Statute,” he said in response to a question in parliament Thursday. Other European officials were more cautious. In France, a spokesman for the Foreign Ministry said he supported the International Criminal Court's prosecutor but declined to comment when asked more specifically if France would arrest Netanyahu if he were to step on French soil. “Today, combating impunity is our priority. We ratified the ICC Statute in 2000 and have consistently supported the court’s actions. Our response will align with these principles,” Christophe Lemoine told reporters at a press conference. Lemoine added that the warrants were “a complex legal issue ... It’s a situation that requires a lot of legal precautions.” In Italy, the foreign and justice ministries didn’t immediately respond to emails seeking comment about whether Italy, an ICC member which hosted the Rome conference that gave birth to the court, would honor the arrest warrant. Premier Giorgia Meloni hosted Prime Minister Benjamin Netanyahu in March 2023 and has strongly supported Israel since Oct. 7, while providing humanitarian aid for Palestinians in Gaza. JERUSALEM — Israel’s mostly ceremonial president, Isaac Herzog, has called the International Criminal Court's arrest warrants against Prime Minister Benjamin Netanyahu “a dark day for justice. A dark day for humanity.” In a post on X, he said the international court “has chosen the side of terror and evil over democracy and freedom, and turned the very system of justice into a human shield for Hamas’ crimes against humanity." Israel Katz, Israel’s new defense minister, said the decision was “a moral disgrace, entirely tainted by antisemitism, and drags the international judicial system to an unprecedented low.” He said it “serves Iran, the head of the snake, and its proxies.” Benny Gantz, a retired general and political rival to Netanyahu, also condemned the decision, saying it showed “moral blindness” and was a “shameful stain of historic proportion that will never be forgotten.” Hamas has welcomed the decision by the International Criminal Court to issue warrants against Israeli President Benjamin Netanyahu and his former defense minister Yoav Gallant, calling it an “important and historic precedent” after what it said was decades of injustice at the hands of a “fascist occupation.” The statement did not refer to the warrants issued for the militant group’s own leaders. Hamas called on all nations to “cooperate with the court in bringing the Zionist war criminals, Netanyahu and Gallant, to justice, and to work immediately to stop the crimes of genocide against innocent civilians in the Gaza Strip.” DEIR AL-BALAH, The Gaza Strip — Bakeries have reopened in the central Gaza Strip after being closed for several days because of flour shortages. The shortages appear to have been linked to the looting of nearly 100 truckloads of aid by armed men in southern Gaza last weekend. Associated Press footage showed a crowd of hundreds pushing and shouting outside a bakery in the central city of Deir al-Balah on Thursday. The day before the reopening, the price of a bag of 15 loaves of pita bread had climbed above $13. “In my house, there is not a morsel of bread, and the children are hungry,” said Sultan Abu Sultan, who was displaced from northern Gaza during the war. The amount of aid entering Gaza plunged in October as Israel launched a major offensive in the isolated north, where experts say famine may be underway . Hunger is widespread across the territory, even in central Gaza where aid groups have more access. Humanitarian organizations say Israeli restrictions, ongoing fighting and the breakdown of law and order make it difficult to deliver assistance. Israel’s offensive, launched after Hamas’ October 2023 attack, has displaced around 90% of Gaza’s population of 2.3 million people. Hundreds of thousands are crammed into tent camps with little in the way of public services and are reliant on international food aid. NICOSIA — The president of Cyprus says the European Union must play a bigger role in the Middle East as it can no longer stand by as an observer. President Nikos Christodoulides said the 27-member bloc needs to establish closer ties with countries that bolster regional stability like Egypt, Jordan and the Gulf states. “The conflict in the Middle East is taking place on the EU’s doorstep, in an area of vital interest to the bloc’s interests, where any escalation or regional spillover will have significant consequences on its security and stability,” Christodoulides told an Economist conference in the Cypriot capital. Christodoulides said EU member Cyprus for years has tried to get this message across to Brussels. The island nation earlier this year was the staging ground for a maritime corridor delivering some 20,000 tons of humanitarian aid to Gaza. The EU is wracked by members’ divisions over how peace should come about in the Middle East THE HAGUE — The International Criminal Court issued arrest warrants on Thursday for Israeli Prime Minister Benjamin Netanyahu, his former defense minister and Hamas officials, accusing them of war crimes and crimes against humanity over the war in Gaza and the October 2023 attacks that triggered Israel’s offensive in the Palestinian territory. The decision turns Netanyahu and the others into internationally wanted suspects and is likely to further isolate them and complicate efforts to negotiate a cease-fire to end the 13-month conflict. But its practical implications could be limited since Israel and its major ally, the United States, are not members of the court and several of the Hamas officials have been subsequently killed in the conflict. Netanyahu and other Israeli leaders have previously condemned ICC Chief Prosecutor Karim Khan’s request for the warrants as disgraceful and antisemitic. U.S. President Joe Biden also blasted the prosecutor and expressed support for Israel’s right to defend itself against Hamas. Hamas also slammed the request. The death toll in the Gaza Strip from the 13-month-old war between Israel and Hamas has surpassed 44,000, local health officials said Thursday. The Gaza Health Ministry does not distinguish between civilians and combatants in its count, but it has said that more than half of the fatalities are women and children. The Israeli military says it has killed over 17,000 militants, without providing evidence. The Health Ministry said 44,056 people have been killed and 104,268 wounded since the start of the war. It has said the real toll is higher because thousands of bodies are buried under rubble or in areas that medics cannot access. The war began when Hamas-led militants stormed into southern Israel on Oct. 7, 2023, killing some 1,200 people, mostly civilians, and abducting another 250 . Around 100 hostages are still inside Gaza, at least a third of whom are believed to be dead. Most of the rest were released during a cease-fire last year. Around 90% of Gaza's population of 2.3 million people have been displaced, often multiple times, and hundreds of thousands are living in squalid tent camps with little food, water or basic services. Israel says it tries to avoid harming civilians and blames their deaths on Hamas because the militants operate in residential areas, where they have built tunnels, rocket launchers and other military infrastructure. JERUSALEM — A rocket fired from Lebanon killed a man and wounded two others in northern Israel on Thursday, according to the Magen David Adom rescue service. The service said paramedics found the body of the man in his 30s near a playground in the town of Nahariya, near the border with Lebanon, after a rocket attack on Thursday. Israel meanwhile struck targets in southern Lebanon and several buildings south of Beirut, the Lebanese capital, after warning people to evacuate.
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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 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 © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.Watchdog told about fake Fine Gael social media account
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