Aadi Enters into Exclusive License for Three-Asset ADC Portfolio Developed through a Collaboration between WuXi Biologics and HANGZHOU DAC Aadi Enters Agreement to Sell FYARRO ® and Associated Infrastructure to KAKEN Pharmaceutical for $100M ; Announces PIPE Financing of $100M Cumulative Capital Expected to Fund Operations into Late 2028, Including Anticipated Clinical Data for the ADC Portfolio Co-Founder and Former CEO of ProfoundBio, Baiteng Zhao, Appointed to Aadi Board of Directors Aadi to Hold Webcast and Conference Call on December 20 at 8:00 AM EST LOS ANGELES , Dec. 19, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI) today announced it has entered into an exclusive license agreement for development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and HANGZHOU DAC BIOTECHNOLOGY CO., LTD. ( HANGZHOU DAC), a global leader in ADC innovation. Per the terms of the license agreement, Aadi is granted exclusive rights to certain patents and know-how pertaining to three preclinical ADC programs leveraging HANGZHOU DAC's CPT113 linker payload technology targeting each of Protein Tyrosine Kinase 7 (PTK7), Mucin-16 (MUC16) and Seizure Related 6 Homolog (SEZ6). Aadi will pay aggregate upfront payments of $44 million for in-licensing such ADC programs. Additionally, Aadi is obligated to pay cumulative development milestone payments of up to $265 million , cumulative commercial milestone payments of up to $540 million and single-digit royalties of sales. To support this transaction, Aadi entered into a subscription agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $100 million , before deducting placement agent fees and other offering expenses. The Company is selling an aggregate of 21,592,000 shares of its common stock ("Common Stock") at a price of $2.40 per share, representing a premium of approximately 3.4% to the closing price on December 19, 2024 on Nasdaq, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 20,076,500 shares of Common Stock at a purchase price of $2.3999 per Pre-Funded Warrant share. The syndicate was led by Ally Bridge Group, with participation from new investors OrbiMed, Invus, Kalehua Capital and other accredited investors, Tae Han co-founder of ProfoundBio, as well as existing investors, including Avoro Capital, KVP Capital and Acuta Capital Partners. The PIPE financing is expected to close in the first half of 2025, subject to stockholder vote and satisfaction of customary closing conditions. "I'm thrilled to announce our partnership with WuXi Biologics and HANGZHOU DAC to bring forward this thoughtfully selected ADC portfolio. We were deliberate in identifying broadly expressed tumor targets where first-generation ADCs have already shown proof of concept. With our next wave ADC portfolio, we aim to build upon these earlier therapies to deliver improved outcomes for people living with cancer," said David Lennon , PhD, President and CEO of Aadi Bioscience. "The financing underscores the confidence our investors have in both the potential of this portfolio and the strength of Aadi's management team." About the ADC Portfolio Each of the three ADC assets utilizes HANGZHOU DAC's CPT113 ADC platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The CPT113 platform's linker stability and novel payload has the potential to be highly competitive among the next generation ADC platforms. To effectively leverage the CPT113 platform, Aadi selected tumor targets that are upregulated in high-potential cancer indications and where clinical efficacy has been demonstrated by first-generation ADCs. These assets were discovered through the collaborative efforts of WuXi Biologics and HANGZHOU DAC, utilizing the innovative antibody discovery platform provided by WuXi Biologics and advanced linker-payload technology provided by HANGZHOU DAC. "Leveraging our advanced antibody discovery service, we're glad to enable Aadi to accelerate the discovery of precision therapies targeting some of the most challenging cancers," said Dr. Chris Chen , CEO of WuXi Biologics. "This collaboration underscores our wide recognition as an industry leader in discovery service solutions, and further validates our ability to provide integrated discovery technology platforms for global partners to develop next-generation modalities. We look forward to partnering with Aadi and HANGZHOU DAC to expeditiously move these assets forward into clinical development and benefit patients worldwide." " HANGZHOU DAC's CPT-ADC platform is designed to enable next wave ADC capabilities that surpass first-generation technologies, including two programs already in clinical development in China ," said Dr. Robert Y. Zhao , President and CEO of HANGZHOU DAC Biotechnology. "As a global leader in ADC innovation, we are excited to partner with Aadi and WuXi Biologics to deliver this promising portfolio to patients." Aadi to Sell FYARRO for $100 Million , Cumulative Capital Expected to Fund Operations into Late 2028 In a separate agreement, KAKEN Pharmaceutical Co., Ltd., an R&D driven pharmaceutical company in Japan , has entered into a stock purchase agreement under which KAKEN will acquire Aadi Subsidiary, Inc. and all of its assets, including FYARRO ® (sirolimus protein-bound particles for injectable suspension) (albumin-bound) and associated infrastructure, including the majority of Aadi employees who support the FYARRO ® business. FYARRO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), with cumulative revenue of $25.2 million reported over the prior four quarters ended September 30, 2024 . Per the terms of the agreement, Kaken will pay Aadi $100 million in cash at closing, subject to certain adjustments. The transaction is expected to close in the first half of 2025, subject to Aadi stockholder approval and certain closing conditions. Upon the closing of this transaction, KAKEN will also acquire the rights to the Aadi name and trademark. "We are enormously proud of the impact FYARRO has had for people with PEComa, and Kaken's capabilities, coupled with the proven track record of the Aadi team, ensures physicians and patients will continue to have access to this critical treatment," said Lennon. The net proceeds from the PIPE financing and the sale of FYARRO, together with the Company's existing cash, cash equivalents and marketable securities are expected to fund operations into late-2028, including anticipated clinical data readouts for the ADC portfolio. Baiteng Zhao Appointed to the Board of Directors, Brings Significant ADC Expertise Baiteng Zhao, PhD, joins Aadi's board of directors. Zhao co-founded ProfoundBio, a clinical stage next-gen ADC developer, in 2018 and served as the Chairman and CEO of the company until it was acquired by Genmab for $1.8 billion in May 2024 . Prior to ProfoundBio, Dr. Zhao worked at Seagen (now part of Pfizer) for more than eight years and was responsible for the modeling and simulation strategies for the development pipeline and supported preclinical and clinical development of ADC drug candidates. "We are delighted to welcome Baiteng to our Board. His deep expertise and successful track record in ADC development will be instrumental as we tenaciously move this exciting portfolio forward," said Caley Castelein , MD, Chair of the Board of Directors of Aadi Bioscience. "I am thrilled to join the Board at this pivotal moment for Aadi," said Baiteng Zhao, PhD, Board of Directors of Aadi Bioscience and co-founder of ProfoundBio. "PTK7, MUC16 and SEZ6 represent highly promising targets that are commonly overexpressed in cancers with significant unmet therapeutic needs. Coupled with an advanced linker-payload platform that has the potential to enable next-gen ADCs, I believe Aadi is uniquely positioned to make a meaningful impact on patient outcomes. I look forward to collaborating with the leadership team and fellow Board directors to advance these innovative programs and drive transformative progress for patients." Advisors Leerink Partners is serving as financial advisor to Aadi on the sale of FYARRO and the licensing of the ADC portfolio. Jefferies LLC is acting as exclusive placement agent for the PIPE financing. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Aadi. McDermott Will & Emery LLP is serving as legal counsel to Kaken. Cooley LLP is serving as legal counsel to Jefferies LLC. Nomura Securities Co., Ltd. is serving as financial advisor to KAKEN. Conference Call Information The Aadi management team is hosting a conference call and webcast tomorrow, Friday, December 20 th at 8:00 AM EST ( 5:00 AM PST ) to discuss these updates. Participants may access a live webcast of the call and the associated slide presentation on these data through the "Investors & News" page of the Aadi Bioscience website at aadibio.com . To participate via telephone, please register in advance at this link . Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. Additional Information for Stockholders This communication relates to the proposed sale of FYARRO and the proposed PIPE financing and may be deemed to be solicitation material in respect of such transactions. In connection with these proposed transactions, Aadi will file a Proxy Statement with the SEC. This communication is not a substitute for the Proxy Statement or any other documents that Aadi may file with the SEC or send to Aadi stockholders in connection with the proposed transactions. Before making any voting decision, investors and securityholders are urged to read the Proxy Statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transactions as they become available because they will contain important information about the proposed transactions and related matters. Stockholders may obtain a copy of the Proxy Statement and other documents the Company files with the SEC (when they are available) through the website maintained by the SEC at www.sec.gov , as well as on the Investor and News section of Aadi's website at www.aadibio.com . Certain stockholders of Aadi holding approximately 36% of Aadi's outstanding shares, as of the date hereof, including members of its board of directors and related entities, have entered into voting and support agreements in favor of KAKEN Pharmaceutical and Aadi, pursuant to which such stockholders have agreed to vote in favor of the stock purchase transaction with KAKEN Pharmaceutical and the other transactions described above. Participants in the Solicitation Aadi and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Aadi in connection with the proposed transactions. Information about Aadi's directors and executive officers is set forth in Aadi's definitive proxy statement filed with the SEC on April 26, 2024 , and in subsequent filings made by Aadi with the SEC. Other information regarding the interests of such individuals, as well as information regarding Aadi's directors and executive officers and other persons who may be deemed participants in the proposed transactions, will be set forth in the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of these documents as described in the preceding paragraph. No Offer or Solicitation This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor a solicitation of any vote or approval with respect to the proposed transactions or otherwise, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offer and sale of securities of Aadi described above are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the subscription agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file, following the closing of the PIPE financing, a registration statement with the SEC registering the resale of the shares of Common Stock and the shares of Common Stock underlying the Pre-Funded Warrants sold in the PIPE financing. About Aadi Bioscience Aadi is a precision oncology company with a vision to make bold choices in applying technology to efficiently deliver improved precision oncology therapies for people living with difficult-to-treat cancers. More information on the Company is available on the Aadi website at www.aadibio.com and connect with us on LinkedIn. Forward-Looking Statements This press release contains certain forward-looking statements regarding the business of Aadi Bioscience that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the timing and completion of the proposed sale of FYARRO to Kaken Pharmaceuticals and the anticipated timing of the closing of the transaction; expectations regarding the timing, closing and completion of the PIPE financing; Aadi's expected cash position at the closing and cash runway of the company following the sale of FYARRO and PIPE financing; the future operations of Aadi; the development and potential benefits of any of Aadi's product candidates, including the preclinical ADC assets proposed to be licensed from WuXi; anticipated preclinical and clinical development activities and related timelines, including the expected timing for announcement of data and other preclinical and clinical results and potential submission of IND filings for one or more product candidates; and other statements that are not historical fact. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with (i) the risk that the conditions to the closing of the proposed sale of FYARRO or the PIPE financing are not satisfied, including the failure to timely obtain stockholder approval for the transactions, if at all; (ii) uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of Kaken and Aadi to consummate the proposed sale of FYARRO; (iii) risks related to Aadi's ability to manage its operating expenses and its expenses associated with the proposed transactions pending the closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed transactions; (v) unexpected costs, charges or expenses resulting from the transactions; (vii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed sale of FYARRO or the proposed PIPE financing; (vii) the uncertainties associated with Aadi's product candidates, as well as risks associated with the preclinical and clinical development and regulatory approval of product candidates, including potential delays in the completion of preclinical studies and clinical trials; (viii) risks related to the inability of Aadi to obtain sufficient additional capital to continue to advance these product candidates; (ix) uncertainties in obtaining successful preclinical and clinical results for product candidates and unexpected costs that may result therefrom; (x) risks related to the failure to realize any value from product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with the possible failure to realize certain anticipated benefits of the proposed sale of FYARRO or the proposed PIPE financing, including with respect to future financial and operating results. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 , including under the caption "Item 1A. Risk Factors," and in Aadi's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Aadi's reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov . All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes 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. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: IR@aadibio.com View original content to download multimedia: https://www.prnewswire.com/news-releases/aadi-bioscience-transforms-with-in-licensing-of-novel-adc-portfolio-100-million-sale-of-fyarro-and-100-million-pipe-financing-302336743.html SOURCE Aadi Bioscience
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TIMMINS - A Northern Ontario healthcare leader has been recognized with a prestigious provincial award. Lynne Innes, president and CEO of the Weeneebayko Area Health Authority (WAHA), has received the 2024 Premier’s Award in the health sciences category. Innes, a graduate of Northern College’s nursing program, was selected from 18 nominees in her category. She accepted the award on Nov. 25 during a ceremony in Toronto. “It’s a really special and humbling feeling to be recognized for all the hard work that not only I participated in, but our entire team, to better the health of our region,” Innes told TimminsToday. The award includes a bursary in Innes’ name for health sciences students at Northern College. The inaugural bursary, funded with a $5,000 investment from Ontario Colleges, will be awarded in the New Year. Annual bursaries of $500 will follow and Innes will help create the criteria for recipients. The bursary will be part of the winter awards at Northern College. For those considering a career in healthcare, Innes said her journey is an example of how starting at a small, local college can lead to success. “Starting in Northern Ontario and being as accomplished as I am today, and knowing that that’s where I started, I think is something that can resonate with many people,” she said. “People don’t have to go to Harvard or McGill, they can go to Northern College and be just as successful and accomplished.” Innes hopes her award will inspire Indigenous advocates and frontline healthcare workers to drive positive change. “I hope my recognition from this award inspires any Indigenous advocate and frontline healthcare worker to think outside the box, to be innovative, to constantly put the pressure on, be resilient, and ensure we are working toward the betterment of our people who are the hardest to reach in this province,” she said. “Setting it up with the seven grandfather teachings, or seven sacred teachings, to always be kind, to always be humble and to do everything with love and compassion.” For those aspiring to make a difference in healthcare, Innes said education is key. “I think the most important thing that we can do as people is to continuously educate people about our history and a path forward, ensuring we are moving forward in a good way,” she said. “I’m very proud to have started my educational journey at Northern College, and very proud to be a northerner and still living and working in the north.” This marks the second consecutive year a Northern College alum has received the Premier’s Award, following Christina Kioke’s win in 2023. SEE: Premier’s Award: Christina Kioke supports Indigenous students Launched in 1992, the Premier’s Awards honour graduates across seven categories: business, community services, creative arts and design, health sciences, recent graduates, skilled trades, and science, technology, and engineering.
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Aadi Bioscience Transforms with In-Licensing of Novel ADC Portfolio, $100 Million Sale of FYARRO® and $100 Million PIPE FinancingSam Darnold's second TD pass gives Vikings 20-3 lead
Carlsquare Advises Boomi on Acquisition of Data Integration Provider RiverySome consumers learn they'd have to bundle to keep their insurance policyIf you've been following the currents of online culture over the past couple of weeks, there's a good chance you've heard about Bluesky with increasing frequency. The microblogging site, which was founded by a former Twitter CEO, has been skyrocketing in popularity since the presidential election earlier this month, in which Donald Trump won his second term in the White House. Some users of X (formerly known as Twitter), many of whom were already growing frustrated with the many changes made by its owner, Trump mega-donor Elon Musk, are finally jumping ship to Bluesky. Aside from being less politically fraught, Bluesky is fundamentally different from X/Twitter in a few key ways. Its decentralized structure means users have more freedom with their data, and it has several features that make it easier to find the kind of content you're looking for — or avoid the content you're not. But can this brash new upstart really unseat X as the de-facto microblogging site? To find out, we took Bluesky through its paces and spoke to experts. Bluesky was founded by former Twitter CEO Jack Dorsey , along with a number of people interested in decentralized technology — tech designed so that it isn't subject to the whims of a single company or its owner. The idea was that anyone could host their own instance of Bluesky, leaving the company responsible only for its own app and not for the platform as a whole. It may seem strange for the head of a company to work on a potential competitor, but Dorsey has a reputation as an iconoclast within Silicon Valley. In fact, further Twitter alumni got in on the ground floor of Bluesky, including Parag Agrawal, the CEO whose tenure stretched from Dorsey's exit to Elon Musk's arrival at the company. But when it came time to launch as its own company, Dorsey and Agrawal tapped Lantian "Jay" Graber, a promising young developer, as Bluesky's CEO. The decision to keep Bluesky independent of Twitter proved prophetic. When Elon Musk took over the latter company in late 2022, he promptly nullified a prior agreement that would have seen Twitter folded into the decentralized web of platforms using Bluesky's technology and fired the people working to incorporate that tech. However, as Twitter changed under its new owner and was eventually rebranded as X, Bluesky continued to develop in the background. After a beta period during which sign-ups were available via invite only, Bluesky opened its doors to the general public in early 2024. Since then, it has grown slowly, but the platform began to explode in mid-November 2024. On the surface, Bluesky may look like just another Twitter clone, but under the hood, it's a very different platform. Just as on Twitter, you can post, repost, quote, and like posts. The difference is that Bluesky is decentralized, meaning anyone can host their own data and take their account with them to another instance of the platform. By default, a new user will appear as @username.bsky.social, but if you don't like that, you can use your own domain. For example, SlashGear could theoretically rehost an account on its own domain, giving it a username like @username.slashgear.com. (At the time of this writing, SlashGear does not have a Bluesky account.) Another unique aspect of Bluesky is algorithmic choice. On Twitter, Threads, and many other social media sites, users are shown content based on a secretive algorithm closely guarded by the platform. On Twitter and Threads, you can choose between letting a proprietary algorithm decide what you see or sorting your timeline into pure chronological order. Bluesky, by contrast, lets you select between multiple open-source algorithms, giving users far more control over how their content gets sorted. This algorithmic control manifests most clearly in the Feeds feature, which lets users create and subscribe to custom timelines based on particular topics, sets of users, or other criteria. When creating a Feed, you can choose which algorithm you want to rank the posts and even select how much weight the algorithm will give to the recency of any given post. This feature helped Bluesky to take on a life of its own, with a community-curated DIY culture that feels both fresh and distinct from other Twitter-like competitors. Buzz around Bluesky spread quickly through tech and media circles at its initial launch, hitting a million app installs last year . Now, it's taken on new life since the 2024 presidential election. With X owner Elon Musk having thrown his weight behind President-elect Donald Trump, many X users who don't align with Musk's politics now see the platform as politically hostile. That feeling was egged on by the explosion of hate speech that coincided with Musk's loosened moderation on the site, some of which Musk himself has engaged with. SlashGear reached out to journalist and Internet culture expert Taylor Lorenz, who says of X, "It's a very intense political environment on the app, and Elon has removed user controls that used to protect people." The result has been a mass exodus of users, which has been Bluesky's gain. At the time of this writing, Bluesky is the number one app on both the Apple App Store and Google Play Store, where it has remained for several days. Bluesky is not the only alternative to X. Meta's Threads platform integrates seamlessly with Instagram and has already scored 175 million users as of July 2024. However, given that the point of leaving X was to escape from under the thumb of a tech billionaire, it's understandable that Threads, which is ultimately tied to Meta CEO Mark Zuckerberg, would prove nearly as unpalatable for a large portion of expatriated X users. "Threads ended up going crazy with the content moderation," Lorenz said, "and now I think people are realizing that Bluesky is the best alternative. Bluesky offers a very comparable experience to kind of the original Twitter." While Bluesky is benefitting from the X exodus, whether the current spike in growth can continue as a long-term trend remains to be seen. Lorenz suggested that, due to Elon Musk's entrenchment in the incoming Trump administration, X will remain an important part of the media landscape. "I think political people are so incredibly addicted to Twitter," Lorenz says. "And now with Trump in office, Twitter is going to remain a politically relevant platform that keeps journalists on there because they're going to want to see what Elon says." Lorenz points out that X also remains the de-facto platform for Congresspeople and other public figures. However, she's not willing to write Bluesky off in that regard just yet. "If lawmakers and pundits and journalists all do go to Bluesky, then I think it could replicate what Twitter had," Lorenz says. Some public figures have already decamped to Bluesky from X, including journalists like New York Times columnist Jamelle Bouie and celebrities like "Star Wars" star Mark Hamill. According to award-winning author Charlie Jane Anders, who referred SlashGear to a public statement on the subject, her final straw was a reported proliferation of child sexual abuse material (CSAM) on X. "I feel the need to make a clean break from Twitter at this point," she wrote. "After all of the proliferation of hate speech, and the random shutdowns of progressive accounts that challenge the owner's rigid orthodoxy, I was already wanting to make a break for it. But after the latest scandals involving CSAM, I really feel as though I have no choice." Whether or not Bluesky becomes the new Twitter, it's clearly promising what many people crave: a fresh start.
Lil Wayne, GloRilla, Camila Cabello to perform at College Football National ChampionshipArt Wager/iStock Unreleased via Getty Images Ambitious 3-5 Year Plan Although there are seven weeks left until AT&T ( NYSE: T ) releases 4Q 2024 results, the company rolled out financial plans for the next three years and strategic plans going out to 2029. This was done Analyst’s Disclosure: I/we have a beneficial long position in the shares of T either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.