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Apple shows off updated, mixed-reality headset at AI-focused event

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By Aditya Soni, Stephen Nellis

(Reuters) -Apple kicked off its annual developer conference on Monday, where the technology giant is expected to showcase how it is integrating artificial intelligence across its software suite, including a revamped Siri voice assistant and a possible tie-up with ChatGPT owner OpenAI.

The company began the event by offering details on the latest operating system for its Vision Pro mixed-reality headset and iPhone. It said that iOS 18, the software powering its flagship device, makes the iPhone home screen more customizable and includes improved versions of its in-house apps.

The new software will also come with a “lock an app” feature that will help people protect sensitive information. Users can opt to lock specific apps and keep data more tightly controlled in the OS.

Apple also said it would group messages in its email client starting later this year, categorizing them in a primary folder, a transactions folder, a promotions folder and other more specific groupings, for instance communications by an airline. The high-level categorizations are similar to a now-old feature in competitor Google (NASDAQ:)’s Gmail. 

Apple said it would make its mixed-reality headset Vision Pro available in eight more countries including China and Japan. The new VisionOS 2 software for the headset will use machine learning to create natural depth photos and come with new gestures.

Shares of the company were down 1.6% on Monday afternoon.

Apple uses the developer conference at its Cupertino, California, headquarters each year to showcase updates to its own apps and operating systems as well as to show developers new tools they will be able to use in their apps.

But more is at stake at the Apple Worldwide Developers Conference (WWDC 2024) than in previous such events, as the iPhone maker seeks to reassure investors that it has not lost the AI battle to Microsoft (NASDAQ:) even though it may have forfeited a few rounds. 

Apple will have to show the vast majority of its more than 1 billion users – most of whom are not tech aficionados – why they would want the new breed of AI that has swept Silicon Valley, analysts said. 

“Apple will put on a show,” said Ryan Reith, analyst at market research firm IDC. “If they nail the landing, the potential is to get the consumer actually interested in AI because so far it has been mostly about enterprise.”

Apple has been using AI behind the scenes for years to power features on its devices, such as the ability of its watches to detect crashes and falls. But it has been reluctant to tout how this technology boosts functionality in its devices, as Microsoft has done with the help of its early bet on OpenAI.

Microsoft overtook Apple as the world’s biggest company by market capitalization in January, and Apple’s shares have trailed those of other Big Tech companies this year. AI chip giant Nvidia (NASDAQ:) briefly overtook Apple last week as the world’s second-most valuable company, underscoring for some investors a shift in power in the tech world.

SIRI MAKEOVER 

Apple is expected to enable Siri to essentially control many apps on a user’s behalf. This has proven tricky as Siri needs to understand the user’s exact intentions and also how the app works. 

For example, if a user asks Siri to delete an email, Siri needs to understand which email the user wants to delete and how that function works on, say, Microsoft Outlook versus Gmail.

Apple tried to make Siri smarter in 2018 with tools that allowed developers to code into their apps ways for Siri to have more control, but few showed interest.

Now, Apple is expected to revamp Siri’s underlying software with generative AI. Media have reported that Apple and OpenAI struck a deal to integrate the ChatGPT maker’s technology into Apple’s next iPhone operating system, iOS 18.

Some Apple investors are confident that the AI new features will boost sales of new iPhones at a time when the company is grappling with strong competition in China and slower growth in the U.S.

“This should translate into a strong hardware refresh cycle for Apple,” in 2025, said Dan Eye, chief investment officer at Fort Pitt Capital Group, which holds Apple shares (NASDAQ:). Eye expects Apple to limit some AI features on older models to entice people to buy newer phones.

CHIPS FOR AI

Earlier this month, Apple unveiled a new AI-focused chip in its latest iPad Pro models and analysts expect the company to offer details to developers on how they can use the chip’s capabilities to support all the new AI computing.

The company may also begin to talk about its own cloud-computing capabilities amid reports that Apple was planning to use its own chips inside data centers for the first time.

© Reuters. Apple CEO Tim Cook attends the annual developer conference event at the company's headquarters in Cupertino, California, U.S., June 10, 2024. REUTERS/Carlos Barria

By using its own chips for cloud services, Apple can roll out advanced AI features that devices cannot handle alone, without requiring expensive processors from Nvidia. The approach also retains many of Apple’s privacy and security features that are baked in to the design of its in-house chips.

The developer conference runs until Friday.

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Altimmune Presents Data from Phase 2 MOMENTUM Trial of Pemvidutide in Obesity during Oral Presentation at the American Diabetes Association’s 84th Scientific Sessions

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GAITHERSBURG, Md., June 23, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc.  (Nasdaq: NASDAQ:), a clinical-stage biopharmaceutical company, today presented data from the 48-week Phase 2 MOMENTUM clinical trial of pemvidutide, its GLP-1/glucagon dual receptor agonist candidate, in obesity, including the results of a recently completed body composition analysis, at the American Diabetes Association’s (ADA) 84th Scientific Sessions.

We’re pleased with the data presented at ADA that highlight the impressive lean mass preservation achieved with pemvidutide, with only 21.9% of weight loss attributable to lean mass, said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. The preservation of lean mass observed in this trial was better than reported historically with diet and exercise programs and greater than what has been publicly reported with other incretin weight loss drugs, where lean mass has accounted for as much as 40% of total weight loss. Preservation of lean mass, which is primarily muscle tissue, is believed to be important in maintaining healthy weight loss and physical function. We believe that the level of muscle preservation observed in the Phase 2 trial further adds to the differentiation of pemvidutide in the treatment of obesity.

The trial enrolled 391 subjects with obesity, or overweight with at least one co-morbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. A subgroup of subjects was evaluated in a body composition analysis.

At Week 48, subjects receiving pemvidutide achieved mean weight losses of 10.3%, 11.2%, 15.6% and 2.2% at the 1.2 mg, 1.8 mg, and 2.4 mg doses and placebo, respectively, with a near-linear continued weight loss observed on the 2.4 mg dose at the end of treatment. The full MRI-based body composition analysis included 50 subjects who received pemvidutide and showed that subjects in the pemvidutide groups had an average lean mass loss of 21.9% with 78.1% of weight loss attributable to fat. In addition, pemvidutide resulted in robust reductions in serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate.

Obesity is a multifactorial disease, and patients will need a variety of treatment options that fit their specific needs and comorbidities, said Louis Aronne, M.D., Director of the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes & Metabolism at Weill Cornell Medicine and Scientific Advisor of Altimmune. These latest findings are particularly exciting given that pemvidutide has not only demonstrated significant weight loss but an impressive ability to preserve lean mass. With its favorable safety profile to-date and the potential to drive clinically meaningful improvements in other obesity-related conditions such as dyslipidemia and hypertension, pemvidutide could offer a highly promising, long-term treatment option for multiple segments of the obese patient population to safely and effectively manage body weight.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The¯U.S.¯FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.

About Altimmune

Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit  www.altimmune.com.

Forward-Looking Statement

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words may, could, should, anticipate, believe, estimate, expect, intend, plan, predict and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy;  the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading Risk Factors in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov.

Follow @Altimmune, Inc. on  LinkedIn
Follow @AltimmuneInc on  Twitter

Company Contact:
Richard Eisenstadt
Chief Financial Officer
Phone: 240-654-1450
ir@altimmune.com

Investor Contacts:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com

Julia Weilman
Burns McClellan
Phone: 646-732-4443
jweilman@burnsmc.com

Media Contact:
Danielle Cantey
Inizio Evoke, Biotech
Phone: 619-826-4657
Danielle.cantey@inizioevoke.com

Source: Altimmune, Inc

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Fractyl Health Presents New Preclinical Data on Sustained Weight Maintenance and Improved Body Composition from its Rejuva ® Single-Administration GLP-1 Pancreatic Gene Therapy in President’s Select

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Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model

Rejuva also prevented weight and glycemic rebound after semaglutide withdrawal

Data provide first demonstration that Rejuva treatment has potential to mimic natural release of GLP-1 from pancreas

BURLINGTON, Mass., June 23, 2024 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, FL. The presentation titled Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity, and was chosen as noteworthy and one of eight President’s Select Abstracts at ADA this year.

Rejuva is the Company’s adeno-associated virus (AAV)-based GLP-1 pancreatic gene therapy program (PGTx), designed to enable durable production of GLP-1 in the pancreas for the treatment of obesity and T2D. The study presented at ADA compared the effects of a single dose of Rejuva and daily semaglutide treatment on body composition and glycemic parameters in the well-validated mouse model of diet-induced obesity (DIO). It also examined the effects of single-dose Rejuva in the DIO mice after semaglutide was discontinued.

These data demonstrate that Rejuva can durably improve body composition and fasting glucose, compared to or better than semaglutide, by restoring GLP-1 production in a ˜one-and-done’ treatment, said Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Executive Officer of Fractyl. These data also show Rejuva could help maintain improvements after semaglutide is withdrawn, highlighting our therapy’s potential to fill an emerging and critical need in the management of obesity and T2D: a reliable, ˜off ramp’ from chronic GLP-1 drugs that allows people to maintain the weight loss and blood sugar benefits, even as they stop taking these medicines.

In the study presented at ADA, obese (DIO) mice were randomized 1:1:1 to one of the following and followed for 4 weeks:

  • Arm 1: single administration of a Rejuva GLP-1-based gene therapy candidate,
  • Arm 2: daily semaglutide injections, or
  • Arm 3: placebo

At the end of 4 weeks, semaglutide was discontinued for mice in Arm 2 and those animals were further randomized 1:1 to receive either a single administration of the Rejuva gene therapy candidate or placebo, and all animals were followed for an additional 4 weeks, leading to the following assessment arms at 8 weeks:

  • Arm 1: continued follow-up of a single administration of a Rejuva GLP-1-based gene therapy candidate
  • Arm 2a: semaglutide withdrawal at week 4
  • Arm 2b: semaglutide withdrawal with crossover to single administration Rejuva at week 4
  • Arm 3: continued follow up of placebo

At the end of 8 weeks, the pancreatic islets were then isolated to study the effect of glucose exposure on GLP-1-based transgene release from genetically modified islets.

At week 4, the Rejuva arm experienced reduced fat mass of 21% versus 16% of body weight with semaglutide (both p

At week 8, fat mass rebounded to 1% below baseline (n.s.) in the semaglutide withdrawal group (Arm 2a), whereas semaglutide-withdrawn mice treated with Rejuva (Arm 2b) maintained fat reduction of 17% (p

Glucose and insulin levels in all intervention groups corresponded to changes observed in fat mass, with statistically significant improvements in fasting glucose and fasting insulin in semaglutide-treated and Rejuva treated mice at 4 and 8 weeks, but no improvement in glucose or insulin in semaglutide-withdrawn mice that did not crossover to Rejuva at week 8.

In addition to the compelling durability of weight loss, body composition, and glucose improvements seen in this model, we are pleased that isolated, genetically modified islets from Rejuva-treated mice show this release of GLP-1 in response to nutrients, said Timothy Kieffer, Ph.D., Chief Scientific Officer of Fractyl. We believe this clearly demonstrates that Rejuva can mimic the physiologic release of GLP-1 that occurs naturally in the human body.

About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington (NYSE:), MA. For more information, visit‰www.fractyl.com‰or‰https://twitter.com/FractylHealth.

About Rejuva
Fractyl Health’s Rejuva ®‰platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical trials or readouts, the content, information used for, timing or results of any IND-enabling studies or IND applications, the potential launch or commercialization of any of our product candidates or products, the sufficiency of our cash, cash equivalents, and investments to fund our operating activities for any specific period of time, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company’s need for substantial additional financing; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; additional time may be required to develop and obtain regulatory approval or certification for the Company’s Rejuva gene therapy candidates; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the Company’s reliance on third parties for the manufacture of the materials for its Rejuva gene therapy platform for preclinical studies and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company’s product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 13, 2024 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.

Contacts‰
Corporate Contact‰
Lisa Davidson, Chief Financial Officer‰
ir@fractyl.com, 781.902.8800

Media Contact‰
Jessica Cotrone, Corporate Communications‰
jcotrone@fractyl.com, 978.760.5622

Investor Contact
Stephen Jasper Gilmartin Group
stephen@gilmartinir.com, 619.949.3681

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Israeli airstrike kills eight at Gaza aid centre, witnesses say

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By Nidal al-Mughrabi

CAIRO (Reuters) -Eight Palestinians were killed on Sunday in an Israeli airstrike on a training college near Gaza City being used to distribute aid, Palestinian witnesses said, as Israeli tanks pushed further into the southern city of Rafah.

The strike hit part of a vocational college run by the U.N. Palestinian refugee agency UNRWA that is now providing aid to displaced families, the witnesses said. 

“Some people were coming to receive coupons and others had been displaced from their houses and they were sheltering here. Some were filling up water, others were receiving coupons, and suddenly we heard something falling. We ran away, those who were carrying water let it spill,” said Mohammed Tafesh, one of the witnesses.

A Reuters photographer saw a low-rise building completely demolished and bodies wrapped in blankets laid out beside the road, waiting to be taken away. 

“We pulled out martyrs (from beneath the rubble), one who used to sell cold drinks and another who used to sell pastries and others who distributed or received coupons,” Tafesh said. “There are about four or five martyrs and 10 injured. Thank God, the condition of the injured is good.”

The Israeli military said the site, which it said had served in the past as a UNRWA headquarters, has been used by Hamas and Islamic Jihad militants. It added that precautionary measures were taken before the strike to reduce the risk of harming civilians.

“This morning (Sunday), IAF fighter jets directed by IDF and ISA intelligence struck terrorist infrastructure in which Hamas and Islamic Jihad terrorists were operating,” the military said in a statement.

“This is another example of Hamas’ systematic exploitation of civilian infrastructure and the civilian population as a human shield for its terrorist activities,” it added.

Hamas denies Israeli accusations it uses civilians as human shields or uses civilian facilities for military purposes.

Juliette Touma, UNRWA’s Director of Communications, said the agency was looking into the details of the reported attack before providing more information.

“Since the beginning of the war, we have recorded that nearly 190 of our buildings have been hit. This is the vast majority of our buildings in Gaza,” she said. A total of 193 UNRWA team members have been killed in the conflict, she added.

ADVANCE INTO RAFAH

More than eight months into Israel’s war in the Hamas-administered Palestinian enclave, its advance is focused on the two areas its forces have yet to seize – Rafah on Gaza’s southern tip and the area surrounding Deir al-Balah in the centre.

Israel’s ground and air campaign in Gaza was triggered when Hamas-led militants stormed into southern Israel on Oct. 7, killing around 1,200 people and seizing more than 250 hostages, according to Israeli tallies.

The offensive has killed almost 37,600 people, according to Palestinian health authorities, and left Gaza in ruins .

Residents said Israeli tanks had advanced to the edge of the Mawasi displaced persons’ camp in the northwest of Rafah in fierce fighting with Hamas-led fighters, part of a push into western and northern Rafah in which they had blown up dozens of houses in recent days.

“The fighting with the resistance has been intense. The occupation forces are overlooking the Mawasi area now, which forced families there to head for Khan Younis,” said one resident, who asked not to be named, on a chat app.

The Israeli military said it was continuing “intelligence-based, targeted operations” in the Rafah area and had located weapons stores and tunnel shafts, and killed Palestinian gunmen.

The armed wings of Hamas and the Islamic Jihad movement said their fighters had attacked Israeli forces in Rafah with anti-tank rockets and mortar bombs and pre-planted explosive devices.

© Reuters. Gaza City, June 23, 2024. REUTERS/Mahmoud Issa

Another strike killed two people in Nuseirat in central Gaza.

In Beit Lahiya in the northern Gaza Strip, health officials at Kamal Adwan Hospital said two babies had died of malnutrition, taking the number of children who have died of malnutrition or dehydration since Oct. 7 to at least 31, a number that health officials say reflects under-recording.

(Reporting and writing by Nidal al-MughrabiAdditional reporting by Ari Rabinovitch, Maayan Lubell in Jerusalem and Mahmoud Issa in GazaEditing by Kevin Liffey and Frances Kerry)

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