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Iran’s Bet on Autonomous Weapons – War on the Rocks

Editors Note: Some links in this article lead to media sites and journals that are affiliated with the Iranian military. If access to such sites is prohibited by your employers policy, please do not click links in this article from a work computer.

Attempting to pass off a childs astronaut costume as an innovation of Irans space agency was bizarre but familiar. Shared online by Minister of Information and Communications Technology Azari Jahromi in February 2020, the fit-for-Halloween suit exemplified the Iranian governments penchant for fabricating technical achievements, whether through farcical stealth fighter jets, fake space monkeys, or oil drum surface-to-air missiles.

Irans history of shameless exaggeration leaves plenty of reason for skepticism when the nations military unveils new capabilities or when Iranian officials announce ambitious technological goals, as they did earlier this year. In a widely publicized January exercise, the Iranian Army Ground Forces showcased what they said was the countrys first autonomous suicide drones, reportedly capable of detecting and destroying targets using advanced image processing capabilities and artificial intelligence. Not to be outdone, the Islamic Revolutionary Guard Corps followed up with a demonstration of an explosive suicide drone, purportedly piloted with some level of AI. Later that month, Brig. Gen. Mohammad Hassan Nami one of Jahromis predecessors as minister of information and communications technology claimed that Iran would have fully autonomous systems on the battlefield by 2024.

Notwithstanding the well-founded reasons to avoid taking such claims at face-value, Irans pursuit of autonomous weapons is no fanciful moonshot. Buoyed by technically educated Iranians and unencumbered by the rigors of thorough weapons testing, Iranian forces have the resources necessary to follow through on their autonomous aspirations. Iranian military literature suggests that the countrys army, air force, and the revolutionary guard corps seek an early adopter advantage by deploying AI-guided systems to the battlefield as soon as viable, however rudimentary and unreliable they may be. If that happens, it could be particularly destabilizing given Irans proxy operations strategy, with autonomous systems potentially empowering Iranian-backed militants to conduct faster and deadlier attacks at greater range.

AI as Irans Force Multiplier

The Iranian militarys interest in AI and autonomous systems is best understood in the context of its long pursuit of force-multiplying, asymmetric capabilities. Similar to constructing a network of loyal proxy militias and terrorist organizations across the region, employing a small army of the nations many educated computer engineers is feasible and scalable. A 2016 World Economic Forum study reported that Iranian universities graduated some 335,000 science, technology, engineering, and mathematics students annually ranking the country the fifth highest in the world based on that metric. Yet, Irans Ministry of Science, Research, and Technology found that 41 percent of the nations computer science Ph.D. graduates were unemployed in 2018. While modern hardware and processors remain difficult to acquire, the nations public and private sectors have put some of this skilled labor to work in developing rudimentary AI tools for various purposes, from space-based agricultural monitoring to seminary research in Islamic sciences. Determined to compensate for the nations material weakness, Iranian military thinkers see immense value in employing this abundance of talent to integrate AI into the nations drone fleet, air defense network, and command systems.

Iranian military officials envisage AI tools as helping them to overcome persistent challenges, such as undertaking aerial navigation and precision targeting without domestic global positioning system infrastructure. AI could allow drones to fly on autopilot to predetermined locations and then conduct targeting based on image recognition technology. Networks of autonomous reconnaissance drones, armed with Irans improving compact radar and imaging sensors, could also feed volumes of surveillance data into a centralized, intelligent data processor, improving broader situational awareness. For example, a 2019 article in the Journal of Military Science and Technology, which is affiliated with Irans army, explored possible applications of the Internet of Things to the Iranian air force and urged the development of integrated data processing platforms to help guide everything from high-level military decisions to fleet management.

In April, the Research and Self-Sufficiency Jihad Organization of the Army Ground Force which is responsible for producing and mainstreaming innovations presented a stationary model of an autonomous drone swarm featuring one large drone and a cadre of smaller suicide drones at a technology exhibition. Tasnim News, an outlet with links to the revolutionary guard, reported that the new drones can operate either with ground control or using AI based on predetermined information stored in the mother drone. The self-sufficiency organizations display signals an intent to produce and deploy such autonomous suicide drones and to use them in swarms, although a static hardware exhibition does not prove operability of the necessary software. Regardless, Tasnim described the new system as perhaps the edge of unmanned control and operation technology in the world.

The Iranian armys handiwork has been more conspicuous than that of the revolutionary guard, which remains tight-lipped about its internal development efforts and stands to gain the most from the rise of Iranian autonomous systems. Enjoying a vast budget, political dominance, and control over much of the nations industrial base, the guard corps not only inherits the armys innovations but can also independently develop capabilities for their more advanced drone hardware. And the Quds Force, the revolutionary guards external operations branch, will ultimately deploy and distribute new capabilities to Irans proxy forces across the region.

On the sidelines of the Great Prophet 15 exercise in January, the commander of the guard corps Aerospace Force, Amir Hajizadeh, told media that the combination of new missile capabilities, drone operations, and AI technology has born new possibilities and power into the IRGC. Hajizadehs statement suggests that the Aerospace Force harbors broader multi-platform ambitions for militarized AI. For example, autonomous drones could collect, interpret, and relay data, in real-time, to aid the delivery of precision-targeted missiles.

While drones are the area in which Irans autonomous efforts are most advanced, they may not be the only benefactors of the nations investment in AI. Iranian officials claim that the Mobin, a cruise missile first displayed in 2019 at an air show in Russia, uses digital scene matching area correlation guidance, a type of AI developed in the 1980s capable of helping cruise missiles autonomously navigate to a target. Iran is also signaling ambitions for armed, remote-controlled ground robots, apparently with plans to link them in an autonomous network. If Iran can translate these ambitions into reality, armed surface robots could integrate with aerial intelligence to help sweep battlefields or patrol urban areas. And the potential applications dont end on Earths surface. Last May, Iran revealed its latest foray into underwater vehicles: an unmanned midget submarine. Ramshackle as the submarine may appear, an intelligent command system could allow it to operate in networked packs, possibly lying in wait for adversaries beyond communications range. Nothing in the publicly available Iranian literature suggests that the countrys military has started exploring such underwater autonomy or possesses the necessary sensing equipment, but technical carryover from drones could speed progress. If Iran developed and deployed autonomous underwater loitering capabilities, even if they came with severe technical limitations, it could have major implications for maritime security in the Persian Gulf and beyond.

Detailed Iranian military science articles also suggest that the countrys technologists are contemplating AI-enhanced air defense systems capable of taking action without human input. As Iran brings online new indigenous radar and missile systems including their improved copy of the S-300 the armys Khatam al-Anbia Joint Air Defense Base is emerging as a powerful hub of national command and control in a previously disaggregated system. The base has increased cooperation with the revolutionary guard corps separate air defense systems, including by hosting recent joint command exercises. This centralization will allow Iranian forces to more easily integrate AI tools into their command systems. If successful, Iran could use decision-making algorithms to augment its defense capabilities, possibly avoiding catastrophic human errors of the type that led the Aerospace Force to mistakenly shoot down a Ukrainian passenger plane in January 2020. However, Iran would need to develop sophisticated systems that can negate human mistakes to avoid repeating such deadly negligence across its own military networks and those of its proxy forces.

The final frontier of Irans AI goals lies in strategic integration across platforms with a central command and control system to speed decision-making. In a 2018 journal article, an author at the armed forces elite University and Institute of National Defense and Strategic Research extoled the virtues of centralized, intelligent battlefield management, especially the way it would enable the processing of intelligence from hundreds of sources and the command of weapon systems in real-time across numerous commands. Iran is far from achieving such synergistic integration its divided military forces create structural barriers to doing so but it is investing in the necessary computing capabilities to solve these problems.

Learning from Others

In seeking guidance for their work on autonomous capabilities, Iranian media and strategic thinkers have looked to U.S. discourse surrounding these systems. Iranian popular media has translated and reported on remarks by U.S. officials calling AI the key to future military superiority and has closely followed AI-related efforts at Americas Defense Advanced Research Projects Agency. Media outlets in Iran noted that the final report of the U.S. National Security Commission on Artificial Intelligence endorsed strategic investment in AI to compete with China. Ignoring the reports accompanying discussion of escalatory and ethical risks, Iranian thinkers have evidently taken away two messages: The rapid development of AI-enabled tools is critical to future competition, and efforts to limit this pursuit should be resisted.

Iranian thinkers are also learning through careful observation of other drone powers. In an article titled Artificial Intelligence in the Armenia-Azerbaijan Air and Missile War, the editorial board of the Iranian Journal of International Relations attributed Azerbaijans gains in the 2020 Nagorno-Karabakh war to its skilled use of coordinated drone warfare. While it is not clear that Azerbaijan actually employed AI in its operations it is possible given the autonomous offerings of the Turkish arms firm STM the authors argued that the conflict showed how the synchronization of new weapons makes the modern battlefield deadlier. They also emphasized that Azerbaijans military faced little opposition to its successful use of coordinated drone strikes.

A concerning lack of domestic debate in Iran suggests that legal and ethical concerns about autonomous systems, if they exist, will not challenge the militarys ambitions. A 2017 article is the only one to address lethal autonomous weapons and international humanitarian law in Irans International Law Journal, the countrys preeminent journal on international legal issues. Likewise, the only relevant article in the Iranian journal Islamic Law examines civil liability for AI-enabled autonomous robots yet entirely ignores autonomous machines designed to cause harm. Meanwhile, Irans popular media and civil society organizations have produced limited coverage and discussion about the potential implications of developing AI-enabled military capabilities. One rare exception was a 2018 Fars News translation of Michael Klares essay Alexa, Launch Our Nukes! that emphasized the dangers of creating nuclear command and control systems devoid of human input.

The Potential for Destabilizing Effects

The United States, Russia, China, and even Turkey far exceed Irans capacity for the development of AI systems. But the Iranian militarys pursuit of such technology is especially dangerous because of its propensity for rapidly deploying novel technologies, often through unpredictable proxies. In the hands of non-state groups, even simplistic autonomous weapons systems will enable unprecedented aerial operations and could carry risks of dangerous malfunction.

Some experts have called for classifying swarms of autonomous, armed drones such as the Foji swarming drones that the Iranian army claims it successfully used during the January exercise as weapons of mass destruction. Through decentralized and adaptable command, swarms of such drones could overwhelm air defense systems in order to deliver explosives or rocket fire, all with rapid speed and adaptability. In 2018, rebel forces used 13 highly rudimentary and reportedly pre-programmed drones operating in a swarm to damage two Russian military bases in Syria. Those explosive-laden drones lacked advanced sensors or AI, but the incident was a harbinger of the type of destructive power that could be delivered by autonomous drones in the future.

Armed with such capabilities, Iranian proxy forces may find themselves benefiting from remarkable improvements in the speed, precision, and, critically, range of lethal aerial operations. While militant groups have not yet used conventional drone arsenals for strategic bombing, its possible that autonomous systems may embolden them and allow militants to pursue more destructive objectives. Not only could these advantages make the sort of militant attacks plaguing U.S. forces in Iraq deadlier, but they could also facilitate coordinated strikes against targets far beyond their territories of control.

The 2019 attack on Saudi Aramco facilities serves as a potential warning of what may lie ahead. While the Iran-backed Houthis in Yemen claimed credit for that drone and cruise missile strike, U.S. intelligence suggests that the drones composed of Iranian components came from the north, not the south. Whether Iran itself or its proxies in Iraq launched those drones remains uncertain. But the event was suggestive of future potential dangers: With autonomous weapons in hand, Iran-backed militants could work in concert with other groups or Iranian forces themselves to orchestrate multi-system strikes, emanating from several locales, on distant, high-value targets.

Autonomous reconnaissance drones provided to an Iranian proxy group could also give Quds Force commanders access to unprecedented intelligence and speed their decision-making in relation to regional operations. No longer tied to commanding or operating drones locally, the Quds Force could program proxy-launched autonomous systems from the comfort of Iran, reducing their ground presence on foreign battlefields. Of course, an Iranian-built drone would be exposed as such by its Iranian components in the event it was downed, but a proxy group could still claim responsibility for any attacks. Proving otherwise and attributing a drones code to its Iranian authors will be extremely difficult.

Adapting to a Dangerous Future

American officials, and their counterparts in allied and partner nations, should closely monitor Iranian progress in relation to autonomous weapons and begin to craft a response. In the near term, Irans targets should invest in technologies to jam and disrupt emerging aerial systems while carefully considering the risks that these tools may provoke unpredictable malfunctions in Iranian systems. Recent reports of looming U.S. sanctions on Irans drone component procurement networks may slow the countrys advances. But such steps wont overcome the Iranian militarys intense desire for autonomous weapons. Irans targets will ultimately need to adapt to a future of potentially rapid escalation enabled by networked, intelligent weapons.

In formulating a strategy to deter attacks conducted using Iranian-built autonomous weapons, the United States and others will find themselves grappling with complex considerations of escalatory risk and holding Iranian-backed proxies accountable. Responding to small-scale attacks on U.S. bases in Iraq is only the beginning of this challenge. Israels recent shootdown of a single armed Iranian drone at the Jordanian border was a small step toward denying Iran the ability to wield its burgeoning airpower, although one that failed to deter Irans deadly suicide drone attack on an Israeli-operated tanker off the coast of Oman. But the big policy challenge that lies ahead is how to deter Iran and its proxies from using autonomous systems to launch more destructive attacks on high-value targets. Among the means to do so, American officials should consider ways to credibly threaten the imposition of clear and decisive costs on not only Iran-backed proxies that launch any such attacks, but also on the Iranian forces supplying the weapons and programming the targets. Most critically, Irans potential targets should not risk emboldening Iranian military officials by allowing them to develop a sense of AI-enabled impunity.

Evan Omeed Lisman is a research associate at the Center for Global Security Research at Lawrence Livermore National Laboratory, where he uses Persian-language materials to assess military technology programs in Iran, and a J.D. candidate at Yale Law School. He holds a B.A. in Middle Eastern studies from the University of California, Berkeley. The views and opinions of the author expressed herein do not necessarily state or reflect those of the U.S. government or Lawrence Livermore National Security, Inc.

Image: Defense Department (Photo by EJ Hersom)

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Iran's Bet on Autonomous Weapons - War on the Rocks

Chaotic US Withdrawal, Taliban Control of Afghanistan May Give Rise to ISIS Branch – The Media Line

An Islamic State suicide bombing outside Kabul airport last week killed at least 92 people, including 13 US service members, as thousands of desperate Afghans were at the airport hoping to get on any evacuation flight out of the country in order to flee the Taliban.

The Islamic State in Khorasan Province issued a statement claiming responsibility for the suicide bombing attack, which reminded people of similar complex, vicious and cruel assaults during the reign of the original organization in Syria and Iraq.

Despite claims that the Islamic State, or ISIS, group was defeated in the area of the Levant, affiliated branches sprouted in Yemen, Sinai and North Africa, including the groups regional chapter in Afghanistan called Islamic State-Khorasan or ISIS-K.

Khorasan is a historical name for the region, taking in parts of what is today Pakistan, Iran, Afghanistan and Central Asia.

The Islamic State organization declared a caliphate in Iraq and Syria in 2014, when its fighters rolled over Iraqi army forces. ISIS took advantage of the chaos in neighboring Syria, controlling large swaths of land in the war-torn country.

That year, fighters from the Pakistani Taliban led by Pakistani national Hafiz Saeed Khan split and joined militants in Afghanistan to form an ISIS regional chapter, pledging allegiance to its leader Abu Bakr al-Baghdadi.

ISIS-K began operating in Afghanistan in 2015 when the top leadership of ISIS recognized the branch. It established roots in northeastern Afghanistan, particularly Kunar, Nangarhar and Nuristan provinces.

With the US-backed government out of power, the Taliban have now come face to face with ISIS-K.

According to a report by the Center for Strategic and International Studies (CSIS), ISIS-Ks founder died in a US airstrike in 2016.

The US has conducted several attacks against the group in the past, killing dozens of ISIS-K fighters in 2017, when US warplanes dropped the mother of all bombs the biggest one in the US arsenal on a cave the group was using as a hideout. That bombing killed 96 ISIS-K members.

Analysts estimate that the US military had killed 75% of ISIS-K fighters.

Despite the deadly attack, the United Nations estimates that ISIS-K still has between 500 and 2,000 fighters in Afghanistans Konar and Nangahar provinces. Smaller cells are scattered across the country.

But attacks like the ones last Thursday will be used to recruit new members for the group.

With the chaotic US withdrawal, and Taliban success in taking over control of most of Afghanistan, membership to Taliban and ISIS-K is likely to spike as the country becomes a fertile ground to attract new fighters for these groups.

Wake up to the Trusted Mideast News source Mideast Daily News Email

The UN Security Council estimates as many as 10,000 foreign fighters from Central Asia, southern Russia, Pakistan and western China have rushed into Afghanistan in recent months.

And while a majority have joined the Taliban or al-Qaida, others joined ISIS-K.

The Islamic States Afghanistan-Pakistan regional chapter has been responsible for some of the most lethal attacks in recent years, its fighters charged with the most gruesome assaults on civilians in both countries, at mosques, shrines, public squares and even hospitals.

The group has especially targeted Muslims from sects it considers heretical, including Shiites.

ISIS-K conducted at least 77 attacks in Afghanistan during the first four months of 2021, according to a UNSC report in June, a huge increase from the 21 attacks during the same period in 2020.

Talibans ideology centers around enforcing its version of sharia law in Afghanistan, while ISIS-K has its eyes on a bigger prize and that is to establish an Islamic caliphate across the Middle East and Asia.

Its no secret that the two groups are rivals, and last Thursdays deadly bombing with the many fatalities and chaos that ensued as a result, had another goal in ISIS-Ks mind, and that is to undermine the Taliban.

A new leader was appointed to head the group late last year, Shahab al-Muhajir, an Arab from the Middle East, believed to be Iraqi, who previously served with al-Qaida in the Afghanistan-Pakistan region.

A UN report in July described al-Muhajir as ambitious, and called operations under his leadership active and dangerous.

Following last Thursdays deadly suicide bombing at Kabul airport, the US military said Friday it had carried out a drone strike against a planner of the Islamic State-Khorasan.

The unmanned airstrike occurred in the Nangarhar Province of Afghanistan. Initial indications are that we killed the target, said Captain Bill Urban of the US Central Command.

A Sunday explosion in the Afghan capital, Kabul, reportedly was an American retaliatory drone strike on a vehicle carrying multiple Islamic State suicide bombers on the way to the Kabul airport.

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Chaotic US Withdrawal, Taliban Control of Afghanistan May Give Rise to ISIS Branch - The Media Line

DHEC Supports Awareness and Education during National Sickle Cell Awareness Month – SCDHEC

FOR IMMEDIATE RELEASE:Aug. 30, 2021

COLUMBIA, S.C. Sickle cell disease is a serious genetic disorder that impacts many families around the country and around the world. The South Carolina Department of Health and Environmental Control (DHEC) supports the annual recognition of September as National Sickle Cell Awareness Month to help focus attention on the need for further research and treatment of sickle cell disease.

As the most common inherited blood disorder in the United States, sickle cell disease (SCD) currently affects approximately 100,000 Americans, including more than 4,000 South Carolinians who have the disease. Complications from SCD include pain attacks that can cause the individual to need hospitalization. Other potentially life-threatening complications include infections, stroke, and organ damage.

Because symptoms and complications of SCD can vary, treatment options are different for each person depending on their symptoms. The only known cure for SCD is bone marrow or stem cell transplant.

Sickle cell disease can be a debilitating and life-threatening disease for those who have it, and it can also affect the lives of their family and friends, said Dr. Brannon Traxler, DHEC Public Health Director. While September is National Sickle Cell Awareness Month, increasing public knowledge about sickle cell should be a year-long initiative.

The theme of this years monthly recognition is Sickle Cell Matters, which underscores the need to raise awareness about the daily struggles of those living with SCD as well as the need to address the stereotypes and stigmas associated with people who have the disorder.

Babies are born with SCD; it isnt a disease that someone can develop later in life. In people who are born with SCD, both copies of a hemoglobin gene are abnormal. A person born with one abnormal copy of the gene and one normal copy has "sickle cell trait." People with sickle cell trait usually don't have symptoms although in rare cases they can experience complications of SCD like pain crises. When two people with sickle cell trait have a child, there is a 25-percent chance the child will have SCD. Even if only one parent has a sickle cell trait, their child could still have an increased risk of inheriting a type of sickle cell disease.

Blood tests can confirm whether a person has sickle cell trait or SCD, and the disorders are commonly detected during newborn health screenings.

SCD disproportionally affects those with African ancestry or who identify as Black. The disease also can be found in anyone with genetic makeup from a part of the world where malaria is more widely spread, such as India, South America and Central America.

South Carolina has a Sickle Cell Disease State Plan developed by a group of dedicated partners who work to help mitigate this life-threatening disorder, said Dr. Traxler. We can all help increase awareness about sickle cell disease by sharing education and information within our communities, especially in minority or underserved communities that may struggle with access to routine health care.

In 2017, South Carolina established the South Carolina Sickle Cell Disease Advocacy Team, which remains focused on one common goal to improve the treatment and care received by individuals and their families who have sickle cell disease.

DHEC provides a printable sickle cell disease flyer available for anyone here. Organizations can order printed copies of the flyer for distribution by placing an order here. Learn more about the disease at cdc.gov/sicklecell.

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About the South Carolina Sickle Disease Advocacy TeamMembers of the South Carolina Sickle Cell Disease Advocacy Team (SCSCDAT), who came together to develop the South Carolina Sickle Cell Disease State Plan, include physicians, hematologists, government agencies non-profit organizations, healthcare management organizations and individuals living with SCD and their family members.

Media Contacts:

COBRA Sickle Cell Program http://www.cobraagency70.com/home.html sicklecell@cobraagency70.com 843-225-4870

Louvenia D. Barksdale Sickle Cell Anemia Foundation http://www.ldbarksdalesc.org/ ldbarksdalesc@gmail.com 864-582-9420

James R Clark Memorial Sickle Cell Foundation http://www.jamesrclarksicklecell.org office@jamesrclarksicklecell.org 803-799-6471

Orangeburg Area Sickle Cell Anemia Foundation orangeburgsickle@gmail.com 803-534-1716

The B Strong Group thebstronggroup.org thebstronggroup@gmail.com 803-875-1266

DRE 365 (Dream Reach Empower) dre365sc@gmail.com 803-759-0700

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DHEC Supports Awareness and Education during National Sickle Cell Awareness Month - SCDHEC

Operational Highlights and Financial Results for the Year Ended June 30, 2021 – GlobeNewswire

NEW YORK, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the fourth quarter and full-year ended June 30, 2021 (FY2021).

During this calendar year we made significant progress in both regulatory and clinical outcomes for our lead product candidate, remestemcel-L, after experiencing a disappointing set-back last year said Silviu Itescu, Chief Executive of Mesoblast. We are pleased with recent recommendations by FDAs CBER to meet with the review team and address remaining CMC items for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease in children. Additionally, our most recent meeting with the FDA has provided clarity on the pathway towards an emergency use authorization for remestemcel-L in the treatment of COVID ARDS.

Operational Highlights

Remestemcel-L Outcome of recent meeting with FDA on regulatory pathway for emergency use authorization in the treatment of COVID-19 ARDS:

Remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children:

Rexlemestrocel-L in the treatment of chronic heart failure and chronic low back pain:

Manufacturing

Financial Highlights

DETAILED CLINICAL ACTIVITIES FOR THE FISCAL YEAR FY2021

Remestemcel-L

Acute Respiratory Distress Syndrome due to COVID-19

Mesoblast recently presented results from the randomized controlled trial of remestemcel-L in 222 ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) at the biennial Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases conference hosted by the University of Vermont, Burlington, VT, and at the International Society for Cell & Gene Therapy (ISCT) Scientific Signatures Series event on Cell and Gene-Based Therapies in Lung Diseases and Critical Illnesses.

The presented data included improved respiratory function in patients treated with remestemcel-L, as well as 90-day survival outcomes showing remestemcel-L significantly reduced mortality by 48% at 90 days compared to controls in a pre-specified exploratory analysis of 123 treated patients under 65 years old. The trial had been halted after the third interim analysis since the 30-day primary endpoint would not be attained.

Key presentation findings were:

Mesoblast plans to move forward with an additional Phase 3 trial in COVID-19 ARDS with the next step being to agree with the FDA the final protocol and potency assay.

Inflammatory Bowel Disease Crohns Disease and Ulcerative Colitis

A randomized, controlled study of remestemcel-L delivered by an endoscope directly to areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohns disease and ulcerative colitis commenced at Cleveland Clinic in October 2020. The investigator-initiated study is the first in humans using local cell delivery in the gut and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohns disease where remestemcel-L was administered intravenously.

Rexlemestrocel-L

Chronic Heart Failure

The results from the landmark DREAM-HF randomized controlled trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR) or control sham, demonstrated that a single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. The trials primary endpoint of reduction in volume overload related hospitalizations was not achieved. The results of this trial identify New York Heart Association (NYHA) class II HFrEF patients as the optimal target population for greatest rexlemestrocel-L treatment effect, and therefore a focus for developing rexlemestrocel-L in the largest market in heart failure.

The incidence of heart attacks and strokes were reduced by 60% over a median follow-up period of 30 months following a single dose of rexlemestrocel-L in the entire population of 537 treated patients. The incidence of death from cardiovascular causes was reduced by 60% in the 206 patients with NYHA class II disease, a significant reduction which was evident in both ischemic and non-ischemic subgroups as well as diabetic and nondiabetic patients.

The results also show that the NYHA class II patients in the control group, following an initial period of approximately 20 months of disease stability, progressed to cardiac death rates in-line with NYHA class III patients. NYHA class II patients treated with a single dose of rexlemestrocel-L did not show such cardiac death progression.

The combination of the three pre-specified outcomes of cardiac death, heart attack or stroke into a single composite outcome - called the three-point major adverse cardiovascular events (MACE) is a well-established endpoint used by the FDA to determine cardiovascular risk. Rexlemestrocel-L reduced this three-point MACE by 30% compared to controls across the entire population of 537 treated patients. In the NYHA class II subgroup of 206 patients, rexlemestrocel-L reduced the three-point MACE by 55% compared to controls.

Mesoblast expects feedback from the FDA in the next quarter on the potential pathway to US regulatory approval for rexlemestrocel-L in patients with chronic heart failure.

Chronic Low Back Pain due to Degenerative Disc Disease

The results from the randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments indicate that a single injection of rexlemestrocel-L+hyaluronic acid (HA) carrier may provide a safe, durable, and effective opioid-sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred. The trial's composite outcomes of pain reduction together with functional responses to treatment were not met by either MPC group.

The rexlemestrocel-L+HA treatment group achieved substantial and durable reductions in CLBP compared to control through 24 months across the entire evaluable study population (n=391) compared with saline controls. Greatest pain reduction was observed in the pre-specified population with CLBP of shorter duration than the study median of 68 months (n=194) and subjects using opioids at baseline (n=168) with the rexlemestrocel-L+HA group having substantially greater reduction at all time points (1, 3, 6, 12, 18 and 24 months) compared with saline controls. There was no appreciable difference in the safety of MPC groups compared to saline control over the 24-month period of follow-up in the entire study population. In subjects using opioids at baseline, the MPC+HA demonstrated a reduction in the average opioid dose over 24 months, while saline control subjects had essentially no change.

There is a significant need for a safe, efficacious, and durable opioid-sparing treatment in patients with chronic low back pain due to severely inflamed degenerative disc disease. Mesoblast has filed a request and expects to receive feedback from the FDA on the pathway to US regulatory approval in patients with chronic low back pain due to degenerative disc disease.

Intellectual Property

Mesoblast has an extensive patent portfolio with over 1,000 patents and patent applications across 77 patent families, and patent terms extending through 2041. These patents cover composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells, and provide strong commercial protection for our products in all major markets, including the United States, Europe, Japan and China. During the fiscal year Mesoblast has significantly expanded its patent portfolio, focusing on areas of its strategic commercial interests.

Licensing agreements with JCR, Grnenthal, Tasly and Takeda highlight the strength of Mesoblast's extensive intellectual property portfolio covering mesenchymal lineage cells. Mesoblast will continue to use its patents to prosecute its commercial rights as they relate to its core strategic product portfolio. When consistent with the Companys strategic objectives, it may consider providing third parties with commercial access to its patent portfolio.

DETAILED FINANCIAL RESULTS

Financial Results for the Year Ended June 30, 2021 (FY2021)

In August we entered into a contractual amendment to extend the interest-only period of its current senior debt facility to at least January 2022 and as a result no loan repayments will be required prior to January 2022. Mesoblast is in active discussions to refinance the facility.

We expect to recognize the existing US$21.9 million of remestemcel-L pre-launch inventory on the balance sheet if we receive FDA approval.

As a result of the above and other remeasurements on revaluation of assets and liabilities, the loss after tax for FY2021 was US$98.8 million compared to US$77.9 million for FY2020. The net loss attributable to ordinary shareholders was 16.33 US cents per share for FY2021, compared with 14.74 US cents per share for FY2020.

Conference Call

There will be a webcast today, beginning at 7.00pm EDT (Monday, August 30, 2021); 9.00am AEST (Tuesday, August 31). It can be accessed via:https://webcast.boardroom.media/mesoblast-limited/20210826/NaN61036c41df5665001c97fc67

The archived webcast will be available on the Investor page of the Companys website: http://www.mesoblast.com

About Mesoblast

Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

Forward-Looking Statements

This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Originally posted here:
Operational Highlights and Financial Results for the Year Ended June 30, 2021 - GlobeNewswire

Victory Square Technologies Reports Record 6th Consecutive – GlobeNewswire

VANCOUVER, British Columbia, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Victory Square Technologies Inc. (Victory Square or Company) (CSE:VST) (OTC:VSQTF) (FWB:6F6), a company that provides investors access to a diverse portfolio of next generation technology companies in key sectors including: the Creator Economy, Digital Health, Gaming, Web 3.0, VR/AR and Green Tech, announces it has filed its consolidated condensed interim financial statements and associated managements discussion and analysis (MD&A) for the three and six months ended June 30, 2021.

"Q2 2021 was another strong quarter for Victory Square in which we achieved a sixth consecutive quarter with positive net income & earnings per share, issued a share dividend, and listed GameOn (CSE:GET). In addition to closing our investment in Stardust Solar Technologies Inc. (Stardust), we closed an oversubscribed financing for Immersive, launched DiscreetCare.com and Covalent Network Corporation completed a $10,000,000 USD public sale of their CQT token, said Shafin Diamond Tejani, Chief Executive Officer of Victory Square.

Financial Highlights for the three months ending June 30, 2021:

Financial Highlights for the six months ending June 30, 2021:

*During the three months ended June 30, 2021, the company had net income from continuing operations of $1,144,572, adjusted for non-cash costs for share based payments of $519,548, and non-controlling interest for the period of $558,060, the adjusted net income of the Company was $2,222,180. Adjusted basic earnings per share was $0.02 and diluted earnings per share was $0.02.

* During the six months ended June 30, 2021, the Company had net income from continuing operations of $4,583,453, adjusted for non-cash costs for share-based payments of $2,085,606 and non-controlling interest for the period of $984,196, the adjusted net income of the Company was $7,653,255. Adjusted basic earnings per share was $0.08 and diluted earnings per share was $0.07.

The Companys consolidated financial statements for the quarter ending June 30, 2020 along with its MD&A are available under the Companys profile on SEDAR at http://www.sedar.com.

Business Highlights for the three months ending June 30, 2021:

April 2021

May 2021

June 2021

Subsequent business highlights to June 30, 2021:

July 2021

August 2021

Outlook:

The Company expects to focus on the following primary goals for the next 90 - 120 days are:

Finally, Victory Square integrates a strong ESG (environmental, social and corporate governance) component throughout its operations. Our portfolio highlights minority entrepreneurs, often overlooked by traditional investors, including many from developing countries. We are also dedicated to giving back to the communities in which we serve and operate. The Companys mandate is to assist organizations through its time, talent and treasure. The Company is committed to organizations that provide services in the youth, mental health, special needs, sport, tech, education, marginalized groups, First Nations, and accessibility sectors.

The company and the management team contributed approximately $500,000 in donations to: Variety The Children Charity of BC, CKNW KIDS FUND, Simon Fraser University Tech Camp, The BC Sports Hall of Fame & Museum, Covenant House Vancouver, YWCA, Coast Mental Health, The Cerebral Palsy Association of BC, Mealshare and the BC Childrens Hospital Foundation. These gifts are in conjunction with VSTs GIVING BACK pledge made by its Executive, Staff, and Board.

We are living in the midst of the 4th Industrial Revolution; The Tech Revolution that will undoubtedly change everything as we know it, said Shafin Diamond Tejani. Digital health, AR/VR, Cybersecurity, Gaming, Sports, Entertainment, and Web 3.0 are sectors that Victory Square has invested in. We offer investors the chance to invest in the most exciting tech trends all in one place.

Check out VictorySquare.com and sign up to VSTs official newsletter at http://www.VictorySquare.com/newsletter.

On behalf of the Board of Directors

Shafin Diamond TejaniDirector and Chief Executive OfficerVictory Square Technologies Inc.www.victorysquare.com

For further information about Victory Square, please contact:

Investor RelationsContact Edge Communications GroupEmail: ir@victorysquare.comTelephone: 604 283-9166

Media RelationsContact Howard Blank, DirectorEmail: howard@victorysquare.com

ABOUT VICTORY SQUARE TECHNOLOGIES INC.

Victory Square (VST) builds, acquires and invests in promising startups, then provides the senior leadership and resources needed for fast-track growth. VSTs sweet spot is cutting-edge tech thats shaping the 4th Industrial Revolution. Our corporate portfolio consists of 20+ global companies using AI, VR/AR, and blockchain to disrupt sectors as diverse as fintech, insurance, health and gaming.

What we do differently for startups

VST isnt your ordinary investor. With real skin in the game, were committed to ensuring each company in our portfolio succeeds. Our secret sauce starts with selecting startups that have real solutions, not just ideas. We pair you with senior talent in product, engineering, customer acquisition and more. Then we let you do what you do best build, innovate and disrupt. In 24-36 months, youll scale and be ready to monetize.

What we do differently for investors

For investors, we offer early-stage access to the next unicorns before theyre unicorns. Our portfolio represents a uniquely liquid and secure way for investors to get access to the latest cutting-edge technologies. Because we focus on market-ready solutions that scale quickly, were able to provide strong and stable returns while also tapping into emerging global trends with big upsides.

VST is a publicly-traded company headquartered in Vancouver, Canada, and listed on the Canadian Securities Exchange (VST), Frankfurt Exchange (6F6) and the OTCQX (VSQTF).

For more information, please visit http://www.victorysquare.com.

ABOUT THE CANADIAN SECURITIES EXCHANGE (CSE)

The Canadian Securities Exchange, or CSE, is operated by CNSX Markets Inc. Recognized as a stock exchange in 2004, the CSE began operations in 2003 to provide a modern and efficient alternative for companies looking to access the Canadian public capital markets."

This news release is qualified in its entirety by its interim financial statements and associated MD&A for the period ended June 30, 2021, copies of which are available on the Companys profile on SEDAR at http://www.sedar.com. In the case of any conflict between this news release and the financial statements and MD&A, the information provided in the financial statements and MD&A shall prevail. Investors are referred to the entirety of the financial statements and MD&A.

FORWARD-LOOKING INFORMATION

This news release contains forward-looking information within the meaning of applicable securities laws relating to the outlook of the business of Victory Square and its portfolio companies, including, without limitation, statements relating to future performance, execution of business strategy, future growth, business prospects and opportunities of Victory Square and its related subsidiaries and portfolio companies and other factors beyond our control. Such forward-looking statements may, without limitation, be preceded by, followed by, or include words such as believes, expects, anticipates, estimates, intends, plans, continues, project, potential, possible, contemplate, seek, goal, outlook or similar expressions, or may employ such future or conditional verbs as may, might, will, could, should or would, or may otherwise be indicated as forward-looking statements by grammatical construction, phrasing or context. All statements other than statements of historical facts contained in this news release are forward-looking statements. Forward-looking information is based on certain key expectations and assumptions made by the management of Victory Square. Although Victory Square believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on them because Victory Square can give no assurance that they will prove to be correct. Although Victory Square believes that the expectations reflected in forward-looking statements in this press release are reasonable, such forward-looking statements has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond the Victory Squares control, including, but not limited to, the risk factors discussed in the continuous disclosure materials of the Victory Square which are available under the Victory Squares profile on SEDAR at http://www.sedar.com. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement and are made as of the date hereof. Actual results and developments may differ materially from those contemplated by these statements. The statements contained in this news release are made as of the date of this news release. Victory Square disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof.

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Victory Square Technologies Reports Record 6th Consecutive - GlobeNewswire