Should Biotechnology Stock Checkpoint Therapeutics Inc (CKPT) Be in Your Portfolio Monday? InvestorsObserver
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Should Biotechnology Stock Checkpoint Therapeutics Inc (CKPT) Be in Your Portfolio Monday? - InvestorsObserver
Posted: March 28, 2023 at 12:12 am
Should Biotechnology Stock Checkpoint Therapeutics Inc (CKPT) Be in Your Portfolio Monday? InvestorsObserver
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Should Biotechnology Stock Checkpoint Therapeutics Inc (CKPT) Be in Your Portfolio Monday? - InvestorsObserver
Posted: March 28, 2023 at 12:12 am
Where Does IGM Biosciences Inc (IGMS) Stock Fall in the Biotechnology Field After It Has Fallen -1.80% This Week? InvestorsObserver
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Where Does IGM Biosciences Inc (IGMS) Stock Fall in the Biotechnology Field After It Has Fallen -1.80% This Week? - InvestorsObserver
Posted: March 28, 2023 at 12:12 am
Is Day One Biopharmaceuticals Inc (DAWN) Stock at the Top of the Biotechnology Industry? InvestorsObserver
Posted: March 28, 2023 at 12:12 am
Where Does Jasper Therapeutics Inc (JSPR) Stock Fall in the Biotechnology Field After It Has Risen 3.16% This Week? InvestorsObserver
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Where Does Jasper Therapeutics Inc (JSPR) Stock Fall in the Biotechnology Field After It Has Risen 3.16% This Week? - InvestorsObserver
Posted: March 20, 2023 at 12:07 am
By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.
The FDAs November 2017 regenerative medicine policy framework was developed to help facilitate and support innovation in the area of regenerative medicine therapies. As part of this framework, we encourage sponsors to take advantage of ongoing expedited programs that might be available to them, including Regenerative Medicine Advanced Therapy, breakthrough therapy, and fast track designations, to support product development and licensure.
The framework also outlines the agencys intent to exercise enforcement discretion with respect to the FDAs investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products until November 2020, which was later extended through May 2021. This compliance and enforcement discretion policy gives manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.
We are now reaffirming the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies. The period during which the FDA intends to exercise enforcement discretion with respect to the IND and premarket approval requirements for certain HCT/Ps ends on May 31, 2021, and will not be extended further.
Since November 2017, the FDA has worked with product developers to help them determine if they need to submit an IND or marketing application and, if so, how they should submit their application to the FDA. The FDA developed programs that provide opportunities for engagement between HCT/P manufacturers and the agency, including the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP). TRIP helped manufacturers of HCT/Ps, including stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated. TRIP was a temporary program of the TRG. The TRIP began in June 2019 and was extended twice. It recently ended on March 31, 2021.
Despite all of the FDAs efforts to engage industry, there continues to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to the FDA.
These regenerative medicine products are not without risk and are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they havent been adequately studied in clinical trials. Weve said previously and want to reiterate here there is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law, including by not having an IND in effect or an approved biologics license. We will continue to take action regarding unlawfully marketed products. Our oversight of cellular and related products has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious violations of the law.
Since December 2019, the agency has issued more than 350 letters to manufacturers, clinics, and health care providers, noting that it has come to our attention that they may be offering unapproved regenerative medicine products and reiterating the FDAs compliance and enforcement policy.
We encourage the public and patients who are considering treatment with regenerative medicine products to work with their health care providers to learn about the treatment being offered. Ask questions and understand the potential risks of treatment with unapproved products. It is critical to only seek treatment using legally marketed products, or, for unapproved products, to enroll in clinical trials under FDA oversight. The public can visit the FDAs website to find out if a particular regenerative medicine product is approved.
The FDA remains committed to helping advance the development of safe and effective regenerative medicine products, including stem cell-based products, to benefit individuals in need. We look forward to working with those who share this goal.
Originally posted here:
Advancing Safe and Effective Regenerative Medicine Products
Posted: March 12, 2023 at 12:10 am
Genetic engineering, also calledgenetic modification, is the direct manipulation of an organismsgenomeusing biotechnology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novelorganisms. Read important facts about Genetic Engineering in this article for the IAS Exam.
NewDNAmay be inserted in the host genome by first isolating and copying the genetic material of interest usingmolecular cloningmethods to generate a DNA sequence, or by synthesizing the DNA and then inserting this construct into the host organism.Genesmay be removed, or knocked out, using anuclease.Gene targetingis a different technique that useshomologous recombinationto change an endogenous gene and can be used to delete a gene, removeexons, add a gene, or introducepoint mutations.
Aspirants reading, GEAC can also refer to topics lined below:
Medicine, research, industry and agriculture are a few sectors where genetic engineering applies. It can be used on various plants, animals and microorganisms. The first microorganism to be genetically modified is bacteria.
Genetic Engineering Appraisal Committee (GEAC) is the biotech regulator in India. It is created under the Ministry of Environment and Forests. Read more about GEAC in the linked article.
There are five bodies that are authorized to handle rules noted underEnvironment Protection Act 1986 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989. These are:
Soybean-Herbicide tolerance,Canola-Altered fatty acid composition,Plum-Virus resistance,Corn-Insect resistance
Pros:Tackling and Defeating Diseases,Getting Rid of All Illnesses in Young and Unborn Children,Potential to Live Longer,Produce New Foods,Faster Growth in Animals and Plants,Pest and Disease Resistance.Cons:May Lead to Genetic Defects,Limits Genetic Diversity,Reduced Nutritional Value,Risky Pathogens,Negative Side Effects
UPSC Preparation:
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Genetic Engineering - Meaning, Applications, Advantages and Challenges ...
Posted: March 12, 2023 at 12:09 am
Likewise, its no surprise that armies around the world are eager to lead the way into the new frontier of transhumanism, generals and war leaders have always sought any means to give their army the upper hand over an opponent.
The US Defense Advanced Research Projects Agency (DARPA) has come right out and said that humans [were] the weakest link in defense systems. Some examples of DARPAs research into transhumanist technologies include allowing humans to convert plant matter to glucose, threat detection through optical implants, and even a way for humans to cling to the surface of a flat wall the way lizards do.
As computer technologies advance alongside biotechnologies, there is a growing convergence between the two in the form of neural interfaces that in the future can open the door to linking your mind directly to an AI in order to facilitate greater learning, overcome neurological conditions, or just to use the internet.
In the coming decades, as more advanced computer technologies continue to shrink in size, its not out of the question that brain implants, linked to an AI, might be possible. In fact, DARPA has already started research along these lines.
Without question, these examples of transhumanism point to one of the essential questions every student or teacher of philosophy has grappled with: what does it mean to be human?
Evolution gave us the brain which has given us technologies such as flint tools, the wheel, and clothing that enabled us to extend ourselves past our biological limitations. Is an artificial eye any different? Are we any less human for using an arrow to kill a deer rather than our bare hands? Who gets to decide?
Some critics argue that the two positions transhumanists propose, rejecting human enhancement through augmentation and implants entirely or wholeheartedly embracing everything the transhumanist movement represents is a false dichotomy.
Writing in Psychology Today, Dr. Massimo Pigliucci, a Professor of Philosophy at the University of New York-Lehman College, believes that there is a necessary discussion society must have before we introduceor even think of developingsuch technologies: it is perfectly acceptable indeed necessary for individuals and society to have a thorough discussion about what limits are or are not acceptable when it comes to the ethical issues raised by the use of technologies.
The rest is here:
The Transhuman Revolution: What it is and How to Prepare for its Arrival
Posted: March 12, 2023 at 12:09 am
Imagine a future when earths inhabitants are not humans, but cyborgsrobotlike beings with both biological and mechanical components. With exosuits for added strength, cybernetic arms and legs, surgically-implanted earbuds for advanced hearing, bionic eyes for X-ray and infrared vision, and digitally-enhanced brains, these superbots think and act at lightning speed. Nanobots inside their bodies work continually to maintain and repair organs and tissues. Equally impressive are their organic parts, which have been genetically engineered for health.
These superbeings may sound like something out of a sci-fi movie, but they are the very real aspiration of influential business leaders, government officials, biotech engineers, scientists and futurists around the world, who are spearheading a philosophical and socio-political movement known as transhumanism.
In a nutshell, the transhumanist movement seeks to develop and use technology to radically transform humanity beyond its current physiology and limitationsto augment or amplify natural abilities like intellect and physical strength, create disease-resistant bodies, and extend lifespans or prevent death altogether.
To accomplish its goals, the transhumanist movement is looking to such technologies as genetic engineering (the deliberate altering of DNA sequences to produce new traits), implant technology (the embedding of digital implants in the body to interface with computers), artificial intelligence (the development of computer systems that mimic the thinking capabilities of the human mind), nanotechnology(the manipulation of atoms and molecules to produce new molecular structures), and cybernetics (the replacement of biological body parts with biomechanical devices).
Those involved in the transhumanism movement concede that much of what they envision is only in the early stages of development. We dont have cyborgs living in our midst quite yet, and many question whether it would even be possible to create such beings. But a lot of research is currently underway, in all of the areas just mentioned, to try to speed the transhumanist agenda along.
Many times the innovations that move us closer to transhumanism were devised for totally different purposes. For instance, invitro fertilization was developed to assist with the conception of a child and screen for genetic diseases, but could also be used to select for certain desirable traits and create designer babies. Neural lace, a wireless brain-computer interface, is being billed as a new way to treat neurological disorders, but could also connect the brain with artificial intelligence (AI) software to boost mental acuity. Radiofrequency ID microchips got their start in retail and business applications, but are now being implanted in peoples hands as universal I.D. cards, building access card keys and credit cards, all under the auspices of convenience and security.
Our world is certainly moving towards a transhuman future. Some leaders in the movement are hoping to have created full-fledged cyborgs by the early 2030s. And while transhumanists would see that as a huge accomplishment, thats not all they want to do. Ultimately, they hope to not only digitally and genetically enhance fleshly bodies, but to actually be liberated from them.
Many futurist thinkers envisage the day when people will be able to separate their minds from their biological bodies, and transfer them to a super computer or mega server (in the same way a computer file could be moved from one machine to another), and live forever in a virtual reality environment. Transhumanists refer to this as the posthuman state. They believe at that point, the distinctions between virtual reality and actual reality, or human and machine, will have been completely dissolved. Individuals will be able to take on holographic-like avatars, changing and shifting their identities to their liking, free to roam the Metaverse as immortal cyberbeings.
Futurist Ray Kurzweil, one of the main leaders in the transhumanism movement, predicts that around 2045, earth will be inhabited entirely by computers. Purely organic humans will have become extinct, he asserts. Those who survive will be the ones who will have fused their minds with the all-powerful computers.
It can be tempting to just laugh all this off, because much of what transhumanists want to do really DOES sound like science fiction. But the fact remains, the early workings of transhumanism ARE here. There are many negative implications of going that direction as a society, particularly from a biblical standpoint. We need to be aware of what this movement is about, because even though its unlikely transhumanists will be able to pull off everything they want to do, some of their ideas could impact us. Here are six very big reasons why transhumanism is so very wrong:
1. God is not part of the thinking.
Transhumanists reject any belief in God or a spiritual realm. Instead, they have generally adopted the philosophical position known as materialism, which regards the natural, material and physical universe as the only reality. They insist that anything which is not composed of matter, does not exist. They see science as the source of all knowledge, and the lens in which to understand the world, find solutions to lifes challenges, and discover meaning in existence.
Romans 1:28 Romans 1:28And even as they did not like to retain God in their knowledge, God gave them over to a reprobate mind, to do those things which are not convenient;American King James Versionaptly applies to transhumanism: And even as they did not like to retain God intheirknowledge, God gave them over to a debased mind, to do those things which are not fitting. When people dismiss the Bible, their thinking immediately starts going in the wrong direction. Nothing truly good can come out reasoning that relies on human perspectives alone. Starting with a wrong premise only leads to more bad ideas.
2. The posthuman virtual world is a counterfeit version of eternal life.
Transhumanism is basically an attempt by mankind to achieve eternal life withoutGod. Rather than being thankful for Christs sacrifice and looking to His return as the only hope for mankind, transhumanists regard technology as their savior. They still want to live forever, and have deluded themselves into thinking this can be done via a physical meansby uploading their minds onto a computer-generated virtual world. Even if that was doable, it would not be a joyful existence, as true peace and happiness is not possible apart from God.
3. Transhumanism is a form of evolution.
Materialism, which transhumanism is built on, posits that mankind came into existence through evolutionthe theory that lifeforms are continually changing for the better, and that the present form of any organism is a diminished version of what is to come. Transhumanism offers its own twist: that mankind should use technology to artificially speed up the evolutionary process and bring on the next phasemerging humans with machines.
According to transhumanism, our physical bodies are the primary impediment to our advancement as a species. Yet the Bible describes the human body as fearfully and wonderfully made (Psalms 139:14 Psalms 139:14I will praise you; for I am fearfully and wonderfully made: marvelous are your works; and that my soul knows right well.American King James Version). God created us as He intended. His design for us does not require improvement.
This does not mean that we should oppose thoughtful use of gene editing and other biomedical procedures to treat or screen for genetic diseases, or restore normal body functioning after catastrophic injuries. But if we cross the line to reinvent the human body, we are, in effect, saying that we can do better than God, writes B.M. Coaker in Who are You? (AuthorHouse, 2018). We have been given the ability to appreciate and admire Gods handiwork in His originally unflawed design . . . but He has not given us the mandate to take our exploration and curiosity beyond his handiwork (p. 56). The primary concern lies in implementing biotechnological enhancements to the point that we lose our identity as human beings.
4. There is no recognition of the spiritual components of the mind.
The Bible tells us that we human beings have a spiritual component to our makeup (Job 32:8 Job 32:8But there is a spirit in man: and the inspiration of the Almighty gives them understanding.American King James Version, 1 Corinthians 2:11 1 Corinthians 2:11For what man knows the things of a man, save the spirit of man which is in him? even so the things of God knows no man, but the Spirit of God.American King James Version). It is this spirit of man that imparts intellect to our brains, creating the human mind. Transhumanists, as materialists, are not open to this truth. They posit that the human mind (including our thoughts and personalities) is purely physical, consisting of groups of chemicals, neural connections and electrical impulses that operate in predetermined ways. This is why they think its possible to capture and digitize the information patterns that supposedly comprise a persons consciousness, and upload it to a computer server.
However, some scientists, even within the transhumanism movement, have expressed doubts about whether this idea of mind uploading is actually possible, acknowledging that the faculties of the human mind cannot be reduced to simple patterns of brain chemistry. They point out that even if a persons mind could be reproduced in machine form, the results would not preserve the original person in any true sense. At best, it might be a rough copy of a few personality traits or mimic some of the persons attitudes, but without true self-awareness, sentience, and consciousness.
5. Morality is not addressed or seen as important.
When transhumanists talk about the future they envisage, they focus on physical health and strength and cognitive abilities. Thats because they see the human condition as purely a physical problem, needing physical solutions.But the fact is, humanitys foundational problems are spiritual in nature, and require spiritual solutions. We wont be able to control our human nature or have true morality without God.
Human nature cant be changed through the augmentation of intelligence, writes Sandra Godde in Reaching for Immortality: Can Science Cheat Death? (Wipf and Stock, 2022). Even a cursory view of history reminds us that sophisticated societies can still invent more horrific ways to destroy their neighbors and exalt themselves . . . It follows that technological advance does not inevitably lead to advance in human goodness (p. 40).
For the most part, transhumanists have no explanation for what human nature is, where it comes from, or how to manage it. There is also no consensus among them as to how morals are developed. Some transhumanists will at least admit that moral character is not an attribute that can be programmed in. The Bible makes it clear that character development requires the free choice of individuals who must want to build it, and that it is something we have to diligently pursue (2 Peter 1:5-8 2 Peter 1:5-8 [5] And beside this, giving all diligence, add to your faith virtue; and to virtue knowledge; [6] And to knowledge temperance; and to temperance patience; and to patience godliness; [7] And to godliness brotherly kindness; and to brotherly kindness charity. [8] For if these things be in you, and abound, they make you that you shall neither be barren nor unfruitful in the knowledge of our Lord Jesus Christ.American King James Version).
Even if character could be instilled as an enhancement, there would be no agreement among transhumanists as to what constitutes good morals. Moral absolutes depend on an absolute law giver, which could only be our Creator. Without belief in God, transhumanists become moral relativists by default, meaning individuals decide for themselves whats right and wrong. This inevitably leads to individuals to pursuing their own selfish motives. Living in a world like that for eternity hardly sounds pleasant.
6. Transhumanism could intensify conflict or lead to enslavement.
Without God and His standards of morality and justice being integrated into the theoretical transhuman or posthuman worlds, the machine-beings that exist would still have human nature and the same type of evil predispositions as mankind has always had, but with much more power to perform their acts. Some warn that in the future there could be two classes of beings on earth: the bionically-enhanced superhumans, who brutalize the other weaker class of beings, the non-enhanced humans. Others warn that if computers were to achieve super AI (a level of intelligence thats vastly superior to that of humans) and human minds were able to live via a cloud connection in the virtual world, their more intelligent machine overlords could enslave them.
But even the softer forms of transhumanism were seeing now could set the stage for control. For instance, subdermal microchips and brain computer interfaces could be used for surveillance, or even for reading and manipulating our thoughts and behavior. This is particularly troubling if those who are doing the monitoring are positions over us and have different values or beliefs than we do.
There can be no doubt that Satan is behind the transhumanism movement. Satan hates Gods plan to bring many sons to glory (Hebrews 2:10 Hebrews 2:10For it became him, for whom are all things, and by whom are all things, in bringing many sons to glory, to make the captain of their salvation perfect through sufferings.American King James Version). He will do everything he can to try to destroy mankind before that happens, and transhumanism appears to be a way he is trying to do that. But it is a futile endeavor. Many of the worlds intellectuals too have convinced themselves transhumanism will work, despite facts indicating just the opposite.
Futurists often point to recent innovations like brain-controlled prosthetic limbs, surgically-implanted hearing aids, and antenna implants in the skull to help colorblind individuals perceive colorsas proof that were on our way to transhumanism. But these kinds of augmentations are a far cry from the creation of cyborgs and avatars.
Transhumanists face some insurmountable challenges. For one, the human mind with its nonphysical components, cannot be removed from a physical body and transferred over to a robot, computer server or any other machine. Moreover, qualities like emotions, beliefs, values and intuition cannot be reduced to mere computer codes, to be uploaded to a digital medium.
The other huge challenge is their quest to achieve strong AI, which is central to creating the superbeings they desire. Strong AI includes Super AI and General AI (intelligence equal to humans), and would have all features of human cognition, including self-awareness, sentience, consciousness. Scientists have been trying to develop Strong AI for several decades and they are still only in the theoretical stage. There is growing doubt about whether a computer could ever really think and understand like a human.
In so many ways, transhumanism is Satans attempt to detour God in His incredible plans for mankind. Thankfully, its unlikely transhumanism will ever come to fruition. It really IS mostly fiction. Still, understanding what transhumanism is about is a helpful exercise and a huge reminder of what happens when humans do not include God in their thinking.
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Transhumanism: What It Is, and Why It Is So Fundamentally Wrong
Posted: March 4, 2023 at 12:14 am
New positive data demonstrate oral AMT-101’s gut-restricted profile with tissue-level pharmacodynamics (PD) effects and no systemic exposure by design
Posted: March 4, 2023 at 12:14 am
SEATTLE, Wash. and VANCOUVER, British Columbia, March 03, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, announced data from the Phase 3 ORCA-2 trial will be presented at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting, being held in San Antonio, TX, March 1-4, 2023.Additional findings from the ORCA-2 trial, that evaluated cytisinicline as a treatment for smoking cessation, will be included in the “Novel Treatments for Smoking Cessation” session held today, March 3, 2023, at 3:15 p.m. CST. The presentation will be given by ORCA-2 Principal Investigator, Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital.Positive topline results from the ORCA-2 trial were reported in April 2022, demonstrating 6-8 times increased likelihood of smoking abstinence with 3mg cytisinicline dosed 3 times daily for a period of 6-weeks or 12-weeks compared to placebo in 810 adult U.S. smokers. The study population was approximately 52 years in age, smoked a pack of cigarettes a day, and had made 5 to 6 prior quit attempts.Additional analyses being reported today confirm that successful abstinence was observed in subgroups of smokers who received cytisinicline, regardless of age, gender, smoking history, or previous quit attempts. Subjects who received either 6 or 12-weeks of cytisinicline treatment experienced consistently higher rates of abstinence. The improvement was observed by the second week of treatment, maintained weekly throughout study treatment and during the 24- week follow-up period, compared to those who received placebo. Study compliance was high with 82% of subjects completing the 12 weeks of treatment. No treatment-related serious adverse events were reported and the majority of adverse events were mild in all subjects.Dr. Cindy Jacobs, Achieve Chief Medical Officer and President commented, “The ORCA-2 population represents a vast majority of smokers in the real world who remain heavy smokers, want to quit smoking, and have made multiple, unsuccessful quit attempts utilizing various methods. The ability of cytisinicline to improve the likelihood of quitting, regardless of prior treatments and level of nicotine dependence, will be critical for increased adoption and future prescribing, if ultimately approved by the FDA.”Achieve is currently conducting the final FDA-registration enabling Phase 3 ORCA-3 trial for smoking cessation and the Phase 2 ORCA-V1 trial evaluating cytisinicline for e-cigarette cessation. The Company continues to expect topline data results for both trials to be announced in the second quarter of 2023. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. To learn more about SRNT or the SRNT Annual Meeting, please visit www.srnt.org.About Achieve and Cytisinicline?Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2In addition, there are over 9 million adults in the United States who use e-cigarettes, also known as vaping.3 While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of the COVID-19 pandemic or similar public health crises and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable.Investor Relations ContactNicole Jonesachv@cg.capital(404) 736-3838Media ContactGlenn SilverGlenn.Silver@Finnpartners.com(646) 871-8485References1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.2U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.3Cornelius ME, Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco Product Use Among Adults — United States, 2020. MMWR Morb Mortal Wkly Rep 2022;71:397–405.4Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].5Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.6Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.