Good afternoon, everyone, and thank you for joining us today. At this time, all participants are in a listen-only mode. Following management's remarks, we will hold a brief question-and-answer session. At this time, the lines will be open for you. If anyone would like to ask a question during the time, please press star followed by the number one on your telephone keypad. As a reminder, this conference call is being recorded. I will now turn the call over to Miguel Arcinas, Vice President of Corporate Development and Investor Relations, Silverback Therapeutics.
Thank you and good afternoon. Joining me on today's call from the Silverback team are Laura Shawver, Chief Executive Officer, Valerie Odegard, President and Chief Scientific Officer, and Jonathan Piazza, Chief Financial Officer. From the ARS Pharmaceutical team, we have Richard Lowenthal, Chief Executive Officer, Sarina Tanimoto, Chief Medical Officer, Eric Karas, Chief Commercial Officer, Kathleen Scott, Chief Financial Officer, and Justin Chakma, Chief Business Officer. The recording and the slides presented during this call will be available on the investor relations section of Silverback's website and the news section of ARS' website for thirty days. Before I start, I would like to remind you that today's call and the accompanying presentation will include forward-looking statements which include, but are not limited to, statements regarding the expected timing, completion, effects, and potential benefits of the transaction and our future expectations, plans, and prospects for the combined company.
Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. Silverback and ARS undertake no obligation to update or revise any forward-looking statements. Slide two provides an overview of these forward-looking statements and the risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated in these forward-looking statements. Please refer to Silverback's most recent filings with the SEC, which are available from the SEC at sec.gov or on Silverback's website, for additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated in these forward-looking statements, including in our press release issued this afternoon and our Form 8-K filed with the SEC this afternoon announcing the transaction and our most recent quarterly report on Form 10-Q.
As indicated on slide 3, we intend to file a preliminary and definitive proxy statement with the SEC relating to the proposed merger. Please be advised to read, when available, the proxy statements and other relevant documents filed with the SEC, as these will contain important information about Silverback, ARS, and the transaction. Once available, these documents can be obtained free of charge from the SEC at sec.gov or on Silverback's website. I will now turn the call over to Dr. Laura Shawver, CEO of Silverback Therapeutics.
Thank you, Miguel, and good afternoon, everyone. Today, we announced the proposed merger of Silverback Therapeutics and ARS Pharmaceuticals. I am pleased to have the opportunity to discuss this important and transformative transaction. I'll start by providing background surrounding Silverback's process to identify strategic alternatives and the rationale for this transaction. I'll then hand it off to Richard Lowenthal, CEO of ARS Pharmaceuticals, to provide an overview of ARS Pharmaceuticals and its lead product candidate, Neffy, the first no-needle, no-injection solution for Type I allergic reactions. Let's start with an overview of what brought us here today. On March 31, 2022, Silverback announced a strategic corporate realignment to discontinue our TLR8 oncology programs, SBT6050 and SBT6290, to focus resources on the development of SBT8230 for chronic hepatitis B virus infections and Silverback's preclinical pipeline.
As a part of this strategic realignment, we restructured our workforce to support prioritized development, reduce operating expenses, and extend our cash runway into the second half of 2026. Beginning in April of 2022, Silverback initiated a process to evaluate alternatives for the company, including strategic mergers and acquisitions, asset acquisitions and sales, remaining a standalone company pursuing a limited pipeline focusing on SBT 8230 and our preclinical programs, and liquidation to distribute available cash. The goal of this evaluation was to identify the opportunity that would, in the Silverback board's opinion, create the most value for Silverback stockholders.
After a thorough review of strategic alternatives by Silverback's board of directors, including discussions with Silverback's senior management, financial advisors, and legal counsel, the board unanimously supported a merger with ARS Pharmaceuticals and believes that this transaction is likely to be more beneficial to Silverback stockholders than the potential value that might result from any other strategic option available to Silverback. Silverback stockholders should be excited about this transaction for several reasons. ARS Pharmaceuticals has been developing Neffy, a potential first-in-class, no needle, no injection solution for Type I allergic reactions that is expected to launch in the U.S. in 2023. The product offers a clear value proposition over epinephrine injection devices in a sizable potential market. Importantly, ARS is led by a highly experienced management team that has a proven track record developing and commercializing intranasal and consumer-driven medicines.
This transaction has the potential to create value for the stockholders of the combined company and is an opportunity for Silverback stockholders to participate in the potential growth of the combined company. In addition to closing the merger with ARS, Silverback will focus on exploring opportunities to divest our legacy programs, including SBT8230 for chronic HBV and our preclinical assets. Moving to slide five, let's review the details of the transaction. We announced today that we have entered into a definitive agreement under which ARS will merge with a wholly owned subsidiary of Silverback in an all stock transaction. The merger is currently expected to close in the fourth quarter of this year. The combined company is expected to have approximately $265 million in cash equivalents and marketable securities at closing, which we estimate will provide at least three years of operating runway.
Under the terms of the merger agreement, assuming that Silverback's net cash at closing is $240 million, Silverback equity holders prior to the transaction are expected to own approximately 37% of the combined company and ARS equity holders prior to the transaction will own approximately 63% of the combined company on a fully diluted basis using the treasury stock method. ARS was valued at approximately $400 million in enterprise value, plus an additional approximately $35 million in cash on hand. Silverback was valued at a total value of approximately $255 million. The percentage of the combined company that stockholders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback's net cash at closing.
Upon stockholder approval and the closing of the transaction, Silverback is expected to operate under the name ARS Pharmaceuticals, Inc., and be headquartered in San Diego, California, and trade on the Nasdaq Capital Market under the ticker symbol SPRY. With respect to management team for the combined company, I will step down as CEO by close of the transaction and anticipate staying on as a member of the board of directors. The combined company will be led by ARS Pharmaceuticals' experienced executive team, including Richard Lowenthal, CEO, Sarina Tanimoto, CMO, Eric Karas, Chief Commercial Officer, Kathleen Scott, CFO, and Justin Chakma, CBO. Coincident with this announcement, Silverback will terminate R&D activities associated with its internal programs and reduce our headcount.
Remaining Silverback employees and management will focus on the closing of the merger and exploring opportunities to divest our preclinical assets and will generally depart the organization on a rolling basis as activities are completed. Finally, I would like to extend my sincere thanks to Silverback's employees for remaining diligently focused on our programs, to the patients and investigators that participated in our trials, and to our stockholders, partners, and board of directors who have supported us all along the way. With that, I'll turn the call over to Richard Lowenthal, CEO of ARS Pharmaceuticals.
Thank you, Laura, for that kind introduction. My name is Richard Lowenthal, CEO and founder of ARS Pharmaceuticals. As outlined on this slide, we wanted to first remind everybody that Neffy is an investigational product and is not yet approved by the US Food and Drug Administration or the European Medicines Agency. The trade name Neffy has been tentatively approved by the US FDA but has not received final approval. It's a great pleasure for me to introduce you to ARS Pharmaceuticals and Neffy, our needle free epinephrine nasal spray. Our goal for Neffy is to achieve what has not been possible before, which is to deliver epinephrine with comparable pharmacokinetics to intramuscular injection, but with a nasal spray that is easy to use and eliminates the fear of injecting with a needle.
Once approved, we believe Neffy's optimal product profile has the potential to transform the treatment of Type I allergic reactions. We founded ARS in 2015 with a goal of solving many of the issues patients and caregivers expressed about their current epinephrine injection devices. From day one, our team was focused on taking this well known life saving medication for severe allergies and making administration needle free, easy to use and a safer alternative to needle injectors. that the patients and caregivers would have less hesitation to dose immediately after symptoms of an allergic reaction are detected. At that time, our co-founder and Chief Medical Officer, Dr. Tanimoto, and I, along with many on our extended team, were working on the approval of NARCAN nasal spray and VALTOCO nasal spray, which are now FDA-approved products for the emergency treatment of opioid overdose and acute repetitive seizures.
We were also working with Aegis, a company developing an excipient known as Intravail or Dodecyl maltoside. While epinephrine is not normally absorbed in the nose, we licensed Intravail's remarkable properties to facilitate penetration through mucosal membranes and achieved injection-like absorption with Neffy. We use the same single-dose nasal spray device that has been proven to be easy to use and highly reliable for NARCAN and VALTOCO, as well as many other U.S. approved products. Type one allergic reactions are life-threatening hypersensitivity reactions that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only known medication for this disease.
The only approved community-based products to treat this condition today are epinephrine injection devices, which are effective if carried, used properly, and used in time. However, research indicates that patients and caregivers do not always carry their injection devices, and if they do, they sometimes use these products incorrectly or significantly delay administration. This reluctance to use needle-based injection devices in a timely manner is often driven by fear. Fear of the needles, fear of the pain, concerns about safety, and the complexity of the device used. Neffy is needle-free. It's small and easy to use. It fits in the palm of your hand or pocket, as you can see. Our motto is, "No needle, no fear, no wait." If FDA approved, we hope that patients will carry Neffy always and dose immediately at the first signs of an allergic reaction.
We believe Neffy is ideally positioned to shift this market into an entirely new paradigm with better treatment outcomes. ARS is a late-stage company on the verge of submitting our NDA for Neffy in the third quarter of 2022. Assuming approval by the FDA and EMA, we anticipate launching Neffy in 2023 in the U.S. and 2024 in Europe. We currently estimate that the U.S. market is approximately $1 billion. However, we believe that there is potential opportunity not only to capture a majority of the current injection device market, but to grow towards a potential multi-billion-dollar market driven by strong physician interest and consumer demand for a better way to treat their severe Type I allergies.
ARS has also built a strong patent position expected to provide protection to at least 2038 with two patent families that include composition of matter and method of use claims. To execute on the development and commercialization of Neffy, we built a deeply experienced and robust management team, many of whom have firsthand experience leading the development and commercial efforts for approved nasal spray products such as Narcan, as well as extensive drug development, R&D, business, and regulatory expertise, all of which position ARS for near and long-term success. We've been supported by a strong board of directors with broad industry experience and industry-leading investors who share our view of the opportunities with Neffy. Nearly all of our current board members are expected to continue to serve on the board of the combined companies, along with three of Silverback's directors.
We also have meaningful partnerships outside North America, where ARS will focus our efforts, including license deals with Recordati in the European region, along with partners in Japan and China. Type one allergic reactions can lead to serious and sometimes scary symptoms that can be life-threatening if allowed to progress. There are approximately 25 million people in the United States today that suffer from severe allergies and that involve two or more organ systems when exposed to an antigen. If the reaction is not stopped quickly, it can cause serious symptoms that last for days or can even have long-term adverse effects and comorbidities. These severe allergic reactions result in more than 500,000 visits to the emergency room per year, costing an average of $1,600 or more for each patient.
As noted, epinephrine injection devices are effective and have helped many people with severe allergic reactions. However, the fear of the needle, fear of the pain, and associated side effects can cause apprehension to dose, resulting in patients and caregivers not dosing when needed or significantly delaying administration of epinephrine. These behaviors result in further disease progression and more serious symptoms that can lead to worse clinical outcomes. In addition, the devices themselves are not user-friendly. They are often intimidating and have a long history of poor reliability, with reports of product failures, recalls, and warnings from the FDA. To understand the best way to stop an allergic reaction, it's important to first know how severe allergic reactions progress. Following exposure to an antigen, an allergic reaction can progress rapidly, resulting in very severe symptoms and a state of anaphylaxis in just 15-30 minutes.
Early intervention with epinephrine is critical. Current labeling for epinephrine indicates that dosing should occur as rapidly as possible after initial symptoms of an allergic reaction are experienced, typically in the first five minutes after exposure to the antigen. Epinephrine is exceptionally effective if dosed early in the course of the reaction. If treatment is delayed, there is a point where even repeat doses of epinephrine may not be effective in stopping the reaction, sometimes with tragic outcomes. Experts in the field, the literature and our extensive market research with patients and caregivers tell us that there are several key consumer issues with epinephrine injection devices that, if addressed, can significantly improve treatment outcomes. The key limitations of these injection devices are that 50% of people do not carry them when needed.
Of those that carry their devices, 25%-50% do not dose them when an allergic reaction occurs and present themselves at an emergency room without first administering epinephrine. Even when people dose, approximately 60% delay treatment, allowing the reaction to progress, resulting in worse clinical outcomes. Finally, up to 35% of people fail to use their device properly, sometimes resulting in lack of effective treatment. We believe that once approved, Neffy is positioned to solve many of these problems. Neffy is small, similar in size to your AirPod case, allowing people to carry it in your pocket discreetly at all times. Neffy has no needle and thus eliminates the fear that causes much of the hesitation that those in the community.
By removing the needle, Neffy can be safer for both the patient and caregiver as there is no risk of accidental injection into your hand or other extremities which can result in an ER visit. As a nasal spray, there's no risk of accidental injection into a blood vessel causing a laceration or painful injection into the bone of a small child. Neffy has been shown to be both easier to use and more consistent in dosing. It's simple for people to use. In human factor validation studies, the FDA even requested we evaluate the use of Neffy in a group called Passersby. This is somebody who has no knowledge of the disease or the device, but represents a person that would aid a patient in time of need.
These passersby were able to simply read the directions and figure out how to use Neffy very quickly and effectively 100% of the time. If FDA deems it appropriate, it may be possible for Neffy to be available in public places such as restaurants or airplanes for use in allergy emergency, where this would not be possible with an injection device, given the needle-related risks. Finally, the Neffy device has been proven to be highly reliable in delivering an effective dose accurately with less than one in 100,000 chances of being outside of the specifications for dose delivered. Taken together, Neffy has the potential to address almost all of the limitations associated with injection devices and improve outcomes for patients. Our top goal is to get Neffy to patients and caregivers as soon as possible.
We have had multiple meetings with FDA and EMA to validate our development approach. ARS plans to file our NDA and MAA for the 2 mg dose based on four key clinical trials in both adults and pediatric patients. These studies will be supported by multiple early pilot studies and several large clinical trials with a commercial 1 mg dose of Neffy. The data being filed includes an interim analysis with 57 children with severe allergies from our ongoing EPITAN study in patients aged four years and older. We believe that these data could support an initial approval of Neffy 2 mgs for children 30 kilograms body weight and above. We plan to seek approval for the Neffy 1 mg dose based on the final EPITAN results in children 15 to 30 kilograms body weight immediately after the initial approval of our NDA and MAA applications.
The main criteria for Neffy approval by regulators are based on the maximum observed concentration of the drug or Cmax, time to peak concentration or Tmax, and the early partial exposures or partial AUC in the first 20-45 minutes. While IM injection with a needle and syringe is the reference listed drug, regulators agree that the ideal pharmacokinetic profile for Neffy is to be within the range of injection products, or in other words, bracketed by the other injection products pharmacokinetic profile. Overall exposure or AUC zero to T is less important for efficacy with epinephrine, but is an important consideration to ensure safety. Our clinical data show Neffy meets all of the regulator confirmed endpoints. As a frame of reference when looking at both our clinical data and recent literature.
If you compare different approved injection products, we see a wide range of pharmacokinetic profiles depending on the device used. FDA considers a 0.3 mg dose of epinephrine given by IM injection with needle and syringe of the reference listed drug, as mentioned, given approximately 100 years of safe and effective use. Despite this wide range of pharmacokinetics, it's important to remember that the literature and clinical practice support that there is no known difference in efficacy between these different injection devices, either on timed onset or overall effect. IM needle and syringe gives the same clinical outcomes as EpiPen. Results from our key clinical trials compared to injection products is presented on slide 17.
The data is distilled down to the simple concept that Neffy's pharmacokinetics when dosed by a caregiver to adults or children and upon self-administration, are within the range of approved efficacious injection products and therefore should meet all criteria established by regulators. On the left and in the middle are box and whisker plots of Cmax and Tmax. On the right are tables showing partial AUCs between zero and 20 and zero and 45 minutes, as well as overall AUC. The significance of the partial AUCs is to show exposures in the early time points after administration of an epinephrine product. As mentioned, the overall AUC is not meaningful for efficacy, but is an important factor for safety based on regulators' advice. Starting with the first chart on the left, this is a box and whisker plot of Cmax for Neffy and approved injection products.
The hashed horizontal lines show the range of Cmax values from 277-581 pg/mL across all injection products. As denoted by the circled numbers, Neffy Cmax is clearly within this range. The middle plot shows Tmax, or time to maximum concentration, and again, the mean for Neffy is within the range of approved injection products. The table on the right shows partial and overall AUC, and again, Neffy meets the criteria established by regulators. Turning to the next slide, our data show that Neffy is well-tolerated. We've treated over 500 individuals with Neffy in our clinical programs with doses ranging from 0.5-2 mg, many with repeat doses in crossover studies and twice dosing so that they received 4 mg in 10 minutes, as could occur in real life.
Most adverse events were mild and comparable to injection products. There is no meaningful irritation caused by Neffy, and pain is measured by a validated visual analog scale, gives mean scores between five and eight out of 100 across all ARS studies, including in children down to four years old. These pain scores are similar to those observed using VAS scales with saline in published studies. While Neffy is more rapidly absorbed than IM injection with a needle and syringe, there is no risk of bolus injection into a blood vessel or absorption of epinephrine too rapidly. The FDA labeling for epinephrine injection products warns of possible IV bolus injection that can result in very serious adverse effects.
In ARS clinical studies, possible injection into a blood vessel resulting in very rapid and high peak exposures of epinephrine have been observed to occur more than 13% of the time with EpiPen. Finally, by simply removing the needle, that one change, Neffy will offer safety advantages for both patients and caregivers by eliminating the risk of accidental self injection into extremities like your hand, or injecting into a blood vessel, or giving a laceration, or injection into the bone of a small child, as we've talked about. Taken together, we believe our clinical package supports filing our NDA in the third quarter of 2022. With positive FDA meetings behind us and data that support Neffy meets all of the FDA's recommendations for submission, we believe that there are no additional data or gating factors needed for our planned NDA submission.
If approved, we anticipate executing the commercial launch of Neffy in 2023 in both adults and children 30 kilograms and greater. Our IP portfolio for Neffy is strong and atypical of such 505(b)(2) products with both composition of matter and method of use patents. We have 2 main patent families with expiration dates out to 2038 before any patent term extension, which we expect will offer protection for at least 15 years after approval of Neffy. Our main product claims have been approved in many major regions around the world, including in the United States, European Union, United Kingdom, Japan, Australia, and South Korea, with many other countries pending approval. Our intention is to secure worldwide coverage of Neffy by the time of approval in the US and Europe.
The product profile demonstrated by Neffy across our clinical trials gives us confidence in our ability to penetrate the existing market in the U.S., which we estimate is approximately $1 billion. There is potential to expand over time to a multi-billion dollar market opportunity. We know there are 25 million people with serious type one allergies that may benefit from having epinephrine rescue medication. Our goal is to first convert a significant portion of the existing 3.3 million people with injection devices today to Neffy users. We believe that with strong community education programs, partnership with advocacy groups, and a user-friendly, small, and needle-free way to administer epinephrine when needed in an emergency, that Neffy can reach many more of the patients and caregivers that currently should have epinephrine with them at all times, but fear and avoid needle-based products.
With this backdrop, let me ask Eric Karas, our Chief Commercial Officer, who was responsible for the impressive market expansion of NARCAN nasal spray, to walk through our market opportunity and go-to-market strategy for Neffy.
Thank you, Richard. This is an exciting time for ARS, and the opportunity for Neffy is significant. We know that many physicians, patients, parents, and caregivers are dissatisfied with their epinephrine needle injectors and are seeking. Patients don't carry them, and for those who do, many hesitate to use them because they fear needles. For parents, the angst of injecting a child is a considerable barrier. Not only did Neffy perform as well as injection products in our clinical program, but it can also offer a more convenient and desirable alternative for those who currently carry a needle injector and are at risk of a type one allergic reaction. Before joining ARS, I led the commercialization of NARCAN, and there are many similarities to Neffy.
Opiate overdose reversal was an injection-based market with generic options, and the disease resulted in severe and life-threatening outcomes. When I began working on NARCAN, the market research with healthcare professionals and patients showed expected adoption rates in the low 40% range. During my time leading the commercial team, we far exceeded that expectation. Starting at 14% in year one, jumping to 46% the following year, and 90% by the end of 2019. NARCAN remains a brand leader today. With our capabilities and broad insights gained through similar experiences, I'm confident our commercial plans for Neffy will achieve strong results. We believe that Neffy has the opportunity to fill a significant void that needle injectors can't address. Think of a parent whose child has food allergies. This is highly concerning, as all reactions are unpredictable and can potentially become life-threatening.
Sadly, hundreds of deaths occur each year from severe allergic reactions. These reactions present in multiple ways, and as Richard mentioned, they progress very quickly and time to treatment is critical. We believe the solution is a product that can address the deficiencies of needle injectors. On an annual basis, the community-used epinephrine market is growing at 5% year-over-year and is projected to reach 25 million patients in 2023. There are three main segments of patients, and Neffy has the potential to address all three. The first segment is our primary launch target, the 3.3 million patients with severe allergic reactions who have a prescription for an epinephrine product. The second segment is our secondary launch target, the 13 million patients with severe allergic reactions diagnosed and managed by an HCP, but don't have a current prescription for epinephrine.
The third segment is an opportunity for future expansion, addressing the 8.6 million patients with severe allergic reaction who are not being managed by an HCP today. We believe that over time, we'll be able to capture the lion's share of our primary target audience. From there, we'll turn to segment two and focus on the patients who need epinephrine but avoid injection products, and ultimately to segment three. Combined, our primary and secondary targets represent about 16 million potential patients, which is a substantial opportunity for growth in this category. If approved, Neffy is poised to be the first epinephrine product to treat a type one allergic reaction at the first sign of symptoms without a needle, reducing the hesitation to dose. This is critical to lowering the frequency of ER visits and hospitalizations.
A survey of 40,000 patients with severe allergic reactions in 2015 showed that 38% reported at least one food allergy-related lifetime emergency room visit. In just a few minutes, symptoms can progress to respiratory distress and over time to the most severe state of an allergic reaction, anaphylaxis. Hesitation to treat is a major limitation for epinephrine needle injectors, and we believe that Neffy can change that. We've conducted extensive market research showing strong preference numbers and indicating a favorable reception for Neffy across all stakeholders. HCPs characterize Neffy as a significant advancement in therapy and rated it an 8.5 out of 10, a much higher rating than the other products currently in the marketplace.
100% of physicians surveyed said they would prescribe Neffy if their patients asked for it, and many physicians reported they would recommend Neffy immediately upon its launch, and eventually the majority over time.
The patient feedback for Neffy is also compelling and indicates strong demand. Our market research tells us about 80% of patients who have needle injectors prefer Neffy. Among patients who have an epinephrine prescription but haven't filled it, 75% of them stated they would also ask their physician about a prescription for Neffy. Our patient research also indicates that they'd be more likely to use Neffy sooner and would be more comfortable using it in public, which is a challenge with needle injectors.
Neffy is seen as a possible game changer by physicians, something that will make the current needle injectors as dated a technology as the flip phone is today. This type of sentiment points to the potential for adoption, and the quotes on this slide show that outlook. The critical point among caregivers is that an injection is a barrier and can cause delays because the size is awkward, the mode of injection can be embarrassing and painful. The comments on this slide capture consumer sentiment. As you can see, parents are motivated for something new and tell us they are excited about Neffy. We surveyed 200 patients and caregivers who had used a needle injector over the last 12 months to see if their time to administer would change if they had Neffy.
Findings suggest that the average time to use across patients and caregivers would drop significantly if they had Neffy instead of a needle injector, an important insight and potential advantage for Neffy. Patients and parents also indicated they would use Neffy sooner and obtain more units than they do currently with needle injectors. They were more comfortable with Neffy and indicate they would be willing to fill and carry the prescription to make sure it's readily available in case of an emergency. Equally important for commercial success is how payers will view Neffy, as access and affordability will be critical. Based on market research with over 50 decision makers within the major payers, we believe they also view Neffy as a differentiated product. Based on our product profile, responsible pricing and contracting, Neffy could obtain coverage for a significant portion of patients within the first 12 months of launch.
To execute this market opportunity, experience has told us that we need to launch strong, and the team at ARS has deep insights and extensive experience in successfully launching and commercializing dozens of transformational products. We've applied that experience and have comprehensive launch readiness plans for Neffy in place. We're confident in our ability to execute the critical success factors for healthcare professionals, consumers, and payers that will have the potential to drive market share and revenue. We'll deploy a combination of direct promotion, virtual sales consultants, and non-personal promotion intended to reach, at a minimum, the HCPs that account for 45% of the current epinephrine prescriptions. Among consumers, we want to educate and build demand to drive adoption. We plan to partner with advocacy groups to leverage their voice and drive patient and caregiver awareness.
We also plan to deploy online and social media promotion and targeted direct consumer campaigns to drive awareness and motivate consumers to ask for Neffy. Finally, with payers, we plan to contract and provide patient support programs to make Neffy simple to access and affordable for all patients. Overall, we are excited and confident about the opportunity to transform the lives of millions of patients with severe allergic reactions. In our view, Neffy is the future of epinephrine delivery. Let me pass the call back to Richard to close us out.
Thanks, Eric. As you've heard, we believe Neffy has the opportunity to shift the treatment paradigm for type one allergic reactions. With its no-needle delivery, small size, easy to use, and consistent, reliable dosing, we believe Neffy will improve the lives of our caregivers and patients struggling to properly treat their type one severe allergies. We plan to work effectively with advocacy groups and implement patient and caregiver education programs to help support the allergy community and expand the protection epinephrine affords to these patients to a broader population, even those that desperately fear needles. The merger of Silverback and ARS will provide the funding and resources needed to support commercialization of Neffy and the type of patient education programs we feel will add value. I encourage you to view our website for more information, including the slides that were developed to complement this discussion.
We look forward to keeping you updated on our progress in the coming months. Thank you very much. The floor is now open for questions.
Thank you. Again, ladies and gentlemen, if you'd like to ask a question, please press star one on your touchtone telephone. Again, to ask a question, please press star, then one. Our first question comes from Paul Choi of Goldman Sachs. Your line is open.
Hi there. Can you hear me?
Yes, your line is open.
Okay. Thank you. Hi. Good afternoon, everyone. A couple questions from our side for Laura and the Silverback team. As you thought about your strategic options, could you maybe give us some details on how you thought about doing the development in HBV relatively early stage, admittedly, but you hadn't turned over any data cards, and you had the cash runway to do that. How did that factor in sort of the calculus of your strategic review here?
Yeah, thanks for that question, Paul. As we looked at strategic options, we looked at quite a number of them, including continuing as a standalone company focusing on SBT8230, as well as our other preclinical programs. As you may recall, we were planning for a regulatory filing yet this year, and that certainly continued and was in the cards. As we looked at everything, particularly as it related to HBV, it looked that it would be a ways away to reach important value inflection milestones in the clinical development of SBT8230. Both from the standpoint of it being a fairly competitive space, HBV as well as the need for combination treatment.
Our other programs would not enter the clinic for another 18-24 months, and it would be longer yet to reach those important milestones. Hence we focused on mergers. We also looked at other options such as in-licensing clinical stage programs that were closer to a clinical milestone.
Okay. Thanks for that, Laura. Then my second question is just on deal process here. Did you engage in discussions with any other about a potential transaction? Then, in terms of, you know, I guess things that would be revealed in the merger document down the road, any mechanics and so forth you can provide would be appreciated. Thank you for taking our questions.
Yeah. Thank you, Paul, and thanks for all your support along the way. Yes, we did have quite a number of companies that we looked at that will be detailed in the proxy. We will file a preliminary proxy as soon as practical. You'll find the details there along with what our criteria were for speaking with companies. Once we file that preliminary proxy, we'll be undergoing the review process. We will then file a definitive proxy. We'll have a waiting period there before we have the shareholder vote. Of course, we already have approval from both boards of directors and the majority, the overall vast majority of the ARS shareholders, and as well as support agreements from our major investors, including OrbiMed and Nextech.
Thank you. Our next question comes from Tim Lugo, William Blair.
Thanks for taking the question. I hope you can hear me. On the market slide, for the ARS team, you mentioned that the EPI market was growing at 5% year-over-year over the past 15 years. Can you just talk maybe, you know, how that market has looked, you know, a little bit more recently, I guess over the past, you know, few years, past two or three years? How durable that growth is. I know, you know, years ago, pricing was very much a talking point around the market. Can you just maybe give us a update on the latest views on pricing in the market? You know, and maybe even how you think about pricing given the differentiated product.
All right. Thank you, Eric. I would defer some of that to Eric Karas. Eric, can you answer?
Thank you, Richard. Thank you, Tim, for the question this afternoon. The first part on annual growth of what we've seen, you know, based on the IQVIA data that we've analyzed, we do see a very conservative 5% year-over-year growth. We're also seeing some increased prevalence and diagnosis that's consistent with what we see also in the literature. One of the things that we also looked at when analyzing the market is the overall segments. The primary market of the 3.3 million patients, plus that secondary market of 13 million patients that are diagnosed but are not prescribed the epinephrine product.
Within that group, there's a significant amount of patients, about 2.5 million, that we know have been prescribed, but either haven't filled their epinephrine prescription or they're a lapsed patient and they haven't renewed. I think what's most encouraging for us as we look at this marketplace and the opportunity for growth is that this is highly dissatisfied. When we've talked to patients and parents and caregivers in our market research, formally, even informally, clearly there is a fear of needles. There's a hesitation of using epinephrine. We really feel that Neffy can address those deficiencies of the needle injectors. When you look at also growth of the market over the last couple of years, there hasn't been a lot of promotion in terms of direct to consumer.
That's something that we will look to invest in at the right time to really make sure that, again, consumers are aware of this and, you know, encourage them to talk to their doctor about this product. In terms of price, I think you mentioned some of the focus on price over the last couple of years. You know, at this time, we're really focused on the NDA. We're not planning to go through any details about pricing. You know, in evaluating the market opportunity, you know, even if one assumes that this is comparable to the current lack of brand epinephrine products, the opportunity is quite compelling. As we noted in the presentation, there are many, many attributes of Neffy that really differentiate this product in the marketplace.
This isn't potentially a product that has one attribute or marginal differences. It has many differences, and we believe the demand will be quite significant for this product.
Understood. Going over the market data, that was very helpful. I'm actually a little surprised that 20% of those who use injectable products wouldn't switch over to Neffy. I just wanted to double-check. If there's a filing in Q3, are we assuming that there could be a launch in, you know, Q4 2023?
Well, the timing of the launch would depend obviously on the length of time of the NDA review and whether we get priority review or it's a standard review. If assuming a standard review, you're correct, Tim, that that's approximately the timing of the approval and launch.
Great. Thank you for the question.
Thank you. I'm showing no further questions at this time. I'd like to turn the call back over to Richard Lowenthal for any closing remarks.
Okay. Well, thank you very much for joining the call today, and we look forward to keeping you updated on the progress of ARS Pharmaceuticals and the merger with Silverback, as well as our progress in filing Neffy and gaining approval of this product, as we go forward. If any other questions, we're happy to take other questions as time goes on and overall. Thank you.
Thank you. Ladies and gentlemen, this does conclude today's conference. Now disconnect. Have a great day.