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GET A PIECE OF ALLERGENIS
The Next Generation of Food Allergy Testing
Allergenis provides the next generation of food allergy testing using cutting-edge systems biology and data analytics to accurately determine allergic status, tolerance levels, and reaction severity for a more informed quality of life when living with a diagnosis of food allergy. Additionally, Allergenis is the first food allergy test that can be initiated by a caregiver and/or individual via a partner telemedicine channel, all while receiving the necessary medical support from an allergist with expertise in managing food allergies. We currently provide peanut allergic status and threshold testing in 49 states, and Washington DC, with milk allergy testing launching later this year, and egg allergy testing in 2024.
$547,923.66 Raised
REASONS TO INVEST
AllerGenis' patent-protected food allergy diagnostic platform offers 93% accuracy, the highest rate for peanut allergy diagnosis compared to 60% accuracy of current blood tests.** AllerGenis offers an in-market suite of peanut allergy tests and is in the advanced stages of development for additional food allergens.
AllerGenis is targeting the food allergy market with a current global valuation of $39B, expected to grow to $66B by the end of 2033.* The Company has partnered with multiple global therapeutic companies generating revenue. It offers its tests through food allergist practices, including the largest allergy clinics in the U.S., as well as directly to consumers via a tele-medicine platform.
AllerGenis has previously raised $19 million, and its expert team of senior leaders have successfully developed and commercialized many diagnostic products currently in use as well as leading meaningful corporate exits. AllerGenis is a Mount Sinai Innovation Partner (MSIP) company.
*Information from Future Market Insights (Source)
**Information based on an internal analysis of the total amino acids targeted by other tests, data on file as well as Wiley Online Library (Source)
The Pitch
Helping People with Food Allergies Live Safer, Healthier Lives
Over 32 million Americans have food allergies, including 1 in every 13 children or approximately 2 in every classroom (Source). As many as 60% are over-diagnosed with current blood and skin testing, causing a mental, emotional, and financial toll on individuals, caregivers, and their families (Source | Source). The gold standard in diagnosing food allergies is an oral food challenge (OFC) which is anxiety-inducing, time and resource-intensive, may incur a risk of anaphylactic reactions, and is not widely available in clinical practice (Source). The OFC is also often required by therapeutic products during clinical trials which can inhibit trial enrollment and slow time-to-market for treatment solutions.
Individuals need a comprehensive road map to understand if they are allergic, how allergic they are, what their threshold levels are, and whether they are at increased risk of experiencing a life-threatening reaction. The Allergenis diagnostic offers a safe, easy-to-access, alternative to an OFC with up to 93% accuracy, far superior to currently available blood or skin tests, that helps individuals get clarity on these questions (Source).
Working with Hugh A. Sampson, M.D., the world's leading expert in the food allergy field at the Jaffe Food Allergy Institute at Mount Sinai and, who has devoted over 20 years to the development of the epitope (Source) based technology, Allergenis has an in-market, clinically available assay for peanuts, with multiple allergens (milk, egg, wheat, and tree nuts) in the pipeline. With these additional allergens available, Allergenis addresses 85% of pediatric food allergies in the United States. Finally, Allergenis is collaborating with 6 of more than 30 therapeutic companies, with meaningful, ongoing dialog with 10 others, to utilize our biomarkers in conjunction with clinical trials pursuing FDA approval for needed treatments.
Product & Business Model
The Next Generation of Technology Disrupting the Food Allergy Market
Individuals, caregivers, allergists, food manufacturers, therapeutic developers, and regulators are all looking for more detailed information on food allergy characterization to improve the safety of food-related decisions, increase access to accurate testing, and develop treatments for the growing number of food allergy individuals.
Individuals, caregivers, and allergists look to new tests to provide tolerance levels and reaction types, as existing food allergy testing such as IgE, component, and skin prick tests, do not identify these ranges. The current most accurate test in the market is the Oral Food Challenge, in which individuals consume the allergen in a clinical setting. This test can cause tremendous anxiety due to the potential risk of severe reactions such as anaphylaxis, and can take many months to schedule.
Individuals and caregivers can access Allergenis testing, which has up to 93% accuracy, through their current allergist or our consumer-directed digital food allergy clinic launched in partnership with LifeMD. Allergists can order testing directly through our online portal.
Allergenis collaborates with therapeutic companies pursuing regulatory approvals in the field of food allergies, integrating our biomarkers into the development and clinical use of their products to advance the acceptance of reliable biomarkers as safe and effective alternatives to oral food challenges.
This partnership is mutually beneficial, as it increases trial enrollment and accelerates time-to-market for treatment solutions while generating profitable revenue for Allergenis. We provide our proprietary epitope mapping platform technology to therapeutic companies and partner with them to use our biomarkers for clinical patient selection and to evaluate the effectiveness of their therapeutic products. Our tests may also be used to track treatment response once products become FDA-approved and available, further securing our position as a global leader in this burgeoning therapeutic field, while generating additional revenue.
By diversifying our revenue streams, we create a sustainable business model and maintain a competitive advantage in the field of food allergy diagnostics and treatments. We are committed to driving innovation and progress in this field and look forward to continued growth and success through our collaborations with partners.
The Product
Allergenis utilizes an individual’s blood sample to conduct the diagnostic test. We receive the request from an allergist or from an online telehealth partner, coordinate the blood draw, and then provide the results along with a comprehensive, personalized guide to the individual and their allergist.
While tolerance levels and subsequent reactions vary among individuals, existing food allergy testing does not identify these ranges. Current blood-test options in the marketplace produce ambiguous and inaccurate results which lack a full spectrum view of an individual’s allergy. The most commonly administered blood tests have as high as a 60% false-positive rate, while the gold standard tool, an oral food challenge (OFC) is costly, time-consuming, and sometimes anxiety-inducing due to the potential risk of clinical reaction. The Allergenis Peanut Diagnostic test is 93% accurate compare to OFC and can be used as an alternative.
The Allergenis test works by a proprietary method of analyzing epitopes, or the exact location where the IgE antibody binds to the cell, and is thus recognized by the immune system. By focusing on antibody binding to immunodominant epitopes versus the whole antibody (IgE), Allergenis can better determine which epitopes catalyze reactions and can predict an individual’s likelihood of having a serious reaction from a food allergen with up to 93% accuracy. We have been issued proprietary insurance billing codes and have established reimbursement rates on the federal clinical lab fee schedule to make our commercial tests accessible to individuals everywhere.
*The above testimonials may not be representative of the opinions or the experiences of other customers and is not a guarantee of future performance or success.
*The above testimonial may not be representative of the opinions or the experiences of other customers and is not a guarantee of future performance or success.
The Market & our traction
Validated Technology Filling A Major Market Need
According to research by the Food Allergy Patient and Family Registry, 32 million Americans suffer from food allergies, including 1 in 13 children. While the proprietary AllerGenis test may address most of this market, in the near term AllergGenis is focused on the top three food allergens, peanut, milk and egg, which impact 3.5 million children and a large cross-section of adults.
Given food allergies often evolve over time (i.e., sometimes they are outgrown) combined with a growing level of various immunotherapies, periodic retesting by customers is expected. Therefore, not only is AllerGenis addressing a large market in terms of likely testing events, those individuals will also most likely use our test multiple times, creating repeat sales. Even if Allergenis achieves only a 1.0% penetration of its three initial markets (peanut, milk, and egg testing) for children and adults, there is a sizable target addressable market and revenue opportunity.
In 2022, we raised over $4 million in follow-on funding, bringing our total raised to $19 million. In the same year, we validated and launched our peanut reactivity threshold assay. Our technology has been validated by multiple peer-reviewed studies, including the Jaffe Food Allergy Institute at Mount Sinai, and the Sean Parker Institute for Food Allergy at Stanford University. We routinely present at premiere allergy conferences including AAAA&I, ACAAI, EAACI, the Gordon Conference, and the Next-Generation Food Allergy Drug Development Summit. We have on-boarded over 200 allergists at academic centers and clinics throughout the U.S., and partnered with multiple therapeutic companies enabling the use of biomarkers in clinical trials focused on bringing FDA-approved therapeutic interventions to better treat and manage food allergies.
*The above testimonial may not be representative of the opinions or experiences of other publications and is not a guarantee of future performance or success.
WHy Invest
Changing the Way We Understand Food Allergies
While Allergenis technology benefits the individual, it inherently may also benefit:
- Medical Providers – Improving outcomes through personalized care, generating higher revenue from increased procedures, and administration of therapy.
- Employers, Commercial and Government – Improved employee/members' satisfaction, better outcomes, more efficiency, and parents are less likely to have to decide whether to work or stay home to monitor their child(ren)'s diet.
- Therapeutic Developers – Increased trial enrollment and accelerates time-to-market for treatment solutions.
- Food & Industry – Increased clarity allows for more consumption of food products.
- Travel & Hospitality – Increased clarity allowed reduced travel anxiety and higher utilization of services.
We believe Allergenis is the first in the food allergy market to offer precision molecular diagnostics with a machine-learning, AI-enabled approach to predictive analytics. Additionally, Allergenis is the first food allergy test that can be initiated by a caregiver and/or individual via a partner telemedicine channel, all while receiving the necessary medical support from an allergist with expertise in managing food allergies.
Our testing platform has been validated and proven to have an up to 93% accuracy rate compared with OFC, with numerous patents issued on an array of products. We are now ready to ramp up commercial activity by adding sales and marketing staff, increasing market share, and creating widespread adoption of our in-market Allergenis Peanut Diagnostic.
With key immunodominant epitopes identified for other allergens, this raise will also fuel the final validation and 2023 commercial launch of a suite of assays for milk allergy and accelerate the development of highly demanded allergens including egg, wheat, and tree nuts. Join us as we harness the potential of our technology to help change the lives of people living with food allergies.
ABOUT
HEADQUARTERS
10 East 40th Street, Suite 3210
New York, NY 10016
WEBSITE
View Site
Allergenis provides the next generation of food allergy testing using cutting-edge systems biology and data analytics to accurately determine allergic status, tolerance levels, and reaction severity for a more informed quality of life when living with a diagnosis of food allergy. Additionally, Allergenis is the first food allergy test that can be initiated by a caregiver and/or individual via a partner telemedicine channel, all while receiving the necessary medical support from an allergist with expertise in managing food allergies. We currently provide peanut allergic status and threshold testing in 49 states, and Washington DC, with milk allergy testing launching later this year, and egg allergy testing in 2024.
TEAM
James A. Garner
Chief Executive Officer
Jim was the Chief Business Officer of Integrated Diagnostics, a diagnostics company developing technology for early detection, prediction and prevention of disease. Prior to that he was Senior Vice President of Global Sales and Senior Director of Corporate Development for UnitedHealth Group, Director of Marketing & Corporate Development at Elan Diagnostics and Sales Manager at DIANON Systems.
Jim received the Meritorious Service Medal among other honors while serving as Captain in the United States Army where he was Air-Cavalry Troop Commander, Aviation Task Force Operations Officer, Attack and Scout Helicopter Pilot, among other roles and distinctions.
Jim lives in Florida with his family where he enjoys surfing, golfing and tennis with his wife and two sons.
Albert A. Luderer, Ph.D.
Chairman of the Board
Dr. Luderer has developed and commercialized major In Vitro Diagnostic (IVD) systems including the global market leader for microbial detection and antibiotic susceptibility testing – Vitek®II; co-invented and established Standard of Care Diagnostics in cancer detection and has participated in the creation of one of the dominant global IVD companies – Siemens Diagnostics – through his participation in the negotiation and formation of the joint venture IVD firm Ciba Corning. Dr. Luderer holds a Ph.D. from Rutgers University where he was an NSF predoctoral fellow and performed postgraduate work in immunology and genetics at Sidney Kimmel Medical College (formerly Jefferson Medical College). He is an independent director of BioNano Genomics (BNGO) and the chairman of Allergenis.
Hugh A. Sampson, M.D.
Board Member
Russ S. Fein
CFO & Board Member
David A. Esposito
Board Member
David is currently the CEO of ONL Therapeutics based in Ann Arbor, MI. ONL Therapeutics is developing therapeutics based on Fas inhibition to protect the vision of patients with retinal disease. David is the former CEO of Armune BioScience. The Company successfully launched the only non-PSA blood test to improve the detection of prostate cancer. Armune BioScience was sold to Exact Sciences (EXAS) in 2017.
He was President of Phadia US Inc. (allergy and autoimmune diagnostics) and played a pivotal role in the sale of the business to Thermo Fisher Scientific (TMO) in 2011. David began his career as a sales representative with Merck & Co. Inc. and rose through the ranks of sales, marketing and commercial strategy for the US Division. David is a combat veteran, led an infantry platoon with the 101st Airborne Division through several combat operations, and was recognized with a Bronze Star for combat action in Iraq in 1991. David earned his B.S. degree in Civil Engineering from the United States Military Academy at West Point and his MBA from Syracuse University.
Vijay Aggarwal, Ph.D.
Board Member
During his tenure with SBCL, he held many positions, including Executive Vice President of Laboratories, having direct responsibility for all of SBCL’s U.S.-based laboratories, and as Vice President of Managed Care, responsible for third party reimbursement.
In addition to his position with Allergenis, he holds Board positions at Accugenomics, Interpace Biosciences, Moleculera and Slone Partners. He holds a Ph.D. in Pharmacology/Toxicology from the Medical College of Virginia.
John C. Simons
Board Member
John is the Chairman of the Board of The United Hospital Fund, and a former director of amfAR, The American Foundation for Aids Research, The Greater Jamaica Capital Corporation and a former Trustee of the Brooklyn Academy of Music. John was also Chairman of the Lincoln Center Business Council and a member of Lincoln Center Corporate Fund. John was appointed by Mayor Bloomberg in 2003 to be a member of the Mayor's Fund to Advance New York City. John has a bachelor's degree from Trinity College.
Kristy Consalvo, MBA
Head of Marketing
Kristy’s expertise includes commercial strategy, building efficient organizations, marketing automation, product management, medical marketing, B2B and B2C business development, and genomics. She has a track record of launching novel technologies that change clinical practice both nationally and globally. With her undergraduate in Mechanical Engineering, she is skilled at taking complex, technical concepts and communicating them in a manner that is easily understandable.
Kristy is also a mother of four kids, 3 of which have or had food allergies (some have outgrown). She is intimately familiar with the pain and anxiety of food avoidance, the time and resources required for risk preparation, and the inadequacy of current food allergy testing that families must go through.
Paul Kearney, Ph.D.
Head of Product and Clinical Development
Paul has developed five complex diagnostic products currently in clinical use including PreTRM from Sera Prognostics where he currently oversees the evidence development strategy and is the Chief Data Officer. Formally, he co-founded four successful biotech companies including Data Incites and Integrated Diagnostics which was acquired by Biodesix (BDSX) in 2018.
Paul has developed multiple high-value diagnostics in oncology, pregnancy and food allergy with supporting evidence development of over 100 publications and 12 patents issued. He has also been successful and central in raising $200M in public and private funding and has experience assembling top management team of scientists, data analysts, laboratorians and IP experts to support company formation.
Thomas Vollmers
Head of Strategic Partnerships & Commercial Strategy
As a dedicated professional, Thomas excels at forging strategic and long-term partnerships with stakeholders within the Therapeutic and CDx ecosystem. His deep understanding of diagnostic platforms, technologies, and trends, coupled with his ability to collaborate effectively with diagnostic manufacturers, reference labs, lab networks, and key opinion leaders (KOLs), positions him as a valuable contributor to the growth and success of healthcare companies.
Throughout his distinguished career, Thomas has held significant roles at renowned companies such as The Upjohn Company, GlaxoSmithKline, ViiV Healthcare, Pfizer, and Merck. In these roles, he has been pivotal in developing, implementing, and managing commercial strategies that propel growth and innovation in the therapeutic and diagnostic sectors.
TERMS
AllerGenis
Overview
PRICE PER SHARE
$5
DEADLINE
Aug. 22, 2023 at 6:59 AM UTC
VALUATION
$40M
FUNDING GOAL
$10k - $1.24M
Breakdown
MIN INVESTMENT
$250
MAX INVESTMENT
$1,235,000
MIN NUMBER OF SHARES OFFERED
2,000
MAX NUMBER OF SHARES OFFERED
247,000
OFFERING TYPE
Equity
SHARES OFFERED
Non-Voting Common Stock
Maximum Number of Shares Offered subject to adjustment for bonus shares
*The Offering Maximum Non-Voting Common Stock subject to adjustment for bonus shares. See “Investment Incentives and Bonuses.”
Voting Rights of Securities Sold in this Offering
Pursuant to the Subscription Agreement, investors agree to appoint the CEO, or his or her successor, as the investor’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with the Subscription Agreement and on behalf of the investor, (i) vote all Securities held of record by the investor (including any shares of the Company’s capital stock that the investor may acquire in the future), (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument at its own discretion, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the investor are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the investor is an individual, will survive the death, incompetency and disability of the investor and, so long as the investor is an entity, will survive the merger or reorganization of the investor or any other entity holding the Securities. Such proxy shall be binding upon the heirs, estate, executors, personal representatives, successors and assigns of the investor (including any transferee of any Securities held by investor); any transferee receiving the investor’s Securities (or any portion thereof) shall agree to be bound by the proxy as set forth in the Subscription Agreement. However, the proxy will terminate upon the closing of a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act covering the offer and sale of common stock or the effectiveness of a registration statement under the Securities Exchange Act covering the common stock.
Investment Incentives and Bonuses1
Time-Based:
Friends and Family
Invest within 72 hours and receive 10% bonus shares and a Food Allergy Care Kit.
Early Bird Bonus
Invest within two weeks and receive 5% bonus shares.
Comb/Avid Investor
Invest $10,000+ within the first 48 hours and receive 20% bonus shares.
Amount-Based:
Tier 1 | Premier
Invest $1,000+ and receive a Food Allergy Care Kit.
Tier 2 | Silver
Invest $2,000+ and receive a Rebate Coupon* and a Food Allergy Care Kit.
Tier 3 | Gold
Invest $10,000+ and receive a Rebate Coupon, a Food Allergy Care Kit, 30-minute Zoom with CEO, Scientific & Medical Advisory Webinar, and 5% bonus shares.
Tier 4 | Diamond
Invest $25,000+ and receive a Rebate Coupon, Allergy Care Kit, 30-minute Zoom with CEO, Scientific & Medical Advisory Webinar, and 10% bonus shares.
Tier 5 | Platinum
Invest $100,000 + and receive a Rebate Coupon, a Food Allergy Care Kit, 30-minute Zoom with CEO, Advisory Webinar, and 15% bonus shares.
*Rebate Coupon valid for one Allergenis commercially available test (one food allergen) for one year from issue date and is fully transferable. Individual utilizing coupon must be eligible for testing.
The Allergy Care Kit is valued at approximately $60. Components may include but not guaranteed: water bottle, snack safe stickers, sample allergy guide, restaurant cards, red sneakers for Oakley keychain, food allergy book, and others.
30 Minute Zoom includes a 1:1 session with Allergenis CEO, Jim Garner.
The Scientific & Medical Advisory Webinar includes a 60-minute session with a member of our medical and/or development team.
1 In order to receive incentives and bonuses from an investment, you must submit a single investment in the same offering that meets the minimum incentive or bonus requirement. Bonus shares from perks will not be granted if you submit multiple investments that, when combined, meet the incentive or bonus requirement. All incentives and bonuses will occur when the Offering is completed.
The 10% StartEngine Owners' Bonus
AllerGenis will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.
This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Non-Voting Common Stock at $5.00/ share, you will receive 110 shares of Non-Voting Common Stock, meaning you'll own 110 shares for $5. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.
This 10% Bonus is only valid during the investor's eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.
Investors will receive the highest single bonus they are eligible for among the bonuses based on the amount invested and the time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus and the aforementioned bonus.
Irregular Use of Proceeds
We will not incur any irregular use of proceeds.
PRESS
ALL UPDATES
REWARDS
10%
Stack Owner's Bonus & Rewards!
Members get an extra 10% shares in addition to rewards below!
Owner’s Bonus
Owner’s Bonus Members earn 10% bonus shares on top of this and all eligible investments for an entire year. Not a member? Sign up at checkout ($275/year).
JOIN THE DISCUSSION
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Virginia Luke
5 months ago
How is this diagnostic test different from the ones already available on the market that measure IgA or IgE and include tolerance ranges at a cost under $300?
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Ranajit Banerjee
7 months ago
On your website, it mentions that the price for the Allergenis peanut diagnostic test is $1,450.00. Is this the average price paid by customers or is typically negotiated down? With commercially available allergy tests costing only a fraction of this, how is Allergenis providing value? As you achieve scale, is there any effort to lower the price in the next few years?
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Anthony Tarkowski
7 months ago
How many shares does the company intend on selling, and how many are already owned by someone? I want to be sure the value that I am paying is relevant. I am talking about total shares in the company not just what is on StartEngine.
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Edgar Garcia
7 months ago
Hello, just curious if your forthcoming milk allergy test will also detect lactose intolerance? Thank you!
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Adam Forster
7 months ago
Hello! Is the intention for Allergenis to sell large numbers of allergy tests or test kits or to earn consulting revenue and/or royalties working with pharma companies? Are these revenue streams each large enough to justify an investment here or is the pharma consulting work useful to fund the company as more allergy tests are developed? Also, can you provide a scale of the total market for food allergy tests that Allergenis is targeting?
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Michael Stanis
7 months ago
Can you explain to me why revenue decreased by around 70% from 2021 to 2022 to a mere $74,140? I find that concerning given the valuation of $40 Million with 1.7 million having been spent on "Sales and Marketing" what kind of marketing have you been wasting millions of dollars on with a net revenue of $75,000 in an entire year? Also, considering your burn rate of around $300,000 /month you are on track to have no cash and be in significant debt in May. I would appreciate some insight into what your business is fundamentally valued on and how you plan to make real money, much less become profitable.
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Wendy Van Peenan
7 months ago
Is it possible to invest through a trust?
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Nathaniel Putnam
5 months ago
Stories sell.. Post more from kids and parents about the benefits and ease of Allergenis tests compared to horrors of in-office testing.
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