GET A PIECE OF AIVIVA
Our diverse product pipeline potentially will deliver a combined multi-billion dollar revenue potential, protected by 22 issued patents and 41+ patents pending worldwide.
We are a world class team that had brought many successful drugs through FDA approval and executed successful reverse merger, and IPOs on the NYSE and NASDAQ.
AiViva has successfully raised over 30 million dollars, with 9.3 million dollars raised in the first half of 2022. We are rated as a top 20 Clinical Stage BioPharma company by Life Sciences Review in 2022.
AiViva’s mission is to develop novel, innovative pharmaceutical products through an efficient development strategy to address major unmet medical needs. We have four clinical trials (two ongoing, two planned) focused on wet AMD, prostate disorders, and non-melanoma skin cancer.
*AiViva's JEL™ technology is currently in development and not yet publicly available.
Our proprietary JEL™ Technology prolongs the therapeutic effects of drugs and enhances their benefit, thereby reducing treatment frequency, relieving the burden for patients and physicians, and improving outcomes.
AiViva’s proprietary JEL™ technology will allow placement of the drug directly at the site of disease and will form a drug depot for prolonged drug release, thereby delivering an effective therapy. This JEL™ Technology is unique because the delivery medium is a liquid at room temperature, and upon injection into the diseased tissue at body temperature, it transforms into a jello-like mass. This drug containing “jello” serves as a drug depot that releases the drug over time.
Our Traction
*based upon 2019, 2020, & 2021 audit reports
AiViva's funds are allocated extremely efficiently. We put roughly 80% of our raised capital to research and development. AiViva has brought several projects through FDA’s IND (Investigational New Drug Application) and demonstrated positive proof-of-concept in clinical trials in three areas:
These large market potentials are protected by AiViva’s patent applications in major markets including Europe, Japan, China, and the US beyond the year 2040.
The Problem
Wet age-related macular degeneration (also known as wet AMD) is a chronic eye disorder that causes blurred vision or a blind spot in your visual field. It's generally caused by abnormal blood vessels that leak fluid or blood and scars the macula, the area of the eye that provides the sharp, central vision needed for reading, driving and seeing fine detail. (source)
Current and emerging therapies treating this disorder tend to only address neovascularization (abnormal blood vessel growth) - resulting in unsatisfactory treatment outcomes of long-term visual loss. The goal of an ideal treatment is to address all underlying causes of the disease - e.g., abnormal blood vessel growth and scar formation - to help patients to keep more of their vision and prevent further vision loss over time.
AiViva has a special focus on wet AMD. The drug of interest is AIV007, which addresses neovascularization, inflammation, and fibrosis (scarring), causes of wet AMD and thus impaired vision. AIV007 is delivered in JEL™ to prolong the treatment duration.
Other major diseases which involve neovascularization, abnormal tissue growth, and fibrosis include cancers, benign hyperplasia, and skin disorders. Our next clinical trial will focus on prostate disorders. Starting around age 25, hyperplasia, or enlargement, of men’s prostates occurs and continues over time. Symptoms of benign prostate hyperplasia may start to present as early as age 40. These symptoms may include frequent urination throughout the day and night, dribbling at the end of urination, and inability to fully empty the bladder. Benign prostate hyperplasia and prostate cancer may happen at the same time.
AiViva has ongoing clinical trials in skin cancer and keloid scarring using compound AIV001.
Our Solution
Our innovative discoveries provide novel pharmacotherapy and reduce the treatment burden for both patients and physicians.
Our proprietary JEL™ delivery platform offers customizable drug release and treatment duration. It will potentially lead to many novel treatments for major diseases.
*AiViva's JEL™ technology is currently in development and not yet publicly available.
AiViva is positioned to bring new treatment options to benefit patients, and here’s how:
1. AIV007
AIV007 is a novel compound which targets all of the key pathways leading to neovascularization, cell proliferation, and fibrosis. Its receptor targets are VEGFR, PDGFR, and FGFR, and it also modulates TGFβ1 mRNA expression and TGFβ1 levels to reduce collagen production and scarring.
AIV007, when embedded in JEL™, has the potential to be effective in treating wet AMD, benign prostatic hyperplasia (BPH), low grade prostate cancer, and certain solid tumors.
2. AIV001
AIV001 is an extremely potent kinase receptor inhibitor and has been demonstrated to reduce neovascularization and cell proliferation associated with certain cancers in patients. AIV001 may also modulate inflammation and fibroplasia, causes of scarring.
The Market
The indications AiViva are targeting represent a combined revenue potential of $5.3B.
a. See CDC for AMD prevalence number estimates (https://www.cdc.gov/visionhealth/basics/ced/)- the US prevalence for all retinal diseases is estimated to be 11M; US Retina Market was >$7B annually in years of 2018-2020. Eylea sales in 2020 were $8.36 billion globally and $4.95 billion in the U.S. Source: Company annual financial reports for Regeneron, Genentech, Roche and Novartis
b. Internal forecast based on achieving a target product profile that would offer clear differentiation from competitors in several key aspects such as prolonged dosing interval 3-6 months, early onset of vision improvement, reversal of retinal scarring, and long-term positive visual outcome and favorable reimbursement.
c. See CDC for non-melanoma skin cancer (NMSC) prevalence number estimates (https://www.cdc.gov/cancer/skin/statistics/) and the CDC estimate that NMSC has a treatment cost of about $4.8 billion. AIV001 could also be developed for Actinic Keratosis besides squamous cell carcinoma (SCC) and basal cell carcinoma (BCC).
d. Internal forecast based on achieving an indication in both SCC and BCC with a target product profile that would offer a novel drug delivery modality with enhanced benefit-risk outcome, competitive as compared to Standard-of-Care surgical option and providing maximal cosmetic effect while being patient friendly and favorable reimbursement.
e. Internal estimation of the addressable keloid market available for AIV001. There is no FDA approved therapies for hypertrophic or keloid scarring; current treatments are topical ointments, gels, and creams, pressure dressing, and steroid Injections. See American Academy of Dermatology (https://www.aad.org/public/diseases/a-z/scars-treatment). Besides preventative measures Keloid scars can also be treated with surgery (https://www.aad.org/public/diseases/a-z/keloids-overview).
f. Internal forecast based on a target product profile of an injectable agent that would offer superior local efficacy for the treatment of keloid scarring post-surgery from one to three treatments every 2-4 weeks, and no local skin reactions. The treatment would be an in-office treatment and would be assumed to offer favorable reimbursement to HCPs. AIV001 could also be developed for hypertrophic scarring and for scarring related to post-carpal tunnel surgery.
g. See National Cancer Institute (https://seer.cancer.gov/statfacts/) for Prostate cancer and for other solid tumor cancers of breast, kidney, and thyroid that could be applicable for AIV007.
h. Internal forecast based on a target product profile as a localized intra-prostatic injection to provide cancer clearance without the sexual effects such as erectile dysfunction and urinary incontinence common with surgical and radiation treatments for prostate cancer (https://www.pcf.org/about-prostate-cancer/prostate-cancer-side-effects/surgery-side-effects/). AIV001 would target Prostate cancer patients who are on early stage, active surveillance and would be offered as a non-surgical option. AIV007 could also be developed for breast (DCIS and non-DCIS), kidney, and thyroid cancers, respectively.
Why Invest
AiViva believes in continuing the advancement and development of innovative and novel treatment paradigms.
We are dedicated to our vision and committed to bringing transformative therapies to the millions of patients living with diseases that negatively impact their lives.
AiViva is a clinical stage biotech company which has created proprietary technology and new treatments to address significant, unmet medical needs in ophthalmology, dermatology, urology, and oncology. The company is led by a team of seasoned industry experts who have an outstanding track record in successful drug development, commercialization, and multiple IPOs on the NYSE and NASDAQ.
Co-founder, Allgenesis, Inc.
Previously Diane has held various senior executive positions at Allergan, Inc. where she built and led R&D programs for 30 years. She is a full adjunct professor of Pharmacology and Pharmaceutical Sciences and Regulatory and Quality Sciences at the University of Southern California and served as a full adjunct professor of Bioengineering and Therapeutic Sciences at the University of California, San Francisco. She published extensively and holds many patents. Diane received many awards and is Elected fellow, American Association of Pharmaceutical Scientists and American College of Clinical Pharmacology.
Larry Hsu Ph.D.
Board of Director
Chairman & CEO, LifeMax Healthcare International.
Chairman & CEO, AmMax Bio.
Chairman & CEO, LifeMax Labs.
Chairman & CEO, LifeMax Biotechnology (Taiwan).
Under his leadership, Impax established partnerships with multiple companies including Teva, AstraZeneca, Pfizer and Shire.
LifeMax Labs currently has a partnership with Novartis.
AmMax Bio currently has a partnership with Amgen.
Jinn Wu Ph.D.
Chairman & Director at AiViva Biopharma Inc.
He served as Adjunct Professor at the University of Medicine and Dentistry of New Jersey (UMDNJ at Rutgers) and Adjunct Professor at The Hong Kong Polytechnic University.
Hannah Hershoff, MD, Ph.D.
Chief Medical Officer
Before her pharmaceutical industry experience, Dr. Hershoff was a senior ophthalmologist, eye surgeon, and physician-in-charge at Zhongshan Eye Hospital, Guangzhou, China. Prior to becoming an ophthalmologist, she practiced as a neurologist at Nanchang First Hospital, China. She is an inventor and author of more than 20 patents and publications in the field of Ophthalmology and Neurology.
Dr. Hershoff received her M.D. from Jiangxi Medical School, China, Ph.D. in Experimental Ophthalmology from Lund University, Sweden, and Post-Doctoral Fellowship from Harvard Medical School. She also received her M.S. in Neurology from Sun Yat-sen University Zhongshan Medical School, China.
Darlene Deecher, Ph.D.
Vice President Clinical Development
Shulin Ding, Ph.D.
Executive Director Pharmaceutical Development
Yi Zhao, MD, Ph.D.
Executive Director Preclinical Development
Shane Cerrato
Vice President Business Development
Mr. Cerrato works full-time as an independent contractor for the Company.
Les Kaplan, PhD
Board of Director
Dr. Kaplan began his career at Allergan Inc., where he served as the Executive Vice President and President, Research & Development and Global Botox, and a board member of Allergan. During his tenure heading Allergan's R&D function more than 20 major pharmaceutical products and new indications were approved by the FDA, the European Union, Japan and major Ministries of Health around the world. Prior to joining Allergan, Dr. Kaplan held research positions at the Upjohn Company and at the University of California, Los Angeles. He previously served as a member of the board of directors of Acadia Pharmaceuticals, Acucela Inc., Altheos (Executive Chair), Neurotech, Oculex and National Neurovision Research Institute (FFB). Dr. Kaplan received a Ph.D. in organic chemistry from the University of California, Los Angeles.
Jung-Chin (Rongjin) Lin
Board of Director
Mr. Lin is currently Honorary President of Center Laboratories, Inc. and Chairman of Lumosa Therapeutics Co., Ltd. in Taiwan. Mr. Lin transformed Center Labs from a multiple-dosage pharmaceutical company into a professional oral solution pharmaceutical, which drives over 70% market shares in Taiwan. In recent years, Center Labs, Inc. played a role as an Industrial Biotech Bank platform, which targets to invest and integrate more biotech companies. The new investing fields include new drug development, antibody engineering and protein design, cell line generation, biosimilar drug development and production, medical devices, nutrition, and agricultural biotech; investing regions cover the Greater China Region and other Asian countries such as Japan and Korea. In late 2014, Center Labs Inc. also acquired Ausnutria Dairy Corp, expanding the investment in the infant formula industry.
Mr. Lin received his B.S. degree in Pharmacy from the School of Pharmacy, Taipei Medical University, and was awarded Doctorate of Philosophy, Honoris Causa by Taipei Medical University in 2010.
Maximum Number of Shares Offered subject to adjustment for bonus shares
*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.
The fully diluted pre-money valuation calculation was made prior to the Company's offering of 2,518,891 shares of Series A-1 Preferred shares that occured after the launch of this Regulation Crowdfunding Campaign.
Voting Rights of Securities Sold in this Offering
Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (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, 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 Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. 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 of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.
Investment Incentives and Bonuses*
Time-Based:
Community Super Early Birds
Invest within the first week and receive 20% bonus shares
Super Early Bird Bonus
Invest within the first two weeks and receive 15% bonus shares
Early Bird Bonus
Invest within the first three weeks and receive 10% bonus shares
Amount-Based:
$1,000+
Friends
5% bonus shares
$2,000+
Partners
5% bonus shares
$5,000+
Ambassadors
10% bonus shares, plus the ability to vote on product names
$10,000+
Benefactors
15% bonus shares, Zoom Meeting with Founding Team
$25,000+
Elite Benefactors
20% bonus shares, In-person Meeting with Founding Team,
On March 15, 2022, the Company effected a one-for-five reverse stock split.
*All perks occur when the offering is completed.
The 10% StartEngine Owners' Bonus
AiViva Holding Limited 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 Common Stock at $2.00 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $200. 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 investors' 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 time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus in addition to the aforementioned bonus.
Insider Investment Notice
Officers, directors, executives, and existing owners with a controlling stake in the company (or their immediate family members) may make investments in this offering. Any such investments will be included in the raised amount reflected on the campaign page.
Members get an extra 10% shares in addition to rewards below!
0/2500
PINNED BY STARTUP
a year ago
1
0
10 months ago
1
0
10 months ago
1
0
a year ago
1
0
a year ago
1
0
a year ago
1
0
a year ago
2
1
a year ago
1
0
Cancel anytime before 48 hours before a rolling close or the offering end date.
We want you to succeed and get the most out of your money by offering rewards and memberships!
Your info is your info. We take pride in keeping it that way!
Invest in over 200 start-ups and collectibles!
With Regulation A+, a non-accredited investor can only invest a maximum of 10% of their annual income or 10% of their net worth per year, whichever is greater. There are no restrictions for accredited investors.
With Regulation Crowdfunding, non-accredited investors with an annual income or net worth less than $124,000, are limited to invest a maximum of 5% of the greater of those two amounts. For those with an annual income and net worth greater than $124,000, he/she is limited to investing 10% of the greater of the two amounts.
At the close of an offering, all investors whose funds have “cleared” by this time will be included in the disbursement. At this time, each investor will receive an email from StartEngine with their Countersigned Subscription Agreement, which will serve as their proof of purchase moving forward.
Please keep in mind that a company can conduct a series of “closes” or withdrawals of funds throughout the duration of the campaign. If you are included in that withdrawal period, you will be emailed your countersigned subscription agreement and proof of purchase immediately following that withdrawal.
StartEngine assists companies in raising capital, and once the offering is closed, we are no longer involved with whether the company chooses to list shares on a secondary market, or what occurs thereafter. Therefore, StartEngine has no control or insight into your investment after the close of the live offering. In addition, we are not permitted to provide financial advice. You may want to contact a financial professional to discuss possible investment outcomes.
For Regulation Crowdfunding, investors are able to cancel their investment at any point throughout the campaign up until 48 hours before the closing of the offering. Note: If the company does a rolling close, they will post an update to their current investors, giving them the opportunity to cancel during this timeframe. If you do not cancel within this 5-day timeframe, your funds will be invested in the company, and you will no longer be able to cancel the investment. If your funds show as ‘Invested’ on your account dashboard, your investment can no longer be canceled.
For Regulation A+, StartEngine allows for a four-hour cancelation period. Once the four-hour window has passed, it is up to each company to set their own cancelation policy. You may find the company’s cancelation policy in the company’s offering circular.
Once your investment is canceled, there is a 10-day clearing period (from the date your investment was submitted). After your funds have cleared the bank, you will receive your refund within 10 business days.
Refunds that are made through ACH payments can take up to 10 business days to clear. Unfortunately, we are at the mercy of the bank, but we will do everything we can to get you your refund as soon as possible. However, every investment needs to go through the clearing process in order to get sent back to the account associated with the investment.
Both Title III (Regulation Crowdfunding) and Title IV (Reg A+) help entrepreneurs crowdfund capital investments from unaccredited and accredited investors. The differences between these regulations are related to the investor limitations, the differing amounts of money companies are permitted to raise, and differing disclosure and filing requirements. To learn more about Regulation Crowdfunding, click here, and for Regulation A+, click here.
Important Message
IN MAKING AN INVESTMENT DECISION, INVESTORS MUST RELY ON THEIR OWN EXAMINATION OF THE ISSUER AND THE TERMS OF THE OFFERING, INCLUDING THE MERITS AND RISKS INVOLVED. INVESTMENTS ON STARTENGINE ARE SPECULATIVE, ILLIQUID, AND INVOLVE A HIGH DEGREE OF RISK, INCLUDING THE POSSIBLE LOSS OF YOUR ENTIRE INVESTMENT.
www.StartEngine.com is a website owned and operated by StartEngine Crowdfunding, Inc. (“StartEngine”), which is neither a registered broker-dealer, investment advisor nor funding portal.Unless indicated otherwise with respect to a particular issuer, all securities-related activity is conducted by regulated affiliates of StartEngine: StartEngine Capital, LLC, a funding portal registered here with the US Securities and Exchange Commission (SEC) and here as a member of the Financial Industry Regulatory Authority (FINRA), or StartEngine Primary, LLC, a broker-dealer registered with the SEC and FINRASIPC . You can review the background of our broker-dealer and our investment professionals on FINRA’s BrokerCheck here. StartEngine Secondary is an alternative trading system regulated by the SEC and operated by StartEngine Primary, LLC, a broker dealer registered with the SEC and FINRA. StartEngine Primary, LLC is a member of SIPC and explanatory brochures are available upon request by contacting SIPC at (202) 371-8300.Investment opportunities posted and accessible through the site are of three types:
1) Regulation A offerings (JOBS Act Title IV; known as Regulation A+), which are offered to non-accredited and accredited investors alike. These offerings are made through StartEngine Primary, LLC (unless otherwise indicated). 2) Regulation D offerings (Rule 506(c)), which are offered only to accredited investors. These offerings are made through StartEngine Primary, LLC. 3) Regulation Crowdfunding offerings (JOBS Act Title III), which are offered to non-accredited and accredited investors alike. These offerings are made through StartEngine Capital, LLC. Some of these offerings are open to the general public, however there are important differences and risks.
Any securities offered on this website have not been recommended or approved by any federal or state securities commission or regulatory authority. StartEngine and its affiliates do not provide any investment advice or recommendation and do not provide any legal or tax advice with respect to any securities. All securities listed on this site are being offered by, and all information included on this site is the responsibility of, the applicable issuer of such securities. StartEngine does not verify the adequacy, accuracy or completeness of any information. Neither StartEngine nor any of its officers, directors, agents and employees makes any warranty, express or implied, of any kind whatsoever related to the adequacy, accuracy, or completeness of any information on this site or the use of information on this site. See additional general disclosures here.By accessing this site and any pages on this site, you agree to be bound by our Terms of use and Privacy Policy, as may be amended from time to time without notice or liability.Canadian Investors Investment opportunities posted and accessible through the site will not be offered to Canadian resident investors. Potential investors are strongly advised to consult their legal, tax and financial advisors before investing. The securities offered on this site are not offered in jurisdictions where public solicitation for offerings is not permitted; it is solely your responsibility to comply with the laws and regulations of your country of residence.
California Investors Only – Do Not Sell My Personal Information(800-317-2200). StartEngine does not sell personal information. For all customer inquiries, please write to contact@startengine.com.
StartEngine’s Reg A+ offering is made available through StartEngine Crowdfunding, Inc. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. For more information about this offering, please view StartEngine’s offering circular and risk associated with this offering.StartEngine Marketplace
The availability of company information does not indicate that the company has endorsed, supports, or otherwise participates with StartEngine.
None of the information displayed on or downloadable from www.startengine.com (the 'Website') represents a recommendation, offer, or solicitation of an offer to buy or sell any security. It also does not constitute an offer to provide investment advice or service. StartEngine does not (1) make any recommendations or otherwise advise on the merits or advisability of a particular investment or transaction, or (2) assist in the determination of fair value of any security or investment, or (3) provide legal, tax, or transactional advisory services.
All investment opportunities are based on indicated interest from sellers and will need to be confirmed.
Investing in private company securities is not suitable for all investors. An investment in private company securities is highly speculative and involves a high degree of risk. It should only be considered a long-term investment. You must be prepared to withstand a total loss of your investment. Private company securities are also highly illiquid, and there is no guarantee that a market will develop for such securities. Each investment also carries its own specific risks, and you should complete your own independent due diligence regarding the investment. This includes obtaining additional information about the company, opinions, financial projections, and legal or other investment advice. Accordingly, investing in private company securities is appropriate only for those investors who can tolerate a high degree of risk and do not require a liquid investment.
StartEngine Marketplace (“SE Marketplace”) is a website operated by StartEngine Primary, LLC (“SE Primary”), a broker-dealer that is registered with the SEC and a member of FINRA and the SIPC. StartEngine Bulletin Board ("SE BB") is a bulletin board platform that advertises interest in shares of private companies that previously executed Reg CF or Reg A offerings. SE BB enables shareholders to communicate interest in potential sales of shares in private companies and investors to discover, review, and potentially invest in private companies. As a bulletin board platform, SE BB provides a venue for investors to access information about private company offerings and connect with potential sellers. SE BB is distinct and separate from StartEngine Secondary (“SE Secondary”), which is an SEC-registered Alternative Trading System (ATS) operated by SE Primary. SE Secondary facilitates the trading of securities by matching orders between buyers and sellers and facilitating executions of trades on the platform. While a security may be displayed on the bulletin board, these securities will be subject to certain restrictions which may prevent the ability to buy and sell these securities in a timely manner, if at all. Even if a security is qualified to be displayed on the bulletin board, there is no guarantee an active trading market for the securities will ever develop, or if developed, be maintained. You should assume that you may not be able to liquidate your investment for some time or be able to pledge these shares as collateral.
PINNED BY STARTUP
Viral Kothary
a year ago
1
0