AiViva

Developing treatments that change lives

AiViva

Developing treatments that change lives

Closing in 10 days
Newport Beach, CA
Biotechnology
Health Tech
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.

$649,130

raised
167
Investors
$48.8M
Valuation
$2.00
Price per Share
$400.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$5M
Offering Max
10
Days Left

$649,130

raised
167
Investors
$48.8M
Valuation
$2.00
Price per Share
$400.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$5M
Offering Max
10
Days Left

Stack Owner's Bonus & Rewards!

Members get an extra 10% shares in addition to rewards below!

Rewards

Get rewarded for investing more into AiViva:

$400+
Investment
StartEngine Owner’s Bonus
This offering is eligible for the StartEngine Owner’s 10% Bonus program. For details on this program, please see the Offering Summary section below.
$1,000+
Investment
$1,000+
5% bonus shares
$2,000+
Investment
$2,000+
5% bonus shares
$5,000+
Investment
$5,000+
10% bonus shares, plus ability to vote on product names
$10,000+
Investment
$10,000+
15% bonus shares, Zoom Meeting with Founding Team
$25,000+
Investment
$25,000+
20% bonus shares, In-person Meeting with Founding Team

Reasons to Invest

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.

Innovative products, transformational treatments

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


AiViva has successfully raised capital & demonstrated positive human results in three areas


*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:


  1. Vision improvement by reducing retina swelling and scarring
  2. Fibrosis reduction (thus reducing scarring potential) for surgical incisional wounds
  3. Histological clearance of basal cell carcinoma and nodular carcinoma


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


Imagine losing your sight, day by day


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


Discovering therapeutics to address major unmet medical needs

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


Our diverse pipeline presents a large, combined market potential

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


Bringing transformative therapies to millions of patients

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.


Issuer 17b Disclosure

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Offering Summary


Company

:

AiViva Holding Limited

Corporate Address

:

1300 Bristol Street North, STE 220, Newport Beach, CA 92660

Offering Minimum

:

$10,000.00

Offering Maximum

:

$5,000,000.00

Minimum Investment Amount

(per investor)

:

$400.00











Terms


Offering Type

:

Equity

Security Name

:

Common Stock

Minimum Number of Shares Offered

:

5,000

Maximum Number of Shares Offered

:

2,500,000

Price per Share

:

$2.00

Pre-Money Valuation

:

$48,772,314.00











*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.

The Company will not incur any irregular use of proceeds.


Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$4,583,591.00 USD
$8,589,570.00 USD
Cash And Cash Equivalents
$3,601,734.00 USD
$5,419,620.00 USD
Accounts Receivable
$0.00 USD
$0.00 USD
Short Term Debt
$437,051.00 USD
$597,651.00 USD
Long Term Debt
$23,892.00 USD
$0.00 USD
Revenues And Sales
$17,000.00 USD
$153,000.00 USD
Costs Of Goods Sold
$0.00 USD
$0.00 USD
Taxes Paid
$4,070.00 USD
$800.00 USD
Net Income
-$3,960,872.00 USD
-$4,542,477.00 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. 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. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


Updates

The Woman Aiming to Develop Transformative Treatment Options

23 hours ago

Dr. Tang-Liu, CEO and Co-Founder of AiViva, was featured on “Humans of Fuzia,” an inspirational website empowering creative women through fusion of cultures and ideas. Learn more of her personal story here: http://www.humansoffuzia.com/2022/09/27/the-woman-aiming-to-develop-transformative-treatment-options.


AiViva is attending American Academy of Ophthalmology 2022

4 days ago

AiViva Biopharma, Inc., a biopharmaceutical company revolutionizing the treatment of wet AMD, will be attending in Chicago the American Academy of Ophthalmology 2022 (AAO 2022). AAO 2022 is a prominent event in the ophthalmology field, attracting key leaders from around the world to discuss the latest technological advances in eye care. This event allows the top scientific and clinical minds to convene on progress in the field of ophthalmology. 

AiViva will be attending this event from September 29th to October 22nd meeting key scientific leaders and preparing for its upcoming E02 study using its AIV007 JEL™ technology to provide a new treatment for patients suffering from wet AMD. 

We are looking forward to connecting with industry-leading clinicians, global executives, and mission-driven colleagues in eye care.

About AiViva Biopharma

AiViva is a clinical stage biotech company founded in 2015 by four pharmaceutical industry veterans with more than 160 years of combined industry experience. AiViva's founders have demonstrated a successful track record across the full spectrum of drug development and commercialization, in addition to successful fundraises and IPOs on the NYSE and NASDAQ. AiViva was formed with the mission of developing novel, innovative pharmaceutical products through an efficient, risk-mitigated development strategy to address major unmet medical needs. We are developing drug products with the potential to transform treatment paradigms or significantly reduce the treatment burden for patients and physicians. Our approach leverages our proprietary JEL™ Technology to prolong the therapeutic effects of drugs and enhance their benefit-risk profiles. AiViva has a diverse pipeline of multiple novel drug candidates in development areas of dermatology, ophthalmology, oncology, and urology with the potential to expand to other areas of interest.  



AiViva's Nonmelanoma Skin Cancer — Clinical Development

6 days ago

In the U.S. alone, an estimated 3.6 million cases are diagnosed each year with basal cell carcinoma (BCC). Basal cell carcinoma (BCC) is a type of skin cancer that often develops on areas of skin exposed to the sun, such as the face. Basal cell carcinoma is the most common form of skin cancer and the most frequently occurring form of all cancers. AiViva is targeting two of the four main clinical subtypes of basal cell carcinoma: nodular and superficial.

Currently, we are conducting our phase one clinical trial using our AIV001 compound to potentially cure BCC in patients with these subtypes. In our study, we have noted preliminary data of histological clearance of superficial and nodular BCC skin cancer, leading to our excitement that our product may have promise in treating these types of skin cancers. 

Our treatment is unique because it does not require surgical intervention, the market's most common treatment for BCC. Instead, our treatment avoids surgery entirely — the drug is directly injected into the cancer area and provides a prolonged release of AiV001 directly to the targeted tissue without systemic side effects or visible scarring. We expect the topline results to be completed in 2023. We believe patients would choose a simple injectable treatment for BCC skin cancer to avoid scarring in some cosmetic regions such as the face or chest rather than surgical intervention.

Sources:

• https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/

wet AMD— The Problem / Our Solution / Our Progress

11 days ago

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. It can lead to permanent blindness if left untreated. Several treatments for wet AMD are available around the world. However, the mainstream current treatment duration is anywhere from 4- 12 weeks apart, requiring the patient to visit the doctor and receive injections in the eye frequently. A significant thrust of new product development is to reduce the burden of monthly injections with longer-acting products requiring less frequent doctor trips. This is where AiViva’s AIV007, combined with its JEL™ technology, comes into play.

 

Our Solution:

AiViva is developing AIV007 in JEL™ which potentially will address abnormal blood vessel leakage and underlying scar formation as a once-every-6-month treatment. We believe this drug candidate could address the disease effectively with good clinical outcomes (e.g., preservation and enhancement of vision) and much improved convenience for the patients and physicians. In addition, our drug has shown a proof of concept to remove the scarring within the macula which no other treatment addresses


Our Progress:

AiViva’s GLP (Good Laboratory Practices) study to support the testing in patients is underway. It is the last step required before we can launch our clinical trial in wet AMD patients in 2023. With $9.3 million raised in the first half of 2022, AiViva is in a strong position to focus on clinical development. 

On behalf of the AiViva team, we look forward to a strong campaign and partnership with you! 

Best Regards, 

AiViva Team

How to mitigate risks in drug development

14 days ago

Hello AiViva Community,

AiViva is a pre-IPO clinical stage biopharma company focusing on ophthalmology, oncology, dermatology, and prostate disease. AiViva has two ongoing clinical trials in skin cancer and keloid scarring using compound AIV001. FDA.gov states the following about clinical trials:

• Approximately 70% of drugs move to the next phase after phase 1

• Approximately 33% of drugs move to the next phase after phase 2

• Approximately 25-30% of drugs move to the next phase after phase 3

At AiViva, we understand the challenges in drug development. Great science alone is not enough to develop a successful product. Our roadmap to success is based on these factors:

Our projects are innovative, with the potential to transform treatment paradigms for major diseases. An example of the major disease is wet AMD (age-related macular degeneration), one of the leading causes of visual disability. There is no cure, and AMD affects 170 million people globally and AMD overtime may turn into wet AMD. How significant is this number? In the U.S., the prevalence of AMD is similar to that of all invasive cancers combined and more than double the prevalence of Alzheimer’s Disease.

AiViva has a robust portfolio of intellectual property. We have filed over 63 patent applications worldwide. We demonstrate the novelty of our assets, and 23 patents have been granted in major markets such as the US, Japan, China, Korea, Canada, and Australia. This strong IP position will afford us market exclusivity beyond the year 2040 for any product coming out of our development.

• AiViva has a world-class team of veterans with successful track records in bringing MULTIPLE products to commercialization.

• We have thus far demonstrated our ability to secure funding. Do you know that <1% of US startup companies are able to raise VC funds? VC funding comes with rigorous due-diligence scrutiny, and it is a highly competitive process. AiViva has raised over $30M since its inception and over $9.3M in the first half of 2022.

AiViva is leading the way by developing cutting-edge technology to improve the quality of patients' lives.

Join our team for as little as $400 USD, and become part of AiViva. To learn more about our company please visit www.aiviva.com.

Best Regards,

AiViva Team


Sources:

https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178091/

Cancer Moonshot — The White House Cancer Fighting Effort

18 days ago

On September 12, 2022, the Biden administration announced a new biotechnology and biomanufacturing initiative, which is intended to galvanize sophisticated medical research and manufacturing in the United States. Cancer remains the nation’s second most common cause of death, after heart disease, killing about 600,000 Americans annually. The goal is to reduce the cancer death rate by half within 25 years and improve the lives of people with cancer and cancer survivors.

AiViva is on the cutting-edge treatment for certain cancers. We are currently running a clinical trial in basal cell carcinoma (skin cancer) patients using AIV001 compound and expect topline results in 2023. 

AIV001 is a novel multi-kinase inhibitor formulated in with AiViva's proprietary delivery technology, designed for prolonged drug release via intradermal treatment. There are quite a few advantages of AiViva’s innovation in the treatment of solid tumors. A single intratumoral injection of AiViva’s compounds achieves and maintains very high drug concentrations in the tumor, therefore ensuring anti-tumor effect. Furthermore, a single treatment of AiViva’s drug in JEL™ only contains one milligram of the drug, as compared to a total dose of about 100 milligrams of the same drug when it is given orally, daily over three weeks. This dose efficiency will significantly reduce the drug toxicity to the body which is commonly associated with traditional anti-cancer therapies. We have demonstrated significant improvement of benefit-vs-adverse effect in pre-clinical models grafted with human squamous cell carcinoma, thyroid cancer, and prostate cancer. 

Best Regards, 

AiViva Team 

Sources

• https://news.yahoo.com/biden-outlines-ambitious-moonshot-effort-to-reduce-cancer-deaths-in-the-us-222236226.html 

• https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative

Milestone Activated: $600K Investments!

25 days ago

Hello AiViva Community!

The AiViva team is ecstatic to announce that we have reached over $600K of committed investments on StartEngine within the first three months of our raise! We are beyond grateful to have an amazing community to support us on this mission.

Why Invest?

  • AiViva has raised $9.3M in 2022 ($30M+ to date)!
  • With $9.3 million raised in the first half of 2022, AiViva is positioned to launch two new clinical trials in 2023 focusing on age-related vision loss and prostate disorders
  • Our REG CF Campaign has reached over 600K in committed investments within the first three months on StartEngine
  • Our diverse product pipeline presents a combined multi-billion dollar revenue potential focused on age-related vision loss, prostate disorders, and non-melanoma skin cancer
  • 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

Spread the word about AiViva that's been ranked a top 20 clinical stage BioPharma company in 2022 by Life Sciences Review!

This is your chance to invest alongside venture capitalist and become a part of our team!

Best Regards,

AiViva Team

Insider Investment Disclosure

26 days ago

We're excited to see our community come in and invest in AiViva Biopharma. Our Insiders have invested a total of $49,400 into the offering to date! We hope you join in as well! To learn more about our company, please check out our website at www.aiviva.com

Best Regards, 

AiViva Team

AiViva Pays Tribute to the American Workers

about 1 month ago

Hello AiViva community, 


With Labor Day approaching us, we think it is essential that we reflect on our journey this past year. We have made tremendous progress as a team and are one step closer in making a difference in patients’ lives.


We wish our investors, partners, and employees a Happy Labor Day weekend. We want to thank you for your hard work and investing in AiViva. 


Best regards,


AiViva Team




Hannah Hershoff M.D., Ph.D. has joined AiViva BioPharma as Chief Medical Officer

about 1 month ago

Newport Beach, California – September 1, 2022 – AiViva Biopharma, a clinical stage biopharmaceutical company, today announced it has appointed Hannah Hershoff, M.D., Ph.D. as its Chief Medical Officer. In this new role, Dr. Hershoff will provide leadership and direction to Clinical Strategy, Clinical Operations, Medical Affairs, Clinical Sciences, Data Management/Biometrics, and Drug Safety.

Dr. Hershoff is a trained neuro-ophthalmologist and eye surgeon and has over 30 years of clinical, development, and new drug development experience. She is coming to AiViva BioPharma from Longwood Pharmaceuticals, Inc. as their Chief Medical Officer. Prior experience includes President and Co-owner of MYAD Consulting Group, and Principal Investigator and Team Leader at the Novartis Institutes for BioMedical Research.

“Her breadth and scope in drug development, in a variety of therapeutics areas including ophthalmology will be a great addition to the AiViva management team.” said Diane Tang-Liu, Ph.D., CEO, President & Co-Founder.

Dr. Hershoff commented, “I am excited about being part of an experienced and dedicated team, focusing on developing focal therapies for therapeutic areas that have few options.”

Dr. Hershoff received her Doctor of Medicine at Jiangxi Medical School, China, her Ph.D. in Experimental Ophthalmology at Lund University, Sweden, and her MS at Sun Yat-Sen University, China.

About AiViva Biopharma, Inc.

AiViva is a clinical stage biopharmaceutical company led by a team of seasoned industry experts with proven track records in drug development and commercialization. AiViva has developed innovative approaches to address high unmet medical needs by transforming treatment paradigms through focal therapies that target diseases of neovascularization, abnormal cell proliferation, and fibrosis. Core competencies include development of novel drugs using proprietary technologies, including JEL™, in specialty therapeutic areas of dermatology, ophthalmology, urology and oncology. Our lead products, AIV001 and AIV007, are designed to optimize therapeutic outcomes and lower treatment burden.

Best Regards,

AiViva Team


Notice of Material Change in Offering

about 1 month ago

[The following is an automated notice from the StartEngine team].

Hello! Recently, a change was made to the AiViva offering. Here's an excerpt describing the specifics of the change:


Issuer is extending campaign end date and adding new officer.


When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

AiViva reaches $550K on StartEngine!

about 1 month ago

Hello AiViva community,

AiViva’s mission is to develop novel, innovative pharmaceutical products through an efficient development strategy to address major unmet medical needs. We have a promising product pipeline focused on age-related vision loss, prostate disorders, and non-melanoma skin cancer using our JEL™ technology to provide a focused and long-lasting medication treating the disease.

Thanks to the support of our investor community, we’ve breached a massive milestone during our equity crowdfunding journey.

Over $550K committed investments raised on StartEngine!

This year we have raised over $9.8 million from investors!

We're blown away with the amount of support we've received already, and we are humbled by your enthusiasm.

Our raise is far from over!

To join AiViva as an investor, simply visit our StartEngine raise page and invest for a minimum of $400!

Best Regards,

AiViva Team


80 Percent Spent on R&D — Why does it Matter to the Investor?

about 1 month ago

Hello AiViva community,

We would like to share with you that AiViva allocates 80 percent of our capital to research and development and how this means to the investor.

AiViva historically spent 80 to 85 percent of our capital on research and development (i.e., money spent on innovation and technological advancement). This is based on annual audited GAAP financials in years 2019 to 2021. It means that our management allocates and spends funds extremely efficiently, thus maximizes our productivity in all aspects of drug development including nonclinical testing, manufacturing of investigational products, and conducting clinical trials.

Our management acts extremely judiciously in controlling general and administrative expenses (e.g., accounting and legal expenses, utilities and rent) and executive compensations related to G&A.

We would like to be transparent with you on how our capital has been disbursed in order to support the portfolio growth and to expand our clinical pipeline.

In the graph above the blue bars and orange bars represent the percentages of budget spent on G&A and R&D, respectively, across 2019 to 2021.

Please be assured that AiViva Team operates in an efficient and judicious manner and focuses on bringing transformational treatment options to patients and physicians. Join our community today and become an investor in AiViva! Please follow our page and keep a look out for the latest updates about our company!

Best regards,

AiViva Team

AiViva now has 63 patent applications worldwide!!!

about 2 months ago

On August 2, 2022, AiViva has received United States Patent No. US 11,400,089. This patent is a method of use patent for many sGC stimulator and multikinase inhibitors and to prevent and/or treat fibrosis (thickening or scarring of tissue) associated with reproductive or digestive tract diseases. AiViva has the right to license out this patent to strategic partners.

Obtaining a patent is a rigorous and thorough process, especially in the biopharmaceutical industry. These patents, secure a company’s legal and exclusive position in a specified therapeutic disease or how the drug is used. With granted patents, the company has the right to prevent others from making, using, selling or importing the patented inventions for the remainder of patent life in the countries which have granted patents. Patents are also essential for companies to raise capital and make the needed investments to develop new therapies for patients with unmet needs.

This patent adds to AiViva’s 22 approved patents in the US, Canada, China, Japan, Korea, Australia, and Taiwan. In addition, AiViva has filed 63 patent applications worldwide, and will continue to keep you posted as our patent applications are granted.

Best regards,

AiViva Team

Link to patent announcement on: https://www.prnewswire.com/news-releases/aiviva-biopharma-receives-new-patent-301607705.html?tc=eml_cleartime


Company Highlights from Q2 2022

about 2 months ago

Hello AiViva community,

We have some exciting news to share with you about our Q2 2022 company highlights, and we want to take this opportunity to welcome our new investors.

Company Highlights from Q2 2022

  • AiViva launched its REG CF campaign and raised over $200K of committed investments in the first two weeks.
  • WE RAISED AN ADDITIONAL $5 MILLION ON JUNE 30th. AiViva now has raised over $9.3 million in capital in 2022. This will allow us to proceed with the planned clinical trials in 2023. We thank all our investors for your strong support.
  • AiViva received four notices of allowance/acceptance from patent offices from US, Canada, and Australia. With these patents and proof of concept studies, it continues to secure our corporate position and development strategy.
  • A single intratumor injection of an AiViva compound in JEL demonstrated significant shrinkage of prostate cancer in an animal xenograft model. These results strongly indicated the feasibility for focal treatment of localized prostate cancer in patients.
  • Our R&D Team started two GLP (Good Laboratory Practices) studies in animals which bring us one step closer to the start of two planned clinical trials in 2023.
  • AiViva’s CEO, Dr. Diane Tang-Liu, was the invited keynote speaker at Research Day and International Conference in April. She also lectured at the National Taiwan University School of Pharmacy Alumni Association in June.

Please follow our campaign page to stay in touch with our latest updates about our campaign. We have more exciting news to share with you in the future!

Best regards,

AiViva Team

POSITIVE DATA FROM PRE-CLINICAL CANCER STUDIES

2 months ago

Hello AiViva Community!

We have some exciting news to share with our investors about the potential use of our JEL™ technology to battle solid tumors.

It has been observed that AiViva’s drug delivered in the JEL™, as a single treatment, can shrink human tumors in animal cancer models in contrast to a continuous tumor growth when the same drug was administered orally daily over weeks.

AiViva BioPharma, Inc. has developed the sterile and injectable formulations of our compounds for prolonged residence in the tumor masses. There are quite a few advantages of AiViva’s innovation in the treatment of solid tumors. A single intratumoral injection of AiViva’s compounds achieves and maintains very high drug concentrations in the tumor, therefore ensuring anti-tumor effect. Furthermore, a single treatment of AiViva’s drug in JEL™ only contains one milligrams of the drug, as compared to a total dose of about 100 milligrams of the same drug when it is given orally, daily over three weeks. This dose efficiency will significantly reduce the drug toxicity to the body which is commonly associated with traditional anti-cancer therapies.

We have demonstrated significant improvement of benefit-vs-adverse effect in pre-clinical models grafted with human squamous cell carcinoma, thyroid cancer, and prostate cancer.

We look forward to sharing more exciting results with you in the future about our company and this amazing investment opportunity.

Best regards,

AiViva Team

Insider Investment Disclosure

2 months ago

We're excited to see our community come in and invest in AiViva Biopharma. Our Insiders have invested a total of $24,400 into the offering to date! We hope you join in as well! To learn more about our company, please check out our website at www.aiviva.com

Best Regards, 

Team AiViva

GREAT NEWS!!! AIVIVA RAISED AN ADDITIONAL $5 MILLION IN Q2 2022!

2 months ago

Hello AiViva Community! 

The AiViva team is proud to announce that we raised an additional USD $5 MILLION in Q2 2022, and the total capital AiViva has raised from Series A-1 year to date is $9.3 MILLION! Thank you for all your SUPPORT as we continue to build our pipeline projects. With this new funding, AiViva will focus on initiating planned clinical studies and making additional GMP (Good Manufacturing Practice) supplies in 2023. Our development focus will expand in the wet AMD/retinal diseases and prostate disorders.

We take this opportunity to welcome new investors who joined our team. We look forward to sharing news with you in the future about our company and this amazing investment opportunity.

Best regards,

AiViva Team

Notice of Material Change in Offering

2 months ago

[The following is an automated notice from the StartEngine team].

Hello! Recently, a change was made to the AiViva offering. Here's an excerpt describing the specifics of the change:


Inclusion of concurrent offering and amendment to articles of incorporation.


When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

AiViva Biopharma: What We Focus On

3 months ago

Hello AiViva Community! 

 

We are a clinical stage biotech company formed with the mission of developing novel, innovative pharmaceutical products through an efficient, risk-mitigated development strategy to address major unmet medical needs.

 

Specifically, our pharmacotherapies address neovascularization, abnormal cell proliferation, inflammation, and fibrosis.  In other words, we develop treatments to address abnormal growth of blood vessels and tissues, and aberrant wound healing. In addition, our products have the potential to transform treatment paradigms and significantly reduce the treatment burden for both patients and physicians! 

 

AiViva’s research is based on strong scientific evidence. The validity of our therapeutics has been proven through robust nonclinical proof-of-concept studies. 

 

We have a diverse pipeline of novel products for development areas in: 

 

Dermatology: Developing AIV-001 to address the negative impacts that scarring and abnormal skin wound healing have on patients. Improving the skin appearance and recovery from various wounds (e.g., traumas and surgeries) and diseases (e.g., tumor excisions, rosacea, etc) will improve the patient's emotional well-being and quality of life.  

 

Ophthalmology: Developing AIV-007 JEL™, a proprietary thermo-reversible gel product. This product will form a drug-depot to reduce the need of frequent injections in the eye for patients with age-related retinal diseases that cause vision loss and eventual blindness.

 

Oncology: AiViva’s JEL™ Technology has broad applicability in transforming the treatment of solid tumors. Our investigational program in oncology uses will directly target solid tumors. AiViva is developing AIV-001 as an intradermal therapy to eliminate or reduce the need for surgery in the treatment of nonmelanoma skin cancer.

 

Urology: Developing AIV-007 JEL™ as an intraprostatic treatment for localized benign hyperplasia to optimize drug effect and minimize adverse effects associated with daily oral drugs and radiation and surgical treatments. At around age 25 and throughout a man's life, your prostate will grow larger. Benign prostate hyperplasia is when it gets large enough to cause urinary problems.    

 

(AiViva has development plans to expand to other therapeutic areas!)

 

Join our community and become an investor for improved living tomorrow!

 

Best regards, 

 

Team AiViva


Positive Proof of Concept

3 months ago

 Hello AiViva Community, 

We are developing drug products with the potential to transform treatment paradigms and significantly reduce the treatment burden for patients and physicians. Our approach leverages our proprietary JEL™ Technology to prolong the therapeutic effects of drugs and enhance their benefit-risk profiles. AiViva has a diverse pipeline of multiple novel drug candidates in therapeutic areas of dermatology, ophthalmology, oncology, and urology with the potential to expand to other areas of interest. 

AiViva has brought several projects through the FDA’s IND (Investigational New Drug Application) and demonstrated positive proof-of-concept in clinical trials in three areas: 

  • Vision improvement by reducing retina swelling and scarring 
  • Fibrosis reduction, thereby reducing scarring potential for surgical incisional wounds 
  • Histological clearance of basal cell carcinoma and nodular carcinoma

To Learn more about us please visit our website at www.AiViva.com.

And check out our LinkedIn at https://www.linkedin.com/company/aiviva-biopharmainc/mycompany/.

Best Regards, 

AiViva Team  



AiViva was awarded Top Clinical-Stage Biopharmaceutical Company in 2022

3 months ago

Hello AiViva Community!

We have great news! AiViva Biopharma was awarded Top Clinical-Stage Biopharmaceutical Company in 2022 by Life Sciences Review. We continue to thrive and spread our great news!

Please check out the article: https://www.lifesciencesreview.com/aiviva-biopharma

And please visit our website, www.AiViva.com.

Best regards,

AiViva Team



AiViva reached $200k of committed investments within the second week!

3 months ago

Hello AiViva Community!

The AiViva team is thrilled to announce that we have reached $200K of committed investments within the second week of our campaign!

Please welcome our newest team member @BatmanTheBiewerTerrier, our Chief Social Officer. He is looking forward to working with all of you!

Best regards,

AiViva Team

Diane Tang-Liu was invited to lecture by the National Taiwan University School of Pharmacy Alumni Association (June 25, 2022)

3 months ago

Hello AiViva Community!  

Check out our latest announcements below and make sure to follow our page and check out our website www.aiviva.com to learn more about our exciting news and updates! 

Diane Tang-Liu, CEO and President of AiViva, was invited by the NTU School of Pharmacy to speak to alumni in the US and greater Asia to speak on the unmet needs in AMD patients and the direction of developing future treatment options. Age-related macular degeneration (AMD) is a chronic, progressive disease with two end stages, wet AMD and dry AMD. With an aging population, the size of the affected patient population will inexorably continue to increase. It is estimated that 288 million people will be affected by AMD by 2040, with 113 million people in Asia.  In Asians, a distinct form of wet AMD, polypoidal choroidal vasculopathy (PCV) is four times more prevalent than Caucasians. It is important to develop new, effective therapies that will halt disease progression and preserve and/or improve vision at reduced number of treatments.  The ultimate goal is to improve patient’s quality of life. 


Best regards,  


AiViva Team 

Souce: Wong WL,et al. Lancet Glob Health. 2014;2:e106–116.



Super Early Birds Bonus

3 months ago

Don’t miss your chance to join our growing team of shareholders. Invest within the next 24 hours before the 15% Super Early Birds Bonus is over!

Invest now and take advantage of the Super Early Birds Bonus!

AiViva Presentation at 2022 Research Day and International Conference

3 months ago

Hello AiViva Community! 

Check out our latest announcements below and make sure to follow our page and check out our website www.AiViva.com to learn more about our updates!

As the proportion of people in the U.S. age 55 and older grows larger, more people are developing age-related diseases such as AMD. From 2000-2010, the number of people with AMD grew 18 percent, from 1.75 million to 2.07 million in the US. By 2050, the estimated number of people with AMD is expected to more than double from 2.07 million to 5.44 million. AiViva’s CEO & President, Dr. Diane Tang-Liu, was the keynote speaker at the National Taiwan University (NTU) Research Day and International Conference. Recognized as a Distinguished NTU School of Pharmacy Alumnus, Dr. Tang-Liu’s presentation topic was “Transforming the Standard of Care for Age-Related Macular Degeneration (AMD) to Address Unmet Medical Needs.” 

This presentation reviewed clinical results from current therapies available for AMD patients and highlighted the need to develop longer lasting therapies that would provide additional benefits to patients suffering with AMD-related vision loss. Developing new therapies will benefit patients by preserving and/or improving eye health longer and decreasing the overall frequency of treatment for patients. 

Best regards,

AiViva Team

 

$130K Within the First Week!

3 months ago

Hello AiViva Community! 

The AiViva team is ecstatic to announce that we have reached $130K of committed investments within the first week of our campaign!

We are beyond grateful to have an amazing community to support us on this mission. Please follow our page and stay up to date with our upcoming exciting news! 

Best regards, 

AiViva Team


 

Super Early Birds Bonus

3 months ago

Don’t miss your chance to join our growing team of shareholders. Invest within the next 24 hours before the 20% Super Early Birds Bonus is over!

Invest now and take advantage of the Super Early Birds Bonus


Company Highlights from Q1 2022

4 months ago

Hello and Welcome to AiViva! 

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.  As you may have heard, we’re raising capital via an equity crowdfunding campaign on StartEngine.

 

Here are some of our company highlights from Q1 2022 

 

  • We have four clinical trials (two ongoing, two planned) 

  • AiViva already has successfully raised over $25 million USD, with $4.2 million raised in 2022 alone 

  • We are rated as a top 20 BioPharma company in 2022 by Life Sciences Review 

  • We put roughly 80% of our raised capital to research and development 


Join our community today and become an investor in AiViva. 



 


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