UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM
_________________
(Mark One)
For the fiscal year ending:
For the transition period from
Commission
File Number:
_____________________
(Exact name of registrant as specified in its charter)
_____________________
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
(Address of principal executive offices) | (Zip Code) |
(Issuers’s telephone number)
N/A
(Former name or former address and former fiscal year, if changed since last report)
_________________
Securities registered pursuant to Section 12(b) of the “Exchange Act”: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes
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Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes
☐
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes ☐
APPLICABLE ONLY TO CORPORATE ISSUERS
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: N/A
As of July 30, 2023 SYBLEU INC. had common shares outstanding.
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In this annual report, the terms “Sybleu Inc... ”, “Sybleu”, “Company”, “we”, or “our”, unless the context otherwise requires, mean Sybleu Inc.., a Wyoming corporation.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This annual report on Form 10-K and other reports that we file with the SEC contain statements that are considered forward-looking statements. Forward-looking statements give the Company’s current expectations, plans, objectives, assumptions or forecasts of future events. All statements other than statements of current or historical fact contained in this annual report, including statements regarding the Company’s future financial position, business strategy, budgets, projected costs and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plans,” “potential,” “projects,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend,” and similar expressions. These statements are based on the Company’s current plans and are subject to risks and uncertainties, and as such the Company’s actual future activities and results of operations may be materially different from those set forth in the forward looking statements. Any or all of the forward-looking statements in this annual report may turn out to be inaccurate and as such, you should not place undue reliance on these forward-looking statements. The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. The forward-looking statements can be affected by inaccurate assumptions or by known or unknown risks, uncertainties and assumptions due to a number of factors, including:
• | dependence on key personnel; |
• | competitive factors; |
• | degree of success of research and development programs |
• | the operation of our business; and |
• | general economic conditions |
These forward-looking statements speak only as of the date on which they are made, and except to the extent required by federal securities laws, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements contained in this annual report.
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PART I
Item 1. Business
We were incorporated June 12, 2020 under the laws of the State of Wyoming. We intend to develop therapies for human and animal health, medical devices, and clinical diagnostics. The Company intends to engage in the acquisition, licensing and development of medical and veterinary applications up to the point of successful completion of Phase I and or Phase II clinical trials after which the Company would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.
We are currently focused on acquiring intellectual property and forging strategic partnerships to advance technologies to market.
Acquired Intellectual Property
On July 14, 2020 we were assigned all right, title, and interest to intellectual property related to methods, devices, and techniques useful for enhancing function of a cellular graft through photoceutical ( the use of low level light therapeutics) manipulation ( “Cell Transplant IP”).
On December 2, 2020 Sybleu Inc.. (the “Company”) was assigned all right, title, and interest to intellectual property related to intratumoral administration of a combination of a chemotherapeutic agent and an immunomodulatory agent for cancer therapy ( “Cancer Therapy IP”).
On June 30, 2023 Sybleu Inc. (the “Company”) entered into an agreement (“Agreement”) whereby the Company purchased from Zander Biologics, Inc. (“Zander”) a 50% interest in
(a)the invention disclosed in US Patent US11377442B2 (Small molecule agonists and antagonists of NR2F6 activity), all patent rights to the invention described in US Patent US11377442B2 as well as all trade secrets, trademarks and associated good will to the invention described in US Patent US11377442B2 and
(b) the invention disclosed in US Patent US US10472351B2 (Small molecule agonists and antagonists of NR2F6 activity in animals), all patent rights to the invention described in US Patent US10472351B2 as well as all trade secrets, trademarks and associated good will to the invention described in US Patent US10472351B2.
(“IP Rights”).
The IP rights are to patent protected small molecule compounds which compounds have been found to modulate the immune system.
Pursuant to the Agreement the Company issued to Zander a promissory note in the principal amount of $300,000 bearing simple interest at 10% per annum as consideration for 50% interest in the IP rights. The promissory note and all accrued interest are due and payable June 30, 2025.
In the event that on or prior to July 31, 2023 Zander causes to be filed with the United States Patent and Trademark Office any and all documentation which may be required in order to record the transfer of the 50% Interest to the Company Zander shall receive additional consideration consisting of 1,000,000 common shares of the Company.
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The Company and Zander (The “Parties”) agree to jointly develop and commercialize the IP Rights for veterinary use upon mutually acceptable terms and conditions. Each Party shall be entitled to 50% of any and all revenues derived from development and commercialization ..Each Party shall be responsible for 50% of all any and all expenses incurred in connection with development and commercialization.
Neither Party shall transfer right, title and interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to the IP Rights in whole or in part without the written consent of the other Party. Neither Party shall grant any rights or license to the IP Rights to any entity without the written consent of the other Party.
Licenses Granted by the Company
On February 24, 2021 Sybleu Inc. ( the “Company”) and Oncology Pharma, Inc. ( “Licensee”) entered into an agreement whereby the Company granted the Licensee an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by the Company (“Agreement”).
This intellectual property relates to intratumoral administration of a combination of a chemotherapeutic agent and an immunomodulatory agent for cancer therapy ( “Cancer Therapy IP”). The concept of the Cancer Therapy IP is the simultaneous intratumoral injection of a chemotherapeutic agents in combination with immunomodulatory agents in sustained release formulations. The chemotherapeutic agent is for the purpose of directly killing the tumor cells for the release of antigens while the immunomodulatory protein or factor is to stimulate the antigenic response of the host to the antigens.
The term of the Agreement is fifteen years from the Effective Date.
Pursuant to the Agreement:
(a) | Licensee shall pay to the Company a non-refundable, upfront payment of six thousand five hundred shares of Oncology Pharma, Inc. common stock as a license initiation fee which must be paid within 10 days of the Effective Date of the Agreement |
(b) | royalties equal to five percent (5%) of the Net Sales of any Licensed Products in a quarter. |
Net Sales are defined in the Agreement as the gross invoiced amount, and/or the monetary equivalent of any other consideration actually received by Licensee and/or its sublicensees, for the transfer of a Licensed Product, less any of the following items that are itemized on the relevant invoice or which Licensee can demonstrate have been actually paid or credited with respect to such transfer.
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the licensed intellectual property in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the licensed intellectual property in the U.S. or foreign jurisdictions but for the rights granted pursuant to this Agreement.
Oncology Pharma Inc. is a publicly traded company whose common shares trade on the OTC Pink market under the symbol ONPH.
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Licenses Granted to the Company
On June 26, 2023 Sybleu Inc. ( the “Company”) was granted an exclusive worldwide license by DYO Biotechnologies, Pty, Ltd (“DYO”) to (a) to make, have made, use, offer for sale, sell, perform, have performed export and import Licensed Products and Licensed Services; (b) to practice Licensed Methods; and (c) to use Technology, all in the Field, within the Territory and during the Term (the “License”).
“Technology” is defined in the License as” Artificial intelligence/machine learning engine designed to utilize existing chemical library structures in an integrated model to predict highly specific and sensitive novel chemical structures for molecular targets.”
“Licensed Products” are defined in the License as “any product, kit, composition, or part thereof: (a) that incorporates, uses, or is enabled or derived from the use of the Technology; or (b) that is produced or enabled by a Licensed Method.”
“Licensed Services” are defined in the License as “any service performed by Company or Sublicensee for the benefit of a third party that, in whole or in part, (a) uses Technology; (b) uses Licensed Product(s); or (c) that practices or is enabled by a Licensed Method.”
“Licensed Method” is defined in the License as “any method or process that uses Technology”
“Field” is defined in the License as small molecule drug development and commercialization for human and/or animal health.
“Territory” is defined in the License as “worldwide”.
The Term of the License is the period of time beginning on the effective date of this Agreement which shall be June 26, 2023 and terminating on the last to expire Royalty Term .
“Royalty Term” is defined in the License as that period of time beginning on the first commercial sale of a Licensed Product in a given country and, expires on a country-by-country basis with respect to each Licensed Product, upon the later of: (a) the expiration, abandonment, or invalidation of the last to expire, abandoned or invalidated Valid Claim of the Patent Rights in such country; (b) the expiration of any granted statutory period of marketing exclusivity within a country; and (c) 12 years from of the date of the first commercial sale of such Licensed Product in such country.
Pursuant to the terms and conditions of the License the Company shall raise $2,000,000 US through either debt or equity financing within 2 years of execution of this Agreement (“Funding”). The Company shall enter into a research collaboration agreement with DYO upon mutually acceptable terms and conditions within 30 days of Funding (“Research Agreement).
Substantially all of the Funding shall be utilized to enable the Technology for the benefit of developing Company’s existing and future small molecule drug intellectual property. It is anticipated that this research agreement will utilize substantially all of these funds over two years. It is agreed that the Company shall exclusively possess all right, title and interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to any and all inventions, discoveries, intellectual property and chemical structures resulting from this Research Agreement.
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Pursuant to the terms and conditions of the License the Company shall pay to DYO a Royalty equal to five percent (5%) of the Net Sales ( as such term is defined in the License) of any Licensed Method, Service or Product per annum. The License also imposes an obligation upon the Company to make minimum royalty payments to DYO over the course of the Term.
Pursuant to the terms and conditions of the License the the Company paid to DYO 309,000 common shares of the Company (“Stock Payment”) and a $25,000 License Issuance Fee.
DYO shall not, directly or indirectly, offer, issue, sell, contract to sell (including without limitation short sale), grant any option for the sale of, pledge or otherwise dispose of or transfer any or all of the Stock Payment for a period of two years from the date of issuance.
Pursuant to the terms and conditions of the License Upon the occurrence of each of the following events (each a “Milestone”)), the Company shall make a cash payment (“Milestone Payment”) in the amount corresponding to such Milestone within thirty days after achievement of each Milestone:
Milestone | AMOUNT | |
1. Dosing of a first human patient in a Phase I or Phase I/II Clinical Trial for Licensed Product | $150,000 US | |
2. Dosing of a first patient in a Phase III Clinical Trial for Licensed Product | $500,000 US | |
3. FDA (US) Approval of a Licensed Product | $3,000,000 US | |
4. EMA (EU) Approval of a Licensed Product | $1,500,000 US | |
5. PMDA (JPN) Approval of a Licensed Product | $1,000,000 US | |
6. Cumulative Net Sales of Licensed Products reach $100 Million | $2,000,000 US |
This License may be terminated by DYO in the event:
No licensed Method, Service or Product has been granted Patent Protection in at least one jurisdiction after the expiration of four years from execution
The sum of $2,000,000 shall not have been raised within 2 years of execution of the license
The Research Agreement shall not have been entered into as of thirty days subsequent to the Funding.
The Company shall not have achieved cumulative Net Sales of Licensed Product, Service and Methods of at least $10,000,000 as of a date that is ten years from the execution of the license
The Company shall fail to pay any consideration required under the license and such failure remains uncured for thirty days.
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This License may be terminated by the Company in the event:
DYO shall be determined to not have exclusive unencumbered Patent Rights to the Technology in whole or in part.
Any other entity shall be determined to have the right- exercised or not- to utilize the Technology ( in whole or in part) to develop make, use, offer for sale, sell, perform, have performed export and import and sell products, methods and services which can reasonably be expected to be similar to or competitive with products, methods and services to be developed by the Company utilizing the rights granted by the License. .
DYO shall have failed to demonstrate during the course of due diligence to the satisfaction of the Company that the Technology can be effectively utilized for the purposes intended by this License
In the event that the Agreement is terminated pursuant to the any of the abovementioned the Stock Payment shall be promptly returned by DYO to the Company for cancellation.
Dr. Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing Director of DYO and is a controlling shareholder of DYO.
Distribution methods of the products or services:
If circumstances allow and subject to then current market conditions and available capital, we intend to enter into licensing and/or sublicensing agreements with outside entities in order that the Company may, if the Company is successful in securing its intellectual property claims, allow it to obtain royalty income on the products and services which it may develop and commercialize.
Competitive business conditions and the Company’s competitive position in the industry and methods of competition
We are recently formed and have yet to achieve consistent revenues or profits and there can be no assurance that we will generate revenues or, if are successful, that we can do so at levels that will allow us to achieve and sustain positive cash flow and profitability and, if so, for any period of time.. The industry in which we intend to compete are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do.
We intend to be competitive by utilizing the services and advice of individuals that we believe have expertise in their field in order that we can concentrate our resources on projects in which products and services in which we have the greatest potential to secure a competitive advantage may be developed and commercialized .
To that effect we have established a Scientific Advisory Board considting of members who we believe have a high level of expertise in their professional fields and who have agreed to provide counsel and assistance to us in (a) determining the viability of proposed projects (b) obtaining financing for projects and (c) obtaining the resources required to initiate and complete a project in the most cost effective and rapid manner.
SCIENTIFIC ADVISORY BOARD MENBERS
Dr. Steven E. Hake, M.D.
Dr. Hake obtained his medical degree from The Chicago Medical School. Dr. Hake has been certified by American Board of Radiology since June 1992. Dr. Hake’s professional affiliations are with the Alpha Omega Alpha Honorary Medical Society and the American College of Radiology.
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Dr. Jason E. Garber, MD.
Dr. Garber obtained his medical degree from The University of Texas Health Science Center at San Antonio. Dr. Garber is Board Certified in Neurological Surgery by the American Board of Neurological Surgery
Dr. Garber was awarded a Cloward Fellowship Award in 2001 and has authored the following papers in the following publications:
Hassenbusch, SJ, Garber, JE: “Alternative Intrathecal Agents for Pain,” Neuromodulation, Volume 2, Number 2, 1999 89-95.
Garber, JE, Hassenbusch, SJ: “Innovative Intrathecal Analgesics,” Pain surgery, Burchiel, K (ed): In Press.
Garber, JE, Hassenbusch, SJ: “Interventional Pain Management: Can Charges be Effectively Minimized without Compromising Quality?” Pain Digest: In Press.
Garber, JE, Hassenbusch, SJ: Neurosurgical Operations on the Spinal Cord. Bonica’s Management of Pain, 3rd Edition, Loeser, JD (ed), Medica, PA: Williams and Wilkins, 1998: In Press.
Garber, JE, Hassenbusch, SJ: “Spinal Administration of Non-Opiate Analgesics in the Management of Pain,” Interventional Pain Management, 2nd Edition, Waldman, SD (ed), WB Saunders: In Press
Nguyen H, Garber JE, Hassenbusch SJ: Spinal Analgesics. In: Staats P and Fleisher LA (eds). Anesthesiology Clinics of North America, Saunders: Philadelphia, pp. 805-816, 2003.
Garber, JE, Thalgott JS, Christensen SD: Anterior Lumbar Interbody Fusion via the Anterior Retroperitoneal Approach: Strategic Tactics for Avoiding Complications. The NNI Journal, Volume 2, Issue 3, 2006 62-65.
Garber, JE, Thalgott JS, Fogarty M, Caiazza S: Dynamic Stabilization of the Lumbar Spine: Past, Present, and Future Innovations. The NNI Journal, Volume 3, Issue 1, 2007 pp. 84-87.
Garber, JE, Saxena RC, Malone K: The Identification and Treatment of a Lumbar Plasmacytoma: A Case Report and Topic Review. The NNI Journal, Volume 3, Issue 3, 2007 pp. 135-139
Garber, JE, Malone K: Utilizing a Lateral Extracavitary Approach for Failed Lumbar Spine Fusion Procedures: A Case Study with Imaging Considerations in Lumbar Fusions. The NNI Journal, Volume 4, Issue pp. 14-15.
Garber, JE, Christian G, Serrano S, Malone K: Surgical Treatment of Intradural Extramedullary Spine Tumors. The NNI Journal, Volume 5, Issue 1, April 2009.
Garber, JE, Christian G, Serrano S, Malone, K: Nail-Gun Misfire Resulting in Penetrating Intracranial Injury. The NNI Journal, Volume 5, Issue 1, April 2009.
Garber, JE, Christian G, Serrano S, Malone, K: Craniocervical Fixation Series and Review of Literature. The NNI Journal, Volume 6, Issue 1, Jan 2010.
Dr. Garber has made the following professional presentations:
1. 1999 Congress of Neurological Surgeons (CNS) Meeting, Boston, MA. Oral Presentation, Section on Pain II: Interventional Pain Management: Can Charges Be Effectively Minimized Without Compromising Quality?
2. 2000 Neurosurgery + Science + Management Symposium, New Orleans, LA. Oral Presentation: Cancer and Non-cancerous Pain Management.
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3. 2001 Congress of Neurological Surgeons (CNS) Meeting, San Diego, CA. Poster Presentation: Extralaminar Posterior Cervical Dorsal Ramisectomy: A Modified Surgical Approach for the Treatment of Cervical Dystonia (Spasmodic Torticollis).
4. 2005 Medical Education Resources Making Sense of Spine Surgery Seminar, Las Vegas, NV. Oral Presentation: Spinal Disorders: Cervical Conditions and Treatment. Demonstration: Cervical Construct Demonstration: Atlantis Vision Cervical Plate.
5. Minimally Invasive Spinal Surgery. Sunrise Hospital and Medical Center Grand Rounds, June 1, 2005.
6. Oral Presentation: One Neurosurgeon’s Experience with STALIF, Newport Beach, CA, November 2007.
7. EuroSpine: What is the Role of Mystique plating and Bioresorbable Technology in anterior cervical Fusion Procedures? Bressels, Belgium, 2007.
8. Oral Presentation: Novel Minimally Invasive Spine Techniques, Las Vegas, NV, January 2008.
9. International Meeting on Advanced Spine Techniques, Hong Kong, China, July 2008. Poster Presentation: A Comparison of the Surgical Efficacy of ALIF and XLIF® L4-5 Fusion Procedures with Posterior Fixation.
10. Congress of Neurological Surgeon’s 2008 Annual Meeting, Orlando, FL, September 2008. Poster Presentation: A Comparison of the Surgical Efficacy of ALIF and XLIF® L4-5 Fusion Procedures with Posterior Fixation.
11. North American Neuromodulation Society (NANS) 13th Annual Meeting, Las Vegas, NV, December 3-6 2009. Paper Presentation: Selective Dermatome Activation, Using a Novel Five-Column Spinal Cord Stimulation Paddle Lead: A Case Series.
12. International Society for the Advancement of Spine Surgery – 2 nd Asia Pacific Conference (2010 APSAS), Sanya, China, January 14-17 2010. Paper Presentation: Direct Lateral Approach Corpectomy for Severe Kyphotic Deformity Correction.
13. The Role of Permanent Vascular Protection in Anterior Spine Instrumentation – 39th Annual Symposium, Orlando FL. March 16-19, 2011. A Review of Ten Same Lumbar Level Reoperations, Society of Clinical Vascular Surgery.
14. International Society for the Advancement of Spine Surgery – Annual Meeting (SAS, 2011), Las Vegas. Poster Presentation: A Multi-center Retrospective Evaluation of a Cervical Integrated Interbody System.
15. Conejo Valley Journal Club, Sherman Oaks, CA. January, 2015. Oral Presentation: Benefits of an Integrated Interbody Device over Spacers and Plates.
16. Society for Minimally Invasive Spine Surgery Global Forum ’15 – Las Vegas, NV. November 6, 2015. Minimally Invasive Stabilization: A 5 year Level 1 Study of Spinal Stenosis Disease Management.
17. International Society for the Advancement of Spine Surgery, Metro Toronto, Canada, April 11-13, 2018. Clinical Experience of Integrated Interbody Fusion in Multi-level Cervical Fusion.
18. Society for Minimally Invasive Spine Surgeons Annual Forum ’18, Las Vegas Nevada. Multi-level Cervical Constructs in Clinical Practice using Integrated Interbody Fusion.
19. Society for Minimally Invasive Spine Surgeons Annual Forum ’18, Las Vegas Nevada. Interspinous Decompression Devices – Do They Have a Role?
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20. Congress of Neurological Surgery’s 2018 annual meeting, Houston Texas, October 6-10, 2018. Integrated Interbody Fusion in Multi-level Cervical Constructs in Clinical Practice.
21. Congress of Neurological Surgery’s 2018 annual meeting, Houston Texas, October 6-10, 2018. Swan Neck Deformity Correction with Multilevel Anterior Cervical Integrated Cages.
22. International Spinal Deformity Symposium 4th Annual, November/December 2018. Multilevel Cervical Constructs in Clinical Practice using Integrated Interbody Fusion.
23. International Society for the Advancement of Spine Surgery, Anaheim, California, April 3, 2019. Oral poster presentation: Cervical spinal deformity correction utilizing an integrated interbody fusion devices from a single anterior approach.
24. North American Spine Society 34th annual meeting, Chicago, Illinois, September 25-28, 2019. Poster presentation: Integrated Interbody Fusion in Multilevel Cervical Constructs in Clinical Practice.
25. American College of Surgeons, San Francisco, California, October 28, 2019. Oral presentation: Integrated Interbody Fusion in Multi-level Cervical Constructs in Clinical Prectice.
Dr. Garber is affiliated with the Las Vegas Neurosurgical Institute in Las Vegas, Nevada.
The Company is currently continuing to search for other experts to serve on the Company’s Scientific Advisory Board.
Principal Products and Services:
The Company is currently focused upon:
(a) | developing drugs for treating cancer in companion animals |
(b) | examining the role of Artificial Intelligence and Machine Learning in clinical diagnostics and |
(c) | development of disposable medical devices |
Sources and availability of raw materials and the names of principal suppliers
The supplies and materials required to conduct our operations are available through a wide variety of sources and may be obtained through a wide variety of sources.
Patents, trademarks, licenses, franchises, concessions, royalty agreements or labor contracts, including duration
Patents:
The Company has purchased a 50% interest in and to inventions granted the following patents by the United States Patent and Trademark Office.
US Patent US11377442B2 (Small molecule agonists and antagonists of NR2F6 activity)
US Patent US US10472351B2 (Small molecule agonists and antagonists of NR2F6 activity in animals.
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Royalty Agreements:
On June 26, 2023 Sybleu Inc. ( the “Company”) was granted an exclusive worldwide license by DYO Biotechnologies, Pty, Ltd (“DYO”) to (a) to make, have made, use, offer for sale, sell, perform, have performed export and import Licensed Products and Licensed Services; (b) to practice Licensed Methods; and (c) to use Technology, all in the Field, within the Territory and during the Term (the “License”).
“Technology” is defined in the License as” Artificial intelligence/machine learning engine designed to utilize existing chemical library structures in an integrated model to predict highly specific and sensitive novel chemical structures for molecular targets.”
“Licensed Products” are defined in the License as “any product, kit, composition, or part thereof: (a) that incorporates, uses, or is enabled or derived from the use of the Technology; or (b) that is produced or enabled by a Licensed Method.”
“Licensed Services” are defined in the License as “any service performed by Company or Sublicensee for the benefit of a third party that, in whole or in part, (a) uses Technology; (b) uses Licensed Product(s); or (c) that practices or is enabled by a Licensed Method.”
“Licensed Method” is defined in the License as “any method or process that uses Technology”
“Field” is defined in the License as small molecule drug development and commercialization for human and/or animal health.
“Territory” is defined in the License as “worldwide”.
The Term of the License is the period of time beginning on the effective date of this Agreement which shall be June 26, 2023 and terminating on the last to expire Royalty Term .
“Royalty Term” is defined in the License as that period of time beginning on the first commercial sale of a Licensed Product in a given country and, expires on a country-by-country basis with respect to each Licensed Product, upon the later of: (a) the expiration, abandonment, or invalidation of the last to expire, abandoned or invalidated Valid Claim of the Patent Rights in such country; (b) the expiration of any granted statutory period of marketing exclusivity within a country; and (c) 12 years from of the date of the first commercial sale of such Licensed Product in such country.
Pursuant to the terms and conditions of the License the Company shall raise $2,000,000 US through either debt or equity financing within 2 years of execution of this Agreement (“Funding”). The Company shall enter into a research collaboration agreement with DYO upon mutually acceptable terms and conditions within 30 days of Funding (“Research Agreement).
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Substantially all of the Funding shall be utilized to enable the Technology for the benefit of developing Company’s existing and future small molecule drug intellectual property. It is anticipated that this research agreement will utilize substantially all of these funds over two years. It is agreed that the Company shall exclusively possess all right, title and interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to any and all inventions, discoveries, intellectual property and chemical structures resulting from this Research Agreement
Pursuant to the terms and conditions of the License the Company shall pay to DYO a Royalty equal to five percent (5%) of the Net Sales ( as such term is defined in the License) of any Licensed Method, Service or Product per annum. The License also imposes an obligation upon the Company to make minimum royalty payments to DYO over the course of the Term.
Pursuant to the terms and conditions of the License the l Company paid to DYO 309,000 common shares of the Company (“Stock Payment”).
DYO shall not, directly or indirectly, offer, issue, sell, contract to sell (including without limitation short sale), grant any option for the sale of, pledge or otherwise dispose of or transfer any or all of the Stock Payment for a period of two years from the date of issuance.
Pursuant to the terms and conditions of the License Upon the occurrence of each of the following events (each a “Milestone”)), the Company shall make a cash payment (“Milestone Payment”) in the amount corresponding to such Milestone within thirty days after achievement of each Milestone:
Milestone | AMOUNT | |
1. Dosing of a first human patient in a Phase I or Phase I/II Clinical Trial for Licensed Product | $150,000 US | |
2. Dosing of a first patient in a Phase III Clinical Trial for Licensed Product | $500,000 US | |
3. FDA (US) Approval of a Licensed Product | $3,000,000 US | |
4. EMA (EU) Approval of a Licensed Product | $1,500,000 US | |
5. PMDA (JPN) Approval of a Licensed Product | $1,000,000 US | |
6. Cumulative Net Sales of Licensed Products reach $100 Million | $2,000,000 US |
This License may be terminated by DYO in the event:
No licensed Method, Service or Product has been granted Patent Protection in at least one jurisdiction after the expiration of four years from execution
The sum of $2,000,000 shall not have been raised within 2 years of execution of the license
The Research Agreement shall not have been entered into as of thirty days subsequent to the Funding.
The Company shall not have achieved cumulative Net Sales of Licensed Product, Service and Methods of at least $10,000,000 as of a date that is ten years from the execution of the license
The Company shall fail to pay any consideration required under the license and such failure remains uncured for thirty days.
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This License may be terminated by the Company in the event:
DYO shall be determined to not have exclusive unencumbered Patent Rights to the Technology in whole or in part.
Any other entity shall be determined to have the right- exercised or not- to utilize the Technology ( in whole or in part) to develop make, use, offer for sale, sell, perform, have performed export and import and sell products, methods and services which can reasonably be expected to be similar to or competitive with products, methods and services to be developed by the Company utilizing the rights granted by the License. .
DYO shall have failed to demonstrate during the course of due diligence to the satisfaction of the Company that the Technology can be effectively utilized for the purposes intended by this License
In the event that the Agreement is terminated pursuant to the any of the abovementioned the Stock Payment shall be promptly returned by DYO to the Company for cancellation.
Dr. Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing Director of DYO and is a controlling shareholder of DYO.
Need for any government approval of principal products or services, effect of existing or probable governmental regulations on the business.
The US Food and Drug Administration (“FDA”) and foreign regulatory authorities will regulate our proposed products as drugs or biologics, , depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of the product on the human body. In the United States, products that are intended to be introduced into the body will generally be regulated as drugs, while tissues and cells intended for transplant into the human body will be generally be regulated as biologics.
Our domestic human drug and biological products will be subject to rigorous FDA review and approval procedures. After testing in animals, an Investigational New Drug Application (“IND”) must be filed with the FDA to obtain authorization for human testing. Extensive clinical testing, which is generally done in three phases, must then be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans.
Phase I
Phase 1 trials are designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses usually are a fraction of the dose that causes harm in animal testing and involve a small group of healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have end-stage disease and lack other treatment options.
Phase II
Phase II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II trials are performed on larger groups.
Phase III
Phase III trials are aimed at being the definitive assessment of how effective the product is in comparison with current best standard treatment and to provide an adequate basis for physician labeling. Phase III trials may also be conducted for the purposes of (i) "label expansion" (to show the product works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing or (ii) to obtain additional safety data, or to support marketing claims for the product.
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On occasion Phase IV (Post Approval) trials may be required by the FDA. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.
All phases, must be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans. Each clinical study is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. The time and expense required to perform this clinical testing can far exceed the time and expense of the research and development initially required to create the product. No action can be taken to market any therapeutic product in the United States until an appropriate New Drug Application (“NDA”) or Biologic License Application (“BLA”) or has been approved by the FDA. FDA regulations also restrict the export of therapeutic products for clinical use prior to NDA or BLA approval.
Even after initial FDA approval has been obtained, further studies may be required to provide additional data on safety or to gain approval for the use of a product as a treatment for clinical indications other than those initially targeted. In addition, use of these products during testing and after marketing could reveal side effects that could delay, impede, or prevent FDA marketing approval, resulting in FDA-ordered product recall, or in FDA-imposed limitations on permissible use.
The FDA regulates the manufacturing process of pharmaceutical products, and human tissue and cell products, requiring that they be produced in compliance with Current Good Manufacturing Practices (“cGMP”) . The FDA also regulates the content of advertisements used to market pharmaceutical products. Generally, claims made in advertisements concerning the safety and efficacy of a product, or any advantages of a product over another product, must be supported by clinical data filed as part of an NDA or an amendment to an NDA, and statements regarding the use of a product must be consistent with the FDA approved labeling and dosage information for that product.
Sales of drugs and biologics outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval.
The Center for Veterinary Medicine (“CVM”) at the United States Food and Drug Administration (“FDA”) regulates animal pharmaceuticals under the Food, Drug and Cosmetics Act. Manufacturers of animal health pharmaceuticals must show their products to be safe, effective and produced by a consistent method of manufacture. The new animal drug approval process is complicated. Before a new animal drug may receive FDA approval, the sponsor must establish that the new animal drug is safe and effective. Drug sponsors must submit a New Animal Drug Application (NADA) along with supporting data, including all adverse effects associated with the drug's use. The NADA must also include information on the drug's chemistry; composition and component ingredients; manufacturing methods, facilities, and controls; proposed labeling; analytical methods for residue detection and analysis if applicable; an environmental assessment; and other information. The sponsor of a new animal drug is responsible for submitting all appropriate data to establish effectiveness and safety. If the drug product is intended for use in a food-producing animal, residues in food products must also be established as safe for human consumption. FDA review of the NADA submitted by drug sponsors is extremely detailed and comprehensive. The CVM’s basis for approving a drug application is documented in a Freedom of Information Summary. . We will be required to conduct post-approval monitoring of FDA approved pharmaceutical products and to submit reports of product quality defects, adverse events or unexpected results to the CVM’s Surveillance and Compliance group. No assurance may be given any new animal drug product which the Company may develop will be approved by the FDA to be marketed and sold. Regulatory authorities in countries outside of the United States and Europe also have requirements for approval of veterinary drug candidates with which we must comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country.
Amount spent during the fiscal year ended June 30, 2023 on research and development activities.
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During the fiscal year ended June 30, 2023 we expended $85,489 on research and development activities.
Costs and effects of compliance with environmental laws (federal, state and local)
SYBLEU has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.
Number of total employees and number of full-time employees
As of July 31, 2023 the Company has 2 employees of which each of them is part time.
Item 2. Properties
The Company utilizes approximately 500 square feet of office space at 1034 Throggs Neck Expressway, Bronx NY 10465 provided to the Company by Joseph G. Vaini, the Company’s sole officer and director, on a month to month basis free of charge. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.
Item 3. Legal Proceedings
There are no material pending legal proceedings to which the Company is a party or of which any of the Company’s property is the subject.
Item 4. Submission of Matters to a Vote of Security Holders
No matter was submitted during the fourth quarter of the fiscal year covered by this report to a vote of security holders, through the solicitation of proxies or otherwise.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Prior to March 2023 no public market existed for our securities. In March 2023 the common shares of the Company began trading over the “Pink” market operated by OTC Markets Group under the symbol SYBE.
The Company’s common stock is a "penny stock," as defined in Rule 3a51-1 under the Exchange Act. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its sales person in the transaction, and monthly account statements showing the market value of each penny stock held in the customer's account. In addition, the penny stock rules require that the broker-dealer, not otherwise exempt from such rules, must make a special written determination that the penny stock is suitable for the purchaser and receive the purchaser's written agreement to the transaction. These disclosure rules have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules. So long as the common stock of the Company is subject to the penny stock rules, it may be more difficult to sell common stock of the Company.
The stockholders’ equity section of the Company contains the following class of capital stock as of July 31, 2023:
Common stock, $ 0.0001 par value; 100,000,000 shares authorized: 10,613,492 shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Company.
Below is the range of high and low bid information for our common equity for each quarter within the last two fiscal years that a public market has existed for our common equity. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.
July 1, 2022 to June 30, 2023 | HIGH | LOW | ||||||
Third Quarter | $ | 0.1 | $ | 0.1 | ||||
Fourth Quarter | $ | 0.2899 | $ | 0.02 |
As of July 31, 2023 there were approximately 245 holders of our Common Stock.
Dividends
No cash dividends were paid during the fiscal year ending June 30, 2023. We do not expect to declare cash dividends in the immediate future.
Recent Sales of Unregistered Securities
On December 12, 2022 the Company issued 3,000,000 common shares (“Shares”) to Joseph G Vaini pursuant to an agreement whereby Joseph G. Vaini agreed to serve as President, Chief Executive Officer, Secretary, Chief Financial Officer and Secretary, Treasurer and Principal Accounting Officer of the Company.
On December 12, 2022 the Company issued 3,000,000 common shares (“Shares”) to Harry Lander pursuant to an agreement whereby Harry Lander agreed to serve as Chief Scientific Officer of the Company.
On December 13, 2022 the Company cancelled 6,113,508 common shares owned by David Koos, the Company’s previous sole officer and director, and a company controlled by David Koos. Effective December 13, 2022 David Koos resigned as a Director of the Company and also resigned from any and all other offices he had held of the Company (“Resignation”) . In connection with his Resignation Koos has returned any and all common shares directly or indirectly held by Koos to the Company for cancellation. Also in connection with his Resignation Koos and the Company have entered into an agreement ( “Separation Agreement”) whereby the Company shall pay Koos the sum of $10,000.
On June 28, 2023 the Company issued 309,000 common shares ( “Shares”) to DYO Biotechnologies, Pty, Ltd pursuant to the terms and conditions of an agreement entered into by and between DYO Biotechnologies, Pty, Ltd and the Company.
All Shares issued were issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The shares were sold directly through our management. No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.
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Item 6. Selected Financial Data
As we are a “smaller reporting company” as defined by Rule 229.10(f)(1), we are not required to provide the information required by this Item.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
As of June 30, 2023 we had cash of $3,786 and as of June 30, 2022 we had cash of $66,850. The decrease in cash of 94% is primarily attributable to (a) $15,000 paid out to Joanne Vaini whereby Joanne Vaini agreed to provide bookkeeping services for the Company for the period beginning January 9, 2023 and ending July 9, 2024 (“Agreement”) for total consideration consisting of $15,000 (b) $12,500 paid to Wilson Davis and Co., a registered Broker Dealer, for assistance in obtaining DTC eligibility for the Company’s common shares. DTC Eligibility means that a public company's securities are able to be deposited through Depository Trust and Clearing Corporation and (c) $25,000 paid to DYO Biotechnologies, Pty, Ltd pursuant to the terms and conditions of a license granted to the Company by DYO Biotechnologies, Pty, Ltd.
Joanne Vaini is the spouse of the Company’s Chief Executive Officer Joseph G. Vaini. Dr. Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing Director of DYO and is a controlling shareholder of DYO Biotechnologies, Pty, Ltd.
As of June 30, 2023 we had Prepaid Expenses of $24,762 and as of June 30, 2022 we had Prepaid Expenses of 0. Prepaid Expenses recognized as of June 30, 2023 are attributable to:
(a) 3,000,000 common shares issued to Joseph G Vaini, the Company’s Chief Executive Officer, pursuant to an employment agreement to be expensed over the life of the agreement
(b) 3,000,000 common shares issued to Dr. Harry Lander, the Company’s Chief Scientific Officer, pursuant to an employment agreement expensed over the life of the agreement.
(c) $15,000 prepaid pursuant to an agreement with Joanne Vaini to be expensed over the life of the agreement.
On December 9, 2022 an agreement (“Agreement”) was entered into by and between Sybleu Inc ( the “Company”) and Joseph G. Vaini (“Vaini”) whereby Vaini has agreed to serve as President, Chief Executive Officer, Secretary, Chief Financial Officer and Secretary, Treasurer and Principal Accounting Officer of the Company subject to the authority of the Company's Board of Directors (the “BOD”). Vaini shall perform such duties commensurate with his offices and as directed the BOD.
The Term of this Agreement shall commence on December 13, 2022 and shall expire on December 13, 2023 unless sooner terminated in accordance with specified provisions contained therein.
As sole compensation for performing his duties pursuant to the Agreement Vaini received 3,000,000 of the Common Shares of the Company ( “Vaini Stock Payment”).Vaini has agreed that for a period of three years from December 9, 2022 Vaini shall not directly or indirectly, offer, issue, sell, contract to sell (including, without limitation, any short sale), grant any option for the sale of, pledge, or otherwise dispose of or transfer the Vaini stock payment.
On December 9, 2022 an agreement (“Agreement”) was entered into by and between Sybleu Inc. ( the “Company”) and Harry Lander (“Lander”) whereby Lander has agreed to serve as Chief Scientific Officer of the Company subject to the authority of the Company's Board of Directors (the “BOD”). Lander’s duties will include:
Identifying and introducing to the Company Contract Research Organizations.
Identifying and introducing to the Company potential strategic partners.
Identifying and introducing to the Company potential members for the Company’s Scientific Advisory Board.
Assisting the Company in patent application and prosecution.
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The Term of this Agreement shall commence on December 9, 2022 and shall expire on December 8, 2025 unless sooner terminated in accordance with specified provisions contained therein.
As sole compensation for performing his duties pursuant to the Agreement Lander received 3,000,000 of the Common Shares of the Company (“Lander Stock Payment”).Lander has agreed that for a period of three years from December 9, 2022 Lander shall not directly or indirectly, offer, issue, sell, contract to sell (including, without limitation, any short sale), grant any option for the sale of, pledge, or otherwise dispose of or transfer the Lander stock payment.
On January 8, 2023 an agreement was entered into by and between Joanne Vaini and the Company whereby Joanne Vaini shall assist the Company with entry and updating of financial records in Quickbooks. The term of this agreement commenced on January 9, 2023 and shall expire on July 9, 2024
As of June 30, 2023 we had Investment Securities of $1,920 and as of June 30, 2022 we had Investment Securities of $9,529.
The decrease in Investment Securities of approximately 80% is attributable to the revaluation as of June 30, 2023 of 6,500 common shares of Oncology Pharma, Inc. at the closing price of the common shares on the OTC Pink market.
As of June 30, 2023 we had Acquired Intangible Assets ( net of Amortization) of $300,000 and as of June 30, 2022 we had Acquired Intangible Assets ( net of Amortization) of $0.
Acquired Intangible Assets ( net of Amortization) as of June 30, 2023 consists of intellectual property purchased from Zander Biologics, Inc. On June 30, 2023 the Company entered into an agreement whereby the Company purchased from Zander Biologics, Inc. a 50% interest in
(a)the invention disclosed in US Patent US11377442B2 (Small molecule agonists and antagonists of NR2F6 activity), all patent rights to the invention described in US Patent US11377442B2 as well as all trade secrets, trademarks and associated good will to the invention described in US Patent US11377442B2 and
(b) the invention disclosed in US Patent US US10472351B2 (Small molecule agonists and antagonists of NR2F6 activity in animals), all patent rights to the invention described in US Patent US10472351B2 as well as all trade secrets, trademarks and associated good will to the invention described in US Patent US10472351B2.
(“IP Rights”).
The IP rights are to patent protected small molecule compounds which compounds have been found to modulate the immune system.
As
of June 30, 2023 we had Notes Payable of $477,500 and as of June 30, 2022 we had Notes Payable of $140,000. The increase in Notes Payable
of 241% is primarily attributable to:
(a) a $300,000 Promissory Note issued to Zander Biologics as consideration for the purchase of intellectual property
(b) a $25,000 Promissory Note issued to Bostonia Partners during the quarter ended June 30, 2023
(c) a $12,500 Promissory Note issued to Zander Therapeutics Inc. during the quarter ended June 30, 2023
As
of June 30, 2023 we had expenses accrued but unpaid of 15,500 and as of June 30, 2022 we had expenses accrued but unpaid of $452. The
increase is primarily attributable to:
(a) | expenses of $9,221 recognized during the period in connection with an agreement with a third party to provide on demand telephone support to the Company related to any and all hardware and software computer issues |
(b) | expenses of $3,000 incurred in connection with the design of the Company’s website |
(c) | $920 in legal/ patent prosecution fees |
(d) | $620 in Transfer Agent fees |
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As of June 30, 2023 we had Interest Accrued but Unpaid of $27,476 consisting completely of interest accrued but yet to be paid on Notes Payable and as of June 30, 2022 we had Interest Accrued but Unpaid of $13,253 consisting completely of interest accrued but yet to be paid on Notes Payable.
The increase in Interest Accrued but Unpaid of approximately 107% is attributable to $10,352 of interest accrued but not paid on $140,000
in Notes payable during the nine months ended June 30, 2023 as well as $3,870 interest accrued but not paid on $177,500 in Notes payable
during the quarter ended June 30, 2023.
As of June 30, 2023 we recognized Unearned Income of $150,002 and as of June 30, 2022 we recognized Unearned Income of $161,699. Unearned income recognized by the Company is completely attributable to $177, 450 in licensing fees paid to the Company during the quarter ended June 30, 2021 which are being recognized over the term of the license. The decrease in Unearned Income is attributable to recognition of these fees as earned as required pursuant to Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606).
The Company recognized revenue of $11,696 during the tear ended June 30, 2023 and revenue of $11,700 for the same period ended 2022. In both periods revenue was attributable to $177, 450 in licensing fees paid to the Company during the quarter ended June 30, 2021 which are being recognized over the term of the license.
Operating Loss of $149,180 recognized during the year ended June 30, 2023 was approximately 164% higher than the Operating Loss recognized during the same period ended 2022 which was $56,373. The increase in Operating Loss is primarily attributable to substantially higher Research and Development and Consulting expenses incurred during the period ended 2023 as compared to the same period ended 2022.
Net Loss for the year ended June 30, 2023 was $180,304 which is approximately 26% lower than the Net Loss recognized by the Company during the same period ended 2022. This decrease is primarily attributable to the recognition of $175,721 of Unrealized Loss on Investment Securities during the period ended 2022 .
As
of June 30, 2023 we had $3,786 in cash on hand and current liabilities of $241,411 such liabilities consisting of Income Tax Payable,
Notes Payable, and Accrued Expenses. We feel we will not be able to satisfy our cash requirements over the next twelve months and shall
be required to seek additional financing.
Management plans to raise additional funds by obtaining governmental and nongovernmental grants as well as offering securities for cash.
Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee
that the Company will be able to raise any capital through any type of offerings. Management can give no assurance that any governmental
or nongovernmental grant will be obtained by the Company despite the Company’s best efforts.
As of June 30, 2023 the Company was not party to any binding agreements which would commit SYBLEU to any material capital expenditures.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
As we are a smaller reporting company, as defined by Rule 229.10(f)(1), we are not required to provide the information required by this Item.
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Item 8. Financial Statements and Supplementary Data.
Report of Independent Registered Public Accounting Firm
To the shareholders and the board of directors of SYBLEU INC.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of SYBLEU INC. as of June 30, 2023 and 2022, the related statements of operations, stockholders' equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2023 and 2022, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has suffered recurring losses from operations and has a significant accumulated deficit. In addition, the Company continues to experience negative cash flows from operations. These factors raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matter
Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
We determined that there are no critical audit matters.
/S/
We have served as the Company's auditor since 2020
August 4, 2023
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SYBLEU INC. | ||||||||
BALANCE SHEETS | ||||||||
As of June 30, 2023 | As of June 30, 2022 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash | $ | $ | ||||||
Prepaid Expenses | ||||||||
Total Current Assets | $ | $ | ||||||
OTHER ASSETS | ||||||||
Investment Securities | ||||||||
Prepaid Expenses (Long Term) | ||||||||
Acquired Intangible Assets, net of amortization | ||||||||
Total Other Assets | ||||||||
TOTAL ASSETS | $ | $ | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Income Taxes Payable | ||||||||
Notes Payable | ||||||||
Notes Payable, Related Party | ||||||||
Expenses Accrued but Unpaid | ||||||||
Interest Accrued but Unpaid | ||||||||
Total Current Liabilities | ||||||||
Long Term Liabilities: | ||||||||
Unearned Income | ||||||||
Note Payable | ||||||||
Total Liabilities | $ | $ | ||||||
STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
Common Stock ($.0001 par value) shares authorized; par value $ ; shares issued and outstanding as of June 30, 2022 and shares issued and outstanding as of June 30, 2023 | ||||||||
Additional Paid in capital | ||||||||
Retained Earnings (Deficit ) | ( | ) | ( | ) | ||||
Total Stockholders' Equity (Deficit) | ( | ) | ( | ) | ||||
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT) | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements |
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SYBLEU INC. | ||||||||
STATEMENT OF OPERATIONS | ||||||||
Year Ended June 30, 2023 | Year Ended June 30, 2022 | |||||||
REVENUES | ||||||||
License Fees | ||||||||
TOTAL REVENUES | $ | $ | ||||||
COSTS AND EXPENSES | ||||||||
Research and Development: | ||||||||
Staff Expenses | ||||||||
Consulting Costs | ||||||||
Licensing Expenses | ||||||||
Patent Application Costs | ||||||||
Total Research and Development | ||||||||
General and Administrative: | ||||||||
Transfer Agency Fees | ||||||||
Other General and Administrative Exexpenses | ||||||||
Total General and Administrative | ||||||||
Consulting, Related Party | ||||||||
Consulting: | ||||||||
Legal Fees | ||||||||
Accounting | ||||||||
Other Consulting | ||||||||
Website Development | ||||||||
Information Technology Consulting | ||||||||
Securities Depository Consulting | ||||||||
Total Consulting | ||||||||
Rent | ||||||||
Total Costs and Expenses | ||||||||
OPERATING Income( LOSS) | $ | ( | ) | $ | ( | ) | ||
OTHER INCOME AND EXPENSES | ||||||||
Unrealized Gain ( Loss) on Investment Securities | ( | ) | ( | ) | ||||
Stock Cancellation Expense | ( | ) | ||||||
Interest Income( Expense) | ( | ) | ( | ) | ||||
TOTAL OTHER INCOME ( EXPENSES) | ( | ) | ( | ) | ||||
NET INCOME ( LOSS) before taxes | ( | ) | ( | ) | ||||
Provision for Income Taxes | ||||||||
NET INCOME ( LOSS) | $ | ( | ) | $ | ( | ) | ||
BASIC AND FULLY DILUTED LOSS PER SHARE | $ | ( | ) | $ | ( | ) | ||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||||||
The Accompanying Notes are an Integral Part of These Financial Statements |
22 |
SYBLEU INC. | ||||||||||||||||||||
STATEMENTS OF SHAREHOLDERS EQUITY (DEFICIT) | ||||||||||||||||||||
For the Year Ended June 30, 2023 | ||||||||||||||||||||
Common | ||||||||||||||||||||
Shares | Amount | Additional Paid in Capital | Retained Deficit | Total | ||||||||||||||||
Balance June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Net Loss for the quarter ended September 30, 2022 | ( | ) | ( | ) | ||||||||||||||||
Balance September 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Cancellation of shares 12/13/2022 | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||
Issuance of shares for services 12/12/2022 | $ | $ | $ | |||||||||||||||||
Net Loss for the quarter ended December 31, 2022 | $ | ( | ) | $ | ( | ) | ||||||||||||||
Balance December 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Net Loss for the quarter ended March 31, 2023 | $ | ( | ) | $ | ( | ) | ||||||||||||||
Balance March 31, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Issuance of shares as consideration 06/28/2023 | $ | $ | $ | |||||||||||||||||
Net Loss for quarter ended June 30, 2023 | $ | ( | ) | $ | ( | ) | ||||||||||||||
Balance June 30, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
For the Year Ended June 30, 2022 | ||||||||||||||||||||
Common | ||||||||||||||||||||
Shares | Amount | Additional Paid in Capital | Retained Deficit | Total | ||||||||||||||||
Balance June 30, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Net Loss for the three months ended September 30,2021 | ( | ) | $ | ( | ) | |||||||||||||||
Balance September 30, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Net Loss for the three months ended December 31,2021 | $ | ( | ) | $ | ( | ) | ||||||||||||||
Balance December 31, 2021 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Net Loss for the three months ended March 31, 2022 | $ | ( | ) | $ | ( | ) | ||||||||||||||
Balance March 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
Net Loss for the three months ended June 30, 2022 | $ | ( | ) | $ | ( | ) | ||||||||||||||
Balance June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
The Accompanying Notes are an Integral Part of These Financial Statements |
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SYBLEU INC. | ||||||||
STATEMENT OF CASH FLOWS | ||||||||
Year Ended June 30, 2023 | Year ended June 30, 2022 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net Income (Loss) | $ | ( | ) | $ | ( | ) | ||
Adjustments to reconcile net Income (loss) to net cash | ||||||||
Common Stock Issued for payment of expenses | ||||||||
Changes in Operating Assets and Liabilities | ||||||||
(Increase) Decrease in Prepaid Expenses | ( | ) | ||||||
Increase (Decrease) in Accrued Expenses | ||||||||
(Increase) Decrease in Securities accepted as Payment | ||||||||
Increase( Decrease) in Unearned Income | ( | ) | ( | ) | ||||
Increase ( Decrease) in Income Tax Payable | ( | ) | ||||||
Decrease in Common Stock | ( | ) | ||||||
Decrease in Additional Paid in Capital | ( | ) | ||||||
Unrealized Loss (Gain) in Investment Securities | ||||||||
Net Cash provided by (used) in Operating Activities | $ | ( | ) | $ | ( | ) | ||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Increase (Decrease) in Notes Payable, Related Parties | ( | ) | ||||||
Increase (Decrease) in Notes Payable | ||||||||
Common Stock issued for Cash | ||||||||
Net Cash provided by (used) in Financing Activities | ||||||||
Net Increase (Decrease) in Cash | $ | ( | ) | $ | ||||
Cash at Beginning of Period | ||||||||
Cash at End of Period | $ | $ | ||||||
Supplemental Cash Flow Information: | ||||||||
Interest Paid | $ | $ | ||||||
Income Taxes Paid | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements |
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SYBLEU INC.
Notes to Condensed Financial Statements
As of June 30, 2023
NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
SYBLEU INC. (“Company”) was organized June 12, 2020 under the laws of the State of Wyoming.
The Company intends to engage primarily in the acquisition, licensing and development of regenerative medical applications up to the point of successful completion of Phase I and or Phase II clinical trials after which the Company would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.
A. BASIS OF ACCOUNTING
The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a June 30 year-end.
B. USE OF ESTIMATES
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
C. CASH EQUIVALENTS
The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
D. FAIR VALUE OF FINANCIAL INSTRUMENTS
Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:
Level 1: Quoted prices in active markets for identical assets or liabilities
Level 2: Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
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E. RESEARCH AND DEVELOPMENT COSTS
Research and development expenses relate primarily to the cost of discovery and research programs. Research and development costs are charged to expense as incurred. Research and development expenses consist mainly of evaluating potential Contract Research Organizations and filing of a provisional patent application.
Stock issued for Employee Compensation
Stock based compensation to employees is accounted for at the award’s fair value at grant, less the amount (if any) paid by the award recipient.
During the quarter ended December 31, 2022 shares of common stock were issued as employee compensation.
In determining Fair Value for shares issued to employees an asset based valuation method was utilized , specifically Enterprise Value (Assets Less Cash and Cash Equivalents plus Fair Value of Debt) less Fair Value of Debt. The following inputs were utilized.
Fair Value of Intellectual Property | $ | |||
Securities | $ | |||
Notes Payable | $ | |||
Accrued Interest | $ | |||
Taxes Payable | $ | |||
Less Total Debt | $ | ( |
) | |
Portion of Enterprise Value available to shareholders | $ | |||
Fair Value per share | $ |
Stock issued for Non-Employee Services
Stock Based compensation to non-employees is accounted for in accordance with ASC 505-50. ASC 505-50 requires entities to account for non-employee equity transactions based on either the fair value of the services received or the fair value of the equity instrument issued utilizing whichever measurement is most reliable
During the year ended June 30, 2023 stock was issued for Non-Employee Services .
Pursuant to ASC 505-50-30-11505-50-30-11 an issuer shall measure the fair value of the equity instruments in these transactions using the stock price and other measurement assumptions as of the earlier of the following dates, referred to as the measurement date:
i. | The date at which a commitment for performance by the counterparty to earn the equity instruments is reached (a performance commitment); and |
ii. | The date at which the counterparty’s performance is complete. |
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G. INCOME TAXES
The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.
The
Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides
clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements.
Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the
statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any
such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in
part, upon the results of operations for the given period. As of June 30, 2023 the Company had
The Company generated a deferred tax credit through net operating loss carry forward. However, a valuation allowance of 100% has been established.
Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.
The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.
Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding. There were no Common Stock Equivalents as of June 30, 2023.
I. INTANGIBLE ASSETS
The Company amortizes its intangible assets with definite useful lives over their estimated useful lives and reviews these assets for impairment. The Company’s acquired intangible assets with definite useful lives consists of a 50% interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to (a) the intellectual property disclosed in US Patent US11377442B2 (Small molecule agonists and antagonists of NR2F6 activity) and (b) ) the intellectual property disclosed in US Patent US US10472351B2 (Small molecule agonists and antagonists of NR2F6 activity in animals).
NOTE 2. RECENT ACCOUNTING PRONOUNCEMENTS
The Company has adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606). The guidance in this Update supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific guidance throughout the Industry Topics of the Codification.
The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s) with a customer. Step 2: Identify the performance obligations in the contract. Step 3: Determine the transaction price. Step 4: Allocate the transaction price to the performance obligations in the contract. Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation. The Company has adopted the provisions of this ASU effective the fiscal year ended 2020. This guidance did not have a material impact on the Company’s Financial Statements.
On February 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-02, Leases (Topic 842). The ASU requires organizations that lease assets, referred to as "lessees," to recognize on the consolidated statement of financial position the rights and obligations created by those leases. The ASU also requires disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. These disclosures include qualitative and quantitative requirements, providing additional information about the amounts recorded in the consolidated financial statements. The ASU on leases became effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. This guidance is not expected to have a material impact on the Company’s financial statements.
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In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation. This ASU is effective for annual periods beginning after December 15, 2018 and interim periods within those annual periods, with early adoption permitted. This guidance is not expected to have a material impact on the Company’s financial statements.
NOTE 3. GOING CONCERN
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has
generated net losses of $
Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings.
NOTE 4. RELATED PARTY TRANSACTIONS.
The Company utilizes approximately 500 square feet of office space at 1034 Throggs Neck Expressway, Bronx NY 10465 provided to the Company by Joseph G. Vaini, the Company’s sole officer and director, on a month to month basis free of charge. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.
On
January 8, 2023 the Company entered into an agreement with Joanne Vaini whereby Joanne Vaini agreed to provide bookkeeping services for
the Company for the period beginning January 9, 2023 and ending July 9, 2024 (“Agreement”) for total consideration consisting
of $
On June 26, 2023 the Company was granted an exclusive worldwide license by DYO Biotechnologies, Pty, Ltd (“DYO”) to (a) to make, have made, use, offer for sale, sell, perform, have performed export and import Licensed Products and Licensed Services; (b) to practice Licensed Methods; and (c) to use Technology, all in the Field, within the Territory and during the Term (the “License”).
“Technology” is defined in the License
as” Artificial intelligence/machine learning engine designed to utilize existing chemical library structures in an integrated model
to predict highly specific and sensitive novel chemical structures for molecular targets.”
“Licensed Products” are defined in the License as “any product, kit, composition, or part thereof: (a) that incorporates,
uses, or is enabled or derived from the use of the Technology; or (b) that is produced or enabled by a Licensed Method.”
“Licensed Services” are defined in the License as “any service performed by Company or Sublicensee for the benefit of a third party that, in whole or in part, (a) uses Technology; (b) uses Licensed Product(s); or (c) that practices or is enabled by a Licensed Method.”
“Licensed Method” is defined in the License as “any method or process that uses Technology”
“Field” is defined in the License as small molecule drug development and commercialization for human and/or animal health.
“Territory” is defined in the License as “worldwide”.
The Term of the License is the period of time beginning on the effective date of this Agreement which shall be June 26, 2023 and terminating on the last to expire Royalty Term .
“Royalty Term” is defined in the License as that period of time beginning on the first commercial sale of a Licensed Product in a given country and, expires on a country-by-country basis with respect to each Licensed Product, upon the later of: (a) the expiration, abandonment, or invalidation of the last to expire, abandoned or invalidated Valid Claim of the Patent Rights in such country; (b) the expiration of any granted statutory period of marketing exclusivity within a country; and (c) 12 years from of the date of the first commercial sale of such Licensed Product in such country.
Pursuant to the terms and conditions of the License the Company shall raise $2,000,000 US through either debt or equity financing within 2 years of execution of this Agreement (“Funding”). The Company shall enter into a research collaboration agreement with DYO upon mutually acceptable terms and conditions within 30 days of Funding (“Research Agreement).
Substantially all of the Funding shall be utilized to enable the Technology for the benefit of developing Company’s existing and future small molecule drug intellectual property. It is anticipated that this research agreement will utilize substantially all of these funds over two years. It is agreed that the Company shall exclusively possess all right, title and interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to any and all inventions, discoveries, intellectual property and chemical structures resulting from this Research Agreement.
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Pursuant to the terms and conditions of the License the Company shall pay to DYO a Royalty equal to five percent (5%) of the Net Sales ( as such term is defined in the License) of any Licensed Method, Service or Product per annum. The License also imposes an obligation upon the Company to make minimum royalty payments to DYO over the course of the Term.
Pursuant to the terms and conditions of the License
the l Company paid to DYO
DYO shall not, directly or indirectly, offer, issue, sell, contract to sell (including without limitation short sale), grant any option for the sale of, pledge or otherwise dispose of or transfer any or all of the Stock Payment for a period of two years from the date of issuance.
Pursuant to the terms and conditions of the License Upon the occurrence of each of the following events (each a “Milestone”)), the Company shall make a cash payment (“Milestone Payment”) in the amount corresponding to such Milestone within thirty days after achievement of each Milestone:
Milestone | AMOUNT | |
1. Dosing of a first human patient in a Phase I or Phase I/II Clinical Trial for Licensed Product | $150,000 US | |
2. Dosing of a first patient in a Phase III Clinical Trial for Licensed Product | $500,000 US | |
3. FDA (US) Approval of a Licensed Product | $3,000,000 US | |
4. EMA (EU) Approval of a Licensed Product | $1,500,000 US | |
5. PMDA (JPN) Approval of a Licensed Product | $1,000,000 US | |
6. Cumulative Net Sales of Licensed Products reach $100 Million | $2,000,000 US |
This License may be terminated by DYO in the event:
No licensed Method, Service or Product has been granted Patent Protection in at least one jurisdiction after the expiration of four years from execution
The sum of $2,000,000 shall not have been raised within 2 years of execution of the license
The Research Agreement shall not have been entered into as of thirty days subsequent to the Funding.
The Company shall not have achieved cumulative Net Sales of Licensed Product, Service and Methods of at least $10,000,000 as of a date that is ten years from the execution of the license
The Company shall fail to pay any consideration required under the license and such failure remains uncured for thirty days.
This License may be terminated by the Company in the event:
DYO shall be determined to not have exclusive unencumbered Patent Rights to the Technology in whole or in part.
Any other entity shall be determined to have the right- exercised or not- to utilize the Technology ( in whole or in part) to develop make, use, offer for sale, sell, perform, have performed export and import and sell products, methods and services which can reasonably be expected to be similar to or competitive with products, methods and services to be developed by the Company utilizing the rights granted by the License. .
DYO shall have failed to demonstrate during the course of due diligence to the satisfaction of the Company that the Technology can be effectively utilized for the purposes intended by this License
In the event that the Agreement is terminated pursuant to the any of the abovementioned the Stock Payment shall be promptly returned by DYO to the Company for cancellation.
Dr. Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing Director of DYO and is a controlling shareholder of DYO.
On July 14, 2023 the Company’s Chief Executive
Officer made a $
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NOTE 5. NOTES PAYABLE
Bostonia Partners | $ | |||
Zander Therapeutics Inc. | $ | |||
Zander Biologics, Inc. | $ | |||
Notes Payable, as of June 30, 2023 | $ |
$
$
$
$
$
$
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NOTE 6. INVESTMENT SECURITIES
On March 11, 2021 the Company was paid common shares of Oncology Pharma, Inc. pursuant to an agreement entered into by and between the Company and Oncology Pharma, Inc. whereby the Company granted Oncology Pharma, Inc. an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by the Company.
On June 30, 2023 the Company revalued common shares of Oncology Pharma, Inc. at the closing price of the common shares on the OTC Pink market.
As of June 30, 2023:
Schedule Of Common Shares | ||||||||||||||
6,500 Common Shares of Oncology Pharma, Inc. | ||||||||||||||
Basis | Fair Value | Total Unrealized Losses | Net Unrealized Gain or (Loss) during the quarter ended June 30, 2023 | |||||||||||
$ | $ | $ | ( | ) | $ | ( | ) |
NOTE 7. STOCKHOLDERS’ EQUITY
The stockholders’ equity section of the Company contains the following class of capital stock as of June 30, 2023:
Common stock, $ par value; shares authorized: shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
NOTE 8. INCOME TAXES
As of June 30, 2023
Deferred tax assets: | ||||
Net operating tax carry forwards | $ | |||
Other | ||||
Gross deferred tax assets | ||||
Valuation allowance | ( | ) | ||
Net deferred tax assets | $ |
As
of June 30, 2023 the Company has a Deferred Tax Asset of $
Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain.
In addition, if as a result of a stock transfer or a reorganization, a corporation undergoes an “ownership change,” Code Section 382 limits the corporation’s right to use its NOLs each year thereafter to an annual percentage of the fair market value of the corporation at the time of the ownership change (the “Section 382 Limitation”).
A corporation is considered to undergo “an ownership change” if, as a result of changes in the stock ownership by “5-percent shareholders” or as a result of certain reorganizations, the percentage of the corporation’s stock owned by those 5-percent shareholders increases by more than 50 percentage points over the lowest percentage of stock owned by those shareholders at any time during the prior three-year testing period. Five-percent shareholders are persons who hold 5% or more of the stock of a corporation at any time during the testing period as well as certain groups of shareholders (based typically on whether they acquired their shares in a single offering or exchange transaction) who are not individually 5-percent shareholders.
As the Company will require cash infusions in order to implement its business plan, and as it is probable, although not guaranteed, that such funding needs may be met through the sale of equity securities to “5-percent shareholders”, the Company recognized a valuation allowance equal to the deferred Tax Asset and the Company recorded a valuation allowance reducing all deferred tax assets to 0.
Income
tax is calculated at the
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NOTE 9. STOCK TRANSACTIONS
On December 12, 2022 the Company issued common shares (“Shares”) to Joseph G Vaini pursuant to an agreement whereby Joseph G. Vaini agreed to serve as President, Chief Executive Officer, Secretary, Chief Financial Officer and Secretary, Treasurer and Principal Accounting Officer of the Company.
On December 12, 2022 the Company issued common shares (“Shares”) to Harry Lander pursuant to an agreement whereby Harry Lander agreed to serve as Chief Scientific Officer of the Company.
On
December 13, 2022 the Company cancelled
On June 28, 2023 the Company issued common shares (“Shares”) to DYO Biotechnologies, Pty, Ltd pursuant to the terms and conditions of an agreement entered into by and between DYO Biotechnologies, Pty, Ltd and the Company.
NOTE 10. SUBSEQUENT EVENTS
On
July 14, 2023 the Company’s Chief Executive Officer made a $
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Item 9A. Controls and Procedures
a) Evaluation of disclosure controls and procedures.
The principal executive officer and principal financial officer have evaluated the Company’s disclosure controls and procedures as of June 30, 2023. Based on this evaluation, they have concluded that the disclosure controls and procedures were effective to ensure that the information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms and to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
b) Management’s annual report on internal control over financial reporting.
Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) promulgated under the Securities and Exchange Act of 1934. Rule 13a-15(f) defines internal control over financial reporting as follows:
“The term internal control over financial reporting is defined as a process designed by, or under the supervision of, the issuer's principal executive and principal financial officers, or persons performing similar functions, and effected by the issuer's board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the issuer;
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management and directors of the issuer; and
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the issuer's assets that could have a material effect on the financial statements.”
The Company’s internal control over financial reporting is a process designed under the supervision of the Company’s management to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company’s financial statements for external purposes in accordance with U.S. generally accepted accounting principles.
In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only a reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.
The Company’s management assessed the effectiveness of its internal control over financial reporting as of June 30, 2023 is based on the framework in 2013 Committee of Sponsoring Organizations of the Treadway Commission, or COSO. Based on its assessment, management believes that, as of June 30, 2023 the Company’s internal control over financial reporting is effective.
Management's report was not subject to attestation by the Company's registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the company to provide only management's report in this annual report. This exemption for smaller reporting companies provided under the temporary rules referenced above has been made permanent under Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
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(c) There have been no changes during the quarter ended June 30, 2023 in the Company’s internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting.
Item 10. Directors, Executive Officers and Corporate Governance
Joseph G. Vaini
Joseph G. Vaini, 61, has served as Chief Financial Officer since July21, 2020 and as Chairman and sole Director of the Company since December 13, 2022. Mr. Vaini was appointed Chief Executive Officer, Chief Financial Officer, President, Secretary, Treasurer and Chief Accounting Officer effective December 13, 2022. For the past ten years Mr. Vaini has been a freelance independent consultant assisting microcap companies in complying with securities laws and regulation as well as assisting companies in the preparation of GAAP compliant financial statements. Over the past five years Mr. Vaini has provided consulting services to Bio- Matrix Scientific Group, Inc., Regen BioPharma, Inc., Entest Group, Inc., and Zander Therapeutics, Inc. Mr. Vaini does not possess a college degree. Mr. Vaini worked as a registered securities representative holding a Series 7 and Series 63 License between 1989 and 1995
Harry Lander
On December 9, 2022 Harry Lander, Ph.D., M.B.A was appointed Chief Scientific Officer of SYBLEU INC. effective December 9,2022.
Harry Lander, 57, previously served in the following positions:
Organization: | Title: | Dates: | Primary Business | |||
Dyo Biotechnologies | Managing Director | January 2019 to the Present | Drug Manufacturing and Laboratory Testing | |||
Free Solo Therapeutics, Inc. | Chief Executive Officer, Director | May 2021 to the present | Vascular biology organ regeneration company | |||
Capo Therapeutics, Inc. | Chief Executive Officer, Director | May 2019 to May 2022 | Neurodegenerative disease vaccine company | |||
Regen BioPharma, Inc. | President and Chief Scientific Officer | October 2015 to January 2019 | Cancer Therapies | |||
Zander Therapeutics, Inc. | President and Chief Scientific Officer | October 2017 to January 2019 | Veterinary Therapies |
Education:
M.B.A., Finance, 2001
The Stern School of Business, New York, University, New York, NY
Ph.D., Biochemistry, 1992
Cornell University Graduate School of Medical Sciences, New York, NY
B.S., Biochemistry and B.A., Chemistry, 1987
State University of New York at Stony Brook, Stony Brook, NY
Employment Agreements
On December 9, 2022 an agreement (“Agreement”) was entered into by and between the Company and Joseph G. Vaini (“Vaini”) whereby Vaini has agreed to serve as President, Chief Executive Officer, Secretary, Chief Financial Officer and Secretary, Treasurer and Principal Accounting Officer of the Company subject to the authority of the Company's Board of Directors (the “BOD”). Vaini shall perform such duties commensurate with his offices and as directed the BOD.
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The Term of this Agreement shall commence on December 13, 2022 and shall expire on December 13, 2023 unless sooner terminated in accordance with specified provisions contained therein.
As sole compensation for performing his duties pursuant to the Agreement Vaini shall receive 3,000,000 of the Common Shares of the Company ( “Vaini Stock Payment”).Vaini has agreed that for a period of three years from December 9, 2022 Vaini shall not directly or indirectly, offer, issue, sell, contract to sell (including, without limitation, any short sale), grant any option for the sale of, pledge, or otherwise dispose of or transfer the Vaini stock payment.
On December 9, 2022 an agreement (“Agreement”) was entered into by and between the Company and Harry Lander (“Lander”) whereby Lander has agreed to serve as Chief Scientific Officer of the Company subject to the authority of the Company's Board of Directors (the “BOD”). Lander’s duties will include:
Identifying and introducing to the Company Contract Research Organizations
Identifying and introducing to the Company potential strategic partners
Identifying and introducing to the Company potential members for the Company’s Scientific Advisory Board
Assisting the Company in patent application and prosecution.
The Term of this Agreement shall commence on December 9, 2022 and shall expire on December 8, 2025 unless sooner terminated in accordance with specified provisions contained therein.
As sole compensation for performing his duties pursuant to the Agreement Lander shall receive 3,000,000 of the Common Shares of the Company (“Lander Stock Payment”).Lander has agreed that for a period of three years from December 9, 2022 Lander shall not directly or indirectly, offer, issue, sell, contract to sell (including, without limitation, any short sale), grant any option for the sale of, pledge, or otherwise dispose of or transfer the Lander stock payment.
Code of Ethics
On July 20, 2020 we adopted a Code of Ethics pursuant to Section 406 of the Sarbanes-Oxley Act of 2002.
Director Independence
Audit Committee and Audit Committee Financial Expert
The members of the Company’s board of Directors may not be considered independent. The Company is not a "listed company" under Securities and Exchange Commission (“SEC”) rules and is therefore not required to have an audit committee comprised of independent directors. The Company does not currently have an audit committee, however, for certain purposes of the rules and regulations of the SEC and in accordance with the Sarbanes-Oxley Act of 2002, the Company’s Board of Directors is deemed to be its audit committee and as such functions as an audit committee and performs some of the same functions as an audit committee including: (1) selection and oversight of our independent accountant; (2) establishing procedures for the receipt, retention and treatment of complaints regarding accounting, internal controls and auditing matters; and (3) engaging outside advisors. The Board of Directors has determined that its member is able to read and understand fundamental financial statements and has substantial business experience that results in that member's financial sophistication. Accordingly, the Board of Directors believes that its member has the sufficient knowledge and experience necessary to fulfill the duties and obligations that an audit committee would have.
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Nominating and Compensation Committees
The Company does not have standing nominating or compensation committees, or committees performing similar functions. The board of directors believes that it is not necessary to have a compensation committee at this time because the functions of such committee are adequately performed by the board of directors. The board of directors also is of the view that it is appropriate for the Company not to have a standing nominating committee because the board of directors has performed and will perform adequately the functions of a nominating committee. The Company is not a "listed company" under SEC rules and is therefore not required to have a compensation committee or a nominating committee.
Shareholder Communications
There has not been any defined policy or procedure requirements for stockholders to submit recommendations or nomination for directors. There are no specific, minimum qualifications that the board of directors believes must be met by a candidate recommended by the board of directors. Currently, the entire board of directors decides on nominees, on the recommendation of any member of the board of directors followed by the board’s review of the candidates’ resumes and interview of candidates. Based on the information gathered, the board of directors then makes a decision on whether to recommend the candidates as nominees for director. The Company does not pay any fee to any third party or parties to identify or evaluate or assist in identifying or evaluating potential nominee.
Because the Chief Executive Officer of the Company is also the Chairman of the Board of Directors of the Company, the Board of Directors has determined not to adopt a formal methodology for communications from shareholders on the belief that any communication would be brought to the Board of Directors’ attention by virtue of the co-extensive capacities of the Chairman of the Board of Directors.
Executive Compensation
Name and Principal Position | Fiscal Year | Salary ($) | Bonus ($) | Stock
Awards ($) | Restricted
Stock Awards ($) | Option
Awards ($) | Non
Equity Incentive Plan Compensation ($) | Nonqualified
Deferred Compensation Earnings ($) | All
Other Compensation ($) | Total ($) | ||||||||||||||||||||||||||||||
David Koos, Chairman, President, CEO, CFO (CFO inception to July 20, 2020, Chairman President until December 13, 2022) | 2022 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Name and Principal Position | Fiscal Year | Salary ($) | Bonus ($) | Stock
Awards ($) | Restricted
Stock Awards ($) | Option
Awards ($) | Non
Equity Incentive Plan Compensation ($) | Nonqualified
Deferred Compensation Earnings ($) | All
Other Compensation ($) | Total ($) | ||||||||||||||||||||||||||||||
Joseph G. Vaini CFO (since July 21, 2020) | 2022 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Name and Principal Position | Fiscal Year | Salary ($) | Bonus ($) | Stock
Awards ($) | Restricted
Stock Awards ($) | Option
Awards ($) | Non
Equity Incentive Plan Compensation ($) | Nonqualified
Deferred Compensation Earnings ($) | All
Other Compensation ($) | Total ($) | ||||||||||||||||||||||||||||||
Joseph G. Vaini CFO (since July 21, 2020) Chairman, President, Treasurer, Chief Executive Officer since December 13, 2022 | 2023 | 0 | 0 | 0 | 11,400 | 0 | 0 | 0 | 0 | 11.400 |
Name and Principal Position | Fiscal Year | Salary ($) | Bonus ($) | Stock
Awards ($) | Restricted
Stock Awards ($) | Option
Awards ($) | Non
Equity Incentive Plan Compensation ($) | Nonqualified
Deferred Compensation Earnings ($) | All
Other Compensation ($) | Total ($) | ||||||||||||||||||||||||||||||
Harry Lander Chief Scientific Officer (since December 9, 2022 ) | 2022 | 0 | 0 | 0 | 11,400 | 0 | 0 | 0 | 0 | 11,400 |
36 |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The following table sets forth information known to the Company with respect to the beneficial ownership of each class of the Company’s capital stock for (1) each person known by the Company to beneficially own more than 5% of each class of the Company’s voting securities, (2) each executive officer, (3) each of the Company’s directors and (4) all of the Company’s executive officers and directors as a group.
Based on 10,613,492 Common Shares outstanding as of July 31,2023.
Title of Class | Name and Address of Beneficial Holder | Number of Shares | % | |||||||
Common | Harry Lander | |||||||||
c/o Sybleu Inc. | 3,309,000 | (a) | 31.18 | % | ||||||
Common | Joseph G Vaini | |||||||||
c/o Sybleu Inc. | 3,210,790 | 30.25 | % | |||||||
Common | Stephen Hake | |||||||||
290 Saddle Run St. Henderson Nv | 1,040,000 | (b) | 9.80 | % | ||||||
Common | All officers and directors as a group | 4,349,000 | (c) | 40.98 | % |
(a) Includes 309,000 Common shares held by DYO BIOTECHNOLOGIES PTY LTD.
(b) Includes 1,000,000 Common Shares held by the The Stephen and Fredna Hake Trust DTD August 6, 2014 for which Dr. Hake serves as a Trustee
(c) Includes 309,000 Common shares held by DYO BIOTECHNOLOGIES PTY LTD.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The Company utilizes approximately 500 square feet of office space at 1034 Throggs Neck Expressway, Bronx NY 10465 provided to the Company by Joseph G. Vaini, the Company’s sole officer and director, on a month to month basis free of charge. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.
On January 8, 2023 the Company entered into an agreement with Joanne Vaini whereby Joanne Vaini agreed to provide bookkeeping services for the Company for the period beginning January 9, 2023 and ending July 9, 2024 (“Agreement”) for total consideration consisting of $15,000. Joanne Vaini is the spouse of Joseph G. Vaini the Company’s sole officer and director.
On June 26, 2023 the Company was granted an exclusive worldwide license by DYO Biotechnologies, Pty, Ltd (“DYO”) to (a) to make, have made, use, offer for sale, sell, perform, have performed export and import Licensed Products and Licensed Services; (b) to practice Licensed Methods; and (c) to use Technology, all in the Field, within the Territory and during the Term (the “License”).
“Technology” is defined in the License as” Artificial intelligence/machine learning engine designed to utilize existing chemical library structures in an integrated model to predict highly specific and sensitive novel chemical structures for molecular targets.”
37 |
“Licensed Products” are defined in the License as “any product, kit, composition, or part thereof: (a) that incorporates,
uses, or is enabled or derived from the use of the Technology; or (b) that is produced or enabled by a Licensed Method.”
“Licensed Services” are defined in the License as “any service performed by Company or Sublicensee for the benefit of a third party that, in whole or in part, (a) uses Technology; (b) uses Licensed Product(s); or (c) that practices or is enabled by a Licensed Method.”
“Licensed Method” is defined in the License as “any method or process that uses Technology”
“Field” is defined in the License as small molecule drug development and commercialization for human and/or animal health.
“Territory” is defined in the License as “worldwide”.
The Term of the License is the period of time beginning on the effective date of this Agreement which shall be June 26, 2023 and terminating on the last to expire Royalty Term .
“Royalty Term” is defined in the License as that period of time beginning on the first commercial sale of a Licensed Product in a given country and, expires on a country-by-country basis with respect to each Licensed Product, upon the later of: (a) the expiration, abandonment, or invalidation of the last to expire, abandoned or invalidated Valid Claim of the Patent Rights in such country; (b) the expiration of any granted statutory period of marketing exclusivity within a country; and (c) 12 years from of the date of the first commercial sale of such Licensed Product in such country.
Pursuant to the terms and conditions of the License the Company shall raise $2,000,000 US through either debt or equity financing within 2 years of execution of this Agreement (“Funding”). The Company shall enter into a research collaboration agreement with DYO upon mutually acceptable terms and conditions within 30 days of Funding (“Research Agreement).
Substantially all of the Funding shall be utilized to enable the Technology for the benefit of developing Company’s existing and future small molecule drug intellectual property. It is anticipated that this research agreement will utilize substantially all of these funds over two years. It is agreed that the Company shall exclusively possess all right, title and interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to any and all inventions, discoveries, intellectual property and chemical structures resulting from this Research Agreement.
Pursuant to the terms and conditions of the License the Company shall pay to DYO a Royalty equal to five percent (5%) of the Net Sales ( as such term is defined in the License) of any Licensed Method, Service or Product per annum. The License also imposes an obligation upon the Company to make minimum royalty payments to DYO over the course of the Term.
Pursuant to the terms and conditions of the License the Company paid to DYO 309,000 common shares of the Company (“Stock Payment”) and also paid a $25,000 License Issuance Fee.
DYO shall not, directly or indirectly, offer, issue, sell, contract to sell (including without limitation short sale), grant any option for the sale of, pledge or otherwise dispose of or transfer any or all of the Stock Payment for a period of two years from the date of issuance.
38 |
Pursuant to the terms and conditions of the License Upon the occurrence of each of the following events (each a “Milestone”)), the Company shall make a cash payment (“Milestone Payment”) in the amount corresponding to such Milestone within thirty days after achievement of each Milestone:
Milestone | AMOUNT | |
1. Dosing of a first human patient in a Phase I or Phase I/II Clinical Trial for Licensed Product | $150,000 US | |
2. Dosing of a first patient in a Phase III Clinical Trial for Licensed Product | $500,000 US | |
3. FDA (US) Approval of a Licensed Product | $3,000,000 US | |
4. EMA (EU) Approval of a Licensed Product | $1,500,000 US | |
5. PMDA (JPN) Approval of a Licensed Product | $1,000,000 US | |
6. Cumulative Net Sales of Licensed Products reach $100 Million | $2,000,000 US |
This License may be terminated by DYO in the event:
No licensed Method, Service or Product has been granted Patent Protection in at least one jurisdiction after the expiration of four years from execution
The sum of $2,000,000 shall not have been raised within 2 years of execution of the license
The Research Agreement shall not have been entered into as of thirty days subsequent to the Funding.
The Company shall not have achieved cumulative Net Sales of Licensed Product, Service and Methods of at least $10,000,000 as of a date that is ten years from the execution of the license
The Company shall fail to pay any consideration required under the license and such failure remains uncured for thirty days.
This License may be terminated by the Company in the event:
DYO shall be determined to not have exclusive unencumbered Patent Rights to the Technology in whole or in part.
Any other entity shall be determined to have the right- exercised or not- to utilize the Technology ( in whole or in part) to develop make, use, offer for sale, sell, perform, have performed export and import and sell products, methods and services which can reasonably be expected to be similar to or competitive with products, methods and services to be developed by the Company utilizing the rights granted by the License. .
DYO shall have failed to demonstrate during the course of due diligence to the satisfaction of the Company that the Technology can be effectively utilized for the purposes intended by this License
In the event that the Agreement is terminated pursuant to the any of the abovementioned the Stock Payment shall be promptly returned by DYO to the Company for cancellation.
Dr. Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing Director of DYO and is a controlling shareholder of DYO.
On July 14, 2023 the Company’s Chief Executive Officer made a $3,600 capital contribution to the Company.
39 |
Item 14. Principal Accounting Fees and Services
The following table sets forth the aggregate fees billed to us by BF Borgers CPA PC for the period beginning July 1,2022 and ending June 30, 2023:
Audit Fees | $ | 11,000 | ||
Audit Related Fees | 16,500 | |||
Tax Fees | 0 | |||
All Other Fees | 0 | |||
Total: | $ | 27,500 |
The following table sets forth the aggregate fees billed to us by BF Borgers CPA PC for the period beginning July 1,2021 and ending June 30, 2022:
Audit Fees | $ | 25,800 | ||
Audit Related Fees | 21,600 | |||
Tax Fees | 0 | |||
All Other Fees | 0 | |||
Total: | $ | 47,400 |
Audit Fees: Aggregate fees billed for professional services rendered for the audit of the Company's annual financial statements.
Audit Related Fees: Aggregate fees billed for professional services rendered for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements and are not reported under “Audit Fees” above. These fees were primarily derived from review of financial statements in the Company's Form 10Q Reports.
All services listed were pre-approved by the Board of Directors, functioning as the Audit Committee in accordance with Section 2(a) 3 of the Sarbanes-Oxley Act of 2002.
40 |
EXHIBITS
41 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SYBLEU INC. | ||
By: | /s/ Joseph G. Vaini | |
Name: | Joseph G. Vaini | |
Title: Chairman, Chief Executive Officer, Director, Chief Financial Officer, Chief Accounting Officer | ||
Date: | August 4, 2023 |
42 |
PROMISSORY NOTE (“NOTE”) - 10% SIMPLE INTEREST
$12,500 | September 20, 2021 |
For VALUE RECEIVED, SYBLEU INC. (“Borrower”) promises to pay to Zander Therapeutics, Inc. (“Lender”) the principal sum of Twelve Thousand Five Hundred ($12,500) with accrued simple interest at the rate of 10% percent per annum on the balance. The said principal and accrued interest shall be payable in lawful money of the United States of America on April 4, 2024. This Note may be prepaid in whole or in part at any time without premium or penalty. The Borrower hereby waives any notice of the transfer of this Note by the Lender or by any subsequent holder of this Note, agrees to remain bound by the terms of this Note subsequent to any transfer, and agrees that the terms of this Note may be fully enforced by any subsequent holder of this Note. All terms and conditions of this Note shall be interpreted under the laws of the state of California and venue shall be the state of California.
SYBLEU INC.
By: /s/Joseph G Vaini
Its: Chairman and CEO
Accepted By:
Zander Therapeutics, Inc.
By:/s/David R. Koos
Its: Chairman
PROMISSORY NOTE (“NOTE”) - 10% SIMPLE INTEREST
$25,000.00 | September 20, 2021 |
For VALUE RECEIVED, SYBLEU INC. (“Borrower”) promises to pay to Bostonia Partners, Inc. (“Lender”) the principal sum of Twenty Five Thousand Dollars ($25,000.00] with accrued simple interest at the rate of 10% percent per annum on the balance. The said principal and accrued interest shall be payable in lawful money of the United States of America on June 29, 2024. This Note may be prepaid in whole or in part at any time without premium or penalty. The Borrower hereby waives any notice of the transfer of this Note by the Lender or by any subsequent holder of this Note, agrees to remain bound by the terms of this Note subsequent to any transfer, and agrees that the terms of this Note may be fully enforced by any subsequent holder of this Note. All terms and conditions of this Note shall be interpreted under the laws of the state of California and venue shall be the state of California.
SYBLEU INC.
By: /s/Joseph G Vaini
Its: Chairman and CEO
Accepted By:
Bostonia Partners, Inc.
By:/s/Timothy Foat
Its: President
Exhibit 31.1
CHIEF
EXECUTIVE OFFICER CERTIFICATION
PURSUANT TO SECTION 302
I, Joseph G. Vaini, certify that:
1. I have reviewed this Annual Report on Form 10-K of Sybleu Inc. (the “Registrant”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4. The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
5. The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting to the Registrant’s auditors and the audit committee of Registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
Date: August 04, 2023
/s/ Joseph G. Vaini
Joseph G. Vaini
Chief
Executive Officer
(Principal Executive Officer)
Exhibit 31.2
CHIEF
FINANCIAL OFFICER CERTIFICATION
PURSUANT TO SECTION 302
I, Joseph G. Vaini, certify that:
1. I have reviewed this Annual Report on Form 10-K of Sybleu Inc. (the “Registrant”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4. The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the Registrant’s disclosure controls and procedures presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
5. The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of Registrant’s board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
Date: August 04, 2023
/s/ Joseph G. Vaini
Joseph G. Vaini
Chief Financial Officer
(Principal
Financial Officer)
Exhibit 32.1
CERTIFICATION
PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying Annual Report of Sybleu Inc. (the “Company”) on Form 10-K for the twelve months ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David Koos, Principal Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fully presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 04, 2023
/s/ Joseph G. Vaini |
Joseph G. Vaini |
Principal Executive Officer |
Exhibit 32.2
CERTIFICATION
PURSUANT TO
18 U.S.C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying Annual Report of Sybleu Inc. (the “Company”) on Form 10-K for the twelve months ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joseph G. Vaini, Principal Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fully presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 04, 2023
/s/ Joseph G. Vaini | |
Joseph G. Vaini | |
Principal Financial Officer |
Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2023 |
Jun. 30, 2022 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Common Stock, Shares Authorized | 100,000,000 | 100,000,000 |
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 |
Common Stock, Shares, Issued | 10,613,492 | 10,418,000 |
Common Stock, Shares, Outstanding | 10,613,492 | 10,418,000 |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES SYBLEU INC. (“Company”) was organized June 12, 2020 under the laws of the State of Wyoming. The Company intends to engage primarily in the acquisition, licensing and development of regenerative medical applications up to the point of successful completion of Phase I and or Phase II clinical trials after which the Company would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.
A. BASIS OF ACCOUNTING The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a June 30 year-end. B. USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. C. CASH EQUIVALENTS The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. D. FAIR VALUE OF FINANCIAL INSTRUMENTS Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value: Level 1: Quoted prices in active markets for identical assets or liabilities Level 2: Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. E. RESEARCH AND DEVELOPMENT COSTS Research and development expenses relate primarily to the cost of discovery and research programs. Research and development costs are charged to expense as incurred. Research and development expenses consist mainly of evaluating potential Contract Research Organizations and filing of a provisional patent application. Stock issued for Employee Compensation Stock based compensation to employees is accounted for at the award’s fair value at grant, less the amount (if any) paid by the award recipient. During the quarter ended December 31, 2022 shares of common stock were issued as employee compensation. In determining Fair Value for shares issued to employees an asset based valuation method was utilized , specifically Enterprise Value (Assets Less Cash and Cash Equivalents plus Fair Value of Debt) less Fair Value of Debt. The following inputs were utilized.
Stock issued for Non-Employee Services Stock Based compensation to non-employees is accounted for in accordance with ASC 505-50. ASC 505-50 requires entities to account for non-employee equity transactions based on either the fair value of the services received or the fair value of the equity instrument issued utilizing whichever measurement is most reliable During the year ended June 30, 2023 stock was issued for Non-Employee Services . Pursuant to ASC 505-50-30-11505-50-30-11 an issuer shall measure the fair value of the equity instruments in these transactions using the stock price and other measurement assumptions as of the earlier of the following dates, referred to as the measurement date:
G. INCOME TAXES The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date. The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of June 30, 2023 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future. The Company generated a deferred tax credit through net operating loss carry forward. However, a valuation allowance of 100% has been established. Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19. The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception. Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding. There were no Common Stock Equivalents as of June 30, 2023. I. INTANGIBLE ASSETS
The Company amortizes its intangible assets with definite useful lives over their estimated useful lives and reviews these assets for impairment. The Company’s acquired intangible assets with definite useful lives consists of a 50% interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to (a) the intellectual property disclosed in US Patent US11377442B2 (Small molecule agonists and antagonists of NR2F6 activity) and (b) ) the intellectual property disclosed in US Patent US US10472351B2 (Small molecule agonists and antagonists of NR2F6 activity in animals).
|
RECENT ACCOUNTING PRONOUNCEMENTS |
12 Months Ended |
---|---|
Jun. 30, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
RECENT ACCOUNTING PRONOUNCEMENTS | NOTE 2. RECENT ACCOUNTING PRONOUNCEMENTS The Company has adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606). The guidance in this Update supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific guidance throughout the Industry Topics of the Codification. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s) with a customer. Step 2: Identify the performance obligations in the contract. Step 3: Determine the transaction price. Step 4: Allocate the transaction price to the performance obligations in the contract. Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation. The Company has adopted the provisions of this ASU effective the fiscal year ended 2020. This guidance did not have a material impact on the Company’s Financial Statements. On February 2016, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2016-02, Leases (Topic 842). The ASU requires organizations that lease assets, referred to as "lessees," to recognize on the consolidated statement of financial position the rights and obligations created by those leases. The ASU also requires disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. These disclosures include qualitative and quantitative requirements, providing additional information about the amounts recorded in the consolidated financial statements. The ASU on leases became effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. This guidance is not expected to have a material impact on the Company’s financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting. This ASU is intended to simplify aspects of share-based compensation issued to non-employees by making the guidance consistent with the accounting for employee share-based compensation. This ASU is effective for annual periods beginning after December 15, 2018 and interim periods within those annual periods, with early adoption permitted. This guidance is not expected to have a material impact on the Company’s financial statements. |
GOING CONCERN |
12 Months Ended |
---|---|
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GOING CONCERN | NOTE 3. GOING CONCERN The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has generated net losses of $531,355 during the period from June 12, 2020 (inception) through June 30, 2023. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings. |
RELATED PARTY TRANSACTIONS. |
12 Months Ended | |||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||
Related Party Transactions [Abstract] | ||||||||||||||||||||||
RELATED PARTY TRANSACTIONS. | NOTE 4. RELATED PARTY TRANSACTIONS. The Company utilizes approximately 500 square feet of office space at 1034 Throggs Neck Expressway, Bronx NY 10465 provided to the Company by Joseph G. Vaini, the Company’s sole officer and director, on a month to month basis free of charge. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space. On January 8, 2023 the Company entered into an agreement with Joanne Vaini whereby Joanne Vaini agreed to provide bookkeeping services for the Company for the period beginning January 9, 2023 and ending July 9, 2024 (“Agreement”) for total consideration consisting of $15,000. Joanne Vaini is the spouse of Joseph G. Vaini the Company’s sole officer and director. On June 26, 2023 the Company was granted an exclusive worldwide license by DYO Biotechnologies, Pty, Ltd (“DYO”) to (a) to make, have made, use, offer for sale, sell, perform, have performed export and import Licensed Products and Licensed Services; (b) to practice Licensed Methods; and (c) to use Technology, all in the Field, within the Territory and during the Term (the “License”). “Technology” is defined in the License
as” Artificial intelligence/machine learning engine designed to utilize existing chemical library structures in an integrated model
to predict highly specific and sensitive novel chemical structures for molecular targets.” “Licensed Services” are defined in the License as “any service performed by Company or Sublicensee for the benefit of a third party that, in whole or in part, (a) uses Technology; (b) uses Licensed Product(s); or (c) that practices or is enabled by a Licensed Method.” “Licensed Method” is defined in the License as “any method or process that uses Technology” “Field” is defined in the License as small molecule drug development and commercialization for human and/or animal health. “Territory” is defined in the License as “worldwide”. The Term of the License is the period of time beginning on the effective date of this Agreement which shall be June 26, 2023 and terminating on the last to expire Royalty Term . “Royalty Term” is defined in the License as that period of time beginning on the first commercial sale of a Licensed Product in a given country and, expires on a country-by-country basis with respect to each Licensed Product, upon the later of: (a) the expiration, abandonment, or invalidation of the last to expire, abandoned or invalidated Valid Claim of the Patent Rights in such country; (b) the expiration of any granted statutory period of marketing exclusivity within a country; and (c) 12 years from of the date of the first commercial sale of such Licensed Product in such country. Pursuant to the terms and conditions of the License the Company shall raise $2,000,000 US through either debt or equity financing within 2 years of execution of this Agreement (“Funding”). The Company shall enter into a research collaboration agreement with DYO upon mutually acceptable terms and conditions within 30 days of Funding (“Research Agreement). Substantially all of the Funding shall be utilized to enable the Technology for the benefit of developing Company’s existing and future small molecule drug intellectual property. It is anticipated that this research agreement will utilize substantially all of these funds over two years. It is agreed that the Company shall exclusively possess all right, title and interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to any and all inventions, discoveries, intellectual property and chemical structures resulting from this Research Agreement. Pursuant to the terms and conditions of the License the Company shall pay to DYO a Royalty equal to five percent (5%) of the Net Sales ( as such term is defined in the License) of any Licensed Method, Service or Product per annum. The License also imposes an obligation upon the Company to make minimum royalty payments to DYO over the course of the Term. Pursuant to the terms and conditions of the License the l Company paid to DYO 25,000 License Issuance Fee. common shares of the Company (“Stock Payment”) and also paid a $DYO shall not, directly or indirectly, offer, issue, sell, contract to sell (including without limitation short sale), grant any option for the sale of, pledge or otherwise dispose of or transfer any or all of the Stock Payment for a period of two years from the date of issuance. Pursuant to the terms and conditions of the License Upon the occurrence of each of the following events (each a “Milestone”)), the Company shall make a cash payment (“Milestone Payment”) in the amount corresponding to such Milestone within thirty days after achievement of each Milestone:
This License may be terminated by DYO in the event: No licensed Method, Service or Product has been granted Patent Protection in at least one jurisdiction after the expiration of four years from execution The sum of $2,000,000 shall not have been raised within 2 years of execution of the license The Research Agreement shall not have been entered into as of thirty days subsequent to the Funding. The Company shall not have achieved cumulative Net Sales of Licensed Product, Service and Methods of at least $10,000,000 as of a date that is ten years from the execution of the license The Company shall fail to pay any consideration required under the license and such failure remains uncured for thirty days. This License may be terminated by the Company in the event: DYO shall be determined to not have exclusive unencumbered Patent Rights to the Technology in whole or in part. Any other entity shall be determined to have the right- exercised or not- to utilize the Technology ( in whole or in part) to develop make, use, offer for sale, sell, perform, have performed export and import and sell products, methods and services which can reasonably be expected to be similar to or competitive with products, methods and services to be developed by the Company utilizing the rights granted by the License. . DYO shall have failed to demonstrate during the course of due diligence to the satisfaction of the Company that the Technology can be effectively utilized for the purposes intended by this License In the event that the Agreement is terminated pursuant to the any of the abovementioned the Stock Payment shall be promptly returned by DYO to the Company for cancellation. Dr. Harry Lander serves as Chief Scientific Officer of the Company and is a shareholder of the Company. Dr. Harry Lander also serves as Managing Director of DYO and is a controlling shareholder of DYO. On July 14, 2023 the Company’s Chief Executive Officer made a $3,600 capital contribution to the Company.
|
NOTES PAYABLE |
12 Months Ended | |||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||
NOTES PAYABLE |
$10,000 owed by the Company to Bostonia Partners bears simple interest at 10% and is due and payable September 20, 2022. $30,000 owed by the Company to Bostonia Partners bears simple interest at 10% and is due and payable September 30, 2022. $100,000 owed by the Company to Bostonia Partners bears simple interest at 10% and is due and payable October 5, 2022. $12,500 owed by the Company to Zander Therapeutics, Inc bears simple interest at 10% and is due and payable April 4, 2024. $25,000 owed by the Company to Bostonia Partners bears simple interest at 10% and is due and payable June 29, 2024. $300,000 owed by the Company to Zander Biologics, Inc bears simple interest at 10% and is due and payable June 30, 2025. |
INVESTMENT SECURITIES |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Investments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVESTMENT SECURITIES | NOTE 6. INVESTMENT SECURITIES On March 11, 2021 the Company was paid common shares of Oncology Pharma, Inc. pursuant to an agreement entered into by and between the Company and Oncology Pharma, Inc. whereby the Company granted Oncology Pharma, Inc. an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by the Company. On June 30, 2023 the Company revalued common shares of Oncology Pharma, Inc. at the closing price of the common shares on the OTC Pink market. As of June 30, 2023:
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STOCKHOLDERS’ EQUITY |
12 Months Ended |
---|---|
Jun. 30, 2023 | |
Equity [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 7. STOCKHOLDERS’ EQUITY The stockholders’ equity section of the Company contains the following class of capital stock as of June 30, 2023: Common stock, $ par value; shares authorized: shares issued and outstanding. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1). On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation. |
INCOME TAXES |
12 Months Ended | ||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||
INCOME TAXES | NOTE 8. INCOME TAXES As of June 30, 2023
As of June 30, 2023 the Company has a Deferred Tax Asset of $97,076 completely attributable to net operating loss carry forwards of approximately $60,219 generated during the calendar year ending December 31, 2020 and 98,368 generated during the calendar year ended December 31, 2021 and $77,144 generated during the calendar year ended December 31, 2022 (which expire 20 years from the date the loss was incurred). Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain. In addition, if as a result of a stock transfer or a reorganization, a corporation undergoes an “ownership change,” Code Section 382 limits the corporation’s right to use its NOLs each year thereafter to an annual percentage of the fair market value of the corporation at the time of the ownership change (the “Section 382 Limitation”). A corporation is considered to undergo “an ownership change” if, as a result of changes in the stock ownership by “5-percent shareholders” or as a result of certain reorganizations, the percentage of the corporation’s stock owned by those 5-percent shareholders increases by more than 50 percentage points over the lowest percentage of stock owned by those shareholders at any time during the prior three-year testing period. Five-percent shareholders are persons who hold 5% or more of the stock of a corporation at any time during the testing period as well as certain groups of shareholders (based typically on whether they acquired their shares in a single offering or exchange transaction) who are not individually 5-percent shareholders. As the Company will require cash infusions in order to implement its business plan, and as it is probable, although not guaranteed, that such funding needs may be met through the sale of equity securities to “5-percent shareholders”, the Company recognized a valuation allowance equal to the deferred Tax Asset and the Company recorded a valuation allowance reducing all deferred tax assets to 0. Income tax is calculated at the 21% Federal Corporate Rate.
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STOCK TRANSACTIONS |
12 Months Ended |
---|---|
Jun. 30, 2023 | |
Stock Transactions | |
STOCK TRANSACTIONS | NOTE 9. STOCK TRANSACTIONS On December 12, 2022 the Company issued common shares (“Shares”) to Joseph G Vaini pursuant to an agreement whereby Joseph G. Vaini agreed to serve as President, Chief Executive Officer, Secretary, Chief Financial Officer and Secretary, Treasurer and Principal Accounting Officer of the Company. On December 12, 2022 the Company issued common shares (“Shares”) to Harry Lander pursuant to an agreement whereby Harry Lander agreed to serve as Chief Scientific Officer of the Company. On December 13, 2022 the Company cancelled 6,113,508 common shares owned by David Koos, the Company’s previous sole officer and director, and a company controlled by David Koos. Effective December 13, 2022 David Koos resigned as a Director of the Company and also resigned from any and all other offices he had held of the Company (“Resignation”). In connection with his Resignation Koos has returned any and all common shares directly or indirectly held by Koos to the Company for cancellation. Also in connection with his Resignation Koos and the Company have entered into an agreement ( “Separation Agreement”) whereby the Company shall pay Koos the sum of $10,000. On June 28, 2023 the Company issued common shares (“Shares”) to DYO Biotechnologies, Pty, Ltd pursuant to the terms and conditions of an agreement entered into by and between DYO Biotechnologies, Pty, Ltd and the Company. |
SUBSEQUENT EVENTS |
12 Months Ended |
---|---|
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 10. SUBSEQUENT EVENTS On July 14, 2023 the Company’s Chief Executive Officer made a $3,600 capital contribution to the Company. |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||
BASIS OF ACCOUNTING | A. BASIS OF ACCOUNTING The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a June 30 year-end. |
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USE OF ESTIMATES | B. USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
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CASH EQUIVALENTS | C. CASH EQUIVALENTS The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. |
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FAIR VALUE OF FINANCIAL INSTRUMENTS | D. FAIR VALUE OF FINANCIAL INSTRUMENTS Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value: Level 1: Quoted prices in active markets for identical assets or liabilities Level 2: Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
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RESEARCH AND DEVELOPMENT COSTS | E. RESEARCH AND DEVELOPMENT COSTS Research and development expenses relate primarily to the cost of discovery and research programs. Research and development costs are charged to expense as incurred. Research and development expenses consist mainly of evaluating potential Contract Research Organizations and filing of a provisional patent application. |
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STOCK BASED COMPENSATION | Stock issued for Employee Compensation Stock based compensation to employees is accounted for at the award’s fair value at grant, less the amount (if any) paid by the award recipient. During the quarter ended December 31, 2022 shares of common stock were issued as employee compensation. In determining Fair Value for shares issued to employees an asset based valuation method was utilized , specifically Enterprise Value (Assets Less Cash and Cash Equivalents plus Fair Value of Debt) less Fair Value of Debt. The following inputs were utilized.
Stock issued for Non-Employee Services Stock Based compensation to non-employees is accounted for in accordance with ASC 505-50. ASC 505-50 requires entities to account for non-employee equity transactions based on either the fair value of the services received or the fair value of the equity instrument issued utilizing whichever measurement is most reliable During the year ended June 30, 2023 stock was issued for Non-Employee Services . Pursuant to ASC 505-50-30-11505-50-30-11 an issuer shall measure the fair value of the equity instruments in these transactions using the stock price and other measurement assumptions as of the earlier of the following dates, referred to as the measurement date:
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INCOME TAXES | G. INCOME TAXES The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date. The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of June 30, 2023 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future. The Company generated a deferred tax credit through net operating loss carry forward. However, a valuation allowance of 100% has been established. Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19. |
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BASIC EARNINGS (LOSS) PER SHARE | The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception. Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding. There were no Common Stock Equivalents as of June 30, 2023. |
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INTANGIBLE ASSETS | I. INTANGIBLE ASSETS
The Company amortizes its intangible assets with definite useful lives over their estimated useful lives and reviews these assets for impairment. The Company’s acquired intangible assets with definite useful lives consists of a 50% interest in and to including, but not limited to, the copyrights, trade secrets, trademarks and associated good will and patent rights to (a) the intellectual property disclosed in US Patent US11377442B2 (Small molecule agonists and antagonists of NR2F6 activity) and (b) ) the intellectual property disclosed in US Patent US US10472351B2 (Small molecule agonists and antagonists of NR2F6 activity in animals).
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NOTES PAYABLE (Tables) |
12 Months Ended | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | ||||||||||||||||||||||||||
Debt Disclosure [Abstract] | ||||||||||||||||||||||||||
Schedule of related party debt |
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INVESTMENT SECURITIES (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Investments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule Of Common Shares |
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ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) |
12 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Defined Benefit Plan Disclosure [Line Items] | ||
[custom:FairValueOfIntellectualProperty-0] | $ 35,490 | |
[custom:Securities-0] | 3,771 | |
Notes Payable | $ 477,500 | 140,000 |
Interest Payable, Current | 19,504 | |
Taxes Payable, Current | 10,935 | 10,935 |
Debt, Current | (170,439) | |
[custom:PortionOfEnterpriseValueAvailabletoShareholders-0] | $ 39,261 | |
[custom:FairValuePerShare-0] | $ 0.00381 | |
Uncertain tax positions | $ 0 | |
Employee [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Shares Issued, Shares, Share-Based Payment Arrangement, after Forfeiture | 6,000,000 | |
Non Employee [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Number of shares issued for services | 0 |
GOING CONCERN (Details Narrative) |
37 Months Ended |
---|---|
Jun. 30, 2023
USD ($)
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Net income loss | $ 531,355 |
RELATED PARTY TRANSACTIONS. (Details Narrative) - USD ($) |
3 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|
Jan. 08, 2023 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jul. 15, 2023 |
Jun. 15, 2023 |
|
Related Party Transaction [Line Items] | ||||||
[custom:StockIssuedDuringPeriodSharesIssuedForConsideration] | 309,000 | |||||
[custom:LicenseFees] | $ 25,000 | $ 11,696 | $ 11,700 | |||
[custom:CapitalContribution-0] | $ 3,600 | $ 3,600 | ||||
Joanne Vaini [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Related Party Transaction, Amounts of Transaction | $ 15,000 |
NOTES PAYABLE (Details) - USD ($) |
Jun. 30, 2023 |
Jun. 30, 2022 |
---|---|---|
Defined Benefit Plan Disclosure [Line Items] | ||
Notes payable, related parties | $ 0 | |
Notes payable, related parties | $ 477,500 | $ 140,000 |
Bostonia Partners [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Notes payable, related parties | 140,000 | |
Zander Therapeutics [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Notes payable, related parties | 12,500 | |
Zander Biologics [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Notes payable, related parties | $ 300,000 |
INVESTMENT SECURITIES (Details) - Oncology Pharma Inc [Member] |
12 Months Ended |
---|---|
Jun. 30, 2023
USD ($)
| |
Schedule of Investments [Line Items] | |
Investment securities, basis | $ 177,450 |
Investment securities, fair value | 1,920 |
Investment securities, total unrealized losses | (175,530) |
Investment securities, net unrealized gain or loss realized | $ (718) |
INVESTMENT SECURITIES (Details Narrative) - shares |
12 Months Ended | |
---|---|---|
Mar. 11, 2021 |
Jun. 30, 2023 |
|
Oncology Pharma Inc [Member] | ||
Schedule of Investments [Line Items] | ||
Number of shares issued for property dividend | 6,500 | 6,500 |
STOCKHOLDERS’ EQUITY (Details Narrative) - $ / shares |
Jun. 30, 2023 |
Jun. 30, 2022 |
---|---|---|
Equity [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 10,613,492 | 10,418,000 |
Common stock, shares outstanding | 10,613,492 | 10,418,000 |
INCOME TAXES (Details Narrative) - USD ($) |
12 Months Ended | |||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2020 |
|
Income Tax Disclosure [Abstract] | ||||
Deferred Tax Assets, Operating Loss Carryforwards | $ 97,076 | |||
Deferred Income Taxes and Other Assets, Current | 0 | |||
Deferred Tax Assets, Gross | 97,076 | |||
Deferred Tax Assets, Valuation Allowance | (97,076) | |||
Deferred Tax Assets, Net of Valuation Allowance | $ 0 | |||
Operating Loss Carryforwards | $ 77,144 | $ 98,368 | $ 60,219 | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% |
STOCK TRANSACTIONS (Details Narrative) - shares |
Jun. 30, 2023 |
Jun. 29, 2023 |
Dec. 14, 2022 |
Dec. 13, 2022 |
Jun. 30, 2022 |
---|---|---|---|---|---|
Defined Benefit Plan Disclosure [Line Items] | |||||
Common Stock, Shares, Issued | 10,613,492 | 10,418,000 | |||
[custom:CommonStockCancelled-0] | 6,113,508 | ||||
D Y O Biotechnologies [Member] | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Common Stock, Shares, Issued | 309,000 | ||||
Chief Executive Officer [Member] | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Common Stock, Shares, Issued | 3,000,000 | ||||
Chief Scientific Officer [Member] | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Common Stock, Shares, Issued | 3,000,000 |
SUBSEQUENT EVENTS (Details Narrative) - USD ($) |
Jul. 15, 2023 |
Jun. 15, 2023 |
---|---|---|
Subsequent Events [Abstract] | ||
[custom:CapitalContribution-0] | $ 3,600 | $ 3,600 |
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