Mission Viejo and Irvine, Calif., March 9th, 2023 (PRDistribution) —
Dear Stakeholders,
Nearly our entire portfolio of startups made great strides in progress in 2022 and are off to great start in early 2023.
Here is a link to the Executive Summary of our 2022 Annual Report > https://lventuresnew.wpenginepowered.com/wp-content/uploads/2023/02/Аnnual-Report_2022.pdf (note we are changing photos and making some adds).
We are highly focused on moving to commercialization and exit opportunities our single focused platform bioelectric stimulator technology platform. We are no primarily a one product company with a single bioelectric stimulator platform. This same stimulator circuit board design has been developed into three size configurations; (1) Bench top portable, (2) Palm sized portable, (3) Micro silver dollar sized implantable. We are working on a 4th size the size of a pea. Same circuit design. Same signals delivered. Just in different size configurations.
Our single focused bioelectric stimulator platform technology is packaged in different packages with at times when needed different organ interfaces for particular applications like skin, ED, hair. It is all the same product, often times with the exact same signals, just pointed to different places on the body.
In bold short summary…
1. We believe we have patented and developed the most advanced technology platform in the world for reversing aging and staving off aging related ailments. Patented bioelectric signals for klotho expression and patent pending licensed for klotho expressing MSCs. Patented signals for inflammation modulation. Patent pending signals for controlled up regulation of Sirtuins, Sestrins and NANOG powerful anti-aging and aging reversal proteins. In short we believe we have developed technology that has potential to reverse biological age in humans by up to 5 to 20 years.
2. We believe we have patented and developed the most effective technology platform ever developed for total and complete regeneration of organs including the heart, heart valves, aorta, lungs, brain, liver, kidney, bladder, pancreas, sexual organs, skin, hair, eyes and more.
3. We believe our 12 issued patents and corresponding technology platform for bioelectric cancer treatment have great chance to make a major impact in providing a less toxic treatment alternative for cancer patients with a strong possibility to have higher efficacy with less side effects.
4. We believe in 2022 we made great strides in developing technology to down regulate FABp4 and up regulate klotho to make a major dent in helping people to reverse out of both type I and type II diabetes.
5. Five (5) of our accelerator program graduates moved out of R&D stage into commercial stage of development with FDA 510K clearances in place. SkinStim, HairCell, ErectiStim, OrthoStim and BodStim have entered a distribution and sales agreement with Lionheart Health, Inc. to launch the sales of these products in the USA and OUS markets. Sales of these products are forecasted to be over $7 million in 2023. Shareholders of these portfolio innovation assets will now receive an 8% royalty on all full price sales and 5% on discounted sales made with quarterly disbursements pro-rata.
Below are some of our more specific progress highlights…
Intellectual property of our Portfolio Startups
(Cal-X Stars owns on average about 9% of each organ specific innovation asset with pre-emotive right to acquire up to 20% ownership right up to graduation from the accelerator program – the percentage is less for Second Heart Assist, Inc. at about 2.25% due to anti-dilution clause being waived).
- Over 200 new patent claims issued since 2020.
- Over 700 new patent claims filed and pending.
- Over 300 additional patent claims exclusively licensed.
- Issued patent for bioelectric klotho modulation for anti-aging and muscle regeneration.
- Patents pending for sirtuins, sestrins, NANOG anti-aging protein expressions.
- 12 issued patents for bioelectric cancer treatment.
- Multiple issued patents for bioelectric blood pressure control.
- Multiple issued patents for muscle regeneration.
- Multiple issued patents for nerve regeneration.
- Multiple issued patents for inflammation treatment.
- Multiple issued patents for skin regeneration.
- Multiple issued patents for hair regeneration.
- Multiple issued patents for sexual health and erectile dysfunction treatment.
- Multiple issued patents for total organ regeneration including heart, liver, kidney, lungs, pancreas, brain.
- Multiple issued patents and patents pending for heart valve regeneration.
- Issued patent for bioelectric accelerated teeth straightening.
- Multiple issued patents and patents pending for bone regeneration and osteointegration.
- Multiple issued patents for bladder regeneration.
- Multiple issued and pending patents for treating brain disorders.
- Patents pending for bioelectric control of BDNF, serotonin and klotho up regulation and TNFa down regulation for brain treatment.
- Multiple patents issued and pending for brain memory and cognition improvement.
- Multiple patents issued and pending for brain depression treatment.
- Multiple patents issued and pending for brain addiction treatment.
- Multiple patents issued and pending for aorta regeneration.
- Multiple patents issued and pending for kidney regeneration.
- Multiple patents issued and pending for liver regeneration.
- Multiple patents issued and pending for lung regeneration.
- Multiple patents issued and pending for diabetes reversal and pancreas regeneration.
- Patent pending for bioelectric and biologics treatment and prevention of viral infections including COVID-19.
- Multiple patents issued and pending for treating knee osteoarthritis and other joints recovery.
- Multiple patents issued and pending for bioelectric and biologics based vision recovery.
- Multiple patents pending for hearting recovery.
- Multiple patents issued and pending for treating essential tremor and Parkinson’s.
Regulatory Progress working with OEM manufacturing partners.
- FDA 510K for improving blood circulation.
- 2 FDA 510Ks for building and regenerating muscle.
- FDA 510K for treating pain and inflammation.
- FDA 510K for preventing blood clots following surgery.
- FDA 510K for bioelectric body suit for enhancing benefits of exercises especially more rapid muscle building.
- FDA 510K for treating arthritis including osteoarthritis.
- IRB approvals for 8 clinical studies with more coming soon.
Finance Progress Portfolio
- $3.7 million cash invested by Cal-X Stars shareholders has grown to over $55 million in estimated value.
- Over $19 million in cash capital has been raised by our current portfolio of startups with more than double that also in sweat equity.
- Valuations methodology has been confirmed by more than 5 independent 409a valuation determinations by Morgan Stanley and CARTA.
- 5 products are being launched on the USA market this quarter with an 8% royalty coming to all innovation asset stakeholders on each sale including Cal-X Stars Business Accelerator, Inc. that holds a 9% non-dilutive ownership stake in each. These 5 products are SkinStim, HairCell, ErectiStim, BodStim and OrthoStim.
- We finished last year about 20% under budget with $1,040,000 loss. The lions share of this funding went into accelerating and supporting portfolio R&D pre-clinical and clinical studies.
- $115,000 of our 2022 capital came from the David Brown Fund of Washington. All other cash capital came from convertible debt note funding provided by Leonhardt Ventures LLC.
- About a dozen of our portfolio.stakeholders have already exited about $3 million of portfolio holdings via the FAST ACT 407 (a) 7 regulations for individual private stock sales (under this regulation sellers have to find buyers privately on their own without help from the company).
Clinical Data Progress – Positive Highlights
- 89% of ErectiStim TM by MyoStim ED patients have achieved excellent results. Over 100 patients enrolled so far and more enrolling now.
- PressureStim clinical studies interim results are reporting an average of 10-20mm HG reduction in blood pressure.
- 67% of Stem Cell Bra patients achieved breast volume enhancement with only 4 weeks of treatment 1 hour every other day. 1/3rd of treated patients experienced a full cup size increase in breast volume in just 4 weeks.
- Approximately 40 to 60 percent of BladderCell and B-Alive patients are experiencing improvement of their bladder function with short duration non-invasive stimulation.
- KidneyCell patients are experiencing 19 meters improvement in six minute walk on average with increased strength.
- HairCell patients are experiencing 16.7% improvement in hair density with just 2 treatment sessions a week for 8 weeks.
- BodStim TM and other klotho stimulation patients are experience up to 150% in circulating klohto. More data forthcoming soon.
- Studies have identified low klotho as a primary cause of knee osteoarthritis and OrthoStim is seeking to prove its technology can partially reverse knee osteoarthritis with klotho stimulation.
- SkinStim treated patients in South Africa, Utah and California have achieved measurable improvements in reducing skin inflammation, higher collagen level, higher elasticity and visible reduction of facial and neck wrinkles.
- Second Heart Assist, Inc. applied last week to being a cardio-renal syndrome heart failure study in Canada at 2 sites. The previously completed a successful short duration pilot study in Paraguay.
Major progress was accomplished in 2022 and the plan for 2023 is clear and focused. All serving to build greatly shareholder value.
Portfolio Group
|
2022 Milestones
|
2023 Plan
|
Heart & Cardiovascular
|
Second Heart completed transition to new cGMP manufacturer and filed EFS application. Got 21 new patent claims with USPTO. Filed hundreds of new patent claims for multi-generational pipeline including Regenerator TM first therapeutic pump.
BioLeonhardt launched new round of large animal studies and further developed pump and implantable stimulator. Licensed patent for klotho expressing MSCs.
Valvublator built new simplified design test prototypes.
PressureStim launched OUS clinical study with IRB approval. PressureStim won clinical research grant.
|
Second Heart will complete 5 more large animals at GLP lab. Will completed up to 15 CRS heart failure cases in Canada. Will completed 10 EFS cases in USA.
BioLeonhardt will complete 5 large animals and first in human OUS study.
Valvublator will complete 3 large animals and first in human OUS pilot study.
PressureStim will complete clinical studies and will file for CE mark and FDA 510K clearance.
|
Brain Neuroscience
|
SpineStim completed U.S. pilot study.
DepressiStim completed pre-clinical studies and filed patent claims for BNDF, serotonin up regulation and TNFa down regulation. Filed with IRB to begin clinical studies. Landed research grant at UCI Engineering gaining 4 Masters Engineering students of 6 months.
Patent for bioelectric klotho issued helping all brain portfolio startups.
2nd generation BrainBand TM design initiated.
|
SpineStim launch long duration dosing study with BodStim suit.
DepressiStim complete OUS pilot study and launch USA pivotal study. File 510K application. Complete longer dosing and longer signals
Launch MemoryStim OUS pilot study.
Launch TremorStim OUS pilot study.
Complete development and testing of 2nd generation BrainBand TM design working with UCI Engineering students.
Launch Second Brain pilot clinical study.
|
Cosmetic & Personal Care
|
Completed U.S. SkinStim pilot study.
Completed U.S. HairCell pilot study.
Filed 510K application with the FDA for OrthodontiCell
Launched KlothoYears blood test commercially.
Filed new patents for BMP9 bone integration based on pre-clinical data.
Completed 2nd Stem Cell Bra clinical study.
Filed FDA 510K pre-sub for ErectiStim TM.
ArchStim prototypes developed and additional patent claims filed.
BreatheStim engineering design completed. Prototype build quote received.
ImplantStim mouthpiece further developed and patent application prepared.
|
SkinStim, HairCell, ErectiStim launching commercially on USA market via Lionheart Health, Inc. non-dilutive to their shareholders. 8% royalty on full price sales. 5% royalty on discounted sales.
OrthodontiCell will complete U.S. pivotal clinical trial.
Stem Cell Bra will launch pivotal clinical study.
ArchStim will launch pilot clinical study.
BreatheStim will complete development of 2nd generation devices and will launch 2nd pilot clinical study.
ImplantStim will launch pivotal clinical study.
|
Major Organ Regeneration
|
Completed 3rd BladderCell study OUS.
BladderCell and B-Alive developed 2nd generation wearable design.
Completed 2nd KidneyCell study OUS. Laid foundation for grant supported study.
Began enrollment in 3rd EyeCell study. EyeCell one button software designed.
PancreaCell completed pre-clinical studies and filed new patent application for diabetes reversal with FABp4 inhibition and klohto up regulation.
OrthoStim reached out to numerous potential commercialization partners. Linked up with team in Brazil that has completed already similar clinical studies.
BodStim TM by BIoLeonhardt Whole Body launched commercially via Lionheart Health, Inc.
ReganLung filed patent for lung recovery in COVID-19 and other viral infection patients.
|
BladderCell and B-Alive will complete clinical study with wearable 2nd generation design and will file for FDA 510K.
KidneyCell will complete longer duration dosing study with BodStim TM.
EyeCell will complete 3rd clinical study and will file FDA 510K application.
PancreaCell will launch OUS clinical study for diabetes reversal.
OrthoStim will commercially launch worldwide and will gather post market data on efficacy.
BodStim TM will develop sales and will continue to gather post market data. BodStim TM will develop new simpler to use software and will implement app download capability for re-occurring revenue stream forward.
|
Cancer
|
12th issued patent for bioelectric cancer treatment.
|
Launching clinical studies OUS.
Will complete additional pre-clinical studies.
|
2023 Big Picture FOCUSED Goals
1. Develop sales and royalties for a full pipeline of products including SkinStim, ErectiStim, HairCell, OrthoStim, KlothoYears and BodStim via Lionheart Health, Inc.
2. Complete pre-clinical studies and launch OUS clinical studies for BioLeonhardt and Valvublator.
3. Move PressureStim, OrthodontiCell, BladderCell/B-Alive, TestiStim, Stem Cell Bra, DepressiStim and MemoryStim out of research stage into commercial stage. Launch sales via Lionheart Health, Inc. or other outlets.
4. Complete clinical studies for ImplantStim, ArchStim and BreatheStim license or sell to a commercial partner.
5. Get 510K market clearance for portable stimulators.
6. Get 510K market clearance for full pipeline of HTM Electronics products to be distributed by Lionheart Health, Inc. (this products reached $150 million in sales primarily in Brazil last year).
2019 through 2022 Budget and Actual (adding 2023 budget in later today)
Totals |
Budget
|
Actual
|
Approved
|
Actual
|
Comparison %
|
||||
2019
|
2020
|
2021
|
2021
|
2022
|
Full Year 2022
|
Budget to Actual
|
|||
$ 1,200,000.00 | $ 900,000.00 | $ 1,400,000.00 | $ 1,143,411.00 | $ 1,900,000.00 | $ 1,039,725.00 |
27.3% under
|
|||
R&D |
Budget
|
Actual
|
Approved
|
Actual
|
|||||
2019
|
2020
|
2021
|
2021
|
2022
|
2022
|
||||
$ 500,000.00 | $ 240,000.00 | $ 737,000.00 | $ 619,221.00 | $ 1,000,000.00 | $ 655,279.05 |
48% under
|
|||
Facilities – Labs, Offices All Locations but Utah |
Budget
|
Actual
|
Approved
|
Actual
|
|||||
2019
|
2020
|
2021
|
2021
|
2022
|
2022
|
||||
$ 48,000.00 | $ 29,000.00 | $ 48,000.00 | $ 51,133.00 | $ 68,000.00 | $ 44,968.41 |
49% under
|
|||
Administration | |||||||||
(Includes Travel, Legal Accounting, Regulatory, Quality, Insurance, Marketing, Shipping, Payroll, Tax Preparation, Patents) | |||||||||
Budget
|
Actual
|
Approved
|
Actual
|
||||||
2019
|
2020
|
2021
|
2021
|
2022
|
|||||
$ 355,000.00 | $ 317,000.00 | $ 375,000.00 | $ 334,497.00 | $ 400,000.00 | $ 244,977.93 |
37% under
|
|||
Accrued Interest Loans |
Budget
|
Actual
|
Approved
|
Actual
|
|||||
2019
|
2020
|
2021
|
2021
|
2022
|
2022
|
||||
$ 237,000.00 | $ 276,000.00 | $ 240,000.00 | $ 184,299.00 | $ 290,000.00 | $ 184,621.00 |
43% under
|
|||
Department Detail | |||||||||
R&D |
Budget
|
Actual
|
Approved
|
Actual
|
|||||
2019
|
2020
|
2021
|
2021
|
2022
|
2022
|
||||
Net Wages | $ 192,000.00 | $ 152,000.00 | $ 282,000.00 | $ 282,475.00 | $ 398,000.00 |
$348,940.31
|
14% under
|
||
Health Insurance | $ 12,000.00 | $ 11,000.00 | $ 20,000.00 | $ 41,694.00 | $ 52,000.00 | $ 47,840.00 |
9% under
|
||
Contract Labor | $ 170,000.00 | $ 35,000.00 | $ 50,000.00 | $ 166,159.00 | $ 200,000.00 | $ 55,531.59 | 360% under | ||
Research Materials | $ 125,000.00 | $ 32,000.00 | $ 150,000.00 | $ 81,224.00 | $ 120,000.00 |
$72.421.01
|
66% under
|
||
Administration |
Budget
|
Actual
|
Approved
|
Actual
|
|||||
2019
|
2020
|
2021
|
2021
|
2022
|
2022
|
||||
Dues and Subscriptions | $ 6,000.00 | $ 10,000.00 | $ 15,000.00 | $ 11,683.00 | $ 12,000.00 | $ 10,341.94 |
16% under
|
||
Travel | $ 55,000.00 | $ 17,000.00 | $ 60,000.00 | $ 12,363.00 | $ 60,000.00 | $ 10,814.65 |
553% under
|
||
Accounting | $ 108,000.00 | $ 27,000.00 | $ 40,000.00 | $ 44,527.00 | $ 75,000.00 | $ 48,960.79 |
53% under
|
||
Insurance | $ 17,000.00 | $ 20,000.00 | $ 17,000.00 | $ 23,630.00 | $ 25,000.00 | $ 6,549.35 |
381% under
|
||
Legal Corporate | $ 50,000.00 | $ 50,000.00 | $ 50,000.00 | $ 54,152.00 | $ 50,000.00 | $ 13,578.34 |
368% under
|
||
Legal Patents | $ 85,000.00 | $ 130,000.00 | $ 150,000.00 | $ 90,716.00 | $ 100,000.00 | $ 79,389.48 |
26% under
|
||
Marketing/Conferences | $ 35,000.00 | $ 19,000.00 | $ 100,000.00 | $ 50,531.00 | $ 100,000.00 | $ 33,366.00 |
299% under
|
||
Payroll Fees | $ 1,100.00 | $ 1,200.00 | $ 1,200.00 | $ 4,117.00 | $ 5,000.00 | $ 10,919.28 |
55% over
|
||
Auto-Taxis-Uber | $ 2,600.00 | $ 1,900.00 | $ 1,900.00 | $ 12,677.00 | $ 6,700.00 | $ 378.00 |
1772% under
|
||
Postage & Shipping | $ 30,000.00 | $ 22,000.00 | $ 30,000.00 | $ 14,245.00 | $ 15,000.00 | $ 657.75 |
2280% under
|
||
Utah Lab – Leonhardt’s Launchpads Utah, Inc. |
Budget
|
Actual
|
Approved
|
Actual
|
|||||
2019
|
2020
|
2021
|
2021
|
2022
|
2022
|
||||
$ 93,000.00 | $ 140,000.00 | $ 180,000.00 | $ 175,000.00 | $ 3,000.00 | $ – | 3000% under |
Current Estimated Valuations for each portfolio asset including value of Cal-X Stars Business Accelerator, Inc. holdings in each.
Heart and Cardiovascular Group | |||||
Startup/LTP | Price Per Share | Valuation | Cal-X Ownership Estimated Value | No. Authorized Shares | Website, Video Link or Slide Deck |
Second Heart Assist, Inc. | $8 | $88 million | $2,772,000.00 | 11,000,000 | www.secondheartinc.com |
BioLeonhardt LTP | $3 | $60 million | $5,400,000.00 | 20,000,000 | www.bioleonhardt.com |
AortaCell LTP | $1.67 | $5 million | $450,000.00 | 2,300,000 | https://leonhardtventures.com/aortacell https://vimeo.com/176895719 |
BioPace LTP | $1 | $3 million | $270,000.00 | 3,000,000 | www.bio-pace.com |
Valvublator, Inc. | $1 | $3 million | $270,000.00 | 3,000,000 | www.valvublator.com |
VibroCell LTP | $2.60 | $6 million | $540,000.00 | 2,300,000 | https://leonhardtventures.com/vibrocell/ |
Vascustim LTP | $4.34 | $10 million | $900,000.00 | 30,000,000 | www.vascustim.com |
PressureStim LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.pressurestim.com |
PulseGraft, Inc. | $1 | $8 million | $720,000.00 | 8,000,000 | www.pulsegraft.com |
Brain Group | |||||
Startup/LTP | Price Per Share | Valuation | Cal-X Ownership Estimated Value | No. Authorized Shares | Website, Video Link or Slide Deck |
CerebraCell LTP | $4.35 | $10 million | $900,000.00 | 3,000,000 | www.cerebracell.com |
MemoryStim LTP | $1 | $3 million | $270,000.00 | 3,000,000 | www.memory-stim.com |
Second Brain LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.secondbrainstim.com |
TremorStim LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.tremorstim.com |
SpineStim LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.spine-stim.com (NEW) |
DepressiStim LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.depressistim.com (NEW) |
AddictiStim LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.addictistim.com (NEW) |
Cosmetic, Personal Care and Reproductive Health Group | |||||
Startup/LTP | Price Per Share | Valuation | Cal-X Ownership Estimated Value | No. Authorized Shares | Website, Video Link or Slide Deck |
TestiStim LTP | $2 | $20 million | $1,800,000.00 | 10,000,000 | www.testistim.com |
Stem Cell Bra LTP | $5 | $50 million | $4,500,000.00 | 10,000,000 | www.stemcellbra.com |
OrthodontiCell, Inc | $8 | $40 million | $6,120,000.00 | 5,000,000 | www.orthodonticell.com |
DentaCell Accelerator LTP | $4 | $9.2 million | $828,000.00 | 2,300,000 | www.dentalcellaccelerator.com |
ImplantStim LTP | $1 | $5 million | $450,000.00 | 5,000,000 | www.implantstim.com |
ArchStim LTP | $1 | $8 million | $720,000.00 | 8,000,000 | www.archstim.com |
BreatheStim LTP | $1 | $8 million | $720,000.00 | 8,000,000 | www.breathestim.com |
SinusStim LTP | $1 | $3 million | $270,000.00 | 3,000,000 | www.sinustim.com (NEW) |
HairCell LTP | $5 | $50 million | $4,500,000.00 | 10,000,000 | www.haircellstim.com |
SkinStim LTP | $5 | $15 million | $1,350,000.00 | 3,000.00 | www.skin-stim.com |
MyoStim ED | $15 | $52.5 million | $4,725,000.00 | 3,500,000 | www.erectistim.com |
KlothoBios LTP | $0.40 | $4 million | $360,000.00 | 10,00,000 | www.klothoyears.com |
Lionheart Health, Inc. | $1 | $15 million post money | $0 | 15,000,000 | www.lionhearthealthstim.com |
Major Organ Regeneration Group | |||||
Startup/LTP | Price Per Share | Valuation | Cal-X Ownership Estimated Value | No. Authorized Shares | Website, Video Link or Slide Deck |
EyeCell LTP | $15 | $34.5 million | $3,105,000.00 | 2,300,000 | www.eye-cell.com |
InStim LTP | $3 | $15 million | $1,350,000.00 | 5,000.00 | www.instimcell.com |
PancreaCell LTP | $1 | $3 million | $270,000.00 | 3,000,000 | https://vimeo.com/170533425 |
RegenaLung LTP | $2 | $6 million | $540,000.00 | 3,000,000 | https://leonhardtventures.com/regenalung/ |
OrthoStim and Orthostim Accelerator LTP | $1 | $3 million | $270,000.00 | 3,000,000 | www.ortho-stim.com and www.orthostimaccelerator.com |
LiverCell LTP | $1.30 | $3 million | $270,000.00 | 2,300,000 | www.livercellstim.com |
KidneyCell LTP | $1 | $2.3 million | $207,000.00 | 2,300,000 | www.kidney-cell.com |
EarCell LTP | $1 | $2.3 million | $207,000.00 | 2,300,000 | www.ear-cell.com |
BioLeonhardt Whole Body – BodStim LTP | $1 | $30 million | $2,700,000.00 | 30,000,000 | https://vimeo.com/179280204 |
BladderCell LTP | $5 | $15 million | $1,350,000.00 | 3,000,000 | www.bladdercell.com and www.b-alivestim.com |
Cancer Group | |||||
Startup/LTP | Price Per Share | Valuation | Cal-X Ownership Estimated Value | No. Authorized Shares | Website, Video Link or Slide Deck |
CancerCell LTP | $3 | $9 million | $810,000.00 | 3,000,000 | www.cancercellinc.com |
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to regulatory discussions in Japan, additional sites participating in the Company’s clinical trials, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue Leonhardt Venture’s and its portfolio business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and Leonhardt Ventures LLC, Cal-X Stars Business Accelerator, Inc., Leonhardt’s Launchpads, Lionheart Health, Inc. and our portfolio of startups assumes no obligation to update the forward-looking statements.
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to regulatory discussions in Japan, additional sites participating in the Company’s clinical trials, the efficacy and safety of our products and therapies, preliminary conclusions about new data, the achievement of any of the anticipated upcoming milestones, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue Leonhardt Venture’s and its portfolio business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates. These forward-looking statements are made as of the date of this press release, and Leonhardt Ventures LLC, Cal-X Stars Business Accelerator, Inc., Leonhardt’s Launchpads, Lionheart Health, Inc. and our portfolio of startups assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in our PPMs and our Annual Reports under the caption titled “Risk Factors.” Leonhardt Ventures LLC, Cal-X Stars Business Accelerator, Inc, Leonhardt’s Launchpads and Lionheart Health, Inc. all expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Howard J. Leonhardt
Leonhardt Ventures LLC
1 Kent Court
Mission Viejo, CA 92694
www.lventuresnestg.wpenginepowered.com
Leonhardt Ventures LLC
1 Kent Court
Mission Viejo, CA 92694
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