BIOFEST INVEST APPLICANT

Vitanova Biomedical

Company Contact: Tom Roberts

Legal Entity Type: C-Corp

Company Type: Biotechnology

Company Stage: Development

No. of Employees: 3

Desired Financial Amount: $500,000 up to $1,000,000

Background

Company Background

Vitanova Biomedical Inc. (VNB), is a San Antonio, Texas-based preclinical stage biotechnology company developing for commercialization a University of Texas at San Antonio (UTSA) invented targeted cancer therapy technology (Light Activated Intracellular Acidosis (LAIA) therapy) spun out of the laboratory of Dr. Matthew Gdovin, VNB’s Founder and Chief Science Officer. LAIA therapy is based on the ability to focally induce intracellular acidosis capable of inducing cell death in multiple cancer cell types. In 2014, UTSA performed the initial patent search for the LAIA therapy process. In February 2014, Dr. Gdovin filed a patent application with the U.S. Patent Office, and in June 2014, VNB was incorporated. In February 2015, all international patents were filed. To date, VNB has five patents granted in the following countries/regions: United States, Europe, Mexico, Australia, and Japan. In October 2018, VNB negotiated a fully-owned, world-wide, and in all sectors license agreement with the UT Board of Regents. From 2017, when CEO Tom Roberts joined, until today, VNB has fully developed their proprietary drug targeted to prostate cancer, secured a global partnership with a billion-dollar multinational laser technology company utilized to activate the drug, and completed in vivo proof of principle animal testing demonstrating efficacy of LAIA therapy in a mouse model.

Management

Tom Roberts, B.S., M.B.A, Chief Executive Officer, Founder (San Antonio, TX). Tom has 30 years of experience in significant leadership roles and executive management at large corporations, mid-caps, and start-ups in the medical device and biotech sectors. He has held senior leadership positions at Acelity and Hoffmann-La Roche, including Head of Product Development for a billion-dollar healthcare brand. In this role, Tom led global development, regulatory clearance, and commercialization of 10+ healthcare technology products. Prior to joining VNB, Tom served as CEO/Board Director at Invictus Medical, Inc. (San Antonio, TX), a start-up healthcare technology company where he successfully raised $10M in financing as well as directed the funding, full development, regulatory clearance, and commercialization of a novel UT-licensed healthcare technology. Tom received his B.S (Biology) from Denison University and M.B.A. from Indiana Wesleyan University. Matthew Gdovin, Ph.D., Chief Scientific Officer, Founder (San Antonio, TX). After receiving his Ph.D. in Physiology at Dartmouth College, Dr. Gdovin completed his post-doctoral fellowship at The University of Calgary Faculty of Medicine. From 1997 to 2018, he was an Assistant Professor, then Full Professor of Physiology at UTSA. During his academic tenure, Dr. Gdovin formed VNB and became its full-time Chief Scientific Officer in 2018. In this role, he helped raise $1.28M in financing, participated in the solidification of critical strategic partnerships, and led the development of VNB’s nanoparticle-based drug. Dr. Gdovin has been awarded over $3.2M by the NIH for research in physiology, respiratory control, and neurobiology. He has fostered research collaborations with the Institute for Drug Development at the Cancer Therapy and Research Center at the UT Health Science Center. Greg Espenhover, CPA, Chief Financial Officer, Founder (San Antonio, TX) Greg is an entrepreneur and CPA with 30+ years’ experience in providing accounting, tax, and business consulting services. Since 1988, he has been a CPA under the Texas State Board of Accountancy, as well as a member of the American Institute of Certified Public Accountants and Texas Society of Certified Public Accountants and holds Certified Information Technology Professional AICPA designation. In 1999, Greg became a Shareholder and Partner with Davidson Freedle Espenhover & Overby, P.C., providing accounting, auditing, consulting, and tax services for private companies.

Board of directors

Tom Roberts, B.S., M.B.A, Chief Executive Officer, Founder (San Antonio, TX). Tom has 30 years of experience in significant leadership roles and executive management at large corporations, mid-caps, and start-ups in the medical device and biotech sectors. He has held senior leadership positions at Acelity and Hoffmann-La Roche, including Head of Product Development for a billion-dollar healthcare brand. In this role, Tom led global development, regulatory clearance, and commercialization of 10+ healthcare technology products. Prior to joining VNB, Tom served as CEO/Board Director at Invictus Medical, Inc. (San Antonio, TX), a start-up healthcare technology company where he successfully raised $10M in financing as well as directed the funding, full development, regulatory clearance, and commercialization of a novel UT-licensed healthcare technology. Tom received his B.S (Biology) from Denison University and M.B.A. from Indiana Wesleyan University. Matthew Gdovin, Ph.D., Chief Scientific Officer, Founder (San Antonio, TX). After receiving his Ph.D. in Physiology at Dartmouth College, Dr. Gdovin completed his post-doctoral fellowship at The University of Calgary Faculty of Medicine. From 1997 to 2018, he was an Assistant Professor, then Full Professor of Physiology at UTSA. During his academic tenure, Dr. Gdovin formed VNB and became its full-time Chief Scientific Officer in 2018. In this role, he helped raise $1.28M in financing, participated in the solidification of critical strategic partnerships, and led the development of VNB’s nanoparticle-based drug. Dr. Gdovin has been awarded over $3.2M by the NIH for research in physiology, respiratory control, and neurobiology. He has fostered research collaborations with the Institute for Drug Development at the Cancer Therapy and Research Center at the UT Health Science Center. Greg Espenhover, CPA, Chief Financial Officer, Founder (San Antonio, TX) Greg is an entrepreneur and CPA with 30+ years’ experience in providing accounting, tax, and business consulting services. Since 1988, he has been a CPA under the Texas State Board of Accountancy, as well as a member of the American Institute of Certified Public Accountants and Texas Society of Certified Public Accountants and holds Certified Information Technology Professional AICPA designation. In 1999, Greg became a Shareholder and Partner with Davidson Freedle Espenhover & Overby, P.C., providing accounting, auditing, consulting, and tax services for private companies. Harald Stock, Ph.D., Board Director and Advisor (Logan, UT). Harald is a healthcare entrepreneur, investor, board director, and serial CEO. After obtaining his Ph.D. in Inorganic Chemistry from Heidelberg University, he spent 10+ years in big pharma/medical technology at Roche and Johnson & Johnson. As a serial CEO, he was CEO of the Grünenthal Group (2009 to 2013); ArjoHuntleigh (2014); and OvaScience (NASDAQ:OVAS; 2016). Harald is Board Director at Quantum Diamond Technologies (Somerville, MA) and clinical-stage immuno-oncology company Immatics Biotechnologies (Houston, TX).

Product / Service

disease area / application

Light Activated Intracellular Acidosis (LAIA) therapy is a platform technology proven to kill multiple cancer cell types. VNB has chosen to target early-stage prostate cancer as their initial indication

product / Service

Light Activated Intracellular Acidosis (LAIA) therapy is a light-activated targeted cancer therapy comprised of two critical components: 1) a proprietary targeted drug (VNBp-1) which is activated by deep penetrating 980 nm light; and 2) a medical laser system (laser device and optic probe) which delivers the 980 nm light necessary to activate the drug. Vitanova Biomedical (VNB) has entered a global partnership with LiteCure Medical (LCM) to develop and commercialize light-activated targeted cancer treatments based upon VNB’s targeted drug and LCM’s FDA-cleared laser system. LAIA therapy incorporates three proven principles widely accepted in the cancer therapeutics sector: 1) intracellular acidosis causes pH-induced cancer cell death; 2) compounds can be activated by specific wavelengths of light to elicit a biological response; and 3) nanoparticles conjugated with antibody-antigen or ligand-receptor combinations are an effective means to selectively and specifically target cancer cells. LAIA therapy involves the light-activation of an acid donor, which releases H+. This release of H+ elicits a rapid and precise intracellular acidosis and concomitant pH-induced natural cell apoptosis that cancer cells cannot overcome, causing them to enter the apoptosis pathway. This killing mechanism has been shown effective in multiple cancer cell types. With that said, VNB is focusing on early-stage prostate cancer as our first cancer therapy clinical indication. In the U.S. In 2021, 248,530 men were newly diagnosed with prostate cancer and 34,130 men died from prostate cancer. Prostate cancer is the second leading cause of cancer death in American men, behind only lung cancer20. Currently, men diagnosed with local prostate cancer have three therapeutic treatment choices: 1) surgery; 2) radiation therapy (RT), both with optimistic five-year survival estimates, but also associated with debilitating side effects; or 3) active surveillance (AS) with fewer side effects, but with clinical disease progression and poor five-year survival estimates. Most men only stay on AS for ~2.3 years, eventually electing for surgery due to the anxiety of living with cancer. AS includes one or more annual prostate biopsies that carry risks of bleeding, urination difficulty, and infection. Mortality outcomes of AS patients versus patients choosing other Standard of Care (SOC) therapies are comparable. However, AS patients have a higher risk of metastasis. This risk of cancer progression demonstrates the significant unmet need to provide prostate patients experiencing local disease with an option that treats their cancer, addresses disease progression, and reduces undesirable side effects. VNB is focusing our innovative technology approach to treating cancer with LAIA therapy as a targeted, light-activated treatment that eliminates the side effects caused by current standard of care cancer therapies.

technology / ip

Light Activated Intracellular Acidosis (LAIA) therapy is a platform targeted cancer therapy which elicits a rapid and precise intracellular acidosis and concomitant pH-induced natural cell apoptosis that cancer cells cannot overcome, causing them to enter the apoptosis pathway. This killing mechanism has been shown effective in multiple cancer cell types while eliminating the unwanted side effects caused by standard of care cancer therapies including surgery, radiation therapy, and other ablative therapies. In support of the request for a current IP overview, VNB is providing the following summary of global patent filings and status year to date, as of December 31, 2021:United States-Granted, European Union-Granted, Australia-Granted, Mexico-Granted, Japan-Granted. Drug Targeting – Freedom to Operate: Specific to the patent eligibility of naturally occurring receptors and ligands, Norton Rose Fulbright (Houston, TX) VNB’s intellectual property law firm, has provided the following opinion: “The Supreme Court of the United States has ruled that natural products are not patentable unless they are significantly different than the product as it occurs in nature, including molecules such as naturally occurring nucleic acids and proteins. The court also ruled that isolated molecules are not significantly different from those molecules, as they exist in nature. Thus, isolation of a protein or nucleic acid does not render the isolated protein or nucleic acid patent eligible if it already exists in nature. One can extrapolate that naturally occurring cellular receptors, and naturally occurring ligands, are not patentable based on the isolation of the molecules. Not only can these molecules not be patented, use of these molecules in their natural state cannot be the basis of infringement since any patent that covers a molecule in its natural state is invalid for covering non-patentable subject matter. In conclusion, a peptide or protein that is not structurally or functionally different from the naturally occurring protein is not patent eligible. It follows that a receptor protein used to target a cell in its natural environment is not patent eligible. Nor is a patent on a naturally occurring ligand for that receptor. Note that an engineered ligand with non-natural modifications or attachments may be patent eligible.”

distribution channels

VNB’s goal is to monetize our technology with a pharmaceutical and/or medical diagnostic partner (human and/or animal health sectors) through licensing or acquisition within a five to seven-year period of closing our $6.5M seed financing, and upon the estimated successful completion of our Phase I/IIA trial. To that end, VNB has has secured a Letter of Intent (LOI) from a billion-dollar multinational medical device company with presence in the Animal Health Sector for a co-development project with the intent to acquire and/or license our technology. If an early exit is not possible upon completion of our clinical trial, the company will pursue necessary funding to fully commercialize our technology. VNB’s technology, in the Human Health Sector, will be marketed to urologists, urology clinicals, cancer clinics, and hospitals. It has not yet been determined whether LiteCure Medical or VNB will supply/sell the drug activating laser technology to the end user. In either scenario, the laser system’s price has been established as a one-time purchase of < $50,000 per laser system. VNB has considered several pricing comparables for our targeted drug including surgery, RT, HIFU, and PDT as pricing proxies for the delivery of LAIA therapy to validate our targeted drug’s price point. Using these comparables, VNB has established a conservative 2032 targeted drug price of $24,380 per therapeutic regime, per patient (details available upon request). VNB's envisions our drug being sold/supplied through a third party distributor such as McKesson.

market size

World-wide for both sexes, prostate cancer is the third most common diagnosed cancer, trailing only breast and lung cancers, and is the second most common cancer among men, only trailing lung. In 2020, there were 1.4M cases of prostate cancer and 375,000 deaths worldwide, accounting for 7.3% of total cancers diagnosed, and 3.8% of total cancer deaths. For the US alone in 2021, 248,530 men were newly diagnosed with prostate cancer and 34,130 men died of prostate cancer. The Global Prostate Cancer Therapeutics Market size was estimated at $8.3B in 2020 and was expected to reach $8.9Bin 2021. With a CAGR of 6.12%, it is forecasted to reach $12B by 2026. Vitanova Biomedical (VNB) estimates that LAIA therapy has a forecasted US market potential to be utilized with 15%, or 17,000 of newly diagnosed early-stage local prostate cancer patients during its peak year in 2041 (> 80,000 patients over a 10-year period). This surpasses $500M in gross revenue during its peak year, ten years from initial launch date and a total of $2.2B over a 10-year period.

competition

Several large drug and equipment manufacturers exist within the global prostate cancer diagnostic and therapy markets. Key players in the market include Abbott Laboratories, AstraZeneca, Bayer HealthCare AG, Sanofi-Aventis, GE Healthcare, Rakuten Medical, and F. Hoffmann-La Roche AG. On a broad scale, VNB’s technology competitors include the Standard of Care early-stage prostate cancer treatments of surgery, radiation therapy (RT), and active surveillance (AS). More directly, Vitanova Biomedical (VNB) is competing with several types of photodynamic therapy (PDT), and other ablative therapies including thermal, cryotherapy, and radio frequency. VNB’s LAIA technology is uniquely differentiated from current cancer treatments for solid tumors in three ways: 1) LAIA is targeted to cancer cells only; 2) LAIA spares nearby healthy tissue; and 3) LAIA eliminates unwanted side effects of current solid tumor cancer therapies. Those competitors of particular relevance are Tookad® and HIFU. Tookad® is a PDT that releases reactive oxygen to produce vascular damage. Despite the FDA’s Oncologic Drugs Advisory Committee voting 13-2 in February 2020 against recommending approval of Steba Biotech’s NDA for Tookad®, citing poor study design and execution coupled with a lack of follow-up data, Tookad® was approved for use in 31 different countries for treatment of low-risk prostate cancer. VNB’s LAIA therapy is differentiated from Tookad® as follows: 1) Tookad® uses a light-activated photosensitizer delivered in a non-targeted manner, whereas LAIA therapy employs a prostate cancer-targeted drug that actively targets only prostate cancer cells; 2) Tookad®’s light-activation releases reactive oxygen species (ROS) that cause non-specific vascular damage, while LAIA causes prostate cancer-specific intracellular acidosis and natural cell-specific apoptosis that clearly spares nearby healthy tissue; and 3) LAIA therapy has no unwanted side effects like those seen with Tookad® ; one in four patients who undergo Tookad® therapy experience serious side effects including acute urine retention, prostatitis, and erectile dysfunction. HIFU is an ablative therapy technology that uses focused ultrasound waves to create heat sufficient to kill tissue. It has been cleared in ~50 countries (including the US) with several different branded HIFU systems available globally, including Sonablate® (SonaCare) and Focal One® (EDAP) in the US. Unlike VNB’s antibody-targeted approach to selectively target and kill only prostate cancer cells, ablative heat generated by HIFU is physically localized to contiguous regions, covers a wide area with imprecise delivery and possible zone expansion, and unable to distinguish between cancer cells and surrounding healthy tissue. These significant limitations in cell selectivity likely contributes to the high incidence of erectile dysfunction – rates of 20.0-49.8% – seen with HIFU. HIFU also suffer from poor efficacy, as retreatment patient reported rates range from 7.7 up to 43.0%, and positive-biopsy rates post- HIFU range from 4.9 up to 65.0%. VNB’s LAIA platform is significantly different from HIFU not only by mechanism of action (MOA) – intracellular acidification vs. ROS – but more importantly, by the ability to precisely target prostate cancer while sparing nearby healthy tissue which translates into much lower levels of serious and undesirable side effects. VNB will pursue the development and commercialization of LAIA therapy with VNBp-1 as a first-line treatment for early-stage local prostate cancer patients. Light-activation of NBA is an ideal mechanism because of its nontoxic nature, instant acidification, and versatility in multiple cancer phenotypes. LAIA therapy can produce prostate-specific cancer cell death in a targeted manner, reducing damage to nearby non-cancerous healthy tissue and eliminating the serious and undesirable side effects associated with current standard of care regimens of surgery, RT, PDT, and other ablative therapies. As a platform therapy with potential for application to most solid cancer phenotypes.

Financials

Desired financial amount

$500,000 up to $1,000,000

previous funding

As of December 31, 2021, VNB received a total of $1,280,000 in funding resulting from a successful Friends and Family financing of $470,000 and a Seed financing (currently open) of $810,000. This total funding amount includes $995,000 in Convertible Promissory Notes (CPNs) from a total of thirteen (13) individual private investors, $275,000 in non-dilutive grant funding ($50,000 from two separate cancer foundations, and $225,000 from the National Science Foundation in the form of a Small Business Innovation-Research Phase I Grant), and a $10,000 award received resulting from our participation in the 2021 Texas A&M New Venture Competition.

current financials

Currently, VNB is being funded by the Leadership Team at a burn-rate of $30,000 per month. With that said, the company is optimistic it will be able to leverage our recent prostate cancer animal study results to secure the capital necessary to progress our technology through Investigational New Drug (IND)-enabling studies with the intent to file a future IND application with the U.S. Federal Drug Administration (FDA). In addition to successfully filing an application with the Cancer Prevention and Research Institute of Texas (CPRIT) for a $3M non-dilutive Seed Award, VNB plans to file an application for a $1.5M National Science Foundation (NSF) Phase II grant in Q1 2022, and is engaged in investment considerations with multiple private investors, family offices, and industry strategic partners.

financial use

1. Therapy optimization 2. Conduct IND-enabling pharmacodynamics (PD) and in vivo murine efficacy studies 3. Operating expenses

revenue

VNB is a preclinical/pre-revenue company. With that said, we have forecasted future pricing including: 980nm Laser System (laser and probe) – It has not yet been determined who will supply/sell the LAIA therapy laser technology to the end user, a third-party manufacturing laser technology partner (DJO/Colfax), or VNB. However, in either scenario, the laser system’s price has been established as a one-time purchase of $30,000 to $50,000 per laser system. Targeted Drug – VNB considered several pricing comparables to validate our targeted drug’s price point. First, VNB compared the average cost of SOC prostate cancer therapy treatments including surgery and RT as a pricing proxy for the delivery of LAIA therapy. According to the National Institute of Health (NIH), the average listed price (i.e., for an uninsured patient) of a radical prostatectomy procedure varies widely across the nation with a mean hospital fee of $34,720 (standard deviation of $20,335 and min-max range of $10,000-$135,000). For patients who choose RT, the two main treatment categories include external beam RT (EBRT) or brachytherapy. EBRT for the treatment of prostate cancer is one of the most expensive of all RT cancer treatments with the average cost for all lengths of treatment at a mean cost of $49,504. The mean cost of brachytherapy (1-4 treatments) is from $10,000 to $20,000 (# 7 Tom’s citation page). Next, VNB considered our targeted price point compared to two distinct competitors pricing including HIFU and PDT for esophageal cancer. We did not consider the treatment cost of Tookad® as it has not been FDA-cleared. The cost for HIFU therapy treatment ranges from $15,000 to $25,000. With the upfront cost of the HIFU medical device between $450,000 to $700,000 per instrument. The cost for Photofrin® (Pinnacle Biologics, Inc.), a PDT compound FDA-cleared in 2003 for the treatment of Barrett’s esophageal cancer has an estimated wholesale price of $24,000-27,000 per dose. Lastly, VNB used the American Society of Clinical Oncology’s (ASCO) value-based pricing adjuvant template to estimate the likely cost of the LAIA therapy treatment regime at $34,500 per therapy regime per patient (inclusive of intratumoral guidance). Considering all the before mentioned prostate cancer therapy price points, VNB has established a conservative 2022 targeted drug price of $20,000 per therapeutic regime. After applying a 2% annual price increase (2022 through 2032), VNB established our drug price at $24,380 for the launch year of 2032. In our Regulatory Strategy, VNB anticipates the opportunity to work with the FDA and potentially Centers for Medicare and Medicaid Services (CMS) on innovative, value-based pricing for LAIA as a platform therapy. VNB’s pricing decisions are several years in the future and considers: 1) clinical product attributes as an alternative for men diagnosed with low-risk prostate cancer who elect prostate surgery in lieu of active surveillance, 2) value of innovation and 3) value to patients and providers, especially taking into consideration reduced side effects and QOL improvements. VNB will work with third party pharmacoeconomics consultants to determine a price that will support this type of patient decision and value. At this stage in LAIA therapy’s development, the company and its consultants’ predictions for pricing are early and should be considered as such. Reimbursement: Adequate reimbursement is critical to the successful adoption of any new therapy/drug treatment. “The lack of proper reimbursement may reduce the frequency of use of a therapy/drug and limit a company’s ability to recapture their research investment”. VNB’s technology innovations and advancements are designed to treat solid tumor cancers with a targeted, energy-based phototherapy. To that end, LAIA therapy will likely be classified by CMS as photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s). As a comparable, VNB researched the reimbursement strategy for the use of Photofrin® as a PDT for the treatment of Barrett’s esophageal cancer. Currently, CMS accepts multiple CPT codes for the reimbursement of this therapy including specific codes for the drug (Photofrin®), the drug injection, the endoscopy procedure, and the overall delivery of PDT. The highest reimbursement rate falls under drug code J9600 specific to porfimer sodium, 75mg at the reimbursement level of $21,219.57 per vial. The current regulatory and pricing environment continues to be a challenge for both policy makers and pharma. While insurance benefit managers will continue to have considerable influence in pricing new therapies, the frameworks and processes for new oncology drug pricing and specifically pricing for the VNB LAIA therapy platform will likely come from the CMS. VNB will engage third party reimbursement specialists to provide a more detailed reimbursement assessment and strategy specific to LAIA therapy for the treatment of solid tumors for local prostate cancer.

exit strategy

VNB’s goal is to monetize our technology with a pharmaceutical and/or medical diagnostic partner (human and/or animal health sectors) through licensing or acquisition within a five to seven-year period of closing our $6.5M seed financing, and upon the estimated successful completion of our Phase I/IIA trial. To that end, VNB has has secured a Letter of Intent (LOI) from a billion-dollar multinational medical device company with presence in the Animal Health Sector for a co-development project with the intent to acquire and/or license our technology. If an early exit is not possible upon completion of our clinical trial, the company will pursue necessary funding to fully commercialize our technology.

Pitch Video

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