J.P. Morgan Health Care Conference Elevate Ventures Life Sciences Portfolio Preview

LIFE SCIENCES PORTFOLIO PREVIEW

www.AdipoTherapeutics.com

Company:

Adipo Therapeutics is a late preclinical stage biotech company developing a breakthrough approach to treating metabolic disease

CEO: Karen Wurster kwurster@adipotherapeuitcs.com

Strategic Focus

Harnessing the power of brown fat by transforming energy storing white adipose tissue (WAT) into energy burning brown adipose (BAT)

Intellectual Property Technology platform protected by US 15/771,312; US63/055,410; U S 15/621,627; International: PCT/US16/58997

IP Counsel

Ivor Elrifi, JD, Cooley LLP

General Council

Tim Capen, JD, Ice Miller, LLP

Scientific Advisors

Kuang, Shihuan, PhD - Professor, Dept. of Animal Sciences and Dept. of Biological Sciences, Purdue University; Co-inventor of IP; PhD in Cellular and Molecular Biology, and Physiology

Heiman, Mark, PhD - Chief Scientific Officer, Scioto Biosciences; Key advisor on brown fat physiology and clinical translation

Fried,Susan PhD - Professor at Icahn School of Medicine at Mount Sinai; Director, Translational Adipose Biology and Obesity

Diabetes, Obesity and Metabolism Institute

Funding & Investors

Funding for Adipo to date of $2 4 M has been provided by Purdue Research Foundation, Elevate Ventures, Indiana University Ventures, Angels, and an NIH SBIR grant

Adipo Therapeutics: A Breakthrough for Type 2 Diabetes

➢ ADPO-002-NP: First treatment with potential to harness the power of brown fat to provide weight loss and blood glucose control

➢ US market opportunity $2 bn for lead indication, Type 2 Diabetes (T2D); market has recognized unmet need and well-defined regulatory path

➢ Strong team with diabetes drug development and launch experience

Team: Adipo is led by Karen Wurster, CEO, a pharmaceutical executive with over 25 years of experience in developing and commercializing billion-dollar diabetes products, and Prof. Meng Deng, PhD (Purdue University), Founder & President, who has developed biomaterials technologies for drug delivery, cell and tissue engineering applications, including post-doc work in the MIT Langer lab. The company has recruited a world class team of drug development experts with an average of 27 years industry experience to provide specific, contracted expertise. Problem: By 2025, there will be 37 million people in the US with T2D. Despite multiple available treatments, the majority of treated patients are not reaching their therapeutic goals, resulting in an 8-year reduction in life expectancy and $327bn in US medical costs. The development and progression of Type 2 Diabetes (T2D) is largely driven by an excess of white adipose tissue (WAT) in obese individuals which becomes dysfunctional Brown adipose tissue (BAT), however, is correlated with lower odds of T2D, dyslipidemia, coronary artery disease, cerebrovascular disease, congestive heart failure and hypertension

Solution: Adipo’s ADPO-002-NP, is Notch-inhibitor nanoparticles are delivered as self-administered subcutaneous injections to treat T2D ADPO-002-NP induces localized conversion of WAT to BAT through mitochondrial biogenesis. Animal studies have demonstrated that this localized increase in brown fat leads to systemic improvements in glucose control and clinically relevant weight loss without reductions in calorie intake Localized delivery, with very low systemic circulation, allows for administration of low doses, and reduces the likelihood of side effects and safety concerns.

US Market Size: The US market for direct T2D treatment is in excess of $88B with a forecast CAGR of 14%. $10B of this market is the non-insulin injections (GLP-1 agonists), which is Adipo’s patient target. Customer research has indicated that a therapy with ADPO-002-NP product profile could grow this injectable market and capture 10% SOM in 3 years post launch, yielding $2bn annual US revenue

Competition: Current T2D treatments work by increasing circulating insulin, decrease appetite and removing glucose directly from the blood. ADPO-002 would be the first treatment in its class, directly reducing excess white fat while increasing the metabolically beneficial brown fat. ADPO-002 would be the only treatment to increase energy expenditure, improve insulin resistance, and offer healthier fat storage.

Business Model: Adipo is currently in late preclinical, with plans to develop ADPO002-NP through clinical proof, followed by exiting through partnering, licensing or acquisition prior to Phase 3 pivotal trials and commercialization. Adipo anticipates an exit window to open after completion of Phase I through completion of Phase II. Leading global diabetes companies, Eli Lilly, Novo Nordisk, and Boehringer Ingelheim, have demonstrated interest in continued investment in diabetes including through acquisition. A recent Lilly metabolic drug development collaboration with Evotec SE with a focus on kidney diseases and diabetes was reported to have a potential value up to $1 billion. Opportunities to extend the platform includes treatments for obesity, NASH, and CV, as well as aesthetic treatments for submental fat.

Funding: Adipo has raised $2.4 mil in seed funding to achieve pre-clincial proof of concept, validation of the lead product and a meeting with the FDA for comment on the development plan. Currently seeking $25 mil in Series A to achieve first human dose.

Revolutionizing Pancreatic Cancer Detection

Company Summary: Amplified Sciences is a clinical stage life science diagnostics company focused on accurately detecting and pre-empting the risks of debilitating diseases, including lethal cancers and organ loss with R&D operations in Purdue Research Park and key alliances in San Francisco and Boston. The company is developing a portfolio of fully-integrated diagnostic assays for early detection of disease. An ultra- sensitive molecular sensing technology licensed from Purdue Research Foundation operates with novel test-strips that combine with portable instrumentation and chemometric tools to form a highly versatile clinical assay platform that can scale to point of care. The lead assay in development targets early detection of undiagnosed pancreatic cancers.

Problem: Incidental detection of pancreatic cysts is significantly rising. Pancreatic cysts are incidentally detected in 13%-45% of cases undergoing abdominal imaging for other reasons. The clinical management of these cases is a major challenge for clinicians as there is no reliable risk stratification for malignancy of pancreatic cysts and the surgery to resect cysts is associated with 40% morbidity. Mucinous cyst neoplasms harboring high-grade dysplasia or invasive cancer represent precursor lesions to pancreatic cancer and should be surgically resected. However, retrospective analyses indicate a significant portion of mucinous cysts, serous cystadenomas, and pseudocysts are low grade or benign. Preoperative classification of these cyst types is challenging resulting in unwarranted surgeries, significant cost burdens, and high morbidity.

Solution: This problem is being addressed by the Amplified Sciences’ ultrasensitive detection of biomarker activities in minute volumes of fluid obtained from these cysts. These biomarkers have been clinically validated using non-portable and difficult to commercialize methodologies. Our initial “rule-out” Laboratory Diagnostic Test (LDT) is more sensitive than standard of care (clinical data presented at ASCO June 2022 Annual Meeting), effectively stratifies patients into low risk vs. potential malignancy, and will provide significant cost savings to payers by reducing unneeded surgeries hence avoiding co-morbidities associated with invasive surgery and/or loss of organ function. This enables healthcare providers to define low risk and/or benign pancreatic cysts resulting in significant cost savings and patient peace of mind.

Market: Pancreatic cysts detected in 3M patients each year but the relative risks of those being benign vs. potentially malignant are not accurately diagnosed leading to potential missed malignancies (high false negatives), overtreatment (high false positives), and significant cost burdens. The total pancreatic cancer diagnostic market is over $2.2B. The customers include Gastroenterologists and pancreatic surgeons (decision maker), hospitals/clinics (influencer), and payer (buyer).

Competition: The primary competitors are a molecular diagnostic assay, CEA with low accuracy demonstrating both low sensitivity and low specificity; and PancraGEN® / PanDNA® offered by Interpace Diagnostics Group. Interpace’s DNA based tests have limitations including larger sample volume required, false negative rates particularly in high grade dysplasia, and long lab processing times. The Amplified Sciences’ PanCystProTM is a superior solution that rules out disease (crucial for early disease management decision making), requires a small amount of cyst fluid, overcomes the competitor’s performance features and can follow an established $4,000/test reimbursement rate.

Business Model: In 2022, the test will be offered to researchers for Investigational Use Only (IUO/RUO) to build awareness with thought leaders. In 2023, the lead assay, PancystPro will be launched as a Laboratory Diagnostic Test (LDT) in our CLIA laboratory. The sample access and core platform will provide revenue for follow on development of a 510K approved product. PanCystProTM will initially target Gastroenterologists who perform EUS-FNA procedure to collect the pancyst fluid sample. The proprietary technology is a platform play; therefore, enabling quick scale to multiple assays serving the gastro suite and then expanding to other cancers, cardiovascular markers, and kidney diseases.

Strategy and Progress to Date: Company has raised total of $2M of funding, clinical testing data were presented at ASCO 2022 and published in a peer reviewed journal, and $235k of RUO revenue secured. The lead assay is optimized and technically validated, global IP issued, and thought leader clinicians have been secured at UCSF, UPMC, and IU Simon Cancer Center. Current Seed round (closed in early 2021) will enable technical validation and clinical testing of the PanCystPro product and position the company for entry into a commercializable LDT. Closure of a capital raise (led by OCA Ventures) in late 2022 will enable regulatory CLIA approval and launch in 2023, and the scale of a suite of LDT and 510k assays.

Business and Development Team; Founders V. Jo Davisson, PhD (CSO), Diana Caldwell, MBA (CEO) and lab scientist staff led by Daniel A. Sheik, PhD work with a seasoned team of advisors including Linda O’Keefe (CFO), Charles Craik, PhD, Kim Kirkwood, MD, Mohammad Al-Haddad, MD, Andy Cothrel (Board member, former Roche Diagnostics; serial life science entrepreneur), Patti Connolly (CLIA operations/MiraVista/Renalytic AI, Verici Dx), John Ridge (reimbursement/Roche/Exact Sciences/Lucid Diagnostics), Vince Wong (CCO Geneoscopy) and Tom Tague, PhD (Bruker). A series of consultants with commercial in vitro diagnostic experience have also been recruited to the team to develop operations for product launch.

Contact: Diana Caldwell, President and CEO diana.caldwell@amplifiedsci.com

COMPANY OVERVIEW

Confluence is a neuroscience company developing therapies for Fragile X Syndrome (FXS) and Autism Spectrum Disorder (ASD). The FXS therapy is Phase II ready and has received Orphan Drug Designation in both the USA and Europe ensuring a faster route to market and greater exclusivity protections.

PROBLEM/OPPORTUNITY

FXS and ASD are neurodevelopmental disorders with core symptoms that impact patient’s ability to communicate and socially interact for which there are no approved therapies. The annual cost of patient care is between $40,000-$80,000, with lifetime costs exceeding $3.2 million. Additionally, ASD & FXS patients have challenges swallowing, an issue which impacts 40-70% of patients. To be successful, a product needs to be both efficacious in treating the core symptoms and also must be in a form that is easy for patients to take and for caregivers to administer

PRODUCT/SOLUTION

Attractive Investment with Strong Upside Potential and Mitigated Risk

• Large unmet medical need in a well-defined and highly motivated multi-Billion target market

• Lead product is Phase II ready

• 70% treatment success rate in treating core symptoms of ASD and FXS

• Shorten and cost-effective regulatory path

• Strong commercial position with US & EU Orphan Drug Designation (FXS) market exclusivity

• Defensible IP position with 6 patents covering compounds for treating disorders, biomarkers and formulation technology

Acamprosate has demonstrated core symptom efficacy in multiple open-label studies with more than 200 FXS and ASD patient exposures. Its wider use in pilot studies has been severely impacted as the available formulation cannot easily be administered to FXS & ASD patients due to the tablet size. Crushing tablets ruptures the protective coating and leads to significant gastrointestinal problems. To address this challenge, Confluence developed a patent protected Acamprosate sprinkle formulation that delivers Acamprosate in safe and effective manner. This formulation has successfully completed Phase I and is now Phase II ready.

MARKET POTENTIAL/COMPETITION

The total addressable market ranges between $4.8-$5.2B for FXS, and $11.0-$13.0B for ASD. The Company believes its product potential for the US and EU for FXS is estimated between $0.9-$1.3B, and $2.2-$2.3B for ASD. While a small number of companies are developing therapies targeting FXS and ASD, Confluence is unique in pursuing an approach that targets the rebalancing of two receptor systems that modulate core symptoms.

MANAGEMENT TEAM AND PRINCIPLES

The company was founded by Mr. Steve Johns and Mr. Boyd Sturdevant Jr. with backgrounds in Banking, Financial Services and Mental Health Services. Supporting the founders is a team of clinical & industry veterans, Dr. Craig Erickson (IU, CCH), Dr. Rosenzweig-Lipson (PFE, Wyeth), Dr. Payie (LLY) and Mr. Parshall (LLY, GDT, BSC)

FINANCIALS

Confluence Pharmaceuticals is a Limited Liability Company having raised $8 million through convertible notes, Series A-1/A-2 preferred units and non-dilutive milestone payments. Institutional Investors include 21 Fund/Elevate Venture Partners, IU Philanthropy Venture Fund and Foundry Investment Fund.

CAPITAL NEEDS

Confluence is planning a $15 million Series B offering in order to fund Phase II clinical trials. A post-Phase II increase in valuation would position Confluence’s Fragile X asset for an attractive exit. The Company has recently raised $1,095,000 in convertible notes to fund Phase II protocol development, conduct a second pre-IND meeting, complete the last phase of a juvenile rat toxicology study and extend its working capital runway.

Contact information: Mr. Steven L. Johns, (317) 379-7498, steve@confluencepharma.com

Ensuring Availability of Essential Medications

Company Overview:

Continuity Pharma LLC (Continuity) formed in 2018 to produce critical medicines in the U.S. using our proprietary advanced manufacturing systems. Continuity’s innovative technology produces high-quality active pharmaceutical ingredients (API) with a significantly lower E-factor than traditional batch manufacturing methods.

Market & Commercialization Strategy:

Over 80% of the top 100 generic medicines sold in the US are foreign sourced, posing an unacceptable risk to our country when the supply chain is disrupted. Continuity’s innovative Modular Flow Systems produce API for targeted medications that are (1) critical to the US population, (2) not made in the US, and (3) for which there is a committed customer. We partner with US companies that are highly experienced in taking the API to final drug product and distribution. Continuity creates value for its customers by providing high-quality medications, made in the US, at a very competitive price. Our first customer is the Glioblastoma Foundation, which is committed to securing Lomustine for cancer patients.

Technical & Competitive Advantage:

Continuity’s proprietary assessment tool is used to evaluates commercial viability of a prospective API target We then evaluate technical feasibility and upscale the most promising routes within 9 months. Continuity’s Systems are portable, safe, efficient, and capable of being deployed within cGMP locations to produce at commercial scale high yield API with minimal toxic waste. These systems are designed to replace batch API production methods with reduced CAPEX and OPEX, while also enhancing worker and environmental safety.

Regulatory Strategy & Intellectual Property:

Continuity is a member of the FDA Emerging Technology Program who reviews and provides input on our technology. A recent study undertaken by the FDA demonstrates that regulatory approval for products using continuous manufacturing occurs faster than products using batch systems, and requires fewer supplements and revisions, thus accelerating market entry by at least 12-months. Continuity has licensed IP from Purdue University and has applied for protection of its own IP.

Key Milestones:

2022: Completed Modular Flow Systems for 4 API

2023: Complete Modular Flow Systems for 2 additional API.

2024: Modular Flow Systems for 4 additional API.

Capitalization History:

The co-founders, Nancy Hathaway and David Thompson, own 100% of Continuity The company has received $1.25M in non-dilutive funding, including a DARPA DP2 SBIR, between 2020 - 2022.

Use of Proceeds:

$10M is sought to hire additional scientific personnel and purchase equipment to build a Modular Flow System for a two additional API.

Key Team Members:

Dr. David Thompson is an experienced entrepreneur and academic leader in the field of continuous manufacturing for pharmaceutical ingredients. Nancy Hathaway has outstanding project management and administrative skills from her background as an entrepreneur and a human subjects protection officer. The founders have brought in a team of experts to help commercialize the technology.

GeniPhys is an early-stage regenerative medicine company focused on commercializing its patented Collymer™ technology. Materials fabricated from this novel collagen polymer promote tissue integration and new tissue formation while avoiding inflammation, fibrosis, and scarring. Collymer’s versatility supports the fabrication of regenerative tissue replacements, delivery of pharmaceutical and cell-based therapies, and improvement of device-tissue interfaces.

INITIAL RAISE:

$6 MM

Round will support initial regulatory submissions (510(k) and IDE), team expansion, manufacturing readiness, and initial commercial launch First close ($4.35 MM) complete.

TEAM

Andrew Eibling

President & CEO

Experienced Pharma, MedTech and CRO executive with business development and alliance roles at Lilly, Covance, and Enable Injections

Sherry Harbin, PhD

Founder & CSO

Purdue professor and innovator with 30 years of experience developing regenerative medicine technologies

R.Matthew Neff

Chairman of the Board

Lawyer, entrepreneur, and founder of the Indiana University Health venture capital fund

TJ Puls, PhD

Mfg & Product Development

PhD from Purdue; intimate working knowledge of Collymer technology

Find out more: info@geniphys.com www.geniphys.com

Executive Summary

Problem: Complex tissue defects and non-healing wounds, whether due to congenital birth defects, traumatic injuries, skin ulcers, or tumor removal, represent a global healthcare challenge and a major source of physician and patient dissatisfaction. While various treatment options exist, poor outcomes remain, such as long healing times, high infection rates, scarring, repeat procedures, and high healthcare costs. Therefore, a grand medical challenge is the development of innovative regenerative medicine solutions aimed at restoring tissue appearance, structure, and function.

Solution: GeniPhys’ collagen polymer platform, known as Collymer™ , is positioned to have disruptive impact on tissue regeneration and personalized medicine arenas for multiple reasons:

• Patented polymerizable collagen protein that self-assembles to form a physically stable fibrillar scaffold;

• Collymer materials harness bio-signaling features of collagen found naturally within tissues. Numerous preclinical studies show Collymer materials are long-lasting and support regenerative healing without eliciting inflammation or foreign body reaction (e.g., breast, dermis, larynx, β-cell replacement for type 1 diabetes, skeletal muscle, cartilage);

• Flagship product, Collymer Self-Assembling Scaffold (Collymer SAS™) transitions from liquid to stable fibrillar scaffold in-situ, allowing it to conform to complex tissue voids; and

• Highly customizable material formats support multiple applications, including a variety of regenerative tissue replacements, pharmaceutical and cell delivery, and device/sensor coatings;

Intellectual Property: GeniPhys licenses certain technologies from Purdue Research Foundation and has generated additional IP, resulting in a robust and extensive portfolio.

Market: The global tissue engineering and regeneration therapeutics market is estimated at $38.4B with a CAGR of 33% (2018-2023)*. Collymer has the potential to impact multiple segments of this market. Customer research revealed the primary market target of breast conserving surgery (lumpectomy) in breast cancer patients, which currently has no approved regenerative solutions. Globally, over 1 million of these procedures are conducted annually. Expected market capture would result in peak sales over $1 billion for this indication alone. Significant additional revenue growth will be driven by expanding Collymer SAS indications, development of follow-on products, as well as strategic partnerships.

Business Model: GeniPhys will be the global manufacturer and supplier of polymerizable collagen formulations and custom-fabricated Collymer materials. In addition to the pursuit of multiple 510(k) clearance opportunities, GeniPhys will pursue premarket approval of Collymer SAS for restoration of traumatically-injured tissues and breast restoration immediately following tumor resection (lumpectomy). This sequential strategy has been informed by FDA discussions as well as extensive customer discovery. Other product indications, such as bone filler, soft tissue filler (aesthetic), vocal fold medialization, and therapeutic cell or drug delivery support significant market expansion. We intend to leverage strategic alliances and licensing partnerships to enable the pursuit of novel applications of Collymer technology, such as regenerative vascular grafts, heart valve replacement, or cartilage.

Foglesong

Company Overview:

Grannus Therapeutics is a pre-clinical platform company focused on developing and commercializing small molecule inhibitors that selectively target individual isoforms of the Hsp90 family of chaperone proteins. By selectively targeting individual isoforms, Grannus has overcome the safety limitations of previous non-isoform selective (pan) inhibitors while still delivering strong efficacy results that meet current unmet medical need. Grannus’s lead program is a first-in-class Hsp90�-selective inhibitor for the treatment of advanced triple negative breast (TNBC), prostate cancer, and bladder cancer. The Grannus Team has decades of experience developing and commercializing therapeutics in academia and at leading pharmaceutical and biotechnology companies of various sizes. The company has received ~$700K in Federal and State grants and closed a $1M seed round with private investors in February 2022

Market and Commercialization Strategy:

Bladder and TNBC are both large and growing markets with significant unmet medical need, especially in late line therapy. Although new product launches are anticipated in both indications, forecasts indicate that chemotherapy will maintain a significant market share in late line therapy over the next ten years (~65% TNBC and ~40% BC). This creates an opportunity to position Hsp90�-selective inhibitors as an attractive option vs chemotherapy alone There is also potential to expand via other indications, earlier lines of therapy, and/or combination with immunotherapies. Grannus plans to progress the program through Ph 1 clinical trials, and then enter a codevelopment deal, license the program, or be acquired by a large pharma/biotech to support approval and commercialization.

Technical & Competitive Advantage:

Hsp90 inhibition is a well-known therapeutic approach, with more than 17 Hsp90-targeted drugs investigated in clinical trials, all of which target multiple isoforms with similar affinity (pan-Hsp90 inhibitors). Unfortunately, most have failed in clinical trials due to ocular / cardiac toxicities and dosing / efficacy limitations Research, pioneered by Grannus co-founders, indicates that the toxicity and dosing / efficacy limitations of previous pan-inhibitors are NOT related to the inhibition of Hsp90�. By selectively inhibiting Hsp90�, Grannus can deliver strong efficacy results without the toxicity and dosing / efficacy limitations of previous pan inhibitors

Regulatory Strategy & Intellectual Property:

The regulatory pathway for small molecule inhibitors in oncology is well established and defined. Based on feedback during PreIND meetings, Grannus will explore the potential for regulatory designations such as orphan and breakthrough status as well as potential accelerated approval pathways. Initial assessments performed by the NIH TABA Assessment Program confirm that Grannus has freedom to operate based on a worldwide exclusive license from the University of Notre Dame for a Composition of Matter Patent for Hsp90�-selective inhibitors.

Key Milestones:

Use of Proceeds:

Grannus is seeking additional funds to support continued pre-clinical development efforts including IND-enabling and regulatory activities, and estimate needing ~$5M-$7M in order to reach our next value inflection point of IND filing

Key Team Members:

John Foglesong, MBA (Co-Founder, President & CEO) is responsible for day-to-day operations He is a 20-year industry veteran with deep oncology expertise from his time at Genentech and Atara, where he focused on late-stage development and commercialization of multiple oncology and other biotechnology products.

Dr. Sanket Mishra MS, PhD. (Co-Founder) leads Grannus scientific activities in collaboration with our Scientific Advisory Board and expert consultants. He is an expert in Hsp90 isoform-selective inhibitors and a co-inventor of the Grannus technologies.

RADYUS Research is Grannus’s R&D operating partner supplementing our team and supporting R&D operations. RADYUS’s team of 4 expert consultants brings over 75 years of combined work experience providing scientific expertise, strategic guidance, and operational implantation through their network of CROs.

Overview

Kovina Therapeutics is an early-stage drug discovery company focused on stopping HPV premalignant infections before cancer develops and treating HPV cancers after detection. The company’s proprietary science includes novel small molecule compounds which bind to and inactivate a key HPV protein always expressed in early, premalignant, and cancerous pathologies With $5.1 million in financing, the company assembled a team of experts in HPV and drug development to advance both programs.

Significant market opportunity in HPV related premalignant infections and cancers

Kovina’s target US market is ~$4 billion annually across multiple indications with even larger OUS opportunities Globally, HPV causes ~5% of all cancers and nearly 630,000 HPV-related cancers occur each year. In addition, 300,000 US women are diagnosed with premalignant cervical infections annually. While the existing HPV vaccine is effective, it has not been widely adopted and has no impact on existing HPV infections or malignancies which develop over years or decades. Competitive therapeutics in development include immunogens and non-specific antivirals that have not been highly effective in clinical trials. Kovina’s compounds are the only specific antiviral compounds that induce death of HPV infected cells.

Kovina

uniquely positioned to reduce side effects and improve outcomes

HPV premalignant infections are treated with invasive procedures including lasers, electrocautery, or cryotherapy that may result in serious side effects Kovina’s first-in-class therapeutic replaces existing surgical interventions. Treatments for HPV induced malignancies include surgery, radiation, and chemotherapy with challenging side effects. Kovina’s compounds are designed to specifically kill HPV infected cells and mitigate side effects from intense chemo/radiation and surgical regimens.

IP secured through licensing – Pre-IND meeting planned

Kovina’s intellectual property is protected by a non-provisional patent filing which the company licensed from Indiana University. Kovina will request a pre-IND meeting in late 2023 to seek regulatory guidance for its first-in-class premalignant infection program While oncology small molecule regulatory pathways are well defined, the company intends to explore accelerated approval for HPV head and neck cancers.

$20 million Series A or partner required to fund full IND/Phase I

Over $5 million of funding secured from Seed round and multiple NIH grants

Experienced leadership team and proven model

Kristin Sherman, MBA (CEO) leads the organization with 30 years of experience in drug and device development including large pharma (Eli Lilly), medical devices, and four biotech start-up companies, two with successful exits to Roche and Novo Nordisk. Dr. Elliot Androphy (CSO and co-founder) is a practicing dermatologist, HPV key opinion leader, and researcher at Indiana University Dr. Androphy’s labs have received continuous NIH and other grant funding for 35 years to conduct HPV research. Development model and team – Kovina assembled seasoned drug development experts to advance its programs using CRO partners. The company anticipates partnering for Phase III trials or pursuing an exit after completing Phase II clinical trials.

Contact

• Katie Pawelczak, Ph.D. kspawelczak@nerxbiosciences.com

Financial Information

• Company Stage: Preclinical

• Non dilutive funding: $1,200,000 (SBIR grants-NCI)

• Previous Capital: $1,600,000

• Monthly Net Burn: $18,000

• Incorporated 2009

Management

• President, CSO & co-founder: John Turchi, Ph.D. 25 years in cancer research and the study of DNA repair and drug development

• COO: Katherine Pawelczak, Ph.D. 10+ years in scientific research and business development in academia and industry.

• Board of Directors, Chair: Trent Carrier, Ph.D.: 20 years experience in commercial dev within pharmaceutical industry.

• Business Development Consultants: Henry McCarthy and Than Powell, The Art of Business

Advisors

• Medical Advisors: Lawrence Einhorn MD, Shadia Jalal MD.

• Scientific Advisors: Marc Wold, Ph.D., Richard Wood, Ph.D., Susan Mahony

• Web: Tony Avellana

• Legal: Tim Capen, Ice Miller, LLP

Use of Funds:

NERx goal is to out-license the exclusive global rights of NERx’s lead program of RPA inhibitors NERx329. Resources from licensing will enable the continuous development of the NERx pipeline. In addition, NERx is seeking $10M Series A to use in advancing the pipeline, including lead candidate selection of the Ku targeted asset

5121 Central Ave Suite 120 Indianapolis IN 46220 937-554-4954 www.nerxbiosciences.com

Summary

NĒRx Biosciences is a pre-clinical stage biotechnology company focused on the discovery and development of biopharmaceutical compounds targeting the DNA Damage Response (DDR) pathway. The company’s primary goal is to develop a new generation of anticancer therapeutics that are directed against novel protein targets for the treatment of lung and ovarian cancer.

Problem

Despite recent advances in targeted therapeutics, immune-oncology, and personalized medicine, the clinical reality of many common and aggressive cancers remains bleak. Lung cancer continues to be the number one cancer killer of men and women Ovarian cancer continues to account for more deaths than any other cancer of the female reproductive system. Limited single agent activity and resistance remain major obstacles with molecularly targeted drugs and the low response rate for immune-oncology agents limits their widespread use in lung and ovarian cancer and there are limited therapeutic options for these patients.

Solution/Technology

NERx Biosciences has developed a novel, first in class innovative cancer therapeutic agent that targets the validated DNA damage response pathway. The most successful DDR targeted therapy targets a DNA damage sensor, PARP. NERx capitalizes on this breakthrough to target the other crucial DNA damage sensors in the DDR pathway, for therapeutic intervention in the treatment of cancer. This differentiated strategy avoids redundancy and positions us to be more effective therapeutically. Our lead program is a novel target in the DNA damage response pathway, Replication Protein A (RPA). We are positioned to lead first in class and first in human trials targeting RPA for cancer therapy. The lead asset, NERx-329, demonstrates a robust mechanism of action as a competitive inhibitor of DNA binding as well as showing excellent solubility and stability. We have also found robust single agent anti-cancer activity, as exhibited in multiple animal models, and in vivo efficacy in combination with other DDR targeted therapeutics. Right behind RPA, we have a robust discovery pipeline of first-in-class DDR programs, the most advanced being a class of small molecule inhibitors that impair NHEJ through a completely novel mechanism of inhibiting DNA-PK, by inhibition of the DNA damage sensor Ku NERx has an exclusive license to develop these agents and therapeutics protected by multiple US and international patents with additional patents pending.

Target Market

The market for our therapeutic drug is expansive, as our compound is uniquely targeted to impact patients with solid tumors who will benefit from a molecularly targeted drug with robust single agent activity as well as patients who receive DNA damage inducing agents or DDR targeted molecular therapeutics as part of their treatment regimen. For regulatory purposes, we are focusing our initial clinical efforts on lung and/or ovarian cancer, but also plan to expand indications into other solid tumors. Importantly, NERx has additional data supporting increased potency in a unique patient population, setting NERx-329 apart from the multiple DDR targeted therapeutics currently under development.

Competitors/Competitive Advantage

We have developed the only DNA repair targeted agents that possess robust single agent activity and are specifically designed to work with both traditional therapeutics and a series of novel targeted therapies. Additionally, there are no current therapies that are designed to target the DNA-protein interaction that is critical to the DNA damage sensors activitiy NERx developed agents are novel and directed against previously untargeted proteins and pathways.

Revenue Model

Revenue streams include: non-dilutive grants from the National Institutes of Health, licensing fees, angel investors and venture capital investment.

Funding

Initial shareholder loans ($60,000), NCI STTR/SBIR awards (4 totaling $1,200,000) and Angel investment ($1,600,000) have driven NERx Research and Business activities to date

Exit Strategy

The company is built as an out-licensing model or acquisition target. NERx is seeking a strong partner with proven success in the Oncology space with pre-clinical and clinical capacity to accelerate NERx 329 through IND to the clinic for first-in-human studies.

Scioto Biosciences: Microbiome delivery platform for Activated

Bacterial Therapeutics (Phase 1b Complete)

Executive Summary:

Scioto Biosciences is a clinical stage biotech company dedicated to innovative research and discovery, and development in the field of microbiome therapeutics. The Company’s solution is focused on the activation of beneficial bacteria that have the potential to advance treatment for various diseases including those associated with the central nervous system and gastrointestinal tract. The Company’s platform primes therapeutic bacteria via a symbiotic activated formulation for optimized function. Scioto’s lead asset, SB-121, is an activated formulation of Lactobacillus reuteri demonstrating significantly increased efficacy in severe gut injury models. SB-121 also stimulates neuroendocrine signaling, at least in part, by increased oxytocin levels. The company recently completed a double-blind, placebo-controlled Phase 1b Clinical Trial with 28-day dosing with SB-121 in patients with Autistic Disorder. The study demonstrated that SB-121 was safe and well-tolerated. The study also demonstrated treatment-related improvements measured by the Vineland-3 Adaptive Behavior Composite Score and individual domains. The Vineland-3 data were further supported by improvements in objective eye-tracking measurements monitoring social viewing preferences.

Key Company Highlights:

 Founded in May 2017, IP licensed from Nationwide Children’s Hospital

 Experienced leadership and advisors (Lilly, Assembly Bio, Naurex, Nationwide, Genome)

 Platform strategy to develop next-generation microbiome therapeutics

 Successful Phase 1b study completed (Q1 2022) in patients with Autistic Disorder

 Additional indications in pipeline (C-Difficile colitis, feeding intolerance/necrotizing enterocolitis)

 Raised >$16M in equity financing and ~$3M in Grants from the National Institutes of Health

 Key strategic investor partnership with Genome and Co (S. Korea KOSDAQ KS: 314130)

 Seeking Series C investment of $45M to support Phase II study in Autism and further develop the ABT Platform

Autistic Disorder

In 2021, the CDC reported that 1 in 44 children were diagnosed with Autism. Many adults and their caregivers continue to deal with the disorder. All drugs approved or prescribed off-label have undesirable side effects that significantly discourage their use. The efficacy and safety profile of SB-121 will make it a ‘first option’ to patients and their caregivers when faced with the challenge of treating the disorder creating the first blockbuster opportunity in the space.

Opportunity

Scioto’s lead program (SB-121) uses a proprietary formulation of a select strain of L. reuteri, well-studied for its role in GI tract bacterial pioneering, inhibiting pathogenic bacteria, suppressing inflammation, and strengthening the GI barrier. Recent work has demonstrated L. reuteri’s ability to improve social behaviors via the gut-brain axis. In a critical Phase 1b study at Cincinnati Children’s Hospital, SB-121 demonstrated treatment-associated improvements in adaptive behaviors determined by validated measures in patients aged 15-45 diagnosed with Autistic Disorder. The Phase II trial in patients with Autistic Disorder will begin in the second half of 2023.

Contact:

Joe Trebley, CEO: joe@sciotobiosciences.com

Jim Schulz, CFO: jim@sciotobiosciences.com

9800 Crosspoint Blvd Suite 200, Fishers, IN 46256

Device: FDA 510-K Cleared (K201876) – AAMI / PB70- Removable and Launderable Level 3 Bed Barrier.

Supporting Published Research: Reduction of hospital onset C.diff by 35-50% through use of barrier.

Contact: Bruce Rippe brippe@trinityguardion.com 513-519-8241

Company Overview: Trinity Guardion is a medical device manufacturer providing the only, AAMI, PB 70, level 3, launderable/reuseable bed barrier. Soteria protects the mattress and bed deck from patient fluids while allowing full functionality of the bed/mattress without impeding its’ clinical features. The reusable bed barrier is applied to the bed/mattress and is laundered between patients. Soteria was recently FDA cleared in a new product code (QTV) providing an engineered alternative to manual disinfection processes. Three peer reviewed studies document a 35- 50% reduction in hospital acquired C.diff through the use of the Soteria barrier. There are 17 different models of barriers for most all beds and mattresses on the market. The Company’s 2022 revenue was $700k, expected to grow to $16.0MM by 2026 and it has raised nearly $4.8MM to date. Trinity’s team has decades of experience in hospital patient surface design/engineering, manufacturing processes, as well as cleaning/disinfection/laundry processes.

Market and Commercialization Strategy: The hospital environment has been identified as a key contributor to hospital acquired infections, making it a focus for all stakeholders. Due to the increasing number of drug resistant organisms, disinfection products have seen significant growth in recent years and is seen as a $13 billion-dollar market. Disinfection of soft/porous patient surfaces is a large untapped market as there are no soft/porous surface disinfectants. Trinity plans to expand domestic manufacturing capacity and to develop a sales force. Included in our strategy is the development of relationships with key laundry and environmental service providers.

Technical and competitive Advantage: Soteria’s laundry method is highly effective in removing residual protein and hemoglobin as well as 99.9999% of pathogens including spores that contributes to hospital acquired infections and is 6x more effective than currently used cleaning /disinfection processes on mattresses. Soteria saves labor compared to current processes that also causes damages to the mattress and bed frame.

Regulatory Strategy and Intellectual Property: Soteria has been 510-K cleared by the FDA as a level 3 barrier. Trinity will explore expansion of claims around infection prevention. Three utility patents have been issued; the last in 2022.

Key

Use of Proceeds: Trinity is seeking additional funds to support expansion of manufacturing, sales and marketing efforts and expansion of regulatory claims and estimate needing an additional $5MM to reach next value inflection point.

Key Team Members

Bruce Rippe (Co-founder and CEO) responsible for commercialization and regulatory efforts. He is a 10-year veteran with deep product development experience in patient furnishings

John Miller (Director of Operations) responsible for day-to-day operations. John is a 20 + year veteran in patient surface design/engineering with Hillrom and Virtus (acquired by Hillrom in 2015)

Company Overview:

Incorporated in 2021 and headquartered in South Bend, Indiana, Vital View is an early-detection technology platform company with an initial application in Congestive Heart Failure (CHF) long-term condition management. The platform utilizes a proprietary RF technology solution that fits seamlessly in the home-care setting. This technology enables a new contactless modality allowing a sensor to be installed underneath a patient’s mattress, allowing clinical grade data to be captured while the patient sleeps. This enables early interventions designed to improve patient outcomes and reduce the risk of hospital readmission.

Market & Commercialization Strategy:

Approximately 6.9 million Americans are suffering from heart failure in 2020, growing to 8.5 million by 2030, additionally, the heart failure readmission rate in the US is a staggering 20% within 1 month and reaches 50% within 6 months. There is an unmet need for improving patient adherence and better treatment solutions thus Vital View’s early detection platform is an at-home remote monitor which provides direct fluid change measurements, heart rate, and respiratory rate to clinicians Within healthcare Vital View has a potential market of USD $1.25 billion, successful commercial execution in its applications for heart failure, chronic kidney disease (CKD), chronic liver disease (CLD) and fluid monitoring in ICU units of hospitals and ambulatory surgery centers (ASCs). Specifically, the initial CHF application has a TAM of USD $42.1 billion in the US. Targeting Accountable Care Organizations (ACOs) that represent a SOM of USD $1.2 billion for Vital View.

Technical & Competitive Advantage:

Today’s solutions used to avoid hospital readmittance are often imprecise, inconsistent, or invasive. Devices, such as weight scales, and wearables, suffer from inconsistency, surrogate data, discomfort, and patient adherence issues. Another category of existing solutions, such as pulmonary arterial implants are invasive, as they require surgery and are among the most expensive solutions. Vital View’s solution is contactless, provides a direct measurement of fluid volume changes, utilizes wireless monitoring with vital signs capabilities and the potential for respiratory monitoring.

Regulatory Strategy & Intellectual Property:

Vital View’s proprietary polarimetric mode dispersion (PMD) technology is protected by significant IP, making it extremely difficult for competitors to develop a solution that enables contactless measurements of fluid balance. Vital View currently has an exclusive, worldwide license to 7+ Issued

Utility Patents (+ CIP) and 4+ Patents Pending. Vital View has completed a pre-submission meeting with the FDA in June 2022 and anticipates another pre-submission meeting furthering the relationship with the FDA and confirming testing strategy. Vital View will then submit a 510(k) application in Q1 2024 with an intended use for fluid management in a variety of medically accepted clinical applications.

Key Milestones:

Use of Proceeds:

Vital View is raising a $5M seed extension round to complete its next gen prototype (Valencia), begin its pilot customer program, and conduct a pivotal clinical study, which upon successful completion, will be followed by 510(k) submission to the FDA.

Key Team Members:

Raymond Fraser, MBA | Co-Founder & Chief Executive Officer

Focused on setting and executing the vision for Vital View Technologies, along with fundraising, allocating capital, and building and overseeing the executive team. Mr. Fraser is leveraging his 10+ years in the startup ecosystem as a serial entrepreneur which includes co-founding 3 startups (1 exit), and early employee at 2 startups.

Chris Rauh | Co-Founder & Chief Technology Officer

Mr. Rauh comes from 35+ years of wireless technology experience and is leading VVT’s engineering and design strategy as well as overseeing the device development from prototype to design freeze and its integration with the EMRs of health system providers.

Casandra Adams, M.S.| Co-Founder & Chief Operating Officer

Ms. Adams has 10+ years of Development and Commercialization experience within all phases of the Pharma and MedTech industries and drives operation efforts of key partners, including product development, regulatory/compliance, clinical strategy, and internal coordination of investor relations.

Dr. Rick Snyder, MD, FACC | Co-Founder & Chief Medical Officer

Dr. Snyder leads the strategic direction and execution of the Company’s medical safety & effectiveness program. Dr. Snyder is board certified in cardiovascular disease, interventional cardiology, and advanced heart failure and transplant.