BIOFEST INVEST APPLICANT

RiverWalk Therapeutics, Inc.

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  • What is the problem that your company will solve?

    Currently, over $6 billion is spent for the medical care of late-stage triple negative breast cancer (TNBC) patients. Sadly, that investment does little to significantly improve their dismal 12% 5-year survival rate. These patients truly have an extreme need for more effective treatment options.

    10-15% of the 280k breast cancers diagnosed annually are TNBC, which has high recurrence rates and mortality, often affects younger patients (<40 years old), and disproportionately affects Black and Hispanic women. TNBC is aggressive, spreads quickly, and is more likely to recur within 5 years. Today, 45% of TNBC patients advance to Stage 4, even after treatment, and their 5-year survival rate drops from ~90% to 12%. Management of metastatic TNBC usually consists of successive rounds of treatment using different therapies until all options are exhausted. TNBC is negative for hormone receptors (HR) and HER2 overexpression making treatment with HR/HER2-targeted therapies ineffective. Small subsets of Stage IV patients with PD-L1 over-expression (~20%) or BRCA mutations (~20%) can take advantage of those targeted treatments. However, the available treatment options for most patients are limited and plagued with severe side-effects. Both chemotherapies and targeted treatments are associated with short-lived efficacy due to the development of drug-resistance. Currently, metastatic TNBC cannot be cured and the clinical goal is to shrink or slow TNBC tumor progression and ease symptoms with successive rounds of treatment until no options remain.

  • What is your solution and how does it solve the problem?

    RiverWalk is striving to provide a treatment for late-stage TNBC patients with extreme unmet needs. RiverWalk is developing a suite of potent, novel small molecule inhibitors of adenosine A2 receptor signaling that originated from the lab of Dr. Jean Jiang, our scientific founder. Dr. Jiang’s lab was one of the first to identify the role and mechanisms of action of adenosine, through A2 receptor signaling, in promoting TNBC disease progression. These two receptors modulate three distinct signaling pathways – one directly on the tumor to promote growth and metastasis and two in the immune system to suppress beneficial, anti-tumor responses. Additionally, overexpression of A2B in TNBC tumors has been correlated with poor patient outcomes. Inhibition of this signaling is a promising strategy to overcome the barriers of conventional TNBC therapies, including toxicity and drug resistance.

    Our drug candidate, RW-108, has been identified as an inverse agonist inhibitor – this is a first-in-class mechanism of action on these targets. This unique mechanism inhibits both the adenosine-induced signaling and the baseline signaling, resulting in more potent inhibition at lower concentrations than neutral antagonist inhibitors.

  • Describe any proof of concept or testing you have completed so far.

    Preclinical in vitro and in vivo studies have demonstrated RW-108’s potent effects in metastatic TNBC and satisfactory drug characteristics. RW-108 has been significantly de-risked with in vitro toxicity, safety, and drug metabolism/pharmacokinetic studies:

    • A2A/A2B Receptors – specific and potent inhibition
    • Heart, Liver and Kidneys – minimal toxicity risk
    • Brain – does not cross the blood-brain barrier
    • Therapeutic Exposure – persists in circulation and accumulates in the tumor
    • Off-Target Effects – low risk of unintended effects

    RW-108’s efficacy in metastatic TNBC has been demonstrated in multiple accepted TNBC mouse models, all using oral administration:

    • Primary tumor growth – reduced 70%
    • Metastatic bone tumors – reduced 98%
    • Circulating tumor cells in the blood – reduced 78%
    • Circulating tumor cells in the bone marrow – reduced 98%
    • Survival – increased >50%

  • Describe your market opportunity, i.e., size, competition.

    Drug sales for late-stage TNBC in 2022 were estimated at $1 billion USD (7 major markets), expected to grow at a CAGR of ~9%.

    The current standard of care for most recurrent/refractory TNBC patients is chemotherapy (anthracycline, taxane, carboplatin) with poor tolerability and development of chemo-resistance. Patients that are positive for PARP or BRCA biomarkers (~20% each) are given chemotherapy in combination with a PARP (olaparib, talazoparib) or checkpoint (pembrolizumab, avelumab) inhibitor. Both of these are plagued with drug resistance issues and high treatment costs. Sacituzumab govitecan is a recently approved second line treatment available for refractory patients and it has toxicity, chemo-resistance, and cost issues as well. RW-108’s unique and multifaceted MOA may overcome the barriers of conventional therapies, including toxicity and drug resistance. Because of its strong efficacy, RW-108 could be used as a monotherapy or may provide a superior synergy in combination with these treatments, rather than compete against them.

    No A2A or A2B receptor inhibitors are approved for the treatment of cancer. Only one other dual A2A/A2B inhibitor is in development (Arcus’ AB928), currently in Phase 2 trials as a combination therapy. A direct comparison of AB928’s published preclinical mouse data shows that RW-108 results in 3x the primary tumor reduction using 5% of the dosing. Additionally, a head-to-head in vitro metastasis study showed that RW-108 inhibits tumor cell migration by >80% as compared to 50% for AB928. This striking difference is likely due in large part to RW-108’s unique inverse agonism mechanism of action.

  • Describe your sales strategy, including reimbursement plan, sales channel (distributors, direct), location.

    RiverWalk’s business model centers around developing our assets to major value inflection points that increase the product value and de-risk the technology to increase interest from a potential strategic partner/acquirer, likely a mid-sized pharma company. Inhibition of A2 receptors has gained more attention in recent years and many larger oncology companies are looking to add A2R inhibitors to their portfolios, particularly those with synergistic therapeutics.

    Distribution of our drug after approval will be impacted by the success of the insurance reimbursement strategy and the buy-in of breast oncology prescribers. RiverWalk is fostering support in the oncology community at every opportunity. The development of these molecules has been supported by the MD Anderson/Mays Cancer Center 2022 Drug Development Pilot grant and this continuing relationship will be important when competing for clinical trial and patient enrollment priority. Our advisor, Dr. Virginia Kaklamani, is a KOL in breast cancer oncology and will be critical to heighten awareness of RiverWalk’s development program. Also, technical publications, presentations, and collaborations are core tenets of our G2M strategy.

    No later than the completion of Phase 2 clinical trials, RiverWalk will require a partner(s) with deep expertise in large-scale manufacturing, regulatory, reimbursement, and marketing to complete the clinical trial process and transition the product to market successfully through their pre-existing channels. RiverWalk is open to all forms of collaboration/exit for the benefit of the development, including out-licensing of the technology, a strategic partnership, or M&A.

  • What is your regulatory strategy?
  • Describe your management team.

    The RiverWalk team brings a synergistic combination of expertise in cancer research and early drug development to facilitate the development of these molecules. Dr. Jiang and Ms. Webb have a joint history of successful drug development in two programs that both advanced to clinical trials.

    Johanna Webb, President & Acting CEO, is an experienced Drug Development Project Manager. Johanna is skilled in technical project management (30+ years), technology evaluation, pre-clinical development, rare pediatric/orphan diseases, and regulatory submissions. She holds an MS in Biotechnology from Bachelor of Science degrees in Biochemistry and Chemical Engineering. Before joining RiverWalk, she was the Associate Director of Drug Development Project Management for AlaMab Therapeutics, a clinical-stage start-up biotech company.

    Dr. Jean Jiang, Founder & CSO, is the Zachry Distinguished University Professor in Cancer Research at UTHSA with 25+ years in cancer research. Dr. Jiang co-founded AlaMab Therapeutics, where her contributions and Ms. Webb’s leadership advanced 2 antibody drugs into clinical trials. Her research has been continuously funded by grants from the NIH, DoD, and others. She is a Fellow of the American Association for Advancement of Science and National Academy of Inventors, and the recipient of the Cancer Therapeutic Research Center Discovery of the Year Award, Master Research Award for Distinguished Researcher, and Presidential Distinguished Senior Research Award.

    The RiverWalk Board of Directors currently consists of Dr. Jiang (chairperson), Ms. Webb, and Mr. Greg Erman (independent director). Mr. Erman is a serial biotech entrepreneur with a successful track record of fundraising and exits.

  • How much funding have you received since your company was founded and what types (grants, investors, friends/family, etc.)?

    RiverWalk’s technology has been supported from the following sources:

    Nondilutive funding:
    $1.1M

    Sources:
    DoD KCRP Idea Development Award – $1M/3 years (Dr. Jiang awardee, RiverWalk subawardee)
    MD Anderson/Mays Cancer Center Drug Development Pilot Award – $100k (Dr. Jiang awarded)
    AIM-HI Women’s Venture Competition 2022 First Place Winner with Distinction – $10k prize
    MassBioDrive Award – $5k

    Pending Funding:
    $2.15M

    Source:
    NIH NCI Direct to Phase 2 SBIR – $2M (non-dilutive)
    Cephalo Ventures – Committed $100k in seed round pending lead investor (dilutive)

  • Do you currently have an open round of funding? If yes, how much is the round, how much have you raised so far, and when will the round close?

    RiverWalk is raising a $5.5M seed round. The current seed round combined with the pending funding above would fund development efforts for the next 2 years through IND submittal, including the remaining efficacy studies (MTD, dose dependent efficacy, PDX model validation), remaining drug characterization studies (safety panels, metabolite assessments, continuing PK studies), formulation studies for animal administration, manufacturing process analysis and GLP production, and IND-enabling studies in rats and dogs, as well as corporate operational expenses. A follow-on series A round of approximately $20M will be required for completion of Phase 1 studies.

  • How many pitch competitions have you entered in the last 12 months, and how many have you won?

    RiverWalk was the First Place Winner with Distinction of the 2022 AIM-HI Women’s Venture Competition.

    RiverWalk Therapeutics also participated in the 2021 TNVC competition (Texas A&M), 2023 BioFest Invest (BioMedSA), and 2023 Bexar Bio Pitch (VelocityTX) and presented during the 2022 TMCinnovation’s Accelerator for Cancer Therapeutics and 2023 MassBioDrive demo days.

  • Check the box(es) for your IP situation (licensed or company-owned)
    Non-provisional patent pending, Issued patent
  • If patent applications, please list foundational patent application numbers and application dates

    Our technology is a suite of novel small molecule compounds that inhibit certain adenosine-mediated signaling pathways with high affinity, specificity and efficacy. Below are the composition of matter patents that have been submitted and their issue status. Additionally, RiverWalk Therapeutics has an option for the exclusive, worldwide license from University of Texas Board of Regents, the sole assignee.

    ISSUED PATENT(S):
    United States, Filed: 7/17/2017, Patent No. 10,214,529, Status: Issued 2/26/2019
    United States, Filed: 5/29/2023, Patent No. 11,680,067, Status: Issued 6/20/2023
    China, Filed: 9/17/2017, Patent No. CN107428753, Status: Issued 3/3/2020
    Canada, Filed: 8/17/2017, Patent No. CA2,977,044, Status: Issued: 6/27/2023

    PENDING PATENT APPLICATION(S):
    United States, Filed: 5/29/2023, Continuation of App. No. 17/206,393, Status: Pending
    Canada, Filed: 1/15/2016, App. No. 3,197,570, Status: Pending
    Europe, Filed: 7/18/2017, App. No. EP16737981.7, Status: Pending
    Hong Kong, Filed 4/20/2018, App. No. 18105200.5, Status: Pending
    Hong Kong, Filed: 1/16/2018, App. No. 18100597.7, Status: Pending

    PATENT FAMILY:
    https://patents.google.com/patent/WO2016115487A1/en?oq=WO2016115487

    We also have the rights a method of use utility patent:
    United States, Filed: 10/19/2018, Patent No. 11,400,096, Status: Issued 8/2/2022

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