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Oncolyze

Biotech company aiming to treat cancer by exploding cancer cells

  • $1,008,389Amount Reserved
  • $3.45492Share Price
  • $30,000,000Pre-Money valuation

By making a reservation, you are requesting a spot to invest in Oncolyze's upcoming offering. A reservation is non-binding and you may change the amount at any time.

Oncolyze is accepting reservations for an Offering under Tier II of Regulation A. No money or other consideration is being solicited, and if sent in response, it will not be accepted. No sales of securities will be made or commitment to purchase accepted until qualification of the offering statement by the Securities and Exchange Commission (the "Commission") and approval of any other required government or regulatory agency. A reservation is non-binding and involves no obligation or commitment of any kind. No offer to buy securities can be accepted and no part of the purchase price can be received without an Offering Statement that has been qualified by the Commission. A copy of the Preliminary Offering Circular that forms a part of the Offering Statement may be obtained both here and below.


Company Highlights

  • Lead drug candidate (OM-301) has generated positive results in treating Acute Myelogenous Leukemia (AML), the company’s first target demographic (the AML patient population has a significant unmet need, with a 5-year survival rate of only 25%)
  • Successfully completed in vitro and in vivo (mice) experiments, which support the notion that OM-301 breaks down cancer cells and significantly increases survival rates (from 93 days to 156.5 days); funding from this round goes towards Phase 1/2 of FDA trials
  • OM-301 has received Orphan Drug Designation from the FDA for the treatment of acute myeloid leukemia
  • IP includes three pending patent families covering selective lysis of cancer cells with OM-301, stable formulations of OM-301 and other peptides, and HDM2 antibodies for use in the treatment of cancer
  • Management team brings over 100 years of experience across healthcare and leading institutions such as Pfizer, Johnson & Johnson, and Medimmune; advisors include medical experts such as the Chief of Leukemia at Memorial Sloan Kettering, the Chief of Molecular Hematology at MD Anderson, and the Chief of Leukemia at City of Hope

Fundraise Highlights

  • Total Round Size: US $15,000,000
  • Raise Description:  Series A
  • Minimum Investment:  US $1,000 per investor
  • Security Type:  Preferred Equity
  • Pre-Money valuation :  US $30,000,000
  • Target Minimum Raise Amount:  US $3,000,000

Our mission is to provide cancer patients with a novel therapy that selectively attacks cancer cells and pokes holes in their cell membrane, causing these cancer cells to explode and die (called lysis and necrosis) while leaving normal cells intact.


The Problem

Cancer is the second leading cause of death globally, killing 10 million cancer patients yearly worldwide. The estimated total annual economic impact of cancer is more than $1 trillion in the US alone. There are many types of cancer, but one of the deadliest is acute myelogenous leukemia (AML). Patients with this blood cancer have only a 1 in 4 chance of living for 5 years after diagnosis. As a result, there remains a significant need for more efficacious treatments.

Our Solution

Oncolyze has designed a novel anti-cancer drug (OM-301) that targets a cell surface protein (HDM2) which is unique to cancer cells. OM-301 has two components. The first, a targeting segment, finds HDM2 residing on the external surface of nearly all cancer cells but not normal cells. Once OM-301 finds the HDM2 and anchors, the second segment pokes holes in the surface and kills the cancer cell almost instantly.

Because OM-301 acts on the outside of a cancer cell, we think that its efficacy will be independent of cancer genetics; that is, it will work in cancer patients regardless of mutation type. This is important because AML can be caused by a variety of mutations in a number of proteins in blood cells. Some recently approved drugs only work for a subset of patients, whereas we believe that OM-301 could help most if not all AML patients, especially those with hard-to-treat mutations.

AML is our immediate focus. We have preclinical in vivo evidence supporting the potential use of OM-301 in a number of other types of cancers, including Multiple Myeloma (another blood cancer) and solid tumors such as colon, pancreatic, and sarcoma. We know that our target exists on the cell surface of over 25 types of cancer. If approved by the FDA, as far as we are aware of, OM-301 will be the only therapeutic that treats cancer by targeting this cell-surface HDM2 protein. 

Pitch Deck

The Team

Founders and Officers

Steven J. Evans, MD

FOUNDER, DIRECTOR & CEO

Dr. Evans is an experienced entrepreneur with a 25 year career in the life sciences. Prior to founding Oncolyze, he was CEO of Althera, a company he led through critical restructuring, bridge financing, formation of a US subsidiary, and a successful exit via a stock swap.

Prior to Althera, he was co-founder & CEO of ImaCor Medical Technologies, where he secured more than $10M in financing and led the company through clinical trials, manufacturing and FDA clearance. In addition to his entrepreneurial activities, he has been a strategic advisor to many multinational companies like Biosense, J&J, Medtronic, and Guidant, as well as to venture funds focused on new medical technologies.

Dr. Evans obtained his MD from the New York University School of Medicine and completed a fellowship in Cardiovascular Disease and Electrophysiology at Cedars-Sinai Hospital.

Steven J. Evans, MD

FOUNDER, DIRECTOR & CEO

Dr. Evans is an experienced entrepreneur with a 25 year career in the life sciences. Prior to founding Oncolyze, he was CEO of Althera, a company he led through critical restructuring, bridge financing, formation of a US subsidiary, and a successful exit via a stock swap.

Prior to Althera, he was co-founder & CEO of ImaCor Medical Technologies, where he secured more than $10M in financing and led the company through clinical trials, manufacturing and FDA clearance. In addition to his entrepreneurial activities, he has been a strategic advisor to many multinational companies like Biosense, J&J, Medtronic, and Guidant, as well as to venture funds focused on new medical technologies.

Dr. Evans obtained his MD from the New York University School of Medicine and completed a fellowship in Cardiovascular Disease and Electrophysiology at Cedars-Sinai Hospital.

Alex Stojanovic, PhD

CHIEF OPERATING OFFICER

Dr. Stojanovic joined Oncolyze in 2019 as Chief Operating Officer. He brings 15 years of global consulting and operational experience in the life sciences and has worked or consulted for more than 50 public and private companies.

Prior to Oncolyze, he was Vice President of Business Development & Commercial Operations at Phosphagenics, where he played an instrumental role in overhauling the corporate brand, vision and strategy. He guided the company to reposition R&D efforts, resulting in more than half a dozen new assets and a major partnership with Terumo. Prior to Phosphagenics, he was Head of New Products Marketing at Grunenthal, where he led the commercial development of novel pain therapeutics.

Dr. Stojanovic was a NIH Postdoctoral Fellow at Northwestern University. He earned BS degrees in Chemistry and Cell Biology at the University of Illinois and a PhD in Pharmacology & Toxicology at Dartmouth College.

Alex Stojanovic, PhD

CHIEF OPERATING OFFICER

Dr. Stojanovic joined Oncolyze in 2019 as Chief Operating Officer. He brings 15 years of global consulting and operational experience in the life sciences and has worked or consulted for more than 50 public and private companies.

Prior to Oncolyze, he was Vice President of Business Development & Commercial Operations at Phosphagenics, where he played an instrumental role in overhauling the corporate brand, vision and strategy. He guided the company to reposition R&D efforts, resulting in more than half a dozen new assets and a major partnership with Terumo. Prior to Phosphagenics, he was Head of New Products Marketing at Grunenthal, where he led the commercial development of novel pain therapeutics.

Dr. Stojanovic was a NIH Postdoctoral Fellow at Northwestern University. He earned BS degrees in Chemistry and Cell Biology at the University of Illinois and a PhD in Pharmacology & Toxicology at Dartmouth College.

Larry Altstiel MD, PhD

CHIEF SCIENTIFIC OFFICER

Dr. Altstiel joined Oncolyze in 2019 as Chief Scientific Officer. Before joining Oncolyze, he served as Chief Medical Officer and Executive Vice President of vTv Therapeutics Inc. Prior to that, he was Founder & CEO of Provectra Biotherapeutics, a biotechnology company developing novel gene therapy for neurodegenerative diseases.

Earlier in his career, Dr. Altstiel served as VP of Neuroscience Clinical Development and Neuroscience Therapeutic Area Clinical Lead, at Pfizer. He was responsible for all preclinical biology, early phase clinical research through proof of concept and subsequent Phase 3 clinical trials.

Dr. Altstiel was a NIH Postdoctoral Fellow at The Biological Laboratories, Harvard University. He earned a BS in Chemistry / Physics at the University of Illinois, a PhD in Cell Biology, Virology and Physical Chemistry at The Rockefeller University and a MD at The University of Miami, Miller School of Medicine.

Larry Altstiel MD, PhD

CHIEF SCIENTIFIC OFFICER

Dr. Altstiel joined Oncolyze in 2019 as Chief Scientific Officer. Before joining Oncolyze, he served as Chief Medical Officer and Executive Vice President of vTv Therapeutics Inc. Prior to that, he was Founder & CEO of Provectra Biotherapeutics, a biotechnology company developing novel gene therapy for neurodegenerative diseases.

Earlier in his career, Dr. Altstiel served as VP of Neuroscience Clinical Development and Neuroscience Therapeutic Area Clinical Lead, at Pfizer. He was responsible for all preclinical biology, early phase clinical research through proof of concept and subsequent Phase 3 clinical trials.

Dr. Altstiel was a NIH Postdoctoral Fellow at The Biological Laboratories, Harvard University. He earned a BS in Chemistry / Physics at the University of Illinois, a PhD in Cell Biology, Virology and Physical Chemistry at The Rockefeller University and a MD at The University of Miami, Miller School of Medicine.

Alexander Zukiwski, MD

DIRECTOR & CLINICAL ADVISOR

Dr. Zukiwski has more than 22 years of experience in global drug development and has supported the clinical evaluation and registration of many therapeutics. He currently serves as the Chief Medical Officer of CASI Pharmaceuticals.

He was Chief Executive Officer and Chief Medical Officer of Arno Therapeutics and has been a Director of Arno Therapeutics since 2014. Prior to Arno, he served as Chief Medical Officer and EVP of Clinical Research at MedImmune. Prior to MedImmune, Dr. Zukiwski held key clinical roles at J&J, Ortho Biotech, Hoffmann-LaRoche, Glaxo Wellcome and Rhone-Poulenc Rorer. He has served as a Member of the Medical Advisory Board at Gem Pharmaceuticals and a Director of Ambit Biosciences.

Dr. Zukiwski holds a bachelor’s degree in pharmacy from the University of Alberta and a MD degree from the University of Calgary. He conducted post-graduate training at the University of Texas MD Anderson Cancer Center.

Alexander Zukiwski, MD

DIRECTOR & CLINICAL ADVISOR

Dr. Zukiwski has more than 22 years of experience in global drug development and has supported the clinical evaluation and registration of many therapeutics. He currently serves as the Chief Medical Officer of CASI Pharmaceuticals.

He was Chief Executive Officer and Chief Medical Officer of Arno Therapeutics and has been a Director of Arno Therapeutics since 2014. Prior to Arno, he served as Chief Medical Officer and EVP of Clinical Research at MedImmune. Prior to MedImmune, Dr. Zukiwski held key clinical roles at J&J, Ortho Biotech, Hoffmann-LaRoche, Glaxo Wellcome and Rhone-Poulenc Rorer. He has served as a Member of the Medical Advisory Board at Gem Pharmaceuticals and a Director of Ambit Biosciences.

Dr. Zukiwski holds a bachelor’s degree in pharmacy from the University of Alberta and a MD degree from the University of Calgary. He conducted post-graduate training at the University of Texas MD Anderson Cancer Center.

John H Abeles, MD

FOUNDER & DIRECTOR

Dr. Abeles is General Partner at Northlea Partners, a family office through which he has promulgated and founded many early stage biomedical companies, including Oncolyze. Several of these companies have had successful exits, either through acquisition or IPO.

Earlier in his career, Dr. Abeles became the first full-time Wall Street healthcare analyst with MD qualifications, at Kidder Peabody. He also held senior medical positions with Sterling Drug, Pfizer and USV. He has served as an Advisory Board Member of the College of Chemistry, University of California, Berkeley, an external member of the SPARK program at Stanford University, and an Advisory Board member of the Higuchi BioSciences Institute at the University of Kansas. He is a Fellow of the Royal Society of Medicine, London.

Dr. Abeles received his medical degree and a degree in Physiology and Pharmacology from the University of Birmingham, England.

John H Abeles, MD

FOUNDER & DIRECTOR

Dr. Abeles is General Partner at Northlea Partners, a family office through which he has promulgated and founded many early stage biomedical companies, including Oncolyze. Several of these companies have had successful exits, either through acquisition or IPO.

Earlier in his career, Dr. Abeles became the first full-time Wall Street healthcare analyst with MD qualifications, at Kidder Peabody. He also held senior medical positions with Sterling Drug, Pfizer and USV. He has served as an Advisory Board Member of the College of Chemistry, University of California, Berkeley, an external member of the SPARK program at Stanford University, and an Advisory Board member of the Higuchi BioSciences Institute at the University of Kansas. He is a Fellow of the Royal Society of Medicine, London.

Dr. Abeles received his medical degree and a degree in Physiology and Pharmacology from the University of Birmingham, England.

Barbara Carlin, MBA, CPA

CONSULTING CHIEF FINANCIAL OFFICER

Barbara Carlin, who is employed by Danforth Advisors, has served as our chief financial officer (CFO) since 2021. Since April 2020, she has been serving as Managing Director, Mid-Atlantic for Danforth Advisors, where she serves as a consultant for life science companies. Prior to joining Danforth Advisors, she served as CFO of Enterin, Inc. from May 2019 to March 2020. She previously held finance leadership roles at Egalet Corporation, Sobi, Inc., Topaz Pharmaceuticals, Inc., Genaera Corporation and Vicuron Pharmaceuticals, Inc. She began her career as an auditor at Deloitte. Barbara is a certified public accountant licensed in the Commonwealth of Pennsylvania and holds a BS in Accounting and MBA in Pharmaceutical and Healthcare Marketing from St. Joseph’s University.

Barbara Carlin, MBA, CPA

CONSULTING CHIEF FINANCIAL OFFICER

Barbara Carlin, who is employed by Danforth Advisors, has served as our chief financial officer (CFO) since 2021. Since April 2020, she has been serving as Managing Director, Mid-Atlantic for Danforth Advisors, where she serves as a consultant for life science companies. Prior to joining Danforth Advisors, she served as CFO of Enterin, Inc. from May 2019 to March 2020. She previously held finance leadership roles at Egalet Corporation, Sobi, Inc., Topaz Pharmaceuticals, Inc., Genaera Corporation and Vicuron Pharmaceuticals, Inc. She began her career as an auditor at Deloitte. Barbara is a certified public accountant licensed in the Commonwealth of Pennsylvania and holds a BS in Accounting and MBA in Pharmaceutical and Healthcare Marketing from St. Joseph’s University.

Notable Advisors & Investors

Rosemary Mazanet, MD, PhD

Advisor, DIRECTOR

James L. Foght, PhD

Advisor, DIRECTOR

Daniel Von Hoff, MD, FACP

Advisor, SCIENTIFIC ADVISOR

Matthew Pincus, MD, PhD

Advisor, SCIENTIFIC ADVISOR

Michael Andreeff, MD, PhD

Advisor, SCIENTIFIC COLLABORATOR AND ADVISOR

Martin Tallman, MD

Advisor, SCIENTIFIC ADVISOR

William Haseltine, PhD

Advisor, BUSINESS ADVISOR

Guido Marcucci, MD

Advisor, SCIENTIFIC COLLABORATOR AND ADVISOR

Term Sheet

Fundraising Description

  • Round type:
    Series A

  • Round size:
    US $15,000,000

  • Minimum investment:
    US $1,000

  • Target Minimum:
    US $3,000,000
  • Key Terms

  • Security Type:
    Preferred Equity

  • Share price:
    US $3.45492

  • Pre-Money valuation:
    US $30,000,000
  • Additional Terms

  • Custody of Shares

    Investors who invest less than $100,000 will have their securities held in trust with a Custodian that will serve as a single shareholder of record. These investors will be subject to the Custodian’s Account Agreement, including the electronic delivery of all required information. 


  • Closing Conditions

    SI Securities, LLC has the authority to prevent a closing from occurring if it determines, in its sole discretion, that this investment is no longer suitable at the time of the closing, which includes, but is not limited to, the Company raising at least US $3,000,000 in connection to the current round.


  • Use of Proceeds

    Prior Rounds

    The graph below illustrates the valuation cap or the pre-money valuation of Oncolyze's prior rounds by year.


    This chart does not represent guarantees of future valuation growth and/or declines.

    Pre-Seed

  • Round Size
    US $155,000
  • Closed Date
    Dec 31, 2013
  • Security Type
    Common Equity
  • Pre-Money valuation
    US $1,570,000
  • Seed

  • Round Size
    US $1,140,000
  • Closed Date
    Jun 30, 2018
  • Security Type
    Common Equity
  • Pre-Money valuation
    US $5,500,000
  • Warrants

  • Round Size
    US $300,000
  • Closed Date
    Apr 30, 2019
  • Security Type
    Preferred Equity
  • Bridge

  • Round Size
    US $100,000
  • Closed Date
    Jun 30, 2020
  • Security Type
    Convertible Note
  • Valuation Cap
    US $16,000,000
  • Bridge

  • Round Size
    US $350,000
  • Closed Date
    Jun 30, 2021
  • Security Type
    SAFE Note
  • Valuation Cap
    US $20,000,000
  • Market Landscape

    The global market for AML therapeutics is forecasted to grow at a rate of at least 10% from about $1.5B in 2019 to about $3.5B in 2027 (reportsanddata.com/report-detail/acute-myeloid-leukemia-therapeutics-market).


    Cancer is the second leading cause of death globally. There are about 18 million people that have cancer each year, and about 10 million cancer patients die each year around the world. The estimated total annual economic impact of cancer is more than $1 trillion in the US alone. Reports suggest that the global market for cancer therapeutics is between $150B and $200B per year (www.thebusinessresearchcompany.com/report/oncology-drugs-market). It is expected to grow to about $280B by 2023 and more than $400B in 2030. 

    There are many types of cancer, but one of the deadliest is acute myelogenous leukemia (AML). Patients with this blood cancer have only a 1 in 4 chance of living for 5 years after diagnosis. The global market for AML therapeutics is forecasted to grow at a rate of at least 10% from about $1.5B in 2019 to about $3.5B in 2027 (reportsanddata.com/report-detail/acute-myeloid-leukemia-therapeutics-market).

    The American Cancer Society estimates 20,000 - 25,000 new cases of AML in the US each year. Worldwide, it is estimated that there are about 1 million patients with AML. First-line treatment of AML consists of chemotherapy in two phases: induction and  consolidation therapy. The goal of induction therapy is to achieve a complete remission by reducing the number of leukemic cells to an undetectable level; the goal of consolidation therapy is to eliminate any residual undetectable disease and achieve a cure. 

    About 50% to 75% of AML patients will achieve remission. Yet, even after complete remission, leukemic cells including leukemic stem cells, likely remain in numbers too small to be detected with current diagnostic techniques. Without additional consolidation therapy, almost all AML patients will eventually relapse. Relapse is common, the prognosis is poor and treatment options for relapsed AML are quite limited.

    Risks and Disclosures

    We are a preclinical stage biopharmaceutical company with a limited operating history and have incurred significant losses since our inception. We expect to incur losses over at least the next several years and may never achieve or maintain profitability.

    We are a preclinical stage biopharmaceutical company with a limited operating history. Our net losses were $1.38 million and $0.90 million for the fiscal years ended June 30, 2020 and 2021, respectively and $0.7 million for the six months ended December 31, 2021. To date, we have not generated any revenue from product sales and have financed our operations primarily through sales of our equity interests. We are still in the early stages of development of OM-301 and our other product candidates and expect to initiate our first clinical trial in the second half of 2023. As such, we expect that it will be several years, if ever, before we have a product candidate ready for regulatory licensure and commercialization. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. To become and remain profitable, we must succeed in developing, obtaining marketing licensure for and commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including, without limitation, procuring clinical- and commercial-scale manufacturing, successfully completing preclinical studies and clinical trials of our product candidates, establishing arrangements with third parties for the conduct of our clinical trials, obtaining marketing licensure for our product candidates, manufacturing, marketing and selling any products for which we may obtain marketing licensure, discovering or obtaining rights to additional product candidates, identifying collaborators to develop product candidates we identify or additional uses of existing product candidates and successfully completing development of product candidates for our collaboration partners.

    We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We anticipate that our expenses will increase substantially if and as we:

    • manufacture product candidates, conduct IND-enabling preclinical studies and submit INDs and initiate Phase 1 clinical trials for OM-301;
    • select additional product candidate programs to take into development including manufacturing product candidates, conducting IND-enabling studies, submitting INDs and initiating Phase 1 clinical trials;
    • initiate, conduct and successfully complete later-stage clinical trials;
    • scale up external manufacturing capabilities for later stage trials and to commercialize our product candidates;
    • seek marketing licenses for any product candidates that successfully complete clinical trials and gain approval;
    • ultimately establish a sales, marketing and distribution infrastructure for which we may obtain marketing licensure;
    • expand, maintain and protect our intellectual property portfolio; and
    • hire additional clinical, regulatory, scientific, operational, financial and management information personnel.

    Our expenses could increase beyond our expectations if we are required by the FDA, the European Medicines Agency, or EMA, or other comparable regulatory authorities to perform trials in addition to those that we currently expect to perform, or if we experience any delays in establishing appropriate manufacturing arrangements for completing our planned preclinical studies and clinical trials or the clinical development of any of our product candidates.

    Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses we will incur or when, if ever, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts or continue operations.

    If one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with commercializing those approved product candidates. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.

    We are entirely dependent on the success of our product candidates, including our lead product candidate OM-301, all of which are still in preclinical development, and these product candidates may fail to receive regulatory approval or may not be commercialized successfully.

    We have no product candidates approved for marketing in any jurisdiction, and we have never generated any revenue from product sales. The success of our business, including our ability to achieve and sustain positive cash flow from operations and profitability primarily depends upon obtaining regulatory approvals for and successfully commercializing our product candidates, either alone or with partners, which may never occur. We do not currently have the required approvals to market any of our product candidates in any market, and we may not receive them. We currently have inadequate financial or other resources to advance our product candidates through the clinical trial process. In addition, our clinical development programs for our product candidates may not lead to regulatory approval from the FDA, and we may therefore fail to commercialize our product candidates. Further, our product candidates may not receive regulatory approval even if we are successful in achieving positive results in planned and future clinical trials. We may not generate positive cash flow from operations or be profitable even if we succeed in commercializing our product candidates and we may not achieve or sustain profitability. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

    Our company has a limited operating history and has been experiencing losses since its inception.

    The company was formed as a Delaware corporation in 2011 and is in the business of developing novel drugs. Drug development is expensive, and we may underestimate financial requirements to reach various milestones and how much time and investment we need for approval and/or to launch a new drug. It is likely that we will need to raise additional funds, the success of which is always uncertain. The company has incurred a net loss and has not generated any revenue from operations since inception. We believe that if results from our first clinical trial are positive, we will be able to raise necessary additional funds from existing or new investors. However, there is no assurance that the company will ever be able to establish successful business operations, become profitable or generate sufficient revenues to operate our business or pay dividends.

    The auditor included a “going concern” note in its audit report.

    We may not have enough funds to sustain the business until it becomes profitable. Even if we raise funds through this offering, we may not accurately anticipate how quickly we may use the funds and whether these funds are sufficient to bring the business to profitability.

    We operate in a highly competitive industry, dominated by several very large, well-capitalized market leaders, which is constantly evolving. New entrants to the market, existing competitor actions, or other changes in market dynamics could adversely impact us.

    The level of competition in the pharmaceutical industry is very high. There are many companies, some more established and experienced than Oncolyze, developing new therapeutics for AML and our other forms of cancer we may plan to target. The cancer therapy market is intensely competitive and subject to constant change and consolidation. Changes in market dynamics or actions of competitors or manufacturers, including industry consolidation and the emergence of new competitors and strategic alliances, could materially and adversely impact our business. Disruptive innovation by existing or new competitors could alter the competitive landscape in the future and require us to accurately identify and assess such changes and make timely and effective changes to our strategies and business model to compete effectively. We believe that our product’s mechanism of action remains unique. Some other competitors are aiming for similar mechanisms by leveraging CD33 and other cell surface molecules that are also present on normal cells, which could result in more off-target side effects than we anticipate with OM-301. We also believe that our primary product, OM-301 is well suited to be combined with some of these other treatments. However, if we are not able to anticipate and successfully respond to changes in market conditions and our competitors manage to develop safer or more cost-effective products, our business may suffer.

    A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates.

    Public health crises such as pandemics or similar outbreaks could adversely impact our business. In December 2019, a novel strain of a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes COVID-19 surfaced in Wuhan, China and has spread worldwide. The COVID-19 pandemic continues to evolve and to date has led to the implementation of various responses, including government- imposed quarantines, travel restrictions and other public health safety measures. The continued spread of COVID-19 and its variants globally could adversely impact our preclinical studies and clinical trial activities, including our supply chain and our ability to recruit and retain patients and subjects, principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19. Similar to other biopharmaceutical companies, we may experience delays in enrolling subjects in our clinical trials in the future. The extent to which COVID-19 (including its variants) and the global efforts to contain its spread will impact our business, including our operations, preclinical studies, clinical trials, and financial condition will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity, and scope of the pandemic and the actions taken by other parties, such as governmental authorities, to contain and treat COVID-19. If we or any future third-parties with whom we partner (including manufacturers, vendors, strategic partners, clinical trial sites, and contract research organizations, or contract research organizations (CROs), or the FDA or other health authorities, experience delays or other disruptions associated with the COVID-19 pandemic, our ability to conduct our business and operations could be materially and adversely affected, which could prevent or delay our ability to continue development of our product candidates, and ultimately of reviews and approvals of our product candidates.

    We have been granted orphan drug designation for OM-301 to treat AML by the FDA. We may in the future apply for orphan drug status granted by the FDA and/or EMA for other indications for OM-301 or for other drug candidates for the treatment of rare diseases.

    Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs. The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals annually in the United States. We recently were granted this orphan drug designation by the FDA for OM-301 to treat AML in January 2022. In the European Union, the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of drugs that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5 in 10,000 persons in the European Union. Additionally, such designation is granted for drugs intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug.

    In the United States, orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax credits for certain research and user fee waivers under certain circumstances. In addition, if a drug receives the first FDA approval for the drug and indication for which it has orphan drug designation, the drug is entitled to seven years of market exclusivity, which means the FDA may not approve any other application for the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the drug with orphan drug exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.

    In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the drug is sufficiently profitable so that market exclusivity is no longer justified.

    While the company may wish to apply for Orphan Drug Designation for some of its other pipeline drug candidates, there is no guarantee that FDA or EMA (or any other international regulatory body) will grant an Orphan Drug Designation for any of such other drug candidates. If we are unable to receive approval from the FDA or EMA for the use our products, we will not be able to market and sell our products. Obtaining such authorization is dependent upon a number of factors which are not under our control.

    We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance, which may limit commercialization of our product candidates.

    Our business is exposed to the risk of product liability and other liability risks that are inherent in the development, manufacture, clinical testing and marketing of pharmaceutical products, and we will face an even greater risk if we commercialize our product candidates. These risks exist even if a product is approved for commercial sale by the FDA or regulatory authorities in other countries and manufactured in licensed facilities. Any side effects from our product candidates, manufacturing defects, misuse or abuse associated with our product candidates could result in injury to a patient or even death. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranty. Claims could also be asserted under state consumer protection acts.

    Claims that are successfully brought against us could have a material and adverse effect on our financial condition and results of operations and may require us to limit commercialization of our product candidates. Further, even if we are successful in defending claims brought against us, our reputation could suffer and a successful defense against any such claims would require significant financial and management resources. Regardless of merit or eventual outcome, product liability claims may also result in, among others:

    • a decreased demand for our products;
    • a withdrawal or recall of our products from the market;
    • a withdrawal of participants from our ongoing clinical trials;
    • the distraction of our management’s attention from our core business activities to defend such claims;
    • additional costs to us to defend the related litigation;
    • substantial monetary awards to trial participants and patients;
    • regulatory investigation, product recalls, withdrawals or labeling, marketing or promotional restrictions
    • a loss of revenue; and
    • an inability to commercialize our product candidates.

    We intend to obtain insurance coverage. Our insurance may not provide adequate coverage against our potential liabilities. Furthermore, we, and any of our commercial partners, licensors and licensees may not be able to obtain or maintain insurance on acceptable terms, or at all. In addition, our commercial partners, licensors and licensees may not be willing to indemnify us against these types of liabilities and may not themselves be sufficiently insured or have sufficient assets to satisfy any product liability claims. To the extent that they are uninsured or uninsurable, claims or losses that may be suffered by us, our commercial partners, licensors and licensees may have a material and adverse effect on our financial condition and results of operations.

    Our preclinical studies and clinical trials may not be successful and delays to such preclinical studies or clinical trials may cause our costs to increase and significantly impair our ability to commercialize our product candidates. Results of previous clinical trials or interim results of ongoing clinical trials may not be predictive of future results.

    Before we are able to commercialize OM-301 or any of our product candidates, we are required to undertake extensive preclinical studies and clinical trials to demonstrate that our product candidates are safe and effective for their intended uses. However, we cannot assure you that our product candidates, including OM-301, will, in preclinical studies and clinical trials, demonstrate the safety and efficacy traits necessary to obtain marketing approval. Due to the nature of drug product development, many product candidates, especially those in early stages of development, may be terminated during development. We have completed basic translational research in the preclinical development of OM-301. However, we have not completed IND-enabling toxicology preclinical studies or commenced clinical trials or successfully completed the clinical development of any of our product candidates and, accordingly, do not have a track record of successfully bringing product candidates to market. Additionally, the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and preliminary and interim results of a clinical trial do not necessarily predict final results.

    Preclinical studies and clinical trials may fail due to factors such as flaws in trial design, dose selection and patient enrollment criteria. The results of preclinical studies and early clinical trials may not be indicative of the results of subsequent clinical trials. Product candidates may, in later stages of clinical testing, fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and earlier clinical trials. Moreover, there may be significant variability in safety or efficacy results between different trials of the same product candidate due to factors including, but not limited to, changes in trial protocols, differences in the composition of the patient population, adherence to the dosing regimen and other trial protocols and amendments to protocols and the rate of drop-out among patients in a clinical trial. If our preclinical studies or clinical trials are not successful and we are unable to bring our product candidates to market as a result, our business and prospects may be materially and adversely affected.

    Furthermore, conducting preclinical studies and clinical trials is a costly and time-consuming process. The length of time required to conduct the required studies and trials may vary substantially according to the type, complexity, novelty and intended use of the product candidate. A single clinical trial may take up to several years to complete. Moreover, our preclinical studies and clinical trials may be delayed or halted due to various factors, including, among others:

    • delays in raising the funding necessary to initiate or continue a clinical trial;
    • delays in manufacturing sufficient quantities of clinical trial materials;
    • delays in reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;
    • delays in obtaining institutional review board approval at clinical trial sites;
    • delays in recruiting suitable patients to participate in a clinical trial;
    • delays in patients’ completion of clinical trials or their post-treatment follow-up;
    • regulatory authorities’ interpretation of our preclinical and clinical data; and
    • unforeseen safety issues, including a high and unacceptable severity, or prevalence, of undesirable side effects or adverse events caused by our product candidates or similar drug products or product candidates.

    If our preclinical studies or clinical trials are delayed, the potential regulatory approval and commercialization of our product candidates will be delayed and as a result, we may incur substantial additional costs or not be able to recoup our investment in the development of our product candidates, which would have a material and adverse effect on our business.

    Our product candidates, including OM-301, may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.

    If our product candidates are associated with undesirable side effects or have characteristics that are unexpected, we may need to abandon our development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Any serious adverse or undesirable side effects identified during the development of our product candidates could interrupt, delay or halt clinical trials and could result in the denial of regulatory approval by the FDA or other regulatory authorities for any or all targeted indications, and in turn prevent us from commercializing our product candidates and generating revenues from their sale. In addition, if any of our product candidates receive regulatory approval and we or others later identify undesirable adverse effects caused by the product, we could face one or more of the following consequences:

    • regulatory authorities may require the addition of labeling statements, such as a boxed warning or a contraindication, or other safety labeling changes;
    • regulatory authorities may require a risk evaluation and mitigation strategy, or REMS;
    • regulatory authorities may withdraw their approval of the product;
    • regulatory authorities may seize the product;
    • we may be required to change the way that the product is administered, or conduct additional clinical trials or we may need to recall the product;
    • we may be subject to litigation or product liability claims, fines, injunctions or criminal penalties; and
    • our reputation may suffer.

    In light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities, members of Congress, the U.S. Government Accountability Office, medical professionals and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of drug products, revisions to drug labeling or boxed warnings that further limit use of the drug products and establishment of risk management programs that may, for instance, restrict distribution of drug products. The increased attention to drug safety issues may result in a more cautious approach by the FDA to clinical trials. Data from clinical trials may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate clinical trials before completion or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.

    *Please refer to Offering Circular for full list of Risk Factors

    General Risks and Disclosures

    Start-up investing is risky. Investing in startups is very risky, highly speculative, and should not be made by anyone who cannot afford to lose their entire investment. Unlike an investment in a mature business where there is a track record of revenue and income, the success of a startup or early-stage venture often relies on the development of a new product or service that may or may not find a market. Before investing, you should carefully consider the specific risks and disclosures related to both this offering type and the company which can be found in this company profile and the documents in the data room below.

    Your shares are not easily transferable. You should not plan on being able to readily transfer and/or resell your security. Currently there is no market or liquidity for theseshares and the company does not have any plans to list these shares on an exchange or other secondary market. At some point the company may choose to do so, but until then you should plan to hold your investment for a significant period of time before a "liquidation event" occurs. A "liquidation event" is when the company either lists their shares on an exchange, is acquired, or goes bankrupt.

    The Company may not pay dividends for the foreseeable future. Unless otherwise specified in the offering documents and subject to state law, you are not entitled to receive any dividends on your interest in the Company. Accordingly, any potential investor who anticipates the need for current dividends or income from an investment should not purchase any of the securities offered on the Site.

    Valuation and capitalization. Unlike listed companies that are valued publicly through market-driven stock prices, the valuation of private companies, especially startups, is difficult to assess and you may risk overpaying for your investment. In addition, there may be additional classes of equity with rights that are superior to the class of equity being sold.

    You may only receive limited disclosure. While the company must disclose certain information, since the company is at an early-stage they may only be able to provide limited information about its business plan and operations because it does not have fully developed operations or a long history. The company may also only be obligated to file information periodically regarding its business, including financial statements. A publicly listed company, in contrast, is required to file annual and quarterly reports and promptly disclose certain events through continuing disclosure that you can use to evaluate the status of your investment.

    Investment in personnel. An early-stage investment is also an investment in the entrepreneur or management of the company. Being able to execute on the business plan is often an important factor in whether the business is viable and successful. You should be aware that a portion of your investment may fund the compensation of the company's employees, including its management. You should carefully review any disclosure regarding the company's use of proceeds.

    Possibility of fraud. In light of the relative ease with which early-stage companies can raise funds, it may be the case that certain opportunities turn out to be money-losing fraudulent schemes. As with other investments, there is no guarantee that investments will be immune from fraud.

    Lack of professional guidance. Many successful companies partially attribute their early success to the guidance of professional early-stage investors (e.g., angel investors and venture capital firms). These investors often negotiate for seats on the company's board of directors and play an important role through their resources, contacts and experience in assisting early-stage companies in executing on their business plans. An early-stage company may not have the benefit of such professional investors.

    Oncolyze's Preliminary Offering Circular

    The offering circular is the legal document filed with the SEC for a Regulation A offering and provides facts that an investor needs to make an informed investment decision. The offering circular includes an overview of company and company's business, historical financials and capitalization, and key risk factors.

    Download Oncolyze's  Preliminary Offering Circular here.

    Frequently Asked Questions

    About Reg A Offerings
    What does it mean that the SEC has qualified this offering?

    "The SEC has qualified this offering" means the SEC has permitted Oncolyze to offer for sale the securities described in the Offering Circular to investors such as you. The SEC is not judging the merits, accuracy, or completeness of the offering and information in the Offering Circular.


    Making an Investment in Oncolyze
    How does investing work?

    When you complete your investment on SeedInvest, your money will be transferred to an escrow account where an independent escrow agent will watch over your investment until it is accepted by Oncolyze. Once Oncolyze accepts your investment, and certain regulatory procedures are completed, your money will be transferred from the escrow account to Oncolyze in exchange for your securities. At that point, you will be a proud owner in Oncolyze.


    What is the difference between preferred equity and a convertible note?

    Preferred equity is usually issued to outside investors and carries rights and conditions that are different from that of common stock. For example, preferred equity may include rights that prevent or minimize the effects of dilution or grants special privileges in situations when the company is sold.

    A convertible note is a unique form of debt that converts into equity, usually in conjunction with a future financing round. The investor effectively loans money to a startup with the expectation that they will receive equity in the company in the future at a discounted price per share when the company raises its next round of financing.

    To learn more about startup investment types check out “How to Choose a Startup Investment” in our academy.


    What will I need to complete my investment?

    To make an investment, you will need the following information readily available:

    1. Personal information such as your current address and phone number
    2. Employment and employer information
    3. Net worth and income information
    4. Social Security Number or passport
    5. ABA bank routing number and checking account number (typically found on a personal check or bank statement)

    What if I change my mind about investing?

    Until a closing occurs, you may cancel your investment at any time, for any reason. You will receive an email when the closing occurs and your securities have been issued. If you have already funded your investment and your funds are in escrow, your funds will be promptly refunded to you upon cancellation. To cancel your investment, please go to your portfolio page by clicking your profile icon in the top right corner.


    After My Investment
    How can I sell my securities in the future?

    Currently there is no market or liquidity for these securities. Right now Oncolyze does not plan to list these securities on a national exchange or another secondary market. At some point Oncolyze may choose to do so, but until then you should plan to hold your investment for a significant period of time before a “liquidation event” occurs. A “liquidation event” is when Oncolyze either lists their securities on an exchange, is acquired, or goes bankrupt.


    How do I keep track of this investment?

    You can return to SeedInvest at any time to view your portfolio of investments and obtain a summary statement.


    Other General Questions
    What is this page about?

    This is Oncolyze's fundraising profile page, where you can find information that may be helpful for you to make an investment decision in their company. The information on this page includes the company overview, team bios, and the risks and disclosures related to this investment opportunity. You will also find a copy of the Oncolyze's Offering Circular, which has been qualified by the SEC. The Offering Circular includes important details about Oncolyze's fundraise that you should review before investing.


    What are the risks of this investment?

    This investment is highly speculative and should not be made by anyone who cannot afford to risk the entire investment amount. In addition to these risks, you should carefully consider the specific information and risks disclosed in Oncolyze’s profile and Offering Circular.