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GET A PIECE OF ONCOLYZE

Treating Cancer by Exploding Cancer Cells

Oncolyze is a preclinical stage biotechnology company which is developing an innovative new cancer drug that selectively attacks cancer cells by causing them to explode and die while leaving normal cells intact.

This Reg A+ offering is made available through StartEngine Primary, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.

$982,508.09 Raised



Offering Circular | Selected Risks Related to this Offering | SEC EDGAR Page


REASONS TO INVEST


  • Our lead drug candidate OM-301 has been shown to selectively kill cancer cells by targeting a cell surface protein unique to cancer without the drug having to enter inside the cell, potentially enabling highly effective treatments with fewer side effects.


  • We are led by a team highly skilled in the life sciences across drug discovery, development, and commercialization with over 200 years of combined experience in biopharma. Our advisors are amongst the top thought leaders in leukemia research and therapeutics.


  • We have already raised over $2 million to date. Data from our preclinical trials has demonstrated that OM-301 has the ability to kill human leukemic cells and leukemic stem cells implanted in mice, without suppressing normal blood formation in the bone marrow. Now, we plan to advance this lead product toward clinical trials.





the pitch

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 while leaving normal cells intact. We will start by targeting acute myeloid leukemia (AML), an aggressive type of blood cancer with a low survival rate. With Orphan Drug Designation granted by the FDA, multiple patents filed, and promising trials in mice completed, we are ready to advance our lead product into clinical trials.



OVERVIEW





Developing Technology to Explode Cancer Cells

Cancer is the second leading cause of death globally, killing 10 million patients each year. Oncolyze’s lead drug candidate, OM-301 targets a protein that is found on the cell surface of multiple solid (e.g., pancreatic, ovarian, breast, prostate) and blood (e.g., like leukemia, lymphoma) cancers, but is not seen on the surface of normal cells. OM-301 selectively destroys cancer cells by a mechanism we have termed  “poptosis” (referring to cell bursting, also known as lysis/necrosis) while leaving normal cells intact. One of the deadliest blood cancers is acute myeloid leukemia (AML). Patients with AML have only a 1 in 4 chance of living for 5 years after diagnosis. Our first clinical trial will focus on treating patients with AML. With our team of highly experienced leaders in biopharma and advisors from some of the world’s top cancer institutes, we aim to bring new treatment options to millions of cancer patients.

THE PROBLEM & OUR SOLUTION


Current Treatments Only Give AML Patients a 25% Survival Rate

Anticancer chemotherapy drugs need to go inside cancer cells and then attack them internally, causing them to self-destruct from within. However, chemotherapy has effects that are not specific to cancer cells; as a consequence, normal cells are also killed causing terrible side effects. Although targeted anticancer therapies are designed to interact with specific targets on cancer cells, the targets may also exist on normal cells, and often these drugs only block proliferation of the cancer cells without killing them.


OM-301 combines the best of chemotherapy + targeted therapy. The targeting piece finds a cancer-specific protein that sits on the external surface of nearly all cancer cells (HDM2) but not normal cells. Once OM-301 finds HDM2 and anchors, the active piece pokes holes in the surface and selectively kills the cancer cells almost instantly while sparing the normal cells.

THE MARKET & OUR TRACTION


Promising Preclinical Research and a Massive Market Need

The American Cancer Society projects approximately 20,000 new cases of AML each year in the US. The current annual cost for AML treatment ranges up to $100,000. This translates to a potential total addressable market of $2 billion for AML in the US alone.

We have been granted Orphan Drug Designation by the FDA, which confers significant market protection upon approval of the drug. In addition, we have a growing portfolio of US and international patent applications. Exciting pre-clinical data has already demonstrated that OM-301 has the ability to kill human leukemic cells and leukemic stem cells implanted into mice, an extremely important step on the pathway to testing the drug in patients with AML.

* The above video is an animation illustrating the mechanism of action.


Our leadership team has over 200 years of combined biopharma industry experience. Our advisors are amongst the world’s top thought leaders in leukemia research and therapeutics.

WHY INVEST


Bringing Hope to Millions of Cancer Patients

The estimated total annual economic impact of cancer amounts to more than $1 trillion globally. Our mission is to bring forward a new, effective drug with fewer side effects to treat the most aggressive and deadly cancers. We have built an exceptional team of leaders and advisors in biopharma and cancer research, achieved FDA Orphan Drug Designation, filed multiple patents for our technology, and executed highly promising preclinical trials in mice. Join us as we give hope to cancer patients and their families everywhere.


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THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT CAN BE FOUND HERE


CROWDCHECK VERIFIED REPORT CAN BE FOUND HERE.



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ABOUT

HEADQUARTERS
845 UN Plaza, 61B
New York City, NY 10017

Oncolyze is a preclinical stage biotechnology company which is developing an innovative new cancer drug that selectively attacks cancer cells by causing them to explode and die while leaving normal cells intact.

TEAM

Steven J. Evans, MD

Steven J. Evans, MD

Founder, CEO and Director

Dr. Evans founded the company and has served as our Chief Executive Officer since 2016 and Director since 2011. Dr. Evans obtained his MD from the New York University School of Medicine, completed his fellowship in Cardiovascular Disease and Electrophysiology at Cedars-Sinai Hospital, and in the course of his career became both an experienced entrepreneur and a leading strategic advisor in the life sciences area with 25 years of experience working for clients including Biosense, Johnson & Johnson, Medtronic, Guidant, Impulse Dynamics, St. Jude, and Atricure, and consulting for venture funds focused on new medical technologies. His expertise spans scientific assessment, clinical research, market analysis, regulatory and reimbursement evaluation, and C-level experience. He is the co-inventor and co-founder of ImaCor Medical Technologies; as CEO of ImaCor, he secured a $5 million venture investment in 2004. He led ImaCor through R&D, clinical trials, product manufacturing, a second $5 million round in 2006, and FDA clearance; the company is currently in sales. From 2007 to 2015, Dr. Evans, as CEO of Althera, led the company through a critical restructuring, a $6 million+ bridge financing, the formation of a US subsidiary, and the build-out of strong management and medical teams. Althera exited via a stock swap in 2015 and is currently in very successful clinical trials.

Alex Stojanovic, PhD

Alex Stojanovic, PhD

Chief Operating Officer

Dr. Stojanovic joined Oncolyze in 2019 as COO. He brings 16 years of global consulting and operational experience in the life sciences and has worked or consulted for more than 50 public and private companies throughout that time.

Since 2019, he has served as Managing Partner at The Naissos Group, where he has advised life science companies across the United States, Europe, Asia, and Australia on various operational, commercial and corporate topics. From 2013 to 2018, he was VP of Business Development & Commercial Operations at Phosphagenics, an Australian pharmaceutical company, where he played a key role in overhauling the corporate brand, vision and strategy, to instill investor confidence in a turnaround situation and enable a $19 million financing. He guided the company to reposition R&D efforts, leveraging a proprietary drug delivery technology, from topical to injectable, resulting in more than half a dozen new assets and a major partnership with Terumo. Prior to that, from 2011 to 2013, he was Head of New Products Marketing at Grunenthal, where he led commercial development of pipeline entities from Phase 1 to 3. Earlier in his career, from 2006 to 2011, he was a Consultant with ZS Associates for six years.

He was a NIH Postdoctoral Fellow at the Center for Drug Discovery, Northwestern University. He earned BS degrees in both Chemistry and Cell Biology at the University of Illinois and a PhD in Pharmacology & Toxicology at Dartmouth College.

Larry Altstiel, MD, PhD

Larry Altstiel, MD, PhD

Chief Scientific Officer

Dr. Altstiel joined Oncolyze in 2019 as CSO. Before joining Oncolyze, he served as Chief Medical Officer (2015 to 2018) and Executive Vice President (2016 to 2018) of vTv Therapeutics Inc. He served as the CEO of Provectra Biotherapeutics, an early-stage biotechnology company developing novel gene therapy for neurodegenerative diseases, from 2013 to 2015, and was its founder. He was responsible for all of Provectra’s product development activities, while leading Provectra toward commercializing products based upon its proprietary gene therapy technologies. From 2007 to 2013, he served as VP of Neuroscience Clinical Development and Neuroscience Therapeutic Area Clinical Lead, at Pfizer Inc. His principal responsibilities were directing PGRD Neuroscience Research Unit clinical research, which included governance, operational and budgetary responsibilities for: preclinical biology and first in human studies; supervising of transitional medical plans and related external alliances; supervising clinical teams conducting early phase clinical research from translational medicine 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.

John Abeles, MD

John Abeles, MD

Co-Founder, Chief Corporate Development and Strategy Officer and Director

Dr. Abeles has served as our Chief Corporate Development and Strategy Officer since 2018 and as a director since 2011. Dr. Abeles received his MD and a degree in Physiology and Pharmacology from the University of Birmingham, England. He practiced medicine in London and Connecticut, and has held senior medical positions with Sterling Drug, Pfizer and USV. In 1975, he became the first full-time Wall Street healthcare analyst with MD qualifications, at Kidder Peabody.

In 1980. Dr. Abeles formed MedVest Group, a biomedical consulting firm, and later Northlea Partners, his family office. Dr. Abeles has promulgated, and sometimes founded, many early-stage biomedical companies, several of which have been acquired and/or become public companies.

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. He is a member of the board of several healthcare non-profit organizations in the U.S. and Israel and is active in sponsoring the arts and several charities.

Rosemary Mazanet, MD, PhD

Rosemary Mazanet, MD, PhD

Director

Dr. Mazanet has been an investor, executive and expert in healthcare for more than 25 years. A trained Oncologist, she was intimately involved with the development of Neupogen (among other product candidates) and the Cell Therapy program at Amgen, where she was head of Oncology Clinical Research from 1992 to 1998. After moving to the investment world in 1998, she helped to manage the Oracle Partners Biotech portfolio which had very profitable years from 1998 to 2003. Since 2004, in her role as an investor and a consultant, she has founded companies (Breakthrough Therapeutics, Inc), acted as interim management (Interim CEO, Access Pharmaceuticals OTC: ACCP; Interim CEO, Diabetes America, Inc., CMO, NKT Therapeutics), and corporate advisor to many biotechnology companies, funds and firms. She serves/has served as a director of public (GTI, Inc., (NASD: GTXI), Aksys LTD. Access Pharmaceuticals) and private (Actinium Pharmaceuticals, Amorcyte, Cellumen, Patriot Care) companies.

For the past ten years, she has been a Trustee and Member of the Executive Committee for the School of Medicine and Health System at the University of Pennsylvania. She remains licensed to practice medicine in several states.

James L. Foght, PhD

James L. Foght, PhD

Director

James Foght has been an Independent Director with Oncolyze since 2016. Dr. Foght obtained his PhD from the University of Illinois, having done research in Organic Chemistry, Biochemistry, and Microbiology. He was Co-Founder and Managing Director for DuPont Pharmaceuticals Europe, Africa and Middle East, after which he was a Co-Founder and Co-Director of the first life science investment banking group at Kidder Peabody. He was a Co-Founder and President of Vector Securities, and a Co-Founder of Deerfield Partners Hedge Fund, one of the most successful hedge funds in the life sciences. He serves on the Boards of Cambridge Antibody (UK), Acrux Limited, and Pinnacle Biologics.

Alexander Zukiwski, MD

Alexander Zukiwski, MD

Director

Alexander Zukiwski has been an Independent Director with Oncolyze since 2017. Dr. Zukiwski has more than 22 years of experience in global drug development and has supported the clinical evaluation and registration of many successful therapeutic agents, including Taxotere®, Xeloda®, Procrit®/Eprex®, Velcade®, Yondelis®, and Doxil®, and 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 in 2007, he served as Chief Medical Officer and Executive Vice President of Clinical Research at MedImmune. Prior to MedImmune, Dr. Zukiwski held several roles of increasing responsibility at Johnson & Johnson Pharmaceutical Research & Development LLC (J&JPRD) and Ortho Biotech. Before joining J&J, he served in clinical oncology positions at pharmaceutical companies including Hoffmann-LaRoche, Glaxo Wellcome and Rhone-Poulenc Rorer. He has served as a Member of Medical Advisory Board at Gem Pharmaceuticals, LLC and served as a Director of Ambit Biosciences Corporation.

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 his post-graduate training at St. Thomas Hospital Medical Center in Akron, Ohio and the University of Texas MD Anderson Cancer Center.

Barbara A. Carlin, MBA, CPA

Barbara A. Carlin, MBA, CPA

Consulting Chief Financial Officer

Barbara Carlin, who is employed by Danforth Advisors LLC, 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.

TERMS

Oncolyze
Overview
PRICE PER SHARE
$3.21
DEADLINE
Mar 21, 2024
VALUATION
$29.99M
FUNDING GOAL
$497.55 - $15M
Breakdown
MIN INVESTMENT
$497.55
MAX INVESTMENT
$999,998.46
MIN NUMBER OF SHARES OFFERED
155
MAX NUMBER OF SHARES OFFERED
4,672,897
OFFERING TYPE
Equity
ASSET TYPE
Preferred Stock
SHARES OFFERED
Series A-1 Preferred Stock

Maximum Number of Shares Offered subject to adjustment for bonus shares

*Maximum number of shares offered subject to adjustment for bonus shares. See bonus info below.

Investment Incentives and Bonuses*

Amount-Based Perks:

Tier 1
Invest $1,000+ and receive 2% bonus shares.

Tier 2

Invest $2,500+ and receive 5% bonus shares.

Tier 3

Invest $5,000+ and receive 7% bonus shares.

Tier 4

Invest $10,000+ and receive 10% bonus shares.

ALL UPDATES

REWARDS

Multiple investments in an offering cannot be combined to qualify for a larger campaign perk. Get rewarded for investing more into Oncolyze.

$1,000

Tier 1

Invest $1,000+ and receive 2% bonus shares.

$2,500

Tier 2

Invest $2,500+ and receive 5% bonus shares.

$5,000

Tier 3

Invest $5,000+ and receive 7% bonus shares.

$10,000

Tier 4

Invest $10,000+ and receive 10% bonus shares.

JOIN THE DISCUSSION

0/2500

TW
Tom Wright

2 hours ago

My investment in Oncolyze is coming very soon, guys. And I CAN'T WAIT!!! ....... This one is gonna be HUGE!!! ....... I'm soooo glad for this opportunity to get in on the ground floor, with Oncolyze, a company that is set to REVOLUTIONIZE cancer treatment.

0

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DA
David Amin

a day ago

Biotec is a very risky bet..... $30M good luck to the investors......Way lofty valuation. Ask would shark tank invest..? Why are you ? The chances of this hitting are very low. Botech surefire hits do not come to these platforms. There are professional Biotec investors that beat you to the real game. The seriese A-1 type deals are very very risky.

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JS
Josh Spradling

2 days ago

I can't even read anything on your website without being bombarded with an investment pop-up every click. For that reason, I'm out.

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JB
James Bickel

10 days ago

Is a recording of the webinar available?

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RS
Richard Surmont

3 months ago

I think your work is amazing. Assuming the information from your studying and working with this drug is correct . With the fact that the FDA has approved it as an orphan drug and the USA recently has allowed people who are terminally ill to take experimental drugs to attempt to save their lives --- where is the line to try this drug ??

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JL
Jack Looper

3 months ago

Good Morning, Suggestion: Emphsize your product does NOT attack good/healthy cells, all present cancer related drugs attack destroying cancer & healthy cells combined that's what sets you apart from the other caner treatments Thank you & Have a GREAT DAY! Jack

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ML
Mark Lenz

3 months ago

Have you explored non-dilutive grant money from government or cancer charity sources like the Leukemia Society?

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JS
John Sklarosky

3 months ago

Hello. Do you have any plans/interest in an IPO to raise more funds? I know that would probably be years in the future.

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DD
Daniel Devlin

3 months ago

Hi Dr. Evans, I initially invested in your SeedInvest round in June 2022, so I’m happy to see it back live on StartEngine! I’m excited about Oncolyze’s prospects but have a few questions. 1) Given OM-301’s promising early results, have you received any investment interest from large pharmaceuticals or VCs? Are they participating in this round? 2) Why raise a RegCF round? Is this round critical to moving development forward? If so, is there a minimum amount you’ll need to hit to continue uninterrupted? 3) Since your most recent financials are as of June 2022, can you share your current cash balance, burn rate, and projected runway? 4) I remember the SeedInvest round had a very detailed deck with study results, timelines, roadmaps, etc. What major progress has been made in the past year and would you say Oncolyze is still “on schedule” in terms of development? 5) In another answer you talked about completing the next stage of IND studies in order to move to clinical trials. How long do you foresee this stage taking? Thank you!

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GE
Gerardo Escamilla

3 months ago

Aren’t you concerned that the mechanisms of the drug might target non-cancer cells in a full body beyond the serum? You say on your web site you don’t know why cancer has more of these targeted proteins than normal cells.

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RAISED
$982,508.09
INVESTORS
634
MIN INVEST
$497.55
VALUATION
$29.99M

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