GET A PIECE OF ONCOLYZE
Treating Cancer by Exploding Cancer Cells
$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.
AN OFFERING STATEMENT REGARDING THIS OFFERING HAS BEEN FILED WITH THE SEC. THE SEC HAS QUALIFIED THAT OFFERING STATEMENT, WHICH ONLY MEANS THAT THE COMPANY MAY MAKE SALES OF THE SECURITIES DESCRIBED BY THE OFFERING STATEMENT. IT DOES NOT MEAN THAT THE SEC HAS APPROVED, PASSED UPON THE MERITS OR PASSED UPON THE ACCURACY OR COMPLETENESS OF THE INFORMATION IN THE OFFERING STATEMENT.
THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT CAN BE FOUND HERE
CROWDCHECK VERIFIED REPORT CAN BE FOUND HERE.
THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.
ABOUT
HEADQUARTERS
845 UN Plaza, 61B
New York City, NY 10017
WEBSITE
View Site
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
Founder, CEO and Director
Alex Stojanovic, PhD
Chief Operating Officer
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
Chief Scientific Officer
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
Co-Founder, Chief Corporate Development and Strategy Officer and Director
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
Director
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
Director
Alexander Zukiwski, MD
Director
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
Consulting Chief Financial Officer
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
$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
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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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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James Bickel
10 days ago
Is a recording of the webinar available?
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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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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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Mark Lenz
3 months ago
Have you explored non-dilutive grant money from government or cancer charity sources like the Leukemia Society?
1
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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.
1
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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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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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Tom Wright
2 hours ago
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