INVEST IN ONCOLYZE TODAY!
Offering Circular | Selected Risks Related to this Offering | SEC EDGAR Page
REASONS TO INVEST
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
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
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
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
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.
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.
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
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.
05.31.23
Great news! Oncolyze has surpassed $700k+ in funding through the support of 430+ investors. This incredible achievement speaks volumes about our team's hard work and the value investors see in our mission.
Thank you all for your continued trust and support that contributed to this success. Your investment plays a pivotal role in shaping the future of cancer therapy and bringing hope to patients worldwide.
If you haven’t joined our campaign quite yet, now is the perfect time to get behind the company making major strides in the journey to cure cancer.
Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.30.23
At Oncolyze, our mission is to transform cancer treatment by developing innovative therapies that target genetic mutations in complex blood cancers like acute myeloid leukemia (AML).
Our drug, OM-301 (formerly named PNC-27), has shown promising results in animal models with difficult-to-treat mutations such as FLT3, IDH, and TP53. We believe that OM-301's potential to be mutation-agnostic can greatly improve outcomes for AML patients.
With your support in our crowdfunding round, we can advance the development and clinical trials of OM-301, bringing new hope to patients and their families facing limited treatment options and challenging mutations. Together, let's revolutionize AML treatment and make a meaningful impact. Invest in Oncolyze's StartEngine campaign today and support our efforts to develop innovative cancer therapies.
Sources:
1. https://www.cancer.org/cancer/types/acute-myeloid-leukemia.html
2. https://pubmed.ncbi.nlm.nih.gov/31337857/
You should read the Offering Circular (https://lnkd.in/ezWEQbuX) and Risks (https://lnkd.in/e_N2nCtc) related to this offering before investing. This Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.26.23
We're excited to see our community come in and invest in Oncolyze!
Our Insiders have invested a total of $1926 into the offering to date!
We hope you join in as well! Invest in Oncolyze: https://www.startengine.com/offering/oncolyze
You should read the Offering Circular (https://lnkd.in/ezWEQbuX) and Risks (https://lnkd.in/e_N2nCtc) related to this offering before investing. This Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.25.23
Orphan Drug Designation (which Oncolyze holds for two indications: acute myeloid leukemia and multiple myeloma) is a regulatory status granted by the U.S. FDA for drugs that are intended to treat rare diseases or conditions. The designation provides several benefits including market exclusivity, tax credits, protocol assistance, and priority review. Market exclusivity provides a significant advantage, as it allows the drug manufacturer, once the drug is approved, to have a period of exclusivity during which no other company can market the same drug for the same indication. The exclusivity period is seven years in the United States (companies may also apply for Orphan Drug Designation even after a drug has already been approved for other uses, extending the life of the drug on the market). For example, If OM-301 has successful clinical trials and receives FDA approval for the treatment of acute myeloid leukemia, having Orphan Drug Designation will insure market protection for OM-301 for this indication. Along with our mission to bring new treatments to cancer patients, having Orphan Drug Designation is an important part of Oncolyze’s strategy to bring value to investors if our drug is approved.
To learn more about Oncolyze and join us on our mission to bring new treatments to cancer patients by purchasing shares, please click on the following link: https://lnkd.in/epVsHKTZ.
You should read the Offering Circular (https://lnkd.in/ezWEQbuX) and Risks (https://lnkd.in/e_N2nCtc) related to this offering before investing. This Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.23.23
Dear Valued Oncolyze Supporters,
We are immensely grateful for your unwavering support and belief in our mission to revolutionize cancer treatment. Your continuing investments have brought us closer to achieving our goals, and we look forward to sharing our progress with you during the webinar.
We are thrilled to announce that we will be hosting a live webinar exclusively for prospective investors like yourselves. This webinar is scheduled to take place on May 30th at 10am PST and it will provide an in-depth look into Oncolyze's vision, achievements, and future plans. It will be an excellent opportunity for you to gain further insight into our cutting-edge technology and how it has the potential to revolutionize the field of oncology.During the webinar, you will have the chance to hear directly from me, Steve Evans, Co-Founder and CEO of Oncolyze. I will be going over our body of preclinical data in detail, including the mechanism of action, more recent findings and thoughts about where Oncolyze will play a role in a very personalized approach to immunotherapy, and the positive impact we aim to make in the lives of cancer patients worldwide. It will also be an opportunity to address questions from prospective investors. By attending this webinar, you will:
To secure your spot for this informative session, please visit our webinar registration page. Spaces are limited, so we encourage you to sign up as soon as possible.
Thank you once again for being an integral part of our journey. Together, we can make a profound difference in the lives of countless individuals battling cancer.
Warm regards,
Steven J. Evans, M.D.
Chief Executive Officer
Oncolyze
05.22.23
Continuing strong momentum in our investor community!
Since our last update a week ago, we have gone from $525k and 300+ investors to over $620k raised and more than 395 investors! It is gratifying to see sharply increasing numbers of investors who are alongside us on our journey. By purchasing shares in Oncolyze, you can help us progress along our pathway to treat and kill cancer by exploding cancer cells.
To learn more about Oncolyze and join us on our mission to bring new treatments to cancer patients by purchasing shares, please click on the following link: https://lnkd.in/epVsHKTZ.
You should read the Offering Circular (https://lnkd.in/ezWEQbuX) and Risks (https://lnkd.in/e_N2nCtc) related to this offering before investing. This Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.15.23
Celebrating further steps towards a big goal! We're happy to share good news on our fundraising efforts on StartEngine – we have raised over $525k from more than 300 investors and still counting!
We are grateful to our growing community for their confidence in us as we continue our journey, and we invite all of you to join us as well. By purchasing shares in Oncolyze, you can help us progress along our pathway to treat and kill cancer by exploding cancer cells.
To learn more about Oncolyze and join us on our mission to bring new treatments to cancer patients by purchasing shares, please click on the following link: https://lnkd.in/epVsHKTZ.
You should read the Offering Circular (https://lnkd.in/ezWEQbuX) and Risks (https://lnkd.in/e_N2nCtc) related to this offering before investing. This Reg A+ offering is made available through StartEngine Primary, LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.11.23
At Oncolyze, we are focused on bringing new treatments to treat cancer. We also firmly believe that prevention is just as vital as finding new treatments. As part of the larger picture to save as many lives as possible, we feel it is important to follow the existing guidelines for cancer screening and prevention.
The American Cancer Society has screening recommendations for various cancers including breast, colon and rectal, cervical, endometrial, lung and prostate cancers (source). We encourage you to take an active role in safeguarding your health by learning about these screening recommendations and talking to your doctor. By staying informed and following the guidelines, you can increase the likelihood of early detection, which significantly improves the chances of successful treatment and survival.
Empowered with knowledge and new innovative treatments, we want to make cancer a part of our past!
05.08.23
Dear Oncolyze community,
We are excited to introduce you to Dr. Michael Andreeff, another member of our Scientific Advisory Board.
Dr. Andreeff is an internationally known physician and researcher. He is Professor of Medicine and holds the Paul and Mary Haas Chair in Genetics at The University of Texas MD Anderson Cancer Center. He has received uninterrupted NCI funding for over 30 years, serves as Principal Investigator of the P01 grant entitled “The Therapy of AML”, participates as Principal Investigator in the MD Anderson Cancer Center Leukemia, Lymphoma, Ovarian and Breast Cancer SPORE grants, the CML P01 and additional R21 and R01 grants. He has published over 639 peer-reviewed papers, 5 books and 75 book chapters. He plays an important role in guiding our clinical and scientific strategy as we work towards our mission of revolutionizing cancer treatment.
Join us in our mission to make a meaningful impact in the fight against cancer. Invest in Oncolyze's StartEngine campaign today and support our efforts to develop innovative cancer therapies.
P.S. Is there a team member you’d like us to introduce to the community next? Let us know in the comments!
Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.05.23
Hello and happy Friday!
Oncolyze is proud to showcase Dr. Guido Marcucci as one of our esteemed scientific advisors. Dr. Marcucci is a world-renowned hematologist and oncologist with over 30 years of experience in the field. At the City of Hope Comprehensive Cancer Center in Duarte, California Dr. Marcucci serves as: the Chair and Professor, Department of Hematologic Malignancies Translational Science; the Director, Gehr Family Center for Leukemia Research; and Chief, Division of Leukemia. A passionate and dedicated clinician and researcher, he leads multiple clinical trials and research projects aimed at developing new therapies for leukemia and other blood cancers.
His expertise and leadership in the field of hematology and oncology make him an invaluable addition to our Scientific Advisory Board. He brings a wealth of knowledge and experience to our team, and we are excited to be working with him to advance our mission of revolutionizing cancer treatment.
Invest in Oncolyze's StartEngine campaign today and help us develop innovative cancer therapies that have the potential to change the face of cancer treatment.
Thank you,
The Oncolyze Team
P.S. Is there a team member you’d like us to introduce to the community next? Let us know in the comments!
Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
05.03.23
As of today, we have almost $420k raised, with an ever-increasing number of investors: over 275!
Thank you to all our investors for your trust and support, and we hope that those of you who are following us will join in as well.
Please let us know if you have any questions or comments by posting on our discussion board!
With great appreciation,
Dr. Evans
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.
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Tom Wright
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