On December 7, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported six abstracts accepted for poster sessions at the 2021 San Antonio Breast Cancer Symposium (SABCS) taking place December 7 – 10 (Press release, Tempus, DEC 7, 2021, View Source [SID1234596576]). The presented findings highlight the unique insights that Tempus’ data and smart diagnostics generate to advance breast cancer research.

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"The research that Tempus is presenting at this year’s symposium underscores the impact that our comprehensive genomic profiling data has on enabling clinicians to make more informed treatment decisions while also powering research for future therapeutics," said Dr. Kimberly Blackwell, Chief Medical Officer at Tempus.

Tempus will present six posters that highlight research to support the use of more personalized treatments for breast cancer patients, conducted with researchers from institutions including Rush University Medical Center, Columbia University Irving Medical Center, and Washington University School of Medicine. Three abstracts selected for poster presentation at SABCS 2021 are highlighted below:

PD14-01: Comprehensive molecular characterization of patients with metastatic invasive lobular carcinoma (ILC): Using real-world data to describe this unique clinical entity
Overview: This study characterizes the genomic and transcriptomic landscape of advanced or metastatic ILC and co-mutational landscape of CDH1-mutant disease. Researchers retrospectively analyzed 201 de-identified patients with ILC or mixed lobular/ductal histology who were tested via Tempus xT, with abstracted pathology reports. CDH1 mutations were present in 65.3% of all metastatic ILC cases. PIK3CA mutations were more common in patients with CDH1-mutant disease than in patients with CDH1-wildtype disease, suggesting that therapies targeting PIK3CA may be further investigated for their actionability in CDH1-mutant metastatic ILC.
Session: Spotlight Poster Discussion 14
Date: Friday, December 10, 2021
Time: 7:00 am – 8:30 am CT
P3-08-04: The genomic and transcriptomic landscape of PIK3R1-mutated breast cancers
Overview: This study investigates the significance of PIK3R1 mutations in metastatic breast cancer. Researchers retrospectively analyzed a de-identified cohort of 4,296 patients with breast cancer who underwent Tempus xT testing. Patients with PIK3R1 mutations have more frequent mutations associated with poor outcomes and endocrine therapy resistance (PTEN and NF1) compared with patients who are PIK3R1 wild type.
Session: Poster Session 3
Date: Thursday, December 9, 2021
Time: 7:00 am – 8:30 am CT
P3-09-04: Genomic landscape of HER2-negative advanced or metastatic breast cancer with PIK3CA gain-of-function mutations
Overview: The study provides insight into possible mechanisms of therapeutic resistance to alpelisib/fulvestrant and identifies potential targeted pathways. Researchers retrospectively analyzed a cohort of 2,918 patients with HER2-negative advanced or metastatic breast cancer with PIK3CA gain-of-function mutations sequenced with Tempus xT, xO or xE. From this cohort, researchers found that there is substantial genomic heterogeneity among PIK3CA-mutated HER2- advanced/metastatic breast cancers, however future studies are needed to assess the prognostic and predictive role of the identified co-mutations and other candidate gene alterations.
Session: Poster Session 3
Date: Thursday, December 9, 2021
Time: 7:00 am – 8:30 am CT
Additional Tempus-affiliated abstracts accepted for poster presentation at SABCS 2021 include:

PD2-01: A platform of CDK4/6 inhibitor-resistant patient-derived breast cancer organoids illuminates mechanisms of resistance and therapeutic vulnerabilities
Session: Spotlight Poster Discussion 2
Date: Wednesday, December 8, 2021
Time: 7:00 am – 8:30 am CT
GS3-09: Loss of ASXL1 tumor suppressor promotes resistance to CDK4/6 inhibitors in ER+ breast cancer
Session: General Session 3
Date: Thursday, December 9, 2021
Time: 10:45 am CT
P5-08-05: Preclinical activity of KB-0742, an oral, highlight selective, CDK9 inhibitor, in cell lines and in MYC-high expressing, patient-derived models of multiple breast cancer subtypes
Session: Poster Session 5
Date: Friday, December 10, 2021
Time: 7:00 am – 8:30 am CT
The complete list of Tempus authored and affiliated abstracts can be found on the Tempus publications page.

On December 7, 2021 Odyssey Therapeutics, a biotechnology company pioneering next generation precision immunomodulators and oncology medicines, reported the completion of an oversubscribed $218 million Series A financing led by OrbiMed Advisors and co-led by SR One Capital Management with participation from Foresite Capital, Woodline Partners LP, Logos Capital, HBM Healthcare Investments, Colt Ventures, Creacion Ventures, and other institutional investors (Press release, Odyssey Pharmaceuticals, DEC 7, 2021, View Source [SID1234596539]). Carl L. Gordon, Ph.D., Managing Partner of OrbiMed Advisors, will join Odyssey’s board of directors. The financing will be used to advance multiple pipeline programs and Odyssey’s discovery platform aimed at expanding the druggable genome. Founded by Gary D. Glick, Ph.D., the company is led by a team of drug hunters and executives with an extraordinary track record of accomplishment in helping to bring more than 20 drugs to market.

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Anti-inflammation immunotherapies, such as anti-TNF antibodies and JAK inhibitors, and newer oncology immunotherapies and targeted therapies have improved the standard of care for some patients. However, numerous challenges including limited efficacy, inherent or acquired drug resistance, and mechanism-based toxicity restrict broader patient care and limit their benefits.

Building on these past approaches, Odyssey has developed a strategy to create a portfolio of product candidates that will go beyond the limitations of current medicines and enhance the standard-of-care for patients living with inflammatory diseases and cancer. The company is focused on targets and mechanisms that control validated signaling nodes that drive disease, with the goal of creating medicines that achieve optimal product profiles for patients. In addition, Odyssey is applying its highly integrated drug hunting engine and class-leading computational and data sciences platform to challenging, high-value targets with the potential to revolutionize treatment paradigms, but for which traditional discovery approaches have not succeeded.

"A renaissance in medicinal chemistry, coupled with new drug discovery technologies and an expanded understanding of the drivers of immune dysfunction and cancer, has created an unprecedented opportunity to discover new drugs with much greater potential for patients," said Gary D. Glick, Ph.D., Chief Executive Officer of Odyssey Therapeutics. "Odyssey has brought together the financing, technology, and a team with decades of success in drug discovery and development and is poised to capitalize on this opportunity and take precision therapies to the next level: providing patients with better medicines to improve their lives."

"Odyssey has assembled one of the strongest biotech teams I have seen," said Carl Gordon, Ph.D., CFA, OrbiMed Advisors. "Paired with its next-generation scientific approach, Odyssey is positioned to accelerate the discovery and development of transformative medicines to improve the lives of a broad range of patients living with inflammatory diseases and cancer."

Experienced leadership team with proven successes
Odyssey was founded by Dr. Glick and a group of world-renowned drug hunters and academic experts in immunology, cancer biology, synthetic and systems biology, and proteomics. With headquarters and labs in Boston, Odyssey is rapidly expanding with more than 90 scientists and staff.

Odyssey’s founding team has collectively made a number of the most important discoveries in immunology and cancer biology over the last 15 years. These key scientific insights underpin the discovery and rationale of several marketed drugs and medicines in clinical testing. Odyssey is leveraging this in-house intellectual capital not only to select targets but also to determine the therapeutic modality that will have the greatest clinical impact. To transform scientific insights into medicines, Odyssey is organized in a bottom-up manner that cuts across traditional disciplines and maximizes speed, efficiency, and rigor across the organization.

The Odyssey senior scientific management team includes:

Gary D. Glick, Ph.D., Founder, President, and Chief Executive Officer
Dr. Glick is a chemist and serial biotech entrepreneur with over 15 years’ experience in the biotech industry. He has founded several successful companies, including IFM Therapeutics. While CEO of IFM, the company progressed three programs from ideation to clinical development and executed several major transactions, including the sale of oncology assets to Bristol-Myers Squibb in a transaction valued more than $2.3 billion and the sale of an NLRP3 inhibitor program to Novartis for $1.6 billion. Prior to Odyssey, in 2020, he co-founded and launched Scorpion Therapeutics. Dr. Glick played an instrumental role in the conception and building of the company, and during his tenure as Chief Executive Officer, Scorpion raised $270 million across two financings within nine months of the company’s founding. Dr. Glick received his Ph.D. in Organic Chemistry from Columbia University and completed postdoctoral studies in Organic Chemistry at Harvard University.
Robert Abraham, Ph.D., Executive Vice President, Cancer Biology
Dr. Abraham is a veteran leader in oncology research and development. Prior to Odyssey, Dr. Abraham served as Chief Scientific Officer at Vividion Therapeutics, which was acquired in August 2021 by Bayer for $2 billion. Previously, he held the position of Senior Vice President and Group Head of the Oncology R&D Group in Pfizer Worldwide Research, Development, and Medical. While at Pfizer, he helped launch 10 new oncology medicines, including XALKORI, IBRANCE, BESPONSA, BOSULIF, BAVENCIO, MYLOTARG, TALZENNA, DAURISMO, and LORBRENA, benefiting hundreds of thousands of patients worldwide. Dr. Abraham received his Ph.D. in Pharmacology from the University of Pittsburgh.
Natalie Dales, Ph.D., Senior Vice President, Chemistry and Drug Discovery
Dr. Dales is an accomplished scientist with over 20 years’ small molecule drug discovery experience leading and mentoring teams in pharmaceuticals and biotech. Prior to Odyssey, Dr. Dales was an Executive Director and the Head of Portfolio and Strategy for the Global Discovery Chemistry Group at Novartis. She was also a senior advisor for the Novartis Genesis Labs, an internal innovation incubator which fostered and funded disruptive concepts to accelerate drug discovery. Prior to Novartis, she worked on oncology, cardiovascular, and metabolism programs at Millennium Pharmaceuticals. Dr. Dales received her Ph.D. in Organic Chemistry from the University of Wisconsin.
Joseph McDonald, Ph.D., Chief Data Officer
Dr. McDonald is a distinguished scientist and executive bringing more than 30 years’ experience in the biopharmaceutical industry. Prior to Odyssey, Dr. McDonald served as Executive Director of Machine-Learning and Physics-Based Simulation at BMS and Celgene. In previous roles at Celgene, Avila Therapeutics, and Pfizer, he led increasing roles of responsibility in computational chemistry, patent science, and chemical sample management. Dr. McDonald is also a co-author and inventor of more than 140 papers and applications. Dr. McDonald received his Ph.D. in Biophysics from Roswell Park Memorial Institute and completed postdoctoral studies in Computational Chemistry at Carnegie Mellon University.
Shifeng Pan, Ph.D., Executive Vice President, Head of Discovery
Dr. Pan is a leading medicinal chemist with more than 20 years’ experience. Prior to Odyssey, Dr. Pan served as the Executive Director of Discovery Chemistry at the Genomics Institute of the Novartis Research Foundation (GNF), where he oversaw GNF’s low molecular weight portfolio and all chemistry activities, including medicinal chemistry, chemical technologies, analytical chemistry, and DMPK. He led the discovery of ODOMZO, BRAFTOVI, and MAYZENT, and is the recipient of numerous awards for his accomplishments. Dr. Pan received his Ph.D. in Organic Chemistry from New York University and completed postdoctoral studies in Organic Chemistry at GNF.
David L. Pompliano, Ph.D., Co-Founder and Chief Innovation Officer
Dr. Pompliano is a drug discovery scientist, entrepreneur, and executive with more than 30 years’ experience in the biopharmaceutical industry. Before joining Odyssey, Dr. Pompliano co-founded and served as the Chief Scientific Officer of Revolution Medicines and Lodo Therapeutics, and served as the CEO of BioLeap. Prior to the biotech industry, he served as Worldwide Basic Head of Infectious Diseases at Merck and Vice President of Biology at GlaxoSmithKline, where he led drug discovery teams that produced pre-clinical credentials for more than 30 development candidates and five registered anti-infective and oncology drugs. Dr. Pompliano received his Ph.D. in Chemistry from Stanford University and completed postdoctoral studies in Enzymology and Molecular Biology at Harvard University.
Stephen Soisson, Ph.D., Executive Vice President, Structural Biology and Protein Therapeutics
Dr. Soisson is a leading structural biologist with more than 20 years’ drug discovery experience. Prior to Odyssey, Dr. Soisson served as the Executive Director and Global Head of Structural Chemistry and Structural Protein Sciences at Merck Research Laboratories (MRL) where he architected and oversaw Merck’s network-wide efforts to structurally enable all programs with three-dimensional molecular structures. During his tenure, the structure group contributed to the discovery of virtually all clinical candidates at MRL, including KEYTRUDA, BELSOMRA, and ISENTRESS. Dr. Soisson received his Ph.D. from Johns Hopkins School of Medicine and completed post-doctoral studies as a Damon Runyon-Walter Winchell Cancer Research fellow at Rockefeller University.
Odyssey’s board of directors includes:

Gary D. Glick, Ph.D., President and CEO, Odyssey Therapeutics
Carl L. Gordon, Ph.D., CFA, Managing Partner, OrbiMed Advisors
Jill Carroll, Partner, SR One Capital Management
Charles Baum, M.D., Ph.D., President, Founder, and Head of R&D, Mirati Therapeutics
Valerie Odegard, Ph.D., President and CSO, Silverback Therapeutics

On December 7, 2021 Massive Bio, a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric clinical trial enrollment for oncology reported the launch of its 100K CANCER CLINICAL TRIAL SINGULARITY PROGRAM, a first-of-its-kind program aimed to provide real-time access to cutting-edge clinical trials for cancer patients globally (Press release, Massive Bio, DEC 7, 2021, View Source [SID1234596556]).

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A recent analysis from the National Cancer Database (NCDB) looking at patients enrolled in clinical trials as their initial course of treatment for 46 cancers from 2004 through 2015 found that out of over 12 million patients, less than 0.1% were enrolled in trials. The analysis also importantly revealed that patients with cancer treated in clinical trials lived longer than those not treated in trials. "We can and must do much better than that, using data, technology and services that are laser-focused on targeted therapies and immunotherapies while drastically increasing diversity and inclusion" mentioned Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. "We named the program singularity because the clinical research industry needs transformational change on an exponential scale to effect a quantifiable increase in clinical trial enrollment rates. Otherwise, we will be discussing the same issues in the decades to come," added Loaiza-Bonilla.

"This is our calling. We have been planning this moment for a very long time. We are building and leading the Amazonization of the patient enrollment value chain in oncology. Everything is about efficiency and scale, and we are engineering every component of the value chain with extreme precision and accuracy. We are building the pieces of the puzzle – we have on-boarded 33,000 patients, partnered with 24 pharmaceutical companies, CROs and health systems, hit 1,000 clinical trial sites, and launched the world’s first NASA-style Oncology Clinical Trial Command Center (OCTCC). Now, it is time to activate more patients and enterprise partners to hit critical mass so that there is no going back. As much as we are taking the lead, we are looking forward to collaboration. What is more impressive is that we are providing services to cancer patients for free globally so that anyone can join this movement" said Selin Kurnaz, Co-Founder and CEO.

To achieve 100K patients, Massive Bio has gone through innovative patient acquisition partnerships globally with more than two dozen patient advocacy groups, data driven patient identification companies, provider networks, NGS vendors, payers, specialty pharmacies and local CROs. The company is on target to double its footprint and operationalize in 19 countries within a year.

The 100K SINGULARITY program initially focuses on Lung, Cervical, Breast, Prostate, Gastric, GE Junction, and Pancreatic cancer, as well as Non-Hodgkin Lymphoma, Myelofibrosis, CNS tumors, Pediatric Tumors, Melanoma, Multiple Myeloma, and cancers driven by potentially actionable biomarkers such as gene fusions, and will continue to expand to other malignancies. The new catalog of clinical trial matching solutions will be made available to cancer patients globally, through its website and Apps across iOS and Android.

"Technology is key. We have been working on developing AI models to structure clinical, genomic, and clinical trial information over the past few years to match cancer patients to clinical trials and make patients aware of clinical trials without the need to go to a site. Moreover, we have been spending a significant amount of time integrating various patient identification data to precisely target patient populations – as data is still siloed even with partnerships. All these credentials have positioned us to be the only company to use an AI-integrated mobile app that finds eligible clinical trials with confidence, as well as refer patients to the closest sites once the trial is available for them. The efficiency is astronomical. We are reducing the time of pre-screening from days to minutes. With the addition of our new COO and his expertise in streamlining and scaling operations, Massive Bio’s operations and technology architecture is ready to take on 100K patients. We couldn’t be more excited" said Massive Bio’s Co-founder and Chief Technology Officer (CTO) Cagatay Culcuoglu.

The company says that with close to 14,000 actively recruiting interventional cancer clinical trials globally at any given time, and over 18 million patients being diagnosed with cancer every year, this program will not only provide improved outcomes for cancer patients, but also provide faster drug development and more efficient patient enrollment to pharmaceutical companies, biotechs, CROs and clinical research sites.

The new initiative comes only a few months after Massive Bio successfully implemented its Phase I National Cancer Institute (NCI) SBIR to develop and characterize its Deep Learning Clinical Trial Matching System (DLCTMS) at Columbia’s Herbert Irving Comprehensive Cancer Center.

"Massive Bio is building bridges among all stakeholders in the patient enrollment value chain to hit 100K patient targets. This is just the beginning of a multi-year commitment and a new era. We hope every patient, provider, pharmaceutical company, payer and NGS vendor will join this movement. The clock is ticking, and the time is now" concluded Massive Bio’s Chief Operating Officer (COO), Steve McNamara.

On December 7, 2021 Immunicom, Inc., a clinical-stage biotech pioneering subtractive therapies for advanced cancers, reported that promising preliminary data from a clinical trial investigating Immunopheresis therapy for resistant melanoma and other solid cancers at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021’s 36th annual meeting (Press release, Immunicom, DEC 7, 2021, View Source [SID1234596577]). The clinical trial is being conducted at Sheba Medical Center and uses Immunicom’s proprietary, subtractive LW-02 column to selectively remove immunosuppressive soluble tumor necrosis factor receptors (sTNF-Rs) via apheresis. By depleting TNF receptors from plasma, this therapy is designed to free the cytokine TNF-alpha, thereby unleashing its potent anti-cancer effects.

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The basket oncology clinical trial (NCT04142931; n =30 patients), which is being conducted under the direction of Dr. Ronnie Shapira, MD, and Prof. Gal Markel, MD PhD, is evaluating the safety and the clinical effectiveness of Immunopheresis as a monotherapy, and in combination with Bristol Myers Squibb’s anti-PD-1 immune checkpoint inhibitor, OPDIVO (nivolumab), in heavily pretreated patients. Preliminary data were presented from Part A (Immunopheresis therapy alone) from six patients—three with melanoma, and three with triple negative breast cancer (TNBC)—who have failed multiple prior lines of standard chemo and immunotherapies. Of these six heavily pretreated patients, three completed the 12-week study regimen, and three were withdrawn due to clinical progression. Two patients are still alive after a year (median overall survival 26.6 weeks). Immunopheresis therapy was well-tolerated in these late-stage patients, and no treatment-related serious adverse events were reported. The therapy was demonstrated to significantly reduce the levels of sTNF-Rs in plasma. Immune profiling of blood and tumor specimens showed evidence of upregulation of protein biomarkers and cell populations that are associated with improved activity of the immune system. Specifically, the tumor specimens showed two developments: 1) an increased infiltration of CD8+ T cells, which are known to have anti-tumor cytotoxic effects, and 2) the expression of immune checkpoint proteins PD1 and PD-L1 that show evidence of turning "cold" tumors into "hot" tumors. Part B of the study—evaluating Immunopheresis therapy in combination with nivolumab—is currently ongoing. The SITC (Free SITC Whitepaper) 2021 Congress abstract is available on Immunicom’s Publications page.

"Our preliminary data, which show renewed immune modulation and intra-tumoral antitumor activity, support our hypothesis that Immunopheresis therapy has the potential to overcome immunotherapy resistance, which could be a significant breakthrough in refractory cancer patient care," said Professor Gal Markel, former Director of the Ella Lemelbaum Institute for Immuno-Oncology, and now Director of Davidoff Center & Deputy Director General, Rabin Medical Center at Clalit Health Services. "Immunicom’s innovative subtractive treatment approach to neutralize cancer’s ability to block the patient’s natural immune-defense mechanisms is especially attractive in these heavily pretreated patients, and it offers the potential for achieving much better clinical outcomes with fewer treatment side effects," added Dr. Ronnie Shapira, a melanoma expert, and Head of the Onco-Gynecological Cancer Unit at the Ella Lemelbaum Institute for Immuno-Oncology.

Speaking to the announcement, Amir Jafri, Immunicom’s Founder and CEO, added, "The clinical trial at Sheba Medical Center is one of three ongoing, groundbreaking clinical trials to assess Immunicom’s subtractive therapies. Right now, our other clinical trials are evaluating the LW-02 column for treating additional multiple cancers, including metastatic TNBC, non-small cell lung cancer, melanoma, and renal cell carcinoma."

Immunicom’s various clinical trials are being conducted in collaboration with world-renowned research organizations and thought leaders, including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokine receptors produced by cancer tumors. Selective removal of these targeted cytokine receptors is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms—which are significantly compromised in late-stage, metastatic disease—thereby re-energizing the immune system to aggressively fight the cancer. Immunopheresis is a "subtractive therapy" in contrast to drugs that are "additive." Subtractive therapy is designed to avoid the side effects, toxicity, and negative impact on a patient’s quality of life that are typical of other cancer treatments.

Based on Immunicom’s clinical program, the LW-02 column could be used either in combination with other therapies, or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA) and European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory TNBC. Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of Immunopheresis and how this breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

On December 7, 2021, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with ONE44 Capital LLC, ("ONE44"), pursuant to which ONE44 purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $170,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of ONE44 (Filing, 8-K, Propanc, DEC 7, 2021, View Source [SID1234597015]). The transaction contemplated by the Purchase Agreement is expected to close on or about December 13, 2021. The Company intends to use the net proceeds ($153,000) from the Note for general working capital purposes. The Note contains an original issue discount amount of $17,000.

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The maturity date of the Note is December 7, 2022 (the "Maturity Date"). The Note shall bear interest at a rate of 10% per annum, which interest may be paid by the Company to ONE44 in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. ONE44 has the option to convert all or any amount of the principal face amount of the Note, starting on June 5, 2022, and ending on the later of the Maturity Date and the date of payment of the Default Amount (as defined below) is paid if an event of default occurs, for shares of the Company’s common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Conversion Price" shall mean 65% multiplied by the lowest closing bid price of the Company’s common stock as reported on the OTC Markets. Notwithstanding the foregoing, ONE44 shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by ONE44 and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 120 days from the issuance date, then the prepayment premium shall be 130% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, up to 180 from the issuance date, then the prepayment premium shall be 135% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from ONE44, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Other than as described above, the Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the Note.

Upon the occurrence and during the continuation of certain events of default, the Note will accrue an interest rate of 24%.

The Note was issued, and any shares to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing description of the Note and the Purchase Agreement does not purport to be complete and is qualified in their entirety by reference to the full text of the Purchase Agreement and the Note, which are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.