−Removed: AIkido Pharma Inc.
−Removed: was initially formed in 1967.
−Removed: Since 2017, the Company has operated as a biotechnology company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics
−Removed: in development.
−Removed: The Company’s pipeline consists of patented technology from leading universities and researchers.
−Removed: Our innovative
−Removed: therapeutic drug pipeline is being advanced through strong collaborations with renowned educational institutions, including the University
−Removed: of Texas at Austin, the University of Maryland, Baltimore and Wake Forest University.
−Removed: Our oncology therapeutics include treatments for
−Removed: pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).
−Removed: The Company is also developing a broad-spectrum
−Removed: antiviral platform, in which the lead compounds have activity against multiple viruses including Influenza virus, Ebolavirus and Marburg
−Removed: virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of COVID-19.
−Removed: As a result of the Company’s biotechnology
−Removed: research and development and associated investments and acquisitions, our business portfolio now focuses on the treatment of three different
−Removed: cancers and multiple types of viral infections.
−Removed: Our pancreatic drug candidate, DHA-dFdC, developed at and licensed from the University
−Removed: of Texas at Austin, is a new compound that we hope will become the next generation of chemotherapy treatment for advanced pancreatic
−Removed: DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated in preclinical toxicity tests.
−Removed: Preclinical studies have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine,
−Removed: a current standard therapy), accumulates preferentially in pancreatic tissue, and has demonstrated activities against other cancers,
−Removed: including leukemia, lung and melanoma.
−Removed: Our AML and ALL compound, developed at the Wake Forest University, is a targeted therapeutic designed
−Removed: to overcome multiple resistance mechanisms observed with the current standard of care.
−Removed: Our broad-spectrum antiviral platform was developed
−Removed: at the University of Maryland Baltimore (“UMB”), which granted the Company an exclusive worldwide Master License Agreement
−Removed: (MLA”) to technology covered by three separate patent applications.
−Removed: The licensed technology comprises broadly acting pan-viral
−Removed: inhibitory compounds targeting multiple viral pathogens.
−Removed: The technology was invented by UMB scientists Drs.
−Removed: Matthew Frieman, Alexander
−Removed: MacKerell and Stuart Watson.
−Removed: The Company has also executed a Sponsored Research Agreement with UMB to support the development of the
−Removed: technology under the direction of these inventors at UMB.
−Removed: In addition, we are constantly seeking to grow
−Removed: our pipeline of treatments in oncology indications.
−Removed: For example, in January 2021, the Company invested in Convergent Therapeutics, Inc.,
−Removed: which has exclusive rights to technology related to next-generation dual-action peptide receptor radionuclide therapy (“PRRT”)
−Removed: for prostate cancer covered by multiple issued U.S.
−Removed: and foreign patents.
−Removed: Convergent is currently conducting advanced human trials relating
−Removed: to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen (“PSMA”) present on prostate
−Removed: cancer cells.
−Removed: A phase I clinical trial on the next-generation dual-action PRRT we licensed is also currently underway.
−Removed: The technology
−Removed: was developed under the direction of Dr.
−Removed: Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.
−Removed: Additionally, on January 6, 2021 the Company
−Removed: announced that it entered into an exclusive patent license agreement with Silo Pharma Inc.
−Removed: (“Silo Pharma”) pursuant to which
−Removed: Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain Silo Pharma owned provisional
−Removed: patent applications directed to the use of psilocybin in cancer treatment, and any patents issuing therefrom, including all continuations,
−Removed: continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations, and any applications and all patents issuing
−Removed: from any applications and patents that claim domestic benefit or foreign priority to the provisional patent applications.
−Removed: is for “Field of Use” (as defined in the exclusive patent license agreement) of “treatment of cancer and symptoms caused
−Removed: by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures, confusion,
−Removed: dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type.”
−Removed: O ur Drugs in Development
−Removed: DHA-dFdC from the University of Texas at Austin
−Removed: DHA-dFdC (4-(N)-Docosahexaenoyl 2´, 2´-Difluorodeoxycytidine)
−Removed: is patented technology licensed to the Company from the University of Texas at Austin.
−Removed: DHA-dFdC is a new compound we believe may become
−Removed: the next generation of second-line chemotherapy treatment for advanced pancreatic cancer.
−Removed: DHA-dFdC is designed to overcome tumor cell
−Removed: resistance to current chemotherapeutic drugs and is well tolerated in preclinical toxicity tests.
−Removed: Preclinical studies, referenced in
−Removed: subsection DHA-dFdC Published Data below, have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up
−Removed: to 100,000-fold more potent that gemcitabine, a current standard therapy;
−Removed: for example, the IC 50 value of DHA-dFdC is more
−Removed: than 100,000-fold smaller than gemcitabine), targets pancreatic tissue and has demonstrated activities against other cancer cell lines,
−Removed: including leukemia, lung and melanoma.
−Removed: According to the Hirshberg Foundation for Pancreatic
−Removed: Research, pancreatic cancer has the highest mortality rate of all major cancers.
−Removed: It is currently the 3rd leading cause of cancer-related
−Removed: death in the United States after lung and colon cancer.
−Removed: The Hirschberg Foundation for Pancreatic Cancer estimated in January 2021 that
−Removed: 60,430 Americans would be diagnosed with pancreatic cancer, and more than 48,220 would die from the disease.
−Removed: For all stages combined,
−Removed: the 5-year relative survival rate is 10%.
−Removed: Even for the small percentage of people diagnosed with local disease, the 5-year survival is
−Removed: The majority of patients are diagnosed at a distant stage, for which the 5-year survival is 3%.
−Removed: Pancreatic cancer is one of the few cancers for
−Removed: which survival has not improved substantially over nearly 40 years.
−Removed: Treatment options for pancreatic cancer include surgery, radiation
−Removed: therapy and chemotherapy, which extend survival or relieve symptoms, but seldom produce a cure.
−Removed: Surgical removal of the tumor is possible
−Removed: in less than 20% of patients diagnosed with pancreatic cancer because detection is often in late stages and has spread beyond the pancreas.
−Removed: The current state of the art chemotherapy treatment is gemcitabine, Folfirinox cocktail or gemcitabine in combination with Abraxane.
−Removed: The University of Texas at Austin has identified
−Removed: a new drug, DHA-dFdC, that has shown positive results in vivo (see publications listed below), inhibiting pancreatic tumor growth in
−Removed: clinically relevant transgenic mouse models.
−Removed: In preclinical studies, DHA-dFdC has:
−Removed: pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine, a current
−Removed: standard therapy);
−Removed: pancreatic tumors;
−Removed: overcome tumor cell resistance to current chemotherapeutic drugs;
−Removed: well tolerated in preclinical toxicity test;
−Removed: demonstrated activities against other cancers (e.g.
−Removed: leukemia, lung, melanoma);
−Removed: stimulate immunogenic cell death to activate host antitumor immunity.
−Removed: Foundation for Pancreatic Cancer Research
−Removed: DHA-dFdC Technology Summary
−Removed: DHA-dFdC is a conjugate molecule containing gemcitabine
−Removed: linked to a fatty acid called docosahexaenoic acid (DHA).
−Removed: The chemical structure is shown in the following diagram:
−Removed: The DHA structure is illustrated above the dashed
−Removed: line in the graphic above and the gemcitabine structure is illustrated below the dashed line.
−Removed: The DHA-dFdC published data indicates that
−Removed: DHA-dFdC was more effective than gemcitabine alone in killing cancer cells in vitro and in vivo in clinically relevant transgenic mouse
−Removed: In addition, conjugation of gemcitabine with fatty acids other than DHA did not increase effectiveness over gemcitabine.
−Removed: In collaboration with our contract manufacturing
−Removed: organization, Parimer Scientific, we are currently optimizing the manufacturing procedure for DHA-dFdC.
−Removed: We have now successfully replicated
−Removed: the synthesis as reported in the literature with satisfactory purity.
−Removed: We have also developed a new procedure for producing large-scale
−Removed: quantities of the key chemical intermediate in the synthesis.
−Removed: We are currently optimizing the procedure to ensure that DHA-dFdC can be
−Removed: produced on the same scale as the intermediate.
−Removed: Once we confirm successful large-scale production, we plan to begin DHA-dFdC formulation
−Removed: development, which will require limited animal testing to determine proper dosage and will require us to engage a contract research organization
−Removed: for the purpose of such animal testing.
−Removed: DHA-dFdC Published Data
−Removed: The science behind DHA-dFdC has been published
−Removed: in the following peer-reviewed scientific journals:
−Removed: (2016) Synthesis, characterization, and in vitro and in vivo evaluations of
−Removed: 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine with potent and broad-spectrum
−Removed: antitumor activity, NeoPlasia 18:
−Removed: (2017) Preclinical evaluation of the short-term toxicity of 4-(N)-docosahexaenoyl
−Removed: 2 ́, 2 ́- difluorodeoxycytidine (DHA-dFdC), Pharm.
−Removed: (2019) A solid lipid nanoparticle formulation of 4-(N)-docosahexaenoyl 2 ́,
−Removed: 2 ́- difluorodeoxycytidine with increased solubility, stability, and antitumor activity,
−Removed: (2020) Effect of a Solid Lipid Nanoparticle Formulation on the Bioavailability of
−Removed: 4-(N)-Docosahexaenoyl 2 ́, 2 ́- Difluorodeoxycytidine After Oral Administration, AAPS
−Removed: PharmSciTech 21:77 .
−Removed: Portions of the published date also indicate
−Removed: the following:
−Removed: drug unexpectedly concentrates itself in the pancreas relative to other organs.
−Removed: significantly increases the lifespan of mice with pancreatic cancer in either mice predisposed
−Removed: to develop the cancer, or into which human pancreatic cancer has been injected.
−Removed: significantly decreases the growth of pancreatic tumors in mice, better than gemcitabine,
−Removed: the current standard of care.
−Removed: oral formulation using lipid nanoparticles is highly effective and stable and has outstanding
−Removed: bioavailability.
−Removed: DHA-dFdC Patent Coverage
−Removed: DHA-dFdC is covered by one issued patent on the
−Removed: drug itself and there is one application relating to the oral formulation, as listed in the following table:
−Removed: PCT/US2015013454, filed
−Removed: 1/29/2015, the National Stage Entry of App.
−Removed: 15/115,393, filed 7/29/2016
−Removed: Nucleobase Analogue Derivatives and Their Applications
−Removed: 11,219,633, issued
−Removed: 1/11/22 from App.
−Removed: 16/576,127, filed 9/19/2019 as continuation of App.
−Removed: 15/115,393, filed 7/29/2016
−Removed: Nucleobase Analogue Derivatives and Their Applications
−Removed: 10,463,684, issued
−Removed: 11/5/2019 from App.
−Removed: 15/115,393, filed 7/29/2016
−Removed: Nucleobase Analogue Derivatives and Their Applications
−Removed: filed 12/1/2021 as continuation of App.
−Removed: 16/576,127, filed 9/19/2019
−Removed: Nucleobase Analogue Derivatives and Their Applications
−Removed: PCT/US2020036603, filed
−Removed: Lipid Nanoparticles Containing Pharmaceutical and/or Nutraceutical agents
−Removed: and methods thereof
−Removed: filed 6/8/2020
−Removed: Lipid Nanoparticles Containing Pharmaceutical and/or Nutraceutical agents
−Removed: and methods thereof
−Removed: Pursuant to the Patent License Agreement between
−Removed: the Company and the University of Texas, as amended, the patents listed above have been exclusively licensed to the Company for commercial
−Removed: development worldwide, in all fields, along with all future patent applications that are entitled to claim priority from the listed patents,
−Removed: and all patents that issue from such applications (See also the Licenses section below).
−Removed: Broad Spectrum Antiviral Platform from University
−Removed: of Maryland, Baltimore
−Removed: Scientists at UMB have discovered that the SKI
−Removed: complex present in all mammalian cells, including human cells, is a broad-spectrum, host-directed, antiviral drug target.* Using computer
−Removed: modeling technology and database screening, the scientists identified binding pockets on the SKI complex structure and designed compounds
−Removed: predicted to bind to the pockets.
−Removed: Tests of the designed compounds identified several chemical structures that had antiviral activity
−Removed: against influenza A virus along with the filoviruses Ebola and Marburg and two further coronaviruses, SARS-CoV and SARS-CoV-2, the cause
−Removed: The tests are currently at an early stage and there is no guarantee that the aintiviral platform will be effective on human
−Removed: In conjunction with the MLA, the Company has also executed a Sponsored Research Agreement SRA with UMB to support the development
−Removed: of the technology, which is currently ongoing at UMB under the direction of the inventors.
−Removed: Under the MLA and SRA, to meet the first two
−Removed: milestones of the MLA the Company shall make periodic payments for the support of the research outlined in the SRA totaling $3.1M over
−Removed: a period of two years.
−Removed: The research under the SRA will entail initial development and optimization of the most effective compounds and
−Removed: will be performed by the scientists who invented the licensed technology.
−Removed: Several candidate compounds with optimized chemical structures
−Removed: have been identified and will be tested in vivo in clinically relevant mouse coronavirus models.
−Removed: At the end of 2019, cases of pneumonia of unknown
−Removed: etiology were identified in China.
−Removed: In the first week of January 2020, a novel coronavirus was identified as the cause and was found to
−Removed: be spreading between people.
−Removed: Throughout 2020 and 2021, the virus spread around the world with over 419 million cases and over 5.8 million
−Removed: deaths confirmed worldwide by February 2022.* Among many things that the SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2)
−Removed: outbreak has demonstrated is the immense need for both specific and broadly acting antiviral therapeutics to treat known viruses and
−Removed: those yet to emerge in the human population.
−Removed: Viral infection can have a major burden on human
−Removed: Influenza has historically caused numerous large epidemics and pandemics such as 1918 Spanish flu and swine flu.
−Removed: Ebola has caused
−Removed: sporadic outbreaks since the 1970s, but in recent years these have been growing in scale.
−Removed: The 2014 West Africa Ebola outbreak saw over
−Removed: 28,000 people contract the disease causing over 11,000 deaths.
−Removed: Coronaviruses have always posed a threat of mass spread because of their
−Removed: respiratory transmission.
−Removed: In 2002 to 2003, the emergence of SARS-CoV infected over 8,000 people, killing around 10% in nine months, while
−Removed: MERS-CoV-has sporadically spread since 2012, causing around 2,500 infections with a case fatality rate of around 35%.
−Removed: Weston et al.
−Removed: SKI complex is a broad-spectrum, host-directed antiviral drug target for coronaviruses, influenza, and
−Removed: filoviruses PNAS 117 (48) 30687-30698, https://doi.org/10.1073/pnas.2012939117
−Removed: The year 2020 saw the rapid emergence of the
−Removed: novel coronavirus, SARS-CoV-2, the cause of COVID-19, which rapidly spread after its identification in Wuhan, China, caused a pandemic,
−Removed: and has infected over 419 million people and killed over 5.8 million people worldwide, with over 900,000 deaths in the United States.*
−Removed: Johns Hopkins University of Medicine, Coronavirus
−Removed: Resource Center, https://coronavirus.jhu.edu/
−Removed: Scientists at UMB, including Drs.
−Removed: Matthew Frieman,
−Removed: Alexander MacKerell and Stuart Watson have demonstrated that the SKI complex is a broad-spectrum antiviral target and designed compounds
−Removed: using in silico drug design that target the SKI complex and inhibit replication of several virus types, influenza A
−Removed: virus along with the filoviruses Ebola and Marburg and two further coronaviruses, SARS-CoV and SARS-CoV-2.
−Removed: UMB has filed three separate patent applications
−Removed: on the resulting antiviral compounds and has granted the Company an exclusive worldwide license to the technology.
−Removed: UMB recently filed
−Removed: the following PCT application claiming priority to the first two of the three applications:
−Removed: PCT/US2020036482,
−Removed: Int’l filing date 6/5/2020
−Removed: US62/858,071, filed
−Removed: 6/6/2019, US62/909,352,
−Removed: filed 10/2/2019
−Removed: WO/2020/247860
−Removed: Broad Spectrum Antiviral Compounds Targeting the SKI Complex
−Removed: 17/616,586, filed
−Removed: US62/858,071, filed
−Removed: 6/6/2019, US62/909,352,
−Removed: filed 10/2/2019
−Removed: Broad Spectrum Antiviral Compounds Targeting the SKI Complex
−Removed: PCT/US2021/06183
−Removed: Int’l filing date 12/3/2021
−Removed: 63/121,120, filed 12/3/2020
−Removed: Broad Spectrum Antiviral Compounds Targeting the SKI Complex
−Removed: KPC34 from Wake Forest University
−Removed: Our small molecule treatment for AML and ALL,
−Removed: developed at the Wake Forest University and called KPC34, is a next generation targeted therapeutic designed to overcome multiple resistance
−Removed: mechanisms observed with the current standard of care.
−Removed: AML is an uncommon
−Removed: cancer, making up about 1% of cancers.
−Removed: In 2021, an estimated 20,240 people of all ages (11,230 men and boys and 9,010 women and girls)
−Removed: in the United States will be diagnosed with AML.
−Removed: AML is the second most common type of leukemia diagnosed in adults and children, but
−Removed: most cases occur in adults.
−Removed: AML makes up 31% of all adult leukemia cases.
−Removed: The average age of diagnosis is age 68.
−Removed: AML can be diagnosed
−Removed: An estimated 11,400 deaths (6,620 men and boys and 4,780 women and girls) from AML will occur this year.
−Removed: The majority will
−Removed: be in adults.
−Removed: (https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics).
−Removed: ALL is a rare disease, making up less than
−Removed: 1% of cancers diagnosed in the United States.
−Removed: In 2021, an estimated 5,690 people of all ages (3,000 men and boys and 2,690 women and
−Removed: girls) in the United States will be diagnosed with ALL.
−Removed: A person of any age can be diagnosed with ALL, but most cases occur in children.
−Removed: In children and teens under age 20, ALL is the most common type of leukemia, accounting for 74% of all leukemia diagnosed in this age
−Removed: Children younger than 5 have the highest risk of ALL.
−Removed: After a child grows into adulthood, the general risk of ALL rises again
−Removed: after age 50.
−Removed: About 4 out of every 10 people diagnosed with ALL are adults.
−Removed: An estimated 1,580 deaths (900 men and boys and 680 women
−Removed: and girls) from ALL will occur this year.
−Removed: ( https://www.cancer.net/cancer-types/leukemia-acute-lymphocytic-all/statistics ).
−Removed: KPC34 Technology Summary
−Removed: KPC34, a conjugate molecule made of
−Removed: a gemcitabine molecule linked to a phospholipid, has the following structure:
−Removed: In the illustration above, to the left of the
−Removed: dashed line is the phospholipid portion and to the right of the dashed line is gemcitabine.
−Removed: Gemcitabine is a chemotherapy drug used to treat
−Removed: a wide array of cancers, including breast cancer, ovarian cancer, non-small cell lung cancer, pancreatic cancer and bladder cancer.
−Removed: drug interferes with DNA and the function of the phospholipid to which the gemcitabine is linked in KPC34, is to inhibit protein kinase
−Removed: C-type enzymes, which are involved in multiple signaling pathways in leukemia.
−Removed: The strategy behind targeting both DNA synthesis
−Removed: and protein kinase C with one molecule is to double-target different mechanisms of action in leukemia cells and greatly reduce the possibility
−Removed: of development of resistance to the drug.
−Removed: KPC34 is intended to treat the relatively small
−Removed: population of patients with AML and ALL.
−Removed: Because of the low patient population, FDA orphan drug status can be sought, which provides
−Removed: expedited review and seven years of exclusivity from approval of the new drug application.
−Removed: Preliminary data from preclinical studies at
−Removed: Wake Forest on the drug includes the following results:
−Removed: leukemia cells in vitro;
−Removed: protein kinase C in biochemical assays;
−Removed: central nervous system leukemia;
−Removed: AML exhibiting phosphorylated protein kinase C;
−Removed: Forest claims KPC34 targeted gemcitabine alone or cytarabine (another chemo drug) alone;
−Removed: also appears to overcome resistance to gemcitabine;
−Removed: it is effective against gemcitabine-resistant
−Removed: The technology licensed is much broader than
−Removed: KPC34 represents, and includes additional anticancer and antiviral conjugates, and could include a much broader range of indications,
−Removed: but we have no such drug candidates in development.
−Removed: KPC34 Patent Coverage
−Removed: KPC34 Patent Coverage
−Removed: The KPC34 license includes five issued patents,
−Removed: but only one of them covers KPC34.
−Removed: The patent is US7309696, entitled “Compositions and methods for targeting cancer cells.”
−Removed: It expired on August 11, 2021.
−Removed: All five of the licensed patents will expire by late 2022, and no continuation applications will be filed.
−Removed: On April 12, 2018, CBM entered into a patent
−Removed: license agreement (the “UT Agreement”) with the University of Texas at Austin on behalf of the Board of Regents of the University
−Removed: of Texas System.
−Removed: The UT Agreement granted to CBM an exclusive, royalty-bearing license to certain patent applications related to nucleobase
−Removed: analogue derivatives and their applications, and specifically to the DHA-dFdC drug candidate.
−Removed: On November 13, 2019, the University of
−Removed: Texas at Austin, the Company and CBM entered into an assignment of agreement, whereby CBM assigned all of its rights, title and interest
−Removed: to, and obligations under the UT Agreement to the Company.
−Removed: On April 17, 2018, CBM entered into a license
−Removed: agreement (the “WF Agreement”) with Wake Forest University Health Sciences (“WF”).
−Removed: The WF Agreement granted to
−Removed: CBM an exclusive, royalty-bearing license to WF’s and The University of North Carolina at Chapel Hill’s patents relating
−Removed: to the KPC34 drug candidate.
−Removed: On November 13, 2019, WF, the Company and CBM entered into an assignment of agreement, whereby CBM assigned
−Removed: all of its rights, title and interest to, and obligations under the WF Agreement to the Company.
−Removed: On April 13, 2020, the Company executed a Master
−Removed: License Agreement (the “UMB License Agreement”) with UMB, pursuant to which UMB agreed to license inventions collectively
−Removed: known as “Broad Spectrum Antiviral Compounds Which Target the SKI Complex” (the “Inventions”) to the Company.
−Removed: The Inventions, which are covered by three patent applications on file with the United States Patent and Trademark Office, are currently
−Removed: in the pre-clinical stage and seek to inhibit replication of multiple viruses, including the Influenza virus, SARS-CoV, MERS-CoV, Ebolavirus
−Removed: and Marburg virus.
−Removed: In addition, the Company entered into a Sponsored Research Agreement with UMB to support the development of various
−Removed: technologies.
−Removed: Pursuant to the UMB License Agreement, UMB grants to the Company the ability to utilize the licensed products (“Licensed
−Removed: Products”) and patents associated with the Inventions, subject to certain limitations described in the UMB License Agreement.
−Removed: improvements to the Inventions are solely owned by the party improving the Inventions, unless jointly made, in which case both parties
−Removed: jointly own the improvements;
−Removed: however, the Company grants to UMB the royalty-free license to practice the Company’s improvements.
−Removed: The Company has agreed to deliver to UMB a commercialization plan setting forth the Company’s plan for research and development
−Removed: required to develop the Licensed Products and the Company’s overall commercialization strategy by December 31, 2022.
−Removed: On August 7, 2020, the Company entered into a
−Removed: fixed price agreement (the “Fixed Price Agreement”) with the University of Kentucky Research Foundation (“UKRF”),
−Removed: pursuant to which the Company received an option to negotiate an exclusive license with the UKRF for certain of its patents related to
−Removed: G4-1 for solid tumor treatment in exchange for $67,000.
−Removed: The research, which is currently in progress, involves testing of the drug G4-1
−Removed: and its ability to increase the duration of survival of mice injected with tumor cells relative to an FDA approved drug.
−Removed: subject to the option do not expire until 2035.
−Removed: Commercialization
−Removed: Our business success with our drug portfolio depends not only on the
−Removed: successful development and approval of the products but also on the commercialization.
−Removed: At present, our plan anticipates us making the
−Removed: investments necessary to build an in-house marketing and sales capability for the U.S.
−Removed: market for our drug pipeline, or to partner with
−Removed: a larger drug development company to commercialize our drugs as they move through the FDA approval process.
−Removed: As our drug compounds make
−Removed: their way through clinical development in the U.S., we intend to approach pharmaceutical and biotechnology companies outside the U.S.
−Removed: to negotiate and enter into strategic partnerships that will enable development and commercialization of our platform outside the U.S.,
−Removed: where we believe the market opportunity is larger than that of the U.S.
−Removed: albeit far more complex to reach.
−Removed: We have no operations outside
−Removed: the U.S., nor are we planning to have any non-U.S.
−Removed: Manufacturing and Supply
−Removed: We do not have any manufacturing capabilities
−Removed: and therefore we will have to engage a third party to assist in manufacturing.
−Removed: Such manufacturing will need to be done in accordance
−Removed: with good manufacturing practice requirements (“cGMP”) regulations, to formulate and manufacture our product candidates.
−Removed: A list of third party cGMP manufacturers is currently being developed.
−Removed: Government Regulation
−Removed: Governmental authorities in the U.S.
−Removed: countries extensively regulate the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing
−Removed: of pharmaceutical products such as those being developed by us.
−Removed: In the U.S., the FDA regulates such products under the FDCA and implements
−Removed: related regulations.
−Removed: Failure to comply with applicable FDA requirements, both before and after approval, may subject us to administrative
−Removed: and judicial sanctions, such as a delay in approving or refusal by the FDA to approve pending applications, warning letters, product
−Removed: recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.
−Removed: Food and Drug Administration Regulation
−Removed: United States Drug Development
−Removed: In the United States, the FDA regulates drugs,
−Removed: medical devices and combinations of drugs and devices, or combination products, under the FDCA and its implementing regulations.
−Removed: are also subject to other federal, state and local statutes and regulations.
−Removed: The process of obtaining regulatory approvals and the subsequent
−Removed: compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and
−Removed: financial resources.
−Removed: Failure to comply with the applicable U.S.
−Removed: requirements at any time during the product development process, approval
−Removed: process or after approval, may subject an applicant to administrative or judicial sanctions.
−Removed: These sanctions could include, among other
−Removed: actions, the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, untitled or warning letters,
−Removed: requests for voluntary product recalls or withdrawals from the market, product seizures, total or partial suspension of production or
−Removed: distribution injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil or criminal penalties.
−Removed: or judicial enforcement action could have a material adverse effect on us.
−Removed: The process required by the FDA before a drug
−Removed: may be marketed in the United States generally involves the following:
−Removed: completion of extensive pre-clinical laboratory tests,
−Removed: animal studies and formulation studies in accordance with applicable regulations, including the FDA’s Good Laboratory Practice
−Removed: submission to the FDA of an IND, which must become
−Removed: effective before human clinical trials may begin;
−Removed: performance of adequate and well-controlled human
−Removed: clinical trials in accordance with an applicable IND and other clinical study related regulations, sometimes referred to as good
−Removed: clinical practices, or GCPs, to establish the safety and efficacy of the proposed drug for its proposed indication;
−Removed: submission to the FDA of an NDA;
−Removed: satisfactory completion of an FDA pre-approval inspection
−Removed: of the manufacturing facility or facilities at which the product, or components thereof, are produced to assess compliance with the
−Removed: FDA’s cGMP requirements;
−Removed: potential FDA audit of the clinical trial sites that
−Removed: generated the data in support of the NDA;
−Removed: FDA review and approval of the NDA prior to any commercial
−Removed: marketing or sale.
−Removed: Once a pharmaceutical product candidate is identified
−Removed: for development, it enters the pre-clinical testing stage.
−Removed: Pre-clinical tests include laboratory evaluations of product chemistry, toxicity,
−Removed: formulation and stability, as well as animal studies.
−Removed: An IND sponsor must submit the results of the pre-clinical tests, together with
−Removed: manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND.
−Removed: must also include a protocol detailing, among other things, the objectives of the initial clinical trial, the parameters to be used in
−Removed: monitoring safety and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation.
−Removed: Some pre-clinical testing may continue even after the IND is submitted.
−Removed: The IND automatically becomes effective 30 days after receipt
−Removed: by the FDA, unless the FDA raises concerns or questions related to a proposed clinical trial and places the trial on a clinical hold
−Removed: within that 30-day period.
−Removed: In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial
−Removed: Clinical holds also may be imposed by the FDA at any time before or during clinical trials due to safety concerns or non-compliance,
−Removed: and may be imposed on all drug products within a certain class of drugs.
−Removed: The FDA also can impose partial clinical holds, for example,
−Removed: prohibiting the initiation of clinical trials of a certain duration or for a certain dose.
−Removed: All clinical trials must be conducted under the
−Removed: supervision of one or more qualified investigators in accordance with GCP regulations.
−Removed: These regulations include the requirement that
−Removed: all research subjects provide informed consent in writing before their participation in any clinical trial.
−Removed: Further, an IRB must review
−Removed: and approve the plan for any clinical trial before it commences at any institution, and the IRB must conduct continuing review and reapprove
−Removed: the study at least annually.
−Removed: An IRB considers, among other things, whether the risks to individuals participating in the clinical trial
−Removed: are minimized and are reasonable in relation to anticipated benefits.
−Removed: The IRB also approves the information regarding the clinical trial
−Removed: and the consent form that must be provided to each clinical trial subject or his or her legal Representative and must monitor the clinical
−Removed: trial until completed.
−Removed: Each new clinical protocol and any amendments
−Removed: to the protocol must be submitted for FDA review, and to the IRBs for approval.
−Removed: Protocols detail, among other things, the objectives
−Removed: of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject
−Removed: Human clinical trials are typically conducted
−Removed: in three sequential phases that may overlap or be combined:
−Removed: The product is initially introduced into a small number of healthy human subjects or patients
−Removed: and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion
−Removed: and, if possible, to gain early evidence on effectiveness.
−Removed: In the case of some products for
−Removed: severe or life-threatening diseases, especially when the product is suspected or known to
−Removed: be unavoidably toxic, the initial human testing may be conducted in patients.
−Removed: Involves clinical trials in a limited patient population to identify possible adverse
−Removed: effects and safety risks, to preliminarily evaluate the efficacy of the product for specific
−Removed: targeted diseases and to determine dosage tolerance and optimal dosage and schedule.
−Removed: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety
−Removed: in an expanded patient population at geographically dispersed clinical trial sites.
−Removed: clinical trials are intended to establish the overall risk/benefit relationship of the product
−Removed: and provide an adequate basis for product labeling.
−Removed: Post-approval trials, sometimes referred to as
−Removed: Phase 4 clinical trials, may be conducted after initial marketing approval.
−Removed: These studies are used to gain additional experience from
−Removed: the treatment of patients in the intended therapeutic indication.
−Removed: In certain instances, the FDA may mandate the performance of Phase
−Removed: Companies that conduct certain clinical trials also are required to register them and post the results of completed clinical
−Removed: trials on a government-sponsored database, such as ClinicalTrials.gov in the United States, within certain timeframes.
−Removed: Failure to do
−Removed: so can result in fines, adverse publicity and civil and criminal sanctions.
−Removed: Progress reports detailing the results of the
−Removed: clinical trials, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted
−Removed: to the FDA and the investigators for serious and unexpected adverse events, findings from other studies that suggest a significant risk
−Removed: to humans exposed to the product, findings from animal or in vitro testing that suggest a significant risk to human subjects, and any
−Removed: clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.
−Removed: Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.
−Removed: The FDA or the
−Removed: clinical trial sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research
−Removed: subjects or patients are being exposed to an unacceptable health risk.
−Removed: Similarly, an IRB can suspend or terminate approval of a clinical
−Removed: trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product
−Removed: has been associated with unexpected serious harm to patients.
−Removed: Additionally, some clinical trials are overseen by an independent group
−Removed: of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee.
−Removed: This group provides
−Removed: authorization for whether a trial may move forward at designated check points based on access to certain data from the study.
−Removed: trial sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate.
−Removed: Concurrent with clinical trials, companies usually
−Removed: complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the
−Removed: product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
−Removed: The manufacturing
−Removed: process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer
−Removed: must develop methods for testing the identity, strength, quality and purity of the final product.
−Removed: Additionally, appropriate packaging
−Removed: must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable
−Removed: deterioration over its shelf life.
−Removed: NDA and FDA Review Process
−Removed: The results of product development, pre-clinical
−Removed: studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the drug, proposed labeling
−Removed: and other relevant information, are submitted to the FDA as part of an NDA for a new drug, requesting approval to market the product.
−Removed: The submission of an NDA is subject to the payment of a substantial user fee, and the sponsor of an approved NDA is also subject to an
−Removed: annual program user fee;
−Removed: although a waiver of such fee may be obtained under certain limited circumstances.
−Removed: For example, the agency will
−Removed: waive the application fee for the first human drug application that a small business or its affiliate submits for review.
−Removed: The FDA reviews all NDAs submitted before it
−Removed: accepts them for filing and may request additional information rather than accepting an NDA for filing.
−Removed: The FDA typically makes a decision
−Removed: on accepting an NDA for filing within 60 days of receipt.
−Removed: The decision to accept the NDA for filing means that the FDA has made a threshold
−Removed: determination that the application is sufficiently complete to permit a substantive review.
−Removed: Under the goals and policies agreed to by
−Removed: the FDA under the Prescription Drug User Fee Act (“PDUFA”), the FDA’s goal to complete its substantive review of a
−Removed: standard NDA and respond to the applicant is ten months from the receipt of the NDA.
−Removed: The FDA does not always meet its PDUFA goal dates,
−Removed: and the review process is often significantly extended by FDA requests for additional information or clarification and may go through
−Removed: multiple review cycles.
−Removed: After the NDA submission is accepted for filing,
−Removed: the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use, and
−Removed: whether the product is being manufactured in accordance with cGMPs to assure and preserve the product’s identity, strength, quality
−Removed: The FDA may refer applications for novel drug products or drug products which present difficult questions of safety or efficacy
−Removed: to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as
−Removed: to whether the application should be approved and under what conditions.
−Removed: The FDA is not bound by the recommendations of an advisory committee,
−Removed: but it considers such recommendations carefully when making decisions.
−Removed: The FDA will likely re-analyze the clinical trial data, which
−Removed: could result in extensive discussions between the FDA and us during the review process.
−Removed: The review and evaluation of an NDA by the FDA
−Removed: is extensive and time consuming and may take longer than originally planned to complete, and we may not receive a timely approval, if
−Removed: Before approving an NDA, the FDA will conduct
−Removed: a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMPs.
−Removed: not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements
−Removed: and adequate to assure consistent production of the product within required specifications.
−Removed: In addition, before approving an NDA, the
−Removed: FDA may also audit data from clinical trials to ensure compliance with GCP requirements.
−Removed: After the FDA evaluates the application, manufacturing
−Removed: process and manufacturing facilities, it may issue an approval letter or a Complete Response Letter.
−Removed: An approval letter authorizes commercial
−Removed: marketing of the drug with specific prescribing information for specific indications.
−Removed: A Complete Response Letter indicates that the review
−Removed: cycle of the application is complete and the application will not be approved in its present form.
−Removed: A Complete Response Letter usually
−Removed: describes all the specific deficiencies in the NDA identified by the FDA.
−Removed: The Complete Response Letter may require additional clinical
−Removed: data and/or an additional pivotal Phase 3 clinical trial(s), and/or other significant and time-consuming requirements related to clinical
−Removed: trials, nonclinical studies or manufacturing.
−Removed: If a Complete Response Letter is issued, the applicant may either resubmit the NDA, addressing
−Removed: all the deficiencies identified in the letter, or withdraw the application.
−Removed: Even if such data and information are submitted, the FDA
−Removed: may ultimately decide that the NDA does not satisfy the criteria for approval.
−Removed: Data obtained from clinical trials are not always conclusive,
−Removed: and the FDA may interpret data differently than we interpret the same data.
−Removed: There is no assurance that the FDA will ultimately
−Removed: approve a product for marketing in the United States, and we may encounter significant difficulties or costs during the review process.
−Removed: If a product receives marketing approval, the approval may be significantly limited to specific diseases and dosages or the indications
−Removed: for use may otherwise be limited, which could restrict the commercial value of the product.
−Removed: Further, the FDA may require that certain
−Removed: contraindications, warnings or precautions be included in the product labeling or may condition the approval of the NDA on other changes
−Removed: to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct post-market testing or clinical
−Removed: trials and surveillance to monitor the effects of approved products.
−Removed: For example, the FDA may require Phase 4 clinical trials to further
−Removed: assess drug safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that
−Removed: have been commercialized.
−Removed: The FDA may also place other conditions on approvals, including the requirement for a risk evaluation and mitigation
−Removed: strategy (“REMS”), to assure the safe use of the drug.
−Removed: If the FDA concludes a REMS is needed, the sponsor of the NDA must
−Removed: submit a proposed REMS;
−Removed: the FDA will not approve the NDA without an approved REMS, if required.
−Removed: A REMS could include medication guides,
−Removed: physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other
−Removed: risk minimization tools.
−Removed: Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription
−Removed: or dispensing of products.
−Removed: Product approvals may be withdrawn for non-compliance with regulatory requirements or if problems occur following
−Removed: initial marketing.
−Removed: Reimbursement
−Removed: Potential sales of any of our product candidates,
−Removed: if approved, will depend, at least in part, on the extent to which such products will be covered by third-party payors, such as government
−Removed: health care programs, commercial insurance and managed healthcare organizations.
−Removed: These third-party payors are increasingly limiting coverage
−Removed: and/or reducing reimbursements for medical products and services.
−Removed: A third-party payor’s decision to provide coverage for a drug
−Removed: product does not imply that an adequate reimbursement rate will be approved.
−Removed: Further, one payor’s determination to provide coverage
−Removed: for a drug product does not assure that other payors will also provide coverage for the drug product.
−Removed: In addition, the U.S.
−Removed: state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions
−Removed: on reimbursement and requirements for substitution of generic products.
−Removed: Adoption of price controls and cost-containment measures, and
−Removed: adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our future revenues and
−Removed: results of operations.
−Removed: Decreases in third-party reimbursement or a decision by a third-party payor to not cover a product candidate,
−Removed: if approved, or any future approved products could reduce physician usage of our products, and have a material adverse effect on our
−Removed: sales, results of operations and financial condition.
−Removed: In the United States, the Medicare Part D program
−Removed: provides a voluntary outpatient drug benefit to Medicare beneficiaries for certain products.
−Removed: We do not know whether our product candidates,
−Removed: if approved, will be eligible for coverage under Medicare Part D, but individual Medicare Part D plans offer coverage subject to various
−Removed: factors such as those described above.
−Removed: Furthermore, private payors often follow Medicare coverage policies and payment limitations in
−Removed: setting their own coverage policies.
−Removed: Healthcare Laws and Regulations
−Removed: Sales of our product candidates, if approved,
−Removed: or any other future product candidate will be subject to healthcare regulation and enforcement by the federal government and the states
−Removed: and foreign governments in which we might conduct our business.
−Removed: The healthcare laws and regulations that may affect our ability to operate
−Removed: include the following:
−Removed: The federal Anti-Kickback Statute makes it illegal
−Removed: for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that
−Removed: is in exchange for or to induce the referral of business, including the purchase, order, lease of any good, facility, item or service
−Removed: for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.
−Removed: The term “remuneration”
−Removed: has been broadly interpreted to include anything of value.
−Removed: Federal false claims and false statement laws, including
−Removed: the federal civil False Claims Act, prohibits, among other things, any person or entity from knowingly presenting, or causing to
−Removed: be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services, including
−Removed: drugs, that are false or fraudulent.
−Removed: Health Insurance Portability and Accountability Act
−Removed: of 1996 (“HIPAA”) created additional federal criminal statutes that prohibit among other actions, knowingly and willfully
−Removed: executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors or
−Removed: making any false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items
−Removed: HIPAA, as amended by the Health Information Technology
−Removed: for Economic and Clinical Health Act of 2009 and their implementing regulations, impose obligations on certain types of individuals
−Removed: and entities regarding the electronic exchange of information in common healthcare transactions, as well as standards relating to
−Removed: the privacy and security of individually identifiable health information.
−Removed: The federal Physician Payments Sunshine Act requires
−Removed: certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or
−Removed: the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid
−Removed: Services information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership
−Removed: and investment interests held by physicians and their immediate family members.
−Removed: Also, many states have similar laws and regulations,
−Removed: such as anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to items and
−Removed: services reimbursed under Medicaid and other state programs.
−Removed: Additionally, we may be subject to state laws that require pharmaceutical
−Removed: companies to comply with the federal government’s and/or pharmaceutical industry’s voluntary compliance guidelines, state
−Removed: laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare
−Removed: providers or marketing expenditures, as well as state and foreign laws governing the privacy and security of health information, many
−Removed: of which differ from each other in significant ways and often are not preempted by HIPAA.
−Removed: Additionally, to the extent that our product
−Removed: is sold in a foreign country, we may be subject to similar foreign laws.
−Removed: As of December 31, 2021, we have four full-time
−Removed: employees and one part-time employee, none of which are represented by a labor union or covered by a collective bargaining agreement.
+Added: Holdings Inc.
+Added: (“Dominari”) is a holding company that, through its various subsidiaries, is engaged in financial services,
+Added: investment advising and wealth management, asset management, investment banking, the acquisition of interests in high growth industries,
+Added: and biotechnology and pharmaceutical research and development.
+Added: In addition to capital investment, Dominari provides management
+Added: support to the executive teams of its subsidiaries, helping them to operate efficiently and reduce cost under a streamlined infrastructure.
+Added: and its subsidiaries are collectively referred to herein as “Company”, “we”, “our” or “us”.
+Added: Dominari Financial, Inc.
+Added: (“Dominari Financial”), our wholly-owned
+Added: financial subsidiary, is the M&A arm of Dominari and will execute the Company’s roll-up strategy in the financial sector.
+Added: roll-up strategy seeks to acquire third-party financial assets such as registered investment advisors, broker dealers, asset management
+Added: firms and fintech firms.
+Added: Our first transaction in furtherance of our financial roll-up strategy, the acquisition of 100% of a registered
+Added: broker-dealer from Fieldpoint Private Bank & Trust, was consummated on March 27, 2023.
+Added: The newly acquired dually registered broker-dealer
+Added: and investment adviser will be renamed Dominari Securities, LLC (“Dominari Securities”) and is a wholly-owned subsidiary of
+Added: Dominari Financial.
+Added: Dominari Securities will provide wealth management services, asset management services, investment banking and sales
+Added: The Company is in the process of winding down
+Added: its historical pipeline of biotechnology assets held by Aikido Labs, LLC.
+Added: These biotechnology assets consist of patented technology from
+Added: leading universities and researchers, including prospective treatments for pancreatic cancer, acute myeloid leukemia and acute lymphoblastic
+Added: The Company is also developing a broad-spectrum antiviral platform, in which the lead compounds have activity in
+Added: cell-based assays against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2,
+Added: the cause of COVID-19.
+Added: Company was founded in 1967 as Spherix Incorporated.
+Added: In 2017 the Company changed its name to Aikido Pharma Inc.
+Added: From 2017 to 2022, the
+Added: Company operated as a biotechnology company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics in development.
+Added: During the second half of 2022, in an effort to enhance shareholder value, the Company shifted its primary focus away from biotechnology
+Added: to a new line of business in the financial services industry.
+Added: In furtherance of this new focus, in June of 2022, the Company formed
+Added: Dominari Financial, with the purpose of making strategic acquisitions across the financial services industry.
+Added: On December 22, 2022, the
+Added: Company changed its name to Dominari Holdings Inc.
+Added: September 9, 2022, we entered into a membership interest purchase agreement (the “FPS Purchase Agreement”) with Fieldpoint
+Added: Private Bank & Trust (“Seller”), a Connecticut bank, for the purchase of its wholly owned subsidiary, Fieldpoint Private
+Added: Securities, LLC, a Connecticut limited liability company (“FPS”) and broker-dealer registered with the Financial Industry
+Added: Regulatory Authority (“FINRA”).
+Added: Pursuant to the terms of the FPS Purchase Agreement, we purchased from the Seller
+Added: 100% of the membership interests in FPS (the “Membership Interests”) and, as a result thereof, will operate the newly acquired
+Added: dual registered broker-dealer and investment adviser as a wholly owned subsidiary.
+Added: The FPS Purchase Agreement provided for Dominari’s
+Added: acquisition of FPS’s Membership Interests in two closings, the first of which occurred on October 4, 2022 (the “Initial
+Added: Closing”), at which Dominari paid to the Seller $2,000,000 in consideration for a transfer by the Seller to Dominari of 20% of
+Added: the Membership Interests.
+Added: Following FINRA’s approval of the Continuing Membership Application pursuant to FINRA Rule
+Added: 1017 (the “Rule 1017 Application”) on March 20, 2023, the second closing occurred on March 27, 2023 (the “Second Closing”),
+Added: at which time Dominari paid to the Seller an additional $1.00 in consideration for a transfer by the Seller to Dominari of the remaining
+Added: 80% of the Membership Interests.
+Added: Dominari Securities
+Added: plans to offer a broad range of broker-dealer and registered investment adviser services, commencing shortly after the completion of
+Added: its acquisition of FPS, which is expected to begin in April 2023, including:
+Added: Wealth Management
+Added: Dominari Securities
+Added: plans to provide a comprehensive array of financial services to high-net-worth individuals and families, corporate executives, and public
+Added: and private businesses.
+Added: Clients will be able to choose a variety of ways to establish a relationship and conduct business, including
+Added: by establishing brokerage accounts with transaction-based pricing and/or investment advisory accounts with asset-based fee pricing.
+Added: Securities also plans to provide the following private client services:
+Added: Dominari Securities plans to offer full-service brokerage services covering investment alternatives, including exchange-traded
+Added: and over-the-counter corporate equity and debt securities, money market instruments, exchange-traded options, municipal bonds, mutual
+Added: funds, exchange-traded funds, and unit investment trusts.
+Added: Dominari Securities expects its revenue to be derived from commissions from
+Added: private clients through accounts with transaction-based pricing.
+Added: Dominari Securities will charge brokerage commissions on investment
+Added: products in accordance with a schedule which Dominari Securities plans to formulate.
+Added: Discounts will be made available to and will able
+Added: to be negotiated with customers based on transaction size and volume as well as a number of other factors.
+Added: Dominari Securities also plans to offer financial and wealth planning services which will include asset management, individual
+Added: and corporate retirement solutions, insurance and annuity products, IRAs and 401(k) plans, U.S.
+Added: stock plan services to corporate executives
+Added: and businesses, education savings programs, and trust and fiduciary services to individual and corporate clients through third-party
+Added: trust companies.
+Added: Dominari Securities, through its clearing partnerships, also intends to extend credit to its customers, collateralized by
+Added: securities and cash in the customer’s account, for a portion of the purchase price, and to receive income from interest on such extensions
+Added: of credit at interest rates derived from Dominari Securities’ posted rate as adjusted, from time to time.
+Added: Dominari Securities
+Added: also plans to offer discretionary and non-discretionary fee-based programs to provide tailored investment management solutions and services
+Added: to high-net-worth private clients, institutions and corporations and/or plans sponsored by them.
+Added: These will include, but will not be
+Added: limited to, portfolio management, manager research and due diligence through third party partners, asset allocation advice and financial
+Added: Dominari Securities plans to offer Portfolio management strategies and third-party investment management capabilities through
+Added: separately managed accounts, alternative investments and discretionary and non-discretionary portfolio management programs as well as
+Added: managed portfolios of mutual funds.
+Added: Platform support functions will include sales and marketing along with administrative services such
+Added: as trade execution, client services, records management and client reporting and performance monitoring.
+Added: Dominari Securities expects
+Added: to generate revenues through the receipt of investment advisory and transactional fees for advisory services and to also generate revenue
+Added: from fees earned through sharing arrangements with registered and private alternative investment vehicles.
+Added: Dominari Securities also expects
+Added: to earn investment advisory fees on all assets held in discretionary and non-discretionary asset-based programs.
+Added: These fees will be typically
+Added: billed monthly in advance, and will be calculated based on all fee-based assets under management balances at the end of the prior month.
+Added: Dominari Securities also expects to receive income from revenue-sharing arrangements that are derived from management and incentive fees
+Added: on alternative investments and will be calculated on a pre-determined basis with registered and private investment companies.
+Added: The Company’s
+Added: asset management services are expected to include:
+Added: Managed Accounts .
+Added: The Company plans to provide clients with fee-based programs:
+Added: (i) a unified managed account which allows multiple
+Added: investment managers, mutual funds and exchange-traded funds to be combined in a single custodial account;
+Added: and (ii) an asset review
+Added: dual contract program designed for clients seeking a direct contractual relationship with investment managers.
+Added: Discretionary
+Added: Advisory Accounts .
+Added: Dominari Securities plans to offer client-focused discretionary fee-based investment programs managed by
+Added: Dominari Securities advisors.
+Added: Non-Discretionary
+Added: Advisory Accounts .
+Added: Dominari plans to provide fee-based non-discretionary investment advisory services and consultation to clients.
+Added: Investments .
+Added: Dominari plans to offer high net worth and institutional investors the opportunity to participate in a wide range of
+Added: non-traditional investment strategies.
+Added: Strategies are expected to include single manager hedge funds, fund of funds, diversified private
+Added: equity funds and single investment late stage private equity funds.
+Added: Market Platform .
+Added: Through a collaborative effort among the firm’s business units, Dominari’s private market
+Added: platform will focus on sourcing private investments across various sectors.
+Added: Transactions are expected to cover the full spectrum of private
+Added: investments, including early stage, late stage, direct, co-investments, funds and secondary market transactions in debt, equity and hybrid
+Added: Dominari Securities’
+Added: investment banking division will provide strategic advisory services and capital markets products to emerging growth and middle market
+Added: The investment banking groups will focus on the consumer and retail, energy, financial institutions, healthcare, rental services,
+Added: technology, education, and transportation and logistics sectors.
+Added: Investment banking services include:
+Added: Dominari Securities will advise buyers and sellers on sales, divestitures, mergers, acquisitions, tender offers, privatizations,
+Added: spin-offs, joint ventures, restructurings and liability management.
+Added: Dominari Securities intends to provide dedicated senior bankers to
+Added: clients focusing throughout the financial advisory process, which combines our structuring and negotiating expertise with our industry
+Added: knowledge, extensive relationships and capital markets capabilities.
+Added: Capital Markets .
+Added: Dominari Securities will provide capital raising solutions for corporate clients through initial public offerings,
+Added: follow-on offerings, confidentially marketed public offerings, registered directs, private investments in public equity, private placements,
+Added: at-the-market offerings, and equity-linked offerings.
+Added: Dominari Securities plans to offer debt capital markets solutions for emerging growth and middle market companies.
+Added: Securities will focus on structuring and distributing public and private debt through financing transactions, including leveraged buyouts,
+Added: acquisitions, growth capital financings, recapitalizations and Chapter 11 exit financings.
+Added: Dominari Securities will also participate
+Added: in high yield debt and fixed and floating-rate senior and subordinated debt offerings.
+Added: Fund Placement .
+Added: Dominari Securities will provide alternative investment firms with a broad and deep portfolio of value-added services.
+Added: Services will
+Added: include bespoke strategic and tactical advisory as well as primary fundraises, co-investments and direct transactions.
+Added: Debt Advisory
+Added: & Restructuring .
+Added: Dominari Securities will offer creative solutions to leveraged corporate issuers and credit investors.
+Added: evaluate a full range of strategic alternatives, identify the appropriate structure and source of funds to provide our clients the ability
+Added: to pursue an optimal and value maximizing outcome.
+Added: Sales and Trading
+Added: We intend to provide
+Added: a broad range of sales and trading services to our clients.
+Added: Sales and trading services will include:
+Added: Institutional
+Added: Equity Sales and Trading .
+Added: Dominari Securities will act as an agent in the execution of its customers’ orders through our clearing
+Added: strategic partners.
+Added: Equity Derivatives and Index
+Added: Dominari Securities will offer listed equity and index options strategies for investors seeking to manage risk and
+Added: optimize returns within the equities market.
+Added: Institutional
+Added: Fixed Income Sales and Trading .
+Added: Dominari Securities will trade and in public and private debt (including sovereign debt) securities,
+Added: including investment and non-investment grade, distressed and convertible corporate securities as well as municipal securities through
+Added: our clearing partners.
+Added: In connection with both its trading and brokerage activities, Dominari Securities, through its clearing relationships, will
+Added: borrow securities to cover short sales and to complete transactions in which customers have failed to deliver securities by the required
+Added: settlement date and lend securities to other brokers and dealers for similar purposes.
+Added: Dominari Securities will earn interest on its
+Added: cash collateral provided and will pay interest on the cash collateral received less a rebate earned for lending securities.
+Added: Regulation in the United States
+Added: The financial services industry in which we will operate is subject
+Added: to extensive regulation.
+Added: In the U.S., the SEC is the federal agency responsible for the administration of federal securities laws.
+Added: addition, the Financial Industry Regulatory Authority, Inc.
+Added: (“FINRA”) is a self-regulatory organization (“SRO”)
+Added: that is actively involved in the regulation of securities businesses.
+Added: In addition to federal regulation, we are subject to state securities
+Added: regulations in each state and U.S.
+Added: territory in which we conduct securities or investment advisory activities.
+Added: The SEC, FINRA, and state
+Added: securities regulators conduct periodic examinations of broker-dealers and investment advisors.
+Added: The designated examining authority under
+Added: Securities Exchange Act of 1934, as amended (the “Exchange Act”) for Dominari Securities’ activities as a broker-dealer
+Added: Financial services businesses are also subject to regulation and examination by state securities regulators and attorneys general
+Added: in those states in which they do business.
+Added: In addition, broker-dealers and investment advisors must also comply with the rules and regulation
+Added: of clearing houses, exchanges, and trading platforms of which they are a member.
+Added: Broker-dealers are subject to SEC, FINRA, and
+Added: state securities regulations that cover all aspects of the securities business, including sales and trading methods, trade practices
+Added: among broker-dealers, use and safekeeping of customers’ funds and securities, capital structure and requirements, anti-money laundering
+Added: efforts, recordkeeping and the conduct of broker-dealer personnel including officers and employees (although state securities regulations
+Added: are, in a number of cases, more limited).
+Added: Registered investment advisors are subject to, among other requirements, SEC regulations concerning
+Added: marketing, transactions with affiliates, custody of client assets, disclosures to clients, conflict of interest, insider trading and
+Added: recordkeeping.
+Added: Additional legislation, changes in rules promulgated by the SEC, FINRA, and other SROs of which the broker-dealer is a
+Added: member, and state securities regulators, or changes in the interpretation or enforcement of existing laws or rules may directly affect
+Added: the operations and profitability of broker-dealers and investment advisors.
+Added: The SEC, FINRA, and state securities regulators and state
+Added: attorneys general may conduct administrative proceedings or initiate civil litigation that can result in adverse consequences for Dominari
+Added: Securities, its affiliates, including affiliated investment advisors, as well as its and their officers and employees (including, without
+Added: limitation, injunctions, censures, fines, suspensions, directives that impact business operations (including proposed expansions), membership
+Added: expulsions, or revocations of licenses and registrations).
+Added: SEC Regulation Best Interest (“Reg BI”)
+Added: requires that a broker-dealer and its associated persons act in a retail customer’s best interest and not place their own financial
+Added: or other interests ahead of a retail customer’s interests when recommending securities transactions or investment strategies, including
+Added: recommendations of types of accounts.
+Added: To meet this best interest standard, a broker-dealer must satisfy four component obligations
+Added: including a disclosure obligation, a care obligation, a conflict of interest obligation, and a compliance obligation and both broker-dealers
+Added: and investment advisors are required to provide disclosures about their standard of conduct and conflicts of interest.
+Added: In addition, certain states, have proposed or
+Added: adopted measures that would make broker-dealers, sales agents and investment advisors and their representatives subject to a fiduciary
+Added: duty when providing products and services to customers.
+Added: The SEC did not indicate an intent to pre-empt state regulation in this
+Added: area, and some of the state proposals would allow for a private right of action.
+Added: In the event out wealth management division makes recommendations
+Added: to retail customers, it will be required to comply with the obligations imposed under Reg BI and applicable state laws.
+Added: Regulatory Capital Requirements
+Added: Dominari Securities will be subject to financial
+Added: capital requirements that are set by regulation.
+Added: Dominari Securities is a registered broker-dealer and is required to maintain net capital
+Added: in an amount equal to SEC minimum financial requirements.
+Added: As a broker-dealer, Dominari Securities is subject to the SEC’s Uniform
+Added: Net Capital Rule (the “Net Capital Rule”).
+Added: Compliance with the Net Capital Rule could limit Dominari Securities’ operations,
+Added: such as underwriting and trading activities, and financing customers’ prime brokerage or other margin activities, in each case,
+Added: that could require the use of significant amounts of capital, limit its ability to engage in certain financing transactions, such as
+Added: repurchase agreements, and may also restrict its ability (i) to make payments of dividends, withdrawals or similar distributions or payments
+Added: to a stockholder/parent or other affiliate, (ii) to make a redemption or repurchase of shares of stock, or (iii) to make an unsecured
+Added: loan or advance to such shareholders or affiliates.
+Added: Under the Exchange Act, state securities regulators
+Added: are not permitted to impose capital, margin, custody, financial responsibility, making and keeping records, bonding, or financial or
+Added: operational reporting requirements on registered broker-dealers that differ from, or are in addition to, the requirements in those areas
+Added: established under the Exchange Act, including the rules and regulations promulgated thereunder.
+Added: Regulation outside the United States
+Added: In the event Dominari Securities provides financial
+Added: services internationally, it will be subject to extensive regulations proposed, promulgated and enforced by, among other regulatory bodies,
+Added: the European Commission and European Supervisory Authorities (including the European Banking Authority and European Securities and Market
+Added: Authority), U.K.
+Added: Financial Conduct Authority, German Federal Financial Supervisory Authority (“BaFin”), Investment Industry
+Added: Regulatory Organization of Canada, Hong Kong Securities and Futures Commission, the Japan Financial Services Agency, the Monetary Authority
+Added: of Singapore, and the Australian Securities and Investments Commission.
+Added: Every country in which we may do business will impose upon us
+Added: laws, rules and regulations similar to those in the U.S., including with respect to some form of capital adequacy rules, customer protection
+Added: rules, data protection regulations, anti-money laundering and anti-bribery rules, compliance with other applicable trading and investment
+Added: banking regulations and similar regulatory reform.
+Added: All aspects of our business are expected to be intensely competitive.
+Added: We will compete primarily with small to mid-size bank holding companies that engage in wealth management, investment banking and capital
+Added: markets activities as one of their lines of business and that have greater capital and resources than we do.
+Added: We will also compete against
+Added: other broker-dealers, asset managers and boutique firms.
+Added: We believe the principal factors that will drive our competitiveness in the future
+Added: will include our ability to:
+Added: provide differentiated insights to our clients that lead to better business outcomes;
+Added: attract, retain and
+Added: develop skilled professionals;
+Added: deliver a competitive breadth of high-quality service offerings;
+Added: and to maintain a flat, nimble and entrepreneurial
+Added: culture built on immediacy and client service.
+Added: Cybersecurity
+Added: Cybersecurity presents
+Added: significant challenges to the business community in general, including to the financial services industry.
+Added: Increasingly, bad actors,
+Added: both domestic and international, attempt to steal personal data and/or interrupt the normal functioning of businesses through accessing
+Added: individuals' and companies' files and equipment connected to the internet.
+Added: Recent incidents have reflected the increasing sophistication
+Added: of intruders and their intent to steal personally identifiable information as well as funds and securities.
+Added: These intruders sometimes
+Added: use instructions that are seemingly from authorized parties but in fact, are from parties intent on attempting to steal.
+Added: In other instances
+Added: these intruders attempt to bypass normal safeguards and disrupt or steal significant amounts of information and then either release it
+Added: to the internet or hold it for ransom.
+Added: Regulators are increasingly requiring companies to provide heightened levels of sophisticated
+Added: Dominari Securities will maintain ongoing planning and systems to prevent any such attack from disrupting its services to clients
+Added: as well as to prevent any loss of data concerning its clients, their financial affairs, as well as Company privileged information.
+Added: of December 31, 2022, we have 7 full-time employees and 1 part-time employee, none of which are represented by a labor union or covered
+Added: by a collective bargaining agreement.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.