−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations
−Removed: Forward-Looking
−Removed: should read this discussion together with the Financial Statements, related Notes and other financial information included elsewhere
−Removed: in this Form 10-Q.
−Removed: The following discussion contains assumptions, estimates and other forward-looking statements that involve a number
−Removed: of risks and uncertainties.
−Removed: These risks could cause our actual results to differ materially from those anticipated in these forward-looking
−Removed: All references to “we,” “us,” “our” and the “Company” refer to Aikido Pharma
−Removed: Inc., a Delaware corporation and its consolidated subsidiaries unless the context requires otherwise.
+Added: Management’s Discussion and Analysis of Financial
+Added: Condition and Results of Operations
+Added: Forward-Looking Statements
+Added: You should read this discussion together with
+Added: the Financial Statements, related Notes and other financial information included elsewhere in this Form 10-Q.
+Added: The following discussion
+Added: contains assumptions, estimates and other forward-looking statements that involve a number of risks and uncertainties.
+Added: These risks could
+Added: cause our actual results to differ materially from those anticipated in these forward-looking statements.
+Added: All references to “we,”
+Added: “us,” “our” and the “Company” refer to Aikido Pharma Inc., a Delaware corporation and its consolidated
+Added: subsidiaries unless the context requires otherwise.
+Added: AIkido Pharma Inc.
was initially formed in 1967
−Removed: Since 2017, the Company has operated as a biotechnology company with a diverse portfolio of
−Removed: small-molecule anticancer and antiviral therapeutics in development.
−Removed: The Company’s pipeline consists of patented technology from
−Removed: leading universities and researchers.
−Removed: We are currently in the process of developing our innovative therapeutic drug pipeline through
−Removed: strong partnerships with world renowned educational institutions, including the University of Texas at Austin, the University of Maryland,
−Removed: Baltimore and Wake Forest University.
−Removed: Our oncology therapeutics include treatments for pancreatic cancer, acute myeloid leukemia (AML)
−Removed: and acute lymphoblastic leukemia (ALL).
−Removed: The Company is also developing a broad-spectrum antiviral platform, in which the lead compounds
−Removed: have activity against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the
−Removed: cause of COVID-19.
−Removed: a result of the Company’s biotechnology research and development and associated investments and acquisitions, our business portfolio
−Removed: now focuses on the treatment of three different cancers and multiple types of viral infections.
−Removed: Our pancreatic drug candidate, DHA-dFdC,
−Removed: developed at and licensed from the University of Texas at Austin, is a new compound that we hope will become the next generation of chemotherapy
−Removed: treatment for advanced pancreatic cancer.
−Removed: DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated
−Removed: in preclinical toxicity tests.
−Removed: Preclinical studies have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth (up to 100,000-fold
−Removed: more potent that gemcitabine, a current standard therapy), targets pancreatic tumors 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: broad-spectrum antiviral platform was developed at the University of Maryland Baltimore (“UMB”), which granted the Company
−Removed: an exclusive worldwide Master License Agreement (MLA”) to technology covered by three separate patent applications.
−Removed: technology comprises broadly acting pan-viral inhibitory compounds targeting multiple viral pathogens.
−Removed: The technology was invented by
−Removed: UMB scientists Drs.
−Removed: Matthew Frieman, Alexander MacKerell and Stuart Watson.
−Removed: The Company has also executed a Sponsored Research Agreement
−Removed: with UMB to support the development of the technology under the direction of these inventors at UMB.
−Removed: addition, we are constantly seeking to grow our pipeline of treatments in oncology indications.
−Removed: For example, in January 2021, the Company
−Removed: invested in Convergent Therapeutics, Inc., which has exclusive rights to technology related to next-generation dual-action peptide receptor
−Removed: radionuclide therapy (“PRRT”) for prostate cancer covered by multiple issued U.S.
+Added: and is currently a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics in development.
+Added: The Company’s
+Added: platform consists of patented technology from leading universities and researchers and our innovative therapeutic drug platform is currently
+Added: being advanced through strong collaborations with world-renowned educational institutions, including the University of Texas at Austin,
+Added: the University of Maryland, Baltimore and Wake Forest University.
+Added: Our diverse pipeline of therapeutics includes therapies for pancreatic
+Added: cancer, acute myeloid leukemia (“AML”) and acute lymphoblastic leukemia (“ALL”).
+Added: The Company is also developing
+Added: broad-spectrum antiviral compounds with the potential to inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus),
+Added: MERS-CoV, Ebolavirus and Marburg virus.
+Added: The Company previously focused its efforts on
+Added: owning, developing, acquiring and monetizing intellectual property assets.
+Added: Since May 2016, the Company has received limited funds from
+Added: its intellectual property monetization.
+Added: In addition to its patent monetization efforts, since the fourth quarter of 2017, the Company
+Added: has been transitioning to focus its efforts as a technology and biotechnology development company.
+Added: These efforts have focused on biotechnology
+Added: research and blockchain technology research.
+Added: The Company’s investment in biotechnology research development includes:
+Added: (i) an investment
+Added: in Hoth Therapeutics, Inc.
+Added: (“Hoth”), a development stage biopharmaceutical company focused on unique targeted therapeutics
+Added: for patients suffering from indications such as atopic dermatitis, also known as eczema, (ii) an investment in DatChat, Inc.
+Added: a privately held personal privacy platform focused on encrypted communication, internet security and digital rights management, and (iii)
+Added: the acquisition of assets of CBM BioPharma, Inc.
+Added: (“CBM”), a pharmaceutical company focusing on the development of cancer treatments.
+Added: In January of 2021, the Company acquired an ownership interest in Convergent Therapeutics, Inc., (“Convergent”) which has
+Added: exclusive rights to technology related to dual-action peptide receptor radionuclide therapy (“PRRT”) for prostate cancer covered
+Added: by multiple issued U.S.
and foreign patents.
−Removed: Convergent is currently
−Removed: conducting advanced human trials relating to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen
−Removed: (“PSMA”) present on prostate cancer cells.
−Removed: The technology was developed under the direction of Dr.
−Removed: Neil Bander, Professor
−Removed: of Urologic Oncology at Weill Cornell Medicine.
−Removed: In addition, the Company was granted a license to four patent applications for the use
−Removed: of psilocybin in cancer indications.
−Removed: Additionally,
−Removed: on January 6, 2021 the Company announced that it entered into an exclusive patent license agreement with Silo Pharma Inc.
−Removed: Pharma”) pursuant to which Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain
−Removed: Silo Pharma owned provisional patent applications directed to the use of psilocybin in cancer treatment, and any patents issuing therefrom,
−Removed: including all continuations, continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations, and any applications
−Removed: and all patents issuing from any applications and patents that claim domestic benefit or foreign priority to the provisional patent applications.
−Removed: The license is for “Field of Use” (as defined in the exclusive patent license agreement) of “treatment of cancer and
−Removed: symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures,
−Removed: confusion, dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type.”
−Removed: Accounting Policies
−Removed: critical accounting policies are disclosed in our annual report on Form 10K for the year ended December 31, 2020 and there have been
−Removed: no material changes to such policy or estimates during the nine months ended September 30, 2021.
−Removed: Issued Accounting Pronouncements
−Removed: Note 3 to the condensed consolidated financial statements for a discussion of recent accounting standards.
−Removed: of Operations
−Removed: months ended September 30, 2021 compared to three months ended September 30, 2020
−Removed: the three months ended September 30, 2021, we incurred a loss from operations of approximately $1.8 million, as compared to $1.0 million
−Removed: during the comparable prior year period.
−Removed: The increase in loss was primarily attributed to $0.9 million increase in in general and administrative
−Removed: expenses, partially offset by $91,000 million decrease research and development expense and $38,000 decrease in research and development
−Removed: expense related with license acquisition.
−Removed: the three months ended September 30, 2021, other income was approximately $1.7 million as compared to other expense of approximately
−Removed: $1.1 million during the comparable prior year period.
−Removed: The net loss per share decreased from a decrease in net operating losses and a
−Removed: significant increase in the number of shares outstanding.
−Removed: The increase in other income was primarily attributed to a $5.3 million increase
−Removed: in the change in fair value of investment in DatChat and a decrease in the change in fair value of investment in Hoth, and partially
−Removed: offset by $2.6 million increase in loss on marketable securities.
−Removed: Company experienced very little or no revenue in the last two years and we don’t expect any revenue until a biotechnology product
−Removed: is fully developed which may not occur for many years.
−Removed: months ended September 30, 2021 compared to nine months ended September 30, 2020
−Removed: the nine months ended September 30, 2021, we incurred a loss from operations of approximately $6.9 million, as compared to a loss of
−Removed: $5.2 million during the comparable prior year period.
−Removed: The increase in loss was primarily attributed to $2.2 million increase in general
−Removed: and administrative expenses, and partially offset by $0.5 million decrease in research and development expense $26,000 decrease in research
−Removed: and development expense related to the license acquisition.
−Removed: the nine months ended September 30, 2021, other income was approximately $1.5 million as compared to other expense of approximately $7.5
−Removed: million during the comparable prior year period.
−Removed: The net loss per share decreased from a decrease in net operating losses and a significant
−Removed: increase in the number of shares outstanding.
−Removed: The increase in other income was primarily attributed to a $11.2 million increase in the
−Removed: change in fair value of investment in DatChat, decrease in the change in fair value of investment in Hoth, and partially offset by $2.4
−Removed: million increase in loss on marketable securities.
−Removed: Company experienced very little or no revenue in the last two years and we don’t expect any revenue until a biotechnology product
−Removed: is fully developed which may not occur for many years.
−Removed: and Capital Resources
−Removed: continue to incur ongoing administrative and other expenses, including public company expenses, in excess of corresponding (non-financing
−Removed: related) revenue.
−Removed: We do not expect to incur revenue until any of our biotechnology products are fully developed.
−Removed: While we continue to
−Removed: implement our business strategy, we intend to finance our activities through managing current cash on hand from our past equity offerings.
−Removed: the nine months of 2021, the Company consummated a public offering of 53,905,927 shares of common stock (including the underwriter overallotment).
−Removed: The Company received net proceeds of approximately $78.0 million after deducting underwriting discounts and commissions and estimated
−Removed: offering expenses payable by the Company.
−Removed: Therefore, the Company has adequate cash to fund its operations for at least the next twelve
−Removed: forward, the Company intends to manage its cash through an investment committee focused on asset preservation and reasonable risk allocation.
−Removed: Further, the Company intends to grow its drug platform through additional licensing efforts that are similar to those the Company has
−Removed: already entered into and disclosed.
−Removed: In addition, the Company is seeking partnerships with academic institutions and private enterprise
−Removed: to find, fund and advance new drug compounds that can be brought to commercialization.
−Removed: continues to evaluate the impact of the COVID-19 pandemic on the industry and has concluded that while it is reasonably possible that
−Removed: the virus could have a negative effect on the Company’s consolidated financial position, results of its consolidated operations
−Removed: and/or search for drug candidates, the specific impact is not readily determinable as of the date of these consolidated financial statements.
−Removed: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: August 10, 2021, the Company received a staff deficiency notice from The Nasdaq Stock Market (“Nasdaq”) informing the Company
−Removed: that its common stock failed to comply with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under
−Removed: Nasdaq Listing Rule 5550(a)(2).
−Removed: Nasdaq’s letter advised the Company that, based upon the closing bid price during the period from
−Removed: June 28, 2021 to August 9, 2021, the Company no longer meets this test.
−Removed: to Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has been provided with a compliance period of 180 calendar days, or February 7,
−Removed: 2022, to regain compliance with the minimum bid price requirement.
−Removed: To regain compliance, the closing bid price of the Company’s
−Removed: common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to February 7, 2022.
−Removed: Flows from Operating Activities - For the nine months ended September 30, 2021 and 2020, net cash used in operations was approximately
+Added: Convergent is currently conducting advanced human trials relating to prostate cancer treatments
+Added: utilizing PRRT that targets the prostate-specific membrane antigen (“PSMA”) present on prostate cancer cells.
+Added: The technology
+Added: was developed under the direction of Dr.
+Added: Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.
+Added: Outside of the biotechnology space, the Company
+Added: has put capital into a series of small investments in private companies that are expected to go public in 2022.
+Added: These investments include,
+Added: but are not limited to, an investment in Tevva Motors, an electric truck producer, a space with recent Rivian Automotive (NASDAQ:
+Added: Additionally, the Company has invested in Kerna Health, a growing tele-health business with recurring revenue and large contract
+Added: backlog, as well an investment in Kaya Holding Corp., a holding company with a portfolio of wholly-owned subsidiaries focused on emerging
+Added: technologies and social networking for cannabis enthusiasts.
+Added: As a result of the Company’s biotechnology
+Added: research development and associated investments and acquisitions, our business portfolio now focuses on the treatment of three different
+Added: cancers, including pancreatic cancer, AML and ALL.
+Added: DHA-dFdC, our pancreatic drug candidate developed at the University of Texas at Austin
+Added: (“UTA”), is a new compound that we hope will become the next generation of chemotherapy treatment for advanced pancreatic
+Added: DHA-dFdC is designed to overcome tumor cell resistance to current chemotherapeutic drugs and is well tolerated in preclinical
+Added: toxicity tests.
+Added: Preliminary studies have also indicated that DHA-dFdC inhibits pancreatic cancer cell growth in culture (up to 100,000-fold
+Added: more potent that gemcitabine, a current standard therapy), has documented efficacy against pancreatic tumors in a clinically relevant
+Added: transgenic mouse model and has demonstrated activities against other cancers, including leukemia, lung and melanoma.
+Added: Ultimately, we plan
+Added: to develop DHA-dFdC for oral and intravesous administration in a solid lipid nanoparticle carrier matrix, which has also been licensed
+Added: from UTA, and is intended to be a second-line treatment for advanced pancreatic cancer.
+Added: The Company has entered into an agreement with
+Added: Parimer Scientific , which is working with other third parties, to assist in researching, developing and optimizing the manufacturing
+Added: process of the active ingredient, formulating the dosage formulation and performing drug stability tests.
+Added: The Company’s license
+Added: with UTA (the “License”) is a royalty-bearing exclusive license that, unless terminated earlier, continues until the last
+Added: date of expiration or termination of the patent rights granted under the License (the “Patent Rights”).
+Added: With regard to DHA-dFdC,
+Added: the Patent Rights include two issued U.S.
+Added: Patents, several filed U.S.
+Added: patent applications and an application filed under the Patent Cooperation
+Added: Treaty (“PCT”) that is currently being prosecuted to secure rights in foreign countries.
+Added: So far, two patents have issued,
+Added: 10,463,684 (the “684 Patent”) and U.S.
+Added: 11,219,633 (the “633 Patent”), which contain
+Added: claims covering the compound DHA-dFdC.
+Added: Assuming all maintenance fees are timely paid, the 684 Patent is expected to expire on October
+Added: 27, 2035 and the 633 Patent is expected to expire on May 28, 2035.
+Added: The Company’s license with UTA also covers a U.S.
+Added: patent application relating to the solid lipid nanoparticle carrier matrix for the drug, which was filed on June 6, 2019.
+Added: In June of 2020,
+Added: at the request of the Company, UTA filed both a U.S.
+Added: non-provisional utility patent application as well as a PCT application relating
+Added: to the lipid nanoparticle carrier matrix claiming the June 6, 2019 priority date of the provisional application.
+Added: Patent prosecution on
+Added: all pending patent applications is currently underway.
+Added: The Company is currently engaged in research and development activities related
+Added: to the manufacture of DHA-dFdC, which have thus far confirmed the critical chemical steps required for the manufacturing and scalability
+Added: of the process.
+Added: In collaboration with our contract manufacturing organization, Parimer Scientific, we are currently optimizing the manufacturing
+Added: procedure for DHA-dFdC.
+Added: Our manufacturing activities were initially delayed several months due to COVID-19 because Parimer was recruited
+Added: and South Carolina governments to manufacture hand sanitizer for use in hospitals.
+Added: For that reason, our manufacturing activities
+Added: did not begin in earnest until the beginning of the third quarter of 2020.
+Added: Once manufacturing began, shipping delays due to the pandemic
+Added: further slowed progress.
+Added: Further delay resulted from the inherent difficulty in producing scalable quantities of the key intermediate
+Added: compound in the process.
+Added: Despite these delays, we now have successfully replicated the synthesis as reported in the literature, have developed
+Added: a new procedure for the production of the key intermediate on a large scale, and are currently optimizing the procedure to ensure that
+Added: incorporation of our new procedure into the overall manufacturing process will result in levels of DHA-dFdC on an acceptably large scale.
+Added: In tandem, the Company will also develop the solid lipid nanoparticle delivery system containing DHA-dFdC to optimize the manufacturing
+Added: process for size and consistency of the particles.
+Added: We plan to then develop the drug formulation for oral and intravenous delivery via
+Added: the solid lipid nanoparticles for use in future animal testing.
+Added: We do not currently have FDA approval, which will eventually be required
+Added: to begin administering DHA-dFdC to patients as part of any clinical trials.
+Added: Animal studies will be a necessary prerequisite to filing
+Added: an Investigational New Drug Application (“IND”) with the FDA.
+Added: Depending upon the success of the animal studies, the Company’s
+Added: development activities will also include preparing the IND for submission to the FDA.
+Added: The Company’s formulation is a new chemotherapy
+Added: oral dosage form “repurposing” the chemotherapeutic agent gemcitabine, which we believe enables it to be developed for use
+Added: in patients following a special regulatory pathway codified in Section 505(b)(2) of the FDA rules.
+Added: Section 505(b)(2) was enacted to enable
+Added: sponsors to seek New Drug Application (“NDA”) approval for novel repurposed drugs without the need for such sponsors to undertake
+Added: certain time consuming and expensive safety studies.
+Added: Proceeding under this regulatory pathway, we hope to be able to rely upon all of
+Added: the publicly available safety and toxicology data with respect to gemcitabine in our FDA submissions.
+Added: We believe that this path will dramatically
+Added: reduce the required clinical development efforts, costs and risks as compared to what would be required of us if we were required to conduct
+Added: the entire scope of trials required for new chemical entities that are not eligible to be reviewed pursuant to the Section 505(b)(2) regulatory
+Added: We estimate that by using the Section 505(b)(2) regulatory pathway, the clinical development process may be several years shorter
+Added: than is required for a new chemical entity, and the FDA approval process may be six to nine months shorter than the typical eighteen-month
+Added: period, which we believe may result in lower development costs and shorter development time.
+Added: As of the date hereof, we have not submitted
+Added: an IND or an NDA to the FDA.
+Added: Our AML and ALL compounds, developed at Wake Forest University, are targeted therapeutics designed to overcome
+Added: multiple resistance mechanisms observed with the current standard of care.
+Added: In addition, we are constantly seeking to grow our pipeline
+Added: to treat unmet medical needs in oncology.
+Added: In addition, the Company owns an exclusive world-wide
+Added: license to patented technology from the University of Maryland Baltimore (“UMB”).
+Added: Our license is for a broad-spectrum antiviral
+Added: drug platform.
+Added: The licensed technology is a broadly acting pan-viral inhibitory compound with efficacy against multiple viral pathogens.
+Added: The technology works to inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus
+Added: and Marburg virus.
+Added: The technology is covered by two patent applications already on file with the United States Patent and Trademark Office.
+Added: The Company’s license covers two U.S.
+Added: provisional applications, which were consolidated and timely filed as a PCT application on
+Added: June 5, 2020, commencing patent prosecution.
+Added: Any patents issued from this application are expected to expire 20 years later, on June 5,
+Added: 2040, unless the term is extended by the patent office.
+Added: The PCT application describing the technology to which the Company is licensed
+Added: was published on December 12, 2020 by the World Intellectual Property Organization under International Publication Number WO 2020/247860
+Added: Currently, the Company and UMB are collaborating to identify chemical structures that are as effective as, or more effective than,
+Added: the lead compounds covered in the PCT application.
+Added: The UMB inventors are Drs.
+Added: Matthew Frieman, Alexander MacKerell and Stuart Watson.
+Added: The Company has also executed a Sponsored Research Agreement with UMB to support the development of the technology.
+Added: Effective March 23, 2020, and as amended and restated
+Added: on November 24, 2020, the Company and Continental Stock Transfer & Trust Co.
+Added: entered into a rights agreement (the “Rights Agreement”)
+Added: The Rights Agreement provides each stockholder of record a dividend distribution of one “right” for each outstanding share
+Added: of common stock.
+Added: Rights become exercisable at the earlier of ten days following:
+Added: (1) a public announcement that an acquirer has purchased
+Added: or has the right to acquire 4.99% or more of our common stock, in connection with, (x) the Company consolidating, or merging into any
+Added: other person, (y) any person consolidates or merges with or into the Company or (z) the Company sells or otherwise transfers to any person
+Added: or persons, in one or more transactions, assets or earning power aggregating 50% or more of the assets or earning power of the Company,
+Added: or (2) the commencement of a tender offer which would result in an offer or beneficially owning 10% or more of our outstanding common
+Added: All rights held by an acquirer or offer or expire on the announced acquisition date, and all rights expire at the close of business
+Added: on March 23, 2023, subject to further extension.
+Added: Each right entitles a stockholder to acquire, at a price of $5.00 per one one-thousandth
+Added: of a share of our Series A preferred stock, subject to adjustments, which carries voting and dividend rights similar to one share of our
+Added: common stock.
+Added: The purchase price of the preferred stock fractional amount is subject to adjustment for certain events as described in
+Added: the Rights Agreement.
+Added: At the discretion of a majority of the Board and within a specified time period, we may redeem all of the rights
+Added: at a price of $0.0001 per right.
+Added: The Board may also amend any provisions of the Rights Agreement prior to exercise.
+Added: Critical Accounting Policies
+Added: Our critical accounting policies are disclosed
+Added: in our annual report on Form 10K for the year ended December 31, 2021 and there have been no material changes to such policy or estimates
+Added: during the three months ended March 31, 2022.
+Added: Critical Accounting Estimates
+Added: The preparation of financial statements in accordance
+Added: with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that
+Added: affect the reported amounts and related disclosures in the financial statements.
+Added: Management considers an accounting estimate to be critical
+Added: it requires assumptions to be made that were uncertain at the time the estimate was made, and
+Added: changes in the estimate or different estimates that could have been selected could have material impact inour results of operations or financial condition.
+Added: While we base our estimates and judgments on our
+Added: experience and on various other factors that we believe to be reasonable under the circumstances, actual results could differ from those
+Added: estimates and the differences could be material.
+Added: See Note 2 to our condensed consolidated financial
+Added: statements for a discussion of our significant accounting policies.
+Added: Recently Issued Accounting Pronouncements
+Added: See Note 3 to the condensed consolidated financial
+Added: statements for a discussion of recent accounting standards.
+Added: Results of Operations
+Added: Three months ended March 31, 2022 compared
+Added: to three months ended March 31, 2021
+Added: During the three months ended March 31, 2022,
+Added: we incurred a loss from operations of approximately $3.8 million, as compared to $2.3 million during the comparable prior year period.
+Added: The increase in loss was primarily attributed to $0.6 million increase in in general and administrative expenses and $1.9 million increase
+Added: research and development expense, and was partially offset by $1.0 million decrease in research and development expense related with license
+Added: During the three months ended March 31, 2022, other income was approximately
+Added: $0.3 million as compared to other expense of approximately $1.7 million during the comparable prior year period.
+Added: in other income was primarily attributed to a $1.0 million increase in the change in fair value of investment and $0.8 million decrease
+Added: in loss on marketable securities.
+Added: The Company experienced very little or no revenue
+Added: in the last two years and we don’t expect any revenue until a biotechnology product is fully developed which may not occur for many
+Added: Liquidity and Capital Resources
+Added: We continue to incur ongoing administrative and
+Added: other expenses, including public company expenses, in excess of corresponding (non-financing related) revenue.
+Added: While we continue to implement
+Added: our business strategy, we intend to finance our activities through:
+Added: managing current cash and cash equivalents on hand from our past debt and equity offerings;
+Added: seeking additional funds raised through the sale of additional securities in the future;
+Added: seeking additional liquidity through credit facilities or other debt arrangements;
+Added: increasing revenue from its patent portfolios, license fees and new business ventures.
+Added: Our ultimate success is dependent on our ability
+Added: to obtain additional financing and generate sufficient cash flow to meet our obligations on a timely basis.
+Added: Our business will require
+Added: significant amounts of capital to sustain operations and make the investments it needs to execute its longer-term business plan to support
+Added: new technologies and help advance innovation.
+Added: Our working capital amounted to approximately $98.3 million at March 31, 2022.
+Added: to obtain additional debt or equity financing, especially if we experience downturns in our business that are more severe or longer than
+Added: anticipated, or if we experience significant increases in expense levels resulting from being a publicly-traded company or operations.
+Added: If we attempt to obtain additional debt or equity financing, we cannot assume that such financing will be available to the Company on
+Added: favorable terms, or at all.
+Added: The Company plans to pursue its plans regarding
+Added: research and development of our two pre-clinical products which will require resources beyond those currently, ultimately requiring third
+Added: party capital.
+Added: During this time, the Company does not expect to generate revenue and there is substantial doubt about the Company’s
+Added: ability to continue as a going concern within one year from the date of this filing.
+Added: The consolidated financial statements have been prepared
+Added: assuming that the Company will continue as a going concern, and do not include any adjustments to reflect the possible future effects
+Added: on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome
+Added: of this uncertainty.
+Added: Flows from Operating Activities - For the three months ended March 31, 2022 and 2021, net cash used in operations was approximately
$3.8 million and $1.1 million, respectively.
−Removed: The cash used in operating activities for the nine months ended September 30, 2021 primarily
−Removed: resulted from a net loss of $5.4 million and change in fair value of investment of $3.8 million, and partially offset by $4.3 million
−Removed: unrealized loss on marketable securities and $1.1 million research and development expense related with license acquired.
−Removed: The cash used
−Removed: in operating activities for the nine months ended September 30, 2020 primarily resulted from a net loss of $12.7 million, and partially
−Removed: offset by reduction in fair value of investment of $7.4 million and $1.2 million research and development expense related with license
−Removed: Flows from Investing Activities - For the nine months ended September 30, 2021 and 2020, net cash used in investing activities was
−Removed: approximately $70.3 million and $27.2 million, respectively.
−Removed: The cash used in investing activities for the nine months ended September
−Removed: 30, 2021 primarily resulted from our purchase of marketable securities of $90.5 million, funds to deposit accounts of $4.4 million (net
−Removed: of fee), purchase of investments at fair value of $4.1 million and purchase of convertible note of $2.0 million, partially offset by
−Removed: our sale of marketable securities of $30.4 million since we invest excess cash into marketable securities until additional cash is needed.
−Removed: The cash used in investing activities for the nine months ended September 30, 2020 primarily resulted from our purchase of marketable
−Removed: securities of $98.5 million and research and development expense related with license acquired of $1.2 million, partially offset by our
−Removed: sale of marketable securities of $72.0 million since we invest excess cash into marketable securities until additional cash is needed.
−Removed: Flows from Financing Activities - Cash provided by financing activities for the nine months ended September 30, 2021 was $78.1 million,
−Removed: which reflects the net proceeds of $78.0 million from investors in exchange of issuance of common stock and warrants and net proceeds
−Removed: of $84,000 from the exercise of common warrants.
−Removed: Cash provided by financing activities for the nine months ended September 30, 2020 was
−Removed: $31.6 million, which reflects the net proceeds of $6.6 million from investors in exchange of issuance of common stock, common warrants
−Removed: and prefunded warrants, net proceeds of $17.8 million from investors in exchange of issuance of common stock, and net proceeds of $7.2
−Removed: million from the exercise of common warrants and prefunded warrants.
−Removed: sheet arrangements.
+Added: The cash used in operating
+Added: activities for the three months ended March 31, 2022 primarily resulted from a net loss of $3.5 million and change in fair value of long-term
+Added: investment of $1.4 million, and is partially offset by change in fair value of short-term investment of $0.9 million.
+Added: The cash used in
+Added: operating activities for the three months ended March 31, 2021 primarily resulted from a net loss of $4.0 million, and partially offset
+Added: by $2.0 million unrealized loss on marketable securities and $1.0 million research and development expense related with license acquired.
+Added: Cash Flows from Investing Activities - For the three months ended March
+Added: 31, 2022 and 2021, net cash used in investing activities was approximately $10.1 million and $71.8 million , respectively.
+Added: used in investing activities for the three months ended March 31, 2022 primarily resulted from our purchase of marketable securities of
+Added: $27.1 million and purchase of investments of $7.7 million, partially offset by our sale of marketable securities of $24.7 million since
+Added: we invest excess cash into marketable securities until additional cash is needed.
+Added: The cash used in investing activities for the three
+Added: months ended March 31, 2021 primarily resulted from our purchase of marketable securities of $83.6 million and purchase of convertible
+Added: note of $2.0 million, partially offset by our sale of marketable securities of $14.3 million since we invest excess cash into marketable
+Added: securities until additional cash is needed.
+Added: Cash Flows from Financing Activities - Cash
+Added: provided by financing activities for the three months ended March 31, 2022 was $19.0 million, which reflects the net proceeds of $19.0
+Added: million from investors in exchange of issuance of issuance of Series O and Series P Redeemable Convertible Preferred Stock.
+Added: Cash provided
+Added: by financing activities for the three months ended March 31, 2021 was $78.1 million, which reflects the net proceeds of $78.0 million
+Added: from investors in exchange of issuance of common stock and warrants and net proceeds of $84,000 from the exercise of common warrants.
+Added: Off-balance sheet arrangements.
Quantitative and Qualitative Disclosures About Market Risk
−Removed: required for smaller reporting companies.
+Added: Not required for smaller reporting companies.
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.