20 unchanged sentences
statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable laws or regulations.
−Removed: Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused primarily on developing and commercializing therapies for the treatment of several eye disorders.
−Removed: Ocuphire’s pipeline
−Removed: currently includes two small molecule product candidates targeting front and back of the eye indications.
+Added: Ocuphire is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders.
+Added: Ocuphire’s pipeline currently includes
+Added: two small molecule product candidates targeting several of such indications.
Its lead product candidate, Nyxol ® Eye Drops (“Nyxol”), is a once-daily eye drop formulation of phentolamine mesylate designed to reduce
pupil diameter and improve visual acuity.
−Removed: Based on this mechanism of action, Nyxol can potentially be used for the treatment of multiple indications such as reversal of pharmacologically-induced mydriasis (which refers to the use of pharmacological
−Removed: agents to dilate the pupil for office-based eye exams), presbyopia (a gradual, age-related loss of the eyes’ ability to focus on nearby objects) and dim light or night vision disturbances (“NVD”).
−Removed: Ocuphire management believes this multiple
−Removed: indication potential represents a significant market opportunity.
−Removed: Nyxol has been studied across three Phase 1, five Phase 2, and one Phase 3 trials enrolling over 500 patients with more than 330 patients treated with Nyxol.
−Removed: These trials have
−Removed: demonstrated promising clinical data for use in multiple ophthalmic indications.
−Removed: Ocuphire initiated a Phase 3 trial (MIRA-2) for reversal of pharmacologically-induced mydriasis (“RM”) in the fourth quarter of 2020 and reported positive top-line
−Removed: results within four months on March 15, 2021.
−Removed: Ocuphire initiated a Phase 2 trial in combination with low dose pilocarpine for presbyopia (VEGA-1) in the first quarter of 2021 and reported positive top-line results on June 30, 2021.
−Removed: The company is
−Removed: now further evaluating the VEGA-1 results and designing the Phase 3 program to be initiated in the first half of 2022.
−Removed: Ocuphire also initiated a Phase 3 trial (LYNX-1) for the treatment of NVD in the fourth quarter of 2020;
−Removed: top-line data for this
−Removed: study are expected to be reported in early 2022.
−Removed: Building on the positive results of the MIRA-2 Phase 3 trial for Nyxol, a second Phase 3 registration trial (MIRA-3) and a small pediatric study (MIRA-4) are planned to start in the fourth quarter of
−Removed: 2021, with results expected in early 2022.
−Removed: Assuming successful and timely completion of these RM trials, Ocuphire anticipates submitting a New Drug Application (“NDA”) for Nyxol to the U.S.
−Removed: Food and Drug Administration (“FDA”) in late 2022 under
−Removed: the 505(b)(2) pathway.
−Removed: Ocuphire’s second product candidate, APX3330, is a twice-a-day oral tablet designed to target multiple pathways relevant to retinal and choroidal
−Removed: (the vascular layer of the eye) vascular diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual blindness.
−Removed: DR is a disease resulting from
−Removed: diabetes in which chronically elevated blood sugar levels cause progressive damage to blood vessels in the retina.
−Removed: DME is a severe form of DR which involves leakage of protein and fluid into the macula, the central portion of the retina, causing
−Removed: swelling and damage.
−Removed: Prior to Ocuphire’s in-licensing of the product candidate, APX3330 had been studied by third parties in six Phase 1 and five Phase 2 trials enrolling over 440 patients with more than 340 patients treated with APX3330 for
−Removed: inflammatory and oncology indications.
−Removed: These trials have demonstrated promising evidence of tolerability, pharmacokinetics, durability, and target engagement.
−Removed: Ocuphire initiated enrollment for the Phase 2 trial (ZETA-1) for APX3330 in April 2021
−Removed: for the treatment of patients with moderately severe non-proliferative DR (“NPDR”) or mild proliferative DR (“PDR”).
−Removed: Top-line data for this study are expected to be reported in the second half of 2022.
−Removed: Ocuphire has also in-licensed APX2009 and
−Removed: APX2014, which are additional second-generation product candidates and analogs of APX3330.
+Added: As a result, Nyxol can potentially be used for the treatment of multiple indications such as reversal of pharmacologically-induced mydriasis (“RM”) (dilation of the pupil), presbyopia (age-related blurry
+Added: near vision) and dim light or night vision disturbances (“NVD”) (halos and glares).
+Added: Ocuphire’s management believes these multiple indications potentially represent a significant market opportunity.
+Added: Nyxol has been studied in a total of 11 clinical
+Added: trials (3 Phase 1, 5 Phase 2, 2 Phase 3 and for safety in young pediatric patients (ages 3-11)) in a total of over 950 patients (with over 590 Nyxol-treated) and has demonstrated promising clinical data for use in the multiple ophthalmic
+Added: indications mentioned above.
+Added: Ocuphire reported positive top-line data from the first Phase 3 trial (MIRA-2) for RM, reported positive top-line data from a 2 nd Phase 3
+Added: RM trial (MIRA-3) in March 2022, and reported positive data from a pediatric safety study (MIRA-4) for RM in April 2022.
+Added: Ocuphire also reported positive top-line data from a Phase 2 trial of Nyxol for treatment of presbyopia, both alone and with
+Added: low-dose pilocarpine ( pilocarpine hydrochloride 0.4% ophthalmic solution, “LDP”) as adjunctive therapy.
+Added: Ocuphire announced completion of enrollment of its NVD Phase 3 trial (LYNX-1) in January 2022.
+Added: Ocuphire expects to report top-line results from the LYNX-1 NVD Phase 3 study in the second quarter of 2022.
+Added: Assuming successful and timely completion of the RM trials, Ocuphire anticipates submitting a new drug application (“NDA”) to the U.S.
+Added: and Drug Administration (“FDA”) in late 2022 under the 505(b)(2) pathway for its drug led combination product.
+Added: Ocuphire has started pre-commercialization planning and activities in anticipation of a successful RM approval.
+Added: Ocuphire’s second product candidate, APX3330, is a twice-a-day oral tablet designed to target multiple pathways relevant to retinal and choroidal (the
+Added: vascular layer of the eye) diseases such as diabetic retinopathy (“DR”) and diabetic macular edema (“DME”) which, if left untreated, can result in permanent visual acuity loss and eventual blindness.
+Added: DR is a disease resulting from diabetes in
+Added: which chronically elevated blood sugar levels cause progressive damage to blood vessels in the retina.
+Added: DME is a severe form of DR which involves leakage of protein and fluid into the macula, the central portion of the retina, causing swelling and
+Added: vascular damage.
+Added: Prior to Ocuphire’s in-licensing of the product candidate, APX3330 had been studied by other sponsors in a total of 11 clinical trials (6 Phase 1 and 5 Phase 2) in a total of over 420 healthy volunteers or patients (with over 340
+Added: APX3330-treated) for inflammatory and oncology indications, and had demonstrated evidence of tolerability, pharmacokinetics, durability, and target engagement.
+Added: Ocuphire has also in-licensed APX2009 and APX2014, which are second-generation product
+Added: candidates and analogs of APX3330.
+Added: Ocuphire initiated a Phase 2 trial for APX3330 in April 2021 for the treatment of patients with DR, including moderately severe non-proliferative DR (“NPDR”) and mild proliferative DR (“PDR”), as well as
+Added: patients with DME without loss of central vision.
+Added: Ocuphire reported enrollment completion of 103 patients in the ZETA-1 trial in March 2022 and expects to report top-line results from the ZETA-1 DR/DME Phase 2b study in the second half of 2022.
+Added: In May 2022, Ocuphire reported masked safety data from the ongoing Phase 2 trial in DR/DME for the 103 patients enrolled.
+Added: These safety data are consistent with safety data from the prior 11 clinical trials with total exposure experience of over
+Added: 6,000 subject-days with 600 mg daily dose of APX3330.
Ocuphire Pharma, Inc.
−Removed: Merger with Rexahn
−Removed: On November 5, 2020, Rexahn Pharmaceuticals, Inc., or Rexahn, now known as Ocuphire Pharma, Inc., completed its reverse merger or, the Merger, with what was then known as “Ocuphire Pharma, Inc.,”
−Removed: or Private Ocuphire, in accordance with the terms of the Agreement and Plan of Merger and Reorganization dated as of June 17, 2020, as amended on June 29, 2020 (“Merger Agreement”).
−Removed: Rexahn’s shares of common stock listed on The Nasdaq Capital
−Removed: Market, previously trading through the close of business on November 5, 2020 under the ticker symbol “REXN,” commenced trading on The Nasdaq Capital Market, under the ticker symbol “OCUP,” on November 6, 2020.
−Removed: Immediately following the Merger, Private Ocuphire became a wholly-owned subsidiary of Rexahn.
−Removed: Upon consummation of the Merger, Rexahn adopted the business plan of Private Ocuphire.
−Removed: Although Rexahn was the legal acquirer and issued shares of its common stock to effect the Merger with Ocuphire, Ocuphire was considered the accounting acquirer.
−Removed: In accordance with the accounting
−Removed: guidance under Accounting Standards Update (“ASU”) 2017-01, the Merger was accounted for as an asset acquisition.
−Removed: Accordingly, the assets and liabilities of Rexahn were recorded as of the closing of the Merger at the purchase price of the
−Removed: accounting acquirer, Ocuphire.
−Removed: Ocuphire allocated the total purchase price among the individual assets acquired on a fair value basis or carrying value as appropriate.
−Removed: A final determination of these estimated fair values was based on the actual net
−Removed: tangible assets of Rexahn that existed as of the date of the completion of the transaction.
−Removed: As of the Closing , the net assets of Rexahn were recorded at their acquisition-date relative fair values in the
−Removed: consolidated financial statements of Ocuphire and the reported operating results prior to the Merger are those of Private Ocuphire.
−Removed: Pursuant to the Merger Agreement, the number of shares of common stock issued to Private Ocuphire’s stockholders for each share of Ocuphire’s common stock outstanding immediately prior to the
−Removed: Merger was calculated using an exchange ratio (“Exchange Ratio”) of 1.0565 shares of Common Stock for each share of Private Ocuphire common stock.
Strategic Outlook
−Removed: As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation
−Removed: and commercialization in key global markets.
−Removed: To date, Ocuphire’s primary activities have been conducting research and development activities, planning clinical trials, performing business and financial planning, recruiting personnel and raising
+Added: As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development,
+Added: regulatory preparation and commercialization in key global markets.
+Added: To date, Ocuphire’s primary activities have been conducting research and development activities, planning clinical trials, performing business and financial planning, recruiting
+Added: personnel and raising capital.
Ocuphire does not have any products approved for sale and has not generated any significant amounts of revenue.
−Removed: Ocuphire does not expect to generate significant revenues until, and unless, the FDA or other regulatory authorities approve
−Removed: Nyxol or APX3330 and Ocuphire successfully commercializes its product candidates.
−Removed: Until such time, if ever, as Ocuphire can generate substantial product revenue, Ocuphire expects to finance its cash needs through a combination of equity and debt
−Removed: financings as well as collaborations, strategic alliances and licensing arrangements.
−Removed: Through September 30, 2021, Ocuphire has funded its operations primarily through equity financings that totaled $41.9 million in gross proceeds, of which $21.15
−Removed: million was received in connection with the Merger, net cash at Rexahn, a minor amount of license fee payments earned under license agreements related to Rexahn’s RX-3117 drug compound, and through the issuance of convertible notes in private
−Removed: placements that totaled $8.5 million in gross proceeds.
−Removed: Ocuphire’s net losses were $50.4 million and $5.9 million for the nine months ended September 30, 2021 and 2020, respectively.
−Removed: As of September 30, 2021, Ocuphire had an accumulated deficit of
−Removed: $83.1 million.
+Added: Ocuphire does not expect to generate significant revenues until, and unless, the FDA or other
+Added: regulatory authorities approve Nyxol or APX3330 and Ocuphire successfully commercializes its product candidates.
+Added: Until such time, if ever, as Ocuphire can generate substantial product revenue, Ocuphire expects to finance its cash needs through a
+Added: combination of equity and debt financings as well as collaborations, strategic alliances and licensing arrangements.
+Added: Through March 31, 2022, Ocuphire has funded its operations primarily through equity financings that totaled $50.8 million in
+Added: gross proceeds, of which $21.15 million was received in connection with the merger (“Merger”) with Rexahn Pharmaceuticals, Inc.
+Added: (“Rexahn”), net cash at Rexahn, a minor amount of license fee payments earned under license agreements related to
+Added: Rexahn’s RX-3117 drug compound, and through the issuance of convertible notes in private placements that totaled $8.5 million in gross proceeds.
+Added: Ocuphire’s net losses were $6.6 million and $39.0 million for the three months ended March 31, 2022
+Added: and 2021, respectively.
+Added: As of March 31, 2022, Ocuphire had an accumulated deficit of $96.0 million.
Ocuphire anticipates that its expenses will increase substantially as it:
4 unchanged sentences
contracts to manufacture its product candidates;
−Removed: establishes on its own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which Ocuphire may obtain regulatory approval;
maintains, expands and protects its intellectual property portfolio;
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continues to operate as a public company;
−Removed: Ocuphire’s net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of its preclinical studies, clinical trials and its expenditures on other
−Removed: research and development activities as well as level of license fee payments received under license agreements in connection with the former Rexahn drug compounds.
−Removed: Ocuphire Pharma, Inc.
+Added: establishes on its own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which Ocuphire may obtain regulatory approval;
+Added: Ocuphire’s net losses may fluctuate significantly from quarter–to quarter and year–to year, depending on the timing of its preclinical studies, clinical trials and its
+Added: expenditures on other research and development activities as well as level of license fee payments received under license agreements in connection with the former Rexahn drug compounds.
Recent Developments
−Removed: Clinical and CMC Milestones
−Removed: As of September 30, 2021, three registration stability batches at the 50 L scale of Nyxol (0.75% Phentolamine
−Removed: Mesylate Ophthalmic Solution) were manufactured under cGMP conditions.
−Removed: One clinical stability batch of Placebo (Nyxol vehicle) was manufactured and packaged in a matching container closure configuration.
−Removed: These manufacturing campaigns were
−Removed: important corporate milestones because this material will be used in future Phase 3 clinical trials.
−Removed: Additionally, the product has been placed on an ICH Stability program for a 36-month duration.
−Removed: The body of data including the 12-month stability
−Removed: data from the three Nyxol manufacturing campaigns and stability programs will be used to support the planned Nyxol NDA submission for Reversal of Mydriasis in late 2022.
−Removed: The planned six-month preclinical toxicology study in rabbits for chronic use related to Nyxol has been completed.
−Removed: Reports will be finalized and submitted to the FDA in the first half of 2022.
−Removed: Regulatory Update
−Removed: Ocuphire has submitted a Pediatric Investigation Plan for Nyxol which has been reviewed by the FDA.
−Removed: With the resurgence of COVID-19 cases, Ocuphire may likely continue to experience disruptions in its manufacturing, supply chain, research and development operations, clinical enrollment,
−Removed: regulatory process, as well as impacts to financial position and difficulties in obtaining more favorable financing terms.
+Added: For a discussion of business developments that occurred during the first quarter of 2022 through March 24, 2022, see "Item 7 - Management's Discussion and Analysis of Financial Condition and
+Added: Results of Operations – Recent Developments" included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed on March 24, 2022.
+Added: Clinical Milestones
+Added: On March 29, 2022, Ocuphire announced positive top-line results in MIRA-3, the second Phase 3 FDA registration trial evaluating
+Added: the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis (RM) in 368 subjects.
+Added: The topline results demonstrated that the MIRA-3 trial met its primary endpoint with 58% of patients (study eye) treated with
+Added: Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter (PD) at 90 minutes compared to only 6% of subjects (study eye) treated with placebo (p <0.0001).
+Added: The effect was also significant at 60 minutes (Nyxol 42% vs.
+Added: placebo 2%, p
+Added: In comparison, only 36% of placebo treated subjects returned back to baseline PD at 6 hours.
+Added: These results showed clinically meaningful differences between Nyxol and placebo for accelerating reversal of pharmacologically-induced
+Added: mydriasis with a favorable safety profile.
+Added: On April 28, 2022, Ocuphire announced positive
+Added: results in the MIRA-4 trial evaluating the safety and efficacy of Nyxol eye drops for RM in 23 pediatric patients.
+Added: The results demonstrated that Nyxol’s efficacy and safety in pediatric patients 3-11 years of age was consistent with that
+Added: shown in prior MIRA trials which enrolled both adolescents (age 12-17 years) and adults (age 18 years and older), The primary endpoint was met with Nyxol demonstrating a favorable safety and tolerability profile.
+Added: Specifically, there were no
+Added: complaints of headaches, redness, instillation site discomfort or pain, blurry vision, burning or stinging or change in vital signs reported.
+Added: In May 2022 at the Retina World Congress, Ocuphire presented that new masked safety data for the 103 diabetic patients enrolled in the
+Added: ZETA-1 trial is consistent with APX3330’s favorable safety and tolerability as seen in 11 previous trials in healthy, hepatic and cancer patients.
+Added: APX3330 at 600mg/day dose has over 6,000 subject-exposure days.
+Added: Ocuphire will continue providing
+Added: masked safety data at various conferences prior to reporting the topline data planned for the second half of 2022.
+Added: Ocuphire Pharma, Inc.
+Added: Presentations, Publications and Conferences
+Added: Ocuphire’s management team and medical advisors have participated by invitation at ten major medical and industry conferences since the
+Added: beginning of the year, including sixteen papers, posters and panel talks.
+Added: The Company has been engaging with dozens of key opinion leaders to expand awareness of the Nyxol and APX3330 development programs.
+Added: As a result of the COVID-19 pandemic, Ocuphire has experienced, and may continue to experience, delays and disruptions in our clinical trials, as well as interruptions in our manufacturing and analytical lab
+Added: operations, global supply chain and shipping, and clinical development operations.
+Added: Ocuphire’s plans for further testing or clinical trials may be further impacted by the continuing effects of COVID-19.
The global outbreak of COVID-19 continues to rapidly evolve.
−Removed: Although Ocuphire cannot estimate the length or gravity of the
−Removed: impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on Ocuphire’s results of future operations, financial position, and liquidity over the next 12 or more months.
+Added: The extent to which the COVID-19
+Added: pandemic may further impact our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the effect of the pandemic on our suppliers and distributors and the
+Added: global supply chain, the duration of the outbreak, travel restrictions and social distancing in the U.S.
+Added: and other countries, business closures or business disruptions and the effectiveness of actions taken in the U.S.
+Added: and other countries to
+Added: contain and treat the disease.
+Added: The COVID-19 pandemic may also continue to impact our business as a result of employee illness, school closures, and other community response measures.
+Added: The COVID-19 pandemic may also impact our ability to secure additional financing.
+Added: Although Ocuphire cannot estimate the length or
+Added: gravity of the impact of the COVID-19 outbreak at this time, if the pandemic continues, it may have a material adverse effect on the Company’s results of future operations, financial position, and liquidity in fiscal year 2022 and beyond.
Financial Operations Overview
Collaborations Revenue
−Removed: Collaborations revenue to date was derived from fees earned from a license agreement with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc.
+Added: To date, Ocuphire had limited collaborations revenue during the second and third quarters of 2021 related to fees earned from license agreements with BioSense Global LLC
+Added: (“BioSense”) and Processa Pharmaceuticals, Inc.
(“Processa”) in connection with the Rexahn RX-3117 drug compound.
−Removed: We anticipate that we may earn additional revenues stemming from additional milestone and royalty payments from this or other license
−Removed: agreements related to Rexahn’s legacy drug compounds;
−Removed: however, the attainment of milestones or level of sales required to earn royalty payments is highly uncertain for the reasons explained below.
−Removed: To date, outside of the limited collaborations revenue referenced above, Ocuphire does not expect to generate significant revenue unless or until it obtains regulatory approval of and
−Removed: commercializes Nyxol or APX3330.
−Removed: If Ocuphire fails to complete the development of Nyxol, APX3330, or any other product candidate it may pursue in the future, in a timely manner, or fails to obtain regulatory approval, Ocuphire’s ability to generate
−Removed: future revenue would be compromised.
−Removed: General and Administrative Expenses
+Added: We anticipate that we may earn additional revenues stemming from additional milestone and royalty payments from these or other
+Added: license agreements related to Rexahn’s legacy drug compounds;
+Added: however, the attainment of milestones or level of sales required to earn royalty payments is highly uncertain.
+Added: Ocuphire does not expect to generate significant revenue unless or until it obtains regulatory approval of and commercializes Nyxol or APX3330.
+Added: If Ocuphire fails to complete
+Added: the development of Nyxol, APX3330, or any other product candidate it may pursue in the future, in a timely manner, or fails to obtain regulatory approval, Ocuphire’s ability to generate significant revenue would be compromised.
+Added: Operating Expenses
+Added: Ocuphire’s operating expenses are classified into two categories:
+Added: general and administrative and research and development.
+Added: General and Administrative
General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated
5 unchanged sentences
These increases will include increased costs related to the hiring of additional personnel and fees for legal and professional services as well as other public company related
−Removed: Ocuphire Pharma, Inc.
−Removed: Research and Development Expenses
−Removed: To date, Ocuphire’s research and development expenses have related primarily to the clinical stage development of Nyxol.
−Removed: Research and development expenses consist of costs incurred in performing
−Removed: research and development activities, including compensation and benefits for research and development employees and costs for consultants, costs associated with preclinical studies and clinical trials, regulatory activities, manufacturing
−Removed: activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses.
−Removed: Research and development costs are
−Removed: expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed.
−Removed: Ocuphire accrues for costs incurred as the services are being provided by monitoring the status of the study or project, and the invoices
−Removed: received from its external service providers.
+Added: Research and Development
+Added: To date, Ocuphire’s research and development expenses have related primarily to the clinical-stage development of Nyxol and APX3330.
+Added: Research and development expenses consist
+Added: of costs incurred in performing research and development activities, including compensation and benefits for research and development employees and costs for consultants, costs associated with preclinical studies and clinical trials, regulatory
+Added: activities, manufacturing activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses.
+Added: development costs are expensed as incurred and costs incurred by third parties are expensed as the contracted work is performed.
+Added: Ocuphire accrues for costs incurred as the services are being provided by monitoring the status of the study or
+Added: project, and the invoices received from its external service providers.
Ocuphire adjusts its accrual as actual costs become known.
Research and development activities are central to Ocuphire’s business model.
−Removed: Ocuphire expects that Nyxol and APX3330 will have higher development costs during their later stages of clinical development, as compared to costs incurred during their earlier stages of
−Removed: development, primarily due to the increased size and duration of the later-stage clinical trials.
+Added: Ocuphire Pharma, Inc.
+Added: Ocuphire expects that Nyxol and APX3330 will have higher development costs during their later stages of clinical development, as compared to costs incurred during their
+Added: earlier stages of development, primarily due to the increased size and duration of the later-stage clinical trials.
Ocuphire expects its research and development expenses to significantly increase over the next several years.
−Removed: However, it is difficult for Ocuphire to
−Removed: determine with certainty the duration, costs and timing to complete its current or future preclinical programs and clinical trials of Nyxol, APX3330, and other product candidates.
−Removed: The duration, costs and timing of clinical trials and development of
−Removed: Nyxol, APX3330 and other product candidates will depend on a variety of factors that include, but are not limited to, the following:
+Added: However, it is
+Added: difficult for Ocuphire to determine with certainty the duration, costs and timing to complete its current or future preclinical programs and clinical trials of Nyxol, APX3330, and other product candidates.
+Added: The duration, costs and timing of
+Added: clinical trials and development of Nyxol, APX3330 and other product candidates will depend on a variety of factors that include, but are not limited to, the following:
per patient trial costs;
10 unchanged sentences
the efficacy and safety profile of the product candidates.
−Removed: Acquired In-Process Research and Development Expenses
−Removed: Ocuphire includes costs to acquire or in-license product candidates as acquired in-process research and development expenses.
−Removed: These costs are immediately expensed provided that the payments do not
−Removed: also represent processes or activities that would constitute a “business” as defined under accounting standards generally accepted in the United States of America (“U.S.
−Removed: GAAP”) or provided that the product candidate has not achieved regulatory
−Removed: approval for marketing and, absent obtaining such approval, has no alternative future use.
−Removed: Royalties owed on future sales of any licensed product will be expensed in the period the related revenues are recognized.
−Removed: The costs associated with the
−Removed: Merger and the Apexian Sublicense Agreement were recorded as acquired in-process research and development expenses (“IPR&D”).
Interest Expense
−Removed: Interest expense consists of interest costs related to the Ocuphire convertible notes and was attributed to interest on principal and to amortization of debt discount while these instruments were
−Removed: The Ocuphire convertible notes had an annual interest rate of 8%.
−Removed: Fair Value Change in Warrant Liabilities and Premium Conversion Derivatives
−Removed: The fair value change in warrant liabilities and premium conversion derivatives includes the change in the fair value of the warrant liabilities and the premium conversion derivatives during the
−Removed: period the premium conversion derivatives and warrant liabilities are outstanding.
−Removed: Other Income, net
−Removed: Other income, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in connection with grants and
−Removed: other sources.
−Removed: Other expense reflected in this line item includes payments made by us in connection with the Contingent Value Rights Agreement (the “CVR Agreement”) with former Rexahn shareholders.
−Removed: Ocuphire Pharma, Inc.
+Added: Interest expense consists of interest costs related to interest on principal related to a short-term loan (related to financing an insurance policy) having an
+Added: annual interest rate of 5.5%.
+Added: Fair Value Change in Warrant Liabilities
+Added: The fair value change in warrant liabilities comprises the change in the fair value of the warrant liabilities during the period the warrant liabilities are outstanding.
+Added: Other (Expense) Income, net
+Added: Other (expense) income, net includes interest earned from cash and cash equivalent investments, realized and unrealized gains (losses) from equity investments and reimbursements in connection with
+Added: grants and other sources when they occur.
+Added: In addition, payments made by us in connection with the Contingent Value Rights Agreement (the “CVR Agreement”) with former Rexahn shareholders when they occur are also included in this line item.
Provision for Income Taxes
2 unchanged sentences
Currently, there is no provision for income taxes, as Ocuphire has incurred
−Removed: operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets as of September 30, 2021 and December 31, 2020.
+Added: operating losses to date, and a full valuation allowance has been provided on the net deferred tax assets as of March 31, 2022 and December 31, 2021.
+Added: Ocuphire Pharma, Inc.
Results of Operations
−Removed: Comparison of the Three Months Ended September 30, 2021 and 2020
+Added: Comparison of Three Months Ended March 31, 2022 and 2021
The following table summarizes Ocuphire’s operating results for the periods indicated (in thousands):
For the Three Months Ended
−Removed: September 30,
−Removed: Collaborations revenue
Operating expenses:
4 unchanged sentences
Interest expense
−Removed: Fair value change in warrant liabilities and premium conversion derivatives
−Removed: Other income, net
+Added: Fair value change in warrant liabilities
+Added: Other (expense) income, net
Loss before income taxes
Provision for income taxes
−Removed: Collaborations Revenue
−Removed: Collaborations revenue was $0.5 million for the three months ended September 30, 2021.
−Removed: Revenue during the period was derived from the collaboration and license agreement with Processa related to
−Removed: certain technology transfers.
−Removed: There was no collaborations revenue recognized during the comparable prior year period.
−Removed: General and Administrative Expenses
−Removed: General and administrative expenses for the three months ended September 30, 2021 were $1.6 million compared to $0.6 million for the three months
−Removed: ended September 30, 2020.
−Removed: The $1.0 million increase was primarily attributable to administrative employee headcount, stock-based compensation, insurance, legal costs, and costs associated with operating as a public company subsequent to the
−Removed: reverse merger in the current period.
−Removed: General and administrative expenses included $0.3 million and $0.2 million in stock-based compensation expense during the three months ended September 30, 2021 and 2020, respectively.
−Removed: Research and Development Expenses
−Removed: Research and development expenses for the three months ended September 30, 2021 were $3.1 million compared to $1.4 million for the three months ended September 30, 2020.
−Removed: The $1.7 million increase
−Removed: was primarily attributable to four new clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical and other development activities.
−Removed: Research and development expenses also included $0.2 million and $0.4
−Removed: million in stock-based compensation expense during the three months ended September 30, 2021 and 2020, respectively.
−Removed: Interest Expense
−Removed: Non-cash interest expense for the three months ended September 30, 2020 of $0.2 million was comprised of interest on principal and amortization of debt discounts related to Ocuphire convertible
−Removed: There was no interest expense during the current year period.
−Removed: Fair Value Change in Warrant Liabilities and Premium Conversion Derivatives
−Removed: The fair value change in warrant liabilities and premium conversion derivatives was an expense of $0.9 million for the three months ended September 30, 2020 attributed to the change in fair value
−Removed: for the premium conversion derivatives due primarily to fluctuations in the fair value of Ocuphire common stock and the number of potential shares of common stock issuable upon conversion of the underlying Ocuphire convertible notes that were
−Removed: outstanding during the period.
−Removed: The fair value change in warrant liabilities and premium conversion derivatives during the three months ended September 30, 2021 was under $1,000, related to Rexahn Warrants.
−Removed: Ocuphire Pharma, Inc.
−Removed: Other Income, net
−Removed: Other income during the three months ended September 30, 2021 consisted primarily of unrealized gains from our short-term investments and to a lesser extent interest income from our cash and cash
−Removed: equivalent investments in the aggregate of $94,000.
−Removed: Other income during the three months ended September 30, 2020 was negligible.
−Removed: During the three months ended September 30, 2021, Ocuphire had other expense of $92,000 stemming largely from payments due in connection with the CVR Agreement.
−Removed: Other expense during the three
−Removed: months ended September 31, 2020 was negligible.
−Removed: Comparison of the Nine Months Ended September 30, 2021 and 2020
−Removed: The following table summarizes Ocuphire’s operating results for the periods indicated (in thousands):
−Removed: For the Nine Months Ended
−Removed: September 30,
−Removed: Collaborations revenue
−Removed: Operating expenses:
General and Administrative
+Added: General and administrative expenses for the three months ended March 31, 2022 were $1.7 million compared to $1.7 million for the three months ended March 31, 2021.
+Added: The slight increase period over
+Added: period of $32,000 was primarily attributable to an increase in in administrative employee headcount and stock-based compensation, offset largely by a decrease in professional services, legal support, insurance and public company costs.
+Added: administrative expenses included $0.3 million and $0.2 million in stock-based compensation expense during the three months ended March 31, 2022 and 2021, respectively.
Research and Development
−Removed: Acquired in‑process research and development
−Removed: Total operating expenses
−Removed: Loss from operations
−Removed: Interest expense
−Removed: Fair value change in warrant liabilities and premium conversion derivatives
−Removed: Gain on note extinguishment
−Removed: Other income, net
−Removed: Loss before income taxes
−Removed: Provision for income taxes
−Removed: Collaborations Revenue
−Removed: Collaborations revenue was $0.6 million for the nine months ended September 30, 2021.
−Removed: Revenue during the period was derived from the collaboration and license agreements with Processa and BioSense
−Removed: related to certain technology transfers.
−Removed: There was no collaborations revenue recognized during nine months ended September 30, 2020.
−Removed: General and Administrative Expenses
−Removed: General and administrative expenses for the nine months ended September 30, 2021 were $6.7 million compared to $1.5 million for the nine months
−Removed: ended September 30, 2020.
−Removed: The $5.2 million increase was primarily attributable to administrative employee headcount, stock-based compensation, professional services, insurance, legal and settlement costs, and costs associated with operating as a
−Removed: public company subsequent to the reverse merger in the current period.
−Removed: General and administrative expenses included $0.8 million and $0.4 million in stock-based compensation expense during the nine months ended September 30, 2021 and 2020,
−Removed: respectively.
−Removed: Research and Development Expenses
−Removed: Research and development expenses for the nine months ended September 30, 2021 were $10.4 million compared to $2.3 million for the nine months ended September 30, 2020.
−Removed: The $8.1 million increase
−Removed: was primarily attributable to six new clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical and other development activities.
−Removed: Research and development expenses also included $0.6 million in
−Removed: stock-based compensation expense during the nine months ended September 30, 2021 and 2020.
−Removed: Acquired In-Process Research and Development Expenses
−Removed: On January 21, 2020, Ocuphire entered into a sublicense agreement with Apexian for continued research and development and potential commercialization of its lead product, APX3330 (the “Apexian
−Removed: Sublicense Agreement”).
−Removed: Ocuphire issued 891,422 shares (as adjusted for the Exchange Ratio) of its common stock to Apexian related to the Apexian Sublicense Agreement.
−Removed: The fair value of the common stock issued to Apexian was $2.1 million and was
−Removed: recorded as IPR&D expense during the nine months ended September 30, 2020.
−Removed: Accounting standards require that the fair value of IPR&D with no alternative future use be charged to expense on the acquisition date.
−Removed: There were no IPR&D
−Removed: costs in the current year period.
−Removed: Ocuphire Pharma, Inc.
+Added: Research and development expenses for the three months ended March 31, 2022 were $4.8 million compared to $3.5 million for the three months ended March 31, 2021.
+Added: The $1.3 million increase was
+Added: primarily attributable to an increased activity level associated with clinical trials and manufacturing activities for Nyxol and APX3330 period over period as well as additional preclinical and other development activities during the current
+Added: Research and development expenses also included $0.1 million and $0.3 million in stock-based compensation expense during the three months ended March 31, 2022 and 2021, respectively.
Interest Expense
−Removed: Non-cash interest expense for the nine months ended September 30, 2020 of $1.4 million was comprised of interest on principal and amortization of debt discounts related to Ocuphire convertible
−Removed: There was no interest expense during the current year period.
−Removed: Fair Value Change in Warrant Liabilities and Premium Conversion Derivatives
−Removed: The fair value change in warrant liabilities and premium conversion derivatives was an expense of $33.8 million for the nine months ended September 30, 2021 compared to a benefit of $0.2 million
−Removed: for the nine months ended September 30, 2020.
−Removed: The $34.0 million change was due primarily to the issuance of the Series A Warrants in connection with the Pre-Merger Financing in November 2020 and to the fluctuations in Ocuphire’s common stock fair
−Removed: value and the number of potential shares of common stock issuable upon conversion of the underlying Ocuphire warrant liabilities and convertible notes that were outstanding during the relevant periods.
−Removed: Upon the February 3, 2021 effective date of
−Removed: the Waiver Agreements, the Series A Warrants were reclassified to equity and are no longer subject to remeasurement.
−Removed: Gain on Note Extinguishment
−Removed: Non-cash gain on note extinguishment for the nine months ended September 30, 2020 was $1.3 million as a result of the Note Conversion Agreement (as defined and further described below).
−Removed: Conversion Agreement was deemed to be a substantial modification to the Ocuphire convertible notes (as defined below), and as such, the Company recorded the modification as a note extinguishment.
−Removed: Other Income, net
−Removed: Other income during the nine months ended September 30, 2021 and 2020 was $96,000 and $9,000, respectively.
−Removed: Other income consisted primarily of unrealized gains from our short-term investments and
−Removed: to a lesser extent interest income from our cash and cash equivalent investments during the nine months ended September 30, 2021.
−Removed: During the nine months ended September 30, 2020, Ocuphire had other income from cash and cash equivalent investments
−Removed: and from a grant received from the U.S.
−Removed: Small Business Administration for economic relief stemming from the COVID-19 pandemic.
−Removed: During the nine months ended September 30, 2021, Ocuphire had other expense of $92,000 stemming largely from payments due in connection with the CVR Agreement.
−Removed: Other expense during the nine months
−Removed: ended September 31, 2020 was negligible.
+Added: Interest expense for the three months ended March 31, 2022 of $5,000 was comprised of interest on principal related to a short-term loan (related to financing an insurance policy).
+Added: interest expense during the comparable prior year period.
+Added: Fair Value Change in Warrant Liabilities
+Added: The fair value change in warrant liabilities was an expense of $33.8 million for the three months ended March 31, 2021.
+Added: The fair value change was due primarily to the issuance of the Series A
+Added: Warrants in connection with the Pre-Merger Financing in November 2020, discussed further below, and to the fluctuations in Ocuphire’s common stock fair value and the number of potential shares of common stock issuable upon conversion of the
+Added: underlying Ocuphire warrant liabilities were outstanding during the relevant periods.
+Added: Upon the February 3, 2021 effective date of the Waiver Agreements, discussed further below, the Series A Warrants were reclassified to equity and are no longer
+Added: subject to remeasurement.
+Added: There was a negligible change to the fair value of the warrant liability associated with the Rexahn warrants during the three months ended March 31, 2022.
+Added: Other (Expense) Income, net
+Added: During the three months ended March 31, 2022, Ocuphire had other expense of $84,000 stemming principally from net unrealized losses from our short-term investments.
+Added: expense during the three months ended March 31, 2021 was negligible.
+Added: During the three months ended March 31, 2022 and 2021, Ocuphire had interest income related to cash deposits on hand in the amount of $2,000 and $1,000, respectively.
Liquidity and Capital Resources
Capital Resources
−Removed: As of September 30, 2021, Ocuphire’s principal sources of liquidity consisted of cash and cash equivalents of $22.2 million.
−Removed: Ocuphire’s cash and cash equivalents are invested primarily in cash
−Removed: deposits at a large, long-standing financial institutions.
+Added: As of March 31, 2022, Ocuphire’s principal sources of liquidity consisted of cash and cash equivalents of $19.2 million.
+Added: Ocuphire believes that its cash on hand will be
+Added: sufficient to fund its operations into the second quarter of 2023.
+Added: The Company’s cash and cash equivalents are invested primarily in cash deposits at large, long-standing financial institutions.
Ocuphire has not generated any revenue and anticipates that it will continue to incur losses for the foreseeable future.
−Removed: Future capital requirements depend on many factors, including whether the
−Removed: continues clinical trials and preclinical studies for Nyxol, APX3330 and for any other product candidate in its future pipeline;
−Removed: develops additional product candidates that it identifies, in-licenses or acquires;
−Removed: seeks regulatory approvals for any product candidates that successfully complete clinical trials;
−Removed: contracts to manufacture its product candidates;
−Removed: establishes on its own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which it may obtain regulatory approval;
−Removed: maintains, expands and protects its intellectual property portfolio;
−Removed: hires additional staff, including clinical, scientific, operational and financial personnel, to execute its business plan;
−Removed: adds operational, financial and management information systems and personnel, including personnel to support its product development and potential future commercialization efforts;
−Removed: continues to operate as a public company.
+Added: Future capital requirements depend on many factors, including
+Added: the need for the following:
+Added: continued clinical trials and preclinical studies for Nyxol, APX 3330 and for any other product candidate in its future pipeline;
Ocuphire Pharma, Inc.
+Added: developing additional product candidates that it identifies, in-licenses or acquires;
+Added: seeking regulatory approvals for any product candidates that successfully complete clinical trials;
+Added: contracts to manufacture its product candidates;
+Added: establishing on its own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which it may obtain regulatory approval;
+Added: maintaining, expanding and protecting its intellectual property portfolio;
+Added: hiring additional staff, including clinical, scientific, operational and financial personnel, to execute its business plan;
+Added: adding operational, financial and management information systems and personnel, including personnel to support its product development and potential future commercialization efforts;
+Added: operating as a public company.
Historical Capital Resources
−Removed: Ocuphire’s primary source of cash to fund Ocuphire’s operations has been from various equity offerings in the amount of $41.9 million and the issuance of convertible notes subsequent to the
−Removed: Ocuphire’s incorporation in April 2018 in the amount of $8.5 million, inclusive of the promissory notes exchanged for Ocuphire convertible notes.
+Added: Ocuphire’s primary source of cash to fund its operations has been various equity offerings in the amount of $50.8 million and the issuance of convertible notes in the amount of $8.5 million,
+Added: inclusive of the promissory notes exchanged for Ocuphire convertible notes.
+Added: At-The-Market Program
+Added: On February 4, 2021, Ocuphire filed a Form S-3 shelf registration under the Securities Act which was declared effective by the SEC on February 12, 2021 (the “2021 Shelf”)
+Added: under which the Company may offer and sell, from time to time in its sole discretion, securities having an aggregate offering price of up to $125 million.
+Added: In connection with the 2021 Shelf, on March 11, 2021, Ocuphire entered into a sales
+Added: agreement with JonesTrading Institutional Services LLC (“JonesTrading”) under which the Company may offer and sell, from time to time at its sole discretion, to or through JonesTrading, acting as agent and/or principal, shares of its common stock
+Added: having an aggregate offering price of up to $40 million (the “2021 ATM”).
+Added: During the three months ended March 31, 2022, 336,544 shares of common stock were sold under the 2021 ATM for gross proceeds in the amount of $1.2 million.
+Added: 3,115,434 shares of common stock were sold under the 2021 ATM for gross proceeds through March 31, 2022 in the amount of $14.7 million before deducting issuance expenses in the amount of $0.5 million.
Registered Direct Offering
On June 4, 2021, the Company entered into a placement agency agreement with A.G.P./Alliance Global Partners (“AGP”).
−Removed: Pursuant to the terms of the placement agency agreement,
−Removed: AGP on June 8, 2021, sold of an aggregate of 3,076,923 shares of the Company’s common stock and warrants to purchase 1,538,461 shares of the Company’s common stock (the “RDO Warrants”) at an offering price of $4.875 per one Share and 0.50 RDO
−Removed: Warrants, for gross proceeds of approximately $15,000,000, before deducting AGP’s fees and related offering expenses in the amount of approximately $1.1 million.
−Removed: The purchase agreement contains customary representations, warranties and agreements
−Removed: by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties and termination provisions.
−Removed: The RDO Warrants have an exercise price of $6.09 per share and are exercisable upon the initial issuance date of June 8, 2021, and will expire five years
−Removed: following the initial exercise date.
−Removed: Subject to limited exceptions, a holder of a RDO Warrant will not have the right to exercise any portion of its RDO Warrants if the holder, together with its
−Removed: affiliates, would beneficially own in excess of 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the number of shares of common stock outstanding immediately after giving effect to such exercise;
−Removed: however, that upon prior notice to the Company, the holder may increase or decrease the beneficial ownership limitation, provided further that in no event shall the beneficial ownership limitation exceed 9.99%.
−Removed: As of September 30, 2021,
−Removed: 1,538,461 RDO Warrants were still outstanding.
+Added: Pursuant to the terms of the placement agency agreement, AGP on June 8, 2021,
+Added: sold an aggregate of 3,076,923 shares of the Company’s common stock and warrants to purchase 1,538,461 shares of the Company’s common stock (the “RDO Warrants”) at an offering price of $4.875 per share and 0.50 RDO Warrants, for gross proceeds of
+Added: $15.0 million, before deducting AGP’s fees and related offering expenses in the amount of $1.1 million.
+Added: The purchase agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing,
+Added: indemnification obligations of the Company, other obligations of the parties and termination provisions.
+Added: The RDO Warrants have an exercise price of $6.09 per share, are exercisable upon the initial issuance
+Added: date of June 8, 2021, and will expire five years following the initial exercise date.
+Added: Subject to limited exceptions, a holder of a RDO Warrant will not have
+Added: the right to exercise any portion of its RDO Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the number of shares of
+Added: common stock outstanding immediately after giving effect to such exercise;
+Added: provided, however, that upon prior notice to the Company, the holder may increase or decrease the beneficial ownership limitation, provided further that in no event
+Added: shall the beneficial ownership limitation exceed 9.99%.
+Added: As of March 31, 2022, 1,538,461 RDO Warrants were still outstanding.
The offering of the Securities was made pursuant to the Company’s effective shelf registration statement on Form S-3.
−Removed: At-The-Market Program
−Removed: On February 4, 2021, Ocuphire filed a Form S-3 shelf registration under the Securities Act which was declared effective by the SEC on February 12, 2021 (the “2021 Shelf”) under
−Removed: which the Company may offer and sell, from time to time in its sole discretion, securities having an aggregate offering price of up to $125 million.
−Removed: In connection with the 2021 Shelf, on March 11, 2021, Ocuphire entered into a Capital on Demand TM Sales Agreement with JonesTrading Institutional Services LLC (“JonesTrading”) under which the Company may offer and sell, from time to time at its sole discretion, to
−Removed: or through JonesTrading, acting as agent and/or principal, shares of its common stock having an aggregate offering price of up to $40 million (the “2021 ATM”).
−Removed: During the three and nine months ended September 30, 2021, 332,600 shares and 1,233,543
−Removed: shares were sold under the 2021 ATM, respectively, for gross proceeds in the amount of approximately $1.7 million and $5.8 million, respectively.
+Added: Ocuphire Pharma, Inc.
Pre-Merger Financing
Securities Purchase Agreement
−Removed: On June 17, 2020, Ocuphire, Rexahn and certain investors entered into a Securities Purchase Agreement, which was amended and restated in its entirety on June 29, 2020 (as amended and restated, the
−Removed: “Securities Purchase Agreement”).
−Removed: Pursuant to the Securities Purchase Agreement, the investors invested a total of $21.15 million in cash, including $300,000 invested by directors of Private Ocuphire and one director of Rexahn, upon closing of the
−Removed: Merger (the “Pre-Merger Financing”).
−Removed: Pursuant to the Pre-Merger Financing, (i) Ocuphire issued and sold to the investors shares of Private Ocuphire common stock (the “Initial Shares”) which converted pursuant to the exchange ratio in the Merger
−Removed: into an aggregate of approximately 1,249,996 shares (the “Converted Initial Shares”) of common stock, (ii) Ocuphire deposited into escrow, for the benefit of the Investors, additional shares of Private Ocuphire common stock (the “Additional
−Removed: Shares”) which converted pursuant to the exchange ratio in the Merger into an aggregate of approximately 3,749,992 shares of common stock (the “Converted Additional Shares”), which Converted Additional Shares were delivered (or became deliverable)
−Removed: to the investors on November 19, 2020, and (iii) the Company agreed to issue to each investor on the tenth trading day following the consummation of the Merger (x) Series A Warrants representing the right to acquire shares of common stock equal to
−Removed: the sum of (A) the Converted Initial Shares purchased by the investor, (B) the Converted Additional Shares delivered or deliverable to the investor, without giving effect to any limitation on delivery contained in the Securities Purchase Agreement
−Removed: and (C) the initial number of shares of common stock, if any, underlying the Series B Warrants issued to the Investor and (y) additional warrants to purchase shares of common stock.
+Added: On June 17, 2020, Ocuphire, Rexahn and certain investors entered into a Securities Purchase Agreement, which was amended and
+Added: restated in its entirety on June 29, 2020 (as amended and restated, the “Securities Purchase Agreement”).
+Added: Pursuant to the Securities Purchase Agreement, the investors invested a total of $21.15 million in cash, including $300,000 invested by
+Added: directors of Ocuphire Pharma, Inc.
+Added: prior to the Merger, and one director of Rexahn, upon closing of the Merger (the “Pre-Merger Financing”).
+Added: Pursuant to the Pre-Merger Financing, (i) Ocuphire issued and sold to the investors shares of common
+Added: stock of Ocuphire Pharma, Inc.
+Added: prior to the Merger (the “Initial Shares”) which converted pursuant to the exchange ratio in the Merger into an aggregate of 1,249,996 shares (the “Converted Initial Shares”) of common stock, (ii) Ocuphire deposited
+Added: into escrow, for the benefit of the Investors, additional shares of common stock of Ocuphire Pharma, Inc.
+Added: prior to the Merger (the “Additional Shares”) which converted pursuant to the exchange ratio in the Merger into an aggregate of 3,749,992
+Added: shares of common stock (the “Converted Additional Shares”), which Converted Additional Shares were delivered (or became deliverable) to the investors on November 19, 2020, and (iii) the Company agreed to issue to each investor on the tenth
+Added: trading day following the consummation of the Merger (x) Series A Warrants representing the right to acquire shares of common stock equal to the sum of (A) the Converted Initial Shares purchased by the investor, (B) the Converted Additional
+Added: Shares delivered or deliverable to the investor, without giving effect to any limitation on delivery contained in the Securities Purchase Agreement and (C) the initial number of shares of common stock, if any, underlying the Series B Warrants
+Added: issued to the Investor and (y) additional warrants to purchase shares of common stock.
Waiver Agreements
2 unchanged sentences
leak-out agreements, and, in the case of certain Holders, grant certain registration rights for the shares underlying the warrants.
−Removed: Ocuphire Pharma, Inc.
The Waiver Agreements provide for the permanent waiver of the full ratchet anti-dilution provisions, contained in the Series A Warrants (as certain of the anti-dilution provisions had previously
5 unchanged sentences
The Series A Warrants are exercisable for 5,665,838 shares of common stock in the aggregate (without giving effect to any limitation on exercise contained therein).
−Removed: As of September 30, 2021, 5,665,838 Series A Warrants were still
+Added: As of March 31, 2022, 5,665,838 Series A Warrants were still outstanding.
At issuance, the Series A Warrants contained certain provisions that could have resulted in a downward adjustment of the initial exercise price and an upward adjustment in the number of shares
7 unchanged sentences
for 665,836 shares of common stock in the aggregate (without giving effect to any limitation on exercise contained therein) and ultimately became exercisable for 1,708,334 shares of common stock upon execution of the Waiver Agreements.
−Removed: September 30, 2021, 78,700 Series B Warrants were still outstanding.
+Added: 31, 2022, 78,700 Series B Warrants were still outstanding.
At issuance, the Series B Warrants contained certain provisions that could have resulted in the issuance of additional Series B Warrants depending on the dollar volume-weighted average prices of a
5 unchanged sentences
The final closing of the Ocuphire convertible notes occurred on March 10, 2020.
−Removed: The Ocuphire convertible note had an interest an interest rate of 8% per annum.
−Removed: On November 4, 2020, all
−Removed: of Ocuphire’s outstanding notes were converted into 977,128 shares of Ocuphire common stock as adjusted for the Exchange Ratio in connection with the completion of the Merger.
−Removed: The original Convertible Note Purchase Agreement (the “Note Purchase Agreement”) was dated May 25, 2018.
−Removed: Under the original terms of the Note Purchase Agreement, the Ocuphire convertible notes were
−Removed: payable on demand on July 31, 2019 unless converted earlier pursuant to their terms.
−Removed: Such conversion would automatically occur if Ocuphire (i) completed an initial public offering (“IPO”), (ii) completed a change in control (“CIC”), (iii) completed
−Removed: a sale and issuance of its capital stock resulting in gross proceeds to Ocuphire of at least $5.0 million (“Qualified Financing”), or (iv) completed a reverse merger transaction (“Reverse Merger”), each a “Conversion Event”.
−Removed: Upon a Conversion
−Removed: Event, the Ocuphire convertible notes would have automatically converted into the following:
−Removed: Qualified Financing or IPO:
−Removed: An amount of shares of Ocuphire common stock equal to 135% of the Note Value divided by the per share price of Ocuphire common
−Removed: stock issued to purchasers in the Qualified Financing or IPO.
−Removed: An amount of shares of Ocuphire common stock equal to 200% of the Note Value divided by the per share price of Ocuphire common stock based on the
−Removed: valuation of such CIC.
−Removed: Reverse Merger:
−Removed: Either (i) shares of Ocuphire common stock issued in the Reverse Merger or (ii) equity securities of the Reverse Merger counterparty, in an amount equal to 135% of the Note Value divided by the per share price at which such shares were issued to either stockholders of Ocuphire or stockholders of the Reverse Merger counterparty.
−Removed: The Note Purchase Agreement was amended and restated on January 22, 2019 (the “Amended and Restated Mezz Note Purchase Agreement”).
−Removed: Under the Amended and Restated Mezz Note Purchase Agreement, the
−Removed: demand date of the Ocuphire convertible notes was extended to December 31, 2019 and the conversion provisions under the Ocuphire convertible notes were restated such that, upon a Conversion Event, the Ocuphire convertible notes would have
−Removed: automatically converted into the following:
−Removed: An amount of shares of Ocuphire common stock equal to the greater of:
−Removed: (i) 150% of the Note Value divided by the per share price of Ocuphire common
−Removed: stock issued to purchasers in the IPO, and (ii) 100% of the Note Value divided by the per share price of $10.37.
+Added: The Ocuphire convertible notes had an interest an interest rate of 8% per annum.
+Added: On November 4, 2020,
+Added: all of Ocuphire’s outstanding notes were converted into 977,128 shares of Ocuphire common stock in connection with the completion of the Merger.
Ocuphire Pharma, Inc.
−Removed: An amount of shares of Ocuphire common stock equal to the greater of:
−Removed: (i) 200% of the Note Value divided by the per share price of Ocuphire common
−Removed: stock based on the valuation of such CIC, and (ii) 100% of the Note Value divided by the per share price of $10.37.
−Removed: Qualified Financing :
−Removed: An amount of shares of Ocuphire common stock equal to 150% of the Note Value divided by the per share price of Ocuphire common stock
−Removed: issued to purchasers in the Qualified Financing.
−Removed: Reverse Merger :
−Removed: Either shares of Ocuphire common stock issued in the Reverse Merger or equity securities of the Reverse Merger counterparty, in an amount equal to the greater of:
−Removed: (i) 150% of the
−Removed: Note Value divided by the per share price at which such shares were issued to either stockholders of Ocuphire or stockholders of the Reverse Merger counterparty, and (ii) 100% Note Value divided by the per share price of $10.37.
−Removed: The Amended and Restated Mezz Note Purchase Agreement was further amended on November 20, 2019 (the “First Amendment”).
−Removed: The terms under the First Amendment reflect the current terms in effect for
−Removed: the Ocuphire convertible notes as of the date of this proxy statement/prospectus/information statement, except as further amended by the Note Conversion Agreement (defined below).
−Removed: The First Amendment extended the demand date of the Ocuphire
−Removed: convertible notes from December 31, 2019 to September 30, 2020, and changed the basis of interest from a 360-day year, 30-day month basis to a 365-day year basis.
−Removed: In addition, the First Amendment increased the automatic conversion factor applied to
−Removed: the Note Value to 175% in the event of an IPO, Qualified Financing or Reverse Merger and removed the fixed conversion option provision of $10.37 per share in the event of an IPO, CIC or Reverse Merger.
−Removed: On June 8, 2020, holders of the Ocuphire convertible notes entered into the Note Conversion Agreement with Ocuphire (the “Note Conversion Agreement”).
−Removed: The Note Conversion Agreement provided that
−Removed: prior to the consummation of the merger, following the Rexahn special meeting, all of the Ocuphire convertible notes would automatically convert into an amount of shares of Ocuphire common stock equal to 175% of the Note Value divided by the Fully
−Removed: Diluted Shares.
−Removed: “Fully Diluted Shares” for this purpose means as of the Conversion Date the sum of the following:
−Removed: (1) all of the issued outstanding shares of Ocuphire common stock;
−Removed: and (2) the aggregate number of shares of Ocuphire common stock
−Removed: reserved for issuance under all outstanding options or other awards under equity incentive plans of Ocuphire in effect as of the date of conversion.
−Removed: The Note Conversion Agreement further provided that upon the issuance of shares of Ocuphire common stock in the conversion, each convertible note would be cancelled and extinguished without the
−Removed: need for surrender of such notes and all obligations of Ocuphire, including any obligations for payment of principal and interest on the convertible notes, would be unconditionally and irrevocably discharged.
The following table summarizes Ocuphire’s cash flows for the periods indicated (in thousands):
−Removed: For the Nine Months Ended
−Removed: September 30,
+Added: For the Three Months Ended
Net cash used in operating activities
1 unchanged sentence
Net cash provided by financing activities
−Removed: Net increase (decrease) in cash and cash equivalents
+Added: Net decrease in cash and cash equivalents
Cash Flow from Operating Activities
−Removed: For the nine months ended September 30, 2021, cash used in operating activities of $13.7 million was attributable to a net loss of $50.4 million, partially offset by $36.5 million in non-cash
−Removed: operating expenses and a net change of $0.2 million in Ocuphire’s net operating assets and liabilities.
−Removed: The non-cash expenses consisted of the fair value change in the warrant liabilities of $33.8 million, a share settlement with certain investors
−Removed: in the amount of $1.6 million, stock-based compensation of $1.4 million, non-cash impact from the receipt of common stock stemming from the fulfillment of revenue milestones ($0.4) million and depreciation expense of $3,000.
−Removed: The change in operating
−Removed: assets and liabilities was primarily attributable to a decrease in Ocuphire’s prepaid expenses offset in part by a net decrease in accrued liabilities in connection with operating as a public company post-Merger.
−Removed: For the nine months ended September 30, 2020, cash used in operating activities of $2.4 million was attributable to a net loss of $5.9 million, partially offset by $3.1 million in non-cash expenses
−Removed: and a net change of $0.4 million in Ocuphire’s net operating assets and liabilities.
−Removed: The non-cash expenses consisted of the fair value of common shares issued related to IPR&D in the amount of $2.1 million, interest and discount amortization
−Removed: related to the Ocuphire convertible notes of $1.4 million, fair value change in the premium conversion derivatives of $(0.2) million, gain on note extinguishment ($1.2) million related to the Note Conversion Agreement, $1.0 million related to
−Removed: stock-based compensation and depreciation expense of $7,000.
−Removed: The change in operating assets and liabilities was primarily attributable to a decrease in prepaid expenses and increase in accounts payable and accrued expenses associated with the
−Removed: fluctuations of Ocuphire’s operating expenses.
+Added: For the three months ended March 31, 2022, cash used in operating activities of $6.2 million was attributable to a net loss of $6.6 million, partially offset by $0.5 million in non-cash operating
+Added: expenses and a net change use of $0.1 million in Ocuphire’s net operating assets and liabilities.
+Added: The non-cash expenses consisted principally of stock-based compensation of $0.4 million and unrealized loss on short-term investments of $0.1 million.
+Added: The change in operating assets and liabilities was primarily attributable to a decrease in Ocuphire’s accounts payable and accrued liabilities, offset in part by an decrease in prepaid expenses and other assets associated with the fluctuations of
+Added: Ocuphire’s operating expenses under the normal course of business.
+Added: For the three months ended March 31, 2021, cash used in operating activities of $5.8 million was attributable to a net loss of $39.0 million, partially offset by $34.3 million in non-cash operating
+Added: expenses and a net change of $(1.1) million in Ocuphire’s net operating assets and liabilities.
+Added: The non-cash expenses consisted of the fair value change in the warrant liabilities of $33.8 million, stock-based compensation of $0.5 million and
+Added: depreciation expense of $1,000.
+Added: The change in operating assets and liabilities was primarily attributable to a decrease in Ocuphire’s accrued liabilities, on net basis, and increase in prepaid expenses associated with the fluctuations of Ocuphire’s
+Added: operating expenses and in connection with operating as a public company post-Merger.
Cash Flow from Investing Activities
There were no sources or uses from investing activities during the periods presented.
−Removed: Ocuphire Pharma, Inc.
Cash Flow from Financing Activities
−Removed: Net cash provided by financing activities during the nine months ended September 30, 2021 was $19.6 million in connection with proceeds received from both the Registered Direct Offering and 2021
−Removed: ATM, net of issuance costs, and to a much lesser extent proceeds in connection with the exercise of stock options.
−Removed: Net cash provided by financing activities during the nine months ended September 30, 2020 was $1.6 million consisting of proceeds from the issuance of the Ocuphire convertible notes, offset
−Removed: partially by deferred offering costs of $0.1 million.
+Added: Net cash provided by financing activities during the three months ended March 31, 2022 was $0.9 million in connection with the 2021 ATM financing net proceeds of $1.2 million and exercise of stock
+Added: options in the amount of $27,000, offset by payments made on the short-term loan of $0.3 million.
+Added: Net cash provided by financing activities during the three months ended March 31, 2021 was $10,000 in connection with the exercise of stock options.
Liquidity and Capital Resource Requirements
−Removed: Ocuphire has no significant sources of revenue to sustain its present activities.
−Removed: Ocuphire does not expect to generate significant revenue until, and unless, the FDA or other regulatory
−Removed: authorities approve Nyxol or APX3330 and Ocuphire successfully commercializes its product candidates.
−Removed: Until such time, if ever, as Ocuphire can generate substantial product revenue, it expects to finance its cash needs through a combination of
−Removed: equity and debt financings as well as collaborations, strategic alliances and licensing arrangements.
+Added: Ocuphire has no current source of revenue to sustain its present activities, and Ocuphire does not expect to generate significant revenue until, and unless, the FDA or other
+Added: regulatory authorities approve Nyxol or APX3330 and it successfully commercializes its product candidates.
+Added: Until such time, if ever, as Ocuphire can generate substantial product revenue, it expects to finance its cash needs through a combination
+Added: of equity and debt financings as well as collaborations, strategic alliances and licensing arrangements.
Ocuphire does not have any committed external source of funds.
−Removed: To the extent that Ocuphire raises additional capital through the sale of equity or
−Removed: convertible debt securities, the ownership interest of Ocuphire’s stockholders will be diluted, and the terms of these securities may include liquidation, warrants, or other preferences that adversely affect your rights as a common stockholder.
+Added: To the extent that Ocuphire raises additional capital through the sale of
+Added: equity or convertible debt securities, the ownership interest of Ocuphire’s stockholders will be diluted, and the terms of these securities may include liquidation, warrants, or other preferences that adversely affect your rights as a common
Debt financing, if available, may involve agreements that include covenants limiting or restricting Ocuphire’s ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
−Removed: raises additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, Ocuphire may have to relinquish valuable rights to its technologies, future revenue streams or grant licenses on terms that
−Removed: may not be favorable to Ocuphire.
−Removed: If Ocuphire is unable to raise additional funds through equity or debt financings or through collaborations, strategic alliances or licensing arrangements when needed, Ocuphire may be required to delay, limit,
−Removed: reduce or terminate its product development, future commercialization efforts, or grant rights to develop and market its product candidates that Ocuphire would otherwise prefer to develop and market itself.
+Added: If Ocuphire raises additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, Ocuphire may have to relinquish valuable rights to its technologies, future revenue streams or grant licenses
+Added: on terms that may not be favorable to Ocuphire.
+Added: If Ocuphire is unable to raise additional funds through equity or debt financings or through collaborations, strategic alliances or licensing arrangements when needed, Ocuphire may be required to
+Added: delay, limit, reduce or terminate its product development, future commercialization efforts, or grant rights to develop and market its product candidates that Ocuphire would otherwise prefer to develop and market itself.
Future Capital Requirements
−Removed: Ocuphire’s independent registered public accounting firm included an explanatory paragraph in its report on
−Removed: Ocuphire’s financial statements as of and for the years ended December 31, 2020 and 2019, noting the existence of substantial doubt about Ocuphire’s ability to continue as a going concern.
−Removed: This uncertainty arose from management’s review of
−Removed: Ocuphire’s results of operations and financial condition and its conclusion that, based on Ocuphire’s operating plans, Ocuphire did not have sufficient existing working capital to sustain operations through December 31, 2021.
−Removed: Since the issuance
−Removed: of the independent registered public accounting firm’s report, Ocuphire has raised $19.5 million, net of offering expenses, through the sale of common stock in the Registered Direct Offering and the 2021 ATM.
−Removed: To continue to fund operations,
−Removed: Ocuphire will need to raise capital.
+Added: Ocuphire’s independent registered public accounting firm included an explanatory paragraph in its report on Ocuphire’s financial statements as of and for the years ended December 31,
+Added: 2021 and 2020, noting the existence of substantial doubt about its ability to continue as a going concern.
+Added: This uncertainty arose from management’s review of Ocuphire’s results of operations and financial condition and its conclusion that, based
+Added: on Ocuphire’s operating plans, Ocuphire did not have sufficient existing working capital to sustain operations substantially beyond twelve months following the date of the report filing.
+Added: To continue to fund operations, Ocuphire will need to raise
Ocuphire may obtain additional financing in the future through the issuance of common stock, through other equity or debt financings or through collaborations or partnerships with other companies.
−Removed: may not be able to raise additional capital on terms acceptable to it, or at all, and any failure to raise capital as and when needed could compromise Ocuphire’s ability to execute on its business plan.
−Removed: The development of Nyxol and APX3330 is subject to numerous uncertainties, and Ocuphire has based its operating plans on assumptions that may prove to be substantially different than what Ocuphire
−Removed: currently anticipates, which could result in cash resources being used sooner than Ocuphire currently expects.
−Removed: Additionally, the process of advancing early-stage product candidates and testing product candidates in clinical trials is costly, and
−Removed: the timing of progress in these clinical trials is uncertain.
+Added: Ocuphire may not be able to raise
+Added: additional capital on terms acceptable to it, or at all, and any failure to raise capital as and when needed could compromise Ocuphire’s ability to execute on its business plan.
+Added: Ocuphire Pharma, Inc.
+Added: The development of Nyxol and APX3330 is subject to numerous uncertainties, and Ocuphire has based these estimates on assumptions that may prove to be substantially different than what
+Added: Ocuphire currently anticipates and could result in cash resources being used sooner than what Ocuphire currently expects.
+Added: Additionally, the process of advancing early-stage product candidates and testing product candidates in clinical trials is
+Added: costly, and the timing of progress in these clinical trials is uncertain.
Ocuphire’s ability to successfully transition to profitability will be dependent upon achieving a level of product sales adequate to support its cost structure.
−Removed: Ocuphire may not ever
−Removed: achieve profitability or generate positive cash flow from operating activities.
+Added: cannot give any assurance that it will ever be profitable or generate positive cash flow from operating activities.
Contractual Obligations and Commitments
Facility Lease
−Removed: Ocuphire leases a facility under a non-cancellable operating lease that commenced on June 8, 2019 and expires on December 31, 2022, as amended, for a base rent in the amount of $3,000 per month.
−Removed: Additionally, Ocuphire was leasing 5,466 square feet of office space in Rockville, Maryland previously occupied by Rexahn for a base rent of approximately $13,000 per month.
−Removed: The Rockville, Maryland lease expired in June 2021.
+Added: Ocuphire leases a facility under a non-cancellable operating lease that commenced on June 8, 2019 and expires on December 31, 2022, as amended, for a base rent in the amount of $3,000
Apexian Sublicense Agreement
−Removed: On January 21, 2020, Ocuphire entered into the Apexian Sublicense Agreement, pursuant to which it obtained exclusive worldwide patent and other intellectual property rights that constitute a Ref-1
−Removed: Inhibitor program relating to therapeutic applications to treat disorders related to ophthalmic and diabetes mellitus conditions.
−Removed: The lead compound in the Ref-1 Inhibitor program is APX3330, which Ocuphire intends to develop as an oral tablet
−Removed: therapeutic to treat DR and diabetic macular edema, and potentially wet age-related macular degeneration.
−Removed: In connection with the Apexian Sublicense Agreement, Ocuphire issued 891,422 shares (as adjusted for the Exchange Ratio) of Private Ocuphire common stock to Apexian and certain of Apexian’s
−Removed: The share issuance transaction was recorded in the amount of $2.1 million as IPR&D expense during the nine months ended September 30, 2020 based on the fair market value of the common shares issued since no processes or activities
−Removed: that would constitute a “business” were acquired and none of the rights and underlying assets acquired had alternative future uses or reached a stage of technological feasibility.
−Removed: Ocuphire also paid the balance remaining of $0.4 million of Ref-1
−Removed: Inhibitor program costs to Apexian following the Company’s listing on a major stock exchange.
−Removed: Ocuphire Pharma, Inc.
−Removed: Ocuphire agreed to make one-time milestone payments under the Apexian Sublicense Agreement for each of the first ophthalmic indication and the first diabetes mellitus indication.
−Removed: These milestone
−Removed: payments include (i) payments for specified developmental and regulatory milestones (including completion of the first Phase 2 trial and the first Phase 3 pivotal trial in the United States, and filing and achieving regulatory approval from the FDA
−Removed: for the first New Drug Application for a compound) totaling up to $11 million in the aggregate and (ii) payments for specified sales milestones of up to $20 million in the aggregate, which net sales milestone payments are payable once, upon the
−Removed: first achievement of such milestone.
+Added: On January 21, 2020, Ocuphire entered into the Apexian Sublicense Agreement, pursuant to which it obtained exclusive worldwide patent and other intellectual property rights that
+Added: constitute a Ref-1 Inhibitor program relating to therapeutic applications to treat disorders related to ophthalmic and diabetes mellitus conditions.
+Added: The lead compound in the Ref-1 Inhibitor program is APX3330, which Ocuphire intends to develop as
+Added: an oral tablet therapeutic to treat DR and diabetic macular edema, and potentially wAMD.
+Added: In connection with the Apexian Sublicense Agreement, Ocuphire issued 843,751 shares of Ocuphire common stock to Apexian and certain of Apexian’s affiliates.
+Added: Ocuphire agreed to make one-time milestone payments under the Apexian Sublicense Agreement for each of the first ophthalmic indication and the first diabetes mellitus
+Added: These milestone payments include (i) payments for specified developmental and regulatory milestones (including completion of the first Phase 2 trial and the first Phase 3 pivotal trial in the United States, and filing and achieving
+Added: regulatory approval from the FDA for the first New Drug Application for a compound) totaling up to $11 million in the aggregate and (ii) payments for specified sales milestones of up to $20 million in the aggregate, each of which net sales
+Added: milestone payments is payable once, upon the first achievement of such milestone.
Lastly, Ocuphire also agreed to make royalty payments equal to a single-digit percentage of its net sales of products covered by the patents under the Apexian Sublicense Agreement.
−Removed: milestone or royalty payments were triggered as of the date of this proxy statement/prospectus/information statement.
+Added: None of the milestone or royalty payments were triggered as of the date of this Report.
Other Commitments
2 unchanged sentences
covered by these arrangements are subject to change based on Ocuphire’s research and development efforts.
−Removed: Critical Accounting Policies
−Removed: Our financial statements are prepared in accordance with U.S.
−Removed: generally accepted accounting principles.
−Removed: These accounting principles require us to make estimates and judgments that can affect the
−Removed: reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented.
−Removed: We believe that the estimates and judgments upon which we rely are reasonably
−Removed: based upon information available to us at the time that we make these estimates and judgments.
−Removed: To the extent that there are material differences between these estimates and actual results, our financial results will be affected.
−Removed: The accounting
−Removed: policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described in Note 1 — “Company Description and Summary of
−Removed: Significant Accounting Policies ” to our condensed consolidated financial statements included in “Part 1, Item 1 – Financial Statements” in this Report.
−Removed: There were no additional material changes to our critical accounting policies or estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
−Removed: included in our Annual Report on Form 10-K for the year ended December 31, 2020 other than the new policies itemized below in connection with the commencement of collaborations revenue during the nine months ended September 30, 2021.
−Removed: Revenue Recognition
−Removed: We follow the provisions of ASC 606, Revenue from Contracts with Customers .
−Removed: The guidance provides a unified model to determine how revenue is recognized.
−Removed: We have entered into license agreements which have revenue recognition implications.
−Removed: In determining the appropriate amount of revenue to be recognized, we perform the following steps:
−Removed: (i) identification of the promised goods or services in the contract;
−Removed: (ii) determination of
−Removed: whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;
−Removed: (iii) measurement of the transaction price, including the constraint on variable consideration;
−Removed: (iv) allocation
−Removed: of the transaction price to the performance obligations based on estimated selling prices;
−Removed: and (v) recognition of revenue when (or as) we satisfy each performance obligation.
−Removed: A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606.
−Removed: Performance obligations may include license
−Removed: rights, development services, and services associated with regulatory submission and approval processes.
−Removed: Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect
−Removed: to complete our performance obligations under the arrangement.
−Removed: If we cannot reasonably estimate when our performance obligations are either completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such
−Removed: Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
−Removed: As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the
−Removed: We use key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory
−Removed: We allocate the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation.
+Added: Other Funding Requirements
+Added: As noted above, certain of our cash requirements relate to the funding of our ongoing research and
+Added: development of Nyxol and APX3330, inclusive of any potential milestone and royalty obligations under our intellectual property licenses.
+Added: See “Part I, Item 1— Business—Nyxol and APX3330 Clinical Experience Summaries —Ocuphire Clinical Development
+Added: Plan —Future Planned Nyxol Trials—Potential Clinical Plans for APX3330—Future In-Licensing and Acquisition Opportunities—Manufacturing—Apexian Sublicense Agreement— Review and Approval of Drugs
+Added: in the United States ” in our Annual Report on Form 10-K for the year ended December 31, 2021 for a discussion of design, development, pre-clinical and clinical activities that we may conduct in the
+Added: future, including expected cash expenditures required for some of those activities, to the extent we are able to estimate such costs.
+Added: Our other cash requirements within the next twelve months include accounts payable,
+Added: accrued expenses, purchase commitments and other current liabilities.
+Added: Our other cash requirements greater than twelve months from various contractual obligations and commitments may include operating leases and contractual agreements with
+Added: third-party service providers for clinical research, product development, manufacturing, supplies, payroll, equipment maintenance, and audits for periods into calendar year 2023.
+Added: Refer to Note 4 – Commitments and Contingencies included in Part 1, Item 1 – Financial Statements ” of this Report for further detail of our lease obligation and license agreements with regard to the timing of expected future
+Added: We expect to satisfy our short-term and long-term obligations through cash on hand and from future equity and debt financings until we generate an adequate level of revenue
+Added: from commercial sales to cover expenses, if ever.
+Added: Critical Accounting Policies and Estimates
+Added: Ocuphire’s financial statements are prepared in accordance with U.S.
+Added: These accounting principles require Ocuphire to make estimates and judgments that can affect the reported
+Added: amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented.
+Added: Ocuphire believes that the estimates and judgments upon which it relies are
+Added: reasonably based upon information available to Ocuphire at the time that it makes these estimates and judgments.
+Added: To the extent that there are material differences between these estimates and actual results, Ocuphire’s financial results will be
+Added: The accounting policies that reflect Ocuphire’s more significant estimates and judgments and which it believes are the most critical to aid in fully understanding and evaluating its reported financial results are described below.
Ocuphire Pharma, Inc.
−Removed: Licenses of intellectual property:
−Removed: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize
−Removed: revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license.
−Removed: For licenses that are bundled with other promises, we utilize judgment to
−Removed: assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of
−Removed: recognizing revenue from non-refundable, up-front fees.
−Removed: We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
−Removed: Milestone payments:
−Removed: At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be
−Removed: included in the transaction price using the most likely amount method.
−Removed: If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission) is included in the transaction
−Removed: Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received.
−Removed: When our assessment of probability of achievement changes and variable
−Removed: consideration becomes probable, any additional estimated consideration is allocated to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation and
−Removed: recorded as revenue based upon when the customer obtains control of each element.
−Removed: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties
−Removed: relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: Short-term Investments
−Removed: We determine the appropriate classification of its investments in debt and equity securities at the time of purchase and are recorded on a settlement date basis.
−Removed: Our investments are comprised of
−Removed: equity securities.
−Removed: We classify investments available to fund current operations as current assets on our condensed consolidated balance sheets.
−Removed: Realized and unrealized gains or losses stemming from these investments are recorded in other income,
−Removed: net on the condensed consolidated statements of comprehensive loss.
+Added: Our significant accounting policies are discussed in Note 1 — Company Description and Summary of Significant Accounting Policies, included in “Part I, Item 1 – Financial Statements
+Added: and Supplementary Data” of this Report.
+Added: We believe that the following accounting policies and estimates are the most critical to aid in fully understanding and evaluating our reported financial results.
+Added: estimates require our most difficult, subjective, or complex judgments because they relate to matters that are inherently uncertain.
+Added: We have reviewed these critical accounting policies and estimates and related disclosures with the Audit
+Added: Committee of our Board of Directors.
+Added: We have not made any material changes to date, nor do we believe there is a reasonable likelihood of a material future change to the accounting methodologies for the areas described below.
+Added: Warrant Liabilities
+Added: Following the Merger, Ocuphire issued the Series A Warrants in connection with the Pre-Merger Financing and assumed Rexahn warrants issued prior to the Merger.
+Added: Ocuphire accounts for
+Added: these warrants as a liability at fair value as long as certain provisions precluding equity accounting treatment are present.
+Added: Upon the execution of the Waiver Agreements described in Note 3 — Pre-Merger Financing included in Part 1, Item 1 –
+Added: Financial Statements” of this Report, the Series A Warrants were no longer subject to cash settlement or indexation provisions, precluding equity classification, and as a result, not subject to fair value remeasurement.
+Added: Ocuphire will continue
+Added: to adjust the Rexahn warrant liability for changes in fair value until the earlier of the exercise, expiration, or until such time that cash settlement or indexation provisions are no longer in effect for the Rexahn warrants.
+Added: We do not expect
+Added: that the fluctuations in fair value attributed to the Rexahn warrant liability will be significant.
+Added: Stock-based Compensation
+Added: Ocuphire accounts for stock-based compensation in accordance with the provisions of
+Added: ASC 718, Compensation — Stock Compensation.
+Added: Accordingly, compensation costs related to equity instruments granted are recognized at the grant date fair value which is not subject to remeasurement.
+Added: We record equity instrument forfeitures when
+Added: For discussions about the application of grant date fair value associated with our stock-based compensation, see Note 8 — Stock-based Compensation included in “ Part 1, Item 1 –
+Added: Financial Statements ” of this Report.
+Added: Income Tax Assets and Liabilities
+Added: Currently, there is no provision for income taxes, as we have incurred operating
+Added: losses to date, and a full valuation allowance has been provided on our net deferred tax assets.
+Added: For additional information, see Note 11 — Income Taxes included in “ Part 1, Item 1 – Financial
+Added: Statements ” of this Report.
+Added: Contingencies
+Added: We are subject to numerous contingencies arising in the ordinary course of business,
+Added: including obligations related to certain license agreements.
+Added: For additional information, see Note 4 — Commitments and Contingencies included in “ Part 1, Item 1 – Financial Statements ” of this Report.
Recent Accounting Pronouncements
1 unchanged sentence
Report for a discussion of recently issued accounting pronouncements.
−Removed: Off-Balance Sheet Arrangements
Quantitative and Qualitative Disclosures About Market Risk
1 unchanged sentence
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.