Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: Forward-Looking Statements
−Removed: You should read the
−Removed: following discussion and analysis of our financial condition and results of operations together with “Cautionary Note Regarding
−Removed: Forward-Looking Statements” and our condensed consolidated financial statements and related notes included under Item 1 of this
−Removed: Quarterly Report as well as our most recent Annual Report on Form 10-K for the year ended December 31, 2023, as amended, including Part
−Removed: 1, Item 1A “Risk Factors.”
+Added: Forward-Looking
+Added: should read the following discussion and analysis of our financial condition and results of operations together with “Cautionary
+Added: Note Regarding Forward-Looking Statements” and our condensed consolidated financial statements and related notes included under
+Added: Item 1 of this Quarterly Report as well as our most recent Annual Report on Form 10-K for the year ended December 31, 2023, as amended,
+Added: including Part 1, Item 1A “Risk Factors.”
are a biopharmaceutical company focused on discovering and developing highly targeted anti-cancer drug candidates.
2 unchanged sentences
by identifying patient populations where these drugs are active.
−Removed: Our lead drug candidate is:, the poly-ADP-ribose polymerase (PARP)
−Removed: inhibitor stenoparib, or Stenoparib.
−Removed: Delisting Notifications
−Removed: On February 1, 2024, the
−Removed: Company attended a de-listing appeal hearing with Nasdaq, and on March 12, 2024, the Company received a response from Nasdaq granting
−Removed: the Company’s request to continue its listing on Nasdaq subject to the requirement that on or before April 24, 2024, the Company
−Removed: shall demonstrate compliance with the Bid Price and on Equity Rules.
−Removed: On April 27, 2024, we received a confirmation from Nasdaq that the
−Removed: Company has regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”),
−Removed: as required by the Hearing Panel’s (“Panel”) decision of March 12, 2024.
−Removed: As a result of the capital raise under the
−Removed: ATM Offering, the Company has communicated to Nasdaq its belief that it has achieved compliance with the Equity Rules, subject to a confirmation
−Removed: to the Certificate of Designation of Series A Preferred Stock
−Removed: On January 14, 2024, pursuant
−Removed: to the terms of the First Note, the Company modified the conversion price of the 3i Exchange Warrants from $20.00 to $8.95, thereby increasing
−Removed: the number of Exchange Warrants outstanding from 220,361 at December 31, 2023 to 492,317 outstanding at January 14, 2024.
−Removed: Also on January 14,
−Removed: 2024, the conversion price of the outstanding 1,417 shares of Series A Preferred Stock was revised from $20.00 to $8.95.
−Removed: The Company filed
−Removed: the Fifth Certificate of Amendment to Amended and Restated COD (the “Fifth Amendment”) with the Secretary of State of the
−Removed: State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.95.
−Removed: As of January 14, 2024, the Company used
−Removed: the Black-Scholes option pricing model to determine the fair value of the 1,417 Series A Preferred Stock outstanding at $1,970 versus
−Removed: their carrying value of $1,742.
−Removed: Accordingly, the Company has recorded a deemed dividend of $228 as at January 14, 2024.
−Removed: At a stated value
−Removed: of $1,080 for each share of Series A Preferred Stock, the revised price of $8.95 per share results in the 1,417 shares being convertible
−Removed: into 170,952 shares of Common Stock as of January 14, 2024.
−Removed: On February 13, 2024, pursuant
−Removed: to the terms of the Second Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.95 to $8.10 and thereby
−Removed: increased the number of Exchange Warrants outstanding from 492,317 on January 18, 2024, to 544,101 on February 13, 2024.
−Removed: The Company filed
−Removed: the Sixth Certificate of Amendment to Amended and Restated COD (the “Sixth Amendment”) with the Secretary of State of the
−Removed: State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $8.10.
−Removed: As of February 14, 2024, the Company used
−Removed: the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock outstanding and concluded
−Removed: there was a gain on extinguishment of $122.
−Removed: At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price
−Removed: of $8.10 per share results in the 1,296 shares being convertible into 493,573 shares of Common Stock.
−Removed: On March 14, 2024, pursuant
−Removed: to the terms of the Third Note, the Company modified the conversion price of the 3i Exchange Warrants from $8.10 to $7.00 and thereby
−Removed: increased the number of Exchange Warrants outstanding from 544,101 on February 13, 2024, to 829,423 on March 14, 2024.
−Removed: The Company filed
−Removed: the Seventh Certificate of Amendment to Amended and Restated COD (the “Seventh Amendment”) with the Secretary of State of
−Removed: the State of Delaware to reflect the new conversion price of the Series A Preferred Stock of $7.00.
−Removed: As of March 14, 2024, the Company
−Removed: used the Black-Scholes option pricing model to determine the fair value of the then 1,296 Series A Preferred Stock outstanding and concluded
−Removed: there was a gain on extinguishment of $69.
−Removed: At a stated value of $1,080 for each share of Series A Preferred Stock, the revised price of
−Removed: $7.00 per share results in the 1,215 shares being convertible into 535,286 shares of Common Stock.
−Removed: the period April 1, 2024, through the date of this Quarterly Report, the Company has further amended the conversion prices of the Series
−Removed: A Convertible Preferred Stock, the Exchange Warrants and the 2024 Notes to equal the current last sale price of shares of its common
−Removed: stock of $1.15 as of May 1, 2024.
+Added: Our lead drug candidate is:
+Added: the poly-ADP-ribose polymerase (PARP) inhibitor
+Added: stenoparib, or Stenoparib.
+Added: Nasdaq Delisting Notifications
+Added: June 18, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff (the “Staff”) of Nasdaq indicating
+Added: that the Company has not complied with the Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”) which is the requirement
+Added: that for 30 consecutive business days the bid price for the Company’s common stock close above the $1 per share minimum bid price
+Added: requirement for continued inclusion on the Nasdaq Capital Market.
+Added: On June 27, 2024, the Company was granted a hearing before a Nasdaq
+Added: Hearings Panel.
+Added: On July 30, 2024, the Company was attended a hearing before a Nasdaq Hearings Panel and presented its plan for regaining
+Added: compliance with the Bid Price Rule.
+Added: Nasdaq has advised the Company to expect to receive a ruling within two weeks of July 30, 2024.
Meeting of Stockholders;
Share Consolidation
−Removed: On April 1, 2024, we held
−Removed: a Special Meeting of Stockholders (the “Special Meeting”) for our stockholders of record of our outstanding shares of Common
−Removed: Stock and Series A Preferred Stock.
−Removed: At the Special Meeting, the stockholders of Common Stock and Series A Preferred Stock approved an
−Removed: amendment to our Certificate of Incorporation, to, at the discretion of the Company’s board and after the Company’s stockholders’
−Removed: approval, effected the Reverse Stock Split.
−Removed: In addition, the Company filed a Fifth Certificate of Amendment of the COD in Delware.
−Removed: We effected a 1-for-20 share
−Removed: consolidation of our Common Stock on April 9, 2024 (“Share Consolidation”).
−Removed: No fractional shares were issued in connection
−Removed: with the Share Consolidation.
−Removed: If, as a result of the Share Consolidation, a stockholder would otherwise have been entitled to a fractional
−Removed: share, each fractional share was rounded up to the next whole number.
−Removed: The Share Consolidation resulted in a reduction of our outstanding
−Removed: shares of Common Stock on March 31, 2024 from 6,854,604 to 342,774.
−Removed: The par value of our authorized stock remained unchanged at $0.0001.
−Removed: 3i Transactions
−Removed: During the period April 1, 2024, through May 6,
−Removed: converted 1,215 Series
−Removed: A Preferred Stock for 452,131 shares of Common Stock at prices of between $1.15 and $7.00 per share (as of the date of the Financial Statements,
−Removed: all Series A Preferred Stock have been converted and there are no outstanding shares of Series A Preferred Stock);
−Removed: converted 200,000 Exchange
−Removed: Warrants on a cashless basis for 84,712 shares of Common Stock at $2.30 per share on April 12 2024 and 3,432,366 Exchange Warrants at
−Removed: $1.15 per share for 2,274,938 shares of Common Stock on May 2, 2024 (as of the date of the Financial Statements, there are no outstanding
−Removed: Exchange Warrants);
−Removed: redeemed all of the 3i 2024 Notes and interest for cash in the amount of $1,746, inclusive of principal of $1,540 and interest of $123,200.
+Added: effected a 1-for-20 share consolidation of our Common Stock on April 9, 2024 (“Share Consolidation”).
+Added: No fractional shares
+Added: were issued in connection with the Share Consolidation.
+Added: If, as a result of the Share Consolidation, a stockholder would otherwise have
+Added: been entitled to a fractional share, each fractional share was rounded up to the next whole number.
+Added: The Share Consolidation resulted
+Added: in a reduction of our outstanding shares of Common Stock on June 30, 2024 from 6,854,604 to 342,774.
+Added: The par value of our authorized
+Added: stock remained unchanged at $0.0001.
+Added: SEC Investigation
+Added: On July 19, 2024, the Company
+Added: received a “Wells Notice” from the Staff of the SEC relating to the Company’s previously disclosed SEC investigation.
+Added: The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the
+Added: “FDA”) regarding the Company’s NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.
+Added: understands that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022.
+Added: The Company also understands
+Added: that three of its former officers received Wells Notices from the SEC relating to the same conduct.
+Added: A Wells Notice is neither a formal
+Added: charge of wrongdoing nor a final determination that the recipient has violated any law.
+Added: The Wells Notice informed the Company that the
+Added: SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege
+Added: certain violations of the federal securities laws.
+Added: The Company is continuing to cooperate with the SEC and maintains that its actions
+Added: were appropriate, and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.
and Uncertainties
15 unchanged sentences
to date primarily from convertible notes and the issuance and sale of our ordinary shares.
−Removed: have incurred net losses in each year since inception.
−Removed: Our net losses were $3.8 million and $3.4 million for the three months ended March
−Removed: 31, 2024 and 2023, respectively.
−Removed: As of March 31, 2024, we had an accumulated deficit of $98.3 million and cash of $312 thousand.
−Removed: Substantially
−Removed: all our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative
+Added: We have incurred net losses in
+Added: each year since inception.
+Added: Our net losses were $5.0 million and $5.7 million for the six months ended June 30, 2024 and 2023, respectively.
+Added: As of June 30, 2024, we had an accumulated deficit of $99.9 million and cash and cash equivalents of $19.2 million.
+Added: Substantially all
+Added: our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative
costs associated with our operations.
2 unchanged sentences
We expect our expenses will increase substantially in connection with our ongoing activities, as we:
−Removed: drug candidates through clinical trials;
−Removed: regulatory approval of drug candidates;
−Removed: as a public company;
−Removed: our preclinical programs and clinical development efforts;
−Removed: research activities for the discovery of new drug candidates;
−Removed: supplies for our preclinical studies and clinical trials.
+Added: advance drug candidates
+Added: through clinical trials;
+Added: pursue regulatory approval
+Added: of drug candidates;
+Added: operate as a public company;
+Added: continue our preclinical
+Added: programs and clinical development efforts;
+Added: continue research activities
+Added: for the discovery of new drug candidates;
+Added: manufacture supplies for
+Added: our preclinical studies and clinical trials.
of Operating Expenses
1 unchanged sentence
and development expenses include:
−Removed: incurred under agreements with third-party contract organizations, and consultants;
−Removed: related to production of drug substance, including fees paid to contract manufacturers;
−Removed: and vendor expenses related to the execution of preclinical trials;
−Removed: employee-related
−Removed: expenses, which include salaries, benefits, and stock-based compensation.
−Removed: We expense all research and
−Removed: development costs in the periods in which they are incurred.
−Removed: Costs for certain development activities are recognized based on an evaluation
−Removed: of the progress to completion of specific tasks and estimates of services performed using information and data provided to us by our
−Removed: vendors and third-party service providers.
−Removed: Non-refundable advance payments for goods or services to be received in future periods for
−Removed: use in research and development activities are deferred and accounted for as prepaid expenses.
−Removed: The prepayments are then expensed as the
−Removed: related goods are delivered and as services are performed.
−Removed: To date, most of these expenses have been incurred to advance our lead drug
−Removed: candidate Stenoparib.
−Removed: We expect our research and
−Removed: development expenses on Stenoparib to increase substantially for the foreseeable future as we continue to invest to accelerate Stenoparib
−Removed: in clinical trials designed to attain regulatory approval.
−Removed: Costs related to dovitinib and IXEMPRA will decrease precipitously as these
−Removed: have been deprioritized/ terminated.
−Removed: We expect additional costs in research and development activities as we continue to conduct clinical
−Removed: The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and the
−Removed: successful development of our drug candidates is highly uncertain.
+Added: expenses incurred under
+Added: agreements with third-party contract organizations, and consultants;
+Added: costs related to production
+Added: of drug substance, including fees paid to contract manufacturers;
+Added: laboratory and vendor expenses
+Added: related to the execution of preclinical trials;
+Added: employee-related expenses,
+Added: which include salaries, benefits, and stock-based compensation.
+Added: expense all research and development costs in the periods in which they are incurred.
+Added: Costs for certain development activities are recognized
+Added: based on an evaluation of the progress to completion of specific tasks and estimates of services performed using information and data
+Added: provided to us by our vendors and third-party service providers.
+Added: Non-refundable advance payments for goods or services to be received
+Added: in future periods for use in research and development activities are deferred and accounted for as prepaid expenses.
+Added: The prepayments
+Added: are then expensed as the related goods are delivered and as services are performed.
+Added: To date, most of these expenses have been incurred
+Added: to advance our lead drug candidate Stenoparib.
+Added: expect our research and development expenses on Stenoparib to increase substantially for the foreseeable future as we continue to invest
+Added: to accelerate Stenoparib in clinical trials designed to attain regulatory approval.
+Added: Costs related to dovitinib and IXEMPRA will decrease
+Added: precipitously as these have been deprioritized/ terminated.
+Added: We expect additional costs in research and development activities as we continue
+Added: to conduct clinical trials.
+Added: The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming,
+Added: and the successful development of our drug candidates is highly uncertain.
As a result, we are unable to determine the duration and completion
2 unchanged sentences
and Administrative Expenses
−Removed: General and administrative
−Removed: expenses consist primarily of personnel-related costs, facilities costs, depreciation and amortization expenses and professional services
−Removed: expenses, including legal, human resources, audit, and accounting services.
−Removed: Personnel-related costs consist of salaries, benefits, and
−Removed: stock-based compensation.
+Added: and administrative expenses consist primarily of personnel-related costs, facilities costs, depreciation and amortization expenses and
+Added: professional services expenses, including legal, human resources, audit, and accounting services.
+Added: Personnel-related costs consist of
+Added: salaries, benefits, and stock-based compensation.
Facilities costs consist of rent and maintenance of facilities.
−Removed: We expect our general and administrative expenses
−Removed: to increase for the foreseeable future due to anticipated increases in headcount to advance our drug candidates and as a result of operating
−Removed: as a public company, including expenses related to compliance with the rules and regulations of the SEC, Nasdaq, additional insurance
−Removed: expenses, investor relations activities and other administrative and professional services.
−Removed: of Operations for the Three Months Ended March 31, 2024, and 2023 (unaudited) (in thousands, except where otherwise noted)
−Removed: following table summarizes our results of operations for the three months ended March 31, 2024 and 2023:
+Added: We expect our general
+Added: and administrative expenses to increase for the foreseeable future due to anticipated increases in headcount to advance our drug candidates
+Added: and as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC,
+Added: Nasdaq, additional insurance expenses, investor relations activities and other administrative and professional services.
+Added: of Operations for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited) (in thousands, except where otherwise noted)
+Added: following table summarizes our results of operations for the three and six months ended June 30, 2024 and 2023:
For the three months ended
+Added: For the six months ended
(In thousands)
−Removed: Operating expenses:
+Added: (In thousands)
+Added: Operating costs and expenses:
Research and development
General and administrative
−Removed: Total operating expenses
+Added: Total operating costs and expenses
Loss from operations:
and Development Expenses
−Removed: the three months ended March 31, 2024, compared to March 31, 2023
−Removed: increase of $743 thousand in research and development expenses was primarily because manufacturing and supplies expenses increased by
−Removed: $524 thousand, research study expenses increased by $113 thousand, contractors and consultants expenses increased by $51 thousand, stock
−Removed: based compensation expense increased by $28 thousand, and other research expense increased by $2 thousand;
−Removed: offset by increased tax credits
−Removed: of $56 thousand, decreased staffing expenses of $71 thousand, and decreased amortization of $8 thousand.
−Removed: Manufacturing and supplies expenses
−Removed: have increased because of increased drug manufacturing.
−Removed: Staffing and contractor costs have decreased as a result of cost-cutting measures.
+Added: the three months ended June 30, 2024, compared to June 30, 2023
+Added: decrease of $47 in research and development expenses was primarily because research study costs increased by $204, and patents costs
+Added: increased by $27;
+Added: offset by increased tax credits of $5 and decreases in all other expenses as follows:
+Added: contractors and consultants by
+Added: $88, manufacturing and supplies by $82, staffing by $50, amortization by $8, and other expenses by $5.
+Added: Staffing and contractor costs
+Added: have decreased because of cost-cutting measures.
+Added: the six months ended June 30, 2024, compared to June 30, 2023
+Added: increase of $696 in research and development expenses was primarily because of increased manufacturing and supplies expenses of $442,
+Added: research study costs of $317, milestone payments of $100, and patent costs of $37;
+Added: offset by increased tax credits of $51 and decreases
+Added: in all other expenses as follows:
+Added: contractors by $37, staffing by $93, amortization by $16 and other by $3.
+Added: Manufacturing and supplies
+Added: expenses have increased because of increased drug manufacturing costs.
+Added: Staffing and contractor costs have decreased because of cost-cutting
and Administrative Expenses
−Removed: and administrative expenses decreased by $171 thousand for the three months ended March 31, 2024, compared to March 31, 2023.
−Removed: decrease was primarily due to a decrease in insurance expense of $307 thousand, audit and legal expenses of $54 thousand, financial consultants’
−Removed: expense of $39 thousand, communications expenses of $27 thousand, listings expenses of $16 thousand, finance expenses of $6 thousand,
−Removed: and other expenses of $9 thousand;
−Removed: offset by increased staffing expenses of $115 thousand, and Delaware franchise tax of $162 thousand.
−Removed: Staffing costs have increased as a result of severance accruals.
+Added: the three months ended June 30, 2024, compared to June 30, 2023
+Added: General and administrative expenses decreased by $738 for the three
+Added: months ended June 30, 2024, compared to June 30, 2023.
+Added: The decrease was primarily due to increased audit and legal expenses of $327
+Added: and other expenses of $33;
+Added: offset by decreases in financial consulting costs of $356, finance costs of $374, insurance of $188, staffing
+Added: costs of $140, communication expenses of $40.
+Added: the six months ended June 30, 2024, compared to June 30, 2023
+Added: General and administrative expenses decreased by $909 for the six months
+Added: ended June 30, 2024, compared to June 30, 2023.
+Added: The decrease was primarily due to decreases of $495 in insurance expenses, $380 in
+Added: finance expenses, $395 in financial consultant expenses, $67 in communication expenses, $24 in staffing expenses, and $16 in other administrative
+Added: offset by an increase of $273 in audit and legal expenses, $201 in tax expense and $14 in premises expenses.
+Added: Staffing costs
+Added: have decreased because of cost-cutting measures, and stock-based compensation costs have decreased because of stock option forfeitures
+Added: of recently resigned employees.
Income (Expenses), Net
−Removed: the three months ended March 31, 2024, compared to March 31, 2023
−Removed: Other income (expense) of $393 thousand recognized in the three months
−Removed: ended March 31, 2024, consisted primarily of a $419 thousand fair value adjustment to derivative and warrant liabilities and foreign
−Removed: exchange gains of $76 thousand, offset by ($102) in interest expenses.
−Removed: income (expense) of $316 thousand recognized in the three months ended March 31, 2023, consisted primarily of a $309 thousand fair value
−Removed: adjustment to derivative and warrant liabilities, foreign exchange gains of $95, and interest income of $4, offset by ($92) in interest
−Removed: in fair value of our derivative liabilities and convertible debt are measured using Level 3 inputs as described in our condensed consolidated
−Removed: financial statements.
+Added: the three months ended June 30, 2024, compared to June 30, 2023
+Added: income (expense) of $1,742 recognized in the three months ended June 30, 2024, consisted primarily of a $2,243 fair value adjustment
+Added: to derivative liabilities and interest income of $53, offset by interest expenses of ($426), and foreign exchange losses of ($128).
+Added: income (expense) of $1,776 recognized in the three months ended June 30, 2023, consisted primarily of a $1,941 fair value adjustment
+Added: to derivative liabilities and interest income of $3, offset by interest expenses of ($142), and foreign exchange losses of ($26).
+Added: six months ended June 30, 2024, and June 30, 2023
+Added: income (expense) of $2,135 recognized in the six months ended June 30, 2024, consisted primarily of a $2,662 fair value adjustment to
+Added: derivative and warrant liabilities, foreign exchange losses of ($52), and interest income of $53, offset by interest expense of ($528).
+Added: income (expense) of $2,092 recognized in the six months ended June 30, 2023, consisted primarily of a $2,250 fair value adjustment to
+Added: derivative and warrant liabilities, foreign exchange gains of $69, and interest income of $7, offset by interest expense of ($234).
Capital Resources and Plan of Operations
−Removed: our inception through March 31, 2024, our operations have been financed primarily by the sale of convertible promissory notes and the
−Removed: sale and issuance of our securities.
−Removed: As of March 31, 2024, we had $312 in cash, and an accumulated deficit of $98.3 million.
−Removed: working capital deficit of $15.7 million.
−Removed: Our primary use of cash is
−Removed: to fund operating expenses, which consist of research and development as well as regulatory expenses related to our lead drug candidate
−Removed: and clinical programs for Stenoparib, and to a lesser extent, general and administrative expenses.
−Removed: Cash used to fund operating expenses
−Removed: is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.
−Removed: As of March 31, 2024, the
−Removed: Company’s cash deposits of $312 were determined to be insufficient to fund its current operating plan and planned capital expenditures
−Removed: for the next month.
−Removed: On March 21, 2024, the Company commenced an at the market offering of its common shares and as of March 31,
−Removed: 2024, had sold 6,792 common shares for net proceeds of $40.
−Removed: Subsequent to March 31, 2024, an additional 8,259,150 shares of our common
−Removed: stock were sold at the market for net proceeds of $15,572.
−Removed: In light of the Company’s cash position as of the date of this Quarterly
−Removed: Report, the Company does not have sufficient funds for its current operations and planned capital expenditures.
−Removed: As discussed above the
−Removed: Company intends to seek capital through sale of its securities or other sources.
−Removed: There are no assurances, however, that the Company will
−Removed: be successful in raising additional working capital, or if it is able to raise additional working capital, it may be unable to do so
−Removed: on commercially favorable terms.
−Removed: The Company’s failure to raise capital or enter into other such arrangements if and when needed
−Removed: would have a negative impact on its business, results of operations and financial condition and its ability to develop its product candidates.
+Added: Since our inception through June
+Added: 30, 2024, our operations have been financed primarily by the sale of convertible promissory notes and the sale and issuance of our securities.
+Added: As of June 30, 2024, we had $19.2 million in cash and cash equivalents, and an accumulated deficit of $99.9 million.
+Added: primary use of cash is to fund operating expenses, which consist of research and development as well as regulatory expenses related to
+Added: our lead drug candidate and clinical programs for Stenoparib, and to a lesser extent, general and administrative expenses.
+Added: to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts
+Added: payable and accrued expenses.
+Added: On March 21, 2024, the Company commenced an at the market offering
+Added: of shares of our Common Stock and as of June 30, 2024, had sold 31,891,433 shares of our Common Stock for net proceeds of $27,689.
+Added: Subsequent to June 30, 2024, an additional 7,340,312 shares of our common stock were sold at the market for net proceeds of
+Added: In light of the Company’s cash position as of the date of this Quarterly Report, the Company has sufficient funds for its
+Added: current operations and planned capital expenditures.
+Added: As discussed above the Company intends to seek capital through sale of its securities
+Added: or other sources.
+Added: There are no assurances, however, that the Company will be successful in raising additional working capital, or if it
+Added: is able to raise additional working capital, it may be unable to do so on commercially favorable terms.
+Added: The Company’s failure to
+Added: raise capital or enter into other such arrangements if and when needed would have a negative impact on its business, results of operations
+Added: and financial condition and its ability to develop its product candidates.
plans to mitigate the conditions or events that raise substantial doubt include additional funding through public equity, private equity,
17 unchanged sentences
for operating purposes.
−Removed: We have not included these payments in the table of contractual obligations above since these contracts are generally
+Added: We have not included these payments in a table of contractual obligations since these contracts are generally
cancellable at any time by us following a certain period after notice and therefore, we believe that our non-cancellable obligations
1 unchanged sentence
following table summarizes our cash flows for the periods indicated:
−Removed: For the three months ended
+Added: For the Six Months Ended
(In thousands)
2 unchanged sentences
Effect of foreign exchange rates on cash
−Removed: Net increase (decrease) in cash
−Removed: the three months ended March 31, 2024, net cash used in operating activities was approximately $1.5 million compared to approximately
−Removed: $3.2 million for the three months ended March 31, 2023.
−Removed: The $1.7 million decrease in net cash used in operating activities was primarily
−Removed: the result of an increase in cash provided non-cash operating assets of $2.3 million, offset by an increased loss of $500 thousand and
−Removed: higher non-cash operating expenses of $100 thousand.
−Removed: In the three months ended
−Removed: March 31, 2024, and 2023, there were no cash flows from investing activities.
−Removed: Financing Activities
−Removed: the three months ended March 31, 2024, net cash provided by financing activities was approximately $1.4 million compared to $1.2 million
−Removed: for the three months ended March 31, 2023.
−Removed: The increase in net cash provided by investing activities was primarily due to proceeds from
−Removed: the sale of the 2024 Notes to 3i during the three months ended March 31, 2024.
+Added: Net (decrease) increase in cash
+Added: the six months ended June 30, 2024, net cash used in operating activities was approximately $8.7 million compared to approximately $5.7
+Added: million for the six months ended June 30, 2023.
+Added: The $3.0 million increase in net cash used in operating activities was primarily the
+Added: result of higher non-cash operating expenses of $890 thousand and a decrease in cash provided by non-cash operating assets of $2.8 million,
+Added: offset by a decreased loss of $660 thousand.
+Added: For the six months ended June 30, 2024, net cash provided by financing
+Added: activities was approximately $27.7 million compared to approximately $4.0 million provided in the six months ended June 30, 2023.
+Added: increase in net cash provided by investing activities was primarily due to the receipt of $27,689 in net proceeds from the issuance of
+Added: common stock.
Capital and Capital Expenditure Requirements
−Removed: We believe that our existing cash and cash equivalents and our anticipated
−Removed: expenditures and commitments for the next twelve months, will not enable us to fund our operating expenses and capital expenditure requirements
−Removed: for at least twelve months from the date of this Quarterly Report.
−Removed: Our estimate as to how long we expect our cash to be able to continue
−Removed: to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than
−Removed: we currently expect.
−Removed: Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly
−Removed: faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
+Added: believe that our existing cash and cash equivalents will be sufficient to fund our anticipated expenditures and commitments for the
+Added: next twelve months.
+Added: Our estimate as to how long we expect our cash to be able to continue to fund our operations is based on
+Added: assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
+Added: changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we
+Added: currently anticipate, and we may need to seek additional funds sooner than planned.
Sheet Arrangements
2 unchanged sentences
management’s discussion and analysis of financial condition and results of operations is based upon our unaudited condensed interim
−Removed: consolidated financial statements for the three months ended March 31, 2024 and 2023, and our audited consolidated financial statements
+Added: consolidated financial statements for the three and six months ended June 30, 2024 and 2023, and our audited consolidated financial statements
for the years ended December 31, 2023 and 2022, which have been prepared in accordance with U.S.
8 unchanged sentences
under different assumptions and conditions.
−Removed: significant accounting policies are described in the notes to our consolidated financial statements for the years ended December 31,
−Removed: 2023 and 2022, included in the Form 10-K, and there have been no significant changes to our significant accounting policies during the
−Removed: three months ended March 31, 2024.
−Removed: These unaudited condensed interim consolidated financial statements should be read in conjunction
−Removed: with the Company’s audited financial statements and accompanying notes.
−Removed: Recently Issued Accounting Pronouncements
−Removed: See the sections titled “ Recently
−Removed: adopted accounting pronouncements” in Note 2 (cc) and “Recently issued accounting pronouncements not yet adopted ”
−Removed: in Note 2 (x) to the Company’s consolidated financial statements for the years ended December 31, 2023 and 2022, respectively,
−Removed: appearing in the Form 10-K;
−Removed: and in Note 2 (h) to the Company’s unaudited condensed interim consolidated financial statements
−Removed: for the three months ended March 31, 2024 and 2023.
−Removed: and Qualitative Disclosures About Market Risk.
−Removed: We are a smaller reporting
−Removed: company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
+Added: significant accounting policies are described in the notes to our consolidated financial statements for the year ended December 31, 2023
+Added: included in the Form 10-K, and there have been no significant changes to our significant accounting policies during the six months ended
+Added: June 30, 2024.
+Added: These unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s
+Added: audited financial statements and accompanying notes.
+Added: Issued Accounting Pronouncements
+Added: the sections titled “ Recently adopted accounting pronouncements” in Note 2 (cc) and “Recently issued
+Added: accounting pronouncements not yet adopted ” in Note 2 (x) to the Company’s consolidated financial statements for
+Added: the year ended December 31, 2023 and 2022, appearing in the Form 10-K;
+Added: and in Note 2 (g) to the Company’s unaudited condensed
+Added: interim consolidated financial statements for the three and six months ended June 30, 2024 and 2023.
+Added: Quantitative and
+Added: Qualitative Disclosures About Market Risk.
+Added: a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
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.