What changed in TALPHERA, INC.'s 10-K — 2023 vs 2024
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Paragraph-level year-over-year comparison of TALPHERA, INC.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.
+328 added−394 removedSource: 10-K (2025-03-31) vs 10-K (2024-03-06)
Top changes in TALPHERA, INC.'s 2024 10-K
328 paragraphs added · 394 removed · 231 edited across 1 sections
- Item 6. [Reserved]+328 / −394 · 231 edited
Item 6. [Reserved]
Selected Financial Data — reserved (removed by SEC in 2021)
231 edited+97 added−163 removed185 unchanged
Item 6. [Reserved]
Selected Financial Data — reserved (removed by SEC in 2021)
231 edited+97 added−163 removed185 unchanged
2023 filing
2024 filing
Biggest changeConsolidated Statements of Cash Flows (in thousands) Year Ended December 31, 2023 2022 Cash flows from operating activities: Net (loss) income $ (18,397 ) $ 47,755 Adjustments to reconcile net income (loss) to net cash used in operating activities: Non-cash interest income on liability related to the sale of future royalties — (1,136 ) Depreciation and amortization 311 1,647 Non-cash interest expense related to debt financing 53 393 Non-cash issuance costs for warrant liability — 775 Revaluation of liability for Lowell holdback shares (723 ) — Stock-based compensation 1,729 2,889 Non-cash gain on extinguishment of liability related to the sale of future royalties — (84,152 ) Impairment of property and equipment — 4,948 Revaluation of warrant liability (5,320 ) — Impairment of net assets held for sale 6,853 — Impairment of fixed assets 1,065 — Gain on termination of lease liabilities (1,098 ) — Gain on extinguishment of debt liability (400 ) — Other (24 ) (60 ) Changes in operating assets and liabilities: Accounts receivable (189 ) (149 ) Inventories 61 (107 ) Prepaid expenses and other assets 244 299 Other assets 226 — Accounts payable (575 ) 551 Accrued liabilities (1,132 ) (1,613 ) Operating lease liabilities (147 ) (285 ) Deferred revenue (29 ) (86 ) Net cash used in operating activities (17,492 ) (28,331 ) Cash flows from investing activities: Purchase of property and equipment (100 ) (364 ) Purchase of investments (3,651 ) (7,861 ) Sale of the DSUVIA assets 2,723 — Cash paid for asset acquisition, net of cash acquired — (1,687 ) Proceeds from maturities of investments 500 46,362 Net cash (used in) provided by investing activities (528 ) 36,450 Cash flows from financing activities: Payment of long-term debt (5,416 ) (8,433 ) Net proceeds from issuance of Issuance of Series A Redeemable Convertible Preferred Stock and Warrants — 239 Redemption of Series A Redeemable Convertible Preferred Stock — (315 ) Proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in July 2023 private placement offering 8,856 — Proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in December 2022 registered direct offering — 7,528 Net proceeds from issuance of common stock in connection with exercise of pre-funded warrants 3 — Net proceeds from issuance of common stock in connection with at-the-market sales agreement — 458 Net proceeds from issuance of common stock through equity plans 45 74 Payment of employee tax obligations related to vesting of restricted stock units (22 ) (58 ) Net cash provided by (used in) financing activities 3,466 (507 ) Net change in cash, cash equivalents and restricted cash (14,554 ) 7,612 Cash, cash equivalents and restricted cash—Beginning of period 20,275 12,663 Cash, cash equivalents and restricted cash—End of period $ 5,721 $ 20,275 Supplemental Disclosures of Cash Flow Information: Cash paid for interest $ 119 $ 824 Income taxes paid $ — $ 13 Noncash Investing and Financing Activities: Purchase of property and equipment in accounts payable and accrued expenses $ — $ 825 Equity issuance costs from modification of November 2021 Financing Warrants $ — $ 47 Equity issuance costs in accounts payable and accrued expenses $ — $ 51 (Settlement)/liability for held back shares issued in connection with asset acquisition $ (77 ) $ 800 Issuance of common stock in connection with asset acquisition $ — $ 5,511 Establishment of right-of-use asset and lease liability $ — $ 127 Fair value of warrants issued to placement agent $ 263 $ — See notes to consolidated financial statements.
Biggest changeConsolidated Statements of Cash Flows (in thousands) Year Ended December 31, 2024 2023 Cash flows from operating activities: Net loss $ (13,004 ) $ (18,397 ) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash interest expense on liability related to the sale of future payments 394 — Depreciation and amortization — 311 Net amortization of discount on short-term investments (121 ) (24 ) Non-cash interest expense related to debt financing — 53 Revaluation of liability for Lowell holdback shares — (723 ) Stock-based compensation 989 1,729 Gain on change in fair value of warrant liability (717 ) (5,320 ) Impairment of net assets held for sale — 6,853 Impairment of fixed assets — 1,065 Gain on termination of lease liabilities — (1,098 ) Gain on extinguishment of debt liability — (400 ) Changes in operating assets and liabilities: Inventories — 61 Prepaid expenses and other current assets 1,641 281 Accounts payable (671 ) (575 ) Accrued liabilities (1,194 ) (1,132 ) Operating lease liabilities — (147 ) Deferred revenue — (29 ) Net cash used in operating activities (12,683 ) (17,492 ) Cash flows from investing activities: Purchase of property and equipment — (100 ) Sale of the DSUVIA assets — 2,723 Purchase of investments (4,979 ) (3,651 ) Proceeds from maturities of investments 8,760 500 Net cash provided by (used in) investing activities 3,781 (528 ) Cash flows from financing activities: Payment of long-term debt — (5,416 ) Gross proceeds from sale of future payments 6,654 — Issuance costs related to sale of future payments (521 ) — Net proceeds from issuance of common stock, accompanying warrants and pre-funded warrants in July 2023 private placement offering — 8,856 Net proceeds from issuance of common stock in connection with exercise of pre-funded warrants — 3 Net proceeds from issuance of pre-funded warrants in January 2024 private placement offering 5,884 — Net proceeds from issuance of common stock through equity plans 27 23 Net cash provided by financing activities 12,044 3,466 Net change in cash and cash equivalents 3,142 (14,554 ) Cash and cash equivalents—Beginning of period 5,721 20,275 Cash and cash equivalents—End of period $ 8,863 $ 5,721 Supplemental Disclosures of Cash Flow Information: Cash paid for interest $ — $ 119 Income taxes paid $ — $ — Noncash Investing and Financing Activities: Equity issuance costs from warrant modification $ 251 $ — Settlement of held back shares issued in connection with asset acquisition $ — $ (77 ) Offering costs in accounts payable $ — $ 72 Fair value of warrants issued to placement agent $ — $ 263 See notes to consolidated financial statements.
Our product development portfolio features Niyad (a regional anticoagulant for the dialysis circuit), two ready-to-use pre-filled syringe product candidates (Fedsyra and phenylephrine), and LTX-608 (a nafamostat formulation for direct IV infusion) that we intend to develop for one or more of the following indications: disseminated intravascular coagulation, or DIC, acute respiratory distress syndrome, or ARDS, acute pancreatitis, or as an anti-viral treatment.
Our product development portfolio features Niyad (a regional anticoagulant for the dialysis circuit), LTX-608 (a nafamostat formulation for direct IV infusion) that we intend to develop for one or more of the following indications: disseminated intravascular coagulation, or DIC, acute respiratory distress syndrome, or ARDS, acute pancreatitis, or as an anti-viral treatment, and two ready-to-use pre-filled syringe product candidates (Fedsyra and phenylephrine).
However, inflation, led by supply chain constraints, federal stimulus funding, increases to household savings, and the sudden macroeconomic shift in activity levels arising from the loosening or removal of many government restrictions, has had, and may continue to have, an impact on overhead costs and transportation costs and may in the future adversely affect our operating results.
However, inflation, led by supply chain constraints, federal stimulus funding, increases to household savings, and the sudden macroeconomic shift in activity levels arising from the loosening or removal of many government restrictions, has had, and may continue to have, an impact on overhead costs and transportation costs and may adversely affect our operating results in the future.
For additional information regarding the net income (loss) per share, see Note 12, “Net Income (Loss) per Share of Common Stock” to the consolidated financial statements in this Annual Report on Form 10-K.
For additional information regarding the net income (loss) per share, see Note 12, “Net Loss per Share of Common Stock” to the consolidated financial statements in this Annual Report on Form 10-K.
The Company’s product development portfolio features Niyad™ (a regional anticoagulant for the dialysis circuit), two ready-to-use pre-filled syringe, or PFS, product candidates (Fedsyra and phenylephrine), and LTX-608 (a nafamostat formulation for direct IV infusion) that the Company intends to develop for one or more of the following indications: disseminated intravascular coagulation, or DIC, acute respiratory distress syndrome, or ARDS, acute pancreatitis, or as an anti-viral treatment.
The Company’s product development portfolio features Niyad™ (a regional anticoagulant for the dialysis circuit), and LTX-608 (a nafamostat formulation for direct IV infusion) that the Company intends to develop for one or more of the following indications: disseminated intravascular coagulation, or DIC, acute respiratory distress syndrome, or ARDS, acute pancreatitis, or as an anti-viral treatment, and two ready-to-use pre-filled syringe, or PFS, product candidates (Fedsyra and phenylephrine).
Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values.
Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets. Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values.
In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition.
In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition.
Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values.
Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values.
When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project.
When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project.
Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.
In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations.
In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations.
Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability classified warrants are measured at fair value on the issuance date and at the end of each reporting period.
Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability classified warrants are measured at fair value on the issuance date and at the end of each reporting period.
Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations.
Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations.
Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration and are exercisable after the original issuance date.
Shares of common stock into which the pre-funded warrants may be exercised are considered outstanding for the purposes of computing net loss per share because the shares may be issued for little or no consideration and are exercisable after the original issuance date.
In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. ASU 2023-09 will be effective for annual periods beginning January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively.
In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. ASU 2023-09 will be effective for annual periods beginning January 1, 2025, and will be applied on a prospective basis with the option to apply the standard retrospectively.
Interest expense related to the Loan Agreement was $0.1 million for the year ended December 31, 2023, $0.1 million of which represented amortization of the debt discount.
Interest expense related to the Loan Agreement was $0.1 million, which represented amortization of the debt discount, for the year ended December 31, 2023.
The complaint names ten of the Company’s officers and directors and asserts state and federal claims based on the same alleged misstatements as the securities class action complaint. On September 30, 2021, October 26, 2021, and November 17, 2021, three additional purported shareholder derivative complaints were filed in the U.S. District Court for the Northern District of California.
District Court for the Northern District of California. The complaint names ten of the Company’s officers and directors and asserts state and federal claims based on the same alleged misstatements as the securities class action complaint. On September 30, 2021, October 26, 2021, and November 17, 2021, three additional purported shareholder derivative complaints were filed in the U.S.
The aggregate gross proceeds to the Company from the private placement were approximately $10.0 million, before deducting placement agent fees and other expenses payable by the Company of approximately $1.1 million, and excluding the proceeds, if any, from the exercise of the July 2023 Pre-Funded Warrants and July 2023 Series A and July 2023 Series B common stock warrants issued in the private placement.
The aggregate gross proceeds to the Company from the July 2023 Private Placement were approximately $10.0 million, before deducting placement agent fees and other expenses payable by the Company of approximately $1.1 million, and excluding the proceeds, if any, from the exercise of the July 2023 Pre-Funded Warrants and July 2023 Series A and July 2023 Series B common stock warrants issued in the July 2023 Private Placement.
Net Income (Loss) per Share of Common Stock The Company applies the two-class method to compute basic net income (loss) per share by dividing the net income (loss) attributable to common shareholders by the weighted average number of shares of common stock outstanding for the period.
Net Loss per Share of Common Stock The Company applies the two-class method to compute basic net income (loss) per share by dividing the net income (loss) attributable to common shareholders by the weighted average number of shares of common stock outstanding for the period.
If adequate funds are not available, we may be required to further reduce our workforce, reduce the scope of, or cease, the development of our product candidates in advance of the date on which our cash resources are exhausted to ensure that we have sufficient capital to meet our obligations and continue on a path designed to preserve stockholder value.
If adequate funds are not available, we may be required to further reduce our workforce, delay, reduce the scope of, or cease, the development of our product candidates in advance of the date on which our cash resources are exhausted to ensure that we have sufficient capital to meet our obligations and continue on a path designed to preserve stockholder value.
Amended and Restated 2011 Employee Stock Purchase Plan Additionally, on June 16, 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended and Restated 2011 Employee Stock Purchase Plan, or the Amended ESPP, which increased the aggregate number of shares of the Company’s common stock reserved for issuance under the 2011 Employee Stock Purchase Plan, or ESPP, to 245,000 shares, subject to adjustment for certain changes in the Company’s capitalization, and removed the “evergreen” provision from the ESPP.
Amended and Restated 2011 Employee Stock Purchase Plan On June 16, 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the Amended and Restated 2011 Employee Stock Purchase Plan, or the Amended ESPP, which increased the aggregate number of shares of the Company’s common stock reserved for issuance under the 2011 Employee Stock Purchase Plan, or ESPP, to 245,000 shares, subject to adjustment for certain changes in the Company’s capitalization, and removed the “evergreen” provision from the ESPP.
Accordingly, we express no such opinion. 4 Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
With the closing of the transaction, the Company is entitled to receive (a) up to $116.5 million in sales-based milestones, (b) quarterly payments in an amount equal to 15% of net sales based on sales of the Product to all customers, other than sales to the United States DoD under the Marketing Agreement (as defined below), pursuant to which Alora will pay the Company 75% of Product net sales to the DoD, and sales by or on behalf of Laboratoire Aguettant, or Aguettant, and (c) 20% of any consideration, excluding royalty payments based on sales of the Product and subject to customary exclusions, received by Alora or its affiliates in connection with a grant to any third party of a license related to the Product, or by Alora or its affiliates or equity holders in connection with a sale or transfer to any third party of an ownership interest in any assets acquired by Alora under the DSUVIA Agreement.
The Company is entitled to receive (a) up to $116.5 million in sales-based milestones, (b) quarterly payments in an amount equal to 15% of net sales based on sales of the Product to all customers, other than sales to the United States DoD under the Marketing Agreement (as defined below), pursuant to which Alora will pay the Company 75% of Product net sales to the DoD, and sales by or on behalf of Laboratoire Aguettant, or Aguettant, and (c) 20% of any consideration, excluding royalty payments based on sales of the Product and subject to customary exclusions, received by Alora or its affiliates in connection with a grant to any third party of a license related to the Product, or by Alora or its affiliates or equity holders in connection with a sale or transfer to any third party of an ownership interest in any assets acquired by Alora under the DSUVIA Agreement.
Our cash and investment balances are held in a variety of interest-bearing instruments, including obligations of commercial paper, corporate debt securities, U.S. government sponsored enterprise debt securities and money market funds. Cash in excess of immediate requirements is invested with a view toward capital preservation and liquidity.
Our cash and investment balances are held in a variety of interest-bearing instruments, including obligations of commercial paper, U.S. government sponsored enterprise debt securities and money market funds. Cash in excess of immediate requirements is invested with a view toward capital preservation and liquidity.
Treasury, U.S. government agency securities and commercial paper. As of December 31, 2023 and December 31, 2022, the Company held, in addition to Level II assets, a warrant liability related to the December 2022 Common Stock Warrants (see Note 10, “Warrants” below for further description).
Treasury, U.S. government agency securities and commercial paper. As of December 31, 2024 and December 31, 2023, the Company held, in addition to Level II assets, a warrant liability related to the December 2022 Common Stock Warrants (see Note 10, “Warrants” below for further description).
Accordingly, the proceeds were allocated between common stock and the 2023 Pre-Funded Warrants, Series A and Series B common stock warrants at their respective relative fair value basis to stockholders’ equity and as a component of additional paid-in capital on the consolidated balance sheets.
Accordingly, the proceeds were allocated between Common Stock and the July 2023 Pre-Funded Warrants, Series A and Series B common stock warrants at their respective relative fair value basis to stockholders’ equity and as a component of additional paid-in capital on the consolidated balance sheets.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
Discontinued Operations Asset Purchase Agreement On April 3, 2023, the Company, closed the transactions contemplated by the DSUVIA Agreement entered into on March 12, 2023, with Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of the Company relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product.
Discontinued Operations DSUVIA Agreement On April 3, 2023, the Company, closed the transactions contemplated by the DSUVIA Agreement entered into on March 12, 2023, with Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of the Company relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product.
Upon the closing of the December 2022 Financing, 750,000 of the 875,000 November 2021 Financing Warrants were modified, to reduce the exercise price of the warrants from $20.00 per share to $2.07 per share and to extend the expiration date to December 29, 2028.
F-29 Upon the closing of the December 2022 Financing, 750,000 of the 875,000 November 2021 Financing Warrants were modified, to reduce the exercise price of the warrants from $20.00 per share to $2.07 per share and to extend the expiration date to December 29, 2028.
Financial Statements and Supplementary Data The financial statements required by this item are attached to this Form 10-K beginning with page F-1. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. 61 Item 9A.
Financial Statements and Supplementary Data The financial statements required by this item are attached to this Form 10-K beginning with page F-1. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None. Item 9A.
F-33 At December 31, 2023, the December 2022 Common Stock Warrants were valued at approximately $1.8 million, using the Black-Scholes option pricing model as follows: exercise price of $2.07 per share, stock price of $0.74 per share, expected life of 5 years, volatility of 94.05%, a risk-free rate of 3.84% and 0% expected dividend yield.
At December 31, 2023, the December 2022 Common Stock Warrants were valued at approximately $1.8 million, using the Black-Scholes option pricing model as follows: exercise price of $2.07 per share, stock price of $0.74 per share, expected life of 5 years, volatility of 94.05%, a risk-free rate of 3.84% and 0% expected dividend yield.
Research and Development Expenses Research and development expenses included the following: • expenses incurred under agreements with contract research organizations and clinical trial sites; • employee-related expenses, which include salaries, benefits and stock-based compensation; • payments to third party pharmaceutical and engineering development contractors; • payments to third party manufacturers; • depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, and equipment and laboratory and other supply costs; and • costs for equipment and laboratory and other supplies.
Research and Development Expenses Research and development expenses included the following: • expenses incurred under agreements with contract research organizations and clinical trial sites; 53 • employee-related expenses, which include salaries, benefits and stock-based compensation; • payments to third party pharmaceutical and engineering development contractors; • payments to third party manufacturers; • other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, and equipment and laboratory and other supply costs; and • costs for equipment and laboratory and other supplies.
S-8 333-239213 99.2 06/16/2020 10.7+ Forms of RSU Award Grant Notice and Award Agreement (RSU Award) under the Amended and Restated 2020 Equity Incentive Plan. S-8 333-239213 99.3 06/16/2020 10.8+ Amended and Restated 2011 Employee Stock Purchase Plan. S-8 333-239213 99.4 06/16/2020 10.9+ Amended and Restated Offer Letter between the Registrant and Badri (Anil) Dasu, dated December 30, 2010.
S-8 333-239213 99.2 06/16/2020 10.7+ Forms of RSU Award Grant Notice and Award Agreement (RSU Award) under the Amended and Restated 2020 Equity Incentive Plan. S-8 333-239213 99.3 06/16/2020 10.8+ Amended and Restated 2011 Employee Stock Purchase Plan. S-8 333-239213 99.4 06/24/2024 10.9+ Amended and Restated Offer Letter between the Registrant and Badri (Anil) Dasu, dated December 30, 2010.
The Company has evaluated these items and determined that the items do not have a material effect on the Company's financial statements as of December 31, 2022 or 2023. Additionally, the CARES Act enacted the Employee Retention Credit, or ERC, to incentivize companies to retain employees, which was subsequently modified by extension of the CARES Act.
The Company has evaluated these items and determined that the items do not have a material effect on the Company's financial statements as of December 31, 2023 or 2024. Additionally, the CARES Act enacted the Employee Retention Credit, or ERC, to incentivize companies to retain employees, which was subsequently modified by extension of the CARES Act.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. PART III Item 10. Directors, Executive Officers and Corporate Governance Information regarding our directors and executive officers set forth under the headings “Proposal No.1—Election of Directors,” “Information Regarding the Board of Directors and Corporate Governance,” and “Executive Officers of the Registrant” of the 2024 Proxy Statement is incorporated herein by reference.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. PART III Item 10. Directors, Executive Officers and Corporate Governance Information regarding our directors and executive officers set forth under the headings “Proposal No.1—Election of Directors,” “Information Regarding the Board of Directors and Corporate Governance,” and “Executive Officers of the Registrant” of the 2025 Proxy Statement is incorporated herein by reference.
F-8 Talphera, Inc. Notes to Consolidated Financial Statements (In thousands, except where otherwise noted) 1. Organization and Summary of Significant Accounting Policies The Company Talphera, Inc., or the Company, or Talphera, was incorporated in Delaware on July 13, 2005 as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. and, on January 9, 2024 to Talphera, Inc.
F-6 Talphera, Inc. Notes to Consolidated Financial Statements (In thousands, except where otherwise noted) 1. Organization and Summary of Significant Accounting Policies The Company Talphera, Inc., or the Company, or Talphera, was incorporated in Delaware on July 13, 2005, as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. and, on January 9, 2024, to Talphera, Inc.
The term will automatically renew for successive five marketing year periods unless a party notifies the other party of its intention not to renew at least six (6) months prior to the expiration of the then-current term. F-24 The Company will purchase each product from Aguettant at an agreed price, or the PFS Purchase Price, subject to adjustment.
The term will automatically renew for successive five marketing year periods unless a party notifies the other party of its intention not to renew at least six (6) months prior to the expiration of the then-current term. The Company will purchase each product from Aguettant at an agreed price, or the PFS Purchase Price, subject to adjustment.
On April 25, 2023, the December 2022 Common Stock Warrants were amended to remove these full ratchet anti-dilutive adjustment rights. In the event of certain fundamental transactions involving the Company, the holder of the December 2022 Common Stock Warrants may require the Company to make a payment based on a Black-Scholes valuation, using specified inputs.
On April 25, 2023, the December 2022 Common Stock Warrants were amended to remove these full ratchet anti-dilutive adjustment rights. F-28 In the event of certain fundamental transactions involving the Company, the holder of the December 2022 Common Stock Warrants may require the Company to make a payment based on a Black-Scholes valuation, using specified inputs.
Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows. The Company relies on a single contract manufacturer, or CMO, for the active pharmaceutical ingredient, or API, for Niyad™ and a second single contract manufacturer for the finished Niyad product.
Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company's financial condition, results of operations, and cash flows. F-9 The Company relies on a single contract manufacturer, or CMO, for the active pharmaceutical ingredient, or API, for Niyad™ and a second single contract manufacturer for the finished Niyad product.
F-13 Discontinued Operations In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations , a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results.
Discontinued Operations In accordance with ASC 205-20 Presentation of Financial Statements: Discontinued Operations , a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results.
F-14 Stock-Based Compensation Compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2020 Equity Incentive Plan, or 2020 EIP, the 2011 Equity Incentive Plan, or 2011 EIP, and employee share purchases related to the Amended and Restated 2011 Employee Stock Purchase Plan, or ESPP, is based on estimated fair values at grant date.
Stock-Based Compensation Compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2020 Equity Incentive Plan, or 2020 EIP, the 2011 Equity Incentive Plan, or 2011 EIP, and employee share purchases related to the Amended and Restated 2011 Employee Stock Purchase Plan, or ESPP, is based on estimated fair values at grant date.
January 2024 Private Placement In January 2024, we entered into securities purchase agreements with institutional investors, relating to the issuance and sale of pre-funded warrants to the purchasers in a two-tranche private placement to purchase shares of common stock at a purchase price of $0.769 per share and an exercise price of $0.001 per share.
January 2024 Private Placement In January 2024, we entered into securities purchase agreements with institutional investors, relating to the issuance and sale of pre-funded warrants, or the January 2024 Pre-Funded Warrants, to the purchasers in a two-tranche private placement to purchase shares of our common stock at a purchase price of $0.769 per share and an exercise price of $0.001 per share, or the January 2024 Private Placement.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected.
Limitations on the Effectiveness of Controls A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected.
Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company ’ s Own Stock .
F-11 Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company ’ s Own Stock .
Management has assessed the effectiveness of Talphera’s internal control over financial reporting as of December 31, 2023 and has concluded that such internal control over financial reporting was effective. This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Management has assessed the effectiveness of Talphera’s internal control over financial reporting as of December 31, 2024, and has concluded that such internal control over financial reporting was effective. This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Item 6. Reserved 49 Item 7. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis should be read in conjunction with our audited financial statements and the related notes that appear elsewhere in this Annual Report on Form 10-K.
Item 6. Reserved 48 Item 7. Management ’ s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis should be read in conjunction with our audited financial statements and the related notes that appear elsewhere in this Annual Report on Form 10-K.
We are evaluating the disclosure impact of ASU 2023-09; however, the adoption of ASU 2023-09 will not have an impact on our consolidated financial statements. 54 We do not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on our consolidated financial statements.
We are evaluating the disclosure impact of ASU 2023-09; however, the adoption of ASU 2023-09 will not have a material impact on our consolidated financial statements. We do not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on our consolidated financial statements.
Accordingly, our disclosure controls and procedures and our internal control over financial reporting are designed to provide reasonable, not absolute, assurance that the objectives of the control system are met. We continue to implement, improve and refine our disclosure controls and procedures and our internal control over financial reporting. 62 Item 9B. Other Information None. Item 9C.
Accordingly, our disclosure controls and procedures and our internal control over financial reporting are designed to provide reasonable, not absolute, assurance that the objectives of the control system are met. We continue to implement, improve and refine our disclosure controls and procedures and our internal control over financial reporting. Item 9B. Other Information None . 60 Item 9C.
Certain Relationships and Related Transactions and Director Independence Information contained in the section captioned “Related Person Transactions and Indemnification” of the 2024 Proxy Statement is incorporated herein by reference. Information regarding director independence set forth under the heading “Information Regarding the Board of Directors and Corporate Governance” of the 2024 Proxy Statement is incorporated herein by reference. Item 14.
Certain Relationships and Related Transactions and Director Independence Information contained in the section captioned “Related Person Transactions and Indemnification” of the 2025 Proxy Statement is incorporated herein by reference. Information regarding director independence set forth under the heading “Information Regarding the Board of Directors and Corporate Governance” of the 2025 Proxy Statement is incorporated herein by reference. Item 14.
The July 2023 Series A and Series B common stock warrants were exercisable immediately following the closing date of July 20, 2023 and have a five -year term, unless certain milestone events are met which accelerate the expiration date to 45 days following such announcement.
F-27 The July 2023 Series A and Series B common stock warrants were exercisable immediately following the closing date of July 20, 2023, and have a five -year term, unless certain milestone events are met which accelerate the expiration date to 45 days following such announcement.
There were no accrued interest or penalties related to unrecognized tax benefits in the years ended December 31, 2023 and 2022. The Company files income tax returns in the United States, California, and other states. The tax years 2005 through 2014, and 2016 through 2023, remain open in all jurisdictions.
There were no accrued interest or penalties related to unrecognized tax benefits in the years ended December 31, 2024 or 2023. The Company files income tax returns in the United States, California, and other states. The tax years 2005 through 2014, and 2016 through 2024, remain open in all jurisdictions.
The rights, preferences and privileges of the holders of Common Stock are subject to and may be adversely affected by the rights of the holders of shares of any series of Preferred Stock that we may designate in the future. As of December 31, 2023, there are no shares of Preferred Stock issued and outstanding.
The rights, preferences and privileges of the holders of Common Stock are subject to and may be adversely affected by the rights of the holders of shares of any series of Preferred Stock that we may designate in the future. As of December 31, 2024, there are no shares of Preferred Stock issued and outstanding.
F-27 Subject to the preferences that may be applicable to any outstanding shares of Preferred Stock, the holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared by the Company’s board of directors. No dividends have been declared to date.
Subject to the preferences that may be applicable to any outstanding shares of Preferred Stock, the holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared by the Company’s board of directors. No dividends have been declared to date.
The combined offering price was $1.36 per share of common stock and accompanying July 2023 Series A common stock warrant and July 2023 Series B common stock warrant, or in the case of July 2023 Pre-Funded Warrants, $1.359 per pre-funded warrant and accompanying July 2023 Series A common stock warrant and July 2023 Series B common stock warrant (which is the purchase price per share of common stock and accompanying warrants less $0.001).
The combined offering price of the July 2023 Private Placement was $1.36 per share of Common Stock and accompanying July 2023 Series A common stock warrant and July 2023 Series B common stock warrant, or in the case of July 2023 Pre-Funded Warrants, $1.359 per pre-funded warrant and accompanying July 2023 Series A common stock warrant and July 2023 Series B common stock warrant (which is the purchase price per share of common stock and accompanying warrants less $0.001).
During 2023, cash used in investing activities of $0.5 million was primarily the net result of $2.7 million in cash proceeds on the sale of DSUVIA to Alora, $0.5 million in proceeds from the maturities of investments offset by $3.7 million for purchases of investments.
During 2023, cash used in investing activities of $0.5 million was primarily the net result of by $3.7 million for purchases of investments, partially offset by $2.7 million in cash proceeds on the sale of DSUVIA to Alora and $0.5 million in proceeds from the maturities of investments.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information contained in the sections captioned “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” of the 2024 Proxy Statement is incorporated herein by reference. Item 13.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Information contained in the sections captioned “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” of the 2025 Proxy Statement is incorporated herein by reference. Item 13.
Angotti Chief Executive Officer and Director (Principal Executive Officer) /s/ Raffi Asadorian Raffi Asadorian Chief Financial Officer (Principal Financial and Accounting Officer) 68 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Vincent J.
Angotti Chief Executive Officer and Director (Principal Executive Officer) /s/ Raffi Asadorian Raffi Asadorian Chief Financial Officer (Principal Financial and Accounting Officer) 66 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Vincent J.
Pursuant to the Termination Agreement, as of the date on which the Company has removed and transported certain equipment from Catalent’s site, the SRA Agreement and the CSA Agreement will terminate except with respect to certain specified provisions of such agreements. 9.
Pursuant to the Termination Agreement, as of the date on which the Company has removed and transported certain equipment from Catalent’s site, the SRA Agreement and the CSA Agreement will terminate except with respect to certain specified provisions of such agreements. F-22 9.
Information regarding the procedures by which our shareholders may recommend nominees to our Board of Directors set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Nominating and Corporate Governance Committee” of the 2024 Proxy Statement is incorporated herein by reference.
Information regarding the procedures by which our shareholders may recommend nominees to our Board of Directors set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Nominating and Corporate Governance Committee” of the 2025 Proxy Statement is incorporated herein by reference.
F-28 Common Stock July 2023 Private Placement On July 17, 2023, the Company entered into a securities purchase agreement, or the Purchase Agreement, with several institutional investors, or the Purchasers, relating to the issuance and sale to the Purchasers in a private placement of 5,340,591 shares of common stock, par value $0.001 per share, pre-funded warrants to purchase up to an aggregate of 2,012,356 shares of common stock at an exercise price of $0.001 per share, or the July 2023 Pre-Funded Warrants; July 2023 Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share; and July 2023 Series B common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share.
July 2023 Private Placement On July 17, 2023, the Company entered into a securities purchase agreement, or the July 2023 Purchase Agreement, with several institutional investors, or the July 2023 Purchasers, relating to the issuance and sale to the July 2023 Purchasers in a private placement, or the July 2023 Private Placement, of 5,340,591 shares of Common Stock, pre-funded warrants to purchase up to an aggregate of 2,012,356 shares of Common Stock at an exercise price of $0.001 per share, or the July 2023 Pre-Funded Warrants; July 2023 Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of Common Stock at an exercise price of $1.11 per share; and July 2023 Series B common stock warrants to purchase up to an aggregate of 7,352,947 shares of Common Stock at an exercise price of $1.11 per share.
S-1 333-170594 4.2 01/31/2011 4.4 Form of Warrant to Purchase Common Stock of the Registrant, dated as of May 30, 2019. 8-K 001-35068 4.1 06/03/2019 4.5 Form of Warrant to Purchase Common Stock of the Registrant, dated as of November 15, 2021. 8-K 001-35068 4.1 11/15/2021 4.6 Warrant to Purchase Common Stock of the Registrant, dated as of August 3, 2022. 8-K 001-35068 4.1 08/04/2022 4.7 Form of Common Warrant (December 2022). 8-K 001-35068 4.1 12/28/2022 4.8 Form of Pre-Funded Warrant (December 2022). 8-K 001-35068 4.2 12/28/2022 4.9 Form of Common Warrant, as amended (November 2022). 8-K 001-35068 4.3 12/28/2022 64 10.1+ Form of Indemnification Agreement between the Registrant and each of its directors and executive officers.
S-1 333-170594 4.2 01/31/2011 4.4 Form of Common Warrant(May 2019). 8-K 001-35068 4.1 06/03/2019 4.5 Form of Common Warrant(November 2021). 8-K 001-35068 4.1 11/15/2021 4.6 Common Stock Purchase Warrant (August 2022). 8-K 001-35068 4.1 08/04/2022 4.7 Form of Common Warrant (December 2022). 8-K 001-35068 4.1 12/28/2022 4.8 Form of Pre-Funded Warrant (December 2022). 8-K 001-35068 4.2 12/28/2022 4.9 Form of Common Warrant, as amended (November 2022). 8-K 001-35068 4.3 12/28/2022 10.1+ Form of Indemnification Agreement between the Registrant and each of its directors and executive officers.
Information regarding our Audit Committee, including the members of our Audit Committee, set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Audit Committee” of the 2024 Proxy Statement is incorporated herein by reference.
Information regarding our Audit Committee, including the members of our Audit Committee, set forth under the heading “Information Regarding the Board of Directors and Corporate Governance—Audit Committee” of the 2025 Proxy Statement is incorporated herein by reference.
Our participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the Series A Redeemable Convertible Preferred Stock, and the Series A and Series B Common Stock Warrants, the placement agent Series A and Series B Common Stock Warrants (see Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information).
Our participating securities include the November 2021 Financing Warrants, December 2022 Common Stock Warrants, the Series A and Series B common stock warrants, the placement agent Series A and Series B common stock warrants (see Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information).
Executive Compensation Information regarding executive compensation and director compensation set forth under the headings “Executive Compensation” and “Director Compensation,” respectively, of the 2024 Proxy Statement is incorporated herein by reference. Item 12.
Executive Compensation Information regarding executive compensation and director compensation set forth under the headings “Executive Compensation” and “Director Compensation,” respectively, of the 2025 Proxy Statement is incorporated herein by reference. Item 12.
The Company is evaluating the disclosure impact of ASU 2023-09; however, the adoption of ASU 2023-09 will not have an impact on the Company’s consolidated financial statements. The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial statements. 2.
The Company is evaluating the disclosure impact of ASU 2023-09; however, the adoption of ASU 2023-09 will not have a material impact on the Company’s consolidated financial statements. F-13 The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial statements. 2.
If adequate funds are not available, the Company may be required to further reduce its workforce or delay the development of its regulatory filing plans for its product candidates in advance of the date on which the Company’s cash resources are exhausted to ensure that the Company has sufficient capital to meet its obligations and continue on a path designed to preserve stockholder value.
If adequate funds are not available, the Company may be required to further reduce its workforce, delay the ongoing clinical trial for Niyad, or delay the development of its regulatory filing plans for its product candidates in advance of the date on which the Company’s cash resources are exhausted to ensure that the Company has sufficient capital to meet its obligations and continue on a path designed to preserve stockholder value.
July 2023 Private Placement In July 2023, we entered into securities purchase agreements with institutional investors and issued and sold in a private placement: • 5,340,591 shares of common stock; • pre-funded warrants to purchase up to 2,012,356 shares of common stock with an exercise price of $0.001 per share; • Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock with an exercise price of $1.11 per share; and • Series B common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock with an exercise price of $1.11 per share.
July 2023 Private Placement In July 2023, we entered into securities purchase agreements with institutional investors and issued and sold in a private placement, or the July 2023 Private Placement: • 5,340,591 shares of our common stock; 56 • pre-funded warrants to purchase up to 2,012,356 shares of our common stock with an exercise price of $0.001 per share, or the July 2023 Pre-Funded Warrants; • Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of our common stock with an exercise price of $1.11 per share; and • Series B common stock warrants to purchase up to an aggregate of 7,352,947 shares of our common stock with an exercise price of $1.11 per share.
Our cash used in operating activities also reflected changes in our working capital, net of adjustments for non-cash charges, such as stock-based compensation, depreciation and amortization of our fixed assets, non-cash interest income related to the sale of future royalties and interest expense related to our debt financings.
Our cash used in operating activities also reflected changes in our working capital, net of adjustments for non-cash charges, such as stock-based compensation, depreciation and amortization of our fixed assets, non-cash interest expense related to the sale of future payments and interest expense related to our debt financings.
Controls and Procedures We maintain disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, to allow for timely decisions regarding required disclosure.
Controls and Procedures We maintain disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer and chief financial officer, to allow for timely decisions regarding required disclosure.
Refer to Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information.
See Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information).
Refer to Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information.
See Note 9, “Stockholders’ Equity” and Note 10, “Warrants” to the consolidated financial statements in this Annual Report on Form 10-K for additional information.
As of December 31, 2023, total stock-based compensation expense related to unvested options to be recognized in future periods was $0.9 million which is expected to be recognized over a weighted-average period of 2.1 years. The grant date fair value of options vested during the years ended December 31, 2023 and 2022 was $0.9 million and $1.7 million, respectively.
As of December 31, 2024, total stock-based compensation expense related to unvested options to be recognized in future periods was $1.0 million which is expected to be recognized over a weighted-average period of 2.5 years. The grant date fair value of options vested during the years ended December 31, 2024 and 2023, was $2.0 million and $0.9 million, respectively.
F-37 The July 2023 Series A and Series B Common Stock Warrants, the placement agent July 2023 Series A and Series B Common Stock Warrants, the December 2022 Common Stock Warrants, the Series A Redeemable Convertible Preferred Stock and the November 2021 Financing Warrants are all participating securities which, by definition, entitle the holders thereof to participate in dividends and other distributions of assets by the Company to its holders of common shares as though the holder then held common shares; however, there is no contractual obligation on the part of the warrantholders to participate in the Company’s losses.
The July 2023 Series A and Series B common stock warrants, the placement agent July 2023 Series A and Series B common stock warrants, the December 2022 Common Stock Warrants, and the November 2021 Financing Warrants are all participating securities which, by definition, entitle the holders thereof to participate in dividends and other distributions of assets by the Company to its holders of common shares as though the holder then held common shares; however, there is no contractual obligation on the part of the warrantholders to participate in the Company’s losses.
There were no material realized or unrealized gains or losses on marketable securities for the years ended December 31, 2023 or 2022. As such, we did not record a credit allowance for the year ended December 31, 2023. F-18 Fair Value Measurement The Company’s financial instruments consist of Level I and II assets.
There were no material realized or unrealized gains or losses on marketable securities for the years ended December 31, 2024 or 2023. As such, we did not record a credit allowance for the year ended December 31, 2024 or 2023. Fair Value Measurement The Company’s financial instruments consist of Level I and II assets.
Recently Issued Accounting Pronouncements On December 14, 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.
Recently Issued Accounting Pronouncements On December 14, 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold.
However, upon achievement or anticipated achievement of each milestone, the Company shall recognize the related, appropriate payment as an additional cost of the acquired IPR&D asset. As of December 31, 2023, none of the contingent events have occurred.
However, upon achievement or anticipated achievement of each milestone, the Company shall recognize the related, appropriate payment as an additional cost of the acquired IPR&D asset. As of December 31, 2024, none of the contingent events have occurred. 5.
Potential common shares that are issuable for little or no cash consideration, such as the Company’s July 2023 and December 2022 Pre-Funded Warrants issued with a de minimis exercise price of $0.001 and $0.0001 per share, respectively, are considered outstanding common shares which are included in the calculation of basic and diluted net income (loss) per share in all circumstances.
Potential common shares that are issuable for little or no cash consideration, such as the Company’s January 2024, July 2023 and December 2022 Pre-Funded Warrants issued with de minimis exercise prices of $0.001, $0.001 and $0.0001 per share, respectively, are considered outstanding common shares which are included in the calculation of basic and diluted net income (loss) per share in all circumstances.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Signature Title Date /s/ Vincent J. Angotti Chief Executive Officer and Director March 6, 2024 Vincent J.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Signature Title Date /s/ Vincent J. Angotti Chief Executive Officer and Director March 31, 2025 Vincent J.
Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks.
F-8 Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks.
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