Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands except share and par value amounts)
September 30, 2024
December 31, 2023
Assets
Current Assets
Cash and cash equivalents
$
16,409
$
23,177
Tax credit receivable
1,832
1,812
Prepaid expenses and other current assets
1,292
2,414
Total Current Assets
19,533
27,403
Non-Current Assets
Property and equipment, net
314
422
Restricted cash
103
102
Right of use asset
1,428
1,759
In-process research and development
18,651
19,755
Goodwill
—
5,700
Deposits and other assets
79
78
Total Assets
$
40,108
$
55,219
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
756
$
770
Accrued expenses
3,754
2,995
Accrued employee benefits
1,291
1,517
Deferred research and development tax credit-current portion
916
906
Loans payable-current
65
63
Operating lease liability-current portion
541
487
Total Current Liabilities
7,323
6,738
Non-current Liabilities
Non-current contingent consideration
6,788
6,274
Loan Payable - non-current
98
162
Non-current deferred research and development tax credit
229
906
Non-current operating lease liability
1,035
1,442
Total Liabilities
15,473
15,522
Commitments and Contingencies (Note 13)
Temporary Equity; 10,000,000 authorized
Series C convertible preferred stock, $ 0.001 par value; 0 issued and outstanding at September 30, 2024, and 275,000 issued and outstanding at December 31, 2023
—
2,006
Series D convertible preferred stock, $ 0.001 par value; 0 issued and outstanding at September 30, 2024 and 100,000 issued and outstanding at December 31, 2023
—
728
Stockholders’ Equity:
Common stock, $ 0.001 par value; 14,000,000 shares authorized, 2,646,272 issued and 2,617,462 outstanding at September 30, 2024 and 715,028 issued and 686,219 outstanding at December 31, 2023
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1
Additional paid-in capital
355,333
346,536
Treasury stock at cost, 28,809 shares at September 30, 2024 and at December 31, 2023
( 288 )
( 288 )
Accumulated other comprehensive income
112
32
Accumulated deficit
( 330,525 )
( 309,318 )
Total Stockholders’ Equity
24,635
36,963
Total Liabilities and Stockholders’ Equity
$
40,108
$
55,219
All share numbers have been retrospectively adjusted for the one to twenty-five reverse stock split effective August 26, 2024
See accompanying notes to unaudited condensed consolidated financial statements.
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Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
For the Three months ended September 30,
For the Nine months ended September 30,
2024
2023
2024
2023
Operating Costs and Expenses:
General and administrative
2,302
212
5,702
5,099
Research and development
2,734
4,006
9,145
10,115
In-process research and development impairment
1,325
—
1,325
—
Goodwill impairment
1,526
—
5,594
—
Total Operating Costs and Expenses
7,887
4,218
21,766
15,214
Loss from Operations
( 7,887 )
( 4,218 )
( 21,766 )
( 15,214 )
Other Income/Expense:
Foreign currency exchange gain
3
6
1
7
Interest income
158
382
559
1,127
Total Other Income
161
388
560
1,134
Net Loss
( 7,726 )
( 3,830 )
( 21,206 )
( 14,080 )
Income tax benefit
—
527
—
1,216
Net Loss Attributable to Common Stockholders
$
( 7,726 )
$
( 3,303 )
$
( 21,206 )
$
( 12,864 )
Net Loss Per Share - Basic and Dilutive
$
( 6.81 )
$
( 4.85 )
$
( 24.47 )
$
( 20.38 )
Weighted average number of shares outstanding during the period - Basic and Dilutive
1,134,391
681,708
866,529
631,387
Net Loss
( 7,726 )
( 3,303 )
( 21,206 )
( 12,864 )
Gain (Loss) on foreign currency translation
821
( 702 )
80
( 379 )
Total comprehensive loss
$
( 6,905 )
$
( 4,005 )
$
( 21,126 )
$
( 13,243 )
All share numbers have been retrospectively adjusted for the one to twenty-five reverse stock split effective August 26, 2024
See accompanying notes to unaudited condensed consolidated financial statements.
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Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholder’s Equity
(In thousands, except share and par value amounts)
Common Stock $0.001 Par Value
Accumulated
Additional
Other
Total
Paid-in
Accumulated
Comprehensive
Stockholders’
Shares
Amount
Capital
Deficit
income
Treasury Stock
Equity
Balance at December 31, 2023
715,028
$
1
$
346,536
$
( 309,318 )
$
32
$
( 288 )
$
36,963
Stock-based compensation
—
—
160
—
—
—
160
Foreign currency exchange gains (losses)
—
—
—
—
( 569 )
—
( 569 )
Net loss
—
—
—
( 5,165 )
—
—
( 5,165 )
Balance at March 31, 2024
715,028
$
1
$
346,696
$
( 314,483 )
$
( 537 )
$
( 288 )
$
31,389
Stock-based compensation
—
—
172
—
—
—
172
Stock issued under “at-the-market” offering
174,282
—
1,839
—
—
—
1,839
Foreign currency exchange gains (losses)
—
—
—
—
( 172 )
—
( 172 )
Series C Preferred Stock conversion to Common
35,523
—
988
—
—
—
988
Net loss
—
—
—
( 8,316 )
—
—
( 8,316 )
Balance at June 30, 2024
924,833
$
1
$
349,695
$
( 322,799 )
$
( 709 )
$
( 288 )
$
25,900
Stock-based compensation
—
—
177
—
—
—
177
Stock issued under “at-the-market” offering
395,000
1
1,763
—
—
—
1,764
Issuance of Common Stock and Warrants, net of issuance costs
918,600
1
1,952
—
—
—
1,953
Foreign currency exchange gains (losses)
—
—
—
—
821
—
821
Series C Preferred Stock conversion to Common
36,609
—
1,018
—
—
—
1,018
Series D Preferred Stock conversion to Common
26,230
—
728
—
—
—
728
Conversion of Pre-Funded Warrants to Common
345,000
—
—
—
—
—
—
Net loss
—
—
—
( 7,726 )
—
—
( 7,726 )
Balance at September 30, 2024
2,646,272
$
3
$
355,333
$
( 330,525 )
$
112
$
( 288 )
$
24,635
All share numbers have been retrospectively adjusted for the one to twenty-five reverse stock split effective August 26, 2024
See accompanying notes to unaudited condensed consolidated financial statements.
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Common Stock $0.001 Par Value
Accumulated
Additional
Other
Total
Paid-in
Accumulated
Comprehensive
Stockholders’
Shares
Amount
Capital
Deficit
income
Treasury Stock
Equity
Balance at December 31, 2022
634,069
$
1
$
343,765
$
( 290,969 )
$
( 679 )
$
( 288 )
$
51,830
Stock-based compensation
—
—
126
—
—
—
126
Translation gains
—
—
—
—
374
—
374
Net loss
—
—
—
( 4,478 )
—
—
( 4,478 )
Balance at March 31, 2023
634,069
$
1
$
343,891
$
( 295,447 )
$
( 305 )
$
( 288 )
$
47,852
Stock-based compensation
—
—
146
—
—
—
146
Stock issued under “at-the-market” offering
76,709
—
2,156
—
—
—
2,156
Translation gains(loss)
—
—
—
—
( 51 )
—
( 51 )
Net loss
—
—
—
( 5,084 )
—
—
( 5,084 )
Balance at June 30, 2023
710,778
$
1
$
346,193
$
( 300,531 )
$
( 356 )
$
( 288 )
$
45,019
Stock-based compensation
—
—
135
—
—
—
135
Stock issued under “at-the-market” offering
40
—
1
—
—
—
1
Translation gains(loss)
—
—
—
—
( 702 )
—
( 702 )
Net loss
—
—
—
( 3,303 )
—
—
( 3,303 )
Balance at September 30, 2023
710,818
$
1
$
346,329
$
( 303,834 )
$
( 1,058 )
$
( 288 )
$
41,150
All share numbers have been retrospectively adjusted for the one to twenty-five reverse stock split effective August 26, 2024
See accompanying notes to unaudited condensed consolidated financial statements.
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Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
For the Nine Months Ended September 30,
2024
2023
Cash Flows From Operating Activities:
Net loss
$
( 21,206 )
$
( 12,864 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
509
407
Income tax benefit
—
( 1,216 )
In-process research and development impairment
1,325
—
Goodwill impairment
5,594
—
Change in fair value of contingent consideration
514
( 999 )
Non-cash lease expense
335
283
Depreciation
110
96
Deferred research and development tax credit
( 669 )
—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
1,124
1,524
Deposits and other assets
1
( 54 )
Accounts payable
( 21 )
( 74 )
Accrued expenses
724
883
Accrued employee benefits
( 229 )
( 129 )
Operating lease liability
( 357 )
( 312 )
Net Cash Used In Operating Activities
( 12,246 )
( 12,455 )
Cash Flows from Investing Activities
Purchase of property and equipment
( 1 )
( 146 )
Net Cash Used in Investing Activities
( 1 )
( 146 )
Cash Flows from Financing Activities
Payment of loans payable
( 67 )
( 75 )
Proceeds from issuance Common Stock and Warrants offering, net of issuance costs
1,953
—
Proceeds from issuance ATM offering, net of issuance costs
3,603
2,157
Net Cash provided by Financing Activities
5,489
2,082
Effects of exchange rate changes on cash and cash equivalents
( 9 )
( 109 )
Net decrease in cash and cash equivalents and restricted cash
( 6,767 )
( 10,628 )
Cash and cash equivalents and restricted at the beginning of this period
23,279
41,885
Cash and cash equivalents and restricted cash at the end of this period
$
16,512
$
31,257
Reconciliation of cash, cash equivalents, and restricted cash reported in the consolidated balance sheet
Cash and cash equivalents
$
16,409
$
31,160
Restricted cash included in other long-term assets
103
97
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows
$
16,512
$
31,257
Supplemental non-cash investing and financing activities:
Conversion of Series C Preferred Stock to Common Shares
$
2,005
$
—
Conversion of Series D Preferred Stock to Common Shares
$
728
$
—
Right of use assets obtained in exchange for lease liabilities
$
—
$
937
All share numbers have been adjusted for the one to twenty-five reverse stock split effective August 26, 2024
See accompanying notes to unaudited condensed consolidated financial statements.
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization, Nature of Operations and Basis of Presentation
Description of Business
Theriva Biologics, Inc. (the “Company” or “Theriva Biologics”) is a diversified clinical-stage company developing therapeutics in areas of high unmet need. As a result of the acquisition in March 2022 of Theriva Biologics S.L. (“VCN”, formerly known as VCN Biosciences, S.L.) (the “Acquisition”), described in more detail below, the Company transitioned its strategic focus to oncology through the development of VCN’s new oncolytic adenovirus platform designed for intravenous and intravitreal delivery to trigger tumor cell death, to improve access of co-administered cancer therapies to the tumor, and to promote a robust and sustained anti-tumor response by the patient’s immune system. Prior to the Acquisition, the Company’s focus was on developing therapeutics designed to treat gastrointestinal (GI) diseases in areas which included its clinical development candidates: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the GI tract to prevent microbiome damage thereby preventing overgrowth and infection by pathogenic organisms such as Clostridioides difficile infection (CDI), and vancomycin resistant Enterococci (VRE), and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all the information and notes required by Accounting Principles Generally Accepted in the United States of America (“U.S. GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements include all adjustments, comprised of normal recurring adjustments, considered necessary by management to fairly state the Company’s results of operations, financial position, and cash flows. The operating results for the interim periods are not necessarily indicative of results that may be expected for any other interim period or for the full year. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 25, 2024 (the “2023 Form 10-K”).
On August 15, 2024, the Board of Directors of the Company approved a reverse stock split of the Company’s authorized, issued and outstanding shares of common stock, par value $ 0.001 per share (the “Common Stock”), at a ratio of one (1) share of Common Stock for twenty-five (25) shares of Common Stock (the “Reverse Stock Split”). The Reverse Stock Split was effective on August 26, 2024 (the “Effective Time”).
As a result of the Reverse Stock Split, each twenty-five (25) pre-split shares of Common Stock outstanding automatically combined into one (1) new share of Common Stock without any action on the part of the holders, and the number of outstanding shares of common stock was reduced from 25,131,230 shares to 1,005,249 shares (subject to rounding of fractional shares) and the number of authorized shares of Common Stock was reduced from 350,000,000 share to 14,000,000 shares. Stockholders who otherwise were entitled to receive fractional shares because they held a number of pre-reverse stock split shares of Common Stock not evenly divisible by 25, received, in lieu of a fractional share, that number of shares rounded up to the nearest whole share. The Reverse Stock Split did not alter the par value of the Common Stock or modify any voting rights or other terms of the Common Stock. In addition, pursuant to their terms, a proportionate adjustment was made to the per share conversion exercise price and number of shares issuable under all of the Company’s outstanding shares of convertible preferred stock and stock options and warrants to purchase shares of Common Stock, and the number of shares authorized and reserved for issuance pursuant to the Company’s equity incentive plans was reduced proportionately.
All share amounts and exercise/conversion prices in the condensed consolidated financial statements and footnotes below have been adjusted retrospectively for the Reverse Stock Split.
The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, which requires the use of estimates, judgments and assumptions that affect the amounts of assets and liabilities at the reporting date and the amounts of revenue and expenses in the periods presented. The Company believes that the accounting estimates employed are appropriate and the resulting balances are reasonable; however, due to the inherent uncertainties in making estimates, actual results may differ from the original estimates, requiring adjustments to these balances in future periods. As of September 30, 2024, the Company has one operating segment (which includes the legacy Company business and the VCN business) and therefore one reporting segment.
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
2. Going Concern
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company continues to incur losses and, as of September 30, 2024, the Company had an accumulated deficit of approximately $ 330.5 million. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Since inception, the Company has financed its activities principally from the proceeds from the issuance of equity securities.
The Company’s ability to continue as a going concern is dependent upon the Company’s ability to raise additional debt and equity capital. There can be no assurance that such capital will be available in sufficient amounts or on terms acceptable to the Company. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability of the recorded assets or the classification of liabilities that may be necessary should the Company be unable to continue as a going concern.
The Company does not have sufficient capital to fund its operations beyond the date that is twelve months from the date of the filing of this Quarterly Report on Form 10-Q. In order to address the Company’s capital needs, including its planned clinical trials, the Company is actively pursuing additional equity or debt financing in the form of either a private placement or a public offering. The Company has been in ongoing discussions with strategic institutional investors and investment banks with respect to such possible offerings. Such additional financing opportunities might not be available to the Company when and if needed, on acceptable terms or at all. If the Company is unable to obtain additional financing in sufficient amounts or on acceptable terms under such circumstances, the Company’s operating results and prospects will be adversely affected.
At September 30, 2024, the Company had cash and cash equivalents of approximately $ 16.4 million. Based upon the Company’s current business plans, management believes that the Company’s current cash on hand will be sufficient to fully execute its plans into the third quarter of 2025. Commencement of planned future clinical trials is subject to the Company’s successful pursuit of opportunities that will allow it to establish the clinical infrastructure and financial resources necessary to successfully initiate and complete its plan. The Company anticipates its current cash will allow it to cover overhead costs, manufacturing costs for near-term clinical supply and limited research efforts, including completing its funding requirements for its ongoing current trials for VCN-01. The Company will be required to obtain additional funding in order to continue the development of its current product candidates within the anticipated time periods (including initiation of its planned future clinical trials), if at all, and to continue to fund operations at the current cash expenditure levels. Currently, the Company does not have commitments from any third parties to provide it with capital. Potential sources of financing include strategic relationships, public or private sales of equity (including through its at the market offering sales agreement (the “ATM Sales Agreement”)) or debt and other sources. The Company cannot assure that it will meet the requirements for use of the ATM Sales Agreement or that additional funding will be available on favorable terms at all. If the Company fails to obtain additional funding for its clinical trials, whether through the sale of securities or a partner or collaborator, and otherwise when needed, it will not be able to execute its business plan as planned and will be forced to cease certain development activities (including initiation of planned clinical trials) until funding is received and its business will suffer, which would have a material adverse effect on its financial position, results of operations and cash flows.
The actual amount of funds the Company will need to operate is subject to many factors, some of which are beyond its control. These factors include the following:
● the progress of its research activities;
● the number and scope of its research programs;
● the ability to recruit patients for clinical studies in a timely manner;
● the progress of its preclinical and clinical development activities;
● the progress of the development efforts of parties with whom the Company has entered into research and development agreements and amount of funding received from partners and collaborators;
● its ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements;
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
2. Going Concern – (continued)
● the Company’s ability to achieve its milestones under licensing arrangements;
● the costs associated with manufacturing-related services to produce material for use in its clinical trials;
● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and
● the costs and timing of regulatory approvals.
The Company has based its estimates of funding requirements on assumptions that may prove to be wrong. The Company may need to obtain additional funds sooner or in greater amounts than it currently anticipates.
If the Company raises funds by selling additional shares of Common Stock or other securities convertible into Common Stock, the ownership interest of the existing stockholders will be diluted. If the Company is not able to obtain financing when needed, it may be unable to carry out its business plan. As a result, the Company may have to significantly limit its operations and its business, financial condition and results of operations would be materially harmed.
3. Summary of Significant Accounting Policies
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Such estimates and assumptions impact, among others, the following: the estimated useful lives for property and equipment, research and development costs, business combinations, contingent consideration, fair value of long-lived assets, valuation of goodwill and in process research and development, warrants, preferred stock and stock options granted for services or compensation, respectively, and the valuation allowance for deferred tax assets due to continuing and expected future operating losses.
Making estimates requires management to exercise significant judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of consolidated financial statements, which management considered in formulating its estimate could change in the near term due to one or more future confirming events. Accordingly, actual results could differ from those estimates.
There have been no new or material changes to the significant accounting policies discussed in the Company’s audited financial statements and the notes thereto included in the 2023 Form 10-K.
In-Process Research and Development (“IPR&D”)
IPR&D assets represent the fair value assigned to technologies that the Company acquired, which at the time of acquisition have not reached technological feasibility and have no alternative future use. IPR&D assets are considered to have indefinite-lives until the completion or abandonment of the associated research and development projects. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed to have definite lives and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value.
During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis on October 1, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that could indicate an impairment. The impairment test consists of a comparison of the estimated fair value of the IPR&D with its carrying amount. If the carrying amount exceeds the fair value, an impairment charge is recognized in an amount equal to that excess. The key assumptions used to value IPR&D include estimates of future cash flows and to the discount rate applicable to the future cash flow periods.
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
3. Summary of Significant Accounting Policies – (continued)
Goodwill
The Company tests the carrying amounts of goodwill for recoverability on an annual basis on October 1 or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company performs a one-step test in its evaluation of the carrying value of goodwill if qualitative factors determine it is necessary to complete a goodwill impairment test. In the evaluation, the fair value of the relevant reporting unit is determined and compared to its carrying value. If the fair value is greater than the carrying value, then the carrying value is deemed to be recoverable, and no further action is required. If the fair value estimate is less than the carrying value, goodwill is considered impaired for the amount by which the carrying amount exceeds the reporting unit’s fair value, and a charge is reported in impairment of goodwill in the Company’s consolidated statements of operations. The key assumptions used to value the reporting unit include estimates of future cash flows, the discount rate applicable and those future cash flow periods, and the implied control premium.
Contingent Consideration
Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. The Company estimates the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. Payments for amounts not in excess of original fair values established at acquisition date (including measurement period adjustments), and not paid within a period considered to be close to the transaction date, are reflected as financing activities in the statement of cash flows. Subsequent to the date of acquisition, the Company reassesses the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. The discounted cash flow is the method used to value the contingent consideration which includes inputs of not readily observable market data, which are level 3 inputs. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long-term liabilities in the consolidated balance sheets. See Fair Value of Financial Instruments below.
Research and Development Tax Credits
The Company, through its Theriva S.L. subsidiary, participates in a Research and Development incentive program sponsored by the Spanish government. The program provides for reimbursement of certain expenses incurred in research and development efforts the Company incurs in Spain. The program provides for certain limits on the types and amounts of expenses and requires participants to complete a certification and apply for the refund annually. Subsequent to the period in which expenses are incurred, the program requires participants to maintain certain workforce levels and research and development expenditures over a 24-month period. The Company accounts for the reimbursement as a tax credit receivable related to amounts that had been approved by the Spanish government and a corresponding deferred research and development tax credit as it was determined that amounts became probable of being received upon the receipt of the approval. Additionally, the Company has elected to account for the tax credit as a contra-expense as this most appropriately reflects the nature of the transaction and will reduce future research and development expenditures as the Company continues to incur expenses in the upcoming 24-month period.
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
3. Summary of Significant Accounting Policies – (continued)
Recent Accounting Pronouncements and Developments
In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . This ASU amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related earnings per share guidance for both Subtopics. The ASU is effective for annual reporting periods after December 15, 2023 and interim periods within those annual periods and early adoption is permitted in annual reporting periods ending after December 15, 2020. The Company adopted ASU 2020-06 on January 1, 2022. The ASU impacted the analysis of the accounting treatment for the issuance of Convertible Preferred Series C & D stock during the third quarter of 2022, specifically the cash conversion and beneficial conversion features.
In December 2023, the FASB issued final guidance in ASU No. 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures requiring entities to provide additional information in the rate reconciliation and disclosures about income taxes paid. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company is not early adopting this ASU, and therefore, this ASU is not adopted in the current period. The Company does not expect this ASU to have a material impact on the consolidated financial statements.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which requires public entities to disclose significant segment expenses regularly provided to the chief operating decision-maker. Public entities with a single reporting segment have to provide all disclosures required by ASC 280, including the significant segment expense disclosures. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company is not early adopting this ASU, and therefore has not adopted this ASU in the current period. The Company does not expect this ASU to have a material impact on the consolidated financial statements.
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
4. Goodwill and Intangibles
The following table provides the Company’s Goodwill as of September 30, 2024.
Goodwill (in thousands)
Balance at December 31, 2023
$
5,700
Goodwill impairment
( 5,594 )
Effects of exchange rates
( 106 )
Balance at September 30, 2024
$
—
The following table provides the Company’s in-process R&D as of September 30, 2024.
In-process
R&D (in thousands)
Balance at December 31, 2023
$
19,755
In-process R&D impairment
( 1,325 )
Effects of exchange rates
221
Balance at September 30, 2024
$
18,651
During the three and nine months ending September 30, 2024, the Company experienced a sustained decline in the quoted market price of the Company’s Common Stock and the Company deemed this to be a triggering event for impairment. The Company performed an interim impairment analysis using both the replacement cost method and the “Income approach” that requires significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post-launch cash flows and a risk-adjusted weighted average cost of capital. For the three and nine months ending September 30, 2024, the Company concluded that the in-process R&D with a carrying value of $ 19.8 million was impaired and was written down to its estimated fair value of $ 18.6 million and an impairment charge of $ 1.3 million was recorded. For the three and nine months ending September 30, 2024, the Company concluded that goodwill with a carrying value of $ 1.5 million was impaired and was written down to its estimated fair value of zero and an impairment charge of $ 1.5 million and $ 5.6 million, respectively, was recorded.
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Notes to Condensed Consolidated Financial Statements
5. Fair Value of Financial Instruments
Accounting Standards Codification (“ASC”) 820, Fair Value Measurement , defines fair value as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is determined based upon assumptions that market participants would use in pricing an asset or liability. Fair value measurements are classified on a three-tier hierarchy as follows:
● Level 1 inputs: Quoted prices (unadjusted) for identical assets or liabilities in active markets;
● Level 2 inputs: Inputs, other than quoted prices, that are observable either directly or indirectly; and
● Level 3 inputs: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions.
In many cases, a valuation technique used to measure fair value includes inputs from multiple levels of the fair value hierarchy described above. The lowest level of significant input determines the placement of the entire fair value measurement in the hierarchy.
The carrying amounts of the Company’s short-term financial instruments, including cash and cash equivalents, accounts payable and accrued liabilities, approximate fair value due to the relatively short period to maturity for these level 1 instruments.
As a result of the Acquisition of VCN the Company acquired interest-free or below-market interest rate loans extended by Spanish government. The carrying value of the loans payable approximate fair value and are classified under level 2.
In connection with the Acquisition of VCN, the Company agreed to pay up to $ 70.2 million in additional consideration upon the achievement of certain milestones, including regulatory filings completed. In August 2023, the Company initiated patient dosing in the U.S. in its Phase 2 clinical trial of VCN-01 in PDAC. As a result, payment was made in the third quarter 2023 in the amount of $ 3.25 million. The discounted cash flow method used to value this contingent consideration includes inputs of not readily observable market data, which are Level 3 inputs. The fair value of the contingent consideration was $ 6.8 million as of September 30, 2024 and is all reflected as non-current contingent consideration liability. During the three months ended September 30, 2024 and 2023, the Company recognized in operating expense a $ 587,000 increase and $ 1.6 million decrease, respectfully, fair value adjustment to contingent consideration. During the nine months ended September 30, 2024 and 2023, the Company recognized in operating expense a $ 514,000 increase and $ 1.0 million decrease, respectfully, fair value adjustment to contingent consideration. There were no transfers in or out of the level 3 liabilities during the nine months ended September 30, 2024 and 2023.
The following table summarizes the change in the fair value as determined by Level 3 inputs for the contingent consideration liabilities as of December 31, 2023 and September 30, 2024:
(in thousands)
Balance at December 31, 2022
$
10,184
Payment of contingent consideration
( 3,250 )
Change in fair value
( 660 )
Balance at December 31, 2023
$
6,274
Contingent consideration, current portion
$
—
Contingent consideration, net of current portion
6,274
Balance at December 31, 2023
$
6,274
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
5. Fair Value of Financial Instruments – (continued)
(in thousands)
Balance at December 31, 2023
$
6,274
Change in fair value
514
Balance at September 30, 2024
$
6,788
Contingent consideration, current portion
$
—
Contingent consideration, net of current portion
6,788
Balance at September, 2024
$
6,788
The fair value of financial instruments measured on a recurring basis is as follows:
As of September 30, 2024
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Contingent consideration
$
6,788
$
—
$
—
$
6,788
Total liabilities
$
6,788
$
—
$
—
$
6,788
As of December 31, 2023
Description
Total
Level 1
Level 2
Level 3
Liabilities:
Contingent consideration
$
6,274
$
—
$
—
$
6,274
Total liabilities
$
6,274
$
—
$
—
$
6,274
The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs:
As of September 30, 2024
Valuation
Significant
Weighted Average
Methodology
Unobservable Input
(range, if applicable)
Contingent Consideration
Discounted Cash Flows
Milestone dates
2026-2028
Discount rate
11.6 % to 11.9 %
Weighted Average Discount rate
11.7 %
Probability of Occurrence (periodic for each Milestone)
11.7 % to 92.0 %
Probability of occurrence (cumulative through each Milestone)
5.3 % to 48.8 %
As of December 31, 2023
Valuation
Significant
Weighted Average
Methodology
Unobservable Input
(range, if applicable)
Contingent Consideration
Discounted Cash Flows
Milestone dates
2025-2028
Discount rate
12.9 % to 13.6 %
Weighted Average Discount rate
13.16 %
Probability of Occurrence (periodic for each Milestone)
11.7 % to 92.0 %
Probability of occurrence (cumulative through each Milestone)
5.3 % to 48.8 %
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
5. Fair Value of Financial Instruments – (continued)
The Company measures certain non-financial assets on a non-recurring basis, including goodwill and in-process R&D. As a result of those measurements, during the quarter ended September 30, 2024 in-process R&D with a carrying value of $ 19.8 million was written down to its estimated fair value of $ 18.6 million and an impairment charge of $ 1.3 million was recorded, and goodwill with a carrying value of $ 1.5 million was written down to its estimated fair value of zero and an impairment charge of $ 1.5 million was recorded. For the quarter ending June 30, 2024, goodwill with a carrying value of $ 5.5 million was written down to its estimated fair value of $ 1.5 million and an impairment charge of $ 4.0 million was recorded. This analysis requires significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post-launch cash flows and a risk-adjusted weighted average cost of capital.
The fair value of the Company’s reporting unit was determined using an income approach that utilizes a discounted cash flow model. The discounted cash flow models are dependent upon the Company’s estimates of future cash flows and other factors. The Company’s estimates of future cash flows are based on a comprehensive product by product forecast over a period which covers Phase 1 to approval and 15 years of commercialized revenue and involve assumptions concerning (i) future operating performance, including research and development costs through approval of the drug, the future addressable market, future sales, long-term growth rates, operating margins, allocation and timing of cash flows and the probability of achieving the estimated cash flows and (ii) future economic conditions, all which may differ from actual future cash flows.
Assumptions related to future operating performance are based on management’s annual and ongoing budgeting, forecasting and planning processes and represent the Company’s best estimate of the future results of its operations as of a point in time. These estimates are subject to many assumptions, such as the economic environments in which it operates, demand for the products and competitor actions. Estimated future cash flows are discounted to present value using a market participant, weighted average cost of capital, which considers the risk inherent in the probability adjusted future cash flows from each product. The financial and credit market volatility directly impacts certain inputs and assumptions used to develop the weighted average cost of capital such as the risk-free interest rate, industry beta, debt interest rate and the Company’s market capital structure. These assumptions are based on significant inputs not observable in the market and thus represent Level 3 measurements within the fair value hierarchy. The use of different inputs and assumptions could increase or decrease the Company’s estimated discounted future cash flows, the resulting estimated fair values and the amounts of related goodwill impairments, if any.
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
6. Research and Development Tax Credits
The Company, through its Theriva S.L. subsidiary, participates in a Research and Development program sponsored by the Spanish government. The program provides for reimbursement of certain expenses incurred in research and development efforts the Company incurs in Spain. The reimbursements can be through either tax credits or direct refunds. The program provides for certain limits on the types and amounts of expenses for which reimbursement may be sought and requires participants to complete a certification and apply for the refund annually. Subsequent to the period in which expenses are incurred, the program requires participants to maintain certain workforce levels and research and development expenditures over a 24-month period.
In the quarter ended June 30, 2023, the Company completed the certification and applied for direct reimbursement, as opposed to a tax credit, for its qualifying research and development expenses incurred in the year ended December 31, 2022. The Company received approvals from the Spanish government in September and October 2023. During the quarter ended June 30, 2024, the Company completed the certification and applied for direct reimbursement for its qualifying research and development expenses incurred in the year ended December 31, 2023.
The Company evaluated the program and concluded that it qualified to be accounted for as government assistance. Accordingly, the Company, as allowed by U.S. GAAP, elected to account for the grant by analogizing to the guidance provided by International Accounting Standards (“IAS”) 20, Accounting for Government Grants and Disclosure of Government Assistance. Accordingly, the Company recognized a tax credit receivable of $ 1.8 million related to amounts that had been approved by the Spanish government and a corresponding deferred research and development tax credit current portion of $ 916,000 and a deferred research and development tax credit non-current portion of $ 229,000 , as it was determined that amounts became probable of being received upon the receipt of the approval. Additionally, the Company has elected to account for the tax credit as a contra-expense as this most appropriately reflects the nature of the transaction and will reduce future research and development expenditures as the Company continues to incur expenses in the upcoming 24-month period. During the three and nine months ending September 30, 2024 the Company recorded $ 221,000 and $ 669,000 , respectively, as a reduction in research and development expense.
7. Selected Balance Sheet Information
Prepaid expenses and other current assets (in thousands)
September 30,
December 31,
2024
2023
Prepaid manufacturing expenses
$
382
$
491
Prepaid clinical research organizations
359
1,119
Prepaid consulting, subscriptions and other expenses
286
180
VAT receivable
170
128
Prepaid insurance
95
496
Total
$
1,292
$
2,414
Prepaid clinical research organizations (CROs) expense is classified as a current asset. The Company makes payments to the CROs based on agreed upon terms that include payments in advance of study services.
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Notes to Condensed Consolidated Financial Statements
7. Selected Balance Sheet Information – (continued)
Property and equipment, net (in thousands)
September 30,
December 31,
2024
2023
Computers and office equipment
$
715
$
902
Other property, plant and equipment
421
417
Leasehold improvements
94
94
Software
11
11
1,241
1,424
Less: accumulated depreciation and amortization
( 927 )
( 1,002 )
Total
$
314
$
422
Accrued expenses (in thousands)
September 30,
December 31,
2024
2023
Accrued clinical consulting services
$
2,358
$
1,700
Accrued manufacturing costs
820
843
Accrued vendor payments
576
452
Total
$
3,754
$
2,995
Accrued employee benefits (in thousands)
September 30,
December 31,
2024
2023
Accrued bonus expense
$
982
$
1,307
Accrued compensation expense
181
127
Accrued vacation expense
128
83
Total
$
1,291
$
1,517
8. Stock-Based Compensation
Stock Incentive Plans
On November 2, 2010, the Board of Directors and stockholders adopted the 2010 Stock Incentive Plan (“2010 Stock Plan”) for the issuance of up to 343 shares of Common Stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. From time to time the number of shares authorized for options was increased such that 16,000 were authorized as of September 5, 2019. The exercise price of stock options under the 2010 Stock Plan was determined by the compensation committee of the Board of Directors and could be equal to or greater than the fair market value of the Company’s Common Stock on the date the option was granted. Options become exercisable over various periods from the date of grant and expire between five and ten years after the grant date. As of September 30, 2024, there were 7,843 options issued and outstanding under the 2010 Stock Plan. There are no shares available to be issued under this plan. Only options were issued under the plan.
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Notes to Condensed Consolidated Financial Statements
8. Stock-Based Compensation – (continued)
On September 17, 2020, the stockholders approved and adopted the 2020 Stock Incentive Plan (“2020 Stock Plan”) for the issuance of up to 16,000 shares of Common Stock to be granted through incentive stock options, nonqualified stock options, stock appreciation rights, dividend equivalent rights, restricted stock, restricted stock units and other stock-based awards to officers, other employees, directors and consultants of the Company and its subsidiaries. The number of shares authorized for awards under the 2020 Stock Plan was increased such that 280,000 shares were authorized as of December 31, 2022. As of September 30, 2024, there were 167,364 options issued and outstanding under the 2020 Stock Plan. Only options have been issued under the plan.
In the event of an employee’s termination, the Company will cease to recognize compensation expense for that employee. Stock option forfeitures are recognized as incurred. The fair value of the stock-based payment is recognized over the stated vesting period.
The Company has applied fair value accounting for all stock-based payment awards since inception. The fair value of each option granted is estimated on the date of grant using the Black-Scholes option pricing model. During the three and nine months ended September 30, 2024, the Company granted 420 options to employees with an approximate fair value of $ 1,500 based upon the Black-Scholes option pricing model. There were no options granted during the three and nine months ended September 30, 2023.
Expected dividends —The Company has never declared or paid dividends on its Common Stock and has no plans to do so in the foreseeable future.
Expected volatility —Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. The expected volatility assumption is derived from the historical volatility of the Company’s Common Stock over a period approximately equal to the expected term.
Risk-free interest rate —The assumed risk-free rate used is a zero coupon U.S. Treasury security with a maturity that approximates the expected term of the option.
Expected life of the option —The period of time that the options granted are expected to remain unexercised. Options granted during the prior year have a maximum term of seven years. The Company estimates the expected life of the option term based on the weighted average life between the dates that options become fully vested and the maximum life of options granted.
The Company records stock-based compensation based upon the stated vesting provisions in the related agreements. The vesting provisions for these agreements have various terms as follows:
● immediate vesting,
● in full on the one-year anniversary date of the grant date,
● half vesting immediately and the remaining over three years,
● quarterly over three years,
● annually over three years,
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Notes to Condensed Consolidated Financial Statements
8. Stock-Based Compensation – (continued)
● one-third immediate vesting and the remaining annually over two years,
● one-half immediate vesting and the remaining over nine months,
● one-quarter immediate vesting and the remaining over three years,
● one-quarter immediate vesting and the remaining over 33 months,
● monthly over one year, and
● monthly over three years.
A summary of stock option activity for the nine months ended September 30, 2024 and the year ended December 31, 2023 is as follows:
Weighted
Weighted Average
Aggregate
Average Exercise
Remaining
Intrinsic
Options
Price
Contractual Life
Value
Balance - December 31, 2022
91,862
$
90.47
6.44 years
$
—
Granted
87,801
14.75
Expired
( 4,181 )
387.60
Forfeited
( 433 )
27.79
Balance - December 31, 2023
175,049
45.55
7.70 years
—
Granted
420
5.25
Expired
( 262 )
2,267.32
Forfeited
—
—
Balance - September 30, 2024 - outstanding
175,207
$
42.13
6.96 years
$
—
Balance - September 30, 2024 - exercisable
93,934
$
65.71
5.97 years
$
—
Grant date fair value of options granted – nine months ended September 30, 2024
$
1,526
Weighted average grant date fair value – nine months ended September 30, 2024
$
3.63
Grant date fair value of options granted – year ended December 31, 2023
$
873,140
Weighted average grant date fair value – year ended December 31, 2023
$
0.40
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
8. Stock-Based Compensation – (continued)
Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to employees for the three months ended September 30, 2024 and 2023 was $ 123,000 and $ 90,000 , respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the three months ended September 30, 2024 and 2023 was $ 54,000 and $ 45,000 , respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to employees for the nine months ended September 30, 2024 and 2023 was $ 347,000 and $ 274,000 , respectively. Stock-based compensation expense included in general and administrative expenses and research and development expenses relating to stock options issued to consultants for the nine months ended September 30, 2024 and 2023 was $ 161,000 and $ 133,000 , respectively.
As of September 30, 2024, total unrecognized stock-based compensation expense related to stock options was $ 758,000 , which is expected to be expensed through August 2026.
The FASB’s guidance for stock-based payments requires cash flows from excess tax benefits to be classified as a part of cash flows from operating activities. Excess tax benefits are realized tax benefits from tax deductions for exercised options in excess of the deferred tax asset attributable to stock compensation costs for such options. The Company did not record any excess tax benefits during the three and nine months ended September 30, 2024 and 2023.
9. Stock Warrants
On September 27, 2024, the Company consummated a public offering (the “Offering”) of an aggregate of (i) 918,600 shares (the “Shares”) of Common Stock, (ii) pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 510,000 shares of Common Stock (the “Pre-Funded Warrant Shares”), and (iii) Common Stock purchase warrants (“Common Warrants”) to purchase up to 1,428,600 shares of Common Stock (the “Common Warrant Shares”). Each Share and associated Common Warrant to purchase one (1) Common Warrant Share was sold at a combined public offering price of $ 1.75 . Each Pre-Funded Warrant and associated Common Warrant to purchase one (1) Common Warrant Share was sold at a combined public offering price of $ 1.7499 . The Company received aggregate gross proceeds from the Offering of approximately $ 2.5 million, before deducting placement agent fees and other offering expenses. The Company intends to use the proceeds of the Offering primarily for working capital and general corporate purposes, including research and development and manufacturing scale-up and may use a portion of the proceeds to invest in or acquire other products, businesses or technologies. Each Pre-Funded Warrant is immediately exercisable for one (1) Pre-Funded Warrant Shares at an exercise price of $ 0.0001 per share and will remain exercisable until the Pre-Funded Warrants are exercised in full. Each Common Warrant has an exercise price of $ 2.00 per share, is immediately exercisable for one (1) Common Warrant Share, and expires five (5) years from its issuance date. The Shares, Pre-Funded Warrants and accompanying Common Warrants were issued separately. The exercise price of the Common Warrants and the Pre-Funded Warrants and number of shares of Common Stock issuable upon exercise will adjust in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events. The Common Warrants may be exercised on a cashless basis if at the time of exercise thereof there is no effective registration statement registering, or the prospectus contained therein is not available for, the issuance of the Common Warrant Shares to the holder. The Pre-Funded Warrants may be exercised on a cashless basis at any time. A holder of the Common Warrants and the Pre-Funded Warrants (together with its affiliates) may not exercise any portion of the Common Warrant or Pre-Funded Warrant to the extent that the holder would own more than 4.99 % (or 9.99 %, at the election of the holder) of the outstanding shares of Common Stock immediately after exercise, except that upon at least 61 days ’ prior notice from the holder to the Company, the holder may increase the amount of beneficial ownership of outstanding shares after exercising the holder’s Common Warrants or Pre-Funded Warrants up to 9.99 % of the number of the Company’s shares of Common Stock outstanding immediately after giving effect to the exercise. The Company has concluded that the Common Warrants and Pre-Funded Warrants are required to be equity classified. The Common Warrants were valued on the date of grant using Black Scholes model. During the nine months ended September 30, there were zero Common Warrants exercised and as of September 30, 2024, 345,000 Pre-Funded warrants were exercised.
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Notes to Condensed Consolidated Financial Statements
9. Stock Warrants – (continued)
On October 15, 2018, the Company closed its underwritten public offering pursuant to which it received gross proceeds of approximately $ 18.6 million before deducting underwriting discounts, commissions and other offering expenses payable by the Company and sold (i) Class A Units (the “Class A Units”), consisting of an aggregate of 252,000 shares of the Common Stock, warrants to purchase an aggregate of 252,000 shares of Common Stock at an exercise price of $ 13.80 per share, which subsequently was reduced to $ 6.90 per share and then again to $ 1.22 (each a “Warrant” and collectively, the “Warrants”) and (ii) Class B Units (the “Class B Units”, and together with the Class A Units, the “Units”), consisting of an aggregate of 15,723 shares of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), with a stated value of $ 1,000 and convertible into shares of Common Stock at the stated value divided by a conversion price of $ 11.50 per share, with all shares of Series B Preferred Stock convertible into an aggregate of 1,367,218 shares of Common Stock, and issued with a warrant to purchase an aggregate of 1,367,218 shares of Common Stock. The Warrants were valued on the date of grant using Monte Carlo simulations. There were no Warrants exercised during the year ended December 31, 2023. The Warrants expired in October 2023 and are no longer outstanding. Upon expiration, the balance in additional paid - in capital related to the warrants was transferred to the additional paid - in capital balance related to Common Stock with no effect on additional paid - in capital.
A summary of all warrant activity for the Company for the nine months ended September 30, 2024 and the year ended December 31, 2023 is as follows:
Weighted Average
Number of
Weighted Average
Remaining
Warrants
Exercise Price
Contractual Life
Balance at December 31, 2022
634,426
$
1.22
0.78 years
Granted
—
—
Exercised
—
—
Forfeited
( 634,426 )
1.22
Balance at December 31, 2023
—
$
—
—
Granted
1,938,600
1.47
4.99 years
Exercised
( 345,000 )
0.0001
Forfeited
—
—
—
Balance at September 30, 2024
1,593,600
1.79
4.99 years
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Notes to Condensed Consolidated Financial Statements
10. Net Loss per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding including the effect of common share equivalents. Diluted net loss per share assumes the issuance of potential dilutive common shares outstanding for the period and adjusts for any changes in income and the repurchase of common shares that would have occurred from the assumed issuance, unless such effect is anti-dilutive. Net loss attributable to common stockholders for the three and nine months ended September 30, 2024 was $ 7.7 million and $ 21.2 million, respectively. Net loss per share attributable to common stockholders for the three and nine months ended September 30, 2024 includes 510,000 of pre-funded warrants. Net loss attributable to common stockholders for the three and nine months ended September 30, 2023 was $ 3.3 million and $ 12.9 million, respectively. The number of options and warrants for the purchase of Common Stock that were excluded from the computations of net loss per common share for the three and nine months ended September 30, 2024 were 175,207 and 1,428,600 , respectively, and for the three and nine months ended September 30, 2023 were 2,284,336 and 634,426 , respectively, because their effect is anti-dilutive
11. Common and Preferred Stock
Series C and D Preferred Stock
On July 29, 2022, the Company closed a private placement offering pursuant to the terms of a Securities Purchase Agreement dated as of July 28, 2022 entered into with MSD Credit Opportunity Master Fund, L.P.(the “Securities Purchase Agreement”), pursuant to which the Company issued and sold 275,000 shares of the Company’s Series C Convertible Preferred Stock, par value $ 0.001 per share (the “Series C Preferred Stock”), and 100,000 shares of the Company’s Series D Convertible Preferred Stock, par value $ 0.001 per share (the “Series D Preferred Stock,” and together with the Series C Preferred Stock, the “Preferred Stock”), at an offering price of $ 8.00 per share, for gross proceeds of approximately $ 3.0 million in the aggregate, before the deduction of discounts, fees and offering expenses. The shares of Preferred Stock are convertible, at a conversion price (the “Conversion Price”) of $ 30.50 per share (subject in certain circumstances to adjustments), into an aggregate of 2,459,016 shares of the Company’s Common Stock, at the option of the holders of the Preferred Stock and, in certain circumstances, by the Company. The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing.
The Company included certain shareholder proposals at its 2022 annual meeting of stockholders, including (i) an amendment to the Company’s Articles of Incorporation, as amended (the “Charter”), to change the name of the Company to “Theriva Biologics, Inc.” (the “Name Change”), (ii) an amendment to the Articles of Incorporation, as amended to increase the number of authorized shares of Common Stock from 20,000,000 to 350,000,000 (the “Authorized Common Stock Increase”) and (iii) to adjourn any meeting of stockholders called for the purpose of voting on the Authorized Common Stock Increase (collectively, the “Stockholder Items”). The purchaser of the Preferred Stock agreed in the Securities Purchase Agreement to (i) not transfer, offer, sell, contract to sell, hypothecate, pledge or otherwise dispose of the shares of the Preferred Stock until the earlier of the date that the Authorized Common Stock Increase is effected or October 26, 2022 (which could have been extended to December 31, 2022 if certain conditions were met), and (ii) vote the shares of the Series C Preferred Stock purchased in the offering in favor of the Stockholder Items.
Pursuant to the Securities Purchase Agreement, the Company filed certificates of designation (the “Certificates of Designation”) with the Secretary of the State of Nevada designating the rights, preferences and limitations of the shares of Series C Preferred Stock and Series D Preferred Stock. The Certificate of Designation for the Series C Preferred Stock provides, in particular, that the Series C Preferred Stock will have no voting rights other than the right to vote as a class on the Stockholder Items and the right to cast votes on an as converted to Common Stock basis on the Stockholder Items. The Certificate of Designation for the Series D Preferred Stock provides, in particular, that the Series D Preferred Stock will have no voting rights other than the right to vote as a class on the Stockholder Items and the right to cast 20,000 votes per share of Series D Preferred Stock on the Stockholder Items and to vote the shares of the Series D Preferred Stock purchased in the offering in the same proportion as shares of Common Stock and any other shares of capital stock of the Company that are entitled to vote thereon (excluding any shares of Common Stock that are not voted) on the Stockholder Items.
The holders of Preferred Stock will be entitled to dividends, on an as-if converted basis, equal to dividends actually paid, if any, on shares of Common Stock. The Conversion Price may be adjusted pursuant to the Certificates of Designation for stock dividends and stock splits, subsequent rights offering, pro rata distributions of dividends or the occurrence of a fundamental transaction (as defined in the applicable Certificate of Designation).
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Notes to Condensed Consolidated Financial Statements
11 . Common and Preferred Stock – (continued)
The Series C Preferred Stock and Series D Preferred Stock are classified as temporary equity as a result of the deemed liquidation provision. Transaction expenses paid to third parties will be charged to temporary equity and will not be accreted as deemed dividends until redemption becomes probable.
During three and nine months ending September 30, 2024, the Company issued 36,609 and 72,132 , respectively, shares of its Common Stock upon the conversion effected on such dates by the holder of 139,569 and 275,000 , respectively, shares of its Series C convertible Preferred Stock at a conversion price of $ 30.50 per share. As a result of the conversions during the three and nine months ending September 30, 2024, the Company reduced the Series C Preferred Stock $ 1.0 million and $ 2.0 million, respectively, and increased Common Stock $ 37 and $ 72 , respectively and Additional Paid in Capital $ 1.0 million and $ 2.0 million, respectively. There are no shares of Series C Preferred Stock outstanding as of September 30, 2024.
During three and nine months ending September 30, 2024, the Company issued 26,230 shares of its Common Stock upon the conversion effected on such dates by the holder of 100,000 shares of its Series D convertible Preferred Stock at a conversion price of $ 30.50 per share. As a result of the conversion during the three and nine months ending September 30, 2024 the Company reduced the Series D Preferred Stock $ 728,000 and increased Common Stock $ 26 respectively and Additional Paid in Capital $ 728,000 . There are no shares of Series D Preferred stock outstanding as of September 30, 2024.
At Market Issuance Sales Agreement
On May 2, 2024, the Company and A.G.P./Alliance Global Partners (“AGP”) entered into Amendment No. 2 (“Amendment No. 2”) to that certain Amended and Restated Sales Agreement among the Company, AGP and FBR Capital Markets & Co. (now known as B. Riley Securities) dated as of February 9, 2021, as amended by Amendment No. 1 thereto dated May 3, 2021 (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, at its option, shares of the Common Stock through A.G.P./Alliance Global Partners, as sales agent, in an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”). Sales in the “at the market offering” may occur under the Company’s current effective registration statement on Form S-3 (File No. 333-255726) utilizing a prior prospectus and related prospectus supplements thereto or a newly filed registration statement on Form S-3 which was filed on May 2, 2024 (File No. 333-279077) and declared effective on September 25, 2024. In addition, on May 1, 2024, the Company and B. Riley Securities, Inc. mutually agreed to enter into a notice of termination whereby B. Riley Securities, Inc. would no longer be a party to the Sales Agreement. During the three and nine months ended September 30, 2024, the Company sold through the Sales Agreement approximately 395,000 and 569,000 , respectively, shares of the Company’s Common Stock and received net proceeds of approximately $ 1.8 million and $ 3.6 million, respectively. During the three and nine months ended September, 2023, the Company sold through the At Market Issuance Sales Agreement and the Amended and Restated Sales Agreement approximately 40 and 77,000 shares, respectively, of the Company’s Common Stock and received net proceeds of approximately $ 1,000 and $ 2.2 million.
12. Loans Payable
As a result of the Acquisition of VCN, the Company acquired interest-free or below-market interest rates loans ( 0 %- 1 %) extended by Spanish governmental institutions of Ministerio de Ciencia, Innovacion y Universidades (RETOS loan) and ACC10 Generalitat de Catalunya (NEBT loan). The maturities of these loans are between 2024 and 2028. As a result of the VCN Acquisition, the Company maintains a restricted cash collateral account of $ 103,000 relating to the RETOS loan, which is reflected as a non-current asset on the balance sheet.
September 30, 2024
September 30, 2024
December 31, 2023
December 31, 2023
Current
Non-current
Current
Non-current
NEBT Loan
8
$
17
8
24
RETOS 2015
57
81
55
138
$
65
$
98
$
63
$
162
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Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
12. Loans Payable – (continued)
A maturity analysis of the debt as of September 30, 2024 is as follows (amounts in thousands of dollars) :
2025
65
2026
54
2027
34
2028
10
Total
163
13. Commitments and Contingencies
The Company’s existing leases as of September 30, 2024 for its U.S. and Spanish facilities are classified as operating leases. During the quarter ended June 30, 2021, the Company renewed its Rockville, MD facility lease by entering into a Second Lease Amendment which extends the lease term for 63 months beginning on September 1, 2022 and ending on December 31, 2027 at stated rental rates and including a 3-month rent abatement. The Second Amendment also has options for a Tenant Improvement Allowance and a Second Extension Term. The Second Extension Term is offered at market rates and there is no economic incentive for the lessee, therefore the Company has determined that it is not part of the original lease term.
The Company also leases research and office facilities in Barcelona, Spain for its 100 percent owned Theriva S.L. subsidiary. The lease that was in existence from December 2021 to December 2022 was a short term agreement with a 90-day termination notice provision that can be exercised by either party. On the closing date of the Acquisition, a sublease was executed for Theriva S.L. to lease research and office facilities at a new location in Parets del Valles (Barcelona) from the former owner of Theriva S.L. This lease was executed for an initial term to begin in January 2023 until October 2026, with an option to renew for an additional five years . On January 15, 2023, Theriva S.L. moved into the facilities and the new lease commenced and the prior lease terminated.
Operating lease costs are presented as part of general and administrative expenses in the condensed consolidated statements of operations, and for the three and nine months ended September 30, 2024 approximated $ 158,000 and $ 474,000 , respectively and $ 156,000 and $ 454,000 for the three and six months ended September 30, 2023, respectively. For the Barcelona lease, the day one non-cash addition of right of use assets due to adoption of ASC 842 was $ 937,000 .
A maturity analysis of the Company’s operating leases as of September 30, 2024 is as follows (amounts in thousands of dollars) :
Future undiscounted cash flow for the years ending December 31,
2024
166
2025
673
2026
588
2027
369
Total
1,796
Discount factor
( 220 )
Operating lease liability
1,576
Operating lease liability – current
( 541 )
Operating lease liability – long term
$
1,035
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Table of Contents
Theriva Biologics, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
13. Commitments and Contingencies – (continued)
Risks and Uncertainties
The uncertain financial markets, disruptions in supply chains, mobility restraints, and changing priorities as well as volatile asset values could impact the Company’s business in the future. The Company and its third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to the Company’s research and development activities, including, for example, medical and laboratory supplies used in its clinical trials or preclinical studies, in each case, that are sourced from abroad or for which there are shortages. Further, although the Company has not experienced any material adverse effects on business due to increasing inflation, it has raised operating costs for many businesses and, in the future, could impact demand or pricing manufacturing of its drug candidates or services providers, foreign exchange rates or employee wages. The Company is actively monitoring the effects that these disruptions and increasing inflation could have on its operations.
Through the VCN Acquisition, the Company has operations in Spain related to conducting research and development, manufacturing, and clinical trials in Western European countries. The invasion of Ukraine by Russia, the war in the Middle East, and the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries have created global security concerns that could result in a regional conflict and otherwise have a lasting impact on regional and global economies, any or all of which could disrupt the Company’s supply chain, and despite the fact that it currently does not plan any clinical trials in Eastern Europe, may adversely impact the cost and conduct of R&D, manufacturing, and international clinical trials of its product candidates.
14. Related Party
On December 14, 2023 the Company approved the retention of Mary Ann Shallcross for compensation of $ 152,000 , a bonus of $ 70,000 and the grant of an option to purchase 3,000 shares of Common Stock having a value of $ 30,000 . During the three and nine months ended September 30, 2024, the company paid compensation to Ms. Shallcross of $ 38,000 and $ 114,000 , respectively.
15. Subsequent events
On October 31, 2024, the Company held its 2024 Annual Meeting of Stockholders. At the Annual Meeting, the Company’s stockholders approved an amendment (“Amendment No. 2”) to the Company’s 2020 Stock Incentive Plan (the “2020 Stock Incentive Plan”) to (a) increase the number of shares of Common Stock that we will have authority to grant under the 2020 Stock Incentive Plan from 280,000 shares of Common Stock to 2,500,000 shares of Common Stock and (b) to amend the annual non-employee director grant limit to 250,000 shares of Common Stock; and approved an amendment to our Articles of Incorporation to increase the number of authorized shares of Common Stock to 350,000,000 shares.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.