Avalo Therapeutics(AVTX) - 2024 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements Presents Avalo Therapeutics, Inc.'s unaudited condensed consolidated financial statements for Q1 2024, including core statements and notes Condensed Consolidated Balance Sheets Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2024 (Unaudited) (in thousands) | December 31, 2023 (in thousands) | |:--------------------------------|:------------------------------------------|:---------------------------------| | Assets | | | | Cash and cash equivalents | $110,177 | $7,415 | | Total current assets | $111,213 | $8,395 | | Total assets | $123,728 | $20,993 | | Liabilities | | | | Warrant liability | $194,901 | — | | Contingent consideration | $12,500 | — | | Total current liabilities | $215,700 | $4,618 | | Total liabilities | $224,813 | $13,689 | | Stockholders' (deficit) equity | | | | Total stockholders' (deficit) equity | $(112,542) | $7,304 | - Cash and cash equivalents significantly increased from $7.4 million at December 31, 2023, to $110.2 million at March 31, 2024, primarily due to a private placement investment[8] - Total liabilities saw a substantial increase from $13.7 million to $224.8 million, driven by the recognition of a $194.9 million warrant liability and $12.5 million in contingent consideration[8] - Stockholders' equity shifted from a positive $7.3 million to a deficit of $(112.5) million, largely impacted by the new warrant liability and accumulated deficit[9] Condensed Consolidated Statements of Operations and Comprehensive Loss Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | |:--------------------------------------------------|:-------------------------------------------------|:-------------------------------------------------| | Product revenue, net | $— | $475 | | Total operating expenses | $32,767 | $9,267 | | Research and development | $2,116 | $6,008 | | Acquired in-process research and development | $27,538 | $— | | General and administrative | $3,193 | $2,708 | | Total other expense, net | $(88,516) | $(1,155) | | Net loss and comprehensive loss | $(121,290) | $(9,955) | | Net loss per share of common stock, basic and diluted | $(141) | $(204) | - Product revenue decreased to $0 in Q1 2024 from $0.5 million in Q1 2023 due to the expiration of the Millipred license agreement[11] - Total operating expenses increased significantly to $32.8 million in Q1 2024 from $9.3 million in Q1 2023, primarily driven by $27.5 million in acquired in-process research and development (IPR&D) related to the Almata Transaction[11] - Net loss widened substantially to $(121.3) million in Q1 2024 from $(10.0) million in Q1 2023, largely due to the IPR&D expense and an $(88.5) million 'Excess of warrant fair value over private placement proceeds' recognized in other expense[11] Condensed Consolidated Statements of Preferred Stock and Changes in Stockholders' (Deficit) Equity Condensed Consolidated Statements of Preferred Stock and Changes in Stockholders' (Deficit) Equity (in thousands) | Metric | Balance, December 31, 2023 (in thousands) | Balance, March 31, 2024 (in thousands) | |:--------------------------------------------|:------------------------------------------|:---------------------------------------| | Total stockholders' (deficit) equity | $7,304 | $(112,542) | | Issuance of Series C Preferred Stock pursuant to Almata Transaction | — | $11,457 | | Net loss | — | $(121,290) | - The company's total stockholders' (deficit) equity decreased from $7.3 million at December 31, 2023, to $(112.5) million at March 31, 2024, primarily due to a net loss of $(121.3) million[15] - Issuance of Series C Preferred Stock pursuant to the Almata Transaction contributed $11.5 million to mezzanine equity[15] Condensed Consolidated Statements of Cash Flows Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | |:----------------------------------------|:-------------------------------------------------|:-------------------------------------------------| | Net cash used in operating activities | $(6,202) | $(10,052) |\ | Net cash provided by (used in) investing activities | $356 | $(133) |\ | Net cash provided by financing activities | $108,612 | $13,748 |\ | Increase in cash, cash equivalents and restricted cash | $102,766 | $3,563 |\ | Cash, cash equivalents, and restricted cash at end of period | $110,312 | $16,881 | - Net cash used in operating activities decreased to $(6.2) million in Q1 2024 from $(10.1) million in Q1 2023, despite a larger net loss, due to significant non-cash adjustments like excess warrant fair value and acquired IPR&D[18][162] - Net cash provided by financing activities surged to $108.6 million in Q1 2024, primarily from $115.6 million in gross proceeds from a private placement investment, significantly increasing the company's cash position[18][164] Notes to Unaudited Condensed Consolidated Financial Statements 1. Business - Avalo Therapeutics, Inc. is a clinical-stage biotechnology company focused on immune dysregulation, with lead asset AVTX-009 (anti-IL-1β mAb) targeting inflammatory diseases, acquired through the Almata Transaction on March 27, 2024[23][24] - The company closed a private placement investment on March 28, 2024, for up to $185 million in gross proceeds, with an initial upfront gross investment of $115.6 million, providing approximately $108.1 million in net proceeds[24][25] - Avalo expects its existing cash and cash equivalents of $110.2 million (as of March 31, 2024) to fund operations into 2027[25][26] 2. Basis of Presentation and Significant Accounting Policies - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and include normal recurring adjustments[28][29] - A 1-for-240 reverse stock split was effected on December 28, 2023, and retroactively applied to common share and per share amounts for prior periods[31] - New significant accounting policies for Q1 2024 include asset acquisitions (evaluating business combination vs. asset acquisition) and warrant liability (classifying warrants as equity or derivative liabilities based on specific terms)[33][34][36] 3. Asset Acquisition - On March 27, 2024, Avalo acquired AVTX-009 through a merger with AlmataBio (the 'Almata Transaction'), issuing 171,605 shares of common stock and 2,412 shares of Series C Preferred Stock[37] - The acquisition is treated as an asset acquisition, with substantially all consideration allocated to acquired in-process research and development (IPR&D) of AVTX-009, which was expensed as $27.5 million due to no alternative future use[39][42] - Future potential development milestone payments to former AlmataBio stockholders include $5.0 million upon first patient dosed in a Phase 2 HS trial and $15.0 million upon first patient dosed in a Phase 3 trial, payable in cash, stock, or a combination[38] 4. Revenue - Avalo reported no net product revenues for the three months ended March 31, 2024, compared to $0.5 million in the prior year, due to the expiration of the Millipred license and supply agreement on September 30, 2023[43] - The company continues to monitor commercial liabilities related to Millipred, including potential profit share reconciliation and a fully reserved $0.6 million receivable from Aytu BioScience, Inc[43][45] 5. Net Loss Per Share Net Loss Per Share Data | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | |:--------------------------------------------|:----------------------------------|:----------------------------------| | Net loss (in thousands) | $(121,290) | $(9,955) | | Weighted average shares | 859,381 | 48,845 | | Basic and diluted net loss per share | $(141) | $(204) | - Basic and diluted net loss per share was $(141) for Q1 2024, compared to $(204) for Q1 2023, reflecting a larger net loss but also a significantly higher weighted average share count[49][50] - The two-class method for net loss per share resulted in no allocation of undistributed losses to participating Series C Preferred Stock due to the net loss position[48] - Potentially dilutive securities, including stock options, warrants, and Series C Preferred Stock, were anti-dilutive for both periods due to the net loss[48][51] 6. Fair Value Measurements Fair Value Measurements (in thousands) | Financial Instrument | March 31, 2024 (Level 3, in thousands) | December 31, 2023 (Level 3, in thousands) | |:--------------------------|:---------------------------------------|:------------------------------------------| | Derivative liability | $5,670 | $5,550 | | Warrant liability | $194,901 | — | - A new warrant liability of $194.9 million was recognized at fair value as of March 31, 2024, classified as a Level 3 instrument due to unobservable inputs in its Black-Scholes valuation model[55][60][62] - The derivative liability, related to the sale of economic rights for AVTX-501 and AVTX-007 milestones/royalties, increased slightly to $5.7 million as of March 31, 2024, with a $0.1 million change in fair value recognized as other expense[55][67] - Key unobservable inputs for derivative liability valuation include probabilities of success (23% for AVTX-501, 17% for AVTX-007) and expected timing/sales forecasts[68] 7. Leases - Avalo has two operating leases for administrative office space in Rockville, Maryland, and Chesterbrook, Pennsylvania, with a weighted average remaining term of 4.4 years as of March 31, 2024[71][72] Operating Lease Liabilities and Costs (in thousands) | Metric | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | |:----------------------------------------|:------------------------------|:---------------------------------|\ | Total operating lease liabilities | $1,826 | $1,903 |\ | Operating lease cost (Q1) | $108 | $120 | - Operating lease liabilities totaled $1.8 million as of March 31, 2024, with a weighted average discount rate of 9.1% used for present value calculations[73] 8. Accrued Expenses and Other Current Liabilities Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | |:--------------------------------------------------|:------------------------------|:---------------------------------|\ | Private placement investment transaction costs | $2,034 | — |\ | General and administrative (incl. asset acquisition costs) | $1,934 | $830 |\ | Commercial operations | $1,789 | $1,873 |\ | Total accrued expenses and other current liabilities | $7,383 | $4,172 | - Total accrued expenses and other current liabilities increased significantly to $7.4 million at March 31, 2024, from $4.2 million at December 31, 2023[78] - The increase was primarily driven by $2.0 million in private placement investment transaction costs and a $1.1 million increase in general and administrative expenses, including asset acquisition-related transaction costs[78] 9. Notes Payable - Avalo fully repaid its $35.0 million venture loan with Horizon Technology Finance Corporation and Powerscourt Investments XXV, LP, in September 2023, with the final payment totaling $14.3 million[79][80] - Warrants issued to lenders in connection with the loan, exercisable for 148 common shares at $7,488 per share, remain outstanding with a June 2031 expiration[82][93] 10. Capital Structure - As of March 31, 2024, Avalo is authorized to issue 200,000,000 shares of common stock and 5,000,000 shares of preferred stock, all with a par value of $0.001 per share[83] - The Almata Transaction resulted in the issuance of 171,605 common shares and 2,412 Series C Preferred Stock shares, which are non-voting and convertible into 1,000 common shares each upon stockholder approval[84] - A Q1 2024 private placement generated $115.6 million gross proceeds from issuing 19,946 Series C Preferred Stock shares and warrants to purchase up to 11,967,526 common shares, with potential for an additional $69.4 million upon warrant exercise[85] - The warrants were classified as a derivative liability, with an initial fair value of $194.9 million exceeding proceeds, resulting in a $79.3 million loss recognized in other expense[86][172] - Series D and Series E Preferred Stock were issued to institutional investors, granting them board director appointment rights but no voting or dividend rights, and are redeemable at par value[91] 11. Stock-Based Compensation Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | |:-------------------------------|:-------------------------------------------------|:-------------------------------------------------|\ | Research and development | $269 | $326 |\ | General and administrative | $360 | $529 |\ | Total stock-based compensation | $629 | $855 | - Total stock-based compensation expense decreased to $0.6 million in Q1 2024 from $0.9 million in Q1 2023[96] - As of March 31, 2024, there was $2.2 million of unrecognized compensation cost related to unvested service-based stock options, expected to be recognized over a weighted-average period of 1.4 years[99] - The 2016 Equity Incentive Plan had 32,520 shares available for future issuance as of March 31, 2024, and the Employee Stock Purchase Plan (ESPP) had 958 shares available[94][104] 12. Income Taxes - Avalo recognized minimal income tax expense for both Q1 2024 and Q1 2023 due to a significant valuation allowance against deferred tax assets and ongoing losses[106] 13. Commitments and Contingencies - Avalo settled a dispute with Apollo AP43 Limited for $0.2 million in Q1 2024, related to a license agreement breach[109] - For AVTX-009, Avalo is obligated to pay up to $70 million in development/regulatory milestones and up to $720 million in sales-based milestones, plus mid-single to low-double digit royalties[111] - The Almata Transaction includes future milestone payments to former AlmataBio stockholders: $7.5 million (paid April 2024), $5.0 million upon Phase 2 HS trial initiation (recognized as current liability), and $15.0 million upon Phase 3 trial initiation[129][130] - The second Aevi Merger milestone of $4.5 million, contingent on NDA approval for AVTX-006 or AVTX-007 by February 3, 2025, has not yet been recognized[133] - Avalo is eligible to receive up to $18.6 million in milestones and low single-digit royalties for out-licensed AVTX-301, and up to $6.0 million in milestones plus $20.0 million in sales-based milestones for AVTX-406[123][125] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Avalo Therapeutics, Inc.'s Q1 2024 financial condition and operations, covering recent acquisitions, financing, liquidity, and strategic focus Overview - Avalo Therapeutics is a clinical-stage biotechnology company focused on immune dysregulation, with lead asset AVTX-009 (anti-IL-1β mAb) targeting inflammatory diseases, and a pipeline including quisovalimab and AVTX-008[141] - Management evaluates success based on advancing pipeline assets towards commercialization or opportunistic out-licensing[141] Recent Developments - On March 27, 2024, Avalo acquired AVTX-009, a Phase 2-ready anti-IL-1β mAb, through a merger with AlmataBio Inc[142] - On March 28, 2024, the company closed a private placement investment for up to $185 million in gross proceeds, including an initial upfront gross investment of $115.6 million, yielding approximately $108.1 million in net proceeds[142] Liquidity - Avalo has incurred significant operating and cash losses since inception, primarily funding operations through equity sales, out-licensing, and asset sales[143] - For Q1 2024, Avalo reported a net loss of $121.3 million and negative cash flows from operations of $6.2 million, with $110.2 million in cash and cash equivalents as of March 31, 2024[143] - Existing cash and cash equivalents are expected to fund operations for at least twelve months from the filing date and into 2027[144] Our Strategy - Avalo's strategy includes advancing pipeline compounds to regulatory approval, developing go-to-market strategies, opportunistically out-licensing rights, and acquiring/licensing complementary preclinical and clinical stage compounds[145] Results of Operations - Product revenue, net, was $0 for Q1 2024, down from $0.5 million in Q1 2023, due to the expiration of the Millipred license agreement[146] - Research and development expenses decreased by $3.9 million to $2.1 million in Q1 2024, mainly due to decreased clinical and CMC activities following the AVTX-002 PEAK trial conclusion[149][151] - Acquired in-process research and development (IPR&D) expense was $27.5 million in Q1 2024, related to the AVTX-009 acquisition, with no comparable expense in Q1 2023[150] - General and administrative expenses increased by $0.5 million to $3.2 million in Q1 2024, driven by a $0.4 million increase in legal, consulting, and other professional expenses related to the Almata Transaction[152] - Other expense, net, increased significantly to $(88.5) million in Q1 2024, primarily due to a $79.3 million loss from the excess of warrant fair value over private placement proceeds and $9.2 million in private placement transaction costs[154][155][157] Liquidity and Capital Resources - Avalo primarily uses cash to fund research and development of pipeline assets, especially AVTX-009, and organizational infrastructure costs[158] Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 (in thousands) | Three Months Ended March 31, 2023 (in thousands) | |:----------------------------------------|:-------------------------------------------------|:-------------------------------------------------|\ | Net cash used in operating activities | $(6,202) | $(10,052) |\ | Net cash provided by (used in) investing activities | $356 | $(133) |\ | Net cash provided by financing activities | $108,612 | $13,748 |\ | Net increase in cash and cash equivalents | $102,766 | $3,563 | - Net cash used in operating activities decreased to $6.2 million in Q1 2024, from $10.1 million in Q1 2023, due to non-cash adjustments like warrant fair value and IPR&D[162][163] - Net cash provided by financing activities was $108.6 million in Q1 2024, mainly from $115.6 million gross proceeds from the private placement, partially offset by $7.0 million in transaction costs[164] - The company could receive an additional $69.4 million from the exercise of warrants issued in the private placement, exercisable at approximately $5.80 per share[165] Critical Accounting Policies, Estimates, and Assumptions - Critical accounting policies for Q1 2024 include warrant liability and asset acquisition, both recognized due to transactions closed in the first quarter[167] - The warrant liability, valued at $194.9 million, is measured at fair value using the Black-Scholes model, with key subjective assumptions including expected term (0.5 years), expected volatility (109%), and common stock price ($21.75)[169][170][172] - Asset acquisitions are evaluated using a screen test to determine if substantially all fair value is concentrated in a single identifiable asset; if met, it's an asset acquisition, otherwise, further assessment for a business definition is required[173] - The acquisition of AVTX-009 was accounted for as an asset acquisition, resulting in $27.5 million of IPR&D expense due to no alternative future use[174] Off-Balance Sheet Arrangements - Avalo Therapeutics does not have any off-balance sheet arrangements as defined by SEC rules and regulations[175] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Avalo Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk in this report - Avalo Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk as it is a smaller reporting company[177] Item 4. Controls and Procedures Management, including the principal executive and financial officers, evaluated the effectiveness of Avalo Therapeutics, Inc.'s disclosure controls and procedures as of March 31, 2024, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified during the period - Management concluded that disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2024[177] - No material changes in internal control over financial reporting were identified during the period covered by this report[179] PART II. OTHER INFORMATION Item 1. Legal Proceedings This section incorporates by reference the information regarding legal proceedings from Note 13, 'Commitments and Contingencies,' in the Unaudited Condensed Financial Statements, which details various contractual disputes, litigation, and potential claims arising in the ordinary course of business - Information on legal proceedings is incorporated by reference from Note 13, 'Commitments and Contingencies,' in the Unaudited Condensed Financial Statements[181] Item 1A. Risk Factors Avalo Therapeutics, Inc. states that its risk factors have not materially changed from those described in its Annual Report on Form 10-K for the year ended December 31, 2023. Readers are advised to consider these factors, as well as additional unknown or immaterial risks, which could adversely affect the company's business and financial results - Risk factors have not materially changed from those described in the Annual Report on Form 10-K for the year ended December 31, 2023[182] - Additional risks and uncertainties not currently known or deemed immaterial could also adversely affect the company's business, financial condition, or future results[182] Item 6. Exhibits This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including agreements related to the AlmataBio merger, certificates of designation for various preferred stock series, the form of warrant, and certifications from executive officers - Exhibits include the Agreement and Plan of Merger and Reorganization for AlmataBio, Certificates of Designation for Series C, D, and E Preferred Stock, and the Form of Warrant[184] - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included[184] - Interactive data files in XBRL format are provided for the financial statements[184][185]