Financial Performance - Avalo generated a net loss of $22.8 million and negative cash flows from operations of $22.5 million for the six months ended June 30, 2024[164]. - There was no net product revenue for the three months ended June 30, 2024, compared to $0.6 million for the same period in 2023, due to the expiration of the license and supply agreement for Millipred[169]. - The company had no net product revenue for the six months ended June 30, 2024, compared to $1.1 million for the same period in 2023, due to the planned expiration of the license and supply agreement for Millipred[184]. - The company reported a net cash used in operating activities of $22.5 million for the six months ended June 30, 2024, compared to $21.1 million for the same period in 2023[199]. - Net cash used in operating activities was $21.1 million for the six months ended June 30, 2023, primarily due to a net loss of $18.1 million and non-cash adjustments including stock-based compensation of $1.7 million[201]. Cash Position - As of June 30, 2024, Avalo had $93.4 million in cash and cash equivalents, with expectations to fund operations into 2027[165]. - Interest income increased by $3.1 million due to the company's increased cash position compared to the prior period, with no interest expense incurred in the current period[196]. - Net cash provided by financing activities for the six months ended June 30, 2024 was $115.6 million from a private placement investment, offset by transaction costs of $7.5 million[202]. - The company could receive up to an additional $69.4 million from the exercise of warrants issued in the private placement investment, exercisable at approximately $5.80 per share[203]. Research and Development - Research and development expenses decreased by $0.1 million to $4.6 million for the three months ended June 30, 2024, primarily due to a decrease in CMC expenses[173]. - Avalo expects future research and development expenses to increase in 2024 due to the development plans for AVTX-009[174]. - The company recognized a $79.3 million loss on the excess of initial warrant liability fair value over private placement proceeds, with a fair value of $194.9 million against proceeds of $115.6 million[192]. - Research and development expenses decreased by $4.0 million for the six months ended June 30, 2024, primarily due to a $2.8 million decrease in clinical expenses and a $2.0 million decrease in CMC expenses[188]. - Avalo's IND for AVTX-009 is now active, allowing the commencement of the Phase 2 LOTUS clinical trial, expected to enroll its first patient in the second half of 2024[162]. - The primary efficacy endpoint for the LOTUS Trial is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16[162]. General and Administrative Expenses - General and administrative expenses increased by $2.1 million to $4.5 million for the three months ended June 30, 2024, driven by increased legal and consulting expenses related to the Almata Transaction[177]. - General and administrative expenses increased by $2.6 million for the six months ended June 30, 2024, driven by a $1.7 million increase in legal, consulting, and other professional expenses[191]. Other Income and Expenses - Other income increased by $109.1 million for the three months ended June 30, 2024, primarily due to a $112.0 million gain on the change of fair value of the warrant liability[178]. - Other income, net increased by $21.7 million for the six months ended June 30, 2024, primarily driven by the impact of the warrant liability associated with the March 2024 financing[192]. - The company incurred $9.2 million in private placement transaction costs, primarily related to placement agent fees[194]. Accounting and Controls - There were no significant changes to critical accounting policies during the three months ended June 30, 2024[205]. - The company has no off-balance sheet arrangements as defined by SEC rules[206]. - Disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level as of the end of the reporting period[208]. - There were no changes in internal control over financial reporting that materially affected the company's internal control during the reporting period[210].

Financial Performance - For the six months ended June 30, 2024, Avalo reported a net loss of $22.8 million, an increase of $4.7 million compared to the same period in 2023[4]. - Total operating expenses for the first half of 2024 increased by $25.3 million, primarily due to $27.6 million of acquired in-process research and development expense from the acquisition of AlmataBio, Inc.[4]. - Avalo Therapeutics reported a significant increase in revenue, reaching $50 million for the quarter, representing a 25% year-over-year growth[18]. - The company recognized a $21.7 million increase in other income, net, largely related to changes in warrant liability[4]. - Total liabilities increased to $110.5 million as of June 30, 2024, from $13.7 million at the end of 2023[6]. Cash and Assets - As of June 30, 2024, Avalo had cash and cash equivalents of approximately $93.4 million, with an expected cash runway into 2027[3]. - Avalo's total current assets as of June 30, 2024, were $95.9 million, compared to $8.4 million as of December 31, 2023[6]. Clinical Trials and Development - Avalo expects to enroll the first patient in the Phase 2 LOTUS Trial of AVTX-009 for hidradenitis suppurativa in the second half of 2024[1]. - The LOTUS Trial will evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa[13]. - Avalo plans to develop AVTX-009 in at least one additional chronic inflammatory indication beyond hidradenitis suppurativa[2]. - Avalo is investing in R&D, allocating $10 million towards the development of new therapies aimed at addressing unmet medical needs[18]. Leadership and Strategic Initiatives - The company appointed Dr. Mittie Doyle as Chief Medical Officer and Paul Varki as Chief Legal Officer to strengthen its leadership team[2]. - Avalo is exploring potential acquisition opportunities to enhance its product portfolio and accelerate growth[18]. Market Expansion and Future Guidance - Future guidance indicates projected revenue growth of 30% for the next fiscal year, driven by new product launches and market expansion strategies[18]. - The company plans to expand its market presence in Europe, targeting a 20% increase in market share by the end of the next fiscal year[18]. - Avalo's strategic partnerships are expected to contribute an additional $15 million in revenue over the next two years[18]. Operational Efficiency - The company reported a 10% reduction in operational costs, improving overall profitability margins[18]. - New technology initiatives are expected to streamline operations, with an anticipated cost savings of $5 million annually[18]. - The company remains committed to enhancing shareholder value through consistent performance and strategic investments[18].

WAYNE, Pa. and ROCKVILLE, Md., July 16, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) today announced that Mittie Doyle, MD, FACR has joined the Company as its Chief Medical Officer. “We are thrilled to have Mittie join and grow our leadership team at an exciting time as we prepare to initiate our Phase 2 LOTUS Trial in patients with hidradenitis suppurativa. Mittie brings to Avalo a strong combination of drug development experience through all stages of development and exceptional expert ...

Following FDA review, Avalo’s IND application for AVTX-009 is active allowing Avalo to proceed with its Phase 2 trial (LOTUS) to evaluate the efficacy and safety of AVTX-009 in patients with hidradenitis suppurativa WAYNE, Pa. and ROCKVILLE, Md., July 09, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) today announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the ...

Following FDA review, Avalo's IND application for AVTX-009 is active allowing Avalo to proceed with its Phase 2 trial (LOTUS) to evaluate the efficacy and safety of AVTX-009 in patients with hidradenitis suppurativa WAYNE, Pa. and ROCKVILLE, Md., July 09, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (NASDAQ:AVTX) today announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for the treatment of hidradenitis suppurativa (HS) is now active, permitting the ...

WAYNE, Pa. and ROCKVILLE, Md., June 24, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) today announced that Paul Varki has joined the Company as its Chief Legal Officer. “We are delighted to have Paul join and grow our leadership team at an exciting time at Avalo following our acquisition and private placement earlier this year,” said Garry A. Neil, MD, CEO and Chairman of the Board at Avalo. “Paul’s deep industry experience will immediately enhance our strategic and legal competencies. Fu ...

Core Insights - Avalo Therapeutics has appointed Paul Varki as Chief Legal Officer, enhancing its leadership team during a pivotal time following recent acquisition and private placement [1] - Varki brings over 20 years of experience in the pharmaceutical and biotech sectors, previously serving as US General Counsel at Idorsia Pharmaceuticals and holding various legal roles at other companies [1] - The appointment is expected to strengthen Avalo's strategic and legal capabilities, particularly in the development of AVTX-009 for hidradenitis suppurativa and other autoimmune conditions [1] Inducement Grants - As part of Varki's employment agreement, he has been granted a non-qualified stock option to purchase 150,000 shares of Avalo's common stock, vesting over four years with a twelve-month cliff [2] - The stock option was granted on June 24, 2024, with an exercise price equal to the closing price of Avalo's common stock on that date [2] Company Overview - Avalo Therapeutics is a clinical-stage biotechnology company focused on treating immune dysregulation, with its lead asset being AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [3] - The company's pipeline also includes quisovalimab and AVTX-008, indicating a diverse approach to addressing autoimmune conditions [3] Product Details - AVTX-009 is a humanized monoclonal antibody that binds to interleukin-1β (IL-1β), a key driver in inflammatory processes, and is implicated in various autoimmune diseases [4] - The inhibition of IL-1β is considered a validated therapeutic target, with potential applications in dermatology, gastroenterology, and rheumatology [4]

Company Overview - Avalo Therapeutics, Inc. is a clinical stage biotechnology company focused on treating immune dysregulation [2] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [2] - Avalo's pipeline also includes quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein) [2] Product Details - AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity, neutralizing its activity [3] - IL-1β is a central driver in the inflammatory process, and its overproduction is implicated in many autoimmune and inflammatory diseases [3] - Evidence suggests that inhibition of IL-1β could be effective in treating hidradenitis suppurativa and various inflammatory diseases in dermatology, gastroenterology, and rheumatology [3] Upcoming Events - Garry A. Neil, M.D., CEO and Chairman of the Board, will present on the Novel Immunological Mechanisms for Dermatological Disorders Panel at the Oppenheimer Novel Targets in Immunology Summit on June 24, 2024 [1]

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Has Avalo Therapeutics, Inc. (AVTX) been one of those stocks this year? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Avalo Therapeutics, Inc. is one of 1047 individual stocks in the Medical sector. Collectively, these companies sit at #7 in the Zacks Sector Rank. The Zacks Sector Rank gauges the strength o ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents Avalo Therapeutics, Inc.'s unaudited condensed consolidated financial statements for Q1 2024, including core statements and notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=8&type=chunk) - 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](index=8&type=chunk) - 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](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=11&type=chunk) - Total operating expenses increased significantly to **$32.8 million** in Q1 2024 from **$9.3 million** in Q1 2023, primarily driven by **$27.5 million** in acquired in-process research and development (IPR&D) related to the Almata Transaction[11](index=11&type=chunk) - Net loss widened substantially to **$(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](index=11&type=chunk) [Condensed Consolidated Statements of Preferred Stock and Changes in Stockholders' (Deficit) Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Preferred%20Stock%20and%20Changes%20in%20Stockholders'%20(Deficit)%20Equity) 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](index=15&type=chunk) - Issuance of Series C Preferred Stock pursuant to the Almata Transaction contributed **$11.5 million** to mezzanine equity[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=18&type=chunk)[162](index=162&type=chunk) - 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](index=18&type=chunk)[164](index=164&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Business](index=10&type=section&id=1.%20Business) - 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](index=23&type=chunk)[24](index=24&type=chunk) - 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](index=24&type=chunk)[25](index=25&type=chunk) - Avalo expects its existing cash and cash equivalents of **$110.2 million** (as of March 31, 2024) to fund operations into 2027[25](index=25&type=chunk)[26](index=26&type=chunk) [2. Basis of Presentation and Significant Accounting Policies](index=10&type=section&id=2.%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies) - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP and include normal recurring adjustments[28](index=28&type=chunk)[29](index=29&type=chunk) - 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](index=31&type=chunk) - 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](index=33&type=chunk)[34](index=34&type=chunk)[36](index=36&type=chunk) [3. Asset Acquisition](index=12&type=section&id=3.%20Asset%20Acquisition) - 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](index=37&type=chunk) - 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](index=39&type=chunk)[42](index=42&type=chunk) - 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](index=38&type=chunk) [4. Revenue](index=13&type=section&id=4.%20Revenue) - 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](index=43&type=chunk) - 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](index=43&type=chunk)[45](index=45&type=chunk) [5. Net Loss Per Share](index=14&type=section&id=5.%20Net%20Loss%20Per%20Share) 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](index=49&type=chunk)[50](index=50&type=chunk) - 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](index=48&type=chunk) - Potentially dilutive securities, including stock options, warrants, and Series C Preferred Stock, were anti-dilutive for both periods due to the net loss[48](index=48&type=chunk)[51](index=51&type=chunk) [6. Fair Value Measurements](index=15&type=section&id=6.%20Fair%20Value%20Measurements) 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](index=55&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk) - 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](index=55&type=chunk)[67](index=67&type=chunk) - 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](index=68&type=chunk) [7. Leases](index=19&type=section&id=7.%20Leases) - 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](index=71&type=chunk)[72](index=72&type=chunk) 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](index=73&type=chunk) [8. Accrued Expenses and Other Current Liabilities](index=20&type=section&id=8.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) 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](index=78&type=chunk) - 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](index=78&type=chunk) [9. Notes Payable](index=20&type=section&id=9.%20Notes%20Payable) - 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](index=79&type=chunk)[80](index=80&type=chunk) - 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](index=82&type=chunk)[93](index=93&type=chunk) [10. Capital Structure](index=21&type=section&id=10.%20Capital%20Structure) - 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](index=83&type=chunk) - 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](index=84&type=chunk) - 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](index=85&type=chunk) - 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](index=86&type=chunk)[172](index=172&type=chunk) - 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](index=91&type=chunk) [11. Stock-Based Compensation](index=23&type=section&id=11.%20Stock-Based%20Compensation) 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](index=96&type=chunk) - 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](index=99&type=chunk) - 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](index=94&type=chunk)[104](index=104&type=chunk) [12. Income Taxes](index=25&type=section&id=12.%20Income%20Taxes) - 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](index=106&type=chunk) [13. Commitments and Contingencies](index=25&type=section&id=13.%20Commitments%20and%20Contingencies) - Avalo settled a dispute with Apollo AP43 Limited for **$0.2 million** in Q1 2024, related to a license agreement breach[109](index=109&type=chunk) - 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](index=111&type=chunk) - 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](index=129&type=chunk)[130](index=130&type=chunk) - 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](index=133&type=chunk) - 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](index=123&type=chunk)[125](index=125&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Avalo Therapeutics, Inc.'s Q1 2024 financial condition and operations, covering recent acquisitions, financing, liquidity, and strategic focus [Overview](index=31&type=section&id=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](index=141&type=chunk) - Management evaluates success based on advancing pipeline assets towards commercialization or opportunistic out-licensing[141](index=141&type=chunk) [Recent Developments](index=31&type=section&id=Recent%20Developments) - On March 27, 2024, Avalo acquired AVTX-009, a Phase 2-ready anti-IL-1β mAb, through a merger with AlmataBio Inc[142](index=142&type=chunk) - 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](index=142&type=chunk) [Liquidity](index=32&type=section&id=Liquidity) - Avalo has incurred significant operating and cash losses since inception, primarily funding operations through equity sales, out-licensing, and asset sales[143](index=143&type=chunk) - 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](index=143&type=chunk) - Existing cash and cash equivalents are expected to fund operations for at least twelve months from the filing date and into 2027[144](index=144&type=chunk) [Our Strategy](index=32&type=section&id=Our%20Strategy) - 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](index=145&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) - 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](index=146&type=chunk) - 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](index=149&type=chunk)[151](index=151&type=chunk) - 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](index=150&type=chunk) - General and administrative expenses increased by **$0.5 million** to **$3.2 million** in Q1 2024, driven by a **$0.4 million** increase in legal, consulting, and other professional expenses related to the Almata Transaction[152](index=152&type=chunk) - Other expense, net, increased significantly to **$(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](index=154&type=chunk)[155](index=155&type=chunk)[157](index=157&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) - Avalo primarily uses cash to fund research and development of pipeline assets, especially AVTX-009, and organizational infrastructure costs[158](index=158&type=chunk) 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](index=162&type=chunk)[163](index=163&type=chunk) - 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](index=164&type=chunk) - 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](index=165&type=chunk) [Critical Accounting Policies, Estimates, and Assumptions](index=36&type=section&id=Critical%20Accounting%20Policies,%20Estimates,%20and%20Assumptions) - Critical accounting policies for Q1 2024 include warrant liability and asset acquisition, both recognized due to transactions closed in the first quarter[167](index=167&type=chunk) - 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](index=169&type=chunk)[170](index=170&type=chunk)[172](index=172&type=chunk) - 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](index=173&type=chunk) - 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](index=174&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) - Avalo Therapeutics does not have any off-balance sheet arrangements as defined by SEC rules and regulations[175](index=175&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=177&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=177&type=chunk) - No material changes in internal control over financial reporting were identified during the period covered by this report[179](index=179&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=181&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) 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](index=182&type=chunk) - Additional risks and uncertainties not currently known or deemed immaterial could also adversely affect the company's business, financial condition, or future results[182](index=182&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) 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](index=184&type=chunk) - 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](index=184&type=chunk) - Interactive data files in XBRL format are provided for the financial statements[184](index=184&type=chunk)[185](index=185&type=chunk)