AlmataBio, Inc.

Expects to enroll first patient in Phase 2 LOTUS Trial of AVTX-009 in hidradenitis suppurativa in the second half of 2024Appointed Dr. Mittie Doyle as Chief Medical Officer and Paul Varki as Chief Legal OfficerCash on hand of approximately $93.4 million as of June 30, 2024 with expected cash runway into 2027 WAYNE, Pa. and ROCKVILLE, Md., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced business updates and financial results for the second quarter of 2024. “The team has made outstanding progress in a short amount of time toward initiating the Phase 2 LOTUS Trial, as highlighted by the activation of the IND in July,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “Furthermore, the Company is immediately benefiting from the addition of Mittie and Paul to the leadership team as CMO and CLO, respectively. Their deep expertise and leadership experience will guide us as we focus on initiating the LOTUS Trial, as well as the evaluation and announcement of a second indication, both of which we believe are on track for the second half of the year.” Program Updates and Milestones: AVTX-009: Anti-IL-1β monoclonal antibody (mAb) targeting inflammatory diseases. Avalo is pursuing the development of AVTX-009 in hidradenitis suppurativa (HS).In July 2024, Avalo announced that the Investigational New Drug Application (IND) for the treatment of HS is active, permitting Avalo to commence its Phase 2 LOTUS Trial in patients with HS.Avalo expects to enroll the first patient in its global Phase 2 LOTUS Trial in the second half of 2024.In addition to hidradenitis suppurativa, Avalo plans to develop AVTX-009 in at least one other chronic inflammatory indication. Second Quarter 2024 Financial Update: As of June 30, 2024, Avalo had $93.4 million in cash and cash equivalents. Net cash used in operating activities was $22.5 million for the six months ended June 30, 2024, which includes a $7.5 million milestone payment to AlmataBio, Inc. pursuant to the acquisition in the first quarter. The Company’s current cash on hand is expected to fund operations into 2027. For the six months ended June 30, 2024, Avalo generated a net loss of $22.8 million, representing a $4.7 million increase in net loss as compared to the same period in 2023. Total operating expenses increased by $25.3 million and was primarily driven by the recognition of $27.6 million of acquired in-process research and development (“IPR&D”) expense from the acquisition of AlmataBio, Inc. in the first quarter of 2024. The increase in operating expenses was partially offset by a $21.7 million increase in other income, net which largely related to the loss associated with warrant liability from the private placement in the first quarter being more than offset by the warrant liability change in fair value in the second quarter. Net loss per share of common stock decreased as a result of the increase in the shares outstanding from the second quarter of 2023, partially offset by the increase in net loss. Consolidated Balance Sheets(In thousands, except share and per share data) June 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $93,426 $7,415 Other receivables 33 136 Prepaid expenses and other current assets 2,435 843 Restricted cash, current portion — 1 Total current assets 95,894 8,395 Property and equipment, net 1,780 1,965 Goodwill 10,502 10,502 Restricted cash, net of current portion 131 131 Total assets $108,307 $20,993 Liabilities, mezzanine equity and stockholders’ (deficit) equity Current liabilities: Accounts payable $654 $446 Accrued expenses and other current liabilities 7,888 4,172 Warrant liability 82,855 — Contingent consideration 5,000 — Total current liabilities 96,397 4,618 Royalty obligation 2,000 2,000 Deferred tax liability, net 168 155 Derivative liability 10,710 5,550 Other long-term liabilities 1,183 1,366 Total liabilities 110,458 13,689 Mezzanine equity: Series C Preferred Stock—$0.001 par value; 34,326 and 0 shares of Series C Preferred Stock authorized at June 30, 2024 and December 31, 2023, respectively; 22,358 and 0 shares of Series C Preferred Stock issued and outstanding at June 30, 2024 and December 31, 2023, respectively 11,457 — Series D Preferred Stock—$0.001 par value; 1 and 0 shares of Series D Preferred Stock authorized at June 30, 2024 and December 31, 2023, respectively; 1 and 0 shares of Series D Preferred Stock issued and outstanding at June 30, 2024 and December 31, 2023, respectively — — Series E Preferred Stock—$0.001 par value; 1 and 0 shares of Series E Preferred Stock authorized at June 30, 2024 and December 31, 2023, respectively; 1 and 0 shares of Series E Preferred Stock issued and outstanding at June 30, 2024 and December 31, 2023, respectively — — Stockholders’ (deficit) equity: Common stock—$0.001 par value; 200,000,000 shares authorized at June 30, 2024 and December 31, 2023; 1,034,130 and 801,746 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively 1 1 Additional paid-in capital 344,352 342,437 Accumulated deficit (357,961) (335,134)Total stockholders’ (deficit) equity (13,608) 7,304 Total liabilities, mezzanine equity and stockholders’ (deficit) equity $108,307 $20,993 The consolidated balance sheets as of June 30, 2024 and December 31, 2023 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. Consolidated Statements of Operations(In thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Revenues: Product revenue, net $— $643 $— $1,117 Total revenues, net — 643 — 1,117 Operating expenses: Cost of product sales 343 708 263 1,259 Research and development 4,601 4,658 6,716 10,667 Acquired in-process research and development 103 — 27,641 — General and administrative 4,528 2,427 7,721 5,134 Total operating expenses 9,575 7,793 42,341 17,060 (9,575) (7,150) (42,341) (15,943)Other income (expense): Excess of initial warrant fair value over private placement proceeds — — (79,276) — Change in fair value of warrant liability 112,046 — 112,046 — Private placement transaction costs — — (9,220) — Change in fair value of derivative liability (5,040) (40) (5,160) (220)Interest income (expense), net 1,039 (996) 1,138 (1,945)Other expense, net — — — (25)Total other income (expense), net 108,045 (1,036) 19,528 (2,190)Income (loss) before taxes 98,470 (8,186) (22,813) (18,133)Income tax expense 7 7 14 15 Net income (loss) $98,463 $(8,193) $(22,827) $(18,148)Net income (loss) per share of common stock1: Basic $4.21 $(140.73) $(24.11) $(338.85)Diluted $(14.07) $(140.73) $(30.63) $(338.85) 1 Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-240 reverse stock split effected on December 28, 2023. The unaudited consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. Avalo also has two additional drug candidates, which include quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein). For more information about Avalo, please visit www.avalotx.com. About AVTX-009 AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology. About the LOTUS Trial The LOTUS Trial is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial with two AVTX-009 dose regimens to evaluate the efficacy and safety of AVTX-009 in approximately 180 adults with moderate to severe hidradenitis suppurativa. The primary efficacy endpoint is the proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR75) at Week 16. Subjects will be randomized (1:1:1) to receive either one of two doses of AVTX-009 or placebo. About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by painful nodules, abscesses, and tunnels that form in areas of the body such as the armpits, groin, and buttocks, severely impacting the quality of life of affected individuals.1 HS is often underdiagnosed or misdiagnosed and therefore estimates of HS vary between 0.2-1.7% of the population worldwide.2-5 The exact cause of HS is not fully understood but is believed to involve a combination of genetic, hormonal, and environmental factors. While advances in treatment have been made, limited treatment options are available. IL-1β plays a crucial role in the inflammatory cascade underlying HS, contributing to tissue damage, inflammation, and disease progression. Given the involvement of IL-1β in the inflammatory process of HS, we believe therapies that target IL-1β offer a potential treatment option for HS. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; integration of AVTX-009 into our operations; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. References1Patel ZS et al. Curr Pain Headache Rep. 2017;21(12):49.2Egeberg A, et al. JAMA Dermatol 2016;152:429–343Phan K, et al Biomed Dermatol 2020; 4: 2-64Jfri, A, et al. JAMA Dermatol. 2021;157(8):924-315Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2021;35(1):50-61 For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. ir@avalotx.com 410-803-6793 or Chris BrinzeyICR WestwickeChris.brinzey@westwicke.com 339-970-2843

Topline results from planned Phase 2 trial of AVTX-009 in hidradenitis suppurativa expected in 2026Cash on hand of approximately $110 million as of March 31, 2024 with expected cash runway into 2027 WAYNE, Pa. and ROCKVILLE, Md., May 13, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced business updates and financial results for the first quarter of 2024. “Over the past month we have made considerable progress toward initiating our planned Phase 2 trial of AVTX-009 in hidradenitis suppurativa. Our experienced team has been working closely with subject matter experts on trial enabling activities, and we plan to have the trial underway this year,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “Our main focus remains on the initiation of the Phase 2 trial in hidradenitis suppurativa. Upon trial initiation, we plan to expand our focus to include the evaluation and announcement of a second indication, as well as pursuing the development of a next generation anti-IL-1β mAb.” Program Updates and Milestones: AVTX-009: Anti-IL-1β monoclonal antibody (mAb) targeting inflammatory diseases. Avalo is pursuing the development of AVTX-009 in hidradenitis suppurativa and expects topline data from its planned Phase 2 trial in hidradenitis suppurativa in 2026.In addition to hidradenitis suppurativa, Avalo plans to develop AVTX-009 in at least one other chronic inflammatory indication. Next Generation anti-IL-1β mAb. Avalo is pursuing a next generation anti-IL-1β with an extended half-life. Quisovalimab (AVTX-002): Anti-LIGHT mAb targeting immune-inflammatory diseases. Avalo is conducting a strategic review of the quisovalimab program. AVTX-008: B and T Lymphocyte Attenuator (BTLA) agonist fusion protein targeting immune dysregulation disorders. Avalo is conducting a strategic review of the AVTX-008 program. First Quarter 2024 Financial Update: As of March 31, 2024, Avalo had $110.2 million in cash and cash equivalents. In March 2024, the Company closed a private placement investment for up to $185.0 million in gross proceeds, including an initial upfront gross investment of $115.6 million. The Company could receive up to an additional $69.4 million of gross proceeds upon the exercise of the warrants issued in the financing. The Company’s current cash on hand is expected to fund operations through the data readout of our planned Phase 2 trial in hidradenitis suppurativa and into 2027. For the three months ended March 31, 2024, Avalo generated a net loss of $121.3 million. The increase in net loss as compared to the prior period was primarily driven by the excess of warrant fair value over private placement proceeds. The warrants did not satisfy the conditions to be accounted for as an equity instrument and therefore were classified as a liability upon issuance. The initial fair value of the warrants at issuance was $194.9 million, which exceeded the upfront gross proceeds of $115.6 million, resulting in a $79.3 million loss recognized for the three months ended March 31, 2024. The fair value of the warrant liability was estimated using a Black-Scholes option-pricing model and the key variable input driving the fair value was the closing stock price of $21.75 on March 28, 2024, which was the initial valuation date, as well as the last trading day of the first quarter of 2024. Because the warrants are carried at fair value, future changes in fair value will be recognized in other (expense) income, net at each reporting period until the warrants are either exercised or expired. In addition, Avalo’s acquisition of AlmataBio, Inc. was accounted for as an asset acquisition resulting in the recognition of $27.5 million of acquired in-process research and development (“IPR&D”) expense. Finally, we recognized $9.2 million of private placement transaction expenses within other expense. Net loss per share of common stock decreased as a result of the increase in the shares outstanding from the first quarter of 2023, partially offset by the increase in net loss. Consolidated Balance Sheets(In thousands, except share and per share data) March 31, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents$110,177 $7,415 Other receivables 35 136 Prepaid expenses and other current assets 997 843 Restricted cash, current portion 4 1 Total current assets 111,213 8,395 Property and equipment, net 1,882 1,965 Goodwill 10,502 10,502 Restricted cash, net of current portion 131 131 Total assets$123,728 $20,993 Liabilities, mezzanine equity and stockholders’ (deficit) equity Current liabilities: Accounts payable$916 $446 Accrued expenses and other current liabilities 7,383 4,172 Warrant liability 194,901 — Contingent consideration 12,500 — Total current liabilities 215,700 4,618 Royalty obligation 2,000 2,000 Deferred tax liability, net 162 155 Derivative liability 5,670 5,550 Other long-term liabilities 1,281 1,366 Total liabilities 224,813 13,689 Mezzanine equity: Series C Preferred Stock—$0.001 par value; 34,326 and 0 shares of Series CPreferred Stock authorized at March 31, 2024 and December 31, 2023,respectively; 22,358 and 0 shares of Series C Preferred Stock issued andoutstanding at March 31, 2024 and December 31, 2023, respectively 11,457 — Series D Preferred Stock—$0.001 par value; 1 and 0 shares of Series D PreferredStock authorized at March 31, 2024 and December 31, 2023, respectively; 1 and 0shares of Series D Preferred Stock issued and outstanding at March 31, 2024 andDecember 31, 2023, respectively — — Series E Preferred Stock—$0.001 par value; 1 and 0 shares of Series E PreferredStock authorized at March 31, 2024 and December 31, 2023, respectively; 1 and 0shares of Series E Preferred Stock issued and outstanding at March 31, 2024 andDecember 31, 2023, respectively — — Stockholders’ (deficit) equity: Common stock—$0.001 par value; 200,000,000 shares authorized at March 31,2024 and December 31, 2023; 1,034,130 and 801,746 shares issued andoutstanding at March 31, 2024 and December 31, 2023, respectively 1 1 Additional paid-in capital 343,881 342,437 Accumulated deficit (456,424) (335,134) Total stockholders’ (deficit) equity (112,542) 7,304 Total liabilities, mezzanine equity and stockholders’ (deficit) equity$123,728 $20,993 The consolidated balance sheets as of March 31, 2024 and December 31, 2023 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements. Consolidated Statements of Operations (In thousands, except per share data) Three Months EndedMarch 31, 2024 2023 Revenues: Product revenue, net$— $475 Total revenues, net — 475 Operating expenses: Cost of product sales (80) 551 Research and development 2,116 6,008 Acquired in-process research and development 27,538 — General and administrative 3,193 2,708 Total operating expenses 32,767 9,267 (32,767) (8,792) Other expense: Excess of warrant fair value over private placement proceeds (79,276) — Private placement transaction costs (9,220) — Change in fair value of derivative liability (120) (180) Interest income, net 100 (949) Other expense, net — (26) Total other expense, net (88,516) (1,155) Loss before taxes (121,283) (9,947) Income tax expense 7 8 Net loss and comprehensive loss$(121,290) $(9,955) Net loss per share of common stock, basic and diluted1$(141) $(204) 1 Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-240 reverse stock split effected on December 28, 2023. The unaudited consolidated statements of operations for the three months ended March 31, 2024 and 2023 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. About AVTX-009 AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology. About quisovalimab (AVTX-002) Quisovalimab is a fully human monoclonal antibody (mAb), directed against human LIGHT (Lymphotoxin-like, exhibits Inducible expression, and competes with Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator (HVEM), a receptor expressed by T lymphocytes). There is increasing evidence that the dysregulation of the LIGHT-signaling network which includes LIGHT, its receptors HVEM and LTβR and the downstream checkpoint BTLA, is a disease-driving mechanism in autoimmune and inflammatory reactions in barrier organs. Therefore, we believe reducing LIGHT levels can moderate immune dysregulation in many acute and chronic inflammatory disorders. Quisovalimab previously demonstrated proof of concept in COVID-19 induced acute respiratory distress syndrome including reduction in mortality and respiratory failure, as well as a positive signal in patients with Crohn’s Disease. About AVTX-008 AVTX-008 is a fully human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein in the IND-enabling stage. AVTX-008 is differentiated by having specific binding to BTLA, with no binding to LIGHT or CD160. AVTX-008 also has high-serum stability and solubility. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo’s lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. Avalo’s pipeline also includes quisovalimab (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein). For more information about Avalo, please visit www.avalotx.com. Forward-Looking Statements This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: the intended use of the proceeds from the private placement; integration of AVTX-009 into our operations; drug development costs, timing of trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. ir@avalotx.com410-803-6793 or Chris BrinzeyICR WestwickeChris.brinzey@westwicke.com339-970-2843

2024年第一季度，市场上的资金开始回到生物医药领域。一级市场上，第一季度北美与欧洲Biotech融资同比大幅提升，超1亿美元大额融资多达20起，同比增长66%。最明显的还应是美股Biotech IPO，第一季度以来共有9家公司上市，其中今年首家IPO的溶瘤病毒疗法公司CG Oncology首日大涨95%，至今已涨超130%。此外，今年美股上市Biotech再融资额超过40亿美元。有多家Biotech公司宣布增发并迎来一波股价暴涨。仅在3月，就出现iBio宣布增发当日股价暴涨192%，Avalo宣布增发当日股价暴涨400%的盛况。从全球市场来看，比起冰冷的2023年初，今年的生物医药终于“好起来了”。但是仔细观察第一季度的资金流入，其主旨仍然是：风险厌恶。一级市场：有条件地拥抱创新Biotech一级市场融资在今年3月迎来了久违的“小高峰”，总融资额超过了21亿美元。这主要是由于两家明星公司分别获得了两笔大额融资：TYK2抑制剂同类最佳竞争者公司Alumis获得2.59亿美元C轮融资，以及Prometheus创始人再次创业成立的自免药物公司Mirador Therapeutics获得4亿美元A轮融资。统计范围为北美与欧洲一级市场融资，单位：亿美元大额融资对于生物医药行业有重要的振奋作用。在生物技术投融资领域经历多年低迷之后，最近终于看到了行业的回升势头，尤其是刚刚成立、管线尚未公布的Mirador Therapeutics，也获得了超额A轮融资。2024 Q1一级市场融资事件，统计地区为北美和欧洲今年一季度60余起融资事件中，平均融资额在8000万美元，超5000万美元的融资事件多达39起。不过融资阶段来看，仍以早期为主：种子/天使轮以及A/A+轮融资占比接近60%。资金对于各种创新疗法和药物模式展现了包容度，从更加前沿的CGT、RNA疗法，再到蛋白降解药物、放射性药物，以及光免疫疗法、微生物疗法，还有AI药物筛选等领域，均有公司获得融资。但是，在市场环境复苏的阶段，Biotech继续回归管线逻辑——精简、集中，尽快将产品推进临床。融资列表中几乎没有单纯的平台型公司，而获得较多融资的公司（第一季度融资额Top 20），平均公开管线不超过5条。IPO：门槛悄然变高Biotech公司尤其依赖股票市场，因为它们往往需要大量资金来资助药物开发，然后才能产生足够的收入来偿还债务。这也是为什么今年Biotech美股IPO的再次开闸引起了市场重视。第一季度以来，美国Biotech通过常规途径IPO的公司已有9家，而2023年全年这个数字也仅有19家，2022年有21家。更让人兴奋的是募资额，今年一季度的9家IPO公司共募集约13亿美元，要知道2022年的全年募资额也只有不到16亿美元。2024 Q1美股IPO Biotech，上市后涨跌幅根据发行价与3月最后一个交易日股价计算但是IPO的门槛悄然变高了。自2023年初以来，能够成功上市的公司类型发生了变化。BioPharma Dive的数据显示，2023年至今的前十大IPO事件中，有9家公司的产品管线处于临床中后期阶段。而所有IPO的公司中，没有走到临床试验的公司上市时募集的资金平均不超过9000万美元。回看2020年和2021年，大多数上市的公司要么是在临床前或临床1期的测试。这意味着，手握早期管线或仅拥有技术平台的公司，面临着比之前更艰难的时期。今年IPO的公司中，基因编辑公司Metagenomi是一家典型的早期阶段Biotech，这家与Ionis、Moderna合作的年轻公司，目前暂无候选药物。该公司的上市受到业内人士的关注，其走势被视为IPO是否向处于早期阶段公司开放的风向标。然而，Metagenomi的IPO定价处于其预期区间的底部，且上市后“不出意外地”跌去30%。Metagenomi的上市后跌幅还排不到头名，镇痛新药公司Chromocell与代谢新药公司Fractyl Health都已跌超50%。Chromocell是一家典型的早期阶段公司，核心管线处于临床1期。而Fractyl Health，则正在研发GLP-1的AAV基因疗法候选药物。对比大涨131%的CG Oncology，其核心产品cretostimogene治疗高危、卡介苗无应答NMIBC已同时获得FDA的突破性疗法认证和快速通道资格。投资者的偏好显而易见。“投资者对于一些规模更大、持续时间更长的故事的耐心，已经不像几年前那样了。”硅谷银行相关负责人表示。另外有行业人士认为，考虑IPO的Biotech公司，有很多是因为受到未成功退出的投资方压力，从而采取上市行动。近两年许多公司被收购或濒临被淘汰，释放出了一些资金来支持新的Biotech公司。因此，谈论Biotech美股IPO的盛况回归还为时尚早。上市后再融资：流向确定性的钱上市后的Biotech在商业化跑通之前仍然需要持续烧钱，因此再融资是Biotech的成功必修课。今年一季度，有众多美股Biotech选择增发。2月底，Viking公布VK2735的2期减肥适应症数据后单日股价暴涨超120%，随后Viking迅速宣布增发3.5亿美元将资金用于管线的后续开发，得到了热烈反应。在扣除承销折扣和佣金以及发行费用之前，Viking此次发行的总收益约为6.325亿美元。3月底，自免药物公司Avalo Therapeutics宣布收购AlmataBio公司并获得已进入临床2期阶段的IL-1β靶向单克隆抗体AVTX-009，并宣布完成1.85亿美元私募融资，公司当日股价最高涨幅达625%。另一家通过PIPE获得巨额资金的Biotech是Denali，这家罕见病公司在2月底通过私募股权募得5亿美元，今年年初Denali宣布剥离小分子疗法并进行了裁员调整，此后将专注于大分子疗法研究。增发有助于为公司注入大量资金，凸显出生物技术行业对投资者的吸引力。不过，这些增发的Biotech公司都释放了足够的利好消息，要么是临床数据足够惊艳，要么是在公司战略上让人眼前一亮，且这些公司的增发股价通常不低于交易市价，这也证明市场上的钱依然在向确定性流动。而几年前如Fate Therapeutics一般多次的低价定增股份来筹资公司相应的运营资金，一边大笔亏钱一边融钱的操作，就显得不合时宜了。当下或许是投资Biotech的最好时刻近期，生物医药领域最为专业的投行Jefferies表示，美股Biotech的IPO融资规模仍远低于崩盘前的水平，目前初步的改善迹象可能并不意味着Biotech已经完全走出困境。由于今年预期中的利率削减可能比预期慢，乐观情绪可能会发生变化。生物科技行业具有非线性特征，创新过程难以预测。Biotech公司的表现尤其具有二元性，因为临床试验结果往往会决定药物开发商的成败。通常情况下，Biotech相较于其他行业，由于其高度的复杂性、研发周期的漫长性，以及监管环境的严格性，是最难把控也是商业模式“最差”的资产。但过去一年中，市场见证了 ADC、GLP-1在研发和商业化上的增长态势，美股市值前十的公司中首次出现了医药公司——礼来。除此之外，随着上一代重磅药品专利的陆续创新，各大MNC进入新一轮的“军备竞赛”，而能够给MNC输血的正是一级、二级市场上无数的Biotech。这也是为什么资金对拥有后期及商业化阶段资产的Biotech正在产生兴趣，虽然流向生物医药的资金仍然是谨慎的，但通过各种融资动作、以及在过去6个月内上涨32%的XBI指数来看，至少现在可称为“谨慎乐观”，而投资Biotech的最佳时机，往往就是当下这种市场“谨慎乐观”的阶段——一个低迷期与泡沫期的中间带。尽管北美市场Biotech与国内创新药还未“共此凉热”，但美国作为Biotech创新引擎地，其市场温度、研发动向与商业化兑现的形势，对中国Biotech来说也是重要的风向标。接下来，无论是美国Biotech还是中国Biotech，将通过First-in-Class和Best-in-Class，打开相关疾病赛道和技术领域的更多想象空间，而这一轮新的未来，属于全球的Biotech以及相信Biotech的投资者。*封面图片来源：123rf动脉网第八届未来医疗100强大会现已升级为，将于2024年5月7日-10日在北京·北人亦创国际会展中心盛大举行。本届展会为15000+人次、10000平规模，围绕新产品、新技术、新服务、新生态、新合作构建体系，为医疗健康产业的创新力展示搭建最佳舞台。这里是，公认的医疗产业创新洞察的生成地，年度趋势分享与学习交流的口碑盛会；优秀的医疗创新企业和创新产品都在这，是企业展示创新和面谈合作的最佳场景；这里有，最具前瞻力的思享盛会：500+大咖嘉宾莅临分享，3天主论坛、40余场主题论坛，只做干货议题！最具创新力的生态链接：5大展区，200+首发首创新品、3000+企业、500+投资团，全球买手云集！最具影响力的榜单发布：上市公司创新力榜+未来医疗100强榜+创新力产品榜，700+上榜企业现场交流！目前已有超过600家企业和产品确认参加展会，展览面积预订超过70%，全球买手团已合作了印度尼西亚、新加坡、比利时、爱尔兰、西班牙、德国、澳大利亚、英国、加拿大等国家。余下的合作席位已不多，欢迎企业、品牌方、买手团或相关组织洽谈参会。在这个充满不确定性的时代，寻求高价值资源和高效率链接，将是您的首选。即刻报名，限时福利！声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台