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- Innovate UK, part of UK Research and Innovation, is investing £10 million in innovation projects to advance next-generation immunotherapies for cancer, of which £1.5 million has been awarded to Mestag - Bispecific antibody MST-0300 is a first-of-its-kind approach designed to conditionally induce tertiary lymphoid structures (TLS) in solid tumors, an exciting new therapeutic strategy with potential to revolutionize cancer treatment Aug. 28, 2024 -- Mestag Therapeutics (“Mestag”), a biotech company harnessing new insights into fibroblast-immune interactions, today announced that it has been awarded a “Transforming Cancer Therapeutics” grant from Innovate UK’s Cancer Therapeutics program of £1.5 million ($1.9 million) to accelerate the development of its MST-0300 antibody. MST-0300 is a first-in-class bispecific antibody designed to induce TLS in solid tumors in a highly specific and localized fashion. The presence of TLS in tumors has recently emerged as being strongly correlated with improved outcomes for cancer patients across multiple tumor types. TLS are believed to enable improved immune cell access to the tumor and drive local immune cell education, leading to a powerful orchestrated anti-tumor response. Mestag data in hard-to-treat cancer models, recently presented at the 2024 American Association of Cancer Research conference, demonstrate potent anti-tumor effects. Susan Hill, PhD, Chief Executive Officer of Mestag Therapeutics, said, “We are honored to have been selected as a recipient for this highly competitive translational award. The presence of TLS in tumors is emerging as a key driver of improved treatment outcomes in cancer patients, and our MST-0300 program, designed to induce the formation of TLS in tumors, holds important therapeutic promise. Leveraging the dynamic UK biotech ecosystem, Innovate UK funding will enable us to advance MST-0300 rapidly to solid tumor patients who urgently need new treatment options.” MST-0300 is a first-in-class bispecific antibody that co-engages fibroblast activated protein (FAP) and lymphotoxin beta receptor (LTBR) to conditionally activate LTBR and induce tertiary lymphoid structures (TLS) in the tumor. TLS are aggregates of immune cells that can form in tumor tissue as part of our bodies’ natural anti-cancer mechanisms, and drive powerful immune responses by recruiting, educating, and activating new anti-tumor T- and B-cells. Fibroblast populations play a key role in the induction and maintenance of TLS. TLS in tumors are strongly predictive of both improved patient outcomes across solid tumor types and better response to therapy. Mestag recently presented in vivo preclinical data which showed potent monotherapy efficacy, as well as tumor regression in combination with tumor antigen or a checkpoint inhibitor. Innovate UK, part of UK Research and Innovation (UKRI), is the UK’s innovation agency. It works to create a better future by inspiring, involving and investing in businesses developing life-changing innovations. Its mission is to help companies to grow through their development and commercialisation of new products, processes and services, supported by an outstanding innovation ecosystem that is agile, inclusive and easy to navigate. Mestag harnesses new insights into fibroblast-immune interactions to develop impactful treatments for patients with cancer and inflammatory diseases. We are progressing a pipeline of sophisticated first-in-class antibodies designed to direct and drive the immune system using known and emerging fibroblast-immune biology for a distinctly differentiated class of therapeutics. Our pipeline includes a bispecific antibody MST-0300, which leverages a new understanding of tertiary lymphoid structures (TLS) in solid tumors and their role in driving improved patient outcomes; the M402 program, targeting a stromal checkpoint to dampen down the activation of specific immune cell subsets in inflammatory disease; and earlier programs in discovery stage. Separately, in a collaboration with Janssen Biotech, Inc., a Johnson & Johnson company, we are also identifying novel targets for future therapies.“ Our founding investigators comprise global experts in inflammatory disease, cancer, computational biology and fibroblast biology from the University of Oxford, Brigham & Women’s Hospital, Harvard Medical School and Cold Spring Harbor Laboratory. We are supported by leading life science investors SV Health Investors, Johnson & Johnson Innovation – JJDC, Inc., Forbion, GV (formerly Google Ventures) and Northpond Ventures. Mestag is headquartered in Cambridge, UK, and in 2021 was recognized on the Fierce 15 list of innovative biotechnology companies. The content above comes from the network. if any infringement, please contact us to modify.

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

April 08, 2024 -- Mestag Therapeutics (“Mestag”), a biotech company harnessing new insights into fibroblast-immune interactions, is today presenting data on its M300 program in a late-breaking poster session at the 2024 American Association for Cancer Research (AACR) meeting. The poster titled “Conditionally active, therapeutic lymphotoxin beta receptor (LTBR) agonist bispecific antibodies for induction of tertiary lymphoid structures in the treatment of solid tumors” is being presented as part of the “Late-Breaking Research: Immunology 2” poster session (9:00 a.m. – 12:30 p.m. PT, poster section 52; board number 11). The presented data demonstrate that Mestag’s bispecific antibody co-engages fibroblast activated protein (FAP) and LTBR to conditionally activate LTBR and induce Tertiary Lymphoid Structures (TLS) in the tumor. In vivo data showed potent monotherapy efficacy as well as tumor regression in combination with tumor antigen or a checkpoint inhibitor. Ray Jupp, PhD, Chief Scientific Officer of Mestag Therapeutics, said, “TLS is an exciting new area of anti-cancer immunology. There is now extensive evidence that the presence of these structures plays a critical role in anti-tumor immunity and better survival outcomes in patients. We are excited to share that M300 conditionally induces TLS formation in hard-to-treat tumor models representative of low antigen, cold human tumors, an area of significant unmet need. We look forward to bringing this to patients as soon as possible.” M300 is a first-in-class bispecific antibody designed to conditionally induce the formation of Tertiary Lymphoid Structures (TLS) in solid tumors. TLS are aggregates of immune cells that can form in tumor tissue as part of our bodies’ natural anti-cancer mechanisms, and drive powerful immune responses by recruiting, educating, and activating new anti-tumor T and B-cells. Fibroblast populations play a key role in the induction and maintenance of TLSs. TLSs in tumors are strongly predictive of both improved patient outcomes across solid tumor types and better response to therapy. Mestag harnesses new insights into fibroblast-immune interactions to develop impactful treatments for patients with cancer and inflammatory diseases. We are progressing a pipeline of sophisticated first-in-class antibodies designed to direct and drive the immune system using known and emerging fibroblast-immune biology for a distinctly differentiated class of therapeutics. Our pipeline comprises the M300 program, leveraging new understanding of tertiary lymphoid structures (TLS) in solid tumors, and their role in driving improved patient outcomes; the M402 program, targeting a stromal checkpoint to dampen down the activation of specific immune cell subsets in inflammatory disease; and earlier programs in discovery stage. Separately, in a collaboration with Janssen Biotech, Inc., a Johnson & Johnson company, we are also identifying novel targets for future therapies. Our founding investigators comprise global experts in inflammatory disease, cancer, computational biology and fibroblast biology from the University of Oxford, Brigham & Women’s Hospital, Harvard Medical School and Cold Spring Harbor Laboratory. We are supported by leading life science investors SV Health Investors, Johnson & Johnson Innovation – JJDC, Inc., Forbion, GV (formerly Google Ventures) and Northpond Ventures. Mestag is headquartered in Cambridge, UK, and in 2021 was recognized on the Fierce 15 list of innovative biotechnology companies. The content above comes from the network. if any infringement, please contact us to modify.