Mosquito sample tests positive for West Nile virus in Kern County
On June 13, Kern County Public Health announced the first positive sample of the West Nile virus has been found in a mosquito. There have been no reported cases of a human contracting West Nile virus in the county so far in 2025.
The virus is mainly transmitted to people through mosquito bites, officials said.
Officials said you can reduce mosquito breeding sites by:
Remove standing or stagnate water from containers such flowerpots, fountains, birdbaths, pet bowls, and wading pools.
Clean/scrub containers that collect water weekly to remove any potential mosquito eggs.
Maintain swimming pools in working condition.
Stock garden ponds with fish that eat mosquito larvae.
Report areas of mosquito infestation to your local vector control district.
You can decrease the risk of mosquito-transmitted infections by:
Avoiding mosquitoes and mosquito-infested areas at all times of the day.
Wear long-sleeved shirts and long pants when outdoors.
Apply mosquito repellant to exposed skin when outdoors.
Ensure doors and windows have screens in good repair to keep mosquitoes out of your home.
Although the first positive mosquito sample has been identified in the 93307 zip code, it is important for everyone to take precautions to avoid mosquito bites.
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Business Wire
10 hours ago
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Lineage Cell Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
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'It is notable that among patients who received extensive one-time coverage of OpRegen RPE cells across the area of atrophy, anatomical and functional benefits have lasted for at least three years, outcomes consistent with meaningful disease stabilization and even improvement.' 'In addition to supporting our partners in advancing the OpRegen program, we are equally excited to have reached a milestone with our OPC1 program for the treatment of spinal cord injury, treating our first-ever chronic patient with a new parenchymal spinal delivery system. We also solidified our position as a leader in allogeneic cell process development and manufacturing by reporting in-house GMP production for each of two separate cell-based product candidates from a master and working cell bank system which, in its current form, can support a production capability of several million doses for a single-administration product. This is in addition to continuing to advance our ReSonance TM program for the treatment of sensorineural hearing loss and evaluating other strategically selected early-stage initiatives. As our cell therapy platforms gain further validation, we believe our pipeline and cell manufacturing and related expertise continue to position us as a compelling partner and investment opportunity,' added Mr. Culley. Select Business Highlights RG6501 (OpRegen Cell Therapy) Positive RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month Results featured at Clinical Trials at the Summit (CTS) 2025. 2025 CTS highlights: Gains in Best Corrected Visual Acuity (BCVA) in patients in Cohort 4 (less advanced GA) measured at month 12 remain evident through month 36 following subretinal administration of OpRegen cell therapy; Mean change in BCVA among treated eyes for patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment); Improvement in BCVA and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was greater than in patients with limited coverage and persisted through month 36 Effects were greater on average in the five (5) patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery In these patients' treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing 3-year follow-up (compared to +7.4 ETDRS letters at 24 months) (n=5) These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration Ongoing execution of Lineage's contributions to its collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study (the 'GAlette Study') in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at sites in the U.S. and Israel. In addition to testing of other surgical parameters, Genentech currently plans to evaluate two proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the GAlette Study. Ongoing efforts to further support development of OpRegen RPE cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette Study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies. Manufacturing Capability Successfully completed a production run for two different product candidates, each produced from a customized, two-tiered current Good Manufacturing Practice ('cGMP') cell banking system, highlighting the application of the Lineage platform across multiple programs. This production process utilizes a genetically-stable master cell bank created from a single, well-characterized pluripotent cell line, to generate a working cell bank, which then provides the source material for a final cell-based product candidate. This demonstrated cGMP production process should enable the ability to produce millions of doses of a cost-effective, scalable and consistent supply of an allogeneic, cell-based product derived from a single initial cell line, that can be applied across multiple programs. OPC1 First chronic spinal cord injury patient treated in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study. First chronic SCI patient treated in DOSED was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with a single neurological level of injury (NLI) from levels T1 to T10, and the novel delivery system successfully administered a one-time injection of OPC1. Hosted the 3 rd Annual Spinal Cord Injury Investor Symposium (3 rd SCIIS) in partnership with the Christopher & Dana Reeve Foundation. Balance Sheet Highlights Cash, cash equivalents, and marketable securities of $42.3 million as of June 30, 2025, is expected to support planned operations into Q1 2027. Second Quarter Operating Results Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended June 30, 2025 were $2.8 million, a net increase of $1.4 million as compared to $1.4 million for the same period in 2024. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the Roche Agreement, as well as deferred revenues recognized upon termination of the VAC platform-related collaboration agreement. Operating Expenses: Operating expenses are comprised of research and development ('R&D') expenses and general and administrative ('G&A') expenses. Total operating expenses for the three months ended June 30, 2025 were $22.5 million, an increase of $15.2 million as compared to $7.3 million for the same period in 2024. The overall increase was driven by the $14.8 million expense recognized for the loss on impairment for the intangible asset related to the VAC platform. R&D Expenses: R&D expenses for the three months ended June 30, 2025 were $3.1 million, an increase of $0.2 million as compared to $2.9 million for the same period in 2024. The net increase was primarily driven by ongoing activities within our preclinical programs. G&A Expenses: G&A expenses for the three months ended June 30, 2025 were $4.6 million, an increase of $0.2 million as compared to $4.4 million for the same period in 2024. The net increase was primarily driven by more costs incurred for services provided by third parties. Loss from Operations: Loss from operations for the three months ended June 30, 2025 were $19.8 million, an increase of $13.9 million as compared to $5.9 million for the same period in 2024. This increase in loss was primarily driven by the impairment expense related to the VAC platform of $14.8 million, which is a non-recurring transaction. Other Income/(Expenses): Other income/(expenses) for the three months ended June 30, 2025 reflected other expense of $10.6 million, compared to other income of $0.1 million for the same period in 2024. The net change was primarily attributable to the quarterly fair value remeasurement of the warrant liabilities of $12.7 million primarily due to an increase in our share price as compared to the prior quarter, partially offset by $1.7 million for exchange rate fluctuations related to Lineage's international subsidiaries. Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2025 was $30.5 million, or $0.13 per share (basic and diluted), compared to a net loss of $5.8 million, or $0.03 per share (basic and diluted), for the same period in 2024. The change was primarily driven by the loss on impairment expense related to a 2019 acquisition and the quarterly fair value remeasurement of the warrant liabilities. Conference Call and Webcast Interested parties may access the conference call on August 12, 2025, by dialing (800) 715-9871 from the U.S. and Canada and should request the 'Lineage Cell Therapeutics Call'. A live webcast of the conference call will be available online in the Investors section of Lineage's website. A replay of the webcast will be available on Lineage's website for 30 days and a telephone replay will be available through August 19 th, 2025, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 7788342. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or 'off the shelf', cell therapies for serious neurological and ophthalmic conditions. Lineage's programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage's neuroscience focused pipeline currently includes: (i) OpRegen cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed under a gene editing partnership. For more information, please visit or follow the company on X/Twitter @LineageCell. Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as 'believe,' 'aim,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'design,' 'intend,' 'expect,' 'could,' 'can,' 'plan,' 'potential,' 'predict,' 'seek,' 'should,' 'would,' 'contemplate,' 'project,' 'target,' 'suggest,' or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to AMD and the significance of the Phase 1/2a clinical study data reported to date; the benefits of our services agreement with Genentech and its impact on advancing the OpRegen cell therapy program; Lineage's ability to produce millions of doses of a cost-effective, and consistent supply of an allogeneic cell, cell-based product derived from a single initial cell line across one or more programs; the plans and expectations with respect to OPC1; the potential continued development of ReSonance (ANP1); Lineage's belief that its pipeline and expertise will position it as a compelling partner and investment opportunity; and that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the first quarter of 2027. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to expend our cash, cash equivalents and marketable securities more quickly than expected; that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing further clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction; that competing alternative therapies may adversely impact the commercial potential of OpRegen cell therapy; that OPC1 clinical trials may not be successful; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage's business and other risks discussed in Lineage's filings with the Securities and Exchange Commission (SEC). Lineage's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading 'Risk Factors' in Lineage's periodic reports with the SEC, including Lineage's most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC's website at You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. December 31, 2024 ASSETS CURRENT ASSETS Cash and cash equivalents $ 42,271 $ 45,789 Marketable securities 17 2,016 Accounts receivable 256 638 Prepaid expenses and other current assets 1,300 2,554 Total current assets 43,844 50,997 NONCURRENT ASSETS Property and equipment, net 2,255 2,251 Operating lease right-of-use assets 1,817 2,144 Deposits and other long-term assets 511 614 Goodwill 10,672 10,672 Intangible assets, net 31,700 46,540 TOTAL ASSETS $ 90,799 $ 113,218 LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $ 4,451 $ 5,437 Operating lease liabilities, current portion 998 1,097 Finance lease liabilities, current portion 50 55 Deferred revenues, current portion 5,257 7,388 Total current liabilities 10,756 13,977 LONG-TERM LIABILITIES Deferred tax liability 273 273 Deferred revenues, net of current portion 12,751 14,433 Operating lease liabilities, net of current portion 1,058 1,295 Finance lease liabilities, net of current portion 48 67 Warrant liabilities 18,801 6,161 TOTAL LIABILITIES 43,687 36,206 Commitments and contingencies (Note 13) SHAREHOLDERS' EQUITY Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of June 30, 2025 and December 31, 2024 — — Common shares, no par value, 450,000 shares authorized as of June 30, 2025 and December 31, 2024; 228,356 and 220,416 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively 490,551 484,722 Accumulated other comprehensive loss (4,098 ) (2,876 ) Accumulated deficit (438,068 ) (403,465 ) Lineage's shareholders' equity 48,385 78,381 Noncontrolling deficit (1,273 ) (1,369 ) Total shareholders' equity 47,112 77,012 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 90,799 $ 113,218 Expand LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 REVENUES: Collaboration revenues $ 2,532 $ 1,098 $ 3,802 $ 2,285 Royalties, license and other revenues 233 310 465 567 Total revenues 2,765 1,408 4,267 2,852 OPERATING EXPENSES: Cost of royalties 39 44 75 142 Research and development 3,106 2,868 6,220 5,878 General and administrative 4,560 4,363 9,417 9,360 Loss on impairment of intangible asset (Note 6 and Note 13) 14,840 — 14,840 — Total operating expenses 22,545 7,275 30,552 15,380 Loss from operations (19,780 ) (5,867 ) (26,285 ) (12,528 ) OTHER INCOME (EXPENSES): Interest income, net 454 463 932 925 Loss on marketable equity securities, net (2 ) (10 ) (7 ) (15 ) Change in fair value of warrant liability (12,740 ) — (10,435 ) — Foreign currency transaction gain (loss), net 1,678 (378 ) 1,447 (732 ) Other income (expense), net 26 19 (159 ) 19 Total other income (expenses) (10,584 ) 94 (8,222 ) 197 Net (income) loss attributable to noncontrolling interest (100 ) 13 (96 ) 29 Net loss per common share attributable to Lineage basic and diluted $ (0.13 ) $ (0.03 ) $ (0.15 ) $ (0.07 ) Weighted-average common shares used to compute basic and diluted net loss per common share 228,356 188,813 227,212 185,861 Expand LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) (UNAUDITED) Six Months Ended June 30, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss attributable to Lineage $ (34,603 ) $ (12,302 ) Net income (loss) attributable to noncontrolling interest 96 (29 ) Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. to net cash used in operating activities: Issuance costs for common stock warrant liabilities 183 — Loss on impairment of intangible asset 14,840 — Loss on marketable equity securities, net 7 15 Accretion of income on marketable debt securities (10 ) (102 ) Depreciation and amortization expense 335 295 Change in right-of-use assets and liabilities (88 ) (20 ) Amortization of intangible assets — 22 Stock-based compensation 2,455 2,432 Change in fair value of warrant liability 10,435 — Foreign currency remeasurement and other loss (1,455 ) 767 Changes in operating assets and liabilities: Accounts receivable 381 508 Prepaid expenses and other current assets 1,271 516 Accounts payable and accrued liabilities (459 ) (1,245 ) Deferred revenue (3,813 ) (1,816 ) Net cash used in operating activities (10,425 ) (10,959 ) CASH FLOWS FROM INVESTING ACTIVITIES: Proceeds from the sale of marketable equity securities — 18 Purchases of marketable debt securities — (8,761 ) Maturities of marketable debt securities 2,000 — Purchase of equipment (111 ) (88 ) Net cash (used in) provided by investing activities 1,889 (8,831 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from employee options exercised — 219 Common shares received and retired for employee taxes paid (15 ) (23 ) Proceeds from sale of common shares under ATM, net of offering costs — 68 Proceeds from sale of common shares under registered direct financing, net of offering costs — 13,889 Proceeds from sale of common shares with warrants under registered direct financing, net of offering costs 5,232 — Payment of financed insurance premium (452 ) — Payment of finance lease liabilities (28 ) (27 ) Net cash provided by financing activities 4,737 14,126 Effect of exchange rate changes on cash, cash equivalents and restricted cash 220 (158 ) (3,579 ) (5,822 ) CASH, CASH EQUIVALENTS AND RESTRICTED CASH: At beginning of the period 46,354 35,992 At end of the period $ 42,775 $ 30,170 Expand
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- Business Wire
Astria Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
BOSTON--(BUSINESS WIRE)-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today reported financial results for the second quarter ended June 30, 2025, and provided a corporate update. 'Delivering on navenibart's best-in-class potential is our top priority, and enrollment in the global Phase 3 ALPHA-ORBIT trial is well underway with active sites across the U.S., U.K., Canada, Hong Kong, and South Africa' said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. "We are encouraged by the strong enthusiasm from patients and physicians, including at the recent HAEA conference, where we had the opportunity to engage with the HAE community. We were also thrilled to announce a strategic partnership with Kaken. Their expertise supports our ongoing Phase 3 enrollment, contributes to strengthening our financial position, and may ultimately help expand global patient access to navenibart.' Navenibart (STAR-0215) In August, Astria announced that it has exclusively licensed development and commercialization rights in Japan to Kaken Pharmaceutical for navenibart. Under the agreement, Astria will receive an upfront payment of $16 million, with the potential for an additional $16 million in total commercialization and sales milestones. In addition to these payments, Astria is also eligible for tiered royalties with the royalty rate as a percentage of net sales up to 30%, and partial Phase 3 cost reimbursement. The navenibart Phase 3 program consists of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, which are designed to support registration globally. ALPHA-ORBIT is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of navenibart over a 6-month treatment period, with dosing arms every 3 months (Q3M) and every 6 months (Q6M). Enrollment is ongoing and top-line results are expected in early 2027. After completing ALPHA-ORBIT, eligible patients may continue into the open-label ORBIT-EXPANSE study, which includes 6 months of additional treatment followed by a patient-centric flexible dosing phase. Positive initial results from the ongoing ALPHA-SOLAR long-term open-label trial of navenibart were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. All 16 ALPHA-STAR target enrollment participants continued into ALPHA-SOLAR and the results are highly consistent with ALPHA-STAR - showing robust overall reduction in monthly attack rates (92% mean and 97% median) and a well-tolerated safety profile. STAR-0310 Astria is developing STAR-0310, an investigational high-potency and long-acting monoclonal antibody OX40 antagonist that incorporates YTE technology, for the treatment of atopic dermatitis (AD) and potentially other indications. STAR-0310 was intentionally designed to capitalize on the learnings of OX40 receptor and OX40 ligand programs with the goal of having the best overall OX40 therapy. The Company initiated a Phase 1a clinical trial of STAR-0310 in healthy subjects in January 2025. The Phase 1a trial is intended to assess the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adult participants, with early proof-of-concept (POC) results expected in the third quarter of 2025. Data presented at the European Academy of Allergy and Clinical Immunology (EAACI) annual congress support STAR-0310 as a potential best-in-class OX40 antagonist, with a unique allosteric inhibition mechanism, enhanced disruption of OX40/OX40L signaling compared to other agents, and pure antagonistic activity without agonism. These findings, along with previously reported low ADCC activity and robust cytokine suppression, highlight STAR-0310's differentiated profile and its potential to achieve deeper inhibition of T cell responses. Upcoming Corporate Events Cantor Global Healthcare Conference (September 3-5, 2025, New York, New York) Second Quarter 2025 Financial Results Cash Position: As of June 30, 2025, Astria had cash, cash equivalents and short-term investments of $259.2 million, compared to $328.1 million as of December 31, 2024. The Company expects that its cash, cash equivalents and short-term investments as of June 30, 2025, together with the Kaken upfront payment and expected reimbursement of a portion of the Company's Phase 3 program costs, will be sufficient to fund its current operating plan into 2028, including (i) for navenibart, support for all program activities through completion of our ALPHA-ORBIT Phase 3 trial, including activities related to the planned ORBIT-EXPANSE long-term trial and Phase 3 development and testing of drug device combinations, and (ii) for STAR-0310, the completion of the ongoing Phase 1a clinical trial of healthy subjects. Net cash used in operating activities for the three months ended June 30, 2025 was $36.1 million, compared to $16.8 million for the three months ended June 30, 2024. R&D Expenses: Research and development expenses were $25.9 million for the three months ended June 30, 2025, compared to $20.7 million for the three months ended June 30, 2024. The increase in research and development expenses was attributed to an increase in navenibart expenses related to the support of the ALPHA-ORBIT clinical trial and employee expenses, partially due to increases in stock-based compensation and company growth to support the advancement of our programs, during the three months ended June 30, 2025. G&A Expenses: General and administrative expenses were $9.9 million for the three months ended June 30, 2025, compared to $8.1 million for the three months ended June 30, 2024. The increase in general and administrative expenses was attributable to company growth to support the advancement of our programs, stock-based compensation and other professional services. Operating Loss: Loss from operations was $35.8 million for the three months ended June 30, 2025, compared to $28.8 million for the three months ended June 30, 2024. Net Loss: Net loss was $33.1 million for the three months ended June 30, 2025, compared to a net loss of $24.2 million for the three months ended June 30, 2024. Net Loss Per Share Basic and Diluted: Net loss per share basic and diluted was $0.57 for the three months ended June 30, 2025, compared to a net loss basic and diluted of $0.43 per share for the three months ended June 30, 2024. About Astria Therapeutics: Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is an investigational monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is an investigational monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, or follow us on Instagram @AstriaTx and on Facebook and LinkedIn. Forward Looking Statements: This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the expected timing of receipt of topline results from the navenibart ALPHA-ORBIT Phase 3 trial; the goals and objectives of the ALPHA-ORBIT Phase 3 trial and the ORBIT-EXPANSE long-term trial, including that they are designed to support registration of Q3M and Q6M navenibart administration; our goal of developing two dosing options for navenibart; the potential for navenibart in the HAE market, including the potential to be the market leading treatment in HAE, the potential therapeutic and other benefits of navenibart as a treatment for HAE, and our vision and goals for the program; the objectives, goals and potential payments from our agreement with Kaken Pharmaceutical; the potential therapeutic benefits and potential attributes of STAR-0310 as a treatment for AD; expectations regarding the nature and timing of receipt of early proof-of-concept results from such trial, including our expectation that such results will inform on STAR-0310's differentiated profile; the potential to develop STAR-0310 in additional indications; our goals and vision for STAR-0310; statements about the Company's current operating plan and the Company's anticipated cash runway; and the goal of bringing life changing therapies to patients and families affected by allergic and immunological diseases and to become a leading allergy and immunology company. The use of words such as, but not limited to, 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'goals,' 'intend,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would,' or "vision," and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Astria's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of Astria's product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the following risks and uncertainties: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and/or competitive factors; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies, including of navenibart and STAR-0310, may not be replicated in clinical trials, that the preliminary or interim results from clinical trials may not be indicative of the final results, that the results of early stage clinical trials, such as the results from the navenibart Phase 1a clinical trial and the initial results from the ALPHA-STAR trial, may not be replicated in later stage clinical trials, including additional and final results from the ALPHA-STAR trial or the planned navenibart Phase 3 development program; the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the FDA and other regulatory authorities on our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including investigational review boards at such sites, and other review bodies with respect to navenibart, STAR-0310, and any other future development candidates, and devices for such product candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates, and devices for such product candidates, on a cost-effective and timely basis, and to develop dosages and formulation for navenibart, STAR-0310, and any other future product candidates that are patient-friendly and competitive; our ability to develop biomarker and other assays, along with the testing protocols therefore; our ability to obtain, maintain and enforce intellectual property rights for navenibart, STAR-0310, and any other future product candidates; our potential dependence on collaboration partners; competition with respect to navenibart, STAR-0310, or any of our other future product candidates; the risk that survey results and market research may not be accurate predictors of the commercial landscape for HAE, the ability of navenibart to compete in HAE and the anticipated position and attributes of navenibart in HAE based on clinical data to date, its preclinical profile, pharmacokinetic modeling, market research and other data; risks with respect to the ability of STAR-0310 to compete in AD and the anticipated position and attributes of STAR-0310 in AD based on its preclinical profile; our ability to manage our cash usage and the possibility of unexpected cash expenditures; our ability to obtain necessary financing to conduct our planned activities, including the costs associated with commercialization of navenibart if regulatory approval is obtained, and to manage unplanned cash requirements; the risks and uncertainties related to our ability to recognize the benefits of any additional acquisitions, licenses or similar transactions; and general economic and market conditions; as well as the risks and uncertainties discussed in the 'Risk Factors' sections of our Annual Report on Form 10-K for the period ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and in other filings that we may make with the Securities and Exchange Commission. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Astria may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on Astria's forward-looking statements. Neither Astria, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Astria's views as of any date subsequent to the date hereof. Astria Therapeutics, Inc. C onsolidated Statements of Operations (In thousands, except share and per share data) (Unaudited) Astria Therapeutics, Inc. Selected Consolidated Balance Sheets Data (In thousands) (Unaudited) June 30, December 31, 2025 2024 Assets Cash and cash equivalents $ 76,319 $ 59,820 Short-term investments 182,859 268,312 Right-of-use asset 4,546 5,114 Other current and long-term assets 18,200 9,117 Total assets 281,924 342,363 Liabilities and stockholders' equity Current portion of operating lease liabilities 1,399 1,384 Long term portion of operating lease liabilities 3,367 3,969 Other current and long-term liabilities 16,645 17,747 Total liabilities 21,411 23,100 Total stockholders' equity $ 260,513 $ 319,263 Expand Astria Therapeutics, Inc. Selected Consolidated Statements of Cash Flows Data (In thousands) (Unaudited) Six Months Ended June 30, 2025 2024 Net cash used in operating activities $ (70,076 ) $ (35,885 ) Net cash provided by (used in) investing activities 86,575 (194,334 ) Net cash provided by financing activities - 141,901 Net increase (decrease) in cash, cash equivalents and restricted cash $ 16,499 $ (88,318 ) Expand
