Semaglutide (Novo Nordisk)

MENLO PARK, Calif.--(BUSINESS WIRE)--OrsoBio, Inc. (“OrsoBio” or “the Company”), a clinical-stage biopharmaceutical company developing treatments for obesity and related metabolic disorders, today announced positive topline data from a 24-week Phase 1b/2a trial evaluating its oral, liver-targeted mitochondrial protonophore TLC-6740 in combination with the GLP-1/GIP receptor agonist tirzepatide. The combination met the study’s primary and key exploratory endpoints for safety, tolerability, and weight loss compared with tirzepatide monotherapy. The randomized, double-blind, placebo-controlled study enrolled 55 adults with obesity (BMI ≥30 kg/m2) without diabetes. Participants (mean baseline weight 109.2 kg; BMI 37.5 kg/m2) received tirzepatide 5 mg by weekly subcutaneous injection1 plus either TLC-6740 180 mg (N=33) or placebo (N=22) administered orally once daily for 24 weeks. At week 24, participants receiving TLC-6740 plus tirzepatide achieved mean weight loss of 13.3%, compared with 8.8% with tirzepatide alone. The 4.5% mean incremental weight loss with the combination—representing approximately 5.1 kg or a 51% relative increase versus tirzepatide monotherapy—was statistically significant (p=0.018, intention-to-treat). While weight loss in the tirzepatide monotherapy arm plateaued at 24 weeks, the combination arm showed continued linear decline. TLC-6740 was safe and well tolerated in combination with tirzepatide. Adverse event rates, including gastrointestinal events typical of incretin therapy, were similar between groups. No Grade 3 or severe adverse events, treatment discontinuations, or signs of excessive systemic uncoupling (e.g., fevers) were observed in participants receiving TLC-6740. “Our results demonstrate that TLC-6740 can safely enhance weight loss when added to incretin therapy,” said Rob Myers, MD, Chief Medical Officer and Head of Development at OrsoBio. “The weight loss achieved with TLC-6740 plus low-dose tirzepatide is comparable to that seen with higher-dose tirzepatide in the registrational program,2 supporting the potential to improve efficacy while maintaining tolerability. We believe TLC-6740 could broadly enhance therapies that reduce food intake, including GLP-1 receptor agonists and amylin analogs, given its complementary mechanism to increase energy expenditure.” Across additional endpoints, the combination produced significant improvements in insulin sensitivity, liver biochemistry, adiponectin, and hsCRP. An MRI substudy demonstrated meaningful reductions in liver fat and total, visceral, and skeletal muscle adiposity, with no adverse impact on lean mass. OrsoBio plans to present these findings at a scientific conference and pursue peer-reviewed publication in 2026. OrsoBio Continues Development of Mitochondrial Protonophore Portfolio TLC-6740 is part of OrsoBio’s portfolio of mitochondrial protonophores being developed as potential treatments for obesity and obesity-associated disorders, including type 2 diabetes and MASH. With TLC-6740 continuing to demonstrate safety and potential efficacy, and with more than 300 patients dosed for up to 24 weeks across multiple studies, OrsoBio plans to initiate a larger, longer Phase 2b clinical trial evaluating TLC-6740 in combination with an incretin in 2026. In addition, OrsoBio is enrolling patients in an ongoing, first-in-human clinical trial of TLC-1180, its second-generation mitochondrial protonophore (ISRCTN21589167). Dosing has been completed in the first two single-dose cohorts, with favorable preliminary safety and tolerability. OrsoBio previously presented preclinical data at ObesityWeek® 2025 demonstrating robust weight loss with TLC-1180 administered as monotherapy and in combination with semaglutide in obese mice and non-human primates. “Emerging evidence indicates that our protonophore portfolio, as monotherapy or combined with incretins, may address unmet needs in obesity treatment, including greater weight loss with lean mass preservation, improved tolerability, insulin sensitivity, and liver health,” said Mani Subramanian, MD, PhD, Chief Executive Officer of OrsoBio. “With TLC-6740 and TLC-1180 advancing through clinical development and oral incretins on the horizon, our protonophores are well positioned for use in next-generation treatment regimens, including oral fixed-dose combinations.” About TLC-6740 TLC-6740 is a novel, oral, liver-targeted mitochondrial protonophore in development for obesity and related metabolic diseases, including diabetes and MASH. By increasing energy expenditure through targeted hepatic activity, TLC-6740 is designed to drive weight loss and improve metabolic health, including insulin sensitivity and lipid metabolism. In a Phase 1b/2a trial in individuals with obesity, TLC-6740 combined with tirzepatide resulted in an average of 4.5% greater weight loss compared with tirzepatide alone, with no additional safety concerns, discontinuations, or weight loss plateau at 24 weeks, and improvements across multiple metabolic measures (NCT05822544). About TLC-1180 TLC-1180 is a novel, potent, oral, mitochondrial protonophore with liver-biased distribution that increases energy expenditure and promotes fat-selective weight loss. In preclinical studies of obese mice and non-human primates, TLC-1180 reduced fat mass, improved glucose control, and enhanced the efficacy of GLP-1 receptor agonists. TLC-1180 is currently being evaluated in a first-in-human, Phase 1 dose escalation study (ISRCTN21589167). About OrsoBio, Inc. OrsoBio, Inc. is a privately held, clinical-stage biopharmaceutical company dedicated to developing therapies for obesity and obesity-associated disorders, including type 2 diabetes, MASH, and severe dyslipidemias. OrsoBio currently has four programs in clinical and preclinical development with first-in-class compounds targeting central pathways in energy metabolism. For more information, visit www.orsobio.com. 1 Study participants received tirzepatide 2.5 mg by weekly subcutaneous injection for the first 4 weeks, followed by 5 mg weekly for the remaining 20 weeks. Participants were advised to continue pre-trial diet and exercise regimens without modification. 2 Jastreboff AM, et al. N Engl J Med 2022;387(3):205-216 (SURMOUNT-1trial).

VICTORIA, British Columbia--(BUSINESS WIRE)--MindWalk (NASDAQ: HYFT), a BioNative AI biotherapeutic research and technology company combining in silico and wet lab operations for biologics discovery and development, today announced financial results for the second quarter of fiscal 2026 and provided updates on its AI driven asset pipeline and strategic initiatives. MindWalk operates a proprietary BioNative AI platform built on patented HYFT® patterns—evolution shaped subsequence codes that link sequence, structure and function. These patterns underpin LensAI™, a software platform that harmonizes and analyzes diverse biological data to deliver actionable insights. We look forward to sharing additional insights on our pipeline and strategic partnerships in mid-January, ahead of the J.P. Morgan Healthcare Conference. Financial Highlights (Quarter Ended October 31, 2025) Revenue: $4.1 million, up 54% year-over-year and 30% sequentially, driven by improved project revenue and better utilization across both project-based and platform-related revenue streams. Gross margin: 65%, up from 51% in the prior year quarter. Gross profit increased significantly, by 94% year-over-year to $2.7 million, as fixed cost leverage and higher margin projects improved profitability. Operating loss, excluding amortization and nonrecurring items, improved notably to $2.8 million from $4.1 million a year ago. Adjusted EBITDA: Loss improved to $2.4 million, versus $2.6 million in the prior year period. Liquidity: Cash and cash equivalents of $16.5 million at quarter end (including proceeds from the sale of the Company’s former Netherlands operations), providing flexibility to invest in platform expansion and inhouse pipeline programs. Strategic and Operational Highlights Major portfolio progress GLP1 & longevity program – MindWalk advanced its AI designed GLP1 receptor agonist program, achieving receptor activation above semaglutide in in vitro assays. The Company also identified a companion pathway linked to aging biology and is developing a dual pathway regimen aimed at metabolic control and longevity. Universal dengue vaccine initiative – Using its LensAI platform, which leverages HYFT patterns to analyze multi‑omic data, MindWalk pinpointed a highly conserved, discontinuous epitope shared across all four dengue virus serotypes. Preclinical planning is under way with completion anticipated early next quarter, and a collaborator has been selected to advance this program. Rebranding and leadership expansion The Company completed its corporate rebranding to MindWalk and consolidated its operating units under the HYFT Nasdaq ticker. During the quarter MindWalk welcomed Scott Areglado as Chief Financial Officer and Dr. Thomas Lynch as Chief Business Officer. Strategic divestiture MindWalk closed the sale of its Netherlands operations, generating net proceeds of $14.3 million. The divestiture allows the Company to allocate resources toward its BioNative AI initiatives and high value wet lab programs aligned with LensAI. New structure for AI asset pipeline MindWalk has initiated the formation of a corporation in the Cayman Islands with Walkers law firm to house segregated portfolios for each AI driven program. Under this structure, assets and liabilities for each program will be ringfenced, allowing investors to participate directly in individual portfolios rather than through the public company. Management has received strong expressions of interest from prospective investors and will provide further details as the structure is finalized. Upcoming strategic update MindWalk plans to issue a press release through national media channels on the first day of the J.P. Morgan Healthcare Conference, January 12th. This update will include new information on the AI asset pipeline and the Company’s capital and partnering strategy. Comments from Management “Our second quarter delivered both strong financial performance and meaningful scientific progress. Revenue grew 54 % year over year, and gross profit nearly doubled—up an impressive 94 % to $2.7 million—while margins expanded significantly as we continued to build momentum across our core programs,” commented Dr. Jennifer Bath, CEO of MindWalk. “We advanced our GLP1 receptor agonists and identified a companion longevity pathway, while our research uncovered a conserved dengue epitope that could underpin a universal vaccine. Equally important, we took deliberate steps to align our corporate structure with this vision, including the divestiture of noncore operations, key leadership appointments, and the initiation of a Cayman based structure to house and finance our AI asset portfolios. These achievements reflect disciplined planning and purposeful execution. We look forward to sharing additional insights on our pipeline and strategic partnerships in mid-January, ahead of the J.P. Morgan Healthcare Conference.” Conference Call and Webcast Details The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Monday, December 15, 2025, at 10:30AM ET. The conference call will be webcast live and available for replay via a link provided in the Events section of the Company’s IR pages at https://ir.ipatherapeutics.com/events-and-presentations/default.aspx ***Participant Dial-In Details*** Joining by Phone USA / International Toll +1 (646) 307-1963 USA - Toll-Free (800) 715-9871 Canada - Toronto (647) 932-3411 Canada - Toll-Free (800) 715-9871 Participants call one of the allocated dial-in numbers and advise the Operator of either the Conference ID 3224490 or Conference Name. Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. ***Webcast Details*** Webcast Attendee URL https://events.q4inc.com/attendee/410261259 Anyone listening to the call is encouraged to read the Company's periodic reports available on the Company’s profile at www.sedarplus.com and www.sec.gov, including the discussion of risk factors and historical results of operations and financial condition in those reports. About MindWalk MindWalk is a Bio-Native AI company transforming drug discovery and development. Powered by patented HYFT® technology and the LensAI™ platform, MindWalk unifies sequence, structure, function, and literature into a single computational language and closes the loop with an integrated, full-stack wet lab. The platform supports rapid epitope mapping, de novo molecular design, in silico vaccine exploration, and population-scale biologics analytics that help turn insights into validated candidates at speed. The reconciliation of Net Loss to Adjusted EBITDA is presented in the table below: Three months ended October 31, (in thousands) 2025 $ 2024 $ Net loss (3,195 (2,553 Income taxes 25 (731 Amortization and depreciation 209 694 Accretion — 3 Foreign exchange realized gain (loss) (101 (20 Interest expense 57 93 Interest and other income (expense) (35 117 Loss on disposal of Europe B.V. 458 — Unrealized foreign exchange gain (loss) 8 104 Share-based expense 152 170 Adjusted EBITDA (2,422 (2,123 *All financial figures are in Canadian Dollars (CAD) unless otherwise stated. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward-looking statements include, among others, statements regarding the Company’s financial performance and outlook; revenue growth, margins and profitability trends; liquidity and capital resources; the expected use of proceeds from strategic divestitures; the advancement, timing and potential of the Company’s AI-driven asset pipeline, including its GLP-1, longevity and vaccine programs; anticipated preclinical milestones; the formation and implementation of the Company’s proposed Cayman Islands portfolio structure; expected investor participation and partnering activities; leadership integration; and the timing and content of future strategic updates and announcements, including those planned in connection with the J.P. Morgan Healthcare Conference. Words such as “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “targets,” “seeks,” “may,” “will,” “could,” “potential,” “continue,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current expectations and assumptions as of the date of this release and are subject to risks and uncertainties that could cause actual results to differ materially. Such risks and uncertainties include, among others: the Company’s ability to sustain revenue growth and margin expansion; variability in customer demand and project timing; execution risks associated with AI-driven discovery and wet-lab validation; scientific, technical and regulatory uncertainties inherent in drug discovery and vaccine development; the timing, cost and success of preclinical activities; the ability to establish and operate the proposed Cayman Islands portfolio structure as intended; market conditions affecting investor interest, capital availability and partnering opportunities; foreign exchange fluctuations; changes in laws, regulations, listing requirements or their interpretation; and other risk factors described in the Company’s filings with the U.S. Securities and Exchange Commission and Canadian securities regulators, including the Company’s Annual Report on Form 20-F for the year ended April 30, 2025 and subsequent filings. Forward-looking statements speak only as of the date of this press release. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. MINDWALK HOLDINGS CORP. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited - Expressed in Canadian dollars) Three months ended October 31, Six months ended October 31, (in thousands, except share data) 2025 $ 2024 $ 2025 $ 2024 $ REVENUE 4,124 2,679 7,285 5,152 COST OF SALES 1,462 1,310 3,096 2,773 GROSS PROFIT 2,662 1,369 4,189 2,379 EXPENSES Research and development 1,225 1,006 2,274 2,494 Sales and marketing 1,138 1,056 2,481 1,595 General and administrative 3,074 2,854 6,369 6,208 Amortization of intangible assets — 507 — 1,010 5,437 5,423 11,124 11,307 Loss before other income (expenses) and income taxes (2,775 ) (4,054 ) (6,935 ) (8,928 ) OTHER INCOME (EXPENSES) Accretion — (3 ) — (3 ) Grant income 12 — 19 138 Interest and other income (expense) 35 (117 ) 40 (119 ) Loss on disposal of Europe B.V. (458 ) — (458 ) — Unrealized foreign exchange loss (8 ) (104 ) (39 ) (244 ) (419 ) (224 ) (438 ) (228 ) Loss before income taxes (3,194 ) (4,278 ) (7,373 ) (9,156 ) Income taxes (25 ) 731 66 1,397 NET LOSS FROM CONTINUING OPERATIONS (3,219 ) (3,547 ) (7,307 ) (7,759 ) NET INCOME FROM DISCONTINUED OPERATIONS 24 994 1,153 1,207 NET LOSS FOR THE PERIOD (3,195 ) (2,553 ) (6,154 ) (6,552 ) OTHER COMPREHENSIVE INCOME (LOSS) Items that will be reclassified subsequently to loss Exchange difference on translating foreign operations 71 170 141 689 COMPREHENSIVE LOSS FOR THE PERIOD (3,124 ) (2,383 ) (6,013 ) (5,863 ) LOSS PER SHARE FROM CONTINUING OPERATIONS– BASIC AND DILUTED (0.07 ) (0.13 ) (0.16 ) (0.28 ) INCOME PER SHARE FROM DISCONTINUED OPERATIONS– BASIC AND DILUTED 0.00 0.04 0.02 0.04 WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING 46,156,821 28,132,055 46,155,462 27,630,402 MINDWALK HOLDINGS CORP. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (Unaudited - Expressed in Canadian dollars) (in thousands) October 31, 2025 $ April 30, 2025 $ ASSETS Current assets Cash 16,508 10,665 Amounts receivable, net 3,118 4,115 Tax receivable 152 143 Inventory 531 2,095 Unbilled revenue 925 548 Prepaid expenses 504 1,188 21,738 18,754 Restricted cash 128 126 Deposit on equipment 26 502 Property and equipment 4,210 15,762 Intangible assets — 1,067 Goodwill — 8,230 Total assets 26,102 44,441 LIABILITIES Current liabilities Accounts payable and accrued liabilities 3,432 5,283 Deferred revenue 913 1,090 Income taxes payable 425 475 Leases 421 1,850 Deferred acquisition payments — 314 5,191 9,012 Leases 3,206 11,553 Deferred income tax liability — 250 Total liabilities 8,397 20,815 SHAREHOLDERS' EQUITY Share capital 136,242 136,371 Contributed surplus 13,040 12,833 Accumulated other comprehensive loss 3,357 3,216 Accumulated deficit (134,934 ) (128,794 ) 17,705 23,626 Total liabilities and shareholders’ equity 26,102 44,441 MINDWALK HOLDINGS CORP. CONSOLIDATED STATEMENTS OF CASH FLOWS For the six months ended July 31, 2025 and 2024 (Unaudited - Expressed in Canadian dollars) (in thousands) 2025 $ 2024 $ Operating activities: Net loss for the period (6,154 ) (6,552 ) Items not affecting cash: Amortization and depreciation 1,149 2,810 Deferred income taxes 12 (975 ) Accretion — 5 Foreign exchange (49 ) (16 ) Gain on investment — 266 Loss on sale of Europe B.V. 458 — Share-based expense 207 322 (4,377 ) (4,140 ) Changes in non-cash working capital related to operations: Accounts receivable (1,877 ) (259 ) Inventory (91 ) 172 Unbilled revenue (1,009 ) (639 ) Prepaid expenses (143 ) (220 ) Accounts payable and accrued liabilities (796 ) 1,019 Sales and income taxes payable and receivable 782 (352 ) Deferred revenue 428 352 Net cash used in operating activities (7,083 ) (4,067 ) Investing activities: Purchases of property and equipment (356 ) (328 ) Deferred acquisition payments (312 ) — Net cash used in investing activities (668 ) (328 ) Financing activities: Proceeds on share issuance, net of transaction costs (125 ) 1,507 Repayment of leases (424 ) (801 ) Proceeds on debenture issuance, net of transaction costs — 4,059 Proceeds on sale of Europe B.V. 14,255 — Net cash provided by financing activities 13,706 4,765 Increase in cash during the period 5,955 370 Foreign exchange (110 ) (294 ) Cash – beginning of the period 10,791 3,545 Cash – end of the period 16,636 3,621 Cash is comprised of: Cash 16,508 3,534 Restricted cash 128 87 16,636 3,621 Cash paid for interest — — Cash paid for income tax — — Cash from discontinued operations: Net cash used in operating activities 777 1,587 Net cash used in investing activities (100 ) (253 ) Net cash used in financing activities (359 ) (638 ) Source: MindWalk Holdings Corp.