Biomed Industries Presents Four Breakthrough Studies on Alzheimer's, Rett Syndrome, and Obesity Therapies at AAIC 2025
'NA-831 is the only drug to date that has halted Alzheimer's disease progression. Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.'— Dr. Lloyd L. Tran, CEO of Biomed
SAN JOSE, CA, UNITED STATES, August 4, 2025 / EINPresswire.com / -- Biomed Industries, Inc., a leading biopharmaceutical innovator developing transformative therapies for neurological and metabolic diseases, today announced the presentation of four major scientific papers at the Alzheimer's Association International Conference (AAIC), held July 27–31, 2025, in Toronto, Canada.
The presentations featured Biomed's next-generation oral therapies for Alzheimer's disease, Rett syndrome, and obesity, with a focus on novel combination strategies designed to enhance safety, efficacy, and accessibility.
Featured AAIC 2025 Presentations:
1. The End of the Amyloid Era? Evidence for a Paradigm Shift in the Quest to Treat Alzheimer's Disease
2. A Phase 3 Clinical Protocol of NA-831 Combined with Donanemab in Early Alzheimer's Disease: A Placebo-Controlled, Double-Blind Study
3. Associations Between Alzheimer's Disease and Rett Syndrome: Clinical Trials of NA-831 and NA-921
4. Neuro-Metabolic Link Between Alzheimer's Disease and Obesity: Clinical Evaluation of NA-831 and NA-931
1. PRESENTATION: The End of the Amyloid Era? A Paradigm Shift in Alzheimer's Research
For over three decades, the 'amyloid hypothesis' has dominated Alzheimer's disease (AD) research, asserting that amyloid-β accumulation is a primary driver of neurodegeneration. Biomed's comprehensive analysis of Phase 3 trial data from seven anti-amyloid drugs — including aducanumab, lecanemab, donanemab, gantenerumab, bapineuzumab, crenezumab, and solanezumab — challenges this paradigm.
Across all trials, both treatment and placebo groups exhibited similar cognitive decline, as measured by CDR-SB and ADAS-Cog. The average differences between treatment and placebo arms were minor and not clinically significant (CDR-SB: -0.25; ADAS-Cog: -0.79). Slope comparisons further revealed near-identical rates of decline between groups.
'Our analysis of Phase 3 clinical trial data for seven anti-amyloid drugs, including FDA-approved Aducanumab, Lecanemab, and Donanemab, indicates that none could halt disease progression in a clinically meaningful way — and all carried serious safety concerns,' said Dr. Zung Tran, VP of Biostatistics and AI at Biomed.
2. PRESENTATION: Phase 3 Clinical Protocol of NA-831 Combined with Donanemab
NA-831, Biomed's lead oral candidate, is a first-in-class therapy that promotes neuroprotection, neurogenesis, and memory enhancement. Phase 2 trials demonstrated its disease-modifying potential with a favorable safety profile compared to traditional anti-amyloid drugs.
In this upcoming Phase 3 study, NA-831 will be evaluated in combination with Donanemab, a recently FDA-approved monoclonal antibody, to explore synergistic effects. The goal is to lower Donanemab dosing, thereby reducing risks such as cerebral edema and microbleeds, while enhancing cognitive outcomes.
'NA-831 is the only drug to date that has halted disease progression in Phase 2 trials,' said Dr. Lloyd Tran, CEO of Biomed Industries. 'Combining it with existing drugs like Donanemab could optimize therapeutic efficacy and reduce serious side effects.'
3. PRESENTATION: Alzheimer's and Rett Syndrome: Shared Mechanisms and Dual Therapeutic Potential
Biomed also presented findings on NA-921, a structural analog of NA-831 developed for Rett syndrome, a rare X-linked neurodevelopmental disorder. NA-921 modulates MeCP2 expression, targeting the disorder's core epigenetic dysfunction.
A double-blind, placebo-controlled Phase 2/3 trial (ClinicalTrials.gov ID: NCT06849973) demonstrated promising results:
Clinical Global Impression–Improvement (CGI-I) at week 12:
NA-921: 3.60 | Placebo: 3.83 | P = 0.0020 | Effect size = 0.42
NA-921 was well tolerated, with a significantly improved safety profile compared to trofinetide:
- Diarrhea: Trofinetide 82%, NA-921 24%, Placebo 19%
- Vomiting: Trofinetide 29%, NA-921 9%, Placebo 11%
- Fever: Trofinetide 9%, NA-921 5%, Placebo 4%
These findings underscore a possible biological link between Alzheimer's disease and Rett syndrome, opening new cross-indication opportunities for NA-831 and NA-921.
4. PRESENTATION: Neuro-Metabolic Connections: NA-831 and NA-931 in Alzheimer's and Obesity
Biomed's data also revealed compelling evidence of a neuro-metabolic bridge between Alzheimer's disease, diabetes, and obesity. In addition to NA-831's CNS benefits, Biomed is advancing NA-931, an oral quadruple receptor agonist (IGF-1, GLP-1, GIP, and glucagon) designed to treat obesity.
In a 13-week Multiple Ascending Dose (MAD) study:
- Mean body weight reduction: Up to 13.8% at 150 mg daily, 12.4% greater than placebo
- ≥12% weight loss achieved by 72% of NA-931-treated patients vs. 2% in placebo group
NA-931 demonstrated a strong safety profile, with mild and transient GI-related adverse events, and no observed muscle loss.
'Our pipeline shows how targeting interconnected pathways across the CNS and metabolic systems can unlock significant clinical potential,' said Michael Willis, VP of Business Development. 'With six active programs across Alzheimer's, ALS, Rett syndrome, stroke, obesity, and MASH, we are building a diversified platform to accelerate innovation and value creation.'
ABOUT BIOMED INDUSTRIES, INC.
Biomed Industries, Inc. is a pioneering biopharmaceutical company committed to developing novel therapeutics that address unmet medical needs. Its innovative research platform has produced treatments for conditions including Alzheimer's disease, ALS, Traumatic Brain Injury, Major Depressive Disorder, Diabetes, Obesity, MASH, Stroke, and rare diseases such as Huntington Disease and Rett Syndrome.
(Website: https://www.biomedind.com )
Michael Willis
Biomed Industries, Inc.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS unaudited (in thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenue $ 139,098 $ 89,825 $ 262,923 $ 172,533 Cost of revenue 41,335 23,208 64,927 47,976 Gross profit 97,763 66,617 197,996 124,557 Operating expenses: Research and development 279,962 24,920 303,462 54,683 Sales and marketing 147,228 44,894 193,944 87,037 General and administrative 251,244 14,354 268,125 31,812 Total operating expenses 678,434 84,168 765,531 173,532 Loss from operations (580,671 ) (17,551 ) (567,535 ) (48,975 ) Other income: Other income, net 4,694 4,986 9,695 10,104 Net loss before income taxes (575,977 ) (12,565 ) (557,840 ) (38,871 ) Provision (benefit) for income taxes (326 ) 361 672 519 Net loss $ (575,651 ) $ (12,926 ) $ (558,512 ) $ (39,390 ) Adjustment to reflect deemed contribution from Series D and Series E redeemable convertible preferred stock extinguishment — — 104,174 — Net loss per share attributable to common stockholders, basic and diluted $ (13.10 ) $ (0.96 ) $ (15.05 ) $ (2.93 ) Expand HINGE HEALTH, INC. 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We anticipate that this seasonality will continue and therefore focus on LTM calculated billings. Our revenue generally does not reflect this seasonality and these quarterly fluctuations given that we recognize revenue ratably over the term that members have access to our platform. LTM calculated billings are defined as total revenue, plus the change in deferred revenue, less the change in contract assets for a given 12-month period. Number of Clients: We view this number as an important metric to assess the performance of our business as an increased number of clients drives growth, increases brand awareness, and helps provide scale to our business. Clients are defined as businesses or organizations, which we call entities, that have at least one active agreement with us at the end of a particular period. Entities that procure our platform through our partners are counted as individual clients. We do not count our partners as clients, unless they also separately have at least one active client agreement with us. When a partner has an agreement with us for their fully-insured population, that partner is deemed to be one client, despite there being multiple fully-insured employers within that entity that have access to our platform. Non-GAAP Financial Measures In addition to our results prepared in accordance with GAAP, we believe the following non-GAAP financial measures, including non-GAAP gross profit and gross margin, non-GAAP income (loss) from operations and operating margin, non-GAAP operating expenses, and free cash flow and free cash flow margin included in this press release, provide users of our financial information with additional useful information in evaluating our performance and liquidity and allows them to more readily compare our results across periods without the effect of non-cash and other items as detailed below. Additionally, our management and board of directors use our non-GAAP financial measures to evaluate our performance and liquidity, identify trends and make strategic decisions. There are limitations to the use of the non-GAAP financial measures presented in this press release. For example, our non-GAAP financial measures may not be comparable to similarly titled measures of other companies. Other companies, including companies in our industry, may calculate non-GAAP financial measures differently than we do, limiting the usefulness of those measures for comparative purposes. Our non-GAAP financial measures should not be considered in isolation or as alternatives to gross profit, gross margin, income (loss) from operations, net cash provided by (used in) operating activities or any other measure of financial performance calculated and presented in accordance with GAAP. Non-GAAP Gross Profit and Gross Margin We define non-GAAP gross profit as gross profit presented in accordance with GAAP, adjusted to exclude non-cash, non-operational and non-recurring items, including excess and obsolete inventory charges related to our AI-powered motion tracking technology transition, stock-based compensation expense, employer payroll tax expense related to stock-based compensation, amortization of intangible assets, and restructuring and other expenses. We define non-GAAP gross margin as non-GAAP gross profit divided by revenue. The principal limitation of non-GAAP gross profit and non-GAAP gross margin is that they exclude significant expenses that are required by GAAP to be recorded in our consolidated financial statements, including non-cash expenses, and the impact of non-recurring charges that we do not consider to be indicative of our ongoing core operations. Non-GAAP Income (Loss) From Operations and Operating Margin We define non-GAAP income (loss) from operations as income (loss) from operations presented in accordance with GAAP, adjusted to exclude non-cash, non-operational and non-recurring items, including excess and obsolete inventory charges related to our AI-powered motion tracking technology transition, stock-based compensation expense, employer payroll tax expense related to stock-based compensation, amortization of intangible assets, restructuring and other expenses and acquisition-related expenses. We define non-GAAP operating margin as non-GAAP income (loss) from operations divided by revenue. The principal limitation of non-GAAP income (loss) from operations and non-GAAP operating margin is that they exclude significant expenses that are required by GAAP to be recorded in our consolidated financial statements, including non-cash expenses, and the impact of non-recurring charges that we do not consider to be indicative of our ongoing core operations. Non-GAAP Operating Expenses We define non-GAAP operating expenses as operating expenses presented in accordance with GAAP, adjusted to exclude non-cash, non-operational and non-recurring items, including stock-based compensation expense, employer payroll tax expense related to stock-based compensation, restructuring and other expenses and acquisition-related expenses. The principal limitation of non-GAAP research and development expenses, non-GAAP sales and marketing expenses and non-GAAP general and administrative expenses is that they exclude significant expenses that are required by GAAP to be recorded in our consolidated financial statements, including non-cash expenses, and the impact of non-recurring charges that we do not consider to be indicative of our ongoing core operations. Free Cash Flow and Free Cash Flow Margin We define free cash flow as net cash provided by (used in) operating activities plus cash used for employer payroll taxes related to pre-IPO stock-based compensation less purchases of property, equipment and software (including capitalized internal-use software). We believe that free cash flow is a helpful indicator of liquidity that provides information to management and investors about the amount of cash generated or used by our operations that, after taking into account the employer payroll taxes paid as part of the vesting of shares at IPO as well as investments in property, equipment and software (including capitalized internal-use software), can be used for strategic initiatives, including investing in our business and strengthening our financial position. The principal limitation of free cash flow is that it does not represent the total increase or decrease in our cash balance for a given period. We define free cash flow margin as free cash flow divided by revenue. We adjust the following items from one or more of our non-GAAP financial measures: Excess and obsolete inventory charges. We exclude certain charges related to excess and obsolete inventory related to our AI-powered motion tracking technology transition, which was our strategic decision in the first half of 2023 to shift away from providing kits with tablets and wearable sensors. As part of this shift, we began to provide access to our platform through our app on members' personal smartphones or tablets and replaced sensors for members with our proprietary AI-powered motion tracking technology. We exclude these charges because we do not believe these expenses have a direct correlation to the operating performance of our business. Stock-based compensation expense. We exclude stock-based compensation expense, which is a non-cash expense, from certain of our non-GAAP financial measures because we believe that excluding this item provides meaningful supplemental information regarding our operating performance. Employer payroll tax expense related to stock-based compensation. We exclude expenses for employer payroll taxes related to stock-based compensation from certain of our non-GAAP financial measures because we believe that excluding this item provides meaningful supplemental information regarding operational performance. In particular, this expense is tied to the exercise, vesting or sale of underlying equity awards and the price of our common stock at the time of exercise, vesting or sale which may vary from period to period independent of the operating performance of our business. Amortization of intangible assets. We exclude amortization of intangible assets, which is a non-cash expense, from certain of our non-GAAP financial measures. Our expenses for amortization of intangible assets are inconsistent in amount and frequency because they are significantly affected by the timing, size of acquisitions and the inherent subjective nature of purchase price allocations. We exclude these amortization expenses because we do not believe these expenses have a direct correlation to the operating performance of our business. Restructuring and other expenses. We exclude certain charges that are mainly attributable to workforce reduction in order to simplify our operations and better align our resources with our priorities. We exclude these charges because we do not believe these charges have a direct correlation to the operating performance of our business. Acquisition-related expenses. We exclude certain charges that are attributable to acquiring businesses. We exclude these charges because we do not believe these charges have a direct correlation to the operating performance of our business. Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP loss from operations $ (580,671 ) $ (17,551 ) $ (567,535 ) $ (48,975 ) GAAP operating margin (417 )% (20 )% (216 )% (28 )% Excess and obsolete inventory charges (1) — 1,309 — 1,812 Stock-based compensation expense (2) 590,983 306 590,990 610 Employer payroll tax expense related to stock-based compensation 14,227 (6,253 ) 14,227 (6,253 ) Amortization of intangible assets 225 95 406 189 Restructuring and other expenses — 7,599 — 8,671 Acquisition-related expenses 1,337 100 2,968 100 Non-GAAP income (loss) from operations $ 26,101 $ (14,395 ) $ 41,056 $ (43,846 ) Non-GAAP operating margin 19 % (16 )% 16 % (25 )% Expand (1) Reflects our strategic decision in the first half of 2023 to shift away from providing kits with tablets and wearable sensors. As part of this shift, we began to provide access to our platform through our app on members' personal smartphones or tablets and replaced all sensors for members with our proprietary AI-powered motion tracking technology. (2) Stock-based compensation expense: Expand Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Cost of revenue $ 16,441 $ 37 $ 16,441 $ 72 Research and development 248,809 81 248,809 161 Sales and marketing 95,050 89 95,050 181 General and administrative 230,683 99 230,690 196 $ 590,983 $ 306 $ 590,990 $ 610 Expand HINGE HEALTH, INC. unaudited (in thousands, except for percentages) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP research and development $ 279,962 $ 24,920 $ 303,462 $ 54,683 GAAP research and development as a percentage of revenue 201 % 28 % 115 % 32 % Stock-based compensation expense (2) (248,809 ) (81 ) (248,809 ) (161 ) Employer payroll tax expense related to stock-based compensation (7,020 ) 2,852 (7,020 ) 2,852 Restructuring and other expenses — (3,428 ) — (4,394 ) Acquisition-related expenses (1,358 ) — (2,816 ) — Non-GAAP research and development $ 22,775 $ 24,263 $ 44,817 $ 52,980 Non-GAAP research and development as a percentage of revenue 16 % 27 % 17 % 31 % Expand Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP sales and marketing $ 147,228 $ 44,894 $ 193,944 $ 87,037 GAAP sales and marketing as a percentage of revenue 106 % 50 % 74 % 50 % Stock-based compensation expense (2) (95,050 ) (89 ) (95,050 ) (181 ) Employer payroll tax expense related to stock-based compensation (2,630 ) — (2,630 ) — Restructuring and other expenses — (2,004 ) — (2,053 ) Non-GAAP sales and marketing $ 49,548 $ 42,801 $ 96,264 $ 84,803 Non-GAAP sales and marketing as a percentage of revenue 36 % 48 % 37 % 49 % Expand Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP general and administrative $ 251,244 $ 14,354 $ 268,125 $ 31,812 GAAP general and administrative as a percentage of revenue 181 % 16 % 102 % 18 % Stock-based compensation expense (2) (230,683 ) (99 ) (230,690 ) (196 ) Employer payroll tax expense related to stock-based compensation (3,684 ) 3,401 (3,684 ) 3,401 Restructuring and other expenses — (1,456 ) — (1,512 ) Acquisition-related expenses 22 (100 ) (153 ) (100 ) Non-GAAP general and administrative $ 16,899 $ 16,100 $ 33,598 $ 33,405 Non-GAAP general and administrative as a percentage of revenue 12 % 18 % 13 % 19 % Expand (2) For details on stock-based compensation expense, see above. Expand Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net cash provided by (used in) operating activities $ 20,227 $ 14,923 $ 25,150 $ (17,735 ) Operating cash flow margin 15 % 17 % 10 % (10 )% Adjustment for employer taxes related to pre-IPO stock-based compensation 14,227 — 14,227 — Less purchases of property, equipment and software (including capitalized internal use software) (1,827 ) (934 ) (2,584 ) (1,883 ) Free cash flow $ 32,627 $ 13,989 $ 36,793 $ (19,618 ) Free cash flow margin 23 % 16 % 14 % (11 )% Expand
