
Small Investment, Big Returns: Why This NIH Center Matters
25 years ago, I had a life-changing experience. I got the biggest break in my career. My application to do a PhD at the University of California, Berkeley was accepted, and I was offered funding support through a National Institutes of Health (NIH) program called the Fogarty AIDS International Training Program. I had little money those days, and without NIH funding and a welcoming professor who cared deeply about global health, I could have never left India for higher education in the United States.
Today, I chair a department of global and public health at a leading Canadian university. The life-changing opportunities I had as a Fogarty trainee at Berkeley allow me to pay it forward by training the next generation of global health leaders.
I was not the only scholar to benefit from Fogarty funding - nearly 8,500 individuals from 132 countries have trained through Fogarty programs since 1989, and many have become leaders in their countries. Several have led groudbreaking research projects, and led inspiring programs and institutions.
Soumya Swaminathan is a great example. After her Fogarty training in the United States, she went on to become a leading HIV and TB researcher, become the Director-General of the Indian Council of Medical Research, and subsequently the first Chief Scientist of the World Health Organization. 'My Fogarty fellowship gave me an opportunity to get exposed to advanced immunological techniques and meet leading experts at a critical stage of my career. It helped spark new ideas and initiate collaboration with international experts which may not have happened otherwise,' she said.
Another shining example is Glenda Gray, who was the first female President of the South African Medical Research Council. 'Becoming a Fogarty Fellow catalysed my career as a clinician scientist, and marked the beginning of my research trajectory," she said. "It enabled me to make contributions to HIV vaccine research and development, as well as research in the area of preventing mother to child transmission. The interventions we developed have led to the control of paediatric HIV and improvements in treatment that have reduced HIV-related mortality in children,' she explained. Gray is currently Director of the Infectious Disease and Oncology Research Institute, University of the Witwatersrand.
The Fogarty International Center (FIC) has also benefitted US scientists and institutions. In FY24, Fogarty funded 440 U.S. grantees from 122 U.S. institutions in 39 states. Research conducted in Global South countries have led to improved treatments for health challenges of importance to Americans.
'The training programs supported by the FIC over the past 40 years have been unparalleled in their reach and impact around the world,' said Arthur Reingold, Emeritus professor at Berkeley School of Public Health, who has trained hundreds of scholars through his Fogarty grants. 'They have, through their support of highly talented biomedical scientists from scores of low and middle income countries, dramatically improved research and educational capacity globally, as well as markedly enhanced high impact collaborative research on AIDS, tuberculosis, malaria, and diverse other communicable and non communicable diseases. The benefits resulting from the enhanced research capabilities of scientists supported by the FIC have accrued to people living everywhere, including in the United States,' he elaborated.
Lucian Davis, an Associate Professor at Yale Medicine and the Yale School of Public Health, has also used the Fogarty program to train dozens of American and African scholars. 'Fogarty enables us to train the world's brightest minds to tackle America's leading health priorities—a high-impact, low-cost investment that keeps us connected to the world,' he said.
And guess what, the entire annual budget of the FIC is a merely 0.2% of the total NIH budget - a drop in the bucket. Despite this tiny investment, the FIC has had a spectacular national and global footprint and impact, by any metric.
Today, it greatly saddens me to see defunding of US science agencies, including NIH, and it's devastating impact on US academic institutions and scientists. Several American scientists have either reached out to me to explore options in Canada, or have applied for faculty positions at my university. Scores of American scientists are seeking to flee the country (and become "science refugees"). It boggles my mind that US politicians are allowing this brain drain to happen under their watch. America's economic strength, in part, comes from the nation's immense scientific firepower.
I am especially distressed to learn that the FIC is once again on the chopping block, with the entire $95 million budget FIC budget set to become zero in 2026. How exactly is cutting such an impactful program supposed to make America great?
Even as the world deals with massive crises like pandemics, conflicts, climate change, and widening economic inequities, all of which require truly, global cooperation and coordination, it seems like politicians are choosing narrow self-interests, nationalism, and isolationism. This strategy is not likely to succeed. Why?
We've all witnessed how interconnected the world is during the Covid-19 pandemic. Viruses that emerge in far away places will find us, regardless of who we are or where we happen to live. Every outbreak is merely one long-haul flight away. Smoke from wildfires will travel thousands of miles to darken our skies and choke our lungs.
NEW YORK, NEW YORK - JUNE 7: Smoky haze from wildfires in Canada diminishes the visibility of the Chrysler Building on June 7, 2023 in New York City. (Photo by David) Getty Images
There is no way to protect just one nation or one region when threats are trans-national. Our fates are undisputably intertwined with that of other countries and peoples. There is nothing 'woke' about looking out for each other in an interdependent world.
And that is why America must stay engaged in global health and multi-laterialism. And that is why American lawmakers must work to protect a national treasure like the Fogarty International Center. If an investment is yielding spectacular returns, no smart business person would dream of killing it. So, why defund the FIC and the NIH? If I was a US lawmaker, that is the question I would be asking myself.
I take some hope from the fact that the Senate Appropriations Committee recently rejected the Trump administration's proposed funding cuts to the NIH. But the road ahead is long and hard. I hope good sense will prevail and the powers that be will find a way to save America's phenomenal scientific enterprise. Science matters for America's health. It matters for health of the whole world.
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12 hours ago
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CARLSBAD, Calif.--(BUSINESS WIRE)-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or 'off the shelf', cell therapies for serious neurological and ophthalmic conditions, today reported its second quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update. 'Following the recent positive 36-month clinical data update with the OpRegen RPE cell therapy program, which is licensed by Genentech and Roche, we continue to remain confident in its potential to address a significant medical need, especially because long term clinical outcomes following a single administration of OpRegen cell therapy are challenging the long-held view that GA is an irreversible condition,' stated Brian M. Culley, Lineage CEO. '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