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TRAX

First Tracks BiotherapeuticsA
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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$48.70-$1.83 (-3.62%)
At close · 2026-11-12
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2026-11-03
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Related articleQuarter not tagged2026-11-03

First Tracks Biotherapeutics Reports Third Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
- Announced ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms in Cohort 1 (gluten challenge) of Phase 1b trial in celiac disease (CeD) - Completed enrollment for Cohort 2 (mucosal healing) of Phase 1b ANB033 trial in CeD; top-line data anticipated in Q1 2027 - Anticipate initiating late-stage clinical trial for ANB033 in CeD in 2027 - Enrollment ongoing for Phase 1b ANB033 trial in eosinophilic esophagitis; top-line data anticipated in Q3 2027 - Anticipate initiating Phase 2 development of ANB033 in vitiligo and one additional indication in H1 2027 - Completed private placement with $200 million in gross proceeds; pro forma cash of $343 million SAN DIEGO, Nov. 03, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the third quarter ended Sept. 30, 2026, and provided a business update. "ANB033, a subcutaneously administered CD122 antagonist designed to inhibit signaling of both IL-15 and IL-2 on immune cells, demonstrated statistically significant protection against gluten-induced intestinal damage and symptoms and was well tolerated in the Phase 1b gluten-challenge cohort. These data support our plans to progress ANB033 into late-stage development in 2027 in celiac disease as a potential treatment to prevent both acute symptoms and intestinal damage from gluten exposure despite general adherence to a gluten-free diet," said Daniel Faga, president and chief executive officer. "We will continue to work with regulators, clinicians and the patient community to advance ANB033. We anticipate initiating Phase 2 development in vitiligo and one additional indication in the first half of 2027, and reporting top-line results from the celiac disease mucosal-healing cohort in the first quarter of 2027 and in eosinophilic esophagitis in the third quarter of 2027." ANB033 (CD122 antagonist) - Phase 1b Cohort 1 in CeD is a gluten-challenge study to assess the prevention of mucosal damage through six weeks: - Announced positive top-line results in October 2026 – - ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced…Read full document

- Announced ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms in Cohort 1 (gluten challenge) of Phase 1b trial in celiac disease (CeD) - Completed enrollment for Cohort 2 (mucosal healing) of Phase 1b ANB033 trial in CeD; top-line data anticipated in Q1 2027 - Anticipate initiating late-stage clinical trial for ANB033 in CeD in 2027 - Enrollment ongoing for Phase 1b ANB033 trial in eosinophilic esophagitis; top-line data anticipated in Q3 2027 - Anticipate initiating Phase 2 development of ANB033 in vitiligo and one additional indication in H1 2027 - Completed private placement with $200 million in gross proceeds; pro forma cash of $343 million SAN DIEGO, Nov. 03, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the third quarter ended Sept. 30, 2026, and provided a business update. "ANB033, a subcutaneously administered CD122 antagonist designed to inhibit signaling of both IL-15 and IL-2 on immune cells, demonstrated statistically significant protection against gluten-induced intestinal damage and symptoms and was well tolerated in the Phase 1b gluten-challenge cohort. These data support our plans to progress ANB033 into late-stage development in 2027 in celiac disease as a potential treatment to prevent both acute symptoms and intestinal damage from gluten exposure despite general adherence to a gluten-free diet," said Daniel Faga, president and chief executive officer. "We will continue to work with regulators, clinicians and the patient community to advance ANB033. We anticipate initiating Phase 2 development in vitiligo and one additional indication in the first half of 2027, and reporting top-line results from the celiac disease mucosal-healing cohort in the first quarter of 2027 and in eosinophilic esophagitis in the third quarter of 2027." ANB033 (CD122 antagonist) - Phase 1b Cohort 1 in CeD is a gluten-challenge study to assess the prevention of mucosal damage through six weeks: - Announced positive top-line results in October 2026 – - ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms - Least squares (LS) mean change from baseline in villus height-to-crypt depth (Vh:Cd) ratio of -0.17 on ANB033 vs. -0.66 on placebo, a +0.49 placebo-adjusted delta (p=0.009) - LS mean change from baseline in intraepithelial lymphocyte (IEL) density of -1.20 on ANB033 vs. +18.83 on placebo, a -20.03 placebo-adjusted delta (p<0.001) - Prevented an increase in symptoms throughout the entire gluten challenge, with a lower Celiac Disease Symptom Diary score on ANB033 vs. placebo that was statistically significant from the first day - Well tolerated with no safety signals observed - Full press release can be found here - Phase 1b Cohort 2 in CeD aims to assess mucosal healing through 12 weeks - Enrollment complete with top-line data anticipated in Q1 2027 - Plan to continue to engage with regulatory agencies, including the U.S. Food and Drug Administration (FDA), which has already granted ANB033 Fast Track designation, to discuss and align on the next phase of development for ANB033 in CeD - Anticipate initiating a late-stage clinical trial in CeD in 2027 - Phase 1b trial in eosinophilic esophagitis is ongoing - Includes a 50-patient cohort assessing subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks - Top-line data anticipated in Q3 2027 - Plan to initiate Phase 2 development of ANB033 in vitiligo and one additional indication in H1 2027 Rosnilimab (Pathogenic T cell depleter) - Currently assessing return-on-equity-maximizing strategic options to progress the potential development of rosnilimab in rheumatoid arthritis and other indications ANB101 (BDCA2 modulator) - Phase 1a trial in healthy volunteers completed - Currently evaluating a potential development approach informed by clinical and translational evidence, as well as competitor registrational data in systemic lupus erythematosus and cutaneous lupus erythematosus anticipated in Q4 2026 and early 2027, respectively Cash Position - Cash, cash equivalents and investments totaled $155.6 million as of Sept. 30, 2026, with pro forma cash of $343 million following $200 million private placement completed in Oct. 2026 Third Quarter 2026 Financial Results - The separation of AnaptysBio, Inc. and First Tracks Biotherapeutics, Inc. was completed on April 20, 2026. As a result, for the period from January 1, 2026 to April 19, 2026 and for the three and nine months ended September 30, 2025, the financial results include assets, liabilities, and expenses related to both companies. The combined financial statements reflect allocations of certain expenses from the financial statements of AnaptysBio, Inc. including research and development expenses and general and administrative expenses. These allocations include, but are not limited to, executive management, employee compensation and benefits, facilities and operations, information technology, business development, financial services (such as accounting, audit, and tax), legal, insurance, and stock-based compensation. - Research and development expenses were $23.8 million and $83.4 million for the three and nine months ended September 30, 2026, compared to $33.3 million and $114.1 million for the three and nine months ended September 30, 2025. The decrease for the three and nine months ended September 30, 2026 was primarily due to decreased development costs for rosnilimab and ANB032, offset by increased costs relating to the Phase 1 trial for ANB033. - General and administrative expenses were $9.0 million and $37.1 million for the three and nine months ended September 30, 2026, compared to $11.7 million and $28.2 million for the three and nine months ended September 30, 2025. The increase for the nine months ended September 30, 2026, was due to the allocation of legal costs for the separation of the company from AnaptysBio, Inc. and AnaptysBio, Inc.'s lawsuit with GSK and Tesaro. - Net loss was $31.4 million and $115.2 million for the three and nine months ended September 30, 2026, or a net loss per share of $0.88 and $3.25, respectively, compared to a net loss of $41.9 million and $131.5 million for the three and nine months ended September 30, 2025, or a net loss per share of $1.50 and $4.52. About First Tracks Biotherapeutics First Tracks Biotherapeutics is a clinical-stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Its pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator. To learn more, visit www.FirstTracksBio.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the potential benefits, efficacy and safety profile of ANB033 and the company's other product candidates; the company's regulatory plans for ANB033 in celiac disease; the anticipated timing of the initiation of, enrollment in, and data from, the company's clinical trials, including top-line data from Cohort 2 of ANB033's Phase 1b clinical trial in celiac disease and Phase 1b clinical trial in eosinophilic esophagitis, a late-stage trial in celiac disease and Phase 2 development in vitiligo and one additional indication; and potential next steps with regards to the company's rosnilimab product candidate. Statements including words such as "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor Contact: Nick Montemarano Vice President, Investor Relations 858.732.0178 [email protected] First Tracks Biotherapeutics, Inc. Balance Sheets (in thousands, except share and par value) (unaudited) | | September 30, 2026 | | | December 31, 2025 | ASSETS | | | | | | Current assets: | | | | | | Cash and cash equivalents | | $ | 155,627 | | | $ | 238,196 | Short-term investments | | | — | | | | 73,442 | Prepaid expenses and other current assets | | | 10,095 | | | | 4,762 | Total current assets | | | 165,722 | | | | 316,400 | Property and equipment, net | | | 979 | | | | 1,370 | Operating lease right-of-use assets | | | 3,755 | | | | 12,519 | Other long-term assets | | | — | | | | 256 | Total assets | | $ | 170,456 | | | $ | 330,545 | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | | | Current liabilities: | | | | | | Accounts payable | | $ | 3,949 | | | $ | 3,111 | Accrued expenses | | | 11,723 | | | | 25,832 | Current portion of operating lease liability | | | 2,418 | | | | 2,080 | Total current liabilities | | | 18,090 | | | | 31,023 | Operating lease liability, net of current portion | | | 1,355 | | | | 12,032 | Stockholders' equity: | | | | | | Preferred stock, $0.001 par value, 10,000,000 shares authorized and no shares outstanding at September 30, 2026 | | | — | | | | — | Common stock, $0.001 par value, 500,000,000 shares authorized and 35,902,449 shares issued and outstanding at September 30, 2026 and 100 shares authorized and no shares issued or outstanding at December 31, 2025 | | | 36 | | | | — | Additional paid-in capital | | | 206,907 | | | | — | Accumulated other comprehensive loss | | | — | | | | (24) | Accumulated deficit | | | (55,932) | | | | — | Net former parent investment | | | — | | | | 287,514 | Total stockholders' equity | | | 151,011 | | | | 287,490 | Total liabilities and stockholders' equity | | $ | 170,456 | | | $ | 330,545 | First Tracks Biotherapeutics, Inc. Statements of Operations and Comprehensive Loss (in thousands, except per share data) (unaudited) | | Three Months Ended September 30, | | | Nine Months Ended September 30, | | | 2026 | | | 2025 | | | 2026 | | | 2025 | Operating expenses: | | | | | | | | | | | | Research and development | | | 23,846 | | | | 33,322 | | | | 83,445 | | | | 114,059 | General and administrative | | | 8,998 | | | | 11,735 | | | | 37,147 | | | | 28,176 | Total operating expenses | | | 32,844 | | | | 45,057 | | | | 120,592 | | | | 142,235 | Loss from operations | | | (32,844) | | | | (45,057) | | | | (120,592) | | | | (142,235) | Other income (expense), net: | | | | | | | | | | | | Interest income | | | 1,495 | | | | 3,198 | | | | 5,387 | | | | 10,755 | Other expense, net | | | (7) | | | | — | | | | (9) | | | | (20) | Total other income (expense), net | | | 1,488 | | | | 3,198 | | | | 5,378 | | | | 10,735 | Net loss | | | (31,356) | | | | (41,859) | | | | (115,214) | | | | (131,500) | Other comprehensive loss: | | | | | | | | | | | | Unrealized gain (loss) on available-for-sale securities | | | — | | | | 53 | | | | 24 | | | | (258) | Comprehensive loss | | $ | (31,356) | | | $ | (41,806) | | | $ | (115,190) | | | $ | (131,758) | Net loss per common share: | | | | | | | | | | | | Basic and diluted | | $ | (0.88) | | | $ | (1.50) | | | $ | (3.25) | | | $ | (4.52) | Weighted-average number of shares outstanding: | | | | | | | | | | | | Basic and diluted | | | 35,747 | | | | 27,833 | | | | 35,423 | | | | 29,085 |

Related articleQuarter not tagged2026-10-13

First Tracks Biotherapeutics (TRAX) Reports Positive Phase 1b Cohort 1 Results

Simply Wall St.
- First Tracks Biotherapeutics (NasdaqGS:TRAX) reported positive top-line data from Cohort 1 of its Phase 1b ANB033 trial in celiac disease. - The company said Cohort 1 results showed statistically significant protection against gluten induced intestinal damage along with symptom relief. - Management also highlighted a favorable safety profile for ANB033 in the treated patients in this early stage study. - The positive Cohort 1 Phase 1b ANB033 readout is important, but investors need to weigh it alongside broader risks and fundamentals. We have also flagged 4 warning signs (2 major) for First Tracks Biotherapeutics. For readers tracking how drug discovery and diagnostics are shifting toward data heavy platforms, it is worth exploring 33 healthcare AI stocks. First Tracks Biotherapeutics is a US based clinical stage biotech focused on immunology drugs for autoimmune and inflammatory conditions, so a celiac program like ANB033 fits directly into its core therapeutic focus. With a market cap of about $1.2b, it sits in the mid sized bracket for specialist drug developers in this space. Does the team leading First Tracks Biotherapeutics have what it takes? See our full breakdown of the management team's track record and compensation. For you as an investor, this readout mainly strengthens the idea that First Tracks Biotherapeutics may have a differentiated celiac asset rather than just another early concept. The mix of histologic protection and symptom control under gluten challenge speaks to a potential real world use case in patients who still get exposed to gluten despite a restricted diet. That said, the stock remains tied to a pipeline story with no meaningful revenue and forecasts that point to declining earnings, so funding needs and execution risk on later stage studies still sit at the center of the argument. The unresolved piece is commercial depth. There is no visibility yet on pricing power, treatment duration or how payers might view a CD122 antagonist in celiac disease. The clearest signal to watch is the top line Cohort 2 Phase 1b data in celiac disease, expected in the first quarter of 2027, since those mucosal healing results will likely shape partner interest, trial design for Phase 2 and long term revenue potential more than any other near term event. Add First Tracks Biotherapeutics to your Watchlist and get alerts as these catalysts play out.…Read full document

- First Tracks Biotherapeutics (NasdaqGS:TRAX) reported positive top-line data from Cohort 1 of its Phase 1b ANB033 trial in celiac disease. - The company said Cohort 1 results showed statistically significant protection against gluten induced intestinal damage along with symptom relief. - Management also highlighted a favorable safety profile for ANB033 in the treated patients in this early stage study. - The positive Cohort 1 Phase 1b ANB033 readout is important, but investors need to weigh it alongside broader risks and fundamentals. We have also flagged 4 warning signs (2 major) for First Tracks Biotherapeutics. For readers tracking how drug discovery and diagnostics are shifting toward data heavy platforms, it is worth exploring 33 healthcare AI stocks. First Tracks Biotherapeutics is a US based clinical stage biotech focused on immunology drugs for autoimmune and inflammatory conditions, so a celiac program like ANB033 fits directly into its core therapeutic focus. With a market cap of about $1.2b, it sits in the mid sized bracket for specialist drug developers in this space. Does the team leading First Tracks Biotherapeutics have what it takes? See our full breakdown of the management team's track record and compensation. For you as an investor, this readout mainly strengthens the idea that First Tracks Biotherapeutics may have a differentiated celiac asset rather than just another early concept. The mix of histologic protection and symptom control under gluten challenge speaks to a potential real world use case in patients who still get exposed to gluten despite a restricted diet. That said, the stock remains tied to a pipeline story with no meaningful revenue and forecasts that point to declining earnings, so funding needs and execution risk on later stage studies still sit at the center of the argument. The unresolved piece is commercial depth. There is no visibility yet on pricing power, treatment duration or how payers might view a CD122 antagonist in celiac disease. The clearest signal to watch is the top line Cohort 2 Phase 1b data in celiac disease, expected in the first quarter of 2027, since those mucosal healing results will likely shape partner interest, trial design for Phase 2 and long term revenue potential more than any other near term event. Add First Tracks Biotherapeutics to your Watchlist and get alerts as these catalysts play out. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include TRAX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Related articleQuarter not tagged2026-10-12

First Tracks Biotherapeutics Shares Jump 20% After Positive Phase 1b Celiac Disease Trial Results

InvestorsHub
First Tracks Biotherapeutics (NASDAQ:TRAX) shares surged 20% on Monday after the biotechnology company reported positive top-line results from a Phase 1b clinical trial evaluating its investigational treatment ANB033 in patients with celiac disease. The study demonstrated statistically significant improvements across key measures of intestinal damage and disease symptoms compared with placebo, supporting further clinical development of the therapy. The trial's first cohort included 32 patients, with 17 receiving ANB033 and 15 assigned to placebo. Participants underwent a 14-day gluten challenge, consuming six grams of gluten daily, equivalent to approximately two slices of bread, to assess the treatment's ability to protect against gluten-induced intestinal damage and associated symptoms. According to the company, ANB033 demonstrated a statistically significant benefit in the villus height-to-crypt depth ratio, a measure used to assess structural changes in the small intestine associated with celiac disease. Patients receiving ANB033 recorded a least squares mean change from baseline of -0.17, compared with -0.66 in the placebo group. The difference represented a placebo-adjusted improvement of 0.49, with a p-value of 0.009, indicating statistical significance. The treatment also demonstrated improvements in intraepithelial lymphocyte density, another measure of intestinal inflammation and immune activity. Patients treated with ANB033 recorded a least squares mean change of -1.20, compared with an increase of 18.83 among placebo recipients, resulting in a placebo-adjusted difference of -20.03. The findings suggest that ANB033 may help limit the intestinal damage and inflammatory response associated with gluten exposure in patients with celiac disease. In addition to the tissue-based measurements, the company reported improvements in patient-reported symptoms during the gluten challenge. ANB033 prevented an increase in symptoms throughout the 14-day exposure period, with patients receiving the treatment recording lower Celiac Disease Symptom Diary scores than those receiving placebo. The difference was statistically significant from the first day of the gluten challenge, according to the company. Use of permitted medications to relieve gastrointestinal symptoms was also lower among patients receiving ANB033. Approximately 47% of participants in the placebo gr…Read full document

First Tracks Biotherapeutics (NASDAQ:TRAX) shares surged 20% on Monday after the biotechnology company reported positive top-line results from a Phase 1b clinical trial evaluating its investigational treatment ANB033 in patients with celiac disease. The study demonstrated statistically significant improvements across key measures of intestinal damage and disease symptoms compared with placebo, supporting further clinical development of the therapy. The trial's first cohort included 32 patients, with 17 receiving ANB033 and 15 assigned to placebo. Participants underwent a 14-day gluten challenge, consuming six grams of gluten daily, equivalent to approximately two slices of bread, to assess the treatment's ability to protect against gluten-induced intestinal damage and associated symptoms. According to the company, ANB033 demonstrated a statistically significant benefit in the villus height-to-crypt depth ratio, a measure used to assess structural changes in the small intestine associated with celiac disease. Patients receiving ANB033 recorded a least squares mean change from baseline of -0.17, compared with -0.66 in the placebo group. The difference represented a placebo-adjusted improvement of 0.49, with a p-value of 0.009, indicating statistical significance. The treatment also demonstrated improvements in intraepithelial lymphocyte density, another measure of intestinal inflammation and immune activity. Patients treated with ANB033 recorded a least squares mean change of -1.20, compared with an increase of 18.83 among placebo recipients, resulting in a placebo-adjusted difference of -20.03. The findings suggest that ANB033 may help limit the intestinal damage and inflammatory response associated with gluten exposure in patients with celiac disease. In addition to the tissue-based measurements, the company reported improvements in patient-reported symptoms during the gluten challenge. ANB033 prevented an increase in symptoms throughout the 14-day exposure period, with patients receiving the treatment recording lower Celiac Disease Symptom Diary scores than those receiving placebo. The difference was statistically significant from the first day of the gluten challenge, according to the company. Use of permitted medications to relieve gastrointestinal symptoms was also lower among patients receiving ANB033. Approximately 47% of participants in the placebo group required symptom-relief medication, compared with 6% of patients treated with ANB033. The company said the investigational therapy demonstrated a favourable safety profile during the study. No serious adverse events, severe adverse events or adverse events leading to treatment discontinuation were reported among patients receiving ANB033. Celiac disease is an autoimmune condition in which gluten consumption triggers an immune response that damages the lining of the small intestine. The condition is currently managed primarily through a strict gluten-free diet, although accidental exposure can still cause symptoms and intestinal inflammation. First Tracks Biotherapeutics intends to engage with regulatory authorities, including the US Food and Drug Administration (FDA), to discuss the next stage of ANB033's clinical development. The FDA has previously granted Fast Track designation to ANB033, a status intended to facilitate the development and review of treatments addressing serious conditions with unmet medical needs. The company anticipates initiating a late-stage clinical trial in celiac disease during 2027, subject to regulatory discussions and development planning. Meanwhile, enrolment in the second cohort of the ongoing Phase 1b study is expected to conclude shortly, with top-line results anticipated in the first quarter of 2027. Although the initial findings provide encouraging evidence of biological activity and symptom improvement, the study involved a relatively small patient population. Larger clinical trials will be needed to confirm the treatment's efficacy, establish its longer-term safety profile and determine whether the results can support a future regulatory application. First Tracks Biotherapeutics stock price

Related articleQuarter not tagged2026-10-12

First Tracks Biotherapeutics Announces Positive Top-Line Results for ANB033 in Gluten-Challenge Study in Celiac Disease

GlobeNewswire
- ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms - LS mean change from baseline in Vh:Cd ratio of -0.17 on ANB033 vs. -0.66 on placebo, a +0.49 placebo-adjusted delta (p=0.009) - LS mean change from baseline in IEL density of -1.20 on ANB033 vs. +18.83 on placebo, a -20.03 placebo-adjusted delta (p<0.001) - Prevented an increase in symptoms throughout the entire gluten challenge, with lower CDSD score on ANB033 vs. placebo that was statistically significant from the first day - Well tolerated with no safety signals observed to date - Conference call and webcast today, Monday, Oct. 12, 2026, at 8:30 a.m. ET to discuss these results SAN DIEGO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today announced positive top-line results from Cohort 1 (gluten challenge) of ANB033's Phase 1b trial in celiac disease (CeD). ANB033, an investigational, subcutaneously administered CD122 antagonist, is designed to inhibit the signaling of both IL-15 and IL-2 on immune cells. ANB033 demonstrated a statistically significant difference compared to placebo across key histologic endpoints, including least squares (LS) mean change in villus height-to-crypt depth (Vh:Cd) ratio, intraepithelial lymphocyte (IEL) density, and VCIEL composite scale, as well as symptom endpoints using the Celiac Disease Symptom Diary (CDSD). In the context of an intense gluten challenge, treatment with ANB033 not only prevented an increase in IEL density, but also protected against gluten-induced intestinal damage with changes in Vh:Cd ratio remaining below the threshold considered clinically meaningful. "For people living with celiac disease, trace exposure to gluten can cause intestinal damage and debilitating symptoms despite general adherence to a gluten-free diet. After treatment with ANB033, patients underwent a 14-day gluten challenge consuming the equivalent of two slices of bread a day. ANB033 achieved a statistically significant and clinically meaningful protective effect against gluten-induced intestinal damage and symptoms, while maintaining a favorable safety profile," said Daniel Faga, president and chief e…Read full document

- ANB033 achieved a statistically significant and clinically meaningful protective effect on both gluten-induced intestinal damage and symptoms - LS mean change from baseline in Vh:Cd ratio of -0.17 on ANB033 vs. -0.66 on placebo, a +0.49 placebo-adjusted delta (p=0.009) - LS mean change from baseline in IEL density of -1.20 on ANB033 vs. +18.83 on placebo, a -20.03 placebo-adjusted delta (p<0.001) - Prevented an increase in symptoms throughout the entire gluten challenge, with lower CDSD score on ANB033 vs. placebo that was statistically significant from the first day - Well tolerated with no safety signals observed to date - Conference call and webcast today, Monday, Oct. 12, 2026, at 8:30 a.m. ET to discuss these results SAN DIEGO, Oct. 12, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today announced positive top-line results from Cohort 1 (gluten challenge) of ANB033's Phase 1b trial in celiac disease (CeD). ANB033, an investigational, subcutaneously administered CD122 antagonist, is designed to inhibit the signaling of both IL-15 and IL-2 on immune cells. ANB033 demonstrated a statistically significant difference compared to placebo across key histologic endpoints, including least squares (LS) mean change in villus height-to-crypt depth (Vh:Cd) ratio, intraepithelial lymphocyte (IEL) density, and VCIEL composite scale, as well as symptom endpoints using the Celiac Disease Symptom Diary (CDSD). In the context of an intense gluten challenge, treatment with ANB033 not only prevented an increase in IEL density, but also protected against gluten-induced intestinal damage with changes in Vh:Cd ratio remaining below the threshold considered clinically meaningful. "For people living with celiac disease, trace exposure to gluten can cause intestinal damage and debilitating symptoms despite general adherence to a gluten-free diet. After treatment with ANB033, patients underwent a 14-day gluten challenge consuming the equivalent of two slices of bread a day. ANB033 achieved a statistically significant and clinically meaningful protective effect against gluten-induced intestinal damage and symptoms, while maintaining a favorable safety profile," said Daniel Faga, president and chief executive officer. "We look forward to continuing to work with regulators, clinicians and the patient community as we advance ANB033 into late-stage development in 2027." The randomized, placebo-controlled Phase 1b trial in CeD is evaluating subcutaneous ANB033 administered across two cohorts: Cohort 1, a 6-week study assessing prevention of gluten-induced intestinal damage and symptoms after a 14-day gluten challenge, and Cohort 2, assessing mucosal healing in patients with a broad range of histologic and symptom severity through 12 weeks. Cohort 1 evaluated 32 patients (17 on ANB033 and 15 on placebo) who completed dosing and the gluten challenge at Week 6. Patients received three subcutaneously administered loading doses of ANB033 or placebo at Week 0, Week 2, and Week 4, followed by a 14-day gluten challenge (6g daily, the equivalent of approximately two slices of bread, administered by two gluten cookies). The trial assessed safety and tolerability as well as key histologic and symptom endpoints used to measure clinical benefit with a primary analysis at Week 6. Key Efficacy Endpoints Were Achieved in Cohort 1 ANB033 achieved the key histologic efficacy endpoints of LS mean change from baseline in Vh:Cd ratio, IEL density, and VCIEL vs. placebo at Week 6. Histologic Endpoints (Week 6) | Placebo (n=15) | ANB033 (n=17) | Placebo-Adjusted Delta LS Mean Change in Vh:Cd Ratio | -0.66 | -0.17 | +0.49 (p=0.009) LS Mean Change in IEL Density | +18.83 | -1.20 | -20.03 (p<0.001) LS Mean Change in VCIEL | -3.59 | -0.25 | +3.33 (p=0.002) | | | Using the Celiac Disease Symptom Diary (CDSD), symptoms were assessed daily through the entire 14-day gluten challenge. The CDSD is a validated, patient-reported outcome measure that assesses the frequency and severity of five key celiac disease symptoms which are abdominal pain, bloating, nausea, diarrhea and tiredness. Symptom findings during the gluten challenge were as follows – - Placebo patients experienced a marked increase in symptoms consistent with an intense gluten challenge - ANB033 prevented an increase in symptoms throughout the entire gluten challenge - 47% of placebo patients and only 6% of ANB033 patients took permitted medications to mitigate their GI symptoms - Lower CDSD score on ANB033 vs. placebo, a statistically significant difference from the first day through the seventh day - Lower moderate-to-severe symptoms on ANB033 vs. placebo, a statistically significant difference from the first day through the twelfth day "It is remarkable to see, for the first time, both statistically significant prevention of symptoms and Vh:Cd benefit in the same study. Equally impressive, ANB033 showed changes from baseline that remained below the threshold considered clinically meaningful in an intense gluten challenge," said Benjamin Lebwohl, M.D., MS, professor of Medicine and Epidemiology at NY-Presbyterian/Columbia University Irving Medical Center and director of Clinical Research at the Celiac Disease Center at Columbia University. "ANB033 takes a novel approach to treating celiac disease by targeting CD122 and blocking both IL-15 and IL-2 signaling, two key drivers of inflammation that damage the intestine, with IL-2 closely linked to symptom development. For the largest autoimmune disease without an approved therapeutic option, these findings are an important advance for the celiac disease community." ANB033 Well Tolerated with No Safety Signals Observed to Date ANB033 demonstrated a consistent, favorable safety and tolerability profile with no serious adverse events (SAEs), no severe adverse events (AEs) and no AEs leading to discontinuation. Participants with Adverse Events | Placebo (n=16) | ANB033 (n=18) | Overall (n=34) Any AE (n, %) | 16 (100%) | 16 (88.9%) | 32 (94.1%) Any SAE | 0 (0%) | 0 (0%) | 0 (0%) Any severe AE | 1 (6.3%) | 0 (0%) | 1 (2.9%) Any moderate AE | 12 (75.0%) | 3 (16.7%) | 15 (44.1%) AE leading to treatment discontinuation | 1 (6.3%) | 0 (0%) | 1 (2.9%) AEs occurring in ≥ 3 participants Nausea | 7 (43.8%) | 1 (5.6%) | 8 (23.5%) Abdominal pain | 6 (37.5%) | 2 (11.1%) | 8 (23.5%) Injection site erythema | 2 (12.5%) | 5 (27.8%) | 7 (20.6%) Fatigue | 5 (31.3%) | 1 (5.6%) | 6 (17.6%) Diarrhea | 4 (25.0%) | 2 (11.1%) | 6 (17.6%) Vomiting | 4 (25.0%) | 2 (11.1%) | 6 (17.6%) Upper respiratory tract infection | 3 (18.8%) | 2 (11.1%) | 5 (14.7%) Injection site bruising | 3 (18.8%) | 1 (5.6%) | 4 (11.8%) Headache | 3 (18.8%) | 1 (5.6%) | 4 (11.8%) Abdominal distension | 3 (18.8%) | 0 (0%) | 3 (8.8%) Constipation | 3 (18.8%) | 0 (0%) | 3 (8.8%) Flatulence | 3 (18.8%) | 0 (0%) | 3 (8.8%) Safety analysis set includes two additional participants who were randomized in Cohort 1 but discontinued the study prior to initiating the gluten challenge, were therefore unevaluable for gluten challenge efficacy analysis and did not undergo the second biopsy at Week 6. The one participant on ANB033 discontinued due to a decision not to undergo the gluten challenge. Next Steps for ANB033 First Tracks Biotherapeutics will continue to engage with regulatory agencies, including the U.S. FDA, which has already granted ANB033 Fast Track designation, to discuss and align on the next phase of development for ANB033 in CeD. We anticipate starting a late-stage clinical trial in CeD in 2027. Cohort 2 of ANB033's Phase 1b trial in CeD, which is assessing mucosal healing in patients with a broad range of histologic (Vh:Cd ratio ≤ 2.5) and symptom severity through 12 weeks, is on track to complete enrollment imminently, with top-line data anticipated in Q1 2027. A Phase 1b cohort in eosinophilic esophagitis (EoE) is enrolling 50 patients with top-line data anticipated in Q3 2027. Additionally, we are also on track to initiate Phase 2 development in vitiligo and one additional indication in H1 2027. "The consistency of the histologic and symptom findings strengthens our confidence in the underlying biology and supports continued development of ANB033 in celiac disease and other conditions driven by this pathway, including eosinophilic esophagitis and vitiligo," added Paul Lizzul, M.D., Ph.D., chief medical officer. "We are deeply grateful to the patients, investigators and study teams who made this important milestone possible and look forward to presenting these results at ICDS in Melbourne in November." First Tracks Biotherapeutics Investor Call Management will host an investor call and live webcast, with an accompanying slide presentation, to review the Cohort 1 results today, Monday, Oct. 12, 2026, at 8:30 a.m. ET / 5:30 a.m. PT. A live webcast of the call will be available on the First Tracks Biotherapeutics website at: https://ir.firsttracksbio.com/news-events/events. A replay of the webcast will be available for at least 30 days following the event. About ANB033 ANB033, a potentially best-in-class CD122 antagonist, targets CD122, the common beta subunit of the IL-15 and IL-2 receptors, to reduce subsets of CD8+ and CD4+ T cells, NK cells, as well as ILC2s. Antagonizing CD122 has the potential to achieve and maintain remission of inflammation through the reduction of disease-causing cytolytic CD8 T cell subsets, including IELs and NK cells and reducing inflammatory cytokine secretion by activated CD4+ Th1 and Th2 cells, as well as ILC2 cells. About First Tracks Biotherapeutics First Tracks Biotherapeutics is a clinical stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Its pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator. To learn more, visit www.FirstTracksBio.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the potential benefits, efficacy and safety profile of ANB033 and the Company's other product candidates; the Company's regulatory plans for ANB033 in celiac disease; and the anticipated timing of the initiation of, enrollment in, and data from, the Company's clinical trials, including top-line data from Cohort 2 of ANB033's Phase 1b clinical trial in celiac disease and Phase 1b clinical trial in eosinophilic esophagitis, a late-stage trial in celiac disease and Phase 2 development in vitiligo and one additional indication. Statements including words such as "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company's ability to fund development activities and achieve development goals, the company's ability to protect intellectual property and other risks and uncertainties described under the heading "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor Contact: Nick Montemarano Vice President, Investor Relations 858.732.0178 [email protected] | Media Contact: Monique da Silva Senior Vice President, Corporate Affairs 858.366.9074 [email protected] |

Related articleQuarter not tagged2026-08-12

First Tracks Biotherapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Completed enrollment for Cohort 1 (gluten challenge) of Phase 1b ANB033 trial in celiac disease (CeD); top-line Cohort 1 data reaffirmed for Q4 2026 Cohort 2 (mucosal healing) enhanced to enroll up to 40 patients including those with a broad range of histologic (Vh:Cd ratio ≤ 2.5) and symptom severity to further inform future development; top-line Cohort 2 data anticipated in Q1 2027 U.S. FDA granted Fast Track designation for ANB033 for the treatment of CeD Enrollment ongoing for Phase 1b ANB033 trial in eosinophilic esophagitis (EoE); top-line data anticipated in Q3 2027 Reiterating cash-runway into Q2 2028, including the expansion of ANB033 into two additional indications in H1 2027 SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “First Tracks continues to execute against a broad development strategy for our potentially best-in-class CD122 antagonist, ANB033, and anticipates treating patients across four indications in 2027. We believe ANB033 is uniquely positioned to deliver differentiated clinical and biological outcomes across multiple immune-mediated diseases,” said Daniel Faga, president and chief executive officer. “In celiac disease, FDA’s Fast Track designation for ANB033 underscores both the urgency of the significant unmet need for patients and the potential of this program. We will report top-line data from Cohort 1 of the Phase 1b trial in Q4 2026, evaluating ANB033's potential to prevent gluten-induced mucosal injury. Cohort 2 of this study is enrolling patients with disease across a wide range of histologic and symptom severity at baseline with the goal of generating deeper insights into timing to mucosal healing and disease biology. We anticipate reporting these data in Q1 2027, followed by top-line data from our Phase 1b trial of ANB033 in eosinophilic esophagitis in Q3 2027.” ANB033 (CD122 antagonist) Phase 1b trial in celiac disease ongoing Phase 1b trial in EoE ongoing Plan to initiate Phase 2 trials in two additional indications in H1 2027 ANB101 (BDCA2 modulator) Phase 1a trial in healthy volunteers completed Rosnilimab (Pathogeni…Read full document

Completed enrollment for Cohort 1 (gluten challenge) of Phase 1b ANB033 trial in celiac disease (CeD); top-line Cohort 1 data reaffirmed for Q4 2026 Cohort 2 (mucosal healing) enhanced to enroll up to 40 patients including those with a broad range of histologic (Vh:Cd ratio ≤ 2.5) and symptom severity to further inform future development; top-line Cohort 2 data anticipated in Q1 2027 U.S. FDA granted Fast Track designation for ANB033 for the treatment of CeD Enrollment ongoing for Phase 1b ANB033 trial in eosinophilic esophagitis (EoE); top-line data anticipated in Q3 2027 Reiterating cash-runway into Q2 2028, including the expansion of ANB033 into two additional indications in H1 2027 SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. “First Tracks continues to execute against a broad development strategy for our potentially best-in-class CD122 antagonist, ANB033, and anticipates treating patients across four indications in 2027. We believe ANB033 is uniquely positioned to deliver differentiated clinical and biological outcomes across multiple immune-mediated diseases,” said Daniel Faga, president and chief executive officer. “In celiac disease, FDA’s Fast Track designation for ANB033 underscores both the urgency of the significant unmet need for patients and the potential of this program. We will report top-line data from Cohort 1 of the Phase 1b trial in Q4 2026, evaluating ANB033's potential to prevent gluten-induced mucosal injury. Cohort 2 of this study is enrolling patients with disease across a wide range of histologic and symptom severity at baseline with the goal of generating deeper insights into timing to mucosal healing and disease biology. We anticipate reporting these data in Q1 2027, followed by top-line data from our Phase 1b trial of ANB033 in eosinophilic esophagitis in Q3 2027.” ANB033 (CD122 antagonist) Phase 1b trial in celiac disease ongoing Phase 1b trial in EoE ongoing Plan to initiate Phase 2 trials in two additional indications in H1 2027 ANB101 (BDCA2 modulator) Phase 1a trial in healthy volunteers completed Rosnilimab (Pathogenic T cell depleter) Currently assessing ROE-maximizing strategic options to progress the potential development of rosnilimab in rheumatoid arthritis (RA) and other indications Second Quarter 2026 Financial Results The separation of AnaptysBio and First Tracks Biotherapeutics was completed on April 20, 2026. As a result, from January 1, 2026 to April 19, 2026 and the three and six months ended June 30, 2025, the financial results include assets, liabilities and expenses related to both companies. The combined financial statements reflect allocations of certain expenses from the financial statements of Anaptys including research and development expenses and administrative expenses. These allocations include, but are not limited to, executive management, employee compensation and benefits, facilities and operations, information technology, business development, financial services (such as accounting, audit, and tax), legal, insurance and stock-based compensation. Cash, cash equivalents and investments totaled $168.0 million as of June 30, 2026. Research and development expenses were $25.6 million and $59.6 million for the three and six months ended June 30, 2026, compared to $39.3 million and $80.7 million for the three and six months ended June 30, 2025. The decrease for the three and six months ended June 30, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the Phase 1 trials for ANB033. General and administrative expenses were $9.3 million and $28.1 million for the three and six months ended June 30, 2026, compared to $6.6 million and $16.4 for the three and six months ended June 30, 2025. The increase was due primarily to the allocation of legal costs for the separation of the company. Net loss was $33.4 million and $83.9 million for the three and six months ended June 30, 2026, or a net loss per share of $0.95 and $2.40, compared to a net loss of $42.4 million and $89.6 million for the three and six months ended June 30, 2025, or a net loss per share of $1.47 and $3.02. About First Tracks Biotherapeutics First Tracks Biotherapeutics is a clinical stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Its pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator. To learn more, visit www.FirstTracksBio.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials, including initial data from ANB033's Phase 1b clinical trial in celiac disease and initial data from ANB033's Phase 1b clinical trial in eosinophilic esophagitis; potential benefits, efficacy, and safety profile of the Company’s product candidates and the Company’s projected cash runway. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor Contact:Nick MontemaranoVice President, Investor [email protected]

Related articleQuarter not tagged2026-05-14

First Tracks Biotherapeutics Announces First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
First Tracks launched April 20th with a two-year cash-runway to advance ANB033 through celiac disease and eosinophilic esophagitis Phase 1b data and plans to initiate Phase 2 trials across four indications SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “First Tracks Bio launched to advance a focused, high-value immunology portfolio that can create meaningful impact and a future where autoimmune diseases no longer define a patient’s life,” said Daniel Faga, president and chief executive officer. “We remain committed to executing with speed, rigor and financial discipline with a focus on ANB033, a CD122 antagonist, as we prepare for multiple clinical readouts in celiac disease and eosinophilic esophagitis. Additionally, we completed a productive End-of-Phase 2 meeting for rosnilimab with FDA, and we are assessing ROE-maximizing strategic options for this asset, including potential for development in rheumatoid arthritis and other indications.” ANB033 (CD122 antagonist) Phase 1b trial in celiac disease ongoing 60-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts Cohort 1 (n=30) is a gluten-challenge study to assess the prevention of mucosal damage through six weeks Cohort 2 (n=30) is a study to assess the possibility of mucosal healing through 12 weeks Top-line Phase 1b data anticipated in Q4 2026 Phase 1b trial in eosinophilic esophagitis ongoing 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks Top-line Phase 1b data anticipated in mid-2027 Rosnilimab (Pathogenic T Cell Depleter) Completed End-of-Phase 2 (EOP2) meeting with FDA in Q1 2026. The agency provided constructive feedback on a registrational Phase 3 path in rheumatoid arthritis (RA), a disease with significant remaining patient unmet need Currently assessing ROE-maximizing strategic options that may include a global partnership, out-license or asset financing to progress the potential development of rosnilimab in RA a…Read full document

First Tracks launched April 20th with a two-year cash-runway to advance ANB033 through celiac disease and eosinophilic esophagitis Phase 1b data and plans to initiate Phase 2 trials across four indications SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- First Tracks Biotherapeutics, Inc. (Nasdaq: TRAX), a clinical-stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “First Tracks Bio launched to advance a focused, high-value immunology portfolio that can create meaningful impact and a future where autoimmune diseases no longer define a patient’s life,” said Daniel Faga, president and chief executive officer. “We remain committed to executing with speed, rigor and financial discipline with a focus on ANB033, a CD122 antagonist, as we prepare for multiple clinical readouts in celiac disease and eosinophilic esophagitis. Additionally, we completed a productive End-of-Phase 2 meeting for rosnilimab with FDA, and we are assessing ROE-maximizing strategic options for this asset, including potential for development in rheumatoid arthritis and other indications.” ANB033 (CD122 antagonist) Phase 1b trial in celiac disease ongoing 60-patient trial assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) across two different cohorts Cohort 1 (n=30) is a gluten-challenge study to assess the prevention of mucosal damage through six weeks Cohort 2 (n=30) is a study to assess the possibility of mucosal healing through 12 weeks Top-line Phase 1b data anticipated in Q4 2026 Phase 1b trial in eosinophilic esophagitis ongoing 50-patient cohort assessing one dose level of subcutaneously administered ANB033 vs. placebo (randomized 1:1) through 12 weeks Top-line Phase 1b data anticipated in mid-2027 Rosnilimab (Pathogenic T Cell Depleter) Completed End-of-Phase 2 (EOP2) meeting with FDA in Q1 2026. The agency provided constructive feedback on a registrational Phase 3 path in rheumatoid arthritis (RA), a disease with significant remaining patient unmet need Currently assessing ROE-maximizing strategic options that may include a global partnership, out-license or asset financing to progress the potential development of rosnilimab in RA and other indications ANB101 (BDCA2 modulator) Phase 1a trial in healthy volunteers nearing completion First Quarter 2026 Financial Results The separation of AnaptysBio, Inc., and First Tracks Biotherapeutics was completed on April 20, 2026. As a result, in the first quarter of 2026, the financial results include assets, liabilities and expenses related to both companies. The combined financial statements reflect allocations of certain expenses from the financial statements of Anaptys including research and development expenses and administrative expenses. These allocations include, but are not limited to, executive management, employee compensation and benefits, facilities and operations, information technology, business development, financial services (such as accounting, audit, and tax), legal, insurance and stock-based compensation. Launched First Tracks with $180 million in cash and cash equivalents on April 20, 2026 Research and development expenses were $34.0 million for the three months ended March 31, 2026, compared to $41.5 million for the three months ended March 31, 2025. The decrease for the three months ended March 31, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the phase 1 trials for ANB033. General and administrative expenses were $18.9 million for the three months ended March 31, 2026, compared to $9.8 million for the three months ended March 31, 2025. The increase was due primarily to the allocation of legal costs for the separation of the company and non-cash stock compensation costs. Net loss was $50.5 million for the three months ended March 31, 2026, compared to a net loss of $47.2 million for the three months ended March 31, 2025. About First Tracks Biotherapeutics First Tracks Biotherapeutics is a clinical stage biotechnology company advancing antibody therapies that modulate immune pathways implicated in autoimmune and inflammatory diseases. Its pipeline includes ANB033, a CD122 antagonist in development for celiac disease and eosinophilic esophagitis; rosnilimab, a pathogenic T cell depleter in development for rheumatoid arthritis; and ANB101, a BDCA2 modulator. To learn more, visit www.FirstTracksBio.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company’s clinical trials, including initial data from ANB033's Phase 1b clinical trial in celiac disease and initial data from ANB033's Phase 1b clinical trial in eosinophilic esophagitis; and the projected cash runway for the company. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor Contact:Nick MontemaranoExecutive Director, Investor [email protected]

Related articleQuarter not tagged2026-05-13

Anaptys Announces First Quarter 2026 Financial Results and Provides Business Update

GlobeNewswire
Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda Announced appointment of Chris Murphy as CFO Announced appointments of Susannah Gray, former CFO of Royalty Pharma, and Owen Hughes, current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “Following the completion of the spin-off of First Tracks Bio in late April, Anaptys now exclusively manages the financial collaborations for Jemperli and imsidolimab, with streamlined operations requiring limited FTEs, minimal operating expenses and delivering an EBIT margin greater than 95%,” said Daniel Faga, president and chief executive officer. “With Chris Murphy joining as CFO, who brings deep business development and investment banking experience, our priority continues to be to protect our two royalty streams and return their value to shareholders.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli ($313 million/£232 million in Q1 2026 sales, with >40% year-over-year growth1) Anaptys continues to expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak sales guidance of >$2.7 billion2 Anaptys estimates Sagard will have accrued ~$275 million in royalties and sales milestones through Q1 2026 and anticipates paydown of the remaining ~$325 million non-recourse debt monetization by the end of Q2 20273 Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer Data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month sBLA review timeline for US FDA approval AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer Data expec…Read full document

Completed spin-off of First Tracks Biotherapeutics, Inc., its former biopharma operations business Now exclusively manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda Announced appointment of Chris Murphy as CFO Announced appointments of Susannah Gray, former CFO of Royalty Pharma, and Owen Hughes, current CEO of XOMA Royalty, to its Board of Directors SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a company focused on managing the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “Following the completion of the spin-off of First Tracks Bio in late April, Anaptys now exclusively manages the financial collaborations for Jemperli and imsidolimab, with streamlined operations requiring limited FTEs, minimal operating expenses and delivering an EBIT margin greater than 95%,” said Daniel Faga, president and chief executive officer. “With Chris Murphy joining as CFO, who brings deep business development and investment banking experience, our priority continues to be to protect our two royalty streams and return their value to shareholders.” GSK Jemperli Financial Collaboration GSK announced strong commercial performance for Jemperli ($313 million/£232 million in Q1 2026 sales, with >40% year-over-year growth1) Anaptys continues to expect to achieve >$390 million in annualized Jemperli royalties payable to Anaptys as early as 2029 at GSK’s peak sales guidance of >$2.7 billion2 Anaptys estimates Sagard will have accrued ~$275 million in royalties and sales milestones through Q1 2026 and anticipates paydown of the remaining ~$325 million non-recourse debt monetization by the end of Q2 20273 Substantial GSK investment in additional monotherapy and potential combination trials for Jemperli, including: AZUR-1 – pivotal Phase 2 – dostarlimab monotherapy in untreated stage II/III dMMR/MSI-H locally advanced rectal cancer Data expected in H2 2026; U.S. FDA Breakthrough Therapy Designation Received an FDA Commissioner’s National Priority Voucher (CNPV) in Nov. 2025 allowing for only a one to two-month sBLA review timeline for US FDA approval AZUR-2 – pivotal Phase 3 – dostarlimab versus standard of care in untreated TN40 or stage III dMMR/ MSI-H resectable colon cancer Data expected in 2028 AZUR-4 – Phase 2 – dostarlimab plus chemotherapy versus standard of care (chemotherapy) in untreated stage III MMRp/MSS resectable colon cancer Data expected in Q4 2026 JADE – pivotal Phase 3 – dostarlimab monotherapy versus placebo in locally advanced unresected head and neck squamous cell carcinoma (PD-L1 CPS≥1) post chemoradiation Data expected in 2028 Vanda Imsidolimab Financial Collaboration FDA target action date (PDUFA) of Dec. 12, 2026 for imsidolimab in generalized pustular psoriasis (GPP) Recent Leadership and Board of Directors Appointments Announced appointment of Chris Murphy as Chief Financial Officer (CFO) Mr. Murphy brings >20 years’ experience in business development, commercial operations, corporate strategy and investment banking in the biopharmaceutical industry Announced appointment of industry veterans Susannah Gray and Owen Hughes to Board of Directors Ms. Gray brings >25 years’ experience in both finance and investment banking in the biopharmaceutical industry, formerly CFO of Royalty Pharma Mr. Hughes brings >25 years’ experience as both an operator and investor in the biopharmaceutical industry, currently leading XOMA Royalty as CEO Stock Repurchase Plan Announced a $100.0 million Stock Repurchase Plan in March 2026. It will expire on Dec. 31, 2026, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock First Quarter Financial Results The separation of Anaptys and First Tracks Bio was completed on April 20, 2026. As a result, in the first quarter of 2026, the financial results include assets, liabilities and expenses related to both companies. Beginning in the second quarter of 2026, Anaptys expects to reclassify historical First Tracks Bio related assets, liabilities and expenses as discontinued operations. Cash, cash equivalents and investments totaled $286.5 million as of March 31, 2026, compared to $311.6 million as of Dec. 31, 2025, for a decrease of $25.1 million due primarily to operating activities offset by $14.0 million received from stock option exercises. Collaboration revenue was $25.6 million for the three months ended March 31, 2026, compared to $27.8 million for the three months ended March 31, 2025. The decrease in revenue was primarily due to $9.7 million in revenue recognized for the Vanda license agreement for the three months ended March 31, 2025 offset by Jemperli royalties increasing 44% from $17.2 million to $24.7 million for the three months ended March 31, 2026. Research and development expenses were $34.0 million for the three ended March 31, 2026, compared to $41.2 million for the three months ended March 31, 2025. The decrease for the three months ended March 31, 2026 was primarily due to decreased development costs for rosnilimab and ANB032 offset by increased costs relating to the phase 1 trials for ANB033. The R&D non-cash, stock-based compensation expense was $4.6 million for the three months ended March 31, 2026 as compared to $4.4 million in the same period in 2025. General and administrative expenses were $26.2 million for the three months ended March 31, 2026, compared to $14.1 million for the three months ended March 31, 2025. The increase was due primarily to legal costs for the separation of the company, ongoing GSK litigation and non-cash stock compensation costs incurred for our former Chief Financial Officer and former Chief Legal Officer. The G&A non-cash, stock-based compensation expense was $9.7 million for the three months ended March 31, 2026 as compared to $4.8 million in the same period in 2025. Net loss was $52.9 million for the three months ended March 31, 2026, or a net loss per share of $1.84, compared to a net loss of $39.3 million for the three months ended March 31, 2025, or a net loss per share of $1.28. About AnaptysBio Anaptys manages the financial collaborations for Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning the value of its royalties to shareholders. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to whether Anaptys is able to protect its financial collaborations; and its ability to return value to its shareholders. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to protect its financial collaborations and return value to its shareholders, the company’s ability to operate efficiently with a limited staff, and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. This press release also includes a reference to EBIT margin which is a measure not presented in accordance with generally accepted accounting principles in the United States of America (“GAAP”), which Anaptys believes provides important perspective with respect to operational profitability. Non-GAAP financial measures may exclude items that are significant in understanding and assessing Anaptys’ financial results, should not be considered in isolation or as an alternative to GAAP measures, and should be considered only as a supplement to, and not as superior to, GAAP measures. Anaptys cannot predict with certainty the magnitude or scope of certain items that would be included in the most directly comparable GAAP measure to EBIT margin for the relevant future periods, and such items may be significant. Due to these uncertainties, Anaptys cannot provide a quantitative reconciliation of EBIT margin to the most directly comparable GAAP financial measure without unreasonable effort. Investor Contact: Anaptys Investor Relations [email protected] _______________________________________

As of 2026-11-07 • Updated weeklySource: Earnings sourceIngestion runbook