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業績公告 即時報告 8-K 2026-08-10

Jade Biosciences第二季虧損擴大 核心藥物JADE101中期數據亮眼 IgA降幅達70%

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AI 繁中摘要

Jade Biosciences(納斯達克:JBIO)公佈截至2026年6月30日止第二季度財務業績,並同步更新研發管線進度。公司核心資產JADE101在IgA腎病(IgAN)治療上取得正面中期Phase 1數據,顯示具備每12週皮下注射一次給藥的潛力,並展現同類最佳(best-in-class)臨床活性。數據已於第63屆歐洲腎臟協會(ERA)大會上發表:單次700毫克劑量後,平均IgA水平較基線下降約70%;模擬顯示,以700毫克誘導劑量後,每12週皮下注射350毫克維持劑量,穩態IgA降幅可超過70%。JADE101在所有劑量下均表現良好耐受性。此外,公司已啟動JADE101的Phase 2臨床試驗(JUNIPER),中期數據預計2027年公佈;Phase 3註冊性試驗則計劃於2027年上半年啟動,有待美國FDA反饋。 其他管線進展:JADE201(抗BAFF-R單株抗體)已開始在類風濕關節炎患者中進行Phase 1試驗,中期數據預計2027年取得,將有助於選定優先適應症及制訂臨床開發策略。公司同時公佈新候選藥物JADE301——針對皮肌炎的長半衰期抗IFN-ß單株抗體,設計上可延長給藥間隔,選擇性抑制疾病上游關鍵介質,避免廣泛細胞因子信號通路抑制。JADE301預計提早於2026年第四季度啟動健康志願者Phase 1試驗,中期數據料2027年下半年公佈。流行病學數據顯示,美國約有5萬名成年人受皮肌炎影響,高達80%患者經歷慢性疼痛病程,存在重大未滿足醫療需求。 財務方面,截至2026年6月30日,公司持有現金、現金等價物及投資共4.612億美元,足以支持營運至2028年第四季度。第二季度研發開支為5,010萬美元(其中1,060萬美元為股權激勵開支),高於去年同期的2,250萬美元,主要由於CMC、臨床活動、一次性開發里程碑付款及人事相關費用增加。一般及行政開支為890萬美元(含300萬美元股權激勵開支),去年同期為520萬美元。第二季度淨虧損為5,580萬美元,對比去年同期淨虧損3,210萬美元,虧損擴大主要反映研發及行政開支上升。截至2026年6月30日,公司已發行普通股及等價股份約8,389萬股。 公司已完成一項1.725億美元的公開發售,進一步延長資金跑道;並委任擁有超過25年臨床開發及免疫學領導經驗的Mark Eisner博士加入董事會。管理層表示,JADE101中期數據超出預期,無論在生物標記活性或持久性方面均令人鼓舞,並對整個管線的推進節奏感到興奮,尤其是JADE301提早進入Phase 1。公司相信,針對未滿足醫療需求領域開發疾病修飾療法,配合經臨床驗證的作用機制,將支持其同類最佳藥物策略。 對投資者而言,JADE101的12週給藥間隔及高IgA降幅屬正面訊號,若後續Phase 2/3數據延續佳績,有望在IgAN領域建立差異化優勢;充裕現金流可支持多項臨床試驗同步推進,但短期淨虧損擴大及研發開支上升亦屬需要持續關注的因素。
展開英文正文
EX-99.1
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d40629dex991.htm
EX-99.1

EX-99.1

 

 Exhibit 99.1 

Jade Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Update 

 

 
•
 
 Announced positive interim Phase 1 results for JADE101 demonstrating potential for every 12-week subcutaneous dosing and best-in-class clinical activity in IgA nephropathy 

 

 
•
 
 Phase 2 JADE101 clinical trial in IgA nephropathy underway; interim data expected in 2027

  

 
•
 
 Phase 3 JADE101 registrational trial in IgA nephropathy expected to begin in the first half of 2027

  

 
•
 
 Began dosing participants with rheumatoid arthritis in Phase 1 trial of JADE201; interim data expected in 2027
 

  

 
•
 
 JADE301, a potentially
best-in-class, half-life–extended anti-IFN-ß for dermatomyositis, now
expected to initiate a Phase 1 healthy volunteer trial in the fourth quarter of 2026, with interim data anticipated in second half of 2027 

  

 
•
 
 Cash, cash equivalents, and investments of $461 million as of June 30,
2026 expected to provide runway into the fourth quarter of 2028 

 San Francisco and Vancouver, British Columbia –
August 10, 2026 – Jade Biosciences, Inc. (“Jade” or the “Company”) (Nasdaq: JBIO), a clinical-stage biotechnology company focused on developing
best-in-class therapies for autoimmune diseases, today announced financial results for the second quarter ending June 30, 2026, and provided a corporate update.

 “This was an important period for Jade as we reported positive interim Phase 1 data for JADE101 that exceeded our expectations across biomarker
activity and durability, with a favorable safety profile, strengthening our conviction to rapidly advance the compound to deliver a potentially best-in-class profile in
IgA nephropathy,” said Tom Frohlich, Chief Executive Officer of Jade Biosciences. “We are also excited by the momentum behind the rest of our pipeline, including JADE301, our half-life–extended anti-IFN-ß monoclonal antibody in development for dermatomyositis, which we are advancing toward Phase 1 initiation ahead of plan. We believe the clinically validated anti- IFN-ß mechanism, together with JADE301’s differentiated target product profile, supports our strategy of developing disease-modifying therapies in areas with large unmet need. Alongside the continued
clinical progress of JADE201, these advances reinforce our confidence in the potential of our pipeline.” 
 Pipeline and Corporate Updates 

JADE101: anti-APRIL monoclonal antibody for IgA nephropathy (IgAN) 
  

 
•
 
 Announced positive interim data from the Phase 1 JADE101 trial, which were subsequently presented at the 63rd
European Renal Association (ERA) Congress. Key results included: 

  

 
•
 
 Mean IgA reductions reached approximately 70% from baseline after a single 700 mg dose. Duration of IgA
reductions supports the potential for an every 12-week maintenance dosing interval. 

  

 
•
 
 Greater than 70% IgA reductions simulated at steady state with a single 350 mg subcutaneous maintenance injection
every 12 weeks following one 700 mg induction dose. 

  

 
•
 
 JADE101 was well-tolerated across all doses. 

 

 
•
 
 Announced dosing began in JUNIPER, a Phase 2 trial of JADE101 in IgAN. A Trial-in-Progress update on JUNIPER was presented during the 63rd ERA Congress. Interim data are expected in 2027. 

  

 
•
 
 Jade plans to initiate a registrational Phase 3 clinical trial in the first half of 2027, pending feedback and
requirements from the U.S. Food and Drug Administration. 

 JADE201: anti-BAFF-R monoclonal
antibody for autoimmune diseases 
  

 
•
 
 Announced dosing began in the Phase 1 clinical trial evaluating JADE201 in participants with rheumatoid
arthritis; interim, biomarker-rich data expected in 2027 are anticipated to inform indication prioritization and a focused clinical development strategy. 

  

 
•
 
 JADE201 has broad potential across multiple autoimmune indications supported by B cell and BAFF-R biology. 

 JADE301: anti- IFN-ß monoclonal
antibody for dermatomyositis 
  

 
•
 
 Jade today unveiled JADE301, a potentially
best-in-class monoclonal antibody in development for dermatomyositis (DM), a rare and debilitating autoimmune disease in which excessive
IFN-ß activity is believed to be the central driver of muscle and skin pathology. 

  

 
•
 
 JADE301 is a selective
anti-IFN-ß monoclonal antibody designed for subcutaneous administration at extended dosing intervals. By selectively targeting a key upstream mediator of disease
biology, it has the potential to address DM while avoiding broad inhibition of multiple cytokine-signaling pathways. 

  

 
•
 
 JADE301 targets a validated mechanism in DM with a differentiated molecular profile, including a YTE
half-life–extending modification. This profile has the potential for meaningful efficacy across muscle and skin manifestations, a favorable tolerability profile, and convenient, infrequent subcutaneous dosing. 

 

 
•
 
 Approximately 50,000 adults in the U.S. are affected by DM, and up to 80% of patients experience chronic, painful
disease. This significant unmet need highlights the importance of more effective, durable, and well-tolerated treatment options. 

  

 
•
 
 Jade plans to present preclinical data further characterizing JADE301 at the 2026 European Academy of Dermatology
and Venereology Congress, taking place September 30–October 3, 2026, in Vienna, Austria. 

  

 
•
 
 A Phase 1 trial in healthy volunteers is now expected to begin in the fourth quarter of 2026, with interim data
anticipated in the second half of 2027. 

 Corporate 

 

 
•
 
 Completed a $172.5 million public offering, extending expected runway into the fourth quarter of 2028.

  

 
•
 
 Announced Mark Eisner, M.D., M.P.H., was appointed to the Jade Board of Directors. Dr. Eisner has more than
25 years of leadership in clinical development and immunology. 

 Second Quarter 2026 Financial Results 

 

 
•
 
 Cash Position: As of June 30, 2026, Jade had cash, cash equivalents, and investments of
$461.2 million. Based on its current operating plans, Jade believes that its existing cash, cash equivalents and investments will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2028.

  
 Page 2 

 

 
•
 
 Research and Development (R&D) expenses: R&D expenses were $50.1 million for the second
quarter ended June 30, 2026 and included $10.6 million in stock-based compensation expense. R&D expenses were $22.5 million for the quarter ended June 30, 2025 and included $2.6 million in stock-based compensation
expense. R&D expenses increased primarily due to increased costs around chemistry, manufacturing and controls, clinical activity, one-time development milestone payments, and personnel-related costs and
related stock-based compensation expense. 

  

 
•
 
 General and Administrative (G&A) expenses: G&A expenses were $8.9 million for the second
quarter ended June 30, 2026 and included $3.0 million in stock-based compensation expense. G&A expenses were $5.2 million for the quarter ended June 30, 2025 and included $1.4 million in stock-based compensation expense.
The increase in G&A expenses was primarily due to higher personnel-related costs and related stock-based compensation expense. 

  

 
•
 
 Net loss: Net loss totaled $55.8 million for the second quarter ended June 30, 2026, compared to
$32.1 million for the quarter ended June 30, 2025. Net loss increased primarily due to higher R&D and G&A expenses, as described above. 

  

 
•
 
 Shares Outstanding: As of June 30, 2026, Jade had approximately 83,893,254 shares of common stock and
common stock equivalents outstanding, including shares underlying pre-funded warrants and non-voting convertible preferred stock. 

About Jade Biosciences, Inc. 
 Jade Biosciences is a
clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate,
JADE101, targets the cytokine APRIL, and is currently being evaluated for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal
antibody, as well as JADE301, an anti-IFN-ß monoclonal antibody. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more
information, visit JadeBiosciences.com and follow the Company on LinkedIn.
 Forward-Looking Statements 

Certain statements in this communication, other than purely historical information, may constitute “forward-looking statements” within the meaning
of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied
statements relating to Jade’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation: Jade’s ability to achieve the expected benefits or opportunities with
respect to JADE101, JADE201 and JADE301 and their best-in-class potential; the potential markets for Jade’s product candidates; the expected timeline for the
availability of interim data from the Phase 2 clinical trial of JADE101; Jade’s plans to conduct a Phase 3 clinical trial of JADE101, the design and timing thereof and Jade’s expectations that such trial will serve as a registrational
study; Jade’s proposed dosing strategy for JADE101; projected or simulated pharmacodynamic outcomes, including steady-state IgA reductions; the expected timelines for the initiation of the Phase 1 clinical trial of JADE301 and for the
availability of interim data from the Phase 1 clinical trials of JADE201 and JADE301; expectations regarding the type of data anticipated to be received from the Phase 1 clinical trial of JADE201; the

  
 Page 3 

 

 
potential therapeutic uses, efficacy, durability, safety profiles, and dosing of JADE101, JADE201 and JADE301; the anticipated use of net proceeds from the referenced public offering; and the
potential for Jade’s cash runway to extend into the fourth quarter of 2028. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,”
“strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,”
“intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations
of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and
their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade’s
control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: interim results
of a clinical trial are not necessarily indicative of final results and one or more of the outcomes may materially change following more comprehensive reviews of the data, as follow-up on the outcome of any
particular participant continues and as more participant or final data becomes available; modeled and predicted data for JADE101 may not be realized in actual clinical studies; the ongoing and planned clinical trials of JADE101, JADE201 and JADE301
and any other clinical trials may be delayed or may not demonstrate desirable efficacy or predicted performance; Jade’s planned JADE101 Phase 3 clinical trial may be delayed based on FDA feedback or requirements, as the FDA retains broad
discretion to require additional clinical data for any product candidate prior to the conduct of a Phase 3 clinical trial or submission for regulatory approval; even if such Phase 3 trial is successful, it may not support regulatory approval;
adverse events and safety signals may occur; Jade may experience unanticipated costs, difficulties or delays in the product development process; Jade’s product candidates may be delayed to a point where they are not commercially viable;
clinical trial start up, enrollment or regulatory challenges may occur; challenges associated with Jade’s dependence on third-party vendors for the development, manufacture and supply of its product candidates may occur; Jade may use its
capital resources sooner than expected; and the other risks, uncertainties and factors more fully described in Jade’s most recent filings with the Securities and Exchange Commission (including the Quarterly Report on Form 10-Q for the quarter ended March 31, 2026). Should one or more of these risks or uncertainties materialize, or should any of Jade’s assumptions prove incorrect, actual results may vary in material
respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by
reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements, except as required by law. This communication does not purport to summarize all
of the conditions, risks and other attributes of an investment in Jade. 
 Jade Biosciences Contact 

Priyanka Shah 
 [email protected] 

[email protected] 
 908-447-6134 

  
 Page 4 

 

 JADE BIOSCIENCES, INC. 

CONDENSED CONSOLIDATED BALANCE SHEETS 

(In thousands, except share amounts) 
  

 
  
June 30,2026
 
  
December 31,2025
 

 Cash, cash equivalents and investments

  
$
461,205
 
  
$
336,158
 

 Other assets

  
 
10,908
 
  
 
13,623
 

  
  

  

 
  
  

  

 

 Total assets

  
$
472,113
 
  
$
349,781
 

  
  

  

 
  
  

  

 

 Total liabilities

  
$
32,198
 
  
$
17,263
 

  
  

  

 
  
  

  

 

 Total stockholders’ equity

  
 
439,915
 
  
 
332,518
 

  
  

  

 
  
  

  

 

 Total liabilities and stockholders’ equity

  
$
472,113
 
  
$
349,781
 

  
  

  

 
  
  

  

 

 JADE BIOSCIENCES, INC. 

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS 

(In thousands, except share and per share amounts) 
  

 
 
Three MonthsEndedJune 30, 2026
 
 
Three MonthsEndedJune 30, 2025
 
 
Six MonthsEndedJune 30, 2026
 
 
Six MonthsEndedJune 30, 2025
 

 Operating expenses

 

 

 

 

 Research and development(1)

 
$
50,065
 
 
$
22,547
 
 
$
86,118
 
 
$
42,570
 

 General and administrative(2)

 
 
8,851
 
 
 
5,231
 
 
 
16,243
 
 
 
8,592
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Total operating expenses

 
 
58,916
 
 
 
27,778
 
 
 
102,361
 
 
 
51,162
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Loss from operations

 
 
(58,916
) 
 
 
(27,778
) 
 
 
(102,361
) 
 
 
(51,162
) 

 Other income (expense):

 

 

 

 

 Interest income

 
 
3,228
 
 
 
1,828
 
 
 
6,330
 
 
 
2,443
 

 Change in fair value of Convertible Notes
payable(3)

 
 
— 
 
 
 
(6,184
) 
 
 
— 
 
 
 
(21,584
) 

 Other expense

 
 
(62
) 
 
 
— 
 
 
 
(71
) 
 
 
— 
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Total other income (expense), net

 
 
3,166
 
 
 
(4,356
) 
 
 
6,259
 
 
 
(19,141
) 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Net loss before income tax expense

 
 
(55,750
) 
 
 
(32,134
) 
 
 
(96,102
) 
 
 
(70,303
) 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Income tax expense

 
 
(15
) 
 
 
— 
 
 
 
(31
) 
 
 
— 
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Net loss

 
 
(55,765
) 
 
 
(32,134
) 
 
 
(96,133
) 
 
 
(70,303
) 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Other comprehensive income (loss):

 

 

 

 

 Currency translation adjustment

 
$
(73
) 
 
$
(24
) 
 
$
(71
) 
 
$
(24
) 

 Unrealized loss on investments

 
$
(245
) 
 
$
— 
 
 
$
(718
) 
 
$
— 
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Comprehensive loss

 
$
(56,083
) 
 
$
(32,158
) 
 
$
(96,922
) 
 
$
(70,327
) 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Net loss per share attributable to common stockholders, basic and diluted

 
$
(0.76
) 
 
$
(0.86
) 
 
$
(1.33
) 
 
$
(3.45
) 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Net loss per share attributable to Series A non-voting
convertible preferred stockholders, basic and diluted

 
$
(756.93
) 
 
$
(863.46
) 
 
$
(1,334.34
) 
 
$
(3,450.78
) 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Weighted-average shares used in computing net loss per share attributable to common stockholders,
basic and diluted

 
 
61,050,775
 
 
 
28,431,158
 
 
 
59,423,013
 
 
 
15,932,206
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

 Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted

 
 
12,622
 
 
 
8,781
 
 
 
12,622
 
 
 
4,439
 

 
  

  

 
 
  

  

 
 
  

  

 
 
  

  

 

  

(1)
 Includes related party amounts of $13.0 million and $17.3 million for the three and six months ended
June 30, 2026, respectively, and $3.9 million and $11.7 million for the three and six months ended June 30, 2025, respectively. 

(2)
 Includes no related party amount for the three months ended June 30, 2026 and $0.2 million for the
six months ended June 30, 2026. Includes related party amounts of $0.1 million for each of the three and six months ended June 30, 2025, respectively. 

(3)
 Includes no related party amounts for the three and six months ended June 30, 2026 and $1.3 million
and $4.6 million for the three and six months ended June 30, 2025, respectively. 

  
 Page 5