false000205870700020587072026-11-092026-11-09
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): November 9, 2026 |
Attovia Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-43423 |
92-1510574 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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1091 Industrial Road Suite 310 |
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San Carlos, California |
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94070 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 510 399-5001 |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s) |
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Name of each exchange on which registered
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Common stock, $0.0001 par value per share |
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ATTO |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2026, Attovia Therapeutics, Inc. (the “Company”) issued a press release reporting its financial results for the third quarter ended September 30, 2026. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Section 11 or 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference into any filing by the Company under the Exchange Act or the Securities Act, whether made before or after the date hereof, except as expressly set forth by reference in such filing.
Item 8.01 Other Events.
The Company recently announced positive topline 12-week results from its Phase 1b study of ATTO-1310, a next-generation anti-IL-31 ATTOBODY-based precision itch therapy, in patients with chronic pruritus (“CP”) and high-itch atopic dermatitis (“AD”).
Favorable Tolerability
ATTO-1310 was generally well tolerated in both healthy volunteers (“HV”) and patients. In the HV portion of the study, there was one treatment-emergent adverse event (“TEAE”) that led to treatment discontinuation due to Grade 1 fever. There were no TEAEs that led to study discontinuations in CP and AD patients. There was one serious TEAE (worsening of a pre-existing hiatal hernia), which was deemed unrelated to study treatment.
ATTO-1310 demonstrated low immunogenicity. Anti-drug antibodies were detected in 7.8% of HV and patients, with no observed impact on pharmacokinetics, target engagement, tolerability, or clinical activity.
Pharmacology Supports Potential Quarterly Dosing
In both HV and patient cohorts, a single subcutaneous dose of ATTO-1310 led to rapid, sustained suppression of circulating IL-31 (approximately 95%) through Week 12, and drug concentrations remained above the IC90 throughout this period. Together, these data support the potential for quarterly maintenance dosing of ATTO-1310.
Rapid Itch Relief Deepened and Sustained through Week 12 Following a Single Dose in Patients with CP
A rapid, clinically meaningful reduction in itch of ≥4 points on the Peak Pruritus Numerical Rating Scale (“PP-NRS”), referred to as “PP-NRS4,” was observed as early as Week 2, with 47% of ATTO-1310-treated patients achieving PP-NRS4 vs. 0% with placebo (p < 0.05), increasing to 82% vs. 22% with placebo (p < 0.01) at Week 12. A similar trend was observed in patients who were itch-free or nearly itch-free (“PP-NRS<2”), with 47% of ATTO-1310-treated patients achieving response at Week 12 vs. 0% with placebo (p < 0.05).
Itch Relief and Lesional Improvements Following a Single Dose in Patients with High-Itch AD
In patients with high-itch AD, a rapid reduction in itch was observed as early as Week 2, with 39% of ATTO-1310-treated patients achieving PP-NRS4 vs. 25% with placebo. The ATTO-1310 response rate increased to 44% at Week 4 and was sustained through Week 12. In the pooled placebo group (n=8), the PP-NRS4 response rate increased from 25% at Week 4 to 75% at Week 12. In the more stringent itch-free or nearly itch-free (PP-NRS<2) analysis, 28% (5/18) of ATTO-1310-treated patients achieved a response at Week 12 vs. 13% (1/8) with placebo.
In addition to itch relief, a single dose of ATTO-1310 led to rapid improvements in skin disease severity that deepened through Week 12, with response rates increasing across several stringent Eczema Area and Severity Index (“EASI”) and validated Investigator Global Assessment (“vIGA”) endpoints.
Phase 2 Program
The Company plans to initiate two Phase 2 trials of ATTO-1310. The ATTUNE-CPUO trial aims to enroll approximately 300 patients with chronic pruritus of unknown origin across 78 sites in North America and the EU. The ATTUNE-AD trial aims to enroll approximately 255 patients with high-itch AD across approximately 60 sites in North America, the EU, and the Asia-Pacific region. Both trials are on track to initiate in the first half of 2027.
Item 9.01 Financial Statements and Exhibits.
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Exhibit Number |
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Description |
99.1 |
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Press Release announcing financial results, dated November 9, 2026 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and prospects; any expectations regarding the safety or efficacy of ATTO-1310, ATTO-2306, and ATTO-1091, and other candidates under development; the ability of such candidates to treat their indications; the planned timing of the Company’s clinical trials, data results, and further development of its product candidates; the sufficiency of the Company’s current cash, cash equivalents, and marketable securities to fund its operations; and the Company’s expected cash runway. In addition, when or if used in this Current Report on Form 8-K, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will,” “predict,” and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance, or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the Company’s ability to advance its product candidates and obtain regulatory approval of and ultimately commercialize such product candidates, the timing and results of preclinical studies and clinical trials, the risk that topline or interim results from clinical trials, including results based on a limited number of patients, may not be predictive of final results or of results of later clinical trials, the Company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic and geopolitical conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, public health crises, and geopolitical conflicts. Further information on potential risk factors that could affect the Company’s business and its financial results is detailed under the heading “Risk Factors” included in the documents the Company files from time to time with the U.S. Securities and Exchange Commission. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this Current Report on Form 8-K, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Attovia Therapeutics, Inc. |
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Date: |
November 9, 2026 |
By: |
/s/ Tao Fu |
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Tao Fu Chief Executive Officer, President and Director (Principal Executive Officer) |

Attovia Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Corporate Update
Announced positive topline 12-week Phase 1b results for ATTO-1310 in patients with chronic pruritus (CP) and high-itch atopic dermatitis (AD)
Initiation of global Phase 2 trials of ATTO-1310 in patients with chronic pruritus of unknown origin (CPUO) and high-itch AD expected in 1H 2027
Initiation of Phase 1 trials for ATTO-2306 and ATTO-1091 expected in 1H 2027
Cash, cash equivalents, and marketable securities of approximately $395.9 million as of September 30, 2026, expected to provide cash runway into 2030
SAN CARLOS, Calif., November 9, 2026 – Attovia Therapeutics, Inc. (“Attovia” or the “Company”) (Nasdaq: ATTO), a clinical-stage biopharmaceutical company developing next-generation biotherapeutics for immune-mediated diseases with high unmet need, today reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.
“During the third quarter, we continued to execute on our clinical development priorities, positioning Attovia for an exciting and potentially transformative year ahead,” said Tao Fu, Founder and Chief Executive Officer of Attovia. “The recently announced 12-week topline results from our ATTO-1310 Phase 1b trial exceeded our expectations, building on the compelling Week 4 findings and providing further evidence supporting our differentiated target product profile: rapid, deep, and durable itch relief, meaningful skin lesion improvements, the potential for quarterly dosing, and a favorable safety profile. These results reinforce our confidence in ATTO-1310’s potential to become a next-generation IL-31 therapy for millions of patients suffering from chronic itch conditions. We have also made significant progress in preparing for our two Phase 2 ATTUNE trials in CPUO and high-itch AD, both of which remain on track to initiate in the first half of 2027. In parallel, we continue to advance ATTO-2306 and ATTO-1091 toward clinical development, positioning Attovia for multiple important milestones in 2027.”
Recent Pipeline Highlights and Upcoming Milestones
ATTO-1310 for pruritic diseases: a next-generation, half-life extended ATTOBODY-based Fc-fusion protein targeting the itch cytokine IL-31.
•Hosted a virtual KOL and ATTO-1310 clinical development update featuring leading experts Brian Kim, MD, MTR, FAAD, and Jonathan Silverberg, MD, PhD, MPH.
•Announced positive 12-week topline results from the Phase 1b study of ATTO-1310 in patients with CP and high-itch AD following a single dose of ATTO-1310. Results demonstrated the following:
•CP: a rapid, clinically meaningful reduction in itch of ≥4 points on the Peak Pruritus Numerical Rating Scale (PP-NRS4) was observed, with 82% of ATTO-1310-treated patients achieving PP-NRS4 vs. 22% with placebo (nominal p<0.01) at Week 12. A similar trend was observed in patients who were itch-free or nearly itch-free (PP-NRS<2), with 47% of ATTO-1310-treated patients achieving a response at Week 12 vs. 0% with placebo (p<0.05).
•High-itch AD: in patients with high-itch AD, a rapid reduction in itch was observed, with 44% of ATTO-1310-treated patients achieving PP-NRS4 at Week 4 vs. 25% with placebo. The treatment response was sustained through Week 12. In the more stringent itch-free or nearly itch-free (PP-NRS<2) analysis, 28% (5/18) of ATTO-1310-treated patients achieved a response at Week 12 vs. 13% (1/8) with placebo.
•Additionally, improvements in skin lesions were observed through Week 12, with 44% of ATTO-1310-treated patients achieving at least a 75% improvement on the Eczema Area and Severity Index (EASI-75) and 39% achieving clear or almost clear skin on the validated Investigator Global Assessment (vIGA 0/1), compared with approximately 13% on placebo for both measures.
•Safety and pharmacology: ATTO-1310 was generally well tolerated in both healthy volunteers (HVs) and patients, and demonstrated low immunogenicity. A single subcutaneous (SC) dose of ATTO-1310 led to rapid, sustained suppression of circulating IL-31 (approximately 95%) through Week 12, supporting the potential for quarterly dosing.
•Advanced preparations for the two Phase 2 ATTUNE trials in CPUO and high-itch AD, with both trials on track to initiate in the first half of 2027.
•The Phase 2 ATTUNE-CPUO trial design has been aligned with the U.S. Food and Drug Administration (FDA), and site activation is underway.
•The Phase 2 ATTUNE-AD trial protocol has been finalized, and site selection has been initiated.
•Presented three posters highlighting clinical and translational data for ATTO-1310 at the European Academy of Dermatology and Venereology (EADV) Congress 2026 and Fall Clinical Dermatology Conference 2026. Presentations included Phase 1a safety, pharmacokinetic, and pharmacodynamic data in healthy volunteers, new data supporting the key role of IL-31 across pruritic skin diseases, and interim Phase 1b results demonstrating early clinical activity in patients with CP and high-itch AD.
•Initiated the Phase 1b trial in patients with cholestatic pruritus associated with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC) in China, with topline results expected in the second half of 2027.
ATTO-2306 for AD and other immune-mediated skin diseases: a highly potent, half-life extended ATTOBODY-based bispecific antibody targeting IL-31 and IL-13.
•Presented a poster highlighting new preclinical data at the Fall Clinical Dermatology Conference 2026, demonstrating potent inhibition of IL-13 and IL-31 signaling, significant reductions in pruritus and inflammation in preclinical models, and an extended half-life in nonhuman primates.
•IND-enabling activities are ongoing, with Phase 1 trial initiation expected in the first half of 2027.
ATTO-1091 for inflammatory bowel disease: a next-generation ATTOBODY-based trispecific designed to target TL1A, IL-23p19, and integrin α4β7.
•IND-enabling activities are ongoing, with Phase 1 trial initiation expected in the first half of 2027.
Corporate Highlights
•Completed an upsized initial public offering in August 2026, raising approximately $332.4 million in aggregate gross proceeds, before deducting underwriting discounts, commissions, and other offering expenses. Attovia’s common stock began trading on the Nasdaq Global Market on August 5, 2026, under the ticker symbol “ATTO.”
Third Quarter Financial Results
Revenue: There was no collaboration revenue for the third quarter of 2026, compared to $0.4 million in the third quarter of 2025 attributable to research and development services provided under the EndPath RadioTherapeutics license agreement.
Cash Position: Cash, cash equivalents, and marketable securities were $395.9 million as of September 30, 2026, compared to $152.3 million as of December 31, 2025. The Company expects that its cash, cash equivalents, and marketable securities as of September 30, 2026, will be sufficient to fund its operations into 2030.
Research & Development (R&D) Expenses: Research and development expenses were $20.3 million for the third quarter of 2026, compared to $12.3 million for the third quarter of 2025. The increase in R&D expenses was primarily driven by clinical and manufacturing costs to advance ATTO-1310 toward completion of its Phase 1 trial, and manufacturing and preclinical costs to advance ATTO-2306 and ATTO-1091 in IND-enabling activities.
General & Administrative (G&A) Expenses: General and administrative expenses were $4.7 million for the third quarter of 2026, compared to $3.6 million for the third quarter of 2025. The increase in G&A expenses was primarily due to higher personnel costs to support the Company’s growth and higher administrative and facility-related expenses.
Net Loss: Net loss was $22.3 million for the third quarter of 2026, as compared to $13.8 million for the third quarter of 2025.
About Attovia Therapeutics, Inc.
Attovia is a clinical-stage biopharmaceutical company developing next-generation biotherapeutics for immune-mediated diseases with high unmet need. All of its product candidates have been internally discovered using its ATTOBODY biparatopic biologics platform. Attovia’s ATTOBODY platform uses an evolution-driven, high-throughput process that allows for rapid discovery and creation of a high diversity of potential product candidates.
Attovia’s lead programs include ATTO-1310, an anti-IL-31 therapeutic in clinical development for chronic pruritic diseases; ATTO-2306, a long-acting bispecific antibody targeting IL-31 and IL-13 in IND-enabling studies for atopic dermatitis and other immune-mediated skin diseases; and ATTO-1091, a trispecific antibody targeting TL1A, IL-23p19, and integrin α4β7 in IND-enabling studies for inflammatory bowel disease. Attovia’s other programs include highly innovative conditional ‘AND’-gated bispecific immune cell survival blockers and multispecifics.
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. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and prospects; any expectations regarding the safety or efficacy of ATTO-1310, ATTO-2306, and ATTO-1091, and other candidates under development; the ability of such candidates to treat their indications; the planned timing of the Company’s clinical trials, data results, and further development of its product candidates; the sufficiency of the Company’s current cash, cash equivalents, and marketable securities to fund its operations; and the Company’s expected cash runway. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will,” “predict,” and similar expressions and their variants, as they relate to the Company, may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance, or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the Company’s ability to advance its product candidates and obtain regulatory approval of and ultimately commercialize such product candidates, the timing and results of preclinical studies and clinical trials, the risk that topline or interim results from clinical trials,
including results based on a limited number of patients, may not be predictive of final results or of results of later clinical trials, the Company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic and geopolitical conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, public health crises, and geopolitical conflicts. Further information on potential risk factors that could affect the Company’s business and its financial results is detailed under the heading “Risk Factors” included in the documents the Company files from time to time with the U.S. Securities and Exchange Commission. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release, and Attovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Investor and Media Contacts
Attovia Therapeutics
Heather Armstrong
Head of Investor Relations
ir@attovia.com
PJ Kelleher
LifeSci Advisors LLC
617-430-7579
pkelleher@lifesciadvisors.com
Attovia Therapeutics, Inc.
Condensed Consolidated Balance Sheets – Selected Data (unaudited)
(in thousands)
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September 30, 2026 |
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December 31, 2025 |
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Cash, cash equivalents, and marketable securities |
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$ |
395,939 |
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$ |
152,268 |
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Total assets |
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411,824 |
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165,893 |
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Total liabilities |
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14,083 |
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15,103 |
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Total stockholders' equity (deficit) |
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397,741 |
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(107,436 |
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Attovia Therapeutics, Inc.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue |
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Collaboration revenue |
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$ |
— |
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$ |
360 |
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$ |
450 |
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$ |
360 |
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Total revenue |
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— |
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360 |
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450 |
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360 |
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Operating expenses |
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Research and development |
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20,290 |
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12,317 |
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55,982 |
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37,761 |
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General and administrative |
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4,734 |
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3,645 |
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11,250 |
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10,925 |
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Total operating expenses |
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25,024 |
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15,962 |
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67,232 |
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48,686 |
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Loss from operations |
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(25,024 |
) |
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(15,602 |
) |
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(66,782 |
) |
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(48,326 |
) |
Other income (expense) |
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Interest income |
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2,787 |
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1,855 |
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5,254 |
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5,022 |
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Change in fair value of preferred stock tranche liability |
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— |
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— |
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— |
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(170 |
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Other income (expense), net |
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(34 |
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(32 |
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(86 |
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105 |
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Total other income (expense), net |
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2,753 |
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1,823 |
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5,168 |
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4,957 |
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Net loss |
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$ |
(22,271 |
) |
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$ |
(13,779 |
) |
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$ |
(61,614 |
) |
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$ |
(43,369 |
) |
Less: Accretion of redeemable convertible preferred stock to its redemption value |
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— |
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— |
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— |
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(271 |
) |
Net loss attributable to common stockholders |
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$ |
(22,271 |
) |
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$ |
(13,779 |
) |
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$ |
(61,614 |
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$ |
(43,640 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.76 |
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$ |
(3.44 |
) |
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$ |
(4.86 |
) |
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$ |
(11.18 |
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Weighted-average common shares outstanding, basic and diluted |
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29,370,016 |
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4,004,963 |
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12,679,296 |
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3,902,967 |
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