STOCK TITAN

Oruka Therapeutics (ORKA) widens Q2 2026 loss but holds $1.1B cash runway

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Oruka Therapeutics, Inc. reported second quarter 2026 results and updated progress across its dermatology pipeline. The company is advancing ORKA-001, a half-life extended IL-23p19 monoclonal antibody, and ORKA-002, a half-life extended IL-17A/F monoclonal antibody, with multiple clinical data readouts planned through 2026 and into 2027. EVERLAST-A Week 28 data are expected at the end of the third quarter of 2026, with 52-week data for all participants anticipated in December 2026, while EVERLAST-B is fully enrolled ahead of schedule with Week 16 data expected in the fourth quarter of 2026. ORCA-SURGE Week 16 data are now expected in the first quarter of 2027, ORCA-SPLASH, a Phase 2 trial of ORKA-002 in hidradenitis suppurativa, has been initiated, and ORKA-004 is expected to enter the clinic in the fourth quarter of 2026.

As of June 30, 2026, Oruka held $1.1 billion in cash, cash equivalents, and marketable securities, which it expects will fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002. Second quarter 2026 research and development expenses were $43.3 million versus $24.1 million a year earlier, and general and administrative expenses were $6.9 million versus $4.3 million. Other income, net, was $8.9 million, primarily from interest on higher cash and marketable securities. Net loss for the quarter was $41.2 million compared with $24.6 million in the prior-year quarter, reflecting increased investment in clinical programs and corporate infrastructure.

Positive

  • $1.1 billion in cash, cash equivalents and marketable securities, with runway expected to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.
  • Multiple near-term clinical catalysts, including EVERLAST-A Week 28 data by end of 3Q 2026, EVERLAST-B Week 16 data in 4Q 2026, and a Phase 3 program for ORKA-001 expected to begin in 1H 2027.

Negative

  • Quarterly net loss increased to $41.2 million in Q2 2026 from $24.6 million in Q2 2025, driven by higher operating expenses.
  • Research and development spending rose to $43.3 million from $24.1 million year over year, reflecting heavier investment and higher cash burn ahead of revenue.
  • General and administrative expenses grew to $6.9 million from $4.3 million, increasing the company’s fixed cost base.

Filing Explained

The August 10 Form 8-K furnishes Oruka’s second-quarter results and corporate update through Exhibit 99.1; the release is not deemed filed under Exchange Act Section 18 or incorporated by reference unless another filing expressly does so.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and marketable securities $1.1 billion As of June 30, 2026; expected to fund operations through anticipated BLA filing for ORKA-001 and ORKA-002 development
Research and development expenses Q2 2026 $43.3 million Three months ended June 30, 2026; compared with $24.1 million in Q2 2025
General and administrative expenses Q2 2026 $6.9 million Three months ended June 30, 2026; compared with $4.3 million in Q2 2025
Other income, net Q2 2026 $8.9 million Three months ended June 30, 2026; driven primarily by interest on higher cash and marketable securities
Net loss Q2 2026 $41.2 million Three months ended June 30, 2026; compared with $24.6 million for the same period in 2025
R&D expenses, six months 2026 $72.4 million Six months ended June 30, 2026; compared with $44.0 million for the same period in 2025
Net loss, six months 2026 $73.0 million Six months ended June 30, 2026; compared with $45.6 million for the same period in 2025
Biologics License Application regulatory
"expected to fund the Company through a BLA filing for ORKA-001"
A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.
hidradenitis suppurativa medical
"a Phase 2 trial of ORKA-002 in moderate-to-severe hidradenitis suppurativa"
A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.
IL-23p19 medical
"ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody"
IL-23p19 is a specific protein subunit that combines with another piece to form the immune signaling molecule called interleukin‑23; think of it as a unique tooth in a two‑tooth gear that helps the immune system rev up inflammation. It matters to investors because many drugs are designed to block this subunit to calm overactive immune responses in conditions like psoriasis and inflammatory bowel disease, so changes in clinical trial results or regulatory decisions around IL‑23p19 inhibitors can directly affect the value of companies developing those therapies.
IL-17A/F medical
"ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody"
IL-17A/F is a signaling protein produced by certain immune cells that combines elements of two related molecules (IL-17A and IL-17F) and helps trigger and amplify inflammation. It matters to investors because therapies that block or modulate IL-17A/F can reduce symptoms in autoimmune and inflammatory diseases, so clinical trial results, regulatory decisions, and safety signals for such drugs can significantly change a biotech or pharmaceutical company's market value—like repairing a faulty circuit that stabilizes a machine.
monoclonal antibody medical
"ORKA-004, a novel half-life extended monoclonal antibody targeting TL1A"
A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.
forward-looking statements regulatory
"Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements”"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Net loss Q2 2026 $41.2 million Compared with $24.6 million in Q2 2025
R&D expenses Q2 2026 $43.3 million Compared with $24.1 million in Q2 2025
G&A expenses Q2 2026 $6.9 million Compared with $4.3 million in Q2 2025
Other income, net Q2 2026 $8.9 million Compared with $3.9 million in Q2 2025
Cash, cash equivalents and marketable securities $1.1 billion As of June 30, 2026; expected to fund through anticipated BLA filing for ORKA-001
Guidance

Company expects cash, cash equivalents and marketable securities to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What were Oruka Therapeutics (ORKA) cash and investments at June 30, 2026?

Oruka reported $1.1 billion in cash, cash equivalents and marketable securities as of June 30, 2026. Management expects this balance to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

How did Oruka Therapeutics (ORKA) second quarter 2026 net loss compare to 2025?

Net loss for Q2 2026 was $41.2 million, compared with $24.6 million in Q2 2025. The larger loss reflects increased research and development spending and higher general and administrative expenses as programs and corporate operations expanded.

What were Oruka Therapeutics (ORKA) R&D and G&A expenses in Q2 2026?

In Q2 2026, research and development expenses were $43.3 million versus $24.1 million a year earlier, and general and administrative expenses were $6.9 million versus $4.3 million. The increases were mainly due to added clinical trial activity and higher employee-related costs.

What clinical milestones did Oruka Therapeutics (ORKA) guide to for ORKA-001 and ORKA-002?

Oruka expects EVERLAST-A Week 28 data by end of 3Q 2026 and 52-week data in December 2026, EVERLAST-B Week 16 data in 4Q 2026, and a Phase 3 program for ORKA-001 to begin in 1H 2027. ORCA-SPLASH for ORKA-002 has been initiated.

When will Oruka Therapeutics (ORKA) start clinical development of ORKA-004?

Oruka plans for ORKA-004, a half-life extended monoclonal antibody targeting TL1A, to enter the clinic in 4Q 2026. The company also plans combination studies of ORKA-004 with ORKA-001 and ORKA-002, according to its forward-looking statements.

What was Oruka Therapeutics (ORKA) other income in Q2 2026?

Other income, net, was $8.9 million in Q2 2026, up from $3.9 million in Q2 2025. The increase was driven primarily by interest income earned on higher balances of cash and marketable securities.
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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

 

Date of Report (Date of Earliest Event Reported): August 10, 2026

 

 

 

Oruka Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware   000-22873   36-3855489
(State or Other Jurisdiction
of Incorporation)
 

(Commission File Number)

  (IRS Employer
Identification No.)

 

855 Oak Grove Avenue

Suite 100

   
Menlo Park, California   94025
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 606-7910

 

N/A

(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:

         
Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common stock, $0.001 Par Value   ORKA   The Nasdaq Global Market 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

 

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 Operating accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On August 10, 2026, Oruka Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2026. A copy of the press release is furnished as Exhibit 99.1 to this report.

 

The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “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, nor shall it be deemed incorporated by reference into any filing under the Exchange Act or under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release, dated August 10, 2026
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

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.

 

  Oruka Therapeutics, Inc.
   
Date: August 10, 2026 By:

/s/ Lawrence Klein

    Lawrence Klein
Chief Executive Officer

 

2

 

Exhibit 99.1

 

Oruka Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

 

EVERLAST-A Week 28 data expected at the end of 3Q 2026; 52-week data for all participants expected in December 2026

 

EVERLAST-B fully enrolled ahead of schedule, with Week 16 data now expected in 4Q 2026

 

Phase 3 program for ORKA-001 expected to begin in 1H 2027

 

ORCA-SURGE Week 16 data accelerated, now expected in 1Q 2027

 

ORCA-SPLASH, a Phase 2 trial of ORKA-002 in moderate-to-severe hidradenitis suppurativa, initiated

 

ORKA-004, a novel half-life extended monoclonal antibody targeting TL1A, to enter the clinic in 4Q 2026

 

Cash, cash equivalents and marketable securities of $1.1 billion expected to fund the Company through a BLA filing for ORKA-001

 

MENLO PARK, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO) and hidradenitis suppurativa (HS), today reported second quarter 2026 financial results and provided a corporate update.

 

“The second quarter and recent months were highly productive as we advanced both of our co-lead programs toward a series of important readouts,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “With EVERLAST-B now fully enrolled and a Phase 3 program for ORKA-001 on the horizon, alongside the initiation of ORCA-SPLASH in HS, we are executing on our strategy to establish ORKA-001 and ORKA-002 as potentially best-in-class options across psoriatic disease and beyond. We look forward to multiple significant clinical catalysts over the coming quarters.”

 

Second Quarter 2026 and Recent Business and Pipeline Updates

 

ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody

 

In April 2026, the Company presented positive data from its EVERLAST-A Phase 2a trial in moderate-to-severe PsO showing 40 of 63 (63.5%) participants treated with ORKA-001 achieved PASI 100 at Week 16. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of treated participants, and IGA 0/1 at Week 16, achieved by 84% of treated participants. ORKA-001 was well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors.

 

The Company expects to report Week 28 data from EVERLAST-A for all participants at the end of the third quarter of 2026. These data will provide the first look at maintenance of response out to six months and potential deepening of responses for patients who did not reach PASI 100 at Week 16.

 

The Company also expects to report 52-week data from EVERLAST-A for all participants in December 2026. These longer-term data are designed to characterize the durability of response and continue to inform the potential for once- to twice-yearly dosing.

 

EVERLAST-B, a Phase 2b dose-ranging trial in moderate-to-severe PsO, completed enrollment of 187 subjects in the second quarter. The Company now expects to report Week 16 data for all participants in the fourth quarter of 2026. These data are intended to support the initiation of a Phase 3 program in the first half of 2027.

 

 

 

 

ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody

 

The Company now expects to report Week 16 data from ORCA-SURGE, a Phase 2 trial in moderate-to-severe PsO, in the first quarter of 2027.

 

The Company initiated ORCA-SPLASH, a Phase 2 trial in moderate-to-severe HS. ORCA-SPLASH is a randomized, double-blind, placebo-controlled study in approximately 160 participants. The study will enroll patients in the United States and Canada. Patients will be randomized 1:1 to receive 320 mg of ORKA-002 or placebo at Weeks 0, 4, 8, and 12. The primary endpoint is HiSCR75 at Week 16. Participants then enter an open-label maintenance period evaluating 320 mg of ORKA-002 every 12 weeks.

 

Additional updates

 

The Company announced ORKA-004, a novel, subcutaneously administered, half-life extended monoclonal antibody targeting TL1A that is anticipated to enter the clinic in the fourth quarter of 2026. The Company plans to pursue ORKA-004 in combination with ORKA-001 and ORKA-002, with Phase 2 combination studies planned to begin in 2027.

 

In April 2026, the Company announced the pricing of an upsized $700 million public offering. Proceeds from this offering, including existing cash, are expected to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

 

In May 2026, Oruka amended its IL-23 license agreement with Paragon Therapeutics to include all therapeutic areas. Prior to the amendment, the Company’s agreement did not include inflammatory bowel disease (IBD). The amendment allows Oruka to pursue ORKA-001 or combinations thereof in IBD, subject to certain timing restrictions on initiating clinical trials.

 

Second Quarter 2026 Financial Results

 

Cash Position: As of June 30, 2026, Oruka had cash, cash equivalents, and marketable securities of $1.1 billion. The Company expects that its cash, cash equivalents, and marketable securities will be sufficient to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002.

 

Research and Development (R&D) Expenses: R&D expenses were $43.3 million for the second quarter of 2026, compared to $24.1 million for the second quarter of 2025. The increase was primarily related to additional clinical trials and associated costs of Oruka’s programs, a non-refundable upfront payment made to Halozyme, and higher employee compensation expenses, including stock-based compensation driven by increased headcount.

 

General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the second quarter of 2026, compared to $4.3 million for the second quarter of 2025. The increase was primarily related to employee compensation-related expenses, including stock-based compensation, and costs associated with operating as a growing public company.

 

Other income, net: Other income, net was $8.9 million for the second quarter of 2026, compared to $3.9 million for the second quarter of 2025, driven primarily by interest earned on higher cash and marketable securities.

 

Net Loss: Net loss was $41.2 million and $24.6 million for the second quarters of 2026 and 2025, respectively.

 

About Oruka Therapeutics

 

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from inflammatory diseases like plaque psoriasis and hidradenitis suppurativa the greatest possible freedom from their condition by achieving high rates of disease clearance with dosing as infrequently as once or twice a year. For more information, visit www.orukatx.com and follow Oruka on LinkedIn.

 

2

 

 

Forward Looking Statements

 

Certain statements in this press release, 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 United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the potential benefits, efficacy, safety, durability of response, dosing profile and therapeutic potential of ORKA-001 and ORKA-002; the planned design, initiation, enrollment, conduct, timing, progress and results of the Company’s clinical studies (including EVERLAST-A, EVERLAST-B, ORCA-SURGE and ORCA-SPLASH); the anticipated initiation of clinical development of ORKA-004 and planned combination studies of ORKA-004 with ORKA-001 and ORKA-002; the anticipated initiation of the Phase 3 program for ORKA-001; the timing of clinical, regulatory and data milestones, including an anticipated BLA filing for ORKA-001; the Company’s ability to develop ORKA-001 and ORKA-002 for additional indications, including hidradenitis suppurativa and inflammatory bowel disease; the expected benefits of the amendment to the Company’s license agreement with Paragon Therapeutics; and Oruka’s expected cash position, cash runway and ability to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002. 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 Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’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, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.

 

Investor Contact:

 

Alan Lada

(650)-606-7911

alan.lada@orukatx.com

 

3

 

 

ORUKA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands)

 

   June 30,   December 31, 
   2026   2025 
Assets        
Current assets:        
Cash and cash equivalents  $268,470   $46,935 
Marketable securities, current   605,094    290,109 
Prepaid expenses and other current assets   10,995    6,813 
Total current assets   884,559    343,857 
Marketable securities, long-term   252,017    142,539 
Property and equipment, net   275    288 
Operating lease right-of-use assets   2,415    1,830 
Other non-current assets   128    103 
Total assets  $1,139,394   $488,617 
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $7,950   $4,155 
Accrued expenses and other current liabilities   14,349    10,591 
Operating lease liability, current   669    619 
Related party accounts payable and other current liabilities   -    9 
Total current liabilities   22,968    15,374 
Operating lease liability, non-current   1,877    1,313 
Total liabilities   24,845    16,687 
           
Commitments and contingencies          
Stockholders’ equity:          
Series B non-voting convertible preferred stock   2,931    2,931 
Common stock   61    49 
Additional paid-in capital   1,375,443    657,561 
Accumulated other comprehensive income (loss)   (1,703)   546 
Accumulated deficit   (262,183)   (189,157)
Total stockholders’ equity   1,114,549    471,930 
Total liabilities and stockholders’ equity  $1,139,394   $488,617 

 

4

 

 

ORUKA THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share data)

 

   Three Months Ended 
June 30,
   Six Months Ended
June 30,
 
   2026   2025   2026   2025 
Operating expenses:                
Research and development(1)  $43,257   $24,087   $72,402   $44,012 
General and administrative(1)   6,850    4,342    14,139    9,503 
Total operating expenses   50,107    28,429    86,541    53,515 
Loss from operations   (50,107)   (28,429)   (86,541)   (53,515)
Other income (expense):                    
Interest income   8,897    3,857    13,503    7,949 
Other income (expense), net   4    (2)   12    (7)
Total other income, net   8,901    3,855    13,515    7,942 
Net Loss  $(41,206)  $(24,574)  $(73,026)  $(45,573)
                     
Net loss per share attributable to common stockholders, basic and diluted  $(0.55)  $(0.46)  $(1.04)  $(0.85)
                     
Net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted  $(46.22)  $(38.26)  $(86.36)  $(71.23)
                     
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted   62,872,318    42,095,951    59,038,131    41,888,906 
                     
Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted   137,138    137,138    137,138    137,138 

 

(1)Amounts include non-cash stock based compensation expense (including Paruka warrant obligation) as follows (in thousands):

 

   Three Months Ended June 30,   Six Months Ended June 30, 
   2026   2025   2026   2025 
                 
Research and development  $3,913   $3,368   $7,492   $6,371 
General and administrative   3,371    1,709    6,760    3,589 
Total  $7,284   $5,077   $14,252   $9,960 

 

5

 

Filing Exhibits & Attachments

4 documents