Jade Biosciences Inc.

08/13/2025 | Press release | Distributed by Public on 08/13/2025 14:21

Quarterly Report for Quarter Ending June 30, 2025 (Form 10-Q)

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the unaudited condensed consolidated financial statements and the related notes included in Part 1 - Item 1 of this Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 (this "Quarterly Report"). The following discussion contains forward-looking statements that reflect our current plans, estimates and beliefs and involve risks and uncertainties. Words such as "may," "might," "will," "would," "shall," "objective," "intend," "target," "should," "could," "can," expect," "anticipate," "believe," "design," "estimate," "forecast," "predict," "potential," "plan," "seek," or "continue" and variations of such words and any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, and similar expressions are intended to identify forward-looking statements. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. Our actual results and the timing of events could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the section of this Quarterly Report titled "Risk Factors" and elsewhere in this Quarterly Report. These and many other factors could affect our future financial and operating results. We undertake no obligation to update any forward-looking statement to reflect events after the date of this Quarterly Report. As used in this Quarterly Report, unless the context suggests otherwise, "we," "us," "our," "the Company," and "Jade," refer to Jade Biosciences, Inc. and its consolidated subsidiaries, taken as a whole.

Overview

We are a biopharmaceutical company developing novel biologic therapies for patients living with autoimmune diseases. Our goal is to improve meaningfully upon the existing treatment paradigm through the delivery of improved dosing and convenience, a comparable safety profile, and potentially increased clinical activity. Our approach is to discover and efficiently develop biologics that address emerging targets supported by third-party clinical data and that overcome shortcomings of existing product candidates in development, such as potency, bioavailability, formulation, and pharmacokinetic properties. Our initial program, JADE-001, is targeting a cytokine called "A PRoliferation Inducing Ligand" ("APRIL") that modulates plasma cell survival and immunoglobulin production. As part of the JADE-001 program, we are developing our lead candidate, JADE101, a monoclonal antibody targeting APRIL that we plan to initially develop for the treatment of IgA nephropathy, with initiation of a first-in-human clinical trial in healthy volunteers planned in the third quarter of 2025 and interim data expected in the first half of 2026. In addition to JADE-001, we are conducting pre-clinical research with respect to two other programs in serious, systemic autoimmune indications with high unmet need, JADE-002, which includes our second product candidate, JADE201, and JADE-003.

Since our inception, we have devoted substantially all of our resources to raising capital, organizing and staffing the company, business and scientific planning, conducting discovery and research activities, establishing arrangements with third parties, and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from the issuance of convertible notes ("Convertible Notes"), from which we received gross proceeds of $80.0 million in July 2024 and $15.0 million in September 2024, and with the $205.0 million in gross proceeds from the Pre-Closing Financing (as defined and described in "-Recent Developments - Pre-Closing Financing" below).

We have incurred operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of JADE101, JADE201 and any future product candidates we may develop. We have generated net losses of $32.1 million for the three months ended June 30, 2025 and $70.3 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $117.3 million. For the six months ended June 30, 2025, we used net cash of $38.9 million for our operating activities. We expect to continue to incur significantly increased expenses for the foreseeable future if and as we:

advance our existing and future research and development and discovery-related development of our JADE-001, JADE-002 and JADE-003 programs, including potential expansion into additional indications;
seek and identify additional research programs and product candidates and initiate discovery related activities and preclinical studies for those programs;
complete future preclinical studies for our pipeline;
pursue investigational new drug applications or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials;
initiate enrollment and successfully complete clinical trials;
pursue positive results from our future clinical trials that support a finding of safety and effectiveness, an acceptable risk-benefit profile in the intended populations and a competitive efficacy, safety and half-life profile;
hire research and development, clinical, manufacturing and commercial personnel;
add operational, financial and management information systems and personnel;
experience any delays, challenges, or other issues associated with the preclinical and clinical development of our programs, including with respect to our regulatory strategies;
develop, maintain and enhance a sustainable, scalable, reproducible and transferable clinical and commercial-scale current good manufacturing practices ("cGMP") capabilities through a third-party or our own manufacturing facility for our current and any future programs;
seek, obtain and maintain regulatory approvals for any product candidates for which we successfully complete clinical trials;
ultimately establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory approval;
generate revenue from commercial sales of product candidates for which we receive regulatory approval, if any;
pursue positive results from future clinical trials that support safety, tolerability and efficacy profile of any product we may develop in additional indications following approval in one indication;
maintain, expand, enforce, defend and protect our intellectual property portfolio and other intellectual property protection or regulatory exclusivity for any products we may develop and defend any intellectual property-related claims;
further acquire or in-license product candidates or programs, intellectual property and technologies;
maintain our current collaboration and establish and maintain any future collaborations, including making milestone, royalty or other payments thereunder; and
incur additional costs of operating as a public company, including increased costs of audit, legal, regulatory and tax-related services associated with maintaining compliance with an exchange listing and SEC requirements, director and officer insurance premiums and investor and public relations costs.

Any changes in the outcome of any of these variables with respect to the development of our current and any future programs could mean a significant change in the costs and timing associated with the development of such programs. For example, if the U.S. Food and Drug Administration or another comparable regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required to complete clinical development and obtain regulatory approval of one or more product candidates, or if we experience significant delays in our preclinical studies or clinical trials, we would be required to expend significant additional financial resources and time to advance and complete clinical development. We may never obtain regulatory approval for any of our product candidates.

We will not generate revenue from product sales unless and until we successfully initiate and complete clinical development and obtain regulatory approval for any product candidates. If we obtain regulatory approval for any of our product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, manufacturing, marketing, and distribution.

As a result of all the foregoing, we expect to need substantial additional funding to support our continued operations and growth strategy. Until such a time we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.

Because of the numerous risks associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of June 30, 2025, we had cash and cash equivalents of $220.9 million. We expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of

filing this Quarterly Report. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure.

Recent Developments

The Merger

On April 28, 2025 (the "Closing Date"), we consummated the previously announced transaction (the "Closing") pursuant to that certain Agreement and Plan of Merger and Reorganization, dated as of October 30, 2024 (the "Merger Agreement"), by and among Jade Biosciences, Inc., a private Delaware corporation ("Pre-Merger Jade"), Aerovate Therapeutics, Inc., a Delaware corporation ("Aerovate"), Caribbean Merger Sub I, Inc., a Delaware corporation and wholly-owned subsidiary of Aerovate ("First Merger Sub"), and Caribbean Merger Sub II, LLC, a Delaware limited liability company and wholly-owned subsidiary of Aerovate ("Second Merger Sub"). As part of the Closing, First Merger Sub merged with and into Pre-Merger Jade, with Pre-Merger Jade continuing as a wholly owned subsidiary of Aerovate and the surviving corporation of the merger (the "First Merger" and such time, the "First Effective Time"), and Pre-Merger Jade merged with and into Second Merger Sub, with Second Merger Sub being the surviving entity of the merger (the "Second Merger" and, together with the First Merger, the "Merger"). In connection with the Merger, Second Merger Sub changed its name to "Jade Biosciences, LLC" and Aerovate changed its name to "Jade Biosciences, Inc." Subsequently, Jade Biosciences, LLC merged with and into Jade Biosciences, Inc. We are led by Pre-Merger Jade's management team and focus on developing differentiated biologic therapies for patients living with autoimmune diseases.

Following the Reverse Stock Split (as defined below), which occurred immediately prior to the Closing of the Merger, and as a result of and upon the First Effective Time, i) each then-outstanding share of common stock, par value $0.0001 per share, of Pre-Merger Jade (the "Pre-Merger Jade common stock") (including shares of Pre-Merger Jade common stock issued in connection with the Pre-Closing Financing) immediately prior to the First Effective Time (excluding shares cancelled pursuant to the Merger Agreement and excluding dissenting shares) automatically converted into the right to receive a number of shares of common stock, par value $0.0001, of Aerovate (the "Company common stock" and prior to the effective time of the Merger, the "Aerovate common stock") equal to an exchange ratio determined in accordance with the Merger Agreement (the "Exchange Ratio"), (ii) each then-outstanding share of Series Seed Convertible Preferred Stock, par value $0.0001 per share, of Pre-Merger Jade immediately prior to the First Effective Time (excluding shares cancelled pursuant to the Merger Agreement and excluding dissenting shares) automatically converted into the right to receive a number of shares of Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share, of Aerovate, which are each convertible into 1,000 shares of Company common stock, equal to the Exchange Ratio divided by 1,000, (iii) each then-outstanding option to purchase Pre-Merger Jade common stock was assumed by Aerovate and was converted into an option to purchase shares of Company common stock, subject to adjustment as set forth in the Merger Agreement, and (iv) each then-outstanding pre-funded warrant to purchase shares of Pre-Merger Jade common stock (including any pre-funded warrants to purchase shares of Pre-Merger Jade common stock issued in the Jade Pre-Closing Financing) was converted into a pre-funded warrant to purchase shares of Company common stock (subject to adjustment as set forth in the Merger Agreement and the form of pre-funded warrant).

The Exchange Ratio was calculated using a formula intended to allocate existing Aerovate and Pre-Merger Jade security holders a percentage of the Company. Based on Aerovate's and Pre-Merger Jade's values as of the date of the Merger Agreement and capitalization as of April 28, 2025, the Exchange Ratio (as adjusted for the Reverse Stock Split (as defined below)) was 0.6311 shares of Aerovate common stock for each share of Pre-Merger Jade common stock.

The Merger was accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, Pre-Merger Jade was deemed to be the accounting acquirer for financial reporting purposes. This determination was primarily based on the fact that, immediately following the Merger: (i) Pre-Merger Jade stockholders owned a substantial majority of the voting rights in the combined company; (ii) Pre-Merger Jade's largest stockholders retained the largest interest in the combined company; (iii) Pre-Merger Jade designated a majority of the initial members of the board of directors of the combined company; and (iv) Pre-Merger Jade's executive management team became the management team of the combined company. Accordingly, for accounting purposes: (i) the Merger was treated as the equivalent of Pre-Merger Jade issuing stock to acquire the net assets of Aerovate, and (ii) the reported historical operating results of the combined company prior to the Merger are those of Pre-Merger Jade. Additional information regarding the Merger is included in Note 3 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report.

Pre-Closing Financing

In connection with the Merger, Pre-Merger Jade entered into a subscription agreement with certain new and existing investors of Pre-Merger Jade (the "Subscription Agreement"), in order to provide Jade with additional capital for its development programs, pursuant to which Pre-Merger Jade issued and sold, and certain new and existing investors purchased, 43,947,116 shares of common stock of Pre-Merger Jade ("Pre-Merger Jade common stock") and 12,305,898 pre-funded warrants, exercisable for 12,305,898 shares

of Pre-Merger Jade common stock ("Pre-Merger Jade pre-funded warrants"), at a purchase price of $5.9407 per share or a purchase price of $5.9406 per pre-funded warrant, for an aggregate amount of $334.2 million, which included $95.0 million of proceeds previously received from the issuance of Convertible Notes (as defined herein) and accrued interest of $8.3 million on such Convertible Notes and the conversion of the Convertible Notes into shares of Pre-Merger Jade pre-funded warrants (the "Pre-Closing Financing").

Under the Merger Agreement, these shares of Pre-Merger Jade common stock and Pre-Merger Jade pre-funded warrants were converted into shares of the common stock of the combined company ("Company common stock") and pre-funded warrants to purchase Company common stock in accordance with the Exchange Ratio.

Reverse Stock Split

Immediately prior to the consummation of the Merger, Aerovate effected a 1-for-35 reverse stock split of Aerovate common stock, which became legally effective on April 28, 2025 (the "Reverse Stock Split"). The Company common stock commenced trading on a post-Reverse Stock Split, post-Merger basis at the open of trading on April 29, 2025. All references to common stock, options to purchase common stock, outstanding common stock warrants, common stock share data, per share data, and related information contained in the condensed consolidated financial statements have been retrospectively adjusted to reflect the effect of the Reverse Stock Split for all periods presented, unless otherwise specifically indicated or the context otherwise requires.

Redomestication

On April 28, 2025, we changed our jurisdiction of incorporation from the State of Delaware to the State of Nevada (the "Redomestication") pursuant to a plan of conversion. The Redomestication became effective on April 28, 2025.

The common stock of the Nevada Corporation resulting from the Redomestication continues to be traded on The Nasdaq Capital Market ("Nasdaq") under the symbol "JBIO." The Redomestication did not cause any interruption in the trading of such common stock.

Impact of General Economic Risk Factors on Our Operations

Uncertainty in the global economy presents significant risks to our business. We are subject to continuing risks and uncertainties in connection with the current macroeconomic environment, including increases in inflation, fluctuating interest rates, new or increased tariffs and other barriers to trade, changes to fiscal and monetary policy or government budget dynamics (particularly in the pharmaceutical and biotech areas), bank failures, geopolitical factors, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the responses thereto and rising tensions with China, and supply chain disruptions. While we are closely monitoring the impact of the current macroeconomic and geopolitical conditions on all aspects of our business, including the impacts on our access to capital, ability to manufacture drug product, ability to conduct clinical trials, and our clinical trial participants, employees, suppliers, vendors and business partners, the ultimate extent of the impact on our business remains highly uncertain and will depend on future developments and factors that continue to evolve. Most of these developments and factors are outside our control and could exist for an extended period of time. We will continue to evaluate the nature and extent of the potential impacts to our business, results of operations, liquidity and capital resources. For additional information, see Item 1A of this Quarterly Report titled "Risk Factors."

Components of Results of Operations

Revenue

To date, we have not generated revenue from any sources, including product sales, and do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales or payments from future collaboration or license agreements that we may enter into with third parties, or any combination thereof. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.

Operating Expenses

Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.

Research and Development

Research and development expenses consist primarily of costs incurred in connection with the research and development of our programs. These expenses include:

costs of funding research performed by third parties, that conduct research and development activities on our behalf, including services rendered under the Antibody Discovery and Option Agreement (the "Paragon Option Agreement") with Paragon Therapeutics, Inc. ("Paragon") and Parade Biosciences Holding, LLC ("Parade"), and our License Agreement with Paragon relating to the JADE-001 research program (the "JADE-001 License Agreement") for the selected target APRIL, and for our JADE-002 and JADE-003 programs, which have currently undisclosed targets;
expenses incurred in connection with continuing our current research programs and discovery- phase development of any programs we may identify, including under future agreements with third parties, such as consultants and contractors; and
personnel-related expenses, including recruiting costs, salaries, bonuses, benefits and equity-based compensation expense.

We expense research and development costs as incurred. For the three and six months ended June 30, 2025, we recognized $3.9 million and $11.7 million of expenses, respectively, in connection with services provided by Paragon under the Paragon Option Agreement and the JADE-001 License Agreement in our condensed consolidated statement of operations and comprehensive loss.

General and Administrative

General and administrative expenses consist primarily of personnel-related expenses, including recruiting costs, salaries, bonuses, benefits, and equity-based compensation, for individuals in our executive, finance, operations, human resources, legal, business development and other administrative functions. Other significant general and administrative expenses include legal fees relating to corporate matters and patent-related activities, insurance costs, information technology, and professional and consulting fees associated with accounting, audit, tax and investor and public relations.

We expect that our general and administrative expenses will increase substantially for the foreseeable future as we increase our headcount and establish office space to support our expected growth. We also incurred and expect to continue to incur increased expenses associated with becoming a public company, including increased costs of accounting, audit, legal, regulatory and tax related services associated with maintaining compliance with SEC requirements, additional director and officer insurance costs, and investor and public relations costs. We also expect to incur additional intellectual property-related expenses as we file patent applications to protect innovations arising from our research and development activities.

Other Income (Expense)

Other income primarily relates to interest income. Change in fair value of convertible notes payable relates to the fair value adjustment related to our Convertible Notes.

Income Taxes

We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date, as we believe it is more likely than not that the benefit won't be realized due to our cumulative losses generated to date and expectation of future losses.

Results of Operations for the Three Months ended June 30, 2025 and the Period from June 18, 2024 (Inception) through June 30, 2024:

The following table summarizes our interim condensed consolidated statement of operations and comprehensive loss for the periods presented (in thousands):

Three Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Increase / (Decrease)

Operating expenses

Research and development(1)

$

22,547

$

78

$

22,469

General and administrative(2)

5,231

512

4,719

Total operating expenses

27,778

590

27,188

Loss from operations

(27,778

)

(590

)

(27,188

)

Other income / (expense):

Interest income

1,828

-

1,828

Change in fair value of convertible notes payable(3)

(6,184

)

-

(6,184

)

Total other expense, net

(4,356

)

-

(4,356

)

Net loss

$

(32,134

)

$

(590

)

$

(31,544

)

(1)
Includes related party amount of $3.9 million for the three months ended June 30, 2025 and $0.1 million for the period from June 18, 2024 (inception) through June 30, 2024.
(2)
Includes related party amount of $0.1 million for the three months ended June 30, 2025 and $0.4 million for the period from June 18, 2024 (inception) through June 30, 2024.
(3)
Includes related party amount of $1.3 million for the three months ended June 30, 2025.

Research and Development Expenses

The following table summarizes our research and development expenses incurred for the period presented (in thousands):

Three Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Increase / (Decrease)

External research and development costs:

JADE-001 external research and development costs(1)

$

7,249

$

78

$

7,171

JADE-002 external research and development costs(2)

8,356

-

8,356

JADE-003 external research and development costs(3)

926

-

926

Other research and development costs:

Personnel-related (including stock-based compensation)(4)

5,710

-

5,710

Other

306

-

306

Total research and development expenses

$

22,547

$

78

$

22,469

(1)
Includes related party amount of $0.6 million for the three months ended June 30, 2025 and $0.1 million for the period from June 18, 2024 (inception) through June 30, 2024.
(2)
Includes related party amount of $0.8 million for the three months ended June 30, 2025.
(3)
Includes related party amount of $0.9 million for the three months ended June 30, 2025.
(4)
Includes related party amount of $1.5 million for the three months ended June 30, 2025.

Research and development expenses were $22.5 million for the three months ended June 30, 2025 and consisted primarily of the following:

$0.6 million of research and development expense related to services rendered by Paragon under the Paragon Option Agreement and the JADE-001 License Agreement for JADE101;
$2.1 million related to toxicology studies for JADE101;
$3.3 million related to chemistry, manufacturing and controls related costs to manufacture our raw materials and for developing drug product for our future clinical trial for JADE101;
$0.5 million related to early clinical related spend for JADE101;
$0.6 million additional research and development costs related to JADE101;
$0.8 million of research and development expense related to services rendered by Paragon under the Paragon Option Agreement for JADE-002;
$5.1 million relating to drug product for our expected future clinical trial of JADE201;
$2.3 million related to toxicology studies for JADE201;
$0.2 million additional research and development costs related to JADE201;
$0.9 million of research and development expense related to services rendered by Paragon under the Paragon Option Agreement in connection with JADE-003 discovery efforts;
$5.7 million of personnel-related costs related to recruiting costs, salaries, benefits, and other compensation-related costs, of which $1.1 million related to stock-based compensation expense, and an additional $1.5 million related to stock-based compensation expense related to the pre-funded warrants issuable to Parade under the Paragon Option Agreement (the "Parade Warrants"); and
$0.3 million of other research and development expenses.

Research and development expenses were $0.1 million for the period from June 18, 2024 (inception) through June 30, 2024 and consisted primarily of early research and development costs.

General and Administrative Expenses

The following table summarizes our total general and administrative expenses for the period presented (in thousands):

Three Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Increase / (Decrease)

Professional and consulting fees

$

1,933

$

512

$

1,421

Personnel-related (including stock-based compensation)

3,118

-

3,118

Legal fees related to patent filings(1)

180

-

180

Total general and administrative expenses

$

5,231

$

512

$

4,719

(1)
Includes related party amount of $0.1 million for the three months ended June 30, 2025.

General and administrative expenses were $5.2 million for three months ended June 30, 2025 and consisted primarily of the following:

$1.9 million of professional and consulting fees associated with accounting, audit, investor and public relations and legal fees due to an increase in our business activity and costs associated with becoming a public company; and
$3.1 million of personnel-related costs related to recruiting costs, salaries, benefits and other compensation-related costs, including stock-based compensation of $1.4 million.

General and administrative expenses were $0.5 million for the period from June 18, 2024 (inception) through June 30, 2024 consisted primarily of early general and administrative costs relating to professional and consulting fees.

Results of Operations for the Six Months ended June 30, 2025 and the Period from June 18, 2024 (Inception) through June 30, 2024:

The following table summarizes our interim condensed consolidated statement of operations and comprehensive loss for the period presented (in thousands):

Six Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Increase / (Decrease)

Operating expenses

Research and development(1)

$

42,570

$

78

$

42,492

General and administrative(2)

8,592

512

8,080

Total operating expenses

51,162

590

50,572

Loss from operations

(51,162

)

(590

)

(50,572

)

Other income / (expense):

Interest income

2,443

-

2,443

Change in fair value of convertible notes payable(3)

(21,584

)

-

(21,584

)

Total other expense, net

(19,141

)

-

(19,141

)

Net loss

$

(70,303

)

$

(590

)

$

(69,713

)

(1)
Includes related party amount of $11.7 million for the six months ended June 30, 2025 and $0.1 million for the period from June 18, 2024 (inception) through June 30, 2024.
(1)
Includes related party amount of $0.1 million for the six months ended June 30, 2025 and $0.4 million for the period from June 18, 2024 (inception) through June 30, 2024.
(3)
Includes related party amount of $4.6 million for the six months ended June 30, 2025.

Research and Development Expenses

The following table summarizes our research and development expenses incurred for the period presented (in thousands):

Six Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Increase / (Decrease)

External research and development costs:

JADE-001 external research and development costs(1)

$

17,016

$

78

$

16,938

JADE-002 external research and development costs(2)

13,510

-

13,510

JADE-003 external research and development costs(3)

1,659

-

1,659

Other research and development costs:

Personnel-related (including stock-based compensation)(4)

9,662

-

9,662

Other

723

-

723

Total research and development expenses

$

42,570

$

78

$

42,492

(1)
Includes related party amount of $2.0 million for the six months ended June 30, 2025 and $0.1 million for the period from June 18, 2024 (inception) through June 30, 2024.
(2)
Includes related party amount of $5.7 million for the six months ended June 30, 2025.
(3)
Includes related party amount of $1.7 million for the six months ended June 30, 2025.
(4)
Includes related party amount of $2.5 million for the six months ended June 30, 2025.

Research and development expenses were $42.6 million for the six months ended June 30, 2025 and consisted primarily of the following:

$2.0 million of research and development expense related to services rendered by Paragon under the Paragon Option Agreement and the JADE-001 License Agreement for JADE101;
$5.1 million related to toxicology studies for JADE101;
$8.6 million related to chemistry, manufacturing and controls related costs to manufacture our raw materials and for developing drug product for our future clinical trial for JADE101;
$0.5 million related to early clinical related spend for JADE101;
$0.8 million additional research and development costs related to JADE101;
$5.7 million of research and development expense related to services rendered by Paragon under the Paragon Option Agreement for JADE-002, including $1.5 million for achievement of the nomination of a development candidate milestone;
$2.4 million related to toxicology studies for JADE201;
$5.4 million of manufacturing drug product for our expected future clinical trial of JADE201;
$1.7 million of research and development expense related to services rendered by Paragon under the Paragon Option Agreement in connection with JADE-003 discovery efforts;
$9.7 million of personnel-related costs related to recruiting costs, salaries, benefits, and other compensation-related costs, of which $1.7 million related to stock-based compensation expense, and an additional $2.5 million related to stock-based compensation expense related to the Parade Warrants; and
$0.7 million of other research and development expenses.

Research and development expenses were $0.1 million for the period from June 18, 2024 (inception) through June 30, 2024 and consisted primarily of early research and development costs.

General and Administrative Expenses

The following table summarizes our total general and administrative expenses for the period presented (in thousands):

Six Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Increase / (Decrease)

Professional and consulting fees

$

3,426

$

512

$

2,914

Personnel-related (including stock-based compensation)

4,799

-

4,799

Legal fees related to patent filings(1)

346

-

346

Other

21

-

21

Total general and administrative expenses

$

8,592

$

512

$

8,080

(1)
Includes related party amount of $0.1 million for the six months ended June 30, 2025.

General and administrative expenses were $8.6 million for the six months ended June 30, 2025 and consisted primarily of the following:

$3.4 million of professional and consulting fees associated with accounting, audit, investor and public relations and legal fees due to an increase in our business activity and costs associated with becoming a public company;
$4.8 million of personnel-related costs related to recruiting costs, salaries, benefits and other compensation-related costs, including stock-based compensation of $2.1 million;
$0.3 million of legal fees related to patent-related activities; and
Less than $0.1 million of other general and administrative expenses.

General and administrative expenses were $0.5 million for the period from June 18, 2024 (inception) through June 30, 2024 and consisted primarily of early general and administrative costs relating to professional and consulting fees.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses for the foreseeable future as we continue the preclinical development of our programs and commence clinical development of JADE101. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have funded our operations primarily with proceeds from the sale of our Convertible Notes and the Pre-Closing Financing. In July 2024, we received $80.0 million in gross proceeds from the issuance of our Convertible Notes, in September 2024 we received $15.0 million in gross proceeds for the issuance of additional Convertible Notes, and in April 2025 we received $205 million in gross proceeds from the Pre-Closing Financing. As of June 30, 2025, we had cash and cash equivalents of $220.9 million.

Our primary use of cash is to fund the development of our product candidates and advance our pipeline. This includes both the research and development costs and the general and administrative expenses required to support those operations. Since we are currently a preclinical-stage biotechnology company, we have incurred significant operating losses since our inception and we anticipate such losses to increase as we continue to pursue clinical development of our product candidates, prepare for the potential commercialization of our product candidates, and expand our pipeline research and development efforts. We expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of issuance of this Quarterly Report. We will need to secure additional financing in the future to fund additional research and development, and before a commercial drug can be produced, marketed, and sold. If we are unable to obtain additional financing or generate license or product revenue, the lack of liquidity could have a material adverse effect on our company.

Cash Flows

The following table summarizes our cash flows for the period presented (in thousands):

Six Months Ended
June 30, 2025

Period from June 18, 2024 (Inception) Through June 30, 2024

Net cash used in operating activities

$

(38,916

)

$

-

Net cash used in investing activities

$

(136

)

-

Net cash provided by financing activities

190,608

-

Net increase in cash and cash equivalents

$

151,556

$

-

Net Cash Used in Operating Activities

For the six months ended June 30, 2025, net cash used in operating activities was $38.9 million, which was primarily attributable to a net loss of $70.3 million, partially offset by non-cash charges of $27.9 million and changes in operating assets and liabilities of $3.5 million. Non-cash charges consisted of a $21.6 million increase in the fair value of convertible notes payable and $6.4 million increase in stock-based compensation expense. Net cash provided by changes in our operating activities consisted of a $4.9 million increase in accounts payable and a change of $2.9 million related to accrued expenses and other current liabilities, partially offset by a $3.1 million decrease in related party accrued expenses and other current liabilities and a $1.4 million increase in prepaid expenses. The increase in accounts payable, accrued expenses and other current liabilities was primarily due to an increase in our business activity and vendor invoicing and payments. The increase in prepaid expenses and other current assets was primarily due to prepaid research and development expenses with our contract research organization as well as prepaid contracts for our Directors and Officers liability insurance.

Net Cash Used in Investing Activities

For the six months ended June 30, 2025, net cash used in investing activities was $0.1 million, which was driven by purchases of leasehold improvements related to the lease of our Canadian office space.

Net Cash Provided by Financing Activities

For the six months ended June 30, 2025, net cash provided by financing activities was $190.6 million, which primarily related to the $205.0 million in gross proceeds from the Pre-Closing Financing partially offset by $14.5 million of deferred offering costs.

Future Funding Requirements

To date, we have not generated any revenue from product sales. We do not expect to generate revenue from product sales unless and until we successfully complete preclinical and clinical development of, receive regulatory approval for, and commercialize a product candidate. We do not know when, or if, that will occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any programs, we expect to incur significant expenses related to product sales, marketing, and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Additionally, in conjunction with the Merger and going public, we expect to incur additional costs associated with operating as a public company.

Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including, but not limited to:

the rate of progress in the development of our existing and future research and development and discovery-related development of our JADE-001, JADE-002 and JADE-003 programs, including potential expansion into additional indications;
the scope, progress, results and costs of additional research programs and product candidates and discovery-related activities and preclinical studies for those programs;
our ability to successfully file investigational new drug applications or comparable foreign applications and obtain authorization to commence our planned clinical trials or future clinical trials;
the costs of enrollment and successful completion of clinical trials;
the costs necessary to pursue positive results from our future clinical trials that support a finding of safety and effectiveness, an acceptable risk-benefit profile in the intended populations and a competitive efficacy, safety and half-life profile;
the costs of hiring research and development, clinical, manufacturing and commercial personnel;
the costs of adding operational, financial and management information systems and personnel;
the costs necessary to obtain regulatory approvals, if any, for any approved products in the United States and other jurisdictions, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where approval is obtained;
the costs of developing, maintaining and enhancing sustainable, scalable, reproducible and transferable clinical and commercial-scale cGMP capabilities through a third-party or our own manufacturing facility for our programs;
the costs and timing of future commercialization activities, including establishing sales, marketing and distribution infrastructure to commercialize any product candidates, for any of our product candidates for which we receive regulatory approval;
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
the costs and timing of preparing, maintaining, expanding, enforcing, defending and protecting our intellectual property rights and protection or regulatory exclusivity for any products we may develop and defending any intellectual property-related claims;
the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and potential future collaborations and licensing arrangements with third parties;
the costs we incur in maintaining business operations;
the costs associated with being a public company, including costs of audit, legal, regulatory and tax- related services associated with maintaining compliance with an exchange listing and SEC requirements, director and officer insurance premiums and investor and public relations costs;
the effect of competing technological and market developments; and
the extent to which we acquire or invests in businesses, products and technologies, including entering into licensing or collaboration arrangements for programs.

Identifying potential programs and product candidates and conducting preclinical studies and clinical trials is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our programs, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.

Adequate additional funds may not be available to us on acceptable terms, or at all. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute ownership interests.

If we raise additional funds through strategic collaborations or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourself.

As of June 30, 2025 we had cash and cash equivalents of $220.9 million. We expect that our existing cash and cash equivalents, together with the proceeds from the Pre-Closing Financing, will be sufficient to fund our operating plans for at least twelve months from the issuance of the condensed consolidated financial statements for the six months ended June 30, 2025. We expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure.

Contractual Obligations and Other Commitments

We enter into contracts in the normal course of business with CROs, CMOs, and with other vendors for preclinical research studies, clinical trials, manufacturing, and other services and products for operating purposes. These contracts generally provide for termination on notice or may have a potential termination fee if the contract is cancelled within a specified time, and therefore, are cancellable contracts. We do not expect any such contract terminations and did not have any non-cancellable obligations under these agreements as of June 30, 2025. See Notes 10, 11, and 12 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for further information on our contractual lease obligations for our office in Vancouver, Canada, and other commitments, including the commitments under the Paragon Option Agreement and JADE-001 License Agreement.

Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenues recognized and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 2 to our audited consolidated financial statements and the related notes thereto beginning on page F-22 of Aerovate's definitive proxy statement/prospectus filed on Form S-4 with the SEC, most recently amended on March 24, 2025 and declared effective on March 25, 2025, we believe the following accounting policies used in the preparation of our condensed consolidated financial statements require the most significant judgments and estimates.

Research and Development Contract Costs Accruals

We record the costs associated with research studies and manufacturing development as incurred. These costs are a significant component of our research and development expenses, with a substantial portion of our ongoing research and development activities conducted by third-party service providers, including contract research organizations and contract manufacturing organizations, and our related party, Paragon.

We accrue for expenses resulting from obligations under Paragon Option Agreement between Paragon, Parade, and us and agreements with Contract Research Organizations ("CROs"), Contract Manufacturing Organizations ("CMOs"), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to us. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with Paragon, CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. We make significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to Paragon, a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be expensed as the contracted services are performed. Changes in these estimates that result in material changes to our accruals could materially affect our results of operations. As of June 30, 2025, we have not experienced any material deviations between accrued and actual research and development expenses.

Stock-Based Compensation

We measure stock-based awards granted to employees, directors, and non-employees in the form of stock options to purchase shares of our common stock, based on their fair value on the date of the grant using the Black-Scholes model. We measure restricted common stock awards using the difference, if any, between the purchase price per share of the award and the fair value of our common stock at the date of grant. Compensation expense for those awards is recognized using the straight-line method over the requisite service period, which is generally the vesting period of the respective award for employees. Compensation expense for awards to non-employees with service-based vesting conditions is recognized in the same manner as if we had paid cash in exchange for the goods or services, which is generally over the vesting period of the award. We account for forfeitures as they occur. We classify our stock-based compensation expenses in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified.

The Black-Scholes model uses inputs that are determined by our board of directors on the date of grant and assumptions we make for the volatility of stock-based awards, the expected term of stock-based awards, the risk-free interest rate for a period that approximates the expected term of our stock-based awards and our expected dividend yield. We have historically been a private company and lack company-specific historical and implied volatility information of our stock. Therefore, we estimate our expected stock volatility based on the historical volatility of a representative group of public companies in the biotechnology industry for a term equal to the remaining time of the expected term. The expected term of our stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" stock options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the options on the date of measurement. We have estimated a 0% dividend yield based on the expected dividend yield and the fact that we have never paid, and do not expect to pay, any cash dividends in the foreseeable future. See Note 8 to our unaudited condensed consolidated financial statements for information concerning certain of the specific assumptions we used in applying the Black-Scholes model to determine the estimated fair value of our stock options granted in the periods presented.

Determination of Fair Value of Common Stock

A public trading market for our common stock has been established in connection with the completion of the Merger and the Nasdaq listing of our common stock. As such, it is no longer necessary for our board of directors to estimate the fair value of our share awards in connection with our accounting for granted share-based awards or other such awards we may grant, as the fair value of our common stock and share-based awards is determined based on the quoted market price of our common stock.

Prior to the Merger, our pre-Merger common stock valuations were prepared by a third-party valuation firm using a hybrid method, including an option pricing method ("OPM"). The OPM treats common stock and preferred stock as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company's securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the preferred stock liquidation preferences at the time of the liquidity event, such as a strategic sale or a merger. The hybrid method is a probability-weighted expected return method ("PWERM"), where the equity value in one or more of the scenarios is calculated using an OPM. The PWERM is a scenario-based methodology that estimates the fair value of common stock based upon an analysis of future values for a company, assuming various outcomes. The common stock value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock. A discount for lack of marketability of the common stock is then applied to arrive at an indication of value for the common stock.

The assumptions underlying these valuations represented management's best estimate, which involved inherent uncertainties and the application of management's judgment. As a result, if our pre-Merger common stock valuations had used significantly

different assumptions or estimates, the fair value of our pre-Merger incentive shares and our share-based compensation expense could have been materially different.

Convertible Notes

Immediately prior to the effective time of the Merger, shares of Pre-Merger Jade common stock and Pre-Merger Jade pre-funded warrants were issued pursuant to the conversion of the Convertible Notes based on the aggregate principal amount of $95.0 million plus unpaid accrued interest divided by the conversion price in connection with the Pre-Closing Financing. As of June 30, 2025, there are no Convertible Notes outstanding. At the effective time of the Merger, the Pre-Merger Jade shares and warrants issued upon conversion of the Convertible Notes (including accrued interest) automatically converted into 9,433,831 shares of Jade Common Stock and 4,289,744 Jade pre-funded warrants.

Prior to the Closing, we accounted for our Convertible Notes under Accounting Standard Codification ("ASC") No. 815, Derivatives and Hedging ("ASC 815"). Under ASC 815, the election can be made at the inception of a financial instrument to account for the instrument under ASC No. 825, Fair Value Measurements and Disclosures (Including the Fair Value Option) ("ASC 825" and the "Fair Value Option"). We performed an analysis of all of the terms and features of the Convertible Notes and have elected to address simplification and cost-benefit considerations to use the Fair Value Option to account for the Convertible Notes as we have identified embedded derivatives, such as automatic conversion upon closing of the Next Equity Financing and automatic conversion upon the event of a Corporate Transaction, both of which required bifurcation and separate accounting. The Convertible Notes were remeasured at fair value at each balance sheet date until conversion. Changes to the fair value of the Convertible Notes were recorded in other expense in the condensed consolidated statement of operations and comprehensive loss. There were no changes in fair value caused by instrument-specific credit risk. The analysis of the fair value of the Convertible Notes contained inherent assumptions related to the market interest rate, instrument-specific credit risk, the probability of alternate financing, change of control, initial public offering, maturity extension, and payment at original maturity. Due to the use of significant unobservable inputs, the overall fair value measurement of the Convertible Notes were classified as Level 3 while the Convertible Notes were outstanding.

Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact Jade's financial position, results of operations or cash flows is disclosed in Note 2 to our condensed consolidated financial statements as of June 30, 2025.

Off-Balance Sheet Arrangements

As of June 30, 2025, we did not have any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Jade Biosciences Inc. published this content on August 13, 2025, and is solely responsible for the information contained herein. Distributed via SEC EDGAR on August 13, 2025 at 20:21 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]