Rallybio RLYB

Rallybio reports $0 revenue

Form
10-Q
Filed
Importance
Notable
  1. Revenue: $0 for the three months ended Sep 30, 2026
  2. Net loss: $2.73 million for the three months ended Sep 30, 2026
  3. Diluted EPS: -$0.48 for the three months ended Sep 30, 2026
  4. Cash and equivalents: $90.69 million at Sep 30, 2026

Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.

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What changed since last quarter

1 new risk factor · 2 removed

Compared with the 10-Q for the period ended Jun 30, 2026.

Key numbers from the XBRL in this filing and the previous one.
This filingPreviousChange vs prior 10-Q
Revenue$0$0—
Operating income and margin−$3.42M−$5.65M+39%
Net income−$2.73M$43.67M−106%
Operating cash flow−$2.28M$45.92M−105%
Cash$90.69M$92.85M−2.3%
New risk factors (1)
  • Furthermore, CMOs may breach existing agreements they have with us because of factors beyond our control. They may also terminate or refuse to renew their agreement at a time that is costly or otherwise inconvenient for us. Finding new CMOs or third-party suppliers involves additional cost and requires our management…
Removed risk factors (2)
  • Recently, drug pricing and payment has been subject to a number of reform initiatives. For example, President Trump issued an Executive Order in April 2025 with multiple directives aimed at lowering drug prices, including refining the Medicare drug price negotiation program established by the IRA; accelerating…
  • Regulation ("GDPR") which imposes obligations and restrictions on the collection, use, and disclosure of personal data relating to individuals located in the EU and the EU/European Economic Area ("EEA") (including health data). See Our business operations may subject us to data protection laws, including the GDPR…

The reading, claim by claim

  1. The statements of operations show net loss per common share, basic and diluted, of $(0.48).
  2. Operating expenses for the three months were $3,423 thousand, compared with $7,137 thousand a year earlier.
  3. Research and development was $584 thousand, compared with $4,143 thousand, and general and administrative was $2,839 thousand, compared with $2,994 thousand.
  4. For the nine months ended September 30, 2026, net income was $32,662 thousand, or $5.73 per basic share.
  5. The statement lists a termination fee of $50,000 thousand in other income, and income tax expense of $1,404 thousand.
  6. The balance sheet shows cash and cash equivalents of $90,693 thousand as of September 30, 2026, compared with $31,374 thousand as of December 31, 2025.
  7. Total assets were $95,579 thousand and total liabilities were $3,283 thousand.
  8. Total stockholders' equity was $92,296 thousand.

8 of 9 claims matched the filing text.

Not found in the filing text

  • The nine months ended September 30, 2025 showed a net loss of $3,126 thousand.

From the filing's financial data, not stated in its text

From this 10-Q's financial data (XBRL) for the quarter ended September 30, 2026

  • Revenue changed -100.0% from a year earlier.

From the filing

Item 6.

Item 6.

Exhibits

94

Signatures

95

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Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning:

• our proposed Merger (as defined below) with Avenzo Therapeutics, Inc, a Delaware corporation ("Avenzo") and any potential benefits of the merger;

• the initiation, timing, progress, results, and cost of our research and development programs, and our current and future preclinical and clinical studies, including statements regarding timing of initiation and completion of our clinical trials for RLYB116, and related preparatory work, and the period during which the results of the trials will become available;

• the success, cost and timing of the clinical development of our product candidates, including RLYB116;

• the potential of our product candidates to treat certain target diseases;

• our ability to initiate, recruit and enroll patients in and conduct our clinical trials at the pace that we project;

• our ability to compete with companies currently marketing or engaged in the development of treatments for diseases that our product candidates are designed to target, including diseases of complement dysregulation, diseases of iron overload, immune platelet transfusion refractoriness ("PTR") and refractory antiphospholipid syndrome ("APS");

• our reliance on third parties to conduct our clinical trials;

• enhancements to the manufacturing process for RLYB116;

• our reliance on third parties to manufacture drug substance and drug product for use in our clinical trials;

• our ability to identify and advance through clinical development any additional product candidates;

• our ability to obtain and maintain regulatory designations allowing for priority review of our product candidates, and our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved;

• the size and growth potential of the markets for RLYB116 and any of our current product candidates or other product candidates we may identify and pursue, and our ability to serve those markets;

• the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build commercial infrastructure or enter into collaborations with third parties to market our current product candidates and any other product candidates we may identify and pursue;

• our ability to retain and recruit key personnel;

• our ability to obtain and maintain adequate intellectual property rights;

• our expectations regarding government and third-party payor coverage and reimbursement;

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• our estimates of our expenses, ongoing losses, capital requirements and our needs for or ability to obtain additional financing;

• our eligibility to receive milestone payments and royalties under our Membership Interest Purchase Agreement, dated July 8, 2025, with Recursion Pharmaceuticals, Inc. ("Recursion");

• the potential benefits of strategic collaboration agreements and arrangements and our ability to enter into strategic collaborations or arrangements, including potential business development opportunities and potential licensing partnerships, and our ability to attract collaborators with development, regulatory and commercialization expertise;

• our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012;

• our financial performance;

• developments and projections relating to our competitors or our industry; and

• other risks and uncertainties, including those listed under the section titled "Risk Factors."

The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report on Form 10-Q entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as guarantees of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risks and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties. Except as required by applicable law, we are not obligated to publicl

Item 1. Financial Statements.

Item 1. Financial Statements.

RALLYBIO CORPORATION

Condensed Consolidated Balance Sheets

(Unaudited) (in thousands, except share and per share amounts) SEPTEMBER 30,

2026 DECEMBER 31,

2025

Assets

Current assets:

Cash and cash equivalents $ 90,693 $ 31,3746

Marketable securities — 23,362

Prepaid expenses and other current assets 4,076 6,517

Total current assets 94,769 61,253

Property and equipment, net — 23

Operating lease right-of-use assets — 175

Other assets, noncurrent 810 810 Total assets $ 95,579 $ 62,2617

Liabilities and stockholders' equity

Current liabilities:

Accounts payable $ 7 $ 126

Accrued expenses and other current liabilities 1,927 3,791

Income tax liabilities 1,349 —

Operating lease liabilities — 94

Deferred revenue — 212

Total current liabilities 3,283 4,223

Operating lease liabilities, noncurrent — 82

Total liabilities 3,283 4,3057

Commitments and contingencies (Note 7)

Stockholders' equity

Common stock, $ 0.0001 par value per share; 200,000,000 shares authorized as of September 30, 2026 and December 31, 2025; and 5,333,190 and 5,283,321 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively 4 4 Preferred stock, $ 0.0001 par value per share; 50,000,000 shares authorized as of September 30, 2026 and December 31, 2025; no shares issued or outstanding as of September 30, 2026 and December 31, 2025

— —

Additional paid-in capital 361,628 359,932

Accumulated other comprehensive gain — 18

Accumulated deficit ( 269,336 ) ( 301,998 ) Total stockholders' equity 92,296 57,9568

Total liabilities and stockholders' equity $ 95,579 $ 62,261

See accompanying notes to the condensed consolidated financial statements

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RALLYBIO CORPORATION

Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income

(Unaudited)

FOR THE THREE MONTHS ENDED SEPTEMBER 30, FOR THE NINE MONTHS ENDED SEPTEMBER 30,

(in thousands, except share and per share amounts) 2026 2025 2026 2025 Revenue: Collaboration and license revenue $ — $ 212 $ 212 $ 636 Total revenue — 212 212 636 Operating expenses: Research and development 584 4,143 4,213 15,9423 General and administrative 2,839 2,994 13,808 11,3463 Total operating expenses 3,423 7,137 18,021 27,2882 Loss from operations ( 3,423 ) ( 6,925 ) ( 17,809 ) ( 26,652 )

Other income (expense):

Termination fee — — 50,000 —5

Interest income 778 462 1,893 1,629 Gain on sale of joint venture and other income (expense) — 22,479 ( 18 ) 22,771 Total other income, net 778 22,941 51,875 24,400 (Loss) income before income tax and equity in losses of joint venture ( 2,645 ) 16,016 34,066 ( 2,252 ) Income tax expense 80 — 1,404 —5

Loss on investment in joint venture — — — 874

Net (loss) income $ ( 2,725 ) $ 16,016 $ 32,662 $ ( 3,126 )4 Net (loss) income per common share, basic $ ( 0.48 ) $ 2.84 $ 5.73 $ ( 0.56 )1 Net (loss) income per common share, diluted $ ( 0.48 ) $ 2.84 $ 5.64 $ ( 0.56 )1 Weighted-average common shares outstanding, basic 5,715,048 5,632,291 5,701,011 5,611,536 Weighted-average common shares outstanding, diluted 5,715,048 5,632,291 5,788,752 5,611,536 Other comprehensive (loss) gain: Net unrealized gain (loss) on marketable securities — 7 ( 18 ) ( 44 ) Other comprehensive gain (loss) — 7 ( 18 ) ( 44 ) Comprehensive (loss) gain $ ( 2,725 ) $ 16,023 $ 32,644 $ ( 3,170 )

See accompanying notes to the condensed consolidated financial statements

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RALLYBIO CORPORATION

Condensed Consolidated Statements of Changes in Stockholders' Equity

(Unaudited)

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025 COMMON ADDITIONAL PAID-IN

CAPITAL ACCUMULATED DEFICIT ACCUMULATED OTHER COMPREHENSIVE GAIN STOCKHOLDERS' EQUITY

(in thousands, except share amounts) SHARES AMOUNT

June 30, 2025 5,213,366 $ 4 $ 358,105 $ ( 312,162 ) $ 17 $ 45,964 Share-based compensation — — 1,047 — — 1,047

Issuance of common stock under the stock award plan 28,586 — — — — —

Net income — — — 16,016 — 16,016 Other comprehensive gain — — — — 7 7 Balance, September 30, 2025 5,241,952 $ 4 $ 359,152 $ ( 296,146 ) $ 24 $ 63,034 June 30, 2026 5,306,894 $ 4 $ 361,103 $ ( 266,611 ) $ — $ 94,496 Share-based compensation — — 405 — — 405

Issuance of common stock under the stock award plan 2,085 — — — — —

Issuance of common stock from exercise of stock options 24,211 — 120 — — 120 Net loss — — — ( 2,725 ) — ( 2,725 ) Balance, September 30, 2026 5,333,190 $ 4 $ 361,628 $ ( 269,336 ) $ — $ 92,296

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FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025 COMMON ADDITIONAL PAID-IN

CAPITAL ACCUMULATED DEFICIT ACCUMULATED OTHER COMPREHENSIVE GAIN (LOSS) STOCKHOLDERS' EQUITY

(in thousands, except share amounts) SHARES AMOUNT

December 31, 2024 5,188,743 $ 4 $ 354,602 $ ( 293,020 ) $ 68 $ 61,654 Share-based compensation — — 4,540 — — 4,540

Issuance of common stock under the stock award plan 48,834 — — — — —

Issuance of common stock under the stock purchase plan 4,375 — 10 — — 10 Net loss — — — ( 3,126 ) — ( 3,126 ) Other comprehensive loss — — — — ( 44 ) ( 44 ) Balance, September 30, 2025 5,241,952 $ 4 $ 359,152 $ ( 296,146 ) $ 24 $ 63,034 December 31, 2025 5,283,321 $ 4 $ 359,932 $ ( 301,998 ) $ 18 $ 57,956 Share-based compensation — — 1,442 — — 1,442

Issuance of common stock under the stock award plan 8,769 — — — — —

Issuance of common stock under the stock purchase plan 2,802 — 13 — — 13 Issuance of common stock from exercise of stock options 38,298 — 241 — — 241 Net income — — — 32,662 — 32,662 Other comprehensive loss — — — — ( 18 ) ( 18 ) Balance, September 30, 2026 5,333,190 $ 4 $ 361,628 $ ( 269,336 ) $ — $ 92,296

See accompanying notes to the condensed consolidated financial statements

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RALLYBIO CORPORATION

Condensed Consolidated Statements of Cash Flows

(Unaudited)

FOR THE NINE MONTHS ENDED SEPTEMBER 30,

(in thousands) 2026 2025 Cash Flows Provided by (Used in) Operating Activities: Net income (loss) $ 32,662 $ ( 3,126 )

Adjustments to reconcile net loss to net cash provided by (used in) operating activitie

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Data on this page was fetched . The filing on SEC.gov is the record.