KLRA 8-K
Kailera Therapeutics, Inc. (KLRA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2026, Kailera Therapeutics, Inc. (the "Company") issued a press release reporting its financial results for the quarter ended June 30, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit Number |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Kailera Therapeutics, Inc. |
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Date: |
August 12, 2026 |
By: |
/s/ Douglas Pagán |
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Douglas Pagán |
Exhibit 99.1
Kailera Reports Second Quarter 2026 Financial Results and Provides Business Updates
WALTHAM, Mass. – August 12, 2026 – Kailera Therapeutics, Inc. (Nasdaq: KLRA) (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today reported financial results for the second quarter ended June 30, 2026, and provided a summary of recent business highlights.
Kailera is advancing a diversified GLP-1-based pipeline of clinical-stage therapeutic candidates for the treatment of obesity. The company’s approach seeks to improve upon currently available treatments by bringing forward product candidates that have the potential to maximize weight loss, improve tolerability, and address other critical needs in the current therapeutic landscape. The Kailera portfolio includes single-, dual-, and triple-agonist mechanisms and both oral and injectable formulations.
"Our second quarter marked another period of strong execution across the Kailera portfolio. We advanced our global Phase 3 KaiNETIC program for ribupatide injection, completed enrollment in our U.S. Phase 2b high-dose ribupatide injection trial with data expected in mid-2027, and opened our ribupatide oral IND, with initiation of our global Phase 3 obesity program planned for the first half of 2027," said Ron Renaud, President and Chief Executive Officer of Kailera. “With a strong balance sheet and multiple clinical milestones expected over the next 18 months, we believe Kailera is well positioned to deliver differentiated treatment options to people living with obesity."
Second Quarter Business Highlights and Recent Developments
Pipeline Highlights
Ribupatide Injection (KAI-9531), GLP-1/GIP Receptor Dual Agonist
Ribupatide Oral (KAI-9531-T), GLP-1/GIP Receptor Dual Agonist
KAI-7535, Oral Small Molecule GLP-1 Receptor Agonist
KAI-4729, Injectable GLP-1/GIP/glucagon Receptor Tri-Agonist
Corporate Highlights
Anticipated Key Milestones
Second Quarter 2026 Financial Results
As of June 30, 2026, Kailera had cash, cash equivalents and marketable securities of $1,171.8 million, which is expected to fund operations into mid-2028.
R&D expenses were $101.1 million for the quarter ended June 30, 2026, compared to $19.5 million for the same period in 2025. The increase of $81.5 million was primarily driven by the increase in product candidate development and the related nonclinical, clinical, and contract manufacturing costs associated with the Company's portfolio, as well as the increase in personnel-related costs to support its ongoing R&D activities.
General and administrative expenses were $20.3 million for the quarter ended June 30, 2026, compared to $11.1 million for the same period in 2025. The increase of $9.2 million was primarily driven by personnel-related costs and professional service costs as the Company continues to expand its operations.
Net loss was $111.3 million for the quarter ended June 30, 2026, compared to a net loss of $28.9 million for the same period in 2025.
Upcoming Events
Kailera expects to participate in the following upcoming investor conferences and medical congresses:
About Kailera Therapeutics
Kailera Therapeutics (Kailera) is a clinical-stage biotechnology company focused on elevating the next era of obesity care by progressing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. With an obesity-first focus, Kailera is advancing four clinical-stage product candidates leveraging multiple GLP-1-based mechanisms of action and routes of administration specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate, ribupatide injection (also known as KAI-9531), that has the potential for the greatest weight loss. Ribupatide injection is in global Phase 3 trials as a once-weekly injectable GLP-1/GIP receptor dual agonist. Kailera is expanding the ribupatide franchise by developing a once-daily oral formulation with the goal of providing an oral option with the potential for compelling weight loss and highly differentiated tolerability. Additionally, Kailera is advancing the development of KAI-7535, a once-daily oral small molecule GLP-1 receptor agonist, and KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. Kailera’s vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. Kailera is based in Waltham, MA. For more information, visit www.kailera.com and follow us on LinkedIn and X.
Special Note Regarding Kailera Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the profile of product candidates, the potential of Kailera’s portfolio, the timing, design and outcome of research and development activities, including with respect to the timing of initiation and completion of clinical trials and the design and goals of clinical trials, market opportunities for product candidates, the competitive landscape, timing and format of sharing of full clinical trial data, future results of operations and financial position, sufficiency of cash position to fund operations, and participation in upcoming events. Forward-looking statements can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," “suggest,” "plan," “goal,” “vision,” "potential," "predict," "project," "should," "target," "will," "would," or similar expressions and the negatives of those terms. Kailera cannot assure you that the forward-looking statements in this press release will prove to be accurate. Information in this press release may also include statements relating to past performance, which should not be regarded as a reliable indicator of future performance. Forward-looking statements are based on current expectations and assumptions together with projections of the future which are inherently uncertain, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in clinical development,
regulatory review, manufacturing, competition, market opportunities, reliance on third parties, estimates of capital requirements, needs for additional financing, and other important factors, including those discussed under the caption “Risk Factors” in Kailera’s filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release, and Kailera undertakes no obligation to update or revise any forward-looking statements. Kailera may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements.
1 Based on the efficacy estimand, which was pre-specified as the supplementary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other glucose-lowering medications from the analysis.
2 Based on the efficacy estimand, which was pre-specified as the primary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other glucose-lowering medications from the analysis.
3Based on the efficacy estimand, which was pre-specified as the supplementary estimand: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other medications with a substantial effect on body weight from the analysis.
Contact Information
Maura Gavaghan
Vice President, Investor Relations
[email protected]
Anna Robinson
Vice President, Communications
KAILERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
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June 30, |
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December 31, |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
130,301 |
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$ |
160,267 |
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Marketable securities |
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786,440 |
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385,789 |
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Prepaid expenses and other current assets |
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12,426 |
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11,481 |
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Total current assets |
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929,167 |
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557,537 |
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Property and equipment, net |
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1,753 |
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1,955 |
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Restricted cash |
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761 |
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761 |
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Long-term marketable securities |
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255,076 |
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106,672 |
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Non-current clinical deposits |
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14,671 |
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12,185 |
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Operating lease right-of-use assets |
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9,898 |
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10,463 |
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Other non-current assets |
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90 |
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2,721 |
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Total assets |
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$ |
1,211,416 |
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$ |
692,294 |
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Liabilities, convertible preferred stock and stockholders’ equity (deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
19,202 |
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$ |
7,529 |
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Accrued expenses and other current liabilities |
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63,399 |
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37,836 |
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Operating lease liabilities, current |
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1,050 |
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1,040 |
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Total current liabilities |
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83,651 |
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46,405 |
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Operating lease liabilities, non-current |
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9,166 |
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9,713 |
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Other non-current liabilities |
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135 |
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270 |
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Total liabilities |
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92,952 |
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56,388 |
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Commitments and contingencies |
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Convertible preferred stock: |
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Series A convertible preferred stock |
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— |
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390,306 |
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Series B convertible preferred stock |
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— |
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602,058 |
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Stockholders’ equity (deficit): |
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Preferred stock |
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— |
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— |
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Common stock |
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— |
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— |
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Additional paid-in capital |
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1,679,098 |
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11,981 |
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Accumulated other comprehensive (loss) income |
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(1,794 |
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229 |
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Accumulated deficit |
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(558,840 |
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(368,668 |
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Total stockholders’ equity (deficit) |
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1,118,464 |
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(356,458 |
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Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
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$ |
1,211,416 |
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$ |
692,294 |
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KAILERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS)
(UNAUDITED)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses |
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Research and development |
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$ |
101,061 |
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$ |
19,522 |
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$ |
171,934 |
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$ |
29,651 |
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General and administrative |
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20,312 |
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11,129 |
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34,099 |
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21,457 |
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Total operating expenses |
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121,373 |
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30,651 |
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206,033 |
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51,108 |
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Loss from operations |
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(121,373 |
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(30,651 |
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(206,033 |
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(51,108 |
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Other income |
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Interest income |
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9,994 |
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2,126 |
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15,710 |
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3,801 |
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Other income (expense), net |
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72 |
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(422 |
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151 |
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377 |
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Total other income |
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10,066 |
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1,704 |
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15,861 |
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4,178 |
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Net loss |
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$ |
(111,307 |
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$ |
(28,947 |
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$ |
(190,172 |
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$ |
(46,930 |
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