Kalaris Therapeutics Inc SEC Filings

Kalaris Therapeutics reported initial data from its Phase 1a single ascending dose trial of TH103 in treatment-naïve patients with neovascular age-related macular degeneration. The study used a single intravitreal injection at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in 13 patients who completed six months of follow-up and showed robust improvements in vision and retinal anatomy that are consistent with TH103’s molecular design and preclinical profile.

TH103 was generally well tolerated. Two cases of transient, mild to moderate intraocular inflammation occurred at the 2.5 mg dose and were linked to host cell protein levels in the drug product; after adding extra purification steps, six more patients received the 2.5 mg dose with the new material and no additional inflammation events were seen at one week or more of follow-up. The company is using this updated drug product in ongoing and planned studies and is enrolling a Phase 1b/2 multi-ascending dose, dose-finding trial of four monthly injections, with preliminary data expected in the second half of 2026.

Kalaris Therapeutics (KLRS) filed its Q3 2025 10‑Q, reporting a net loss of $11.9 million for the quarter on total operating expenses of $12.7 million (research and development $9.1 million; general and administrative $3.6 million). Year to date, the net loss was $33.4 million.

As of September 30, 2025, cash, cash equivalents and short‑term investments were $77.0 million, and management states these resources are expected to fund operations for at least twelve months. The balance sheet showed total assets of $81.2 million and stockholders’ equity of $41.9 million. A royalty obligation to a related party of $32.1 million remains on the balance sheet.

Kalaris completed a reverse recapitalization with AlloVir on March 18, 2025, bringing $102.1 million of cash and resulting in 18,702,418 shares outstanding post‑merger. The company focuses on TH103, a clinical‑stage anti‑VEGF candidate for retinal diseases. Quarterly loss per share was $0.64.

Kalaris Therapeutics (KLRS) furnished an 8-K announcing it issued a press release with financial results for the quarter ended September 30, 2025. The press release is provided as Exhibit 99.1 and incorporated by reference as stated.

The company notes the information, including Exhibit 99.1, is being furnished and not filed under the Exchange Act. Kalaris Therapeutics’ common stock trades on The Nasdaq Global Market under the symbol KLRS.

Kalaris Therapeutics (KLRS) reported a Form 4 for CFO Matthew Gall, showing a grant of stock options for 235,000 shares at an exercise price of $4.99 on November 3, 2025.

The options expire on November 2, 2035 and vest over four years: 25% on November 3, 2026, then the remainder in equal monthly installments, subject to continuous service. Following the grant, 235,000 derivative securities were beneficially owned directly.

Kalaris Therapeutics (KLRS) reported an insider ownership update. Chief Financial Officer Matthew Gall filed a Form 3 on 11/03/2025, the initial statement of beneficial ownership. The filing states that no securities are beneficially owned. This is an administrative disclosure and does not reflect any transaction or change in the company’s capital.

Kalaris Therapeutics (KLRS) appointed Matthew Gall as Chief Financial Officer and Treasurer, effective November 3, 2025. He will also serve as principal financial officer. The board approved an Employment Agreement with an annual base salary of $485,000 and an annual incentive bonus opportunity of up to 40% of base salary.

As part of his compensation, Mr. Gall received an option to purchase 235,000 shares of common stock at the Nasdaq closing price on the effective date, vesting 25% on the first anniversary and monthly over 36 months thereafter, subject to continued service. Severance terms include nine months of base salary and COBRA premiums if terminated without cause or for good reason outside a change in control window, and, in a change in control window, 12 months of base salary, a lump-sum 100% Target Bonus, up to 12 months COBRA premiums, and full acceleration of time‑based equity.

Brett Hagan ceased serving as principal financial officer on the effective date and continues as principal accounting officer.

Kalaris Therapeutics is a clinical-stage biopharmaceutical company focused on TH103, an anti-VEGF candidate for retinal disease. The company completed its Merger with AlloVir on March 18, 2025; Legacy Kalaris was treated as the accounting acquirer and AlloVir’s cash contribution was recorded as assets acquired.

As of June 30, 2025, Kalaris reported $88.4 million of cash and cash equivalents and stated that existing cash is expected to fund operations for at least twelve months. For the six months ended June 30, 2025, the company recorded a 21.5 million net loss versus $9.1 million in the prior-year period and had an accumulated deficit of $138.1 million. Material items include a $32.076 million royalty obligation to a related party (Samsara), recognition of merger-related transaction costs of $5.4 million reducing additional paid-in capital, and the elimination of outstanding convertible promissory notes, derivative liabilities and the tranche liability in connection with the Merger. The company discloses identified material weaknesses in internal control, dependence on TH103 for future success, and the need to raise additional financing to continue development.

Kalaris Therapeutics held its 2025 annual meeting on August 12, 2025. Stockholders elected Srinivas Akkaraju, M.D., Ph.D. and Andrew Oxtoby as Class II directors, each to serve three-year terms through the 2028 annual meeting. Vote counts reported were 14,626,646 For, 144,695 Withheld and 1,328,348 Broker Non-Votes for Dr. Akkaraju and 14,668,424 For, 102,917 Withheld and 1,328,348 Broker Non-Votes for Mr. Oxtoby.

Shareholders also ratified Deloitte & Touche LLP as the company’s independent registered public accounting firm for the 2025 fiscal year, with 16,090,928 For, 6,975 Against and 1,786 Abstain. These results reflect routine corporate governance actions reported to the market.

Kalaris Therapeutics, Inc. furnished a press release announcing its financial results for the quarter ended June 30, 2025. The press release is provided as Exhibit 99.1 to this Form 8-K and is incorporated by reference.

This Current Report itself does not include any financial figures or operating metrics; it states that the information in the press release is being furnished and shall not be deemed "filed" under the Exchange Act. The filing was submitted on behalf of the company and is signed by Chief Executive Officer Andrew Oxtoby. Readers must consult Exhibit 99.1 for the detailed results.