# EDGAR Filing Document

**Accession Number:** 0001754068
**File Stem:** 0001193125-25-322950
**Filing Date:** 2025-12
**Character Count:** 51863
**Document Hash:** 47a24001be115c28474ed3478a91aafc
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-322950.hdr.sgml**: 20251217

**ACCESSION NUMBER**: 0001193125-25-322950

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 44

**CONFORMED PERIOD OF REPORT**: 20251217

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251217

**DATE AS OF CHANGE**: 20251217

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Kalaris Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001754068
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 831971007
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39409
- **FILM NUMBER:** 251580243

**BUSINESS ADDRESS:**
- **STREET 1:** 400 CONNELL DRIVE
- **STREET 2:** SUITE 5500
- **CITY:** BERKELEY HEIGHTS
- **STATE:** NJ
- **ZIP:** 07922
- **BUSINESS PHONE:** 650-249-2727

**MAIL ADDRESS:**
- **STREET 1:** 400 CONNELL DRIVE
- **STREET 2:** SUITE 5500
- **CITY:** BERKELEY HEIGHTS
- **STATE:** NJ
- **ZIP:** 07922

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Allovir, Inc.
- **DATE OF NAME CHANGE:** 20190521

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ViraCyte, Inc.
- **DATE OF NAME CHANGE:** 20180924

?xml version='1.0' encoding='ASCII'? 8-K

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): December 17, 2025

## KALARIS THERAPEUTICS, INC.

#### (Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-39409** | **83-1971007** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

---

#### Kalaris Therapeutics, Inc.

---

| |
|:---|
| **400 Connell Drive, Suite 5500** |
| **Berkeley Heights, New Jersey 07922** |
| **(Address of principal executive offices, including zip code)** |

---

(650) 249-2727

#### (Registrant's telephone number, including area code)

#### Not applicable

#### (Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange**<br> **on which registered** |
| Common Stock, $0.0001 par value per share | KLRS | The Nasdaq Global Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 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. ☐

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| | |
|:---|:---|
| **Item 7.01.** | **Regulation FD Disclosure.**  |

---

On December 17, 2025, Kalaris Therapeutics, Inc. (the "Company") issued a press release announcing initial data from its Phase 1a single ascending dose ("SAD") clinical trial of TH103 in treatment-naïve patients with neovascular age-related macular degeneration ("nAMD"). The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In addition, on December 17, 2025, the Company made available a presentation to be used with investors to discuss the initial data from its Phase 1a SAD trial of TH103. The virtual investor event will be held on December 17, 2025, beginning at 4:30 p.m., EST. A copy of the presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference. A live webcast of the event, as well as a replay, will be available under the "Events & Presentations" section of the Company's website: https://investors.kalaristx.com/. The information contained in, or that can be accessed through the Company's website, is not a part of this filing.

The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is being 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 a filing.

---

| | |
|:---|:---|
| **Item 8.01.** | **Other Events.**  |

---

On December 17, 2025, the Company issued a press release announcing initial data from its Phase 1a SAD trial of TH103 in treatment-naïve patients with nAMD. The data demonstrate that TH103's engineered molecular properties translated into clinically meaningful improvements in vision and retinal anatomy, with early signals suggesting the potential for extended treatment durability.

#### Initial Phase 1a Data Support Molecular Hypothesis with Strong Clinical Activity
The Phase 1a trial evaluated a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in treatment-naïve nAMD patients (N=13) who completed 6 months of follow-up. Results demonstrated robust visual and anatomic improvements that support TH103's molecular design and preclinical profile.

#### Rapid, Robust Response in Best Corrected Visual Acuity ("BCVA") and Optical Coherence Tomography Parameters Across Dose Levels at 1 Month
• Mean 10-letter BCVA improvement

• Mean 129 µm improvement in mean central subfield thickness

• Mean approximately 95% reduction in central subfield intraretinal fluid

#### TH103 Generally Well Tolerated, Supporting Exploration of Further Dose Escalation
• No dose-limiting toxicities observed

• No TH103-related serious adverse events observed

• No instances of TH103-related retinal vascular occlusive disease, retinal vasculitis, cataracts, or elevated intraocular pressure observed

Two cases of transient, mild-moderate intraocular inflammation ("IOI") were observed at Day 4 in two subjects dosed at 2.5 mg, which were attributed to levels of host cell protein in the drug product. Additional processing steps were implemented into the manufacturing process, significantly reducing host cell protein levels. Subsequently, six additional subjects were enrolled and treated with new, further purified material at the 2.5 mg dose level and there have been zero new instances of IOI (≥1 week follow-up). Based on these results, the Company plans to use the drug product produced with the updated manufacturing process in its ongoing and planned clinical trials.

#### Initial Phase 1a Data Provides Evidence TH103 May Offer Extended Treatment Durability
• **Pharmacokinetic Profile -** Plasma levels of TH103 dose adjusted mean Cmax were 27 to 51-fold lower compared to current leading anti-VEGF agents, consistent with enhanced intraocular retention and reduced systemic exposure. This pharmacokinetic profile aligns with the molecule's engineered properties and preclinical data demonstrating prolonged intraocular residence time.

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• **Retreatment Analysis -** Following only a single TH103 injection, 31% of patients received no additional anti-VEGF treatment during the entire six-month follow-up period. These single-dose findings suggest the potential for extended durability outcomes after a standard four-dose loading regimen.

#### Next Steps in Clinical Development
Based on these positive initial Phase 1a data, the Company is accelerating its clinical development program. The Company continues to enroll patients in an ongoing Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading injections of TH103 to identify the optimal dose and regimen for potential Phase 3 development. The Company expects to share preliminary data from the ongoing Phase 1b/2 study in the second half of 2026.

#### Forward-Looking Statements
This Current Report on Form 8-K contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this Current Report on Form 8-K, including statements regarding the strategy, future operations, prospects, plans and objectives of management of the Company, including the therapeutic potential of TH103 for nAMD and other exudative and neovascular retinal diseases, the anticipated timelines for reporting clinical data from the Phase 1a and Phase 1b/2 clinical trials of TH103, plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications and the sufficiency of the Company's cash resources for the period anticipated, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current expectations and beliefs of the management of the Company as well as assumptions made by, and information currently available to, the management of the Company and are subject to risks and uncertainties. There can be no assurance that future developments affecting the Company will be those that it has anticipated. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: risks associated with the clinical development and regulatory approval of TH103, including potential delays in the completion of clinical trials; expectations regarding the therapeutic benefits, clinical potential and clinical development of TH103; the timing of and the Company's ability to enroll patients in clinical trials; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance its product candidate; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from any product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the ability to obtain, maintain, and protect intellectual property rights related to product candidates; changes in regulatory requirements and government incentives; the Company's competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies that are or become available; the risk of involvement in current and future litigation; and such other factors as are set forth in the Company's public filings with the SEC, including, but not limited to, those described under the heading "Risk Factors". The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. The forward-looking statements contained in this Current Report on Form 8-K are made as of the date of this Current Report on Form 8-K, and the Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

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---

| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.**  |

---

(d) Exhibits:

---

| | |
|:---|:---|
| **Exhibit**<br> **No.** | **Description** |
| 99.1 | [Press Release, dated December 17, 2025](d25416dex991.htm) |
| 99.2 | [Presentation, dated December 17, 2025](d25416dex992.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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#### 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.

---

| | | |
|:---|:---|:---|
|  | **KALARIS THERAPEUTICS, INC.** | **KALARIS THERAPEUTICS, INC.** |
| Date: December 17, 2025 | By: | /s/ Andrew Oxtoby |
|  | Name: | Andrew Oxtoby |
|  | Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1** 

**Kalaris Therapeutics Reports Initial Positive Phase 1a Data for TH103 in Treatment-Naïve Neovascular AMD** 

*TH103 showed mean 10-letter gain in visual acuity and rapid, robust anatomic improvement at Month 1, following a single injection* 

*TH103 was generally well tolerated, supporting further dose escalation beyond 2.5 mg* 

*TH103 showed a 27 to 51-fold lower plasma Cmax by pharmacokinetic analysis compared with current leading agents, indicative of increased intraocular retention* 

*Accelerating enrollment in ongoing Phase 1b/2 multi ascending dose-finding study; preliminary efficacy and safety data expected 2H 2026* 

*Kalaris conference call today at 4:30 pm EST* 

**BERKELEY HEIGHTS, N.J., December 17, 2025 (GLOBE NEWSWIRE)** – Kalaris Therapeutics, Inc. (NASDAQ: KLRS), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced positive initial data from its Phase 1a single ascending dose (SAD) trial of TH103, a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor, in treatment-naïve patients with neovascular age-related macular degeneration (nAMD). The data demonstrate that TH103's engineered molecular properties translated into clinically meaningful improvements in vision and retinal anatomy, with early signals suggesting the potential for extended treatment durability. The initial data will be presented at 4:30 pm EST today via webcast.

**TH103 was Engineered for Enhanced Potency and Intraocular Retention** 

Invented by Dr. Napoleone Ferrara, Kalaris' scientific co-founder and current board member, whose pioneering research led to the development of the anti-VEGF class of therapies for retinal and oncology diseases, TH103 is an investigational anti-VEGF therapy specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition. Dr. Ferrara designed the molecule with specific structural characteristics intended to prolong residence time in the eye. In preclinical studies, TH103 demonstrated significantly enhanced binding to heparan sulfate proteoglycans (HSPG) and slower systemic clearance compared to aflibercept, supporting the hypothesis that these molecular characteristics could translate to extended durability.

**Initial Phase 1a Data Support Molecular Hypothesis with Strong Clinical Activity** 

The Phase 1a trial evaluated a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in treatment-naïve nAMD patients (N=13) who completed 6 months of follow-up. Results demonstrated robust visual and anatomic improvements that support TH103's molecular design and preclinical profile.

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**Rapid, Robust Response in BCVA and OCT Parameters Across Dose Levels at 1 Month** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Mean 10-letter best corrected visual acuity (BCVA) improvement

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Mean 129 µm improvement in mean central subfield thickness (CST)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Mean ~95% reduction in central subfield intraretinal fluid (IRF)

"These initial Phase 1a data are highly encouraging and validate the molecular engineering approach we pursued in developing TH103," said Dr. Ferrara. "We believe the rapid visual and anatomic improvements we observed are consistent with potent VEGF inhibition."

**TH103 Generally Well Tolerated, Supporting Exploration of Further Dose Escalation** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No dose-limiting toxicities (DLTs) observed

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No TH103-related serious adverse events (SAEs) observed

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• No instances of TH103-related retinal vascular occlusive disease, retinal vasculitis, cataracts, or elevated
intraocular pressure observed

Two cases of transient, mild-moderate intraocular inflammation (IOI) were observed at Day 4 in two subjects dosed at 2.5 mg, which were attributed to levels of host cell protein in the drug product. Additional processing steps were implemented into the manufacturing process, significantly reducing host cell protein levels. Subsequently, six additional subjects were enrolled and treated with new, further purified material at the 2.5 mg dose level and there have been zero new instances of IOI (≥1 week follow-up). Based on these results, Kalaris plans to use the drug product produced with the updated manufacturing process in its ongoing and planned clinical trials.

**Initial Phase 1a Data Provides Evidence TH103 May Offer Extended Treatment Durability** 

**Pharmacokinetic Profile -** Plasma levels of TH103 dose adjusted mean Cmax were 27 to 51-fold lower compared to current leading anti-VEGF agents, consistent with enhanced intraocular retention and reduced systemic exposure. This pharmacokinetic profile aligns with the molecule's engineered properties and preclinical data demonstrating prolonged intraocular residence time.

**Retreatment Analysis -** Following only a single TH103 injection, 31% of patients received no additional anti-VEGF treatment during the entire six-month follow-up period. These single-dose findings suggest the potential for extended durability outcomes after a standard four-dose loading regimen.

"These data are consistent with what was observed in preclinical studies and reinforce what we would expect based on TH103's molecular design," added Andrew Oxtoby, Chief Executive Officer of Kalaris. "The pharmacokinetic profile and retreatment data provide early signals that the enhanced intraocular retention designed into the molecule may translate to extended clinical durability and reduce the treatment burden for patients."

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**Next Steps in Clinical Development** 

Based on these positive initial Phase 1a data, Kalaris is accelerating its clinical development program. Kalaris continues to enroll patients in an ongoing Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading injections of TH103 to identify the optimal dose and regimen for potential Phase 3 development. Kalaris expects to share preliminary data from the ongoing Phase 1b/2 study in the second half of 2026.

**Conference Call & Webcast Information** 

Members of the Kalaris management team, along with Joel Pearlman, MD, PhD and Donald J. D'Amico, MD, will host a live conference call and webcast today at 4:30 pm Eastern Time to review the initial Phase 1a data. Interested parties should dial 1-877-407-0784 or register for the webcast via this link <u>https://viavid.webcasts.com/starthere.jsp?ei=1743701&tp_key=9a6798b828</u>. An accompanying slide presentation for the event, updated corporate presentation, and a replay of the webcast will be available via the investor section of the Kalaris' website at investors.kalaristx.com/events-presentations.

**About Neovascular Age-Related Macular Degeneration** 

Neovascular AMD is a leading cause of vision loss in individuals over 50, affecting millions of people worldwide. The disease is characterized by abnormal blood vessel growth beneath the retina, leading to fluid leakage, retinal damage, and progressive vision loss. While anti-VEGF therapies have transformed outcomes for nAMD patients, many require frequent injections for extended periods, leading to suboptimal adherence and compromised outcomes.

**About Kalaris Therapeutics** 

Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. Founded by renowned scientist Dr. Napoleone Ferrara, whose pioneering research led to the development of anti-VEGF therapy, Kalaris Therapeutics is committed to advancing novel therapeutic approaches for patients with sight-threatening retinal conditions with major unmet medical needs. For more information, visit <u>www.kalaristx.com</u>.

**Forward-Looking Statements** 

This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, prospects, plans and objectives of management of Kalaris, including the therapeutic

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potential of TH103 for nAMD and other exudative and neovascular retinal diseases, the anticipated timelines for reporting clinical data from the Phase 1a and Phase 1b/2 clinical trials of TH103, plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications and the sufficiency of Kalaris' cash resources for the period anticipated, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current expectations and beliefs of the management of Kalaris as well as assumptions made by, and information currently available to, the management of Kalaris and are subject to risks and uncertainties. There can be no assurance that future developments affecting Kalaris will be those that it has anticipated. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: risks associated with the clinical development and regulatory approval of TH103, including potential delays in the completion of clinical trials; expectations regarding the therapeutic benefits, clinical potential and clinical development of TH103; the timing of and Kalaris' ability to enroll patients in clinical trials; whether results from preclinical studies and initial data from early clinical trials will be predictive of the final results of the clinical trials or future trials; risks related to the inability of Kalaris to obtain sufficient additional capital to continue to advance its product candidate; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from any product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the ability to obtain, maintain, and protect intellectual property rights related to product candidates; changes in regulatory requirements and government incentives; Kalaris' competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies that are or become available; the risk of involvement in current and future litigation; and such other factors as are set forth in Kalaris' public filings with the SEC, including, but not limited to, those described under the heading "Risk Factors". Kalaris may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release, and Kalaris does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

**Kalaris Therapeutics Investor Contact:** 

Corey Davis, Ph.D.

LifeSci Advisors, LLC

+1 212 915 2577

<u>cdavis@lifesciadvisors.com</u> 

<u>ir@kalaristx.com</u>

## Exhibit 99.2

![](g25416ex99_2p1g1.jpg)

Exhibit 99.2 TH103 Phase 1a Initial Data Release December 2025

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![](g25416ex99_2p2g1.jpg)

Forward-Looking Statements & Disclaimer This presentation contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this presentation, including statements regarding the strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management of Kalaris, the therapeutic potential of TH103 for neovascular Age-related Macular Degeneration and other exudative and neovascular retinal diseases, the anticipated timeline for reporting data from the ongoing Phase 1a clinical trial of TH103 and the ongoing Phase 1b/2 clinical trial of TH103, plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications and the sufficiency of Kalaris' cash resources for the period anticipated, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current expectations and beliefs of the management of Kalaris as well as assumptions made by, and information currently available to, the management of Kalaris and are subject to risks and uncertainties. There can be no assurance that future developments affecting Kalaris will be those that it has anticipated. Forward-looking statements include, but are not limited to, statements concerning the following: the future operations of Kalaris, including research and development activities; the nature, strategy and focus of Kalaris; the development and commercial potential and potential benefits of any product candidate of Kalaris, including expectations around intellectual property protection; anticipated clinical drug development activities and related timelines, including the expected timing for announcement of data and other clinical results; the uncertainties associated with Kalaris' product candidate, as well as risks associated with the clinical development and regulatory approval of its product candidate, including potential delays in the completion of clinical trials; expectations regarding the therapeutic benefits, clinical potential and clinical development of TH103; risks related to the inability of Kalaris to obtain sufficient additional capital to continue to advance its product candidate; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from any product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the ability to obtain, maintain, and protect intellectual property rights related to product candidates; changes in regulatory requirements and government incentives; Kalaris' competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies that are or become available; potential adverse reactions or changes to business relationships resulting from the completion of Kalaris' merger with AlloVir, Inc. in March 2025; risks associated with the possible failure to realize, or that it may take longer to realize than expected, certain anticipated benefits of the merger, including with respect to future financial and operating results; the risk of involvement in current and future litigation, including securities class action litigation, that could divert the attention of the management of Kalaris, harm Kalaris' business and for which Kalaris may not have sufficient insurance coverage to cover all costs and damages; and such other factors as are set forth in Kalaris' public filings with the U.S. Securities and Exchange Commission, including, but not limited to, those described under the heading "Risk Factors". Kalaris may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Kalaris makes. The forward-looking statements contained in this presentation are made as of the date of this presentation, and Kalaris does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. This presentation also contains estimates, projections and other statistical data made by independent parties and by Kalaris relating to market size and growth and other data about Kalaris' industry and business. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Kalaris has not independently verified the accuracy and completeness of the information obtained by third parties included in this presentation. In addition, projections, assumptions and estimates of Kalaris' future performance and the future performance of the market in which Kalaris operates are necessarily subject to high degree of uncertainty and risk. 2

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![](g25416ex99_2p3g1.jpg)

Your Vision Our Mission Kalaris is a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases Our lead asset, TH103, was invented by Dr. Napoleone Ferrara, whose pioneering research established the anti-VEGF class of therapies for retinal and oncology diseases TH103 is an anti-VEGF therapeutic specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition, to address major unmet needs Napoleone Ferrara, MD Source Photography: Life Science Breakthrough Prize 3

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![](g25416ex99_2p4g1.jpg)

TH103 Engineered to improve upon a drug class that has helped millions of patients, with optimization built directly into the molecule itself. Fully humanized, recombinant fusion protein designed for intravitreal delivery, with potential to be best-in-class for neovascular and exudative retinal diseases. Targets VEGF as a soluble decoy receptor with high affinity for both VEGF and HSPG, engineered for increased and longer-acting activity. 4

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![](g25416ex99_2p5g1.jpg)

TH103 Preclinical Review & Phase 1a Initial Data Summary 5

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![](g25416ex99_2p6g1.jpg)

TH103: Dual-targeting, next generation drug engineered by anti-VEGF pioneer Dr. Napoleone Ferrara to address major unmet needs in retina disease Optimized VEGF Binding: 1 Leverages higher-affinity VEGFR1 , potentially leading to enhanced VEGF inhibition Extended Ocular Retention: 2 Leverages high-affinity binding to HSPG , potentially providing prolonged retinal retention and driving enhanced efficacy and/or durability Source: 1) Holash, J., Davis, S., Papadopoulos, N., Croll, S. D., Ho, L., Russell, M., ... & Rudge, J. S. (2002). VEGF- Trap: a VEGF blocker with potent antitumor effects. Proceedings of the National Academy of Sciences, 99(17), 11393-11398. 2) Xin H, Biswas N, Li P, et al. 2021. 'Heparin-binding VEGFR1 variants as long-acting VEGF inhibitors for treatment of intraocular neovascular disorders', Proc Natl Acad Sci U S A, 118. 6 6

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![](g25416ex99_2p7g1.jpg)

TH103: Increased VEGF-inhibitory activity vs. aflibercept in preclinical studies TH103 achieved 100% inhibition vs. aflibercept 80% inhibition of TH103 increased reduction in mean choroidal neovascularization 2 VEGF-induced endothelial cell proliferation (CNV) area after administration at Day -1 1 (in vitro, bovine choroidal endothelial cell proliferation assay) (in vivo, murine model) Concentration Dependent VEGF Inhibition Mean CNV Area TH103 Standard error = aflibercept Notes: 1) human choroidal endothelial cells proliferate in nAMD pathologic angiogenesis; 2) The rodent laser-induced CNV model is the most widely used animal model to study the effects of anti-VEGFs in inhibiting CNV; Data are based on three independent experiments with at least five mice per group; Asterisks denote significant differences (Student's t test) compared to the appropriate IgG control groups (\*\*P < 0.01, \*P < 0.05); Source: Adapted from Xin H, Biswas N, Li P, et al. 2021. 'Heparin- 7 binding VEGFR1 variants as long-acting VEGF inhibitors for treatment of intraocular neovascular disorders', Proc Natl Acad Sci U S A, 118. Mean CNV Area (ratio to IgG control)

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TH103: Demonstrated prolonged retinal retention vs. aflibercept in preclinical studies TH103 demonstrated increased retention in the retina as compared to TH103 demonstrated reduced systemic exposure after 1 aflibercept at two weeks post-injection intravitreal administration (in vivo, rabbit model) (in vivo, murine model) Serum Levels of TH103 Compared to Aflibercept Rabbit Retina Cross-Sections at Day 14 After Bilateral Intravitreal Injection 150 150 aflibercept TH103 100 100 50 50 aflibercept TH103 Equimolar dose administrated; Darker immuno-histochemistry 0 staining indicates higher drug levels present 1 d 3 d 7 d 14 d 21 d 1 d 3 d 7 d 14 d 21 d Note: 1) Serum levels of aflibercept and TH103 in mice at different time points after intravitreal injection. Each molecule was injected in both eyes in equimolar amounts (2.4 μg). After 1, 3, 7, 14, and 21 d, peripheral blood was collected from the tail vein. Human Fc levels were measured by ELISA. Values shown are means ± SEM. n = 8 per point; Source: Adapted from Xin H, Biswas N, Li P, et al. 2021. 'Heparin-binding VEGFR1 variants as long-acting VEGF inhibitors for treatment of intraocular neovascular disorders', 8 Proc Natl Acad Sci U S A, 118. Serum huFc levels (ng/mL)

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TH103: Demonstrated prolonged bioactivity vs. aflibercept in an animal model Mean CNV Area In a second murine experiment, rather Standard error = than at Day -1, TH103 and aflibercept were administered at Day -14 prior to laser injury to assess durability of treatment effect. In this model, TH103 showed smaller mean CNV area compared to equimolar aflibercept 21 days after injection. Note: TH103 and aflibercept administered 14 days prior to laser injury; CNV measurement at Day 7 post-laser; Symbols denote significant differences (Student's t test) between TH103 and control (\*\*\*P < 0.001) and between TH103 and aflibercept (^^^P < 0.001). Source: Adapted from Xin H, Biswas N, Li P, et al. 2021. 'Heparin-binding 9 VEGFR1 variants as long-acting VEGF inhibitors for treatment of intraocular neovascular disorders', Proc Natl Acad Sci U S A, 118. Mean CNV Area (ratio to IgG control)

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Phase 1a initial data summary Efficacy: rapid, robust response on BCVA and OCT ✓ parameters observed across dose levels at one month Safety: TH103 generally well tolerated, supporting ✓ exploration of further dose-escalation Durability: ✓ - PK analysis consistent with greater TH103 intraocular retention vs. other leading agents - Single-dose durability signal suggests potential for stronger durability outcomes after standard four- dose loading regimen BCVA = Best Corrected Visual Acuity; CST = Central Subfield Thickness; PK = Pharmacokinetics 10 10

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Phase 1a Single Ascending Dose TH103 5.0 mg x 1 (SAD) Study in TH103 2.5 mg x 1 Treatment-Naïve TH103 1.5 mg x 1 nAMD TH103 0.5 mg x 1 Multi-center U.S. study to evaluate safety, tolerability, pharmacokinetics, and anti- Study Details VEGF activity following a single ● Primary timepoint for analysis at Month 1 injection of TH103 ● Frequent follow-up visits within the first month; patients then followed monthly out to Month 6 Criteria for retreatment with aflibercept ● Increase of > 50 ���� m thickness in CST on SD-OCT compared to the lowest previously measured CST ● New macular hemorrhage due to nAMD SD-OCT = Spectral-Domain Optical Coherence Tomography Note: Data safety monitoring oversight occurred before dose-escalations 11

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Key baseline characteristics of patients in Phase 1a trial of TH103 who have reached study completion Study Cohort 0.5 mg 1.5 mg 2.5 mg 1 All Patients (n=13) (n=3) (n=7) (n=3) Age (mean) 78 77 82 79 Sex (female / male) 3 / 0 5 / 2 1 / 2 9 / 4 BCVA (ETDRS letters, 58 (44-71) 59 (35-73) 49 (36-63) 57 (35-73) mean, range) Type 1 1 3 1 5 (38%) Type 2 - 1 - 1 (8%) Lesion Type 2 Type 3 1 3 2 6 (46%) Ungradable 1 - - 1 (8%) CST (���� m, mean, range) 483 (421-550) 442 (329-611) 485 (440-554) 470 (329-611) No study dropouts and 100% protocol adherence 1) Includes all patients who completed the entire 6-month follow-up period, excludes 6 additional patients dosed at the 2.5mg dose level with additionally purified material; 12 2) Also called retinal angiomatous proliferation, or RAP; all Type 3 lesions were determined to be Stage 3

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Phase 1a initial data summary Efficacy: rapid, robust response on BCVA and OCT ✓ parameters observed across dose levels at one month 13 13

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Mean 10 letter gain in BCVA letter score after a single TH103 injection at Month 1 Mean BCVA Change Over Time 12 54% +10 letters (7/13 patients) 10 Gained ≥ 10 letters at Month 1 8 6 4 23% (3/13 patients) 2 Gained ≥ 20 letters at Month 1 0 D1D2 D4 W1 W2 M1 Time ETDRS = Early Treatment Diabetic Retinopathy Study Note: n = 13 at all timepoints except Month 1, where n =12; one patient in the 0.5 mg cohort was treated with aflibercept at Week 2 and therefore the Month 1 data point is censored. Patients dosed at 2.5 mg with additionally purified material (n=6) are excluded from efficacy & PK analyses due to 14 limited follow-up.; Brackets indicate standard error. ETDRS Letters

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Change in mean visual acuity in treatment naïve nAMD patients for current market-leading agents at Month 1 Mean Change in BCVA at Month 1 in Tx-Naive nAMD patients (ETDRS letters) 12 10 8 6 4 2 0 Eylea (VIEW 1&2) Eylea (T&L) Eylea (PULSAR) Eylea HD Vabysmo Eylea HD BCVA Baseline Mean: ~60, n=673 Eylea (VIEW 1&2) BCVA Baseline Mean: ~54, n= 607 Vabysmo BCVA Baseline Mean: ~60, n=665 Eylea (PULSAR) BCVA Baseline Mean: ~59, n=336 Eylea (T&L) BCVA Baseline Mean: ~60, n = 664 The above competitor data is approximate and reflects multiple Phase 3 studies. No head-to-head trials have been conducted comparing TH103 to any approved agents for nAMD. Such data may not be directly comparable due to differences in trial protocols, dosing regimens and patient populations. Accordingly, these cross-trial comparisons may not be reliable. Sources: Khanani, Arshad M., et al. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2. Ophthalmology, vol. 131, no. 8, 2024, pp. 914–926; Lanzetta, P., et al. "Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration (PULSAR): 48-Week Results from a Randomised, Double-Masked, Non-Inferiority, Phase 3 Trial." The Lancet, vol. 403, no. 10344, 2024, pp. 1141-1152; Heier, J., et al. "Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-Related 15 Macular Degeneration." Ophthalmology, vol. 119, no. 12, 2012, pp. 2537-2548. ETDRS Letter Change

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Rapid, robust improvement in CST and total retinal fluid (TRF) volume at Week 1 and Month 1 1 Mean CST Change Over Time Case Example (1.5 mg) 0 -20 -40 Mean ~87% resolution 2 of TRF by Week 1 -60 ���� Mean ~90% resolution Single Dose TH103 2 of TRF at Month 1 -80 -100 -120 -140 -129���� m mean CST change Month 1 -160 D1D2 D4 W1 W2 M1 Time Note: n = 13 at all timepoints except Month 1, where n =12; one patient in the 0.5 mg cohort was treated with aflibercept at Week 2 and therefore the Month 1 data point is censored. Patients dosed at 2.5 mg with further purified material (n=6) are excluded from efficacy & PK analyses due to limited follow-up; Brackets indicate standard error. Sources: 1) As measured by independent reading center; 2) Data from automated fluid measurement software, Notal Vision Inc.; percentage change in mean central subfield 16 1 TRF volume (subretinal fluid + intraretinal fluid in the central subfield, measured in nanoliters) from Day 1 to Week 1 & Month 1 CST Change (m)

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Change in mean CST in treatment naïve nAMD patients for current market-leading agents at Month 1 Mean Change in CST at Month 1 in Tx-Naive nAMD patients (���� m) Eylea (VIEW 1&2) Eylea (T&L) Eylea (PULSAR) Eylea HD Vabysmo -100 -105 ����-110 -115 -120 -125 -130 -135 Eylea HD CST Baseline Mean: ~370, n=673 Eylea (VIEW 1&2) CST Baseline Mean: ~324, n=607 Vabysmo CST Baseline Mean: ~357, n=665 Eylea (PULSAR) CST Baseline Mean: ~367, n=336 Eylea (T&L) CST Baseline Mean: ~358, n = 664 The above competitor data is approximate and reflects multiple Phase 3 studies. No head-to-head trials have been conducted comparing TH103 to any approved agents for nAMD. Such data may not be directly comparable due to differences in trial protocols, dosing regimens and patient populations. Accordingly, these cross-trial comparisons may not be reliable. Sources: Khanani, Arshad M., et al. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2. Ophthalmology, vol. 131, no. 8, 2024, pp. 914–926; Lanzetta, P., et al. "Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration (PULSAR): 48-Week Results from a Randomised, Double-Masked, Non-Inferiority, Phase 3 Trial." The Lancet, vol. 403, no. 10344, 2024, pp. 1141-1152; Heier, J., et al. "Intravitreal Aflibercept (VEGF Trap-Eye) in Wet 17 Age-Related Macular Degeneration." Ophthalmology, vol. 119, no. 12, 2012, pp. 2537-2548. CST Change (m)

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Rapid and consistent resolution of intraretinal fluid (IRF) volume observed across doses Case Example (2.5 mg) IRF Volume Over Time (nL) 160 by Subject 140 120 Single Dose TH103 100 80 Mean ~95% IRF 60 Mean ~99% IRF resolution at Week 1 resolution by Month 1 40 Week 1 20 0 D1 D2 D4 W1 14 W2 M1 1 4 7 10 13 16 19 22 25 28 Month 1 Time Note: Measurement of intraretinal fluid volume (nL) in the central subfield, depicting individual patients (n = 12; one patient in the 0.5 mg cohort was treated with aflibercept 2mg at Week 2 and excluded from the analysis); 3 patients had zero measured IRF throughout depicted timeframe and appear as overlapping lines on the x-axis; Patients dosed at 2.5 mg with additionally purified material (n=6) are excluded from efficacy & PK analyses due to limited follow-up. 18 2 Source: Data from automated fluid measurement software, Notal Vision Inc.; percentage change in mean central subfield IRF volume (nL) from Day 1 to Week 1 / Month 1 (n = 12) Central Subfield IRF Volume (nL)

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Phase 1a initial data summary Efficacy: rapid, robust response on BCVA and OCT ✓ parameters observed across dose levels at one month Safety: TH103 generally well tolerated, supporting ✓ exploration of further dose-escalation 19 19

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Safety Summary 1 from Phase 1a Trial w/ Additional Original Manufacturing Process Processing Steps ● No dose limiting toxicity (DLT) or serious adverse events (SAEs) observed 0.5mg 1.5mg 2.5mg 2.5mg \* (n=3) (n=7) (n=3) (n=6) ● Transient, mild-moderate intraocular inflammation (IOI) Anterior presented at Day 4 in 2 subjects dosed at 2.5mg, attributed chamber cell 0 0 2 (2+) 0 \*\* (Grade) to product host cell protein levels ● Further processing steps added to manufacturing reduced Vitreous chamber cell 0 0 1 (1+) 0 host cell protein levels significantly \*\* (Grade) 2 ● Zero cases of IOI in 6 subjects at 2.5mg with new process material No reported TH103-related adverse events of retinal vascular ● Continuing all future clinical development with new material occlusive disease, retinal vasculitis, cataracts, or elevated intraocular pressure 1) Data as of safety cut-off date December 15, 2025 \* Includes treatment-experienced patients and is intended as a safety cohort 2) Minimum follow-up of 1 week \*\*Standardization of Uveitis Nomenclature (SUN) grading scale: 0, 0.5+, 1+, 2+, 3+, 4+ 20

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Phase 1a initial data summary Efficacy: rapid, robust response on BCVA and OCT ✓ parameters observed across dose levels at one month Safety: TH103 generally well tolerated, supporting ✓ exploration of further dose-escalation Durability: ✓ - PK analysis consistent with greater TH103 intraocular retention vs. other leading agents - Single-dose durability signal suggests potential for stronger durability outcomes after standard four- dose loading regimen 21 21

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Initial SAD plasma PK data is consistent with greater TH103 intraocular retention Plasma Drug Levels Cmax\* Cmax/Dose\* TH103 2.5 mg Treatment (ng/mL) (nM/mmol) Plasma Levels (Cmax/Dose): 1 Eylea 2 mg 40.5 20.6 27x lower than Eylea 2mg 2 Eylea HD 8 mg 247 31.2 3 Vabysmo 6 mg 234 39.0 41x lower than Eylea HD 4 TH103 0.5 mg Not detected n/a 4 TH103 1.5 mg 0.877 0.354 51x lower than Vabysmo 4 TH103 2.5 mg 1.87 0.762 \*Mean, except for Vabysmo which is median Sources: 1) Data from BLA761355 and published studies; 2) Data from BLA761355 ; 3) Data from BLA761235; 4) Data from KLRS-100 Clinical Trial Notes: Dose normalization of a parameter involves converting the mg dose to its molar dose and dividing it by the molar concentration of the administered dose 22

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Single-dose durability signal suggests potential for stronger Phase 1a Single-Dose Time to Retreatment (n = 13) durability outcomes after standard four- Time to first retreatment dose loading regimen 38% ≥ 4M Without any retreatment 31% ≥ 6M M1 M2 M3 M4 M5 M6 Single TH103 Ongoing Phase 1b/2 study designed to further explore durability signal following a standard four-dose loading regimen 23

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Case Example: TH103 single-injection durable response past Month 6 CST Change Over Time 550 500 Single Dose TH103 (0.5mg) 450 ����400 234 ���� m improvement at Month 6 350 300 250 W1 W2 M1 M2 M3 M4 M5 M6 Time Source: As measured by independent reading center 24 Month 6 Month 1 Week 1 CST Change (m)

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First-in-Human data support TH103's potential to be best-in-class, first-line treatment for prevalent retinal diseases Efficacy: rapid, robust response on BCVA and OCT parameters observed across dose levels at one month ✓ - Mean 10-letter BCVA improvement at Month 1 - Mean 129μm improvement in mean CST and mean 95% resolution in CSF intraretinal fluid at Month 1 Safety: TH103 generally well tolerated, supporting exploration of further dose-escalation ✓ - No dose-limiting toxicities or TH103-related SAEs observed 1 - 2 cases of mild/moderate IOI at 2.5mg dose level; no cases of IOI observed to date with new process material at same dose level Durability: ✓ - PK analysis consistent with greater TH103 intraocular retention vs. other leading agents - Single-dose durability signal suggests potential for stronger durability outcomes after standard four-dose loading regimen 1) Data as of safety cut-off date of December 15, 2025; minimum follow up of 1 week 25 25 CSF = Central Subfield

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Phase 1b/2 & Next Steps 26

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Actively Enrolling Phase 1b/2 Trial in nAMD; interim data 2H 2026 Open label, multiple ascending dose design followed by randomized, masked, multi-dose cohort-expansion phase Dose Levels (n~80) Study Phase Extension Phase 5.0mg • Monthly disease activity assessment 2.5mg • Patients exit study after recurrence 1.5mg 0.5mg\* D1 M1 M2 M3 M4 M9 Month 4 Primary timepoint enables rapid Patient Population dose-selection for potential Phase 3 • Age 50+ • Tx-naïve nAMD • > 325 microns CST^ • BCVA: 20/32 to 20/200 \*0.5mg dose level not included in randomized phase ^Confirmed by independent reading center 27

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Kalaris is accelerating First-in-Human data support TH103's potentially clinically 1 meaningful differentiation and advancement into multi-dose TH103 clinical trials development into later stage studies with preliminary readout expected in 2H 2026 Actively enrolling a Phase 1b/2 multiple ascending dose- finding study in up to 80 nAMD patients; preliminary data 2 from Phase 1b/2 trial is expected in 2H 2026 Planned expansions beyond nAMD into other prevalent VEGF-mediated diseases such as Diabetic Macular Edema / 3 Diabetic Retinopathy, Retinal Vein Occlusion 28

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Glossary OCT: Optical Coherence BCVA: Best Corrected Visual Acuity DR: Diabetic Retinopathy Tomography Cmax: Maximum Plasma ETDRS: Early Treatment Diabetic PK: Pharmacokinetics Concentration Retinopathy Study HSPG: Heparan Sulfate CNV: choroidal Neovascularization RVO: Retinal Vein Occlusion Proteoglycans CST: Central Subfield Thickness IOI: Intraocular Inflammation SAD: Single Ascending Dose DLT: Dose Limiting Toxicity IOP: Intraocular Pressure SAE: Serious Adverse Events SD-OCT: Spectral-Domain Optical DME: Diabetic Macular Edema IRF: Intraretinal Fluid Coherence Tomography nAMD: neovascular Age-related TRF: Total Retinal Fluid Macular Degeneration 30