# EDGAR Filing Document

**Accession Number:** 0001907685
**File Stem:** 0001193125-23-079163
**Filing Date:** 2023-3
**Character Count:** 21231
**Document Hash:** 973bec7136d2990b72d4a9d353be07fd
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-079163.hdr.sgml**: 20230324

**ACCESSION NUMBER**: 0001193125-23-079163

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 33

**CONFORMED PERIOD OF REPORT**: 20230324

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230324

**DATE AS OF CHANGE**: 20230324

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Comera Life Sciences Holdings, Inc.
- **CENTRAL INDEX KEY:** 0001907685
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 874706968
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41403
- **FILM NUMBER:** 23760139

**BUSINESS ADDRESS:**
- **STREET 1:** 12 GILL STREET
- **STREET 2:** SUITE 4650
- **CITY:** WOBURN
- **STATE:** MA
- **ZIP:** 01801
- **BUSINESS PHONE:** (617)871-2101

**MAIL ADDRESS:**
- **STREET 1:** 12 GILL STREET
- **STREET 2:** SUITE 4650
- **CITY:** WOBURN
- **STATE:** MA
- **ZIP:** 01801

?xml version="1.0" encoding="utf-8" ? 8-K

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

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

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): March 24, 2023

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## Comera Life Sciences Holdings, Inc.

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

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| | | |
|:---|:---|:---|
| **Delaware** | **1-41403** | **87-4706968** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

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| | |
|:---|:---|
| **12 Gill Street**<br> **Suite 4650**<br> **Woburn, Massachusetts** | **01801** |
| **(Address of principal executive offices)** | **(Zip Code)** |

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#### Registrant's telephone number, including area code: (617) 871-2101

#### Not Applicable

#### (Former name or former address, if changed since last report)

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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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange**<br> **on which registered** |
| Common Stock | CMRA | The Nasdaq Stock Market LLC |
| Warrants | CMRAW | The Nasdaq Stock Market LLC |

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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. ☐

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

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Comera Life Sciences Holdings, Inc. (the "Company") from time to time presents at various industry and other conferences and provides summary business information. A copy of the slide presentation that will be used by representatives of the Company in connection with such presentations (the "Corporate Presentation") is attached to this Current Report on Form 8-K as Exhibit 99.1. The Corporate Presentation is current as of March 24, 2023, and the Company disclaims any obligation to correct or update this material in the future.

The information in the presentation attached as Exhibit 99.1 is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.

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

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | [Corporate Presentation current as of March 24, 2023](d379488dex991.htm) |
| 104 | Inline XBRL for the cover page of this Current Report on Form 8-K |

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#### SIGNATURE
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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| | | |
|:---|:---|:---|
| Dated: March 24, 2023 | COMERA LIFE SCIENCES HOLDINGS, INC. | COMERA LIFE SCIENCES HOLDINGS, INC. |
|  | By: | /s/ Michael Campbell |
|  | Name: | Michael Campbell |
|  | Title: | Executive Vice President and Chief Financial Officer |

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## Exhibit 99.1

![Slide 1](g379488ex99_1s1g1.jpg)

Corporate Presentation March 2023 Exhibit 99.1

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![Slide 2](g379488ex99_1s2g1.jpg)

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by forward-looking words such as "may," "might," "could," "will," "would," "should," "expect," "possible," "potential," "anticipate," "contemplate," "believe," "estimate," "plan," "predict," "project," "intends," and "continue" or similar words, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: the Company's ability to maintain the listing of its securities on the Nasdaq Capital Market; the price of the Company's securities may be volatile due to a variety of factors, including changes in the competitive and highly regulated industries in which the Company plans to operate, variations in performance across competitors, changes in laws and regulations affecting the Company's business and changes in the capital structure; the Company's ability to execute on its business plans, forecasts, and other expectations and identify and realize additional opportunities; the risk of economic downturns and the possibility of rapid change in the highly competitive industry in which the Company operates; the risk that the Company and its current and future collaborators are unable to successfully develop and commercialize the Company's products or services, or experience significant delays in doing so; the risk that we will be unable to continue to attract and retain third-party collaborators, including collaboration partners and licensors; the risk that the Company may never achieve or sustain profitability; the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk that the Company experiences difficulties in managing its growth and expanding operations; the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations; the risk that the Company is unable to secure or protect its intellectual property; the risk that the Company is unable to secure regulatory approval for its product candidates; the effect of any resurgence of the COVID-19 pandemic or other public health emergencies on the Company's business; general economic conditions; and other risks and uncertainties described in the Company's Annual Report on Form 10-K filed with the SEC on March 17, 2023 under "Risk Factors" and in other filings that have been made or will be made with the SEC. Accordingly, nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved, and any forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Forward-Looking Statements

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![Slide 3](g379488ex99_1s3g1.jpg)

Experienced and Accomplished Management Team Successful track record of drug development and life sciences operating expertise Neal I. Muni, MD, MSPH Chief Operating Officer Jeffrey S. Hackman Chairman and Chief Executive Officer Robert Mahoney, Ph.D. Chief Scientific Officer Michael Campbell Chief Financial Officer Janice Marie McCourt Chief Business Officer

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![Slide 4](g379488ex99_1s4g1.jpg)

Comera Life Sciences Investment Highlights Validating Partnerships 3 active R&D partnerships: opportunity to negotiate potentially significant upfront/milestone payments and product royalties Broadly applicable technology, multiple ongoing discussions for additional R&D partnerships Evolutionary Technology Technology enables subcutaneous (SQ) delivery of IV biologics Proprietary SQore technology protected by robust patent portfolio $30+ million invested to date over the past 10 years Offers potential for product life-cycle management and competitive advantages Significant Market Opportunity Opportunity within a variety of existing multi-billion dollar commercial markets Potential benefit to patient, provider, and healthcare system Demonstrated ability to substantially enhance potential for deeper market penetration Capital Efficient Business Model Partners assume responsibility for downstream clinical development Lower risk clinical development strategy Minimal incremental spend to near-term value inflection points

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![Slide 5](g379488ex99_1s5g1.jpg)

Comera Life Sciences Value Development Overview Partner Partnering Stage Engagement Evaluation Agreement Licensing Milestones/ Royalties Undisclosed Top 10 Pharma Company ~6-12 months ~6-18 months ~3-18 months ~12+ months Asset Name Formulation Pre-Clinical Clinical Trials Approval CLS-001 Partnership Pipeline Clinical Development Pipeline

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![Slide 6](g379488ex99_1s6g1.jpg)

Significant Inbound Interest as Well as BD Outreach Efforts Drive Partnerships Target Engagement Proposals Research Collaborations Large Potential Target Universe (Pharmas, Biotechs, CDMOs) Current Partnerships "It would take us over ten years to build a working formulation department, so we prefer to work with Comera to jump start this initiative." - Chief Strategy Officer, Major Biosimilars Company "We love the work at Comera to solve formulation issues that we have not been able to solve ourselves." - Head of BD, Large Biotech ~6-12 months ~1-3 months Top 10 Pharma Company

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![Slide 7](g379488ex99_1s7g1.jpg)

Self-Administered, SQ Biologic Dosing has Multiple Potential Benefits over IV Infusion Better Patient Outcomes Potential for improved compliance Significantly reduced administration time Increased convenience/quality of life Strong physician preference (over 70% prefer SQ to IV biologic, if available)\* For Patients Reduced Healthcare Costs IV infusion centers and staffing not required Potential for improved outcomes Decreased healthcare professional time spent on disease management For Payers Increased Revenue Extend franchise life & patent protections Increased market share Rescue efficacious drugs terminated due to formulation/administration issues For Pharma Partners Potential Advantages of SQ over IV SQ IV \*Source: Ipsos market study and Comera physician interviews, December 2021; base: Total HCPs; n=50 + 5 IDIs with high-prescribing physicians

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![Slide 8](g379488ex99_1s8g1.jpg)

Lack of innovation highlighted by FDA Novel Excipient Review Pilot Program First proposals accepted December 2021 High Viscosity Results from high protein concentration and limits IV to SQ conversion Low Viscosity SQore technology enables IV to SQ conversion by reducing viscosity Formulating SQ Biologics is Technically Challenging, Without Much Innovation by Pharma in this Space High Viscosity a Significant Hurdle to Formulating SQ Biologics Pharma Has Not Brought Innovative New Technology to Solve Problem Historically Reliant on Old, Off-the-Shelf Excipient Technology

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![Slide 9](g379488ex99_1s9g1.jpg)

SQ Value Proposition Validated by Market Conversions SQ Market Penetration After IV Conversion Case Study of Selected Biologic Analogues Source: Symphony; FDA; Biosimilar Development; L.E.K. interviews, research and analysis; https://www.fiercepharma.com/pharma/jjs-switch-iv-subcutaneous-darzalex-85-complete-us#:~:text=Johnson%20%26%20Johnson's%20attempt%20to%20switch,formulation%20of%20the%20cancer%20treatment. \*Herceptin Hylecta utilizes different technology for SQ delivery (Halozyme ENHANZE), which still requires HCP administration in institutional setting, likely dampening rate of conversion % SQ share of U.S. market Year post-launch of SQ formulation The most recent conversion, J&J's Darzalex Faspro, has achieved 85% conversion in less than 2 years Global biologics market ~$383B in 2022, growing at an 8.8% CAGR through 20321 Majority of biologics are IV infusions Significant industry interest in converting IV biologics to SQ

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![Slide 10](g379488ex99_1s10g1.jpg)

Our Solution: The Viscosity Reduction Platform SQore platform predictions validated by testing on 20 different mAbs Lead, caffeine-based SQore excipient evaluated in four pre-clinical studies Validated safety Validated pharmacokinetics of antibody absorption Robust IP portfolio, with 13 patents issued and >35 patents pending 3 patent families including viscosity reduction, stabilization, process Multiple key geographies Coverage up to mid-2040s $30M invested over 10 years to build and validate SQore technology Expert Engineering Computational Modeling Viscosity Reducing Excipients What is SQore? SQore is the integration of advanced computational modeling, a robust library of carefully selected excipients, and protein formulation engineering by an expert team of scientists SQore excipients preventing antibody aggregation

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![Slide 11](g379488ex99_1s11g1.jpg)

IP-Protected and Previous Human Use Does Not Alter Antibody Properties Can Be Taken At Home by Patient Offers Advantages vs. Other SQ Formulation Approaches

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![Slide 12](g379488ex99_1s12g1.jpg)

Lead SQore excipient, caffeine, used to show SQ formulation proof of concept for two leading mAbs Significant viscosity reduction No effect on mAb stability No loss of biological activity : Validated by Scientific Peer-Review Source: "Caffeine as a viscosity reducer for highly concentrated monoclonal antibody solutions", Journal of Pharmaceutical Sciences, 110 (2021) 3594-3604, https://doi.org/10.1016/j.xphs.2021.06.030 Caffeine-based lead SQore excipient proven in externally validated, rigorous scientific evaluation to achieve parameters that we believe demonstrate a viable SQ formulation

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![Slide 13](g379488ex99_1s13g1.jpg)

Platform Optimized to Lower Viscosity for Several Biologics Ipilimumab formulated in Yervoy commercial formulation vehicle (Comm.) and PBS with or without 75 mM caffeine Source: "Caffeine as a viscosity reducer for highly concentrated monoclonal antibody solutions" Journal of Pharmaceutical Sciences 110 (2021) 3594-3604 https://doi.org/10.1016/j.xphs.2021.06.030 77% viscosity reduction 45-78% viscosity reduction Inﬂiximab formulated in a 20 mM phosphate-acetate buffer at pH 6.0 (control) and in the presence of 75 mM caffeine, 100 mM ArgHCl, or 100 mM NaCl infliximab (mg/mL) ipilimumab (mg/mL) Viscosity (cP) Viscosity (cP) Target Viscosity Range Target Viscosity Range

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![Slide 14](g379488ex99_1s14g1.jpg)

Late-stage clinical programs and/or marketed assets with significant commercial potential Willingness to share in upside if collaboration successful (milestones, royalties) Near-term milestone potential (≤2 yrs.) 200+ potential therapeutic antibody program candidates for research collaboration Selective Focus on High-Value Partnerships With Potential Near-Term Milestone Value Selected research collaboration 1 2 3

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![Slide 15](g379488ex99_1s15g1.jpg)

Partnership Value Generated Through Multiple Stages Revenue generating research collaboration to assess feasibility (~$350K-1M+) Evaluation Agreements (~6-18 months) License Option Exercise (~3-18 months) Potential $multi-million upfront payment to license SQore technology (~$10-100M+)1 Milestones/Royalties (12+ months) Potential $multi-million payments upon achievement of key development milestones Potential single to mid-teen % royalty on product sales 0-2 years 2-5 years 5+ years $1B+ Evaluation agreements are the first stage to long-term royalty streams Eval. Agreement Revenue Eval. Agreement Revenue Eval. Agreement Revenue License Payments License Payments License Payments Milestones/ Royalties Milestones/ Royalties 1Based on BioPharma transactions included in the J.P Morgan Biopharma Therapeutics Licensing Deals and Venture April 2022 report; DealForma.com database. Data through 4/7/2022

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![Slide 16](g379488ex99_1s16g1.jpg)

SQ Formulation Feasible With SQore Commercially Validated, Scientifically-Derisked Large Market Opportunity Multiple SQ Opportunities for Internal Pipeline 1 2 3 Several opportunities appear to be attractive for internal development into SQ formulations, representing low capital intensity, lower risk opportunities targeting large markets. Over 150 Therapeutic Antibody Candidates Screened Lead Product Candidate CLS-001 Oncology SQ Candidate Target Market ~$15B Oncology SQ Candidate Target Market ~$10B Inflammation SQ Candidate Target Market ~$1B Oncology SQ Candidate Target Market ~$3B Onc/Inflammation SQ Candidate Target Market ~$2B Inflammation SQ Candidate Target Market ~$2B 6 Prioritized Candidates

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![Slide 17](g379488ex99_1s17g1.jpg)

CLS-001 (SQ Vedolizumab): Initial Product Candidate SQ formulation of vedolizumab Program Therapeutic Area IBD Ulcerative colitis and Crohn's disease Development Status Formulation development Competition No SQ currently in US Estimated SQ Entyvio approval 2024 Differentiation Once monthly SQ dosing vs. every 2 weeks Source: : L.E.K market research and analysis, January 2022; EvaluatePharma; Biosimilardevelopment.com; Parrish (2020); Company website; Cowen (09.2021); SVB Leerink (10.2021); H.C. Wainwright (10.2021); Jefferies (07.2021); https://www.takeda.com/4ada11/siteassets/system/investors/report/quarterlyannouncements/fy2022/qr2022_q2_p01_en.pdf WW Sales (2021): $4B Estimated Peak (2026+): $7.5-9.0B Peak Annual Sales Potential ~$2B CLS-001 is a potential multibillion-dollar opportunity to bring differentiated value to improve the lives of patients with a self-administered SQ formulation having reduced dosing frequency Blockbuster product - large conversion opportunity

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![Slide 18](g379488ex99_1s18g1.jpg)

Comera Life Sciences Investment Highlights Validating Partnerships 3 active R&D partnerships: opportunity to negotiate potentially significant upfront/milestone payments and product royalties Broadly applicable technology, multiple ongoing discussions for additional R&D partnerships Evolutionary Technology Technology enables subcutaneous delivery of IV biologics Proprietary SQore technology protected by robust patent portfolio $30+ Million invested to date over the past 10 years Offers potential for product life-cycle management and competitive advantages Significant Market Opportunity Opportunity within a variety of existing multi-billion dollar commercial markets Potential benefit to patient, provider, and healthcare system Demonstrated ability to substantially enhance potential for deeper market penetration Capital Efficient Business Model Partners assume responsibility for downstream clinical development Lower risk clinical development strategy Minimal incremental spend to near-term value inflection points

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![Slide 19](g379488ex99_1s19g1.jpg)

Thank you! Investor Contact John Woolford ICR Westwicke John.Woolford@westwicke.com Press Contact Jon Yu ICR Westwicke comerapr@westwicke.com 12 Gill Street, Suite 4650 Woburn, MA 01801, USA comeralifesciences.com