Omiganan

Extended and broadened its ongoing research collaboration with Regeneron, a leading U.S. biotechnology company Announces CLS-001 as subcutaneous formulation of vedolizumab, a currently marketed monoclonal antibody for the treatment of inflammatory bowel disease (IBD) WOBURN, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Comera Life Sciences Holdings, Inc. (Nasdaq: CMRA), a life sciences company developing a new generation of bio-innovative biologic medicines to improve patient access, safety, and convenience, today reported financial results for the quarter ended September 30, 2022 and provided a business update. “We are extremely pleased with our progress this quarter. We have made significant advancements in strengthening our internal pipeline, team and capabilities, highlighted by a recent extension and expansion of one of our noteworthy biotechnology partnerships,” said Jeffrey Hackman, Chairman and Chief Executive Officer of Comera. “We continue to execute on our long-term strategy to leverage our SQore™ platform to transform the delivery of biologics from intravenous to subcutaneous form, and achieve our mission of reducing healthcare costs and improving patient quality of life by offering treatments that support greater independence while also creating value for our shareholders.” 3Q 2022 and Recent Business Highlights Recently, Comera extended and broadened its ongoing research collaboration with Regeneron, a leading U.S. biotechnology company. The partnership includes a right to negotiate a license after further technical evaluation is complete. Today, Comera is introducing its lead pipeline candidate CLS-001 as a subcutaneous (SQ) formulation of vedolizumab, a currently marketed product for the treatment of IBD including Crohn’s disease and ulcerative colitis. Comera believes that a SQ formulation of vedolizumab could have significant advantages for patients and the healthcare system, compared to the current intravenous (IV) formulation. In July 2022, Comera announced favorable topline results from its SEQURUS-1 study. The results of this preclinical study provide supportive evidence of safety of Comera’s lead caffeine-based SQore excipient when administered as a SQ biologic drug product formulation with a monoclonal antibody (mAb). SEQURUS-1 demonstrated no evidence of local or systemic toxicity of caffeine when administered subcutaneously with ipilimumab, a mAb therapy that works to activate the immune system by targeting CTLA-4 to treat melanoma, in animals. Furthermore, a rapid clearance of caffeine was seen within eight hours from test animals, in line with modeled predictions. Initial data also demonstrate no evidence of caffeine impact on ipilimumab absorption. In August 2022, Comera announced entry into a purchase agreement with Arena Business Solutions Global SPC II, Ltd. (Arena) for up to $15 million of the Company’s common stock, with an option to increase to $30 million. The equity line of credit will be used to invest in Comera’s pipeline and proprietary SQore platform. Comera has the right to sell to Arena up to $15 million worth of shares, in its sole discretion, over a 36-month period subject to certain limitations. In October 2022, Comera announced the expansion of its Woburn, Mass. facility. The expanded facility spans over 5,000 square feet and includes additional laboratory space for research and development (R&D) activities as well as new executive offices. The increased footprint will allow the company to double its workforce in the coming years. In October 2022, Comera announced favorable safety and pharmacokinetic results from its SEQURUS-2 study. Together with the SEQURUS-1 study, the SEQURUS-2 data demonstrate no evidence of local or systemic toxicity of caffeine in animals when administered subcutaneously with ipilimumab. Additionally, the results establish that caffeine had no impact on ipilimumab half-life and no effect on pharmacokinetic data for both the IV and SQ groups. In November 2022, Comera appointed Janice Marie McCourt as Chief Business Officer. In her role at Comera, Ms. McCourt will be responsible for business development, including evaluation and execution of out-licensing, in-licensing and strategic transaction opportunities, and driving the execution of the Company’s commercial strategy. Ms. McCourt brings more than 30 years of biotechnology and pharmaceutical experience. Third Quarter 2022 Financial Results Comera reported revenues of $235 thousand for the three months ended September 30, 2022, compared to $88 thousand for the same period in 2021, with the increase primarily related to an increase in research activities performed under customer contracts. Cost of revenue totaled $61 thousand for the three months ended September 30, 2022, compared to $48 thousand for the same period in 2021. R&D expenses totaled $395 thousand for the three months ended September 30, 2022, compared to $264 thousand for the same period in 2021, with the increase primarily related to expansion of R&D activities and higher employee related expenses. General and administrative expenses totaled $2.3 million for the three months ended September 30, 2022, compared to $689 thousand for the same period in 2021, due primarily to an increase in expenses in connection with the Company’s growth and costs associated with transitioning to a public company. Comera reported a net loss attributable to common stockholders of $3.2 million, or $0.20 loss per share for the three months ended September 30, 2022, primarily driven by increased expenses to support the Company’s growth and public company related costs, as compared to a net loss of $914 thousand, or $6.34 loss per share, for the same period in 2021. Comera had $3.0 million in cash and receivables at September 30, 2022. About Comera Life Sciences Leading a compassionate new era in medicine, Comera Life Sciences is applying a deep knowledge of formulation science and technology to transform essential biologic medicines from intravenous (IV) to subcutaneous (SQ) forms. The goal of this approach is to provide patients with the freedom of self-injectable care, reduce institutional dependency and to put patients at the center of their treatment regimen. To learn more about the Comera Life Sciences mission, as well as the proprietary SQore™ platform, visit . Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including, but not limited to: risks that the recently completed business combination disrupts the Company’s current plans and ability to retain its employees; the Company’s ability to maintain the listing of its securities on the Nasdaq Capital Market; the effect of the COVID-19 pandemic on the Company’s business; 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 ability to implement business plans, forecasts, and other expectations and identify and realize additional opportunities; the risk of 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; general economic conditions; and other risks and uncertainties indicated in the Current Report on Form 8-K filed with the SEC on May 25, 2022 under “Risk Factors” and in other filings that have been made or will be made with the SEC. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Comera’s Current Report on Form 8-K filed with the SEC on May 25, 2022 and other documents filed by Comera from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Comera assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Comera can give no assurance that it will achieve its expectations. Contacts Comera Investor John Woolford ICR Westwicke John.Woolford@westwicke.com Comera Press Jon Yu ICR Westwicke ComeraPR@westwicke.com

The FDA has handed down inspection reports to several manufacturing sites in New Jersey, revealing a range of quality control issues. The 483 inspection report for Hikma Injectables’ outsourcing facility in Dayton, NJ, notes three observationss from an inspection from late May to early June of this year. The inspection reveals that the “airborne particulate monitoring program for aseptic operations” was not designed to support the quality of drug products meant to be sterile and was not monitoring airborne particulates correctly. The FDA noted on multiple occasions that “particle Counters” were not being directed into the flow of air. The FDA also notes that some drug products were not properly tested to determine an expiration date, with several products highlighted for not having those results. Another 483 spells out the inspection details at an Eli Lilly facility in Branchburg, NJ. Several weeks ago , an inspection in July by the US regulator revealed several issues surrounding quality control at the Lilly site. The two-page report now reveals “unknown debris” in the building and a tank not being “adequately controlled pending satisfactory completion of evaluation by the quality unit.” The site also failed to document and investigate any deviations from lab procedures. Specifically, the report states that the site did not investigate the impact, root cause, and corrective actions when an Analyst in a redacted QC lab had failed to follow procedure before starting system flow during cleaning. The Branchburg site has been on the government’s radar for a while, the DOJ slapping it with a subpoena requesting additional documentation on its work in Branchburg. Meanwhile, the whistleblower brought the company to court in New Jersey to seek damages after revealing a wide range of quality control failures dating back to 2018. HHS should better manage inventory gaps risks within the national stockpile — GAO report While the HHS has been busy filling the Strategic National Stockpile (SNS) with vaccines to counter recent outbreaks, the Government Accountability Office (GAO) has chimed in on the potential gaps and risks in the SNS. The report says that from 2015 through 2019, the stockpile used a “multi-step process involving interagency experts, resulting in annual SNS reviews with inventory recommendations,” but stopped when it underwent reorganization. Annual reviews were not completed in 2020 through 2022. The report states that: HHS has since completed reviews to inform inventory decisions for fiscal years 2023 and 2024. However, these reviews did not meet most statutory requirements—such as by including the amount of additional medical countermeasures procured— because HHS did not update its procedures to account for changes enacted in 2019. Until HHS updates its procedures, the agency risks not meeting the statutory requirements designed to give Congress additional information about the SNS inventory. The SNS has been given $5 billion to keep countermeasures on hand for potential anthrax and smallpox outbreaks, and the GAO’s analysis shows that most medical countermeasure types were acquired but often not in the recommended quantities. “HHS officials noted that gaps in quantities are due to budget constraints and acknowledge these gaps present risks. However, the reviews lack key information needed for managing these risks and communicating them to stakeholders, including to Congress,” the report points out. While the SNS was granted $6.1 billion in Covid-19 relief funds for supplies for the stockpile that significantly increased the amount of certain medical countermeasures, with most of the funding going toward ventilators and personal protective equipment. The GAO is making several recommendations to HHS including a review being conducted following statuary requirements, such as “descriptions of the responsibilities of interagency partners.” The GAO also recommends that the assistant secretary for preparedness and response should develop an approach for “ensuring that medical countermeasures under consideration for SNS procurement receive the same consideration regardless of whether they received development funding from BARDA.” The agency suggests finding a way to manage the risks associated with the gaps between inventory levels and the recommended quantities, and to report risks upon inspection. WHO reports shortage of Cholera vaccine, recommends a change in strategy The World Health Organization (WHO) reported that a strained global supply of cholera vaccines forced the hand of the body that manages the emergency supply of vaccines, the International Coordinating Group (ICG). The organization has suspended the use of two-dose vaccination regimens for cholera and instead will switch to a single dose. This will allow vaccines to last longer while instances of cholera outbreaks have been on the rise according to the WHO with nations such as Haiti, Syria and Malawi experiencing outbreaks this year. WHO stated that the one-dose approach can be effective although the exact length of the protection is limited and is lower in children. It is estimated that of the 36 million doses to be made this year, 24 million have been shipped out mainly to react to outbreaks. The ICG has been approved to get an additional 8 million doses. The WHO also notes that manufacturers are working at max capacity but there is currently no short-term solution to boost production. “The temporary suspension of the two-dose strategy will allow the remaining doses to be redirected for any needs for the rest of the year,” the WHO report said. Grifols opens new manufacturing site in Dublin Plasma medicine manufacturer Grifols is following in the footsteps of other major pharma on the Emerald Isle and capped off an expansion. The company reported that it opened a new 183,000-square-foot albumin manufacturing plant in Dublin, adding to Grifols’ presence in its Grange Castle facilities. The site will aim to triple the filling capacity of the production of its “FlexBag” container. “This new magnificent Dublin manufacturing facility, which incorporates Grifols industry-leading engineering, is indicative of this company’s commitment to investing in essential plasma-medicine infrastructure globally to treat more patients around the world,” said Grifols’ co-CEOs Víctor Grifols Deu and Raimon Grifols Roura, in a statement . The cost of the expansion and the headcount were not disclosed, but the company invested more than €300 million into its Irish operations since 2012 when it first established a presence there. Japanese cell therapy startup nets manufacturing partner A startup in the cell therapy space has netted a manufacturer for its eye disease drug candidate. Cellusion, a startup centered on using cells to treat disease in the eye, is partnering with the CDMO Minaris Regenerative Medicine to manufacture Cellusion’s candidate CLS001 which is aimed to treat bullous keratopathy, a disease that can cause blindness. According to the letter of intent, Cellusion and Minaris will develop the manufacturing process of the candidate, with Minaris’ operations in Allendale, NJ, “performing process optimization to meet requirements from the FDA.” Financial details of the deal or a timeline for the product to be finished were not disclosed. “It is exciting for Minaris Regenerative Medicine to be part of advancing a potential solution to corneal blindness, a widespread need, and we look forward to leveraging our extensive development resources to support Cellusion. We hope to position Cellusion well for its next clinical trial and potentially further support them in their manufacturing needs,” said Minaris CEO Hiroto Bando, in a statement .