Duyuru • Feb 16
The Nasdaq Stock Market to Delist the Common Stock of Comera Life Sciences Holdings The Nasdaq Stock Market announced on February 13, 2024, that it will delist the common stock and warrants of Comera Life Sciences Holdings, Inc. Comera Life Sciences Holdings' securities were suspended on November 17, 2023, and have not traded on Nasdaq since that time. Duyuru • Nov 18
Comera Life Sciences Holdings, Inc.(OTCPK:CMRA) dropped from NASDAQ Composite Index Comera Life Sciences Holdings, Inc. has been removed from NASDAQ Composite Index (^COMP) . Duyuru • Nov 17
Comera Life Sciences Holdings Receives Notice from the Nasdaq Stock Market On November 15, 2023, Comera Life Sciences Holdings, Inc. received notice from The Nasdaq Stock Market LLC that the Nasdaq Hearings Panel has determined to delist the common stock and warrants of the Company. Suspension of trading in the Company’s securities will be effective at the open of trading on November 17, 2023. The Company has a period of 15 days from the date of the notice letter to submit a written request for a review of the Nasdaq Hearings Panel’s delisting determination by the Nasdaq Listing and Hearing Review Council (the “Listing Council”). The Company does not plan to appeal the Nasdaq Hearings Panel’s determination and expects that a Form 25-NSE will be filed with the Securities and Exchange Commission (“SEC”), which would remove the Company’s securities from listing and registration on Nasdaq. As previously disclosed, the Company received a letter from the listing qualifications department staff of The Nasdaq Stock Market on November 18, 2022 notifying the Company that for the last 30 consecutive business days, the Company’s minimum Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2). On August 8, 2023, the Nasdaq Hearings Panel granted the Company’s request for the continued listing of its common stock on the Nasdaq Capital Market, subject to the Company’s satisfaction of certain interim milestones and, ultimately, the Company’s compliance with all applicable criteria for continued listing on Nasdaq, including the bid price requirement and the MVLS rule, by no later than November 14, 2023. On October 31, 2023, the Company received an additional delist determination for failing to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market (the “bid price requirement”), as set in Nasdaq Listing Rule 5550(a)(2) within the 180 calendar day period provided by Rule 5810(c)(3)(A). The Company was unable to regain compliance with the MVLS Rule or any of the alternative standards for continued listing in Nasdaq Listing Rule 5550(b) by November 14, 2023. Following the delisting of its securities from the Nasdaq Capital Market, the Company will continue to be a reporting company under the Securities Exchange Act of 1934, as amended, and will continue to make all required SEC filings. The Company expects its common stock and warrants will commence trading on the OTC Markets Group platform at the open of trading on November 17, 2023 under the symbols “CMRA” and “CMRAW”, respectively, and the Company has applied for trading of its securities on the OTCQB market. Duyuru • Nov 15
Comera Life Sciences Holdings, Inc. Appoints Dorothy Clarke to Board of Directors Comera Life Sciences Holdings, Inc. announced it appointed Dorothy Clarke to its board of directors. Ms. Clarke previously held leadership roles at Johnson & Johnson for over 20 years, including in law, regulatory, compliance and data protection functions. Before that, she was an attorney representing pharmaceutical companies and healthcare organizations. Reported Earnings • Nov 11
Second quarter 2023 earnings released: US$0.078 loss per share (vs US$1.14 loss in 2Q 2022) Second quarter 2023 results: US$0.078 loss per share (improved from US$1.14 loss in 2Q 2022). Revenue: US$315.1k (up 115% from 2Q 2022). Net loss: US$1.50m (loss narrowed 84% from 2Q 2022). New Risk • Nov 10
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 63% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Negative equity (-US$1.7m). Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Market cap is less than US$10m (US$8.57m market cap). Minor Risk Revenue is less than US$5m (US$1.1m revenue). Duyuru • Nov 04
Comera Life Sciences Holdings Receives Non-Compliance Notice From The Nasdaq Stock Market LLC On October 31, 2023, Comera Life Sciences Holdings, Inc. (the “Company”) received notice from The Nasdaq Stock Market LLC that the Company had not regained compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market (the “bid price requirement”), as set in Nasdaq Listing Rule 5550(a)(2) within the 180 calendar day period provided by Rule 5810(c)(3)(A) and that the Company is not eligible for a second 180 day period to regain compliance. The notice letter indicated that the Nasdaq Hearings Panel will consider this matter in their decision regarding the Company’s continued listing on the Nasdaq Capital Market and that the Company should present its views with respect to this additional deficiency in writing no later than November 7, 2023. As previously disclosed, the Company received a letter from the listing qualifications department staff of The Nasdaq Stock Market on November 18, 2022 notifying the Company that for the last 30 consecutive business days, the Company’s minimum Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2). On August 8, 2023, the Nasdaq Hearings Panel granted the Company’s request for the continued listing of its common stock on the Nasdaq Capital Market, subject to the Company’s satisfaction of certain interim milestones and, ultimately, the Company’s compliance with all applicable criteria for continued listing on Nasdaq, including the bid price requirement and the MVLS rule, by no later than November 14, 2023. The Company believes it is unlikely to regain compliance with Nasdaq Listing Rules 5550(a)(2) and 5550(b) by November 14, 2023, and therefore, its securities may be delisted from the Nasdaq Capital Market. If the Company’s securities are delisted from the Nasdaq Capital Market, the Company will continue to be a reporting company under the Securities Exchange Act of 1934, as amended. In addition, the Company expects that its common stock will be traded on one of the three tiered marketplaces of the OTC Markets Group. Duyuru • Sep 13
Comera Life Sciences Holdings, Inc. announced that it has received $4.069993 million in funding On September 11, 2023, Comera Life Sciences Holdings, Inc. closed the transaction. The company issued 3,561,851 common shares and warrants to purchase up to an additional 8,904,641 shares for the gross proceeds of $1.82 million in its final tranche. Duyuru • Aug 17
Comera Life Sciences Holdings, Inc. Announces Publication of Study Reinforcing Caffeine's Viscosity Reducing Capabilities Comera Life Sciences Holdings, Inc. announced the peer-reviewed publication of preclinical data in the Journal of Pharmaceutical Sciences, which provide further evidence of caffeine's viscosity reducing capabilities and support further development of caffeine as a viscosity reducing agent for subcutaneous (SQ) formulations of monoclonal antibodies. These studies aimed to assess the pharmacokinetic (PK) characteristics of caffeine and its influence on the PK behavior of a representative monoclonal antibody (mAb) ipilimumab. The outcomes show rapid SQ absorption and elimination of caffeine, regardless of whether it was administered alone or in conjunction with the monoclonal antibody. Notably, caffeine exhibited no impact on the PK profiles of ipilimumab with SQ administration. Moreover, when caffeine was injected SQ at various dosage levels, no irritation or adverse effects were observed at the injection site. Reported Earnings • Aug 13
Second quarter 2023 earnings released: US$0.078 loss per share (vs US$1.14 loss in 2Q 2022) Second quarter 2023 results: US$0.078 loss per share (improved from US$1.14 loss in 2Q 2022). Revenue: US$315.1k (up 115% from 2Q 2022). Net loss: US$1.50m (loss narrowed 84% from 2Q 2022). Duyuru • Aug 12
Comera Life Sciences Holdings, Inc., Annual General Meeting, Aug 31, 2023 Comera Life Sciences Holdings, Inc., Annual General Meeting, Aug 31, 2023, at 11:00 US Eastern Standard Time. Agenda: To elect one Class I director to serve until the 2026 Annual Meeting of Stockholders; to approve an amendment to increase the number of shares of our common stock reserved for issuance under the Comera Life Sciences Holdings, Inc. 2022 Equity and Incentive Plan by 3,000,000 shares; to approve, for purposes of complying with Nasdaq Listing Rule 5635(b) and (d); to approve a proposal to authorize the Company’s board of directors, in its discretion at any time within one year after stockholder approval is obtained, to amend the Company’s Amended and Restated Certificate of Incorporation; to ratify the appointment of Baker Tilly US LLP as the Company’s independent registered public accounting firm for the 2023 fiscal year; and to transact any other business that may properly come before the meeting or any adjournment thereof. Duyuru • Aug 09
Comera Life Sciences Holdings, Inc. Significantly Expands Intellectual Property Portfolio Strengthening the Proprietary SQore(TM) Platform Comera Life Sciences Holdings, Inc. announced a significant expansion of its SQore(TM) patent portfolio with the issuance of four new patents and two newices of allowance. The six new patents, three issued in the United States and three covering Canada, Korea and India expand the number of proprietary viscosity reducing excipients in Comera's SQore platform and significantly broaden claims covered by previously issued patents. Comera is using its proprietary formulation platform, SQore, to enable subcutaneous (SQ) delivery of intravenous (IV) drugs such as monoclonal antibodies (mAbs). The addition of excipients, such as caffeine, interrupts intermolecular interactions to reduce viscosity of high concentration mAb formulations. The new issuances and allowed patents broaden the number of SQore excipients covered for viscosity reduction claims, including exclusive rights to certain formulations containing combinations of its proprietary excipients. Additionally, the new patents significantly expand previously issued patent claims to provide exclusive rights on magnitude of viscosity reduction versus control, concentration of protein and quantity of excipient in formulations. Today's announcement also marks the first issued patent in India, validating Comera's efforts to ensure a broad geographic scope for SQore patent protection. Duyuru • Aug 02
Comera Life Sciences Holdings, Inc. announced that it expects to receive $4.1 million in funding Comera Life Sciences Holdings, Inc. that it has executed a definitive agreement for the private placement of 8,019,560 common shares at a price of $0.51125 per share for gross proceeds of 4,100,000 on August 1, 2023. The shares are accompanied by five-year warrants to purchase shares of common stock at an exercise price of $0.6135 per share, beginning six months and one day after issuance. On July 31, 2023, Comera sold and issued a total of 4,399,016 shares of its common stock and warrants to purchase an aggregate of 10,997,550 shares of its common stock in a first closing, resulting in gross proceeds of $2.25 million to Comera. Comera expects to sell and issue an additional 3,561,851 shares of its common stock and warrants to purchase an aggregate of 8,904,641 shares of its common stock in a second closing, resulting in additional gross proceeds of $1.82 million, conditioned upon receipt of stockholder approval under the applicable Nasdaq listing standards. Warrants issued in connection with the second closing will be immediately exercisable. New Risk • Jun 22
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.9m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Negative equity (-US$660k). Revenue is less than US$1m (US$931k revenue). Minor Risks Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (US$12.3m market cap). Duyuru • May 22
Comera Life Sciences Holdings Receives A Determination Letter from Nasdaq Regarding Market Value of Listed Securities On May 18, 2023, Comera Life Sciences Holdings, Inc. (the Company) received a determination letter (the Letter) from the staff (the Staff) of The Nasdaq Stock Market LLC (Nasdaq) stating that the Company has not regainedcompliance with the Market Value of Listed Securities (MVLS) Standard, since the Company's common stock, par value $0.0001 per share (the Common Stock), was below the $35 million minimum MVLS requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the MLVS Rule) and had not been at least $35 million for a minimum of 10 consecutive business days at any time during the 180-day grace period granted to the Company. As previously disclosed, the Company was initially notified by the Staff on November 18, 2022 that the minimum MVLS for the Company's Common Stock was below the $35 million minimum MVLS requirement for the previous 30 consecutive business days, and in accordance with the Nasdaq Listing Rules, the Company was provided 180 calendar days, or until May 17, 2023, to regain compliance with the MVLS Rule. Pursuant to the Letter, unless the Company requests a hearing to appeal this determination by 4:00 p.m. Eastern Time on May 25, 2023, the Company's Common Stock will be delisted from The Nasdaq Capital Market, trading of the Company's Common Stock will be suspended at the opening of business on May 30, 2023, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's securities from listing and registration on Nasdaq. The Company intends to request a hearing before the Nasdaq Hearings Panel (the Panel) to appeal the Letter received on May 18, 2023. A hearing request will stay the suspension of trading of the Company's Common Stock, and the Company's Common Stock will continue to trade on The Nasdaq Capital Market until the hearing process concludes and the Panel issues a written decision. There can be no assurance that the Panel will grant the Company's request for a suspension of delisting or continued listing on The Nasdaq Capital Market. If the Company's Common Stock ceases to be listed for trading on The Nasdaq Capital Market, the Company would expect that its Common Stock would be traded on one of the three tiered marketplaces of the OTC Markets Group. Reported Earnings • May 14
First quarter 2023 earnings released: US$0.13 loss per share (vs US$3.09 loss in 1Q 2022) First quarter 2023 results: US$0.13 loss per share (improved from US$3.09 loss in 1Q 2022). Revenue: US$392.9k (up 312% from 1Q 2022). Net loss: US$2.39m (loss narrowed 17% from 1Q 2022). Duyuru • May 08
Comera Life Sciences Holdings Receives Notice from Nasdaq Regarding Not in Compliance with the Minimum Bid Price Requirement On May 2, 2023, Comera Life Sciences Holdings, Inc. received written notice from The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that the Company is not in compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market, as set forth in Listing Rule 5550(a)(2). In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until October 30, 2023, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. If the Company is not in compliance by October 30, 2023, the Company may be eligible for additional time to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the minimum bid price requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the minimum bid price deficiency. If the Company does not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal Nasdaq’s determination, but there can be no assurance that Nasdaq would grant the Company’s request for continued listing. The Company intends to monitor the closing bid price of its common stock and consider options to resolve the noncompliance with the minimum bid price requirement. Reported Earnings • Mar 18
Full year 2022 earnings released: US$1.76 loss per share (vs US$1.40 loss in FY 2021) Full year 2022 results: US$1.76 loss per share (further deteriorated from US$1.40 loss in FY 2021). Revenue: US$633.1k (up 98% from FY 2021). Net loss: US$18.4m (loss widened 237% from FY 2021). Board Change • Dec 31
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. 4 experienced directors. No highly experienced directors. Independent Director Ed Sullivan is the most experienced director on the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Duyuru • Nov 24
Comera Life Sciences Holdings Receives a Non-Compliance Letter from the Listing Qualifications Department Staff of Nasdaq On November 18, 2022, Comera Life Sciences Holdings, Inc. (the “Company”) received a letter from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the last 30 consecutive business days, the Company’s minimum Market Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq listing rule 5550(b)(2). The notice has no immediate effect on the listing of the Company’s common stock, and the Company’s common stock continues to trade on the Nasdaq Capital Market under the symbol “CMRA.” In accordance with Nasdaq listing rule 5810(c)(3)(C), the Company has 180 calendar days, or until May 17, 2023, to regain compliance. The notice states that to regain compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days (or such longer period of time as the Nasdaq staff may require in some circumstances, but generally not more than 20 consecutive business days) during the compliance period ending May 17, 2023. The Company may also regain compliance by meeting the continued listing standard of a minimum stockholders’ equity of at least $2.5 million. If the Company does not regain compliance by May 17, 2023, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a Nasdaq hearings panel. The Company intends to actively monitor the Company’s MVLS between now and May 17, 2023, and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the MVLS rule. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with Nasdaq listing standards. Reported Earnings • Nov 16
Third quarter 2022 earnings released Third quarter 2022 results: US$0.20 loss per share. Net loss: US$3.16m (flat on 3Q 2021). Reported Earnings • Nov 12
Third quarter 2022 earnings released Third quarter 2022 results: US$0.20 loss per share. Net loss: US$3.16m (flat on 3Q 2021). Duyuru • Nov 10
Comera Life Sciences Appoints Janice Marie Mccourt as Chief Business Officer Comera Life Sciences Holdings, Inc. announced the appointment of 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 will report to Jeffrey Hackman, Chairman and CEO, and serve on the Company’s executive leadership team, working closely with the other members of the executive leadership team to secure commercial partnership opportunities and advance the Company's pipeline of drug candidates. Ms. McCourt also served as Senior Vice President of Business Development and Marketing for Ingenix, a health care information, technology and research company and a wholly owned subsidiary of UnitedHealth Group. Prior to Ingenix, she was Vice President of Corporate Development and Marketing at ActivBiotics, a biotechnology company focused on developing and commercializing antibiotics and combination therapies for the treatment of acute and chronic infections. Ms. McCourt’s prior biotechnology and pharmaceutical experience also includes roles in business development, marketing, medical affairs, training, corporate communications, and investor relations at Praecis Pharmaceuticals, Abbott Laboratories, and Takeda. She has led or supported the commercial strategy of more than one hundred products that have advanced from clinical development through regulatory approval globally with billions in sales. Ms. McCourt holds a B.S. in Pharmacy on a full academic scholarship, with a specialization in Industrial Pharmacy from the Massachusetts College of Pharmacy and Health Sciences, and graduated summa cum laude with an MBA from the University of Phoenix in General Management. Duyuru • Oct 19
Comera Life Sciences Holdings, Inc. Announces Favorable Preclinical Results of Lead SQore Excipient in SEQURUS-2 Study Comera Life Sciences Holdings, Inc. announced favorable results from its recently completed SEQURUS-2 study. Together with the SEQURUS-1 study, the preclinical results showed that Comera's caffeine-based SQore(TM) excipient did not result in local or systemic toxicity and had no impact on any measured pharmacokinetic (PK) parameters of ipilimumab when administered subcutaneously. Comera is using its proprietary formulation platform SQore to enable subcutaneous (SQ) delivery of intravenous (IV) drugs such as monoclonal antibodies (mAbs). The addition of excipients, such as caffeine, interrupts intermolecular interactions to reduce viscosity of high concentration mAb formulations. SEQURUS-2 data demonstrate no evidence of local or systemic toxicity of caffeine in animals when administered subcutaneously with ipilimumab. Furthermore, a rapid clearance of caffeine was seen within eight hours. The data also reveal no evidence of caffeine impact on ipilimumab absorption. 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. The SEQURUS-2 study was designed to provide a statistically robust evaluation of caffeine on the PK of SQ-administered ipilimumab, and it expanded on the exploratory PK analysis completed in SEQURUS-1 by increasing sample sizes and including formulations with different caffeine concentrations. The study evaluated three different SQ test formulations, including two concentrations of caffeine-containing ipilimumab formulations and an ipilimumab-only formulation (no caffeine). The monoclonal antibody ipilimumab (branded as Yervoy(R)) was chosen for evaluation as a representative example of a commercially successful, widely used monoclonal antibody for which no SQ formulation is commercially available. Two control IV ipilimumab formulations, one with caffeine and one without, were included as reference groups. Local toxicity was assessed by visualization and palpation of the injection site and systemic toxicity was assessed by body weight and viability. PK data were collected on ipilimumab to assess impact of caffeine on ipilimumab absorption, distribution, and clearance. Recent Insider Transactions • Sep 13
Independent Director recently bought US$102k worth of stock On the 12th of September, James Sherblom bought around 50k shares on-market at roughly US$2.03 per share. This transaction amounted to 16% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$251k more in shares than they have sold in the last 12 months. Duyuru • Sep 02
Comera Life Sciences Holdings, Inc. announced that it expects to receive $15 million in funding from Arena Business Solutions Global SPC II, Ltd Comera Life Sciences Holdings, Inc. announced that it has entered into agreement with Arena Business Solutions Global SPC II, Ltd for a private placement of common shares for proceeds of $15,000,000 on August 31, 2022. The company is subject to to increase at the Company’s option by an additional $15,000,000. The Company has agreed to issue a total of $650,000 worth of shares of Common Stock as Commitment Fee Shares based on a price per share equal to the simple average daily VWAP of the Common Stock during the ten trading days immediately preceding the date. The securities are issued subject to Regulation D. Reported Earnings • Aug 18
Second quarter 2022 earnings released Second quarter 2022 results: US$1.14 loss per share. Net loss: US$9.29m (flat on 2Q 2021). Duyuru • Aug 12
Comera Life Sciences to Present Topline Results of SEQURUS-2 Study at 14th Annual Bioprocessing Summit Comera Life Sciences Holdings, Inc. announced that topline data from its preclinical SEQURUS-2 study will be presented at the 14th Annual Bioprocessing Summit, which will be held in Boston from August 15 – 18, 2022. The Company will also host a booth (#419) in the exhibit hall. Many monoclonal antibody (mAb) therapies previously could not be delivered via intravenous injection due to the high viscosity of the therapies at elevated concentrations, but believe proprietary SQore™ platform will make subcutaneous (SQ) delivery possible. Duyuru • Jul 14
Comera Life Sciences Announces Favorable Preclinical Topline Safety Results of Lead SQore Excipient Comera Life Sciences Holdings, Inc. announced favorable topline results from its recently completed 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 subcutaneous (SQ) biologic drug product formulation with a monoclonal antibody (mAb).Many mAb therapies are delivered by intravenous (IV) injection because the solutions exhibit high viscosity at elevated concentrations, preventing manufacturing and injecting of concentrated drug at volumes needed for SQ administration. Using its proprietary formulation platform, SQore, Comera is developing excipients that make SQ delivery possible. The addition of excipients, such as caffeine, interrupts intermolecular interactions to reduce viscosity of high concentration mAb formulations.The SEQURUS-1 study was designed to evaluate the safety of caffeine when administered SQ in combination with ipilimumab, a mAb therapy that works to activate the immune system by targeting CTLA-4 to treat melanoma, as a model protein. SEQURUS-1 demonstrated no evidence of local or systemic toxicity of caffeine when administered subcutaneously with ipilimumab 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.The study evaluated three different SQ test formulations, including a caffeine-containing ipilimumab formulation, ipilimumab-only formulation (no caffeine), and caffeine-only formulation (no ipilimumab). A control IV ipilimumab formulation with no caffeine was included as a reference group. Local toxicity was assessed by visualization and palpation of the injection site and systemic toxicity was assessed by body weight and viability. Additional exploratory data were collected on ipilimumab pharmacokinetic (PK) parameters to assess impact of caffeine on ipilimumab absorption, distribution, and clearance.A larger study, SEQURUS-2, has been initiated to provide a statistically robust evaluation of caffeine on the PK of SQ-administered ipilimumab, and was designed to expand on the exploratory PK analysis completed in SEQURUS-1. Comera plans to present topline study results from SEQURUS-2 at the 14th Annual Bioprocessing Summit to be held in Boston from August 14-18, 2022.