Welcome to another installment of This Week at FDA, your weekly source for updates big and small on FDA, drug and medical device regulation and what were reading from around the web. This was a busy week for FDA in Congress, with hearings in both chambers touching on FDAs user fee programs, FY2023 budget request, and more. We also saw FDA release a tentative schedule for several upcoming advisory committee meetings to discuss COVID-19 vaccines. Plus, we learned that Moderna has submitted an emergency use authorization (EUA) request for its vaccine in children under 6 years of age.Earlier today, FDA announced that it is holding dates in June for several upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings to discuss some hot button issues related to COVID-19 vaccines. First, the committee is slated to discuss Novavaxs EUA request for its COVID-19 vaccine in adults on 7 June. The agency is holding three dates throughout the month for the committee to discuss extending the use of Pfizer and Modernas vaccines for younger children. On 28 June, the committee is set to meet again to discuss whether the SARS-CoV-2 strain composition of vaccines should be modified in time for the fall.We also got word that Moderna has submitted an EUA request to expand the use of its COVID-19 vaccine to children ages 6 months to 6 years of age. During his testimony on FDAs FY2023 budget request, Califf told the HELP committee the agency would move quickly to review the request. Previous reports suggested that FDA was considering waiting until it had a similar request from Pfizer in hand so it could potentially authorize both shots at the same time.It was a packed week on the Hill, with FDAs medical product center directors testifying before the Senate Health, Education, Labor and Pensions (HELP) committee on the agencys user fee programs on 26 April. FDA Commissioner Robert Califf appeared before the Senate Appropriations committee on 28 April to discuss the agencys FY2023 budget request. The House Appropriations hearing on the agencys FY2023 was originally slated for 27 April, though the hearing was postponed.Other FDA-related hearings this week included a hearing on 27 April on consulting firm McKinseys conflicting work on FDA contracts while it was consulting for opioid makers, including Purdue Pharma, and the House Select Subcommittee on the Coronavirus Crisis hearing earlier today on political interference at federal health agencies during the pandemic. Health and Human Services (HHS) Secretary Xavier Becerra testified before the House Energy & Commerce committee on 27 April on the administrations FY2023 budget request for HHS and all its sub-agencies.CDER Director Patrizia Cavazzoni said the center is not currently contracting with McKinsey and that the agency anticipates that further contracts will not be issued, while investigations are pending.Drugs & biologicsFDA has released data on its generic drug program performance for the first half of FY2022, as well as activity reports for the same period under Section 805 and 807 of the FDA Reauthorization Act.CDER also posted a discussion with Darshini Satchi, deputy director of the Division of Information Disclosure Policy within the Office of Regulatory Policy about the centers efforts to make materials public while complying with the Freedom of Information Act (FOIA) and other public disclosure laws.CBER, meanwhile announced its annual Patient Engagement & Regenerative Medicine Meeting, which will be held on 24 May 2022.MedtechAfter a long wait, FDA finally released the meeting minutes for the remainder of its negotiation sessions with industry on the Medical Device User Fee Amendments (MDUFA V) agreement. Minutes for more than a dozen meetings held since last summer were posted this week after the center was criticized for failing to post them on time.FDA issued several alerts about safety issues pertaining to specific medical devices this week. It warned that patients with Medtronics Heartware Ventricular Assist Device (HVAD) system who appear to present with pump thrombosis may have a weld defect in their device. The advisory was sent to healthcare providers after Medtronic issued an urgent medical device correction about the issue.Additionally, the agency advised healthcare providers of the risk of airway obstruction when using certain electromyogram endotracheal tubes marketed by Medtronic. The Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM Contact Reinforced EMG Endotracheal Tube are the only two silicone-based EMG on the market. FDA said it has received reports of serious adverse events and deaths after airway obstruction for silicone-based EMG endotracheal tubes, and has not received similar reports regarding PVC-based EMG tubes.Medtronic also recalled its Harmony Delivery Catheter, which is part of its Transcatheter Pulmonary Valve (TPV) system due to the risk of capsule breakage during use. FDA notes that there have been 6 reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices.In other recall news, FDA announced that Celltrion USA has recalled some point-of-care DiaTrust COVID-19 Ag Rapid Test Kits that have inadvertently been distributed to unauthorized users. The test should only be used by CLIA-certified laboratories.CDRH also qualified the FACE-Q | Aesthetics patient-reported outcome (PRO) as a medical device development tool (MDDT) that can be used facilitate the evaluation of medical devices. The FACE-Q tool is intended to assess the outcomes of aesthetic facial procedures and is comprised of three modules: Self-Perceived Facial Appearance, Health-Related Quality of Life and Adverse Effects of Treatment.The center also classified the autofluorescence detection device for general surgery and dermatological use into class II (special controls).

2022Regulatory Affairs Professionals Society.

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This Week at FDA: A busy week on the Hill, VRBPAC's June meeting bonanza, and more - Regulatory Focus

Antibe Therapeutics Inc. (OTCMKTS:ATBPF Get Rating) saw a large growth in short interest in April. As of April 15th, there was short interest totalling 46,100 shares, a growth of 45.9% from the March 31st total of 31,600 shares. Based on an average daily trading volume, of 12,500 shares, the short-interest ratio is presently 3.7 days.

ATBPF opened at $0.56 on Friday. Antibe Therapeutics has a one year low of $0.44 and a one year high of $3.70. The stocks fifty day moving average is $0.59 and its 200-day moving average is $0.60. The company has a market capitalization of $29.07 million, a PE ratio of -1.33 and a beta of 0.22.

Antibe Therapeutics (OTCMKTS:ATBPF Get Rating) last posted its quarterly earnings data on Monday, February 14th. The company reported ($0.08) EPS for the quarter, topping the Zacks consensus estimate of ($0.13) by $0.05. Antibe Therapeutics had a negative return on equity of 42.02% and a negative net margin of 244.59%. Research analysts expect that Antibe Therapeutics will post -0.33 earnings per share for the current fiscal year.

Antibe Therapeutics Inc, a biotechnology company, originates, develops, and out-licenses patent novel therapeutics and medical devices in the areas of pain, inflammation and regenerative medicine in Canada, Europe, the United States, and internationally. Its drugs are designed to prevent the gastrointestinal damage and bleeding caused by non-steroidal anti-inflammatory drugs.

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Antibe Therapeutics Inc. (OTCMKTS:ATBPF) Short Interest Update - Defense World

FLYING IN: The National Restaurant Association this week is holding its first in-person fly-in since before the pandemic began, which comes at a crucial time for industry advocates as lawmakers try to rally support for a small-business Covid relief package that would send restaurants additional funding.

More than 500 industry advocates are set to hold 200 meetings with lawmakers of both parties in the House and Senate to push for passage of more pandemic assistance, as well as maintaining the industrys tip credit, progress on labor issues, and the reinstatement of a the Covid-era employee retention tax credit.

MORE FLY-INS: Restaurant advocates arent the only ones getting face time with lawmakers this week. Member companies of the Portland Cement Association, which represents the majority of U.S. cement producers, will be in Washington this week to lobby policymakers on policies to help the cement industry cut carbon emissions, especially with a construction boom expected as a result of the infrastructure bill.

The trade group will discuss its recently released Roadmap to Carbon Neutrality, which includes the expansion of a tax break to install carbon capture equipment, funding for the Energy Department for research and development of carbon capture technologies and more.

Tomorrow, FMI - The Food Industry Association will kick off its fly-in with business leaders and other representatives from the food retailer, wholesaler and supplier community hitting the Hill to discuss inflation and supply chain challenges stemming from the war in Ukraine, as well as workforce shortages.

Not all of the fly-ins scheduled for this week will be in person. The PKD Foundation is keeping virtual its annual event, which is set to kick off Wednesday. The foundation has more than 100 virtual meetings planned with members, including Sen. Mike Braun (R-Ind.), Reps. Mark Amodei (R-Nev.), Judy Chu (D-Calif.) Antonio Delgado (D-N.Y.), Mike Gallagher (R-Wis.), Brett Guthrie (R-Ky.), Donald Payne (D-N.J.) and Lloyd Smucker (R-Pa.), and dozens of other offices to call for more funding opportunities and legislation to benefit kidney disease patients.

Good afternoon and welcome to PI. Whats going on out there? Let me know: [emailprotected]. And be sure to follow me on Twitter: @caitlinoprysko.

JONES RETURNS TO ARENT FOX: Former Sen. Doug Jones has returned to ArentFox Schiff following his stint as the sherpa for incoming Supreme Court Justice Ketanji Brown Jacksons confirmation process. Jones and a top aide landed at the firm about a year ago, working with the firms government relations and government enforcement and white-collar groups as counsel.

Jones had taken a temporary leave of absence from the firm to oversee Jacksons confirmation, and now that hes returned will continue advising clients on a variety of public policy issues and legal matters, particularly in the National Security, Health Care, and Financial Services industries, ArentFox said in a statement.

NEW TWITTER OWNER NO STRANGER TO WASHINGTON BRAWLS: Elon Musk has publicly ridiculed the Securities and Exchange Commission, scrapped with federal airwaves and car-safety regulators and sued the Pentagon to gain access to military space contracts. But with his Twitter acquisition, the billionaire who founded Tesla and SpaceX has cast himself as a central player in Washingtons most contentious political battles a role that could bring him a whole new level of blowback, our Emily Birnbaum writes.

Emily and several other POLITICO policy reporters recount some of Musks most contentious clashes with the halls of power in Washington to game out how Musk might approach his new role as Twitters owner. In his new position helming the favorite social media network of politicians and political journalists, Musk will face a hotter spotlight than ever both giving him a position of power over the regulators hes criticized for years and putting himself in their line of fire, they write.

Musk has made a reputation for himself as a bombastic political player, unafraid to poke his finger in the eye of regulators. And hes likely to continue that approach at Twitter, where Congress could subject him to the same scrutiny targeted toward social media CEOs like Mark Zuckerberg.

PR FIRMS CONTINUE TO WAGE CAMPAIGNS ON BEHALF OF KREMLIN-TIED CLIENTS: Leonard Blavatnik, a Ukrainian-born businessman whose name graces Harvard Medical School and a part of Carnegie Hall, amassed his wealth, in part, from the privatization of oil and aluminum after the fall of the USSR. Over time, he worked alongside a number of oligarchs currently sanctioned by the EU or the U.S. for their ties to the government of Russian President Vladimir Putin, POLITICOs Hailey Fuchs reports.

But as Russia has launched a bloody and internationally condemned invasion of Ukraine, Blavatnik has gone to some lengths to ensure that his name isnt dragged into the matter, working through a public relations firm to make sure the press corps does not tie him to the Kremlin or describe him as an oligarch.

Blavatnik is one of several wealthy businessmen who have turned to public relations professionals to help navigate press coverage emanating from Russias assault on Ukraine. It has created a unique business opportunity for Madison Avenue and beyond.

Whereas K Street and some law firms have worked to distance themselves from Russian interests cutting connections with Kremlin-tied businesses PR professionals have stepped in to help illuminate the distinctions between those businessmen tied to Putin and those who want nothing to do with him, according to interviews and emails.

FIRST IN PI NATIVE AMERICAN GROUP ASKS CHAMBERS CLARK FOR SIT-DOWN: A Native American group that advocates for eliminating stereotypical Native American mascot caricatures and iconography while preserving culturally appropriate American Indian names, logos, and imagery in pop culture says it wants to meet with U.S. Chamber of Commerce President and CEO Suzanne Clark after Clark apologized for posting a photo last month standing beside two people in what appeared to be Native American headdresses.

We at NAGA, along with most American Indians, find Ms. Clarkes (sic) indiscriminate promotion of our sacred bonnet to be highly offensive, Native American Guardians Association board member Eunice Davidson Wicanhpiwastewin (Good Star Woman) said in a statement, adding that Clarks actions are inconsistent with many of the principles of the Chambers Fortune 500 members.

Tony Henson, another board member for the group, which has defended the Redskins name for the Washington football team, argued that while American Indians have overwhelmingly expressed their views that the use of powerful and beautiful native names and images in the public sphere are not offensive, the organization has an issue with the lack of Native Americans in the Chambers leadership ranks and what Henson called a complete lack of philanthropic support for American Indians.

We encourage Ms. Clarke and the U.S. Chamber of Commerce to meet with NAGAs leadership in order to discuss the steps its organization can take to promote the positive and inspiring culture of American Indians, he added.

A Chamber spokesperson said that Clark continues to stand by her apology last month in which she said she was deeply sorry for posting the photo. The spokesperson added that Clark would absolutely consider such a meeting when a request is made.

Maria Bowie is joining SMI as a vice president, where she will be registering to lobby. She was previously a director of government affairs at Leidos and is a Tom Cole and Ken Calvert alum.

Cristina Marcos has joined ROKK Solutions as a senior account director. She was most recently a congressional reporter at The Hill.

Evelyn Farkas will be the next executive director of the McCain Institute at Arizona State University. She was a deputy assistant secretary of Defense in the Obama administration and a congressional candidate in 2020.

Bullpen Strategy Group is promoting Christian Hertenstein to partner, promoting Michael Ahrens to senior vice president and adding Chris Martin as vice president in the communications practice. Martin most recently was deputy executive director of America Rising PAC.

Brownstein Hyatt Farber Schreck has hired Lauren Diekman as a senior policy adviser. She was most recently senior director of energy, infrastructure and environment at the Chambers U.S.-India Business Council.

Daniel Sepulveda is joining Platinum Advisors government relations team. He most recently was at Wiley, and is a former U.S. ambassador for telecommunications and media issues and a USTR and Senate alum.

Joe Hoellerer is now director of government affairs at the Information Technology Industry Council. He previously was senior manager of government relations at the Security Industry Association.

Craig Martell is joining DoD as chief digital and artificial intelligence officer. He most recently was head of machine learning for Lyft.

Jeann Lewis will be interim CEO of Faith in Public Life. She currently is vice chair of the board of directors, and works as vice president and chief engagement officer at the National Committee for Responsive Philanthropy. Lewis will replace the founding CEO, the Rev. Jennifer Butler, who will become founder in residence.

Maria Pica Karp will be vice president of global government relations at ADM. She previously spent 18 years at Chevron, including seven leading its global government affairs.

Alex Mitchell is now director of external relations for the Institute for the Study of War. He previously was vice president at Vox Global.

Wexton Victory Fund 2022 (Rep. Jennifer Wexton, Democratic Party of Virginia)

Build and Protect OK (Super PAC)MISSING VOICES. MISSING VOTES (Hybrid PAC)SAFEGUARDING OKLAHOMA VALUES PAC (Super PAC)

Alliance For Regenerative Medicine: Alliance For Regenerative MedicineArnold & Porter Kaye Scholer LLP: University Of RedlandsBecker & Poliakoff, P.A.: City Of Miami, FloridaBecker & Poliakoff, P.A.: Florida Gulf Coast University Foundation, Inc.Becker & Poliakoff, P.A.: Street Smarts VrCanyon Snow Consulting, LLC: Sanmina CorporationCarpi & Clay, Inc: Verity NowCavarocchi Ruscio Dennis Associates, L.L.C.: EcriContinental Strategy, LLC: Chamber Of Industry Of GuatemalaDla Piper LLP (US): Inter-Tribal Trade ConsortiumFederal Hall Policy Advisors, LLC: National Association Of Mutual Insurance CompaniesHogan Lovells US LLP: AigKing & Spalding LLP: Makana Therapeutics, Inc.Lne Group: Be Perfect FoundationLne Group: Conquer Paralysis NowLne Group: Hero One FoundationLne Group: Push To WalkMiller & Chevalier Chartered: One Town Square Consulting LLCMl Strategies, LLC: Northern Light HealthPaul V. Beddoe Government Affairs, LLC: Cencal HealthPrevail Communications, LLC: Forbes Tate Partners On Behalf Of Coalition For App FairnessSmith Dawson & Andrews: Fuentes Strategies, LLCSonosky, Chambers, Sachse, Endreson & Perry, LLP: Coeur D'Alene TribeThe Campbell Consulting Group: New Morning FoundationThe Ferguson Group: City Of Blaine, MnThe Roosevelt Group: Corning Optical Communications LLCVan Scoyoc Associates: Ohio UniversityWinn Strategies, LLC: Twinlogic Strategies On Behalf Of Nokia Of America CorporationWinn Strategies, LLC: Twinlogic Strategies On Behalf Of Siia

Armory Hill Advocates (Formerly Known As Rawlson Policy Group): Kpc Global ManagementCartwright & Riley, Inc.: Hemlock Court Holdings CorporationChristopher Heinz: American Petroleum InstituteEnvision Strategy, LLC: Boloro Global LimitedGrassroots Political Consulting LLC: Attwill Vascular Technologies Lp/Attwill Medical SolutionsMcallister & Quinn, LLC: Friends University

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Restaurants fly in with more pandemic aid up in the air - POLITICO

DUBLIN--(BUSINESS WIRE)--The "Global Collagen and Gelatin Market Report Size, Trends & Growth Opportunity, By Source, By Type, By Application, By Region and Forecast to 2027" report has been added to ResearchAndMarkets.com's offering.

A protein which serves as one of the main building blocks for bones, skin, hair, muscles, tendons, and ligaments is called as Collagen and it is mostly used as an easy-to-digest nutritional supplement. A colorless, brittle, and water-soluble substance is Gelatin and it has a high molecular weight. Also, it is a rich source of protein and it contains lysine, which helps strengthen the bones.

Market Drivers

Diabetes is an important target indication - it can increase the incidence & complexity of wounds such as ulcerations (leg or foot ulcers), infections, and surgical wounds, requiring treatments & incurring exorbitant medical expenses.

Nearly 25% of diabetics in the Unites States develop foot ulcers during their lifetime, while ~15% of the diabetic population suffers from diabetic foot ulcers.

The increase in prevalence of DFUs is expected to drive the demand for regenerative medicine products like grafts and matrices. Thus, fueling the global collagen and gelatin market growth.

Furthermore, the increase in awareness about the collagen & changing consumer preferences & lifestyles will accelerate the demand for Global Collagen and Gelatin Market.

Market Restraints

The availability of efficient & reliable substitute biomaterials, which can heal, repair, or regenerate injured or diseased tissues & organs, is likely to restrain the market growth.

Several biomaterials such as chitosan, cellulose, alginate, hyaluronic acid, polylactic acid (PLA), polyglycolic acid (PGA), and poly (lactic-co-glycolic acid) (PLGA) are used as alternatives for collagen & gelatin in regenerative medicine. Such substitutes may hinder the global collagen & gelatin market growth across the globe.

Market Segmentation

Collagen and Gelatin Market sis segmented into major 4 categories. Based on Source, the market is segmented into Bovine, Porcine, Marine and Others. Based on Type, the market is segmented into Collagen and Gelatin. Based on Application, the market is segmented into Orthopaedic, Wound Care, Cardiovascular and Others. Based on Region, the market is segmented into North America, Europe, Asia Pacific, Latin America, Middle East.

Regional Analysis

The market in North America is projected to dominate the Collagen and Gelatin market due to the presence of key market players in the region coupled with the rising geriatric population. Also, expected to expand at a significant growth rate over the forecast period of 2021 to 2027 owing to the rising geriatric population.

Furthermore, European region is projected to be second largest market of Collagen and Gelatin globally owing to the rising demand in food processing industry.

Market Key Players

Some of the key players operating in Global Collagen and Gelatin Market are Royal DSM, Collplant Biotechnologies, Nitta Gelatin Inc., Geistlich Pharma AG, Synerheal Pharmaceuticals, Collagen Solutions PLC, Collagen Matrix, Inc., Gelita AG, PB Leiner, Smith & Nephew.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Collagen & Gelatin Market Outlook

4.1 Overview

4.2 Market Dynamics

4.2.1 Drivers

4.2.2 Restraints

4.2.3 Opportunities

4.3 Porters Five Force Model

4.4 Value Chain Analysis

5 Collagen & Gelatin Market, By Type

5.1 Y-o-Y Growth Comparison, By Type

5.2 Collagen & Gelatin Market Share Analysis, By Type

5.3 Collagen & Gelatin Market Size and Forecast, By Type

5.3.1 Collagen

5.3.2 Gelatin

6 Collagen & Gelatin Market, By Application

6.1 Y-o-Y Growth Comparison, By Application

6.2 Collagen & Gelatin Market Share Analysis, By Application

6.3 Collagen & Gelatin Market Size and Forecast, By Application

6.3.1 Orthopedic

6.3.2 Wound Care

6.3.3 Cardiovascular

6.3.4 Others

7 Collagen & Gelatin Market, By Source

7.1 Y-o-Y Growth Comparison, By Source

7.2 Collagen & Gelatin Market Share Analysis, By Source

7.3 Collagen & Gelatin Market Size and Forecast, By Source

7.3.1 Bovine

7.3.2 Porcine

7.3.3 Marine

7.3.4 Others

8 Collagen & Gelatin Market, By Region

8.1 Collagen & Gelatin Market Share Analysis, By Region

8.2 Collagen & Gelatin Market Share Analysis, By Region

8.3 Collagen & Gelatin Market Size and Forecast, By Region

9 North America Collagen & Gelatin Market Analysis and Forecast (2021-2027)

10 Europe Collagen & Gelatin Market Analysis and Forecast (2021-2027)

11 Asia Pacific Collagen & Gelatin Market Analysis and Forecast (2021-2027)

12 Latin America Collagen & Gelatin Market Analysis and Forecast (2021-2027)

13 Middle East Collagen & Gelatin Market Analysis and Forecast (2021-2027)

14 Competitive Analysis

14.1 Competition Dashboard

14.2 Market share Analysis of Top Vendors

14.3 Key Development Strategies

15 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/j4p9wz

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Global Collagen and Gelatin Market Report to 2027 - Size, Trends & Growth Opportunities - ResearchAndMarkets.com - Business Wire

Roger Sawhney, M.D. to serve as Chief Business Officer

CAMBRIDGE, Mass., April 29, 2022 /PRNewswire/ -- Omega Therapeutics (NASDAQ: OMGA) (Omega), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, today announced the appointment of Joshua Reed as Chief Financial Officer, effective May 23, 2022. Roger Sawhney, M.D., Omega's Chief Financial Officer, will serve as Chief Business Officer.

"We are excited to welcome Joshua to our management team. We expect that Joshua's track record of success and diverse experience across many disciplines including finance and operations will be important factors in Omega's future success. This news follows a number of key hires that we have announced this year, providing Omega with a strong and talented senior leadership team with the experience needed to execute on the promise of our pipeline and platform," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "I am equally excited for Roger to be able to focus on our business development efforts as we look to accelerate the potential of our epigenomic programming platform to deliver transformative therapies to patients."

"I am thrilled to be joining an exciting company with an innovative platform and a strong leadership team with the potential to be impactful across a wide-range of diseases and conditions," said Mr. Reed. "I look forward to working closely with our Board of Directors, management team and our shareholders to continue advancing our science."

Mr. Reed most recently served as Chief Financial Officer of Aldeyra Therapeutics, where he was responsible for finance, business development, investor relations, compliance, human resources, and information technology. During his time at Aldeyra, Mr. Reed led multiple capital raises, oversaw the company's interactions with current and prospective investors and managed all aspects of the company's financial close, including quarterly and annual SEC filings. Before Aldeyra, Mr. Reed held a variety of finance roles of increasing responsibility at Bristol-Myers Squibb, most recently serving as Vice President and Head of Finance Operations for the United States and Puerto Rico. While at Bristol-Myers Squibb, Mr. Reed also led financial planning and analysis and worked on various acquisitions, divestitures, alliances, and collaboration agreements. Earlier in his career, Mr. Reed worked at JP Morgan Chase, Credit Suisse First Boston, and Chase Manhattan Bank. Mr. Reed received his Bachelor of Science in Finance from Rutgers University and his Master of Business Administration from the University of Michigan.

About Omega TherapeuticsOmega Therapeutics, founded by Flagship Pioneering, is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines. The company's OMEGA Epigenomic Programming platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth, and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systematic, rational, and integrative drug design, the deterministic OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's modular and programmable mRNA epigenetic medicines, Omega Epigenomic Controllers, target specific epigenomic loci within insulated genomic domains, EpiZips, from amongst thousands of unique, mapped, and validated genome-wide DNA-sequences, with high specificity to durably tune single or multiple genes to treat and cure diseases through Precision Genomic Control. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

For more information, visitomegatherapeutics.com, or follow us onTwitterandLinkedIn

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential of the OMEGA Epigenomic Programming platform, the company's intention to advance its programs into the clinic, and the continued growth and scale up of the company. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controller machines due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights.These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form10-K for the period ended December 31, 2021and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Media contact:Jason BracoLifeSci Communications646.751.4361 [emailprotected]

Investor contact: Kevin MurphyArgot Partners 212.600.1902 [emailprotected]

SOURCE Omega Therapeutics

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Omega Therapeutics Announces Appointment of Joshua Reed as Chief Financial Officer - PR Newswire