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The Beauty Health Company to Report First Quarter Financial Results for The HydraFacial Company on May 13, 2021

The Beauty Health Company to Report First Quarter Financial Results for The HydraFacial Company on May 13, 2021

LONG BEACH, Calif.–(BUSINESS WIRE)–
The Beauty Health Company (“BeautyHealth” or the “Company”; NASDAQ:SKIN), a global category-creator leading the charge with its flagship brand HydraFacial, today announced that it will report first quarter of fiscal 2021 financial results for the HydraFacial Company (“HydraFacial”) after market close on Thursday, May 13, 2021. The Company will host a conference call at 4:30 p.m. Eastern Time to discuss the financial results.

Investors and analysts interested in participating in the call are invited to dial 877-300-8521 (international callers please dial 1-412-317-6026) approximately 10 minutes prior to the start of the call. A live audio webcast of the conference call will be available online at https://investors.beautyhealth.com/.

A recorded replay of the conference call will be available within approximately three hours of the conclusion of the call and can be accessed online at https://investors.beautyhealth.com/ for 90 days.

About The Beauty Health Company

BeautyHealth is a category-creating beauty health company focused on bringing innovative products to market. Our flagship brand, HydraFacial, is a non-invasive and approachable beauty health platform and ecosystem with a powerful community of estheticians, consumers and partners, bridging medical and consumer retail to democratize and personalize skin care solutions for the masses. Leading the charge in beauty health as a category-creator, HydraFacial uses a unique delivery system to cleanse, extract, and hydrate with their patented hydradermabrasion technology and super serums that are made with nourishing ingredients, providing an immediate outcome and creating an instantly gratifying glow in just three steps and 30 minutes. HydraFacial® and Perk™ products are available in over 87 countries with over 16,000 delivery systems globally and millions of treatments performed each year. For more information, visit the brand on LinkedIn, Facebook, Instagram, or at HydraFacial.com. For more information, please visit at https://investors.beautyhealth.com/.

Forward-Looking Statements

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.

These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside BeautyHealth’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.

Important factors, among others, that may affect actual results or outcomes include the inability to recognize the anticipated benefits of the Business Combination; costs related to the Business Combination; the inability to maintain the listing of BeautyHealth’s shares on Nasdaq; BeautyHealth’s ability to manage growth; BeautyHealth’s ability to execute its business plan and meet its projections; potential litigation involving BeautyHealth; changes in applicable laws or regulations; the possibility that BeautyHealth may be adversely affected by other economic, business, and/or competitive factors; and the impact of the continuing COVID-19 pandemic on the Company’s business. BeautyHealth does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

ICR, Inc.

Investors: Dawn Francfort

Email: [email protected]

Press: Alecia Pulman

Email: [email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Cosmetics Retail General Health Health

MEDIA:

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Altimmune to Announce First Quarter 2021 Financial Results on May 17, 2021

GAITHERSBURG, Md., May 11, 2021 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it will report its first quarter 2021 financial results on Monday, May 17, 2021.

Altimmune management will host a conference call for investors beginning at 8:30 am E.T. to discuss the first quarter 2021 financial results and provide a business update.   

Conference Call Information:

Date:  Monday, May 17, 2021
Time: 8:30 am Eastern Time
Domestic Dial-in: 877-423-9813
International Dial-in:  201-689-8573
Conference ID: 13719206
Webcast:
http://public.viavid.com/index.php?id=144634 

About Altimmune

Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating therapeutic for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.

Follow @Altimmune, Inc. on

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Twitter

Investor & Media Contacts:

Will Brown   Stacey Jurchison
Chief Financial Officer  Sr. Dir, Investor Relations
Phone: 240-654-1450  Phone : 410-474-8200
[email protected]  [email protected] 



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Spire Providing Arctic Intelligence

Spire Providing Arctic Intelligence

Accessible data drives insight for commercial, civic, governmental projects in difficult, emerging region

SAN FRANCISCO & RESTON, Va.–(BUSINESS WIRE)–
As new trade routes begin to emerge and competition intensifies in the Arctic, Spire is providing data to inform decisions on critical issues around climate change, navigation, and transportation within the region through its comprehensive data and weather forecasting services.

Research shows that Arctic warming is resulting in shrinking sea ice and changing ocean circulation and weather patterns. These changes are creating new issues that affect governments and businesses in the region and globally.

Spire’s earth intelligence capabilities can help support the study and understanding of various key indicators of climate change and its impacts in the Arctic and Antarctic regions. Specifically, Spire is able to provide radio occultation (RO) data in the polar regions, collecting measurements down to the surface due to the low humidity in the regions and Spire’s broad-scale satellite coverage. This set of near surface temperature measurements enhances Arctic and Antarctic weather forecasts, which Spire believes allows for a more comprehensive understanding of the regions than could be traditionally achieved by non-space based measurements.

Spire’s global weather forecast platform offers data on wind, wave height, and maritime waves, and within the polar regions, Spire measures the extent, classification, and age of sea ice, and can distinguish sea ice from open water. This enables Spire to map sea ice coverage and delineate the marginal ice zone (MIZ), a transitional region between open sea and dense drift ice. This information can be used to inform navigation plans that avoid sea ice, which Spire expects may become increasingly important as governments and companies in the private sector begin to consider the Arctic as a more viable transit route.

Spire also provides near real-time vessel tracking capabilities in the Arctic through satellite, terrestrial, and Dynamic™ AIS data. In addition to collecting AIS signals from over 200,000 vessels around the Earth, Spire maintains extensive coverage in high traffic zones (HTZs) such as the North Sea. Spire’s solution adds dynamically moving AIS receiving stations on vessels throughout all major sea routes and HTZ areas, collecting an additional total volume of 10M AIS messages per day. Through its combination of global vessel tracking data, satellite observations of sea ice, plus weather forecasts of temperature, wind, and other ocean variables, Spire seeks to provide an all-in-one Arctic intelligence solution that gives operators in the Arctic confidence and clarity in this remote area and in uncertain conditions.

“The Arctic is a critically important region for the global economy, but it’s traditionally difficult to observe and track developments there,” said Keith E. Johnson, Vice President and General Manager, Government Solutions. “Spire is making intelligence in the Arctic region more accessible, providing operators in the area with the data they need to make informed decisions.”

About Spire Global, Inc.

Spire is a global provider of space-based data and analytics that offers unique datasets and powerful insights about Earth from the ultimate vantage point so organizations can make decisions with confidence, accuracy, and speed. Spire uses one of the world’s largest multi-purpose satellite constellations to source hard to acquire, valuable data and enriches it with predictive solutions. Spire then provides this data as a subscription to organizations around the world so they can improve business operations, decrease their environmental footprint, deploy resources for growth and competitive advantage, and mitigate risk. Spire gives commercial and government organizations the competitive advantage they seek to innovate and solve some of the world’s toughest problems with insights from space. Spire has offices in San Francisco, CA, Boulder, CO, Washington DC, Glasgow, Luxembourg, and Singapore. On March 1, 2021, Spire announced plans to go public through an anticipated business combination with NavSight Holdings, Inc. (NYSE: NSH), to be traded on the NYSE under the ticker symbol “SPIR.” To learn more, visit spire.com.

About NavSight Holdings, Inc.

NavSight Holdings, Inc. is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. NavSight was organized with the opportunity to pursue a business combination target in any business or industry, with the intent to focus its search on identifying a prospective target business that provides expertise and technology to U.S. government customers in support of their national security, intelligence and defense missions.

Additional Information and Where to Find It

In connection with the planned business combination with Spire (the “Proposed Transaction”), NavSight intends to file a Form S-4 Registration Statement (the “Registration Statement”) with the SEC, which will include a preliminary proxy statement to be distributed to holders of NavSight’s common stock in connection with NavSight’s solicitation of proxies for the vote by NavSight’s stockholders with respect to the Proposed Transaction and other matters as described in the Registration Statement, a prospectus relating to the offer of the securities to be issued to the Company’s stockholders in connection with the Proposed Transaction, and an information statement to Company’s stockholders regarding the Proposed Transaction. After the Registration Statement has been filed and declared effective, NavSight will mail a definitive proxy statement/prospectus, when available, to its stockholders. Investors and security holders and other interested parties are urged to read the proxy statement/prospectus, any amendments thereto and any other documents filed with the SEC carefully and in their entirety when they become available because they will contain important information about NavSight, the Company and the Proposed Transaction. Investors and security holders may obtain free copies of the preliminary proxy statement/prospectus and definitive proxy statement/prospectus (when available) and other documents filed with the SEC by NavSight through the website maintained by the SEC at http://www.sec.gov, or by directing a request to: NavSight Holdings, Inc., 12020 Sunrise Valley Drive, Suite 100, Reston, VA 20191.

Participants in Solicitation

NavSight and the Company and their respective directors and certain of their respective executive officers and other members of management and employees may be considered participants in the solicitation of proxies with respect to the Proposed Transaction. Information about the directors and executive officers of NavSight is set forth in its Form 10-K filed on March 29, 2021. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the Registration Statement and other relevant materials to be filed with the SEC regarding the Proposed Transaction when they become available. Stockholders, potential investors and other interested persons should read the Registration Statement carefully when it becomes available before making any voting or investment decisions. When available, these documents can be obtained free of charge from the sources indicated above.

No Offer or Solicitation

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Forward-Looking Statements

The information in this press release includes “forward-looking statements” within the meaning of the federal securities laws with respect to the Proposed Transaction. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding expectations of accelerating Spire’s sales and marketing efforts, expectations of product development across Spire’s weather segment and the applicability of such products to Spire’s market, the strengthening of Spire’s competitive advantage, the importance of weather forecasting to Spire’s target markets, the increasing need for weather data in the Arctic and resulting expansion in use of Spire’s weather forecasting capabilities in the Arctic, the superiority of space-based data observation to other sources of data observation in the Arctic and Antarctic, customer demand for Spire’s services in the Arctic and Antarctic, the expansion of Spire’s business to new regions and markets, Spire’s future growth, estimates and forecasts of financial and performance metrics, expectations of achieving and maintaining profitability, projections of total addressable markets, market opportunity and market share, net proceeds from the Proposed Transactions, potential benefits of the Proposed Transaction and the potential success of the Company’s market and growth strategies, and expectations related to the terms and timing of the Proposed Transaction. These statements are based on various assumptions and on the current expectations of NavSight’s and the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of NavSight and the Company. These forward-looking statements are subject to a number of risks and uncertainties, including (i) the risk that the Proposed Transaction may not be completed in a timely manner or at all, which may adversely affect the price of NavSight’s securities; (ii) the risk that the Proposed Transaction may not be completed by NavSight’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by NavSight; (iii) the failure to satisfy the conditions to the consummation of the Proposed Transaction, including the approval of the Proposed Transaction by the stockholders of NavSight, the satisfaction of the minimum trust account amount following any redemptions by NavSight’s public stockholders and the receipt of certain governmental and regulatory approvals; (iv) the inability to complete the PIPE investment in connection with the Proposed Transaction; (v) the failure to realize the anticipated benefits of the Proposed Transaction; (vi) the effect of the announcement or pendency of the Proposed Transaction on Spire’s business relationships, performance, and business generally; (vii) risks that the Proposed Transaction disrupts current plans of Spire and potential difficulties in Spire employee retention as a result of the Proposed Transaction; (viii) the outcome of any legal proceedings that may be instituted against NavSight or Spire related to the business combination agreement or the Proposed Transaction; (ix) the ability to maintain the listing of NavSight’s securities on the New York Stock Exchange; (x) the ability to address the market opportunity for Space-as-a-Service; (xi) the risk that the Proposed Transaction may not generate expected net proceeds to the combined company; (xii) the ability to implement business plans, forecasts, and other expectations after the completion of the Proposed Transaction, and identify and realize additional opportunities; (xiii) the occurrence of any event, change or other circumstance that could give rise to the termination of the business combination agreement; (xiv) the risk of downturns, new entrants and a changing regulatory landscape in the highly competitive space data analytics industry; and those factors discussed in NavSight’s final prospectus filed on September 11, 2020 under the heading “Risk Factors,” and other documents of NavSight filed, or to be filed, with the SEC. If any of these risks materialize or the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither NavSight nor the Company presently know or that NavSight and the Company currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect NavSight’s and the Company’s expectations, plans or forecasts of future events and views as of the date of this press release. NavSight and the Company anticipate that subsequent events and developments will cause NavSight’s and the Company’s assessments to change. However, while NavSight and the Company may elect to update these forward-looking statements at some point in the future, NavSight and the Company specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing NavSight’s and the Company’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

For Spire Global, Inc.:

Investor Contact:

Michael Bowen and Ryan Gardella

[email protected]

Media Contact:

Phil Denning

[email protected]

For NavSight Holdings, Inc.:

Investor Contact:

Jack Pearlstein

[email protected]

KEYWORDS: Australia/Oceania United States North America California Virginia

INDUSTRY KEYWORDS: Environment Other Science Research Public Policy/Government Logistics/Supply Chain Management Cruise Travel Maritime Air Engineering Satellite Transport Other Technology Nanotechnology Science Telecommunications Aerospace Networks Manufacturing Hardware Data Management Technology Alternative Energy Energy White House/Federal Government

MEDIA:

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Nurix Therapeutics to Participate in Upcoming Investor Conferences

SAN FRANCISCO, May 11, 2021 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, today announced that members of Nurix management team will participate in the following conferences in May:

  • RBC Capital Markets Global Healthcare Conference

    Tuesday, May 18th, at 1:20 PM EDT
    Fireside chat: Hans van Houte, Nurix’s chief financial officer and Robert J. Brown, M.D., senior vice president of clinical development
  • UBS Global Healthcare Virtual Conference

    Tuesday, May 25th, at 4:00 PM EDT
    Fireside chat: Arthur T. Sands, M.D., Ph.D., Nurix’s chief executive officer

The discussions will be webcast live and may be accessed via a link in the Investors section of the Nurix website under Events and Presentations. Archived copies of the webcasts will be available on the Nurix website for approximately 30 days after the event.

About Nurix Therapeutics, Inc.

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurix.com.

Contacts:

Investors: Media:
Jason Kantor, Ph.D. Elizabeth Wolffe, Ph.D.
Nurix Therapeutics, Inc. Wheelhouse Life Science Advisors

[email protected]
 		[email protected]

 



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Imara Reports First Quarter 2021 Financial Results and Business Highlights

On-track to report interim analyses for both Ardent sickle cell disease and Forte beta-thalassemia Phase 2b clinical trials in the second half of 2021

Completed enrollment in the transfusion-dependent beta-thalassemia arm of the Forte Phase 2b trial

Higher dose arms open in both the Ardent and Forte Phase 2b clinical trials

Applications now being accepted for 2021 Real Impact grant program

Company to host conference call and live webcast today at 8:30 AM ET

BOSTON, May 11, 2021 (GLOBE NEWSWIRE) — Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin, today reported financial results for the first quarter ended March 31, 2021 and reviewed recent business highlights.

“We have made substantial enrollment progress in our higher dose Phase 2b clinical trials for patients with sickle cell disease and beta-thalassemia, which are designed to test higher doses of IMR-687,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “We are now conducting these studies at approximately 75 clinical trial sites across 20 countries and have fully enrolled the transfusion-dependent beta-thalassemia arm of the Forte trial. We remain on track to complete the respective protocol-driven interim analyses for the Ardent and Forte trials and to report interim data in the second half of 2021 for both programs.   Furthermore, following the recommendation of independent data monitoring committees, we opened the higher dose treatment arms in both Phase 2b clinical trials and are currently testing IMR-687 at daily dose levels of up to 400 mg.”

Dr. Ballal continued, “In addition to our progress in the Phase 2b clinical trials, we reported topline data from our Phase 2a clinical trial of IMR-687 in sickle cell disease, in which IMR-687 was well tolerated, and promising reductions in rates of vaso-occlusive crises (VOCs) were observed with variable changes in certain biomarkers, including HbF and F-cells. We also reported preliminary data from our Phase 2a open label extension trial, which showed that IMR-687 was well tolerated and in which increases in fetal hemoglobin and F-cells were observed. We plan to present comprehensive VOC data from the completed, 93-patient, placebo-controlled Phase 2a clinical trial, as well as additional data from the ongoing open label extension trial, at the European Hematology Association (EHA) 2021 Virtual Congress in June 2021.”  

“We have also been working to explore the therapeutic potential of IMR-687 in additional indications. We are pleased to have successfully completed pre-clinical studies of IMR-687 in heart failure with preserved ejection fraction, or HFpEF, and we plan to present these encouraging data at an upcoming cardiovascular medical meeting later in 2021,” said Dr. Ballal.

“Finally, we are proud to continue with our Real Impact community support program, which provides needed resources to community-based organizations around the country that serve patients and families with sickle cell disease and beta-thalassemia,” Dr. Ballal stated. “We have now opened the application process for the Real Impact grant program and expect to award up to $150,000 in funding in 2021 to deserving community-based organizations. We are committed to the sickle cell and beta-thalassemia patient community and supporting these groups are core to the Imara mission.”

Recent Corporate Highlights and Updates

Higher Dose Arms Opened in Global Phase 2b Clinical Trials of IMR-687

Following recommendations from separate independent data monitoring committees for the Ardent and Forte Phase 2b clinical trials of IMR-687 for sickle cell disease and beta-thalassemia, respectively, Imara has opened the higher dose IMR-687 treatment arms. Enrollment is proceeding in each study at either the IMR-687 higher dose (once daily dose of 300 mg or 400 mg based on patient weight), IMR-687 lower dose (once daily dose of 200 mg or 300 mg based on patient weight), or placebo. Imara expects to report interim data from the Ardent and Forte Phase 2b clinical trials in the second half of 2021, data from the primary analysis from each of these trials in the first half of 2022 and data from the final analysis from each of these trials in the second half of 2022.

Opening of Applications Process for 2021 Real Impact Grants

Imara’s Real Impact grant program moves into its second year after distributing $125,000 in funding in 2020 to community-based organizations dedicated to raising awareness for and support of the sickle cell and beta-thalassemia patient communities. Imara expects to increase total grant funding to $150,000 for 2021, which will be distributed according to three key areas of need: social determinants of health (including COVID-19 relief), virtual support programs and community-based organization capacity. The application window is open until May 14th and organizations are encouraged to apply at the following link: https://webportalapp.com/sp/login/real_impact_grants

Completed Preclinical Studies in Heart Failure Indication

Imara completed preclinical studies of IMR-687 in heart failure with preserved ejection fraction, or HFpEF, during the first quarter. The results of these studies continue to support the further development of IMR-687 in HFpEF and Imara is formulating a clinical development plan for IMR-687 in this indication.

First Quarter 2021 Financial Results

  • Cash Position: Cash, cash equivalents and investments were $75.6 million as of March 31, 2021, as compared to cash, cash equivalents and investments of $88.2 million as of December 31, 2020.
  • Research and Development Expenses: Research and development expenses were $7.1 million for the first quarter of 2021, as compared to $5.8 million for the first quarter of 2020. The increase of $1.3 million was primarily related to the development and manufacturing of clinical materials, clinical research and oversight of the Company’s clinical trials and investigative fees related to the development of IMR-687, as well as increased personnel-related and other research and development operational costs.
  • General and Administrative Expenses: General and administrative expenses were $3.2 million for the first quarter of 2021, as compared to $1.6 million for the first quarter of 2020. The increase of $1.6 million was primarily due to increased personnel-related and other general and administrative operational costs as a result of operating as a public company.
  • Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $10.3 million, or $0.58 per share, for the first quarter of 2021, as compared to a net loss of $15.1 million, or $4.31 per share, for the first quarter of 2020.

Financial Guidance

The Company currently expects that its full-year 2021 research and development expenses will range between $50 million and $55 million and that its full-year 2021 general and administrative expenses will range between $12 million and $14 million. The Company expects that its cash, cash equivalents and investments as of March 31, 2021, will be sufficient to enable it to fund its planned operations into mid-2022.

Conference Call and Webcast Information

Imara will host a conference call and live webcast today at 8:30 a.m. ET to discuss its first quarter 2021 financial results and other business updates. The live webcast will be available under “Events and Presentations” in the Investors section of the Company’s website at imaratx.com.   The conference call can be accessed by dialing 1 (833) 519-1307 (U.S. domestic) or +1 (914) 800-3873 (international) and referring to conference ID 7598753. A replay of the webcast will be archived on the Imara website following the presentation.

About Imara

Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin. Imara is currently advancing IMR-687, a highly selective, potent small molecule inhibitor of PDE9 that is an oral, once-a-day, potentially disease-modifying treatment for sickle cell disease and beta-thalassemia. IMR-687 is being designed to have a multimodal mechanism of action that acts on red blood cells, white blood cells, adhesion mediators and other cell types. For more information, please visit www.imaratx.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the timing for reporting of data from the Company’s ongoing Phase 2b clinical trials in patients with sickle cell disease and beta-thalassemia, (ii) the plan for reporting of comprehensive data on the completed Phase 2a clinical trial in sickle cell disease and additional data from the open label extension clinical trial in sickle cell disease, (iii) the plan for reporting of preclinical data in HFpEF (iv) the Company’s beliefs regarding the strength of its clinical data, the therapeutic potential of IMR-687 and advancement of its clinical program, and (v) financial guidance regarding the Company’s projected operating expenses and sufficiency of the Company’s capital resources to fund its operations into mid-2022. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company’s business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to enroll, dose and readout data from its open label extension clinical trial of IMR-687 in sickle cell disease and its Phase 2b clinical trials of IMR-687 in sickle cell disease and beta-thalassemia; the Company’s ability to advance the development of IMR-687 under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of IMR-687; and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:

Marin Bergman
Ten Bridge Communications
818-516-2746

Investor Contact:

Michael Gray
617-835-4061
[email protected]

IMARA INC.

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(in thousands)

(Unaudited)

    March 31,

2021 		    December 31,

2020 		 
Cash, cash equivalents and investments   $ 75,592     $ 88,222  
Working capital(1)     74,858       84,158  
Total assets     81,687       90,842  
Total liabilities     6,093       6,407  
Accumulated deficit     (106,370 )     (96,113 )
Total stockholders’ equity     75,594       84,435  

(1)   Working capital is defined as current assets less current liabilities.

IMARA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(Unaudited)

    Three Months Ended

March 31, 		 
    2021     2020  
Operating expenses:                
Research and development   $ 7,115     $ 5,793  
General and administrative     3,165       1,559  
Total operating expenses     10,280       7,352  
Loss from operations     (10,280 )     (7,352 )
Total other income:                
Interest income     83       132  
Other income (expense)     (60 )     5  
Total other income, net     23       137  
Net loss   $ (10,257 )   $ (7,215 )
Accretion of Series B convertible preferred stock     —       (7,858 )
Net loss attributable to common stockholders—basic and diluted   $ (10,257 )   $ (15,073 )
Weighted-average common shares outstanding—basic and diluted     17,577,454       3,493,359  
Net loss per share attributable to common stockholders—basic and diluted   $ (0.58 )   $ (4.31 )
                 
                 



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Acceleron to Host Conference Call and Webcast to Review Clinical Trial Updates, Preclinical Presentations on Sotatercept in Pulmonary Arterial Hypertension (PAH) Presented at the American Thoracic Society (ATS) 2021 International Conference

Acceleron to Host Conference Call and Webcast to Review Clinical Trial Updates, Preclinical Presentations on Sotatercept in Pulmonary Arterial Hypertension (PAH) Presented at the American Thoracic Society (ATS) 2021 International Conference

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced it will host a conference call and webcast on Wednesday, May 19, 2021 at 10:30 a.m. EDT to review updates from the PULSAR and SPECTRA Phase 2 clinical trials of sotatercept in patients with pulmonary arterial hypertension (PAH). Data from the PULSAR and SPECTRA trials will have been presented during clinical presentations at the American Thoracic Society 2021 International Conference (ATS 2021) earlier that day.

Guest Presenter:

  • Aaron Waxman1, M.D., Ph.D., Director of the Pulmonary Vascular Disease Program at Brigham and Women’s Hospital; Associate Professor of Medicine at Harvard Medical School

The webcast will be accessible under “Events & Presentations” in the Investors & Media page of the Company’s website at www.acceleronpharma.com. To participate in the conference call, please dial 833-494-1483 (domestic) or 236-714-2620 (international) and reference code #6565123.

An archived version of the webcast will be available for replay on the Company’s website for approximately one year.

1 Dr. Waxman is the principal investigator of the SPECTRA trial and a paid consultant to Acceleron.

About Sotatercept

Sotatercept is an investigational reverse-remodeling agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance signaling in the BMP pathway, which is a key molecular driver of PAH. In preclinical studies, sotatercept was shown to reverse the vascular remodeling that is a hallmark of PAH. The PULSAR Phase 2 trial evaluating sotatercept in combination with approved PAH-specific medicines in patients with PAH achieved its primary endpoint of improvement in pulmonary vascular resistance and its key secondary endpoint of improvement in 6-minute walk distance. Sotatercept was generally well tolerated in the trial. Adverse events observed in the study were generally consistent with previously published data on sotatercept in other diseases. Following the PULSAR results, sotatercept was granted Breakthrough Therapy designation from the FDA and Priority Medicines designation from the EMA in PAH. Sotatercept is also being evaluated in the SPECTRA Phase 2 exploratory trial.

The Company recently presented details of its Phase 3 development plan, including the design for the registrational STELLAR trial, which is currently enrolling patients with PAH. Acceleron is planning two additional Phase 3 studies in patients with PAH: the HYPERION trial in newly diagnosed patients and the ZENITH trial assessing intervention in patients diagnosed with World Health Organization (WHO) functional class IV disease.

Sotatercept is an investigational therapy that is not approved for any use in any country. Sotatercept is part of a licensing agreement with Bristol Myers Squibb.

About PAH

PAH is a rare and chronic, rapidly progressing disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. PAH results in significant strain on the heart, often leading to limited physical activity, heart failure, and reduced life expectancy. The 5-year survival rate for patients with PAH is approximately 57%. Available therapies generally act by promoting the dilation of pulmonary vessels without addressing the underlying cause of the disease. As a result, PAH often progresses rapidly for many patients despite standard of care treatment. A growing body of research has implicated imbalances in BMP and TGF-beta signaling as a primary driver of PAH in familial, idiopathic, and acquired forms of the disease.

About Acceleron

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body’s ability to regulate cellular growth and repair.

Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/Phase 2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) this year.

In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis.

For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements about Acceleron’s strategy, future plans and prospects, including statements regarding the development of sotatercept in PAH, the timeline for clinical development and regulatory approval of sotatercept in PAH, the expected timing for reporting of data from ongoing clinical trials, and the potential of Acceleron’s compounds as therapeutic drugs. The words “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of Acceleron’s compounds and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that regulatory approval of Acceleron’s compounds in one indication or country may not be predictive of approval in another indication or country, that the development of Acceleron’s compounds will take longer and/or cost more than planned, that Acceleron will be unable to successfully complete the clinical development of Acceleron’s compounds, that Acceleron may be delayed in initiating, enrolling or completing any clinical trials, that Acceleron’s compounds will not receive regulatory approval or become commercially successful products, and that Breakthrough Therapy or PRIME designation may not expedite the development or review of sotatercept. These and other risks and uncertainties are identified under the heading “Risk Factors” included in Acceleron’s most recent Annual Report on Form 10-K and other filings that Acceleron has made and may make with the SEC in the future.

The forward-looking statements contained in this press release are based on management’s current views, plans, estimates, assumptions, and projections with respect to future events, and Acceleron does not undertake and specifically disclaims any obligation to update any forward-looking statements.

Acceleron Pharma Inc.

Investors:

Jamie Bernard, IRC, 617-301-9650

Associate Director, Investor Relations

Media:

Matt Fearer, 617-301-9557

Senior Director, Corporate Communications

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

MEDIA:

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NVIDIA Transforms Mainstream Laptops into Gaming Powerhouses with GeForce RTX 30 Series

Brings RTX Real-Time Ray Tracing and AI-Based DLSS to Tens of Millions More Gamers and Creators with $799 Portable Powerhouses

SANTA CLARA, Calif., May 11, 2021 (GLOBE NEWSWIRE) — NVIDIA today announced a new wave of GeForce RTX™ laptops from the world’s top manufacturers, delivering real-time ray tracing and AI-based DLSS to tens of millions more gamers and creators, starting at just $799.

The platforms, many based on the new GeForce RTX 3050 Ti and 3050 Laptop GPUs, bring NVIDIA’s Ampere architecture with dedicated RT and Tensor Cores to the most mainstream audience yet, and expand the number of RTX 30 Series laptops to more than 140.

Providing exceptional performance in thin, sleek designs, the new RTX laptops are twice as fast as previous-generation systems, delivering smooth, 60 frames per second gameplay at 1080p in popular titles such as Minecraft RTX and Call of Duty: Black Ops Cold War.

“The latest wave of laptops provides the perfect opportunity to upgrade, particularly for gamers and creators with older laptops who want to experience the magic of RTX,” said Mark Aevermann, director of product management for laptops at NVIDIA. “There are now five times more RTX 30 Series gaming laptops that are thinner than 18mm compared with previous-generation RTX systems, delivering groundbreaking performance with very sleek and portable designs.”

NVIDIA DLSS – The Laptop Game Changer

Laptop owners, who typically upgrade after about four years of use, can see enormous performance gains with the newest GeForce RTX 3050-class Laptop GPUs. With NVIDIA DLSS, GeForce RTX 3050 Ti laptops are also up to 2x faster than previous-generation systems.

Only GeForce RTX GPUs feature specialized Tensor Cores that power DLSS, which is now available in more than 40 AAA titles and indie game hits, with recent additions such as Outriders, Call of Duty: Warzone, Call of Duty: Modern Warfare, NARAKA: BLADEPOINT and Mortal Shell.

Additionally, creators can experience DLSS acceleration in applications such as D5 Render, SheenCity Mars and NVIDIA Omniverse™, which enable artists to visualize their designs in real time instead of waiting for ray-traced scenes to finish rendering.

“Consumers are spending more time than ever on laptops — PC gamers, creators and students are all driving demand for massive improvements in graphics horsepower and AI-accelerated applications,” said Bob O’Donnell, president and chief analyst at TECHnalysis Research. “Laptop manufacturers are responding to this market momentum by designing thinner, higher-performing models to meet the various needs of consumers — it’s no wonder NVIDIA GPUs are powering so many new designs.”

NVIDIA Reflex Brings Low-Latency Esports to Laptops

For those who enjoy competitive games, new GeForce RTX 3050 Ti laptops can deliver 144+ FPS and sub-25ms system latency in titles such as Overwatch, Rainbow Six Siege and Valorant, thanks to the NVIDIA Reflex Low Latency mode. Seven out of the top 10 competitive shooter games have NVIDIA Reflex support, which allows gamers to achieve lower system latency so they can play their absolute best. NVIDIA Reflex is also supported across the entire RTX 30 Series lineup.

New AI Effects for Video Conferencing and Livestreaming in NVIDIA Broadcast

All RTX 30 Series laptops include support for NVIDIA Broadcast, an app that transforms laptops into a home studio. This has now been improved with new AI effects — room echo removal and video noise removal — and updated the audio noise removal to eliminate sounds from cats, dogs and insects. These effects, together with the previously released virtual background and auto frame, can now be stacked to provide more control and quality over audio and video.

New NVIDIA Studio Laptops

RTX-based Studio laptops are designed for creators to meet their demands for performance and reliability. Newly unveiled NVIDIA Studio laptops equipped with RTX 30 Series GPUs now render creative and professional apps up to 2x faster than the previous generation. Video editors can work with 8K RAW footage, use AI to simplify workflows and reduce encode times by up to 75 percent. Additionally, artists can take advantage of up to 16GB of graphics memory to work with huge assets or multiple apps simultaneously for increased productivity and efficiency.

Availability

New GeForce RTX 30 Series laptops, including GeForce RTX 3080, 3070 and 3060, are available starting today from the world’s top manufacturers, including Acer, Alienware, ASUS, Dell, Gigabyte, HP, Lenovo, MSI and Razer. RTX 3050 Ti and 3050-based laptops will be available this summer.

GeForce RTX 30 Series laptops will also be available from local OEMs and system builders, including Aftershock, CyberPower PC, Digital Storm, Eluktronics, Falcon NW, Hasee, Maingear, Mechrevo, Mouse, Origin PC, PC Specialist, Scan, Schenker, Terrans Force, Thunderobot and XOTIC PC. Pricing, configurations and availability will vary among regions and partners.

Press assets, including product photographs, specifications, chip and die shots and other materials, are available on the NVIDIA press site at www.nvidia-press.com.

About NVIDIA


NVIDIA
’s (NASDAQ: NVDA) invention of the GPU in 1999 sparked the growth of the PC gaming market and has redefined modern computer graphics, high performance computing and artificial intelligence. The company’s pioneering work in accelerated computing and AI is reshaping trillion-dollar industries, such as transportation, healthcare and manufacturing, and fueling the growth of many others. More information at https://nvidianews.nvidia.com/.

For further information, contact:

Kelly Musgrave
Senior PR Manager, GeForce
NVIDIA Corporation
+1-650-421-3748
[email protected]

Certain statements in this press release including, but not limited to, statements as to: the number of laptops featuring the NVIDIA Ampere architecture and the number of RTX 30 Series laptops; the performance, benefits, abilities and availability of next-generation GeForce laptops and what they enable; the world’s fastest growing gaming platform; NVIDIA Ampere architecture powering the world’s fastest laptops; the benefits, performance and abilities of NVIDIA DLSS; the performance and benefits of the NVIDIA Ampere architecture multiprocessors used by GeForce laptops, RT Cores, Tensor Cores, NVIDIA Reflex, NVIDIA Broadcast, NVIDIA Studio and what they enable; GeForce RTX 3050 Ti laptops and NVIDIA Reflex enabling lower system latency; the performance increased enabled by the NVIDIA Ampere architecture; the availability of GeForce RTX 30 Series laptops, the OEMs and systems builders offering them and the variance in pricing, configurations and availability are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: global economic conditions; our reliance on third parties to manufacture, assemble, package and test our products; the impact of technological development and competition; development of new products and technologies or enhancements to our existing product and technologies; market acceptance of our products or our partners’ products; design, manufacturing or software defects; changes in consumer preferences or demands; changes in industry standards and interfaces; unexpected loss of performance of our products or technologies when integrated into systems; as well as other factors detailed from time to time in the most recent reports NVIDIA files with the Securities and Exchange Commission, or SEC, including, but not limited to, its annual report on Form 10-K and quarterly reports on Form 10-Q. Copies of reports filed with the SEC are posted on the company’s website and are available from NVIDIA without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, NVIDIA disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

© 2021 NVIDIA Corporation. All rights reserved. NVIDIA, the NVIDIA logo, GeForce, GeForce RTX and NVIDIA Omniverse are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries. Other company and product names may be trademarks of the respective companies with which they are associated. Features, pricing, availability and specifications are subject to change without notice.



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Moody’s Corporation to Present at the Barclays Americas Select Franchise Conference on May 18, 2021

Moody’s Corporation to Present at the Barclays Americas Select Franchise Conference on May 18, 2021

NEW YORK–(BUSINESS WIRE)–
Moody’s Corporation (NYSE:MCO) announced today that Robert Fauber, President and Chief Executive Officer, will speak at the Barclays Americas Select Franchise Conference on Tuesday, May 18, 2021. Mr. Fauber’s presentation will begin at approximately 11:00 a.m. Eastern Time and will be webcast live. The webcast can be accessed at Moody’s Investor Relations website, ir.moodys.com.

ABOUT MOODY’S CORPORATION

Moody’s (NYSE:MCO) is a global risk assessment firm that empowers organizations to make better decisions. Its data, analytical solutions and insights help decision-makers identify opportunities and manage the risks of doing business with others. We believe that greater transparency, more informed decisions, and fair access to information open the door to shared progress. With over 11,500 employees in more than 40 countries, Moody’s combines international presence with local expertise and over a century of experience in financial markets. Learn more at moodys.com/about.

SHIVANI KAK

Investor Relations

212.553.0298

[email protected]

MICHAEL ADLER

Corporate Communications

212.553.4667

[email protected]

moodys.com

ir.moodys.com/

moodys.com/csr

moodys.com/esg

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Professional Services Data Management Technology Finance Software Banking

MEDIA:

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Xtant Medical Files $150 Million Shelf Registration Statement

BELGRADE, Mont., May 11, 2021 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today it has filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC). Under the shelf registration, upon being declared effective by the SEC, Xtant may offer and sell, from time to time over a three-year period, various securities in an amount of up to $150 million. In addition, the registration statement, upon effectiveness, will allow certain stockholders affiliated with OrbiMed Advisors, LLC to offer and sell, from time to time, up to 18,218,374 shares of Xtant common stock.

The shelf registration statement is intended to afford Xtant the flexibility to finance future growth initiatives and business opportunities by accessing the capital markets on a timely and cost-effective basis. At the present time, the Company has no specific plans to issue securities under the registration statement. The specifics of any future offering, along with the prices and terms of any such securities and the use of proceeds of a particular offering, will be determined at the time of any such offering and will be described in a prospectus supplement filed in connection with such offering.

“Filing this shelf registration statement is an important housekeeping step for Xtant and a matter of standard governance as it will allow us to pursue, and increase our flexibility to fund, potential future growth initiatives and business opportunities,” said Sean Browne, President and CEO of Xtant Medical. “In addition, the secondary offering component to the registration statement will provide OrbiMed additional flexibility to sell Xtant shares from time to time, which should increase the number of Xtant shares in our public float and hopefully bring more liquidity to our stock.”

Xtant will not receive any of the proceeds of any sales or other dispositions of shares of common stock by the selling stockholders. The selling stockholders have advised the Company that they have an interest in selling shares of common stock to diversify their respective holdings but that no commitments for the sale of the shares being registered have been made at this point.

The shelf registration statement relating to the securities has been filed with the SEC but has not yet become effective. The securities may not be sold, nor may offers to buy be accepted, prior to the time the shelf registration statement becomes effective under the Securities Act of 1933, as amended. Any offering of the securities will be made solely by means of a prospectus and an accompanying prospectus supplement relating to that offering. A copy of the preliminary base prospectus included in the registration statement may be obtained on the SEC’s website at www.sec.gov.

This press release is for information purposes only and does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal implant systems to facilitate spinal fusion in complex spine, deformity and degenerative procedures. Xtant people are dedicated and talented, operating with the highest integrity to serve our customers.

The symbols ™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property of their respective owners.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘expects,’’ ‘‘anticipates,’’ ‘‘plans,’’ ‘‘believes,’’ “continue,” “should,” “hopefully,” “future,” ‘‘will,’’ “should,” similar expressions or the negative thereof, and the use of future dates. Forward-looking statements in this release include the benefits of the shelf registration statement and its ability to allow Xtant to pursue, and increase its flexibility to fund, potential future growth initiatives and business opportunities and to provide OrbiMed additional flexibility to sell Xtant shares from time to time, which will increase the number of Xtant shares in the public float and bring more liquidity to the stock. The Company cautions that its forward-looking statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s future operating results and financial performance; the ability to increase or maintain revenue; the ability to remain competitive; the ability to innovate and develop new products; the effect of the COVID-19 pandemic on the Company’s business, operating results and financial condition; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals and comply with government regulations; the effect of product liability claims and other litigation to which the Company may be subject; the effect of product recalls and defects; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt, comply with its debt covenants and access additional indebtedness; the ability to obtain additional financing on favorable terms or at all; and other factors. Additional risk factors are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (SEC) on February 24, 2021 and subsequent SEC filings by the Company. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by this cautionary statement.

Investor Relations Contact

David Carey
Lazar FINN
Ph: 212-867-1762
Email: [email protected]



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Gamida Cell Reports First Quarter 2021 Financial Results and Provides Company Update

Gamida Cell Reports First Quarter 2021 Financial Results and Provides Company Update

  • BLA submission for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, expected in fourth quarter of 2021
  • Pre-commercial and manufacturing activities underway to support potential launch of omidubicel in 2022
  • Phase 1/2 clinical trial of allogeneic, off-the-shelf GDA-201 in NHL planned with IND submission anticipated in the second half of 2021
  • Strengthened financial position with sale of $75M exchangeable senior notes in February 2021; sufficient liquidity to fund the company’s operations into the second half of 2022
  • Company to host conference call at 8:00 a.m. ET today

BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today reported financial results for the quarter ended March 31, 2021. The company also highlighted progress with omidubicel, an advanced cell therapy with positive Phase 3 clinical data, as a potentially life-saving treatment option for patients in need of an allogeneic hematopoietic stem cell (bone marrow) transplant, and GDA-201, a natural killer (NK) cell immunotherapy in Phase 1/2 development for patients with non-Hodgkin lymphoma (NHL).

“In the first quarter of this year, we made significant progress on key initiatives across all functions of our business, starting with omidubicel, a potentially transformative treatment option for patients with hematological malignancies,” said Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We are working diligently to bring this novel therapy to patients, with submission of a BLA to the FDA anticipated in the fourth quarter of this year. We are progressing well with our manufacturing readiness activities in response to the clear feedback from the FDA regarding registration of our commercial manufacturing facilities and are actively building our launch readiness capabilities, including market access and support services, to ensure a positive patient experience at transplant at the time of potential FDA approval.”

“We also continue to expand our clinical pipeline with plans to submit an IND for our GDA-201 natural killer cell therapy, initiate a multi-center Phase 1/2 clinical study in NHL and continue to advance our R&D activities to pursue the development of genetically modified NAM-enabled NK cells in solid tumors. Importantly, we are well positioned to deliver our 2021 corporate goals and objectives toward improving the lives of the patients we serve,” Dr. Adams continued.

Omidubicel, a proprietary, investigational advanced cell therapy for allogeneic bone marrow transplant

Omidubicel is the foundational product based on Gamida Cell’s proprietary cell expansion technology. During the quarter, Gamida Cell continued to advance omidubicel, the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The company anticipates submitting a Biologics License Application (BLA) to the FDA in the fourth quarter of this year, based on the results of an international, randomized Phase 3 study of omidubicel that was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to patients who received a standard umbilical cord blood transplant. The study achieved its primary endpoint, a statistically significant reduction in time to neutrophil engraftment, as well as all key secondary endpoints. A key milestone in a patient’s recovery, neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a bone marrow transplant are established and begin to make healthy new cells. In the recently completed Phase 3 study, the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). Additionally, the study met key secondary endpoints related to the speed of platelet engraftment, decrease in infections and reduction in hospitalizations, all significant clinical measures in bone marrow transplant.

In February 2021, the company presented details of the results of the omidubicel Phase 3 study at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. The study’s intent-to-treat analysis included 125 patients aged 13–65 years with a median age of 41. Patients were enrolled at more than 30 clinical centers in the United States, Europe, Asia, and Latin America. Racial and ethnic diversity and baseline characteristics which were well-balanced across the two study groups. Diseases included acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma.

In addition to the efficacy results described above, safety results were also presented, showing decreased incidence related to grade III/IV acute GvHD (14 percent for omidubicel, 21 percent for the comparator) and comparable results for all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Transplants with umbilical cord blood, the comparator, have been historically shown to result in low incidence of GvHD in relation to other graft sources and, in this study, omidubicel demonstrated a similar GvHD profile.

The data from the study relating to exploratory endpoints also supported the clinical benefit demonstrated by the study’s primary and secondary endpoints. The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade II or grade III bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.027). Additionally, the study demonstrated a reduction in the incidence of viral infections. Non-relapse mortality was 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09). Overall survival at 15 months following randomization was 73 percent for patients randomized to omidubicel and 62 percent for patients randomized to control (p=0.16), median overall survival was not yet reached. Non-relapse mortality and overall survival were exploratory endpoints that were not powered for statistical significance. When considering the patient experience following transplant, faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital are all meaningful results and represent potentially important advancements in care. Learn more.

Gamida Cell also reported data from the Phase 3 study in March 2021, in an oral session at the Presidential Symposium of the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021). Additionally, the session was featured in a panel discussion, “EBMT Talks: Live with the Best Abstracts.”

Additional omidubicel highlights:

  • Progress with commercial manufacturing readiness: Gamida Cell is making important progress to address the clear feedback received during a Type B meeting with the FDA in December 2020 for commercial manufacturing facilities to be ready for BLA submission. These facilities include the Gamida Cell facility in Israel and a commercial facility for which the company has a contractual relationship with Lonza. Both of these facilities are currently on track to meet the FDA requirements that will be required for BLA submission.
  • Continued launch readiness: The company continues to progress commercial launch readiness activities for the potential launch of omidubicel in 2022, pending FDA approval. Based on market research insights, there is a clear opportunity to improve outcomes based on clinical needs with current donor sources, increase access for patients who are eligible and not matched for transplant, and increase patient eligibility based on the encouraging clinical profile of omidubicel.
  • Gamida Cell announced the Gamida Cell Assist program. The transplant process can be challenging and complex for patients, caregivers and the entire transplant care team. Gamida Cell Assist is designed to focus on patient access and support at each step of the process. Once the program is launched, the Gamida Cell Assist case management team will provide a consistent, single point of contact for patients and health care professionals, work with the transplant center to track production of omidubicel for each individual patient, and provide real-time updates on the status of the therapy. The services provided will include coverage and reimbursement support, which may include financial, travel and lodging assistance. Gamida Cell is committed to supporting a positive journey for patients and their transplant teams so they can focus on what matters most, the patient experience and successful clinical outcomes. Learn more.
  • Phase 1/2 study of omidubicel in patients with severe aplastic anemia: Gamida Cell is actively evaluating omidubicel in an investigator-sponsored Phase 1/2 study in patients with severe aplastic anemia (SAA). Results to date have shown that omidubicel can result in rapid engraftment and can achieve sustained hematopoiesis in patients who are at high risk for graft failure with conventional umbilical cord blood transplant.

GDA-201, a proprietary innate NK cell immunotherapy

  • Continued advancement of Phase 1/2 study of GDA-201: Gamida Cell is preparing for the submission of an investigational new drug (IND) application for cryopreserved, off-the-shelf GDA-201 to enable a multi-center, Phase 1/2 clinical study in patients with NHL in the second half of this year. Gamida Cell is pioneering a potentially curative, novel approach that harnesses the power of its cell expansion technology, which improves antibody-dependent cellular cytotoxicity and tumor targeting of NK cells. Learn more.
  • Advancing NK cell R&D activities: The company continues to advance R&D activities to support pipeline growth, including the development of genetically modified NK cells.

Corporate Highlights

  • Strengthened financial position: In February 2021, the company completed a $75 million financing with Highbridge Capital Management, LLC, before deducting offering expenses. This financing will be used to support manufacturing, regulatory and potential commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.

First Quarter 2021 Financial Results

  • Research and development expenses in the first quarter of 2021 were $11.4 million, compared to $7.9 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities and advancing the GDA-201 program, including broadening the company’s scientific capabilities and talent.
  • Commercial expenses in the first quarter of 2021 were $4.4 million compared to $1.5 million for the first quarter of 2020. The increase was mainly attributed to progress with commercial readiness activities, including the hiring of an experienced commercial leadership team.
  • General and administrative expenses were $3.4 million for the first quarter of 2021 compared to $3.0 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support the growth of the business.
  • Finance income, net, was $0.7 million for the first quarter of 2021, compared to finance income, net, of $1.7 million for the first quarter of 2020. The decrease was primarily due to interest expenses following the recent $75M financing with Highbridge Capital Management, and non-cash expense resulting from revaluation of warrants, and Israeli Innovation Authority royalty-bearing grant liability.
  • Net loss for the first quarter of 2021 was $18.0 million, compared to a net loss of $10.6 million for the same period in 2020.
  • As of March 31, 2021, Gamida Cell had total cash and cash equivalents of $174.8 million, compared to $127.2 million as of December 31, 2020.

2021 Financial Guidance

Gamida Cell expects cash used for ongoing operating activities in 2021 to range from $110 million to $120 million.

Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into the second half of 2022. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.

Expected 2021-2022 Milestones and Key Events

Gamida Cell expects the following milestones and key events through 2022:

Omidubicel

  • BLA submission to the FDA in the fourth quarter of 2021
  • Manufacturing and launch readiness activities ongoing for potential FDA approval in 2022

GDA-201

  • Submit company-sponsored IND application to the FDA and initiate a Phase 1/2 clinical study in NHL patients in the second half of 2021

Conference Call Information

Gamida Cell will host a conference call today, May 11, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About Gamida Cell

Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s product candidates, anticipated regulatory filings, commercialization efforts and Gamida Cell’s expectations regarding its projected ongoing operating activities and cash runway, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.

___________________

1 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.

2 Gamida Cell press release, “Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies,” issued May 12, 2020. Last accessed August 31, 2020.

3Clinicaltrials.gov identifier NCT03019666

INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands
 
 
March 31, December 31,

 

2021

2020

2020
Unaudited Audited
 
ASSETS
 
CURRENT ASSETS:
 
Cash and cash equivalents

$

174,798

$

40,292

$

127,170

Prepaid expenses and other current assets

 

3,352

 

1,637

 

2,815

 
Total current assets

 

178,150

 

41,929

 

129,985

 
NON-CURRENT ASSETS:
Property, plant and equipment, net

 

21,162

 

8,543

 

18,238

Right-of-use assets

 

5,920

 

5,820

 

6,474

Other assets

 

772

 

637

 

786

 
Total non-current assets

 

28,854

 

15,000

 

25,498

 
Total assets

$

206,004

$

56,929

$

155,483

 
 
 
March 31, December 31,

2021

 

2020

 

2020
Unaudited Audited
 
LIABILITIES AND EQUITY
 
CURRENT LIABILITIES:
Trade payables

$

7,204

$

3,098

$

6,329

Employees and payroll accruals

 

3,854

 

2,549

 

4,705

Current maturities of lease liabilities

 

2,076

 

1,535

 

2,532

Accrued interest

 

634

 

–

 

–

Accrued expenses and other payables

 

6,099

 

2,922

 

7,988

 
Total current liabilities

 

19,867

 

10,104

 

21,554

 
NON-CURRENT LIABILITIES:
Liabilities presented at fair value

 

9,758

 

2,773

 

12,043

Employee benefit liabilities, net

 

768

 

773

 

768

Other long-term liabilities

 

4,988

 

4,920

 

5,378

Liability to Israel Innovation Authority (IIA)

 

18,080

 

13,077

 

17,003

Convertible senior notes, net

 

68,646

 

–

 

–

 
Total non-current liabilities

 

102,240

 

21,543

 

35,192

 
SHAREHOLDERS’ EQUITY:
Share capital –
Ordinary shares of NIS 0.01 par value –

 

167

92

 

166

Authorized: 100,000,000 shares at March 31, 2021 and 2020 (unaudited) and December 31, 2020; Issued and outstanding: 59,247,838 and 33,696,582 shares at March 31, 2021 and 2020 (unaudited), respectively and 59,000,153 shares at December 31, 2020.
Share premium

 

378,478

239,897

 

375,280

Capital reserve

 

-441

-541

 

-441

Accumulated deficit

 

-294,307

-214,166

 

-276,268

 
Total shareholders’ equity

 

83,897

25,282

 

98,737

 
Total liabilities and shareholders’ equity

$

206,004

$56,929

$

155,483

 
INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands
 
 
Three months ended
March 31,		 Year ended
December 31,

2021

2020

2020
Unaudited Audited
 
Operating expenses:
Research and development, net

$ 11,366

$ 7,879

$ 41,385

Commercial activities

4,430

1,468

8,748

General and administrative

3,413

2,994

12,167

 
Operating loss

19,209

12,341

62,300

 
Finance expense

1,690

919

10,640

Finance income

-2,413

-2,658

-236

 
Loss before tax benefit

18,486

10,602

72,704

Tax benefit

-447

–

–

 
Net loss

18,039

10,602

72,704

 
Other comprehensive loss:
 
Items that will be reclassified subsequently to profit or loss:
Actuarial net gain of defined benefit plans

–

–

-100

Changes in the fair value of marketable securities

–

4

4

 
Total comprehensive loss

$ 18,039

10,606

$ 72,608

 
Net loss per share:
 
Basic loss per share

$ 0.31

$ 0.31

$ 1.66

 
Diluted loss per share

$ 0.34

$ 0.31

$ 1.66

 
Weighted average share count

60,011,038

33,674,506

43,725,584

 
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
 
 
Three months ended
March 31,		 Year ended
December 31,

2021

 

2020

 

2020

 

Unaudited Audited
 
Cash flows from operating activities:
 
Net loss

$ (18,039

)

$ (10,602

)

$ (72,704

)

Adjustments to reconcile net loss to net cash used in operating activities:
 
Adjustments to the profit or loss items:
 
Depreciation of property, plant and equipment and right-of-use assets

635

 

550

 

2,397

 

Financial income (expense) net

485

 

-132

 

483

 

Share-based compensation

1,014

 

899

 

2,864

 

Change in employee benefit liabilities, net

–

 

–

 

94

 

Amortization of premium on available-for-sale financial assets

–

 

4

 

4

 

Revaluation of liabilities presented at fair value

-2,285

 

-2,448

 

6,822

 

Revaluation of liability to IIA

1,026

 

722

 

4,302

 

Deferred income taxes

-447

 

–

 

–

 

 

428

 

-405

 

16,966

 

Changes in asset and liability items:
 
Increase in prepaid expenses, other current assets and other assets

-523

 

-458

 

-1,626

 

Increase in trade payables

875

 

1,934

 

5,083

 

Increase (decrease) in accrued expenses and other payables

-2,724

 

-3,096

 

3,454

 

 

-2,372

 

-1,620

 

6,911

 

 
Cash received during the period for:
 
Interest received

–

 

348

 

361

 

Interest paid

-51

 

-47

 

-161

 

 
Net cash used in operating activities

-20,034

 

-12,326

 

-48,627

 

 
Cash flows from investing activities:
 
Purchase of property, plant and equipment

-2,806

 

-2,119

 

-11,804

 

Proceeds from maturity of marketable securities

–

 

–

 

-158

 

Proceeds from sale of marketable securities

–

 

13,551

 

13,551

 

 
Net cash provided by (used in) investing activities

$ (2,806

)

$ 11,432

 

$ 1,589

 

 
 
 
Three months ended
March 31,		 Year ended
December 31,

2021

 

2020

 

2020

 

Unaudited Audited
 
Cash flows from financing activities:
 
Proceeds from secondary offering, net

–

 

–

 

133,316

 

Receipt of grants from the IIA

52

 

53

 

399

 

Proceeds from issuance of convertible senior notes, net of issuance costs

71,012

 

–

 

–

 

Payment of lease liabilities

-664

 

-787

 

-1,985

 

Exercise of options

502

 

6

 

650

 

Payment of issuance costs related to public offering

-468

 

–

 

–

 

 
Net cash (used in) provided by financing activities

70,434

 

-728

 

132,380

 

 
Exchange differences on balances of cash and cash equivalents

34

 

76

 

-10

 

 
Increase (decrease) in cash and cash equivalents

47,628

 

-1,546

 

85,332

 

Cash and cash equivalents at beginning of period

127,170

 

41,838

 

41,838

 

 
Cash and cash equivalents at end of period

$ 174,798

 

$ 40,292

 

$ 127,170

 

 
Supplemental disclosure of non-cash financing activities:
 
Significant non-cash transactions:
 
Lease liabilities arising from new right-of-use asset

$ –

 

$ –

 

$ 3,409

 

 
IIA liability for grants to be received

$ 49

 

$ –

 

$ 103

 

 
Issuance expenses on credit

$ 235

 

$ –

 

$ 468

 

 
Purchase of property, plant and equipment on credit

$ 216

 

$ 206

 

$ 415

 

 

 

For investors:

Stephanie Ascher

Stern Investor Relations, Inc.

[email protected]

1-212-362-1200

For media:

Rhiannon Jeselonis

Ten Bridge Communications

[email protected]

1-978-417-1946

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: FDA Health Stem Cells Clinical Trials Oncology

MEDIA: