Telos Corporation to Participate in Upcoming Investor Conferences

ASHBURN, Va., May 12, 2023 (GLOBE NEWSWIRE) — Telos Corporation (NASDAQ: TLS), a leading provider of cyber, cloud and enterprise security solutions for the world’s most security-conscious organizations, today announced that John B. Wood, chairman and chief executive officer, and Mark Bendza, executive vice president and chief financial officer will host investor meetings at the following investor conferences:

18

th

Annual Needham Technology and Media Conference

Date: May 18, 2023
Location: Virtual

B. Riley Securities 23

rd

Annual Institutional Investor Conference

Date: May 24 – 25, 2023
Location: Beverly Hills, CA

About Telos Corporation


Telos Corporation
(NASDAQ: TLS) empowers and protects the world’s most security-conscious organizations with solutions for continuous security assurance of individuals, systems, and information. Telos’ offerings include cybersecurity solutions for IT risk management and information security; cloud security solutions to protect cloud-based assets and enable continuous compliance with industry and government security standards; and enterprise security solutions for identity and access management, secure mobility, organizational messaging, and network management and defense. The company serves commercial enterprises, regulated industries and government customers around the world.

Media:


[email protected]

Investors:


[email protected]



Orchestra BioMed Reports First Quarter 2023 Financial Results and Provides Business Update

  • Completed business combination and listing on Nasdaq generating gross proceeds of approximately $70 million
  • BackBeat CNT™ global pivotal study in hypertensive pacemaker patients on track for initiation in the second half of 2023 in collaboration with Medtronic
  • Virtue SAB® U.S. pivotal study in coronary in-stent restenosis (“ISR”) start planned for the second half of 2023 in collaboration with Terumo

NEW HOPE, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its first quarter 2023 financial results and provided a business update.

“The first quarter of 2023 was a transformational period for Orchestra BioMed marked by our successful entrance into the public markets. In the last year, we completed our BackBeat CNT strategic collaboration with Medtronic, the global leader in cardiac pacing therapies, and significantly strengthened our balance sheet with support from leading healthcare and strategic investors. With these accomplishments, we believe we have long-term capital resources to execute pivotal clinical studies for our two lead programs, BackBeat CNT and Virtue SAB,” stated David Hochman, Chairman, Co-founder and Chief Executive Officer of Orchestra BioMed. “We plan to start the BackBeat CNT and Virtue SAB pivotal studies this year and look forward to generating key data to support regulatory submissions for these high-impact therapeutic devices. It is an ideal time to be pursuing our innovative, partnership-enabled business model, and our team is focused on delivering significant value for our shareholders, physicians, and patients.”

Corporate highlights

  • Completed successful business combination with Health Sciences Acquisition Corp 2 (“HSAC2”), a special purpose acquisition company sponsored by an affiliate of RTW Investments, LP (“RTW”), on January 26, 2023. Gross proceeds from the transaction were approximately $70 million and the transaction was supported by approximately $28 million in market purchases of HSAC2 stock and investments by funds managed by RTW affiliates and approximately $10 million in market purchases of HSAC2 stock by an affiliate of Medtronic plc (“Medtronic”).
  • Strengthened senior leadership team with appointment of Avi Fischer, M.D., as Senior Vice President (SVP), Medical Affairs and Innovation; J.C. Simeon as SVP, Quality; George Papandreou, Ph.D., as General Manager and SVP, Focal Therapies; and Kunal Faldu as Vice President, Pharmaceutical Development.

Pipeline highlights

  • BackBeat Cardiac Neuromodulation Therapy (CNT™) – Hypertension in Pacemaker Patients

    • Global pivotal study evaluating the efficacy and safety of BackBeat CNT in adult patients with hypertension who are indicated for a pacemaker on track to start in the second half of 2023
  • Virtue® Sirolimus AngioInfusion

    TM

    Balloon (SAB) – Coronary Indications

    • U.S. pivotal study evaluating Virtue SAB in adult patients with coronary ISR planned to start in the second half of 2023
    • Additional Virtue SAB clinical studies in coronary ISR and small vessel disease planned in partnership with Terumo, the Company’s global strategic partner for development and commercialization of Virtue SAB

Financials

  • Cash Position: As of March 31, 2023, Orchestra BioMed had cash and cash equivalents and marketable securities of $127.1 million, compared to $83.7 million as of December 31, 2022. The increase in cash was primarily due to the net proceeds provided by the closing of the business combination with HSAC2, less cash used in operating activities during the quarter and fees and expenses associated with the business combination. Based on current clinical development and other research and development plans and budget estimates, the Company anticipates that the cash and cash equivalents and marketable securities are sufficient to fund operations into 2026.
  • Revenue: Orchestra BioMed recognized $1.2 million of revenue for the first quarter of 2023 compared to $0.9 million for the first quarter of 2022. The increase was primarily due to increased recognition of partnership revenues earned under the Terumo agreement.
  • Research and Development Expenses: Research and development (R&D) expenses were $8.3 million for the first quarter of 2023 compared to $3.5 million for the first quarter of 2022. The increase was primarily due to additional costs associated with preparations for the launch of the Virtue SAB and BackBeat CNT pivotal clinical studies, as well as an increase of $0.5 million in non-cash stock-based compensation expense.
  • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $4.4 million for the first quarter of 2023, compared to $2.5 million for the first quarter of 2022. The increase was primarily due to additional personnel costs, legal, insurance and finance costs, transaction costs incurred related to the closing of the business combination and included an increase of $0.9 million in non-cash stock-based compensation expense.
  • Other Income (Expense): Other income was $0.6 million for the first quarter of 2023, compared to other expense of $0.6 million for the first quarter of 2022. Interest income (expense), net, increased by $1.1 million from the first quarter of 2022 due to the higher cash balance and an increase in interest rates.
  • Net Loss: Net loss was $10.9 million for the first quarter of 2023, or $0.40 per share, compared to a net loss of $5.7 million, or $0.62 per share, for the same period in 2022. The net loss for the first quarter of 2023 includes $1.8 million in non-cash stock-based compensation expense and loss on fair value adjustment of warrant liability as compared to $0.2 million for the first quarter of 2022.

About BackBeat CNT and the Strategic Collaboration with Medtronic

BackBeat CNT is an investigational bioelectronic treatment designed to lower blood pressure. It is compatible with standard pacemakers as a firmware upgrade and has been evaluated in pilot studies in patients with hypertension who are also indicated for pacemakers. It is estimated that more than 70% of the approximately 1.1 million people globally who are implanted with cardiac pacemakers each year are also diagnosed with hypertension1.

The peer-reviewed, double-blind, randomized pilot study, MODERATO II, showed that patients treated with BackBeat CNT experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) when compared to control patients at six months. Orchestra BioMed plans to conduct a global pivotal study to further evaluate the safety and efficacy of BackBeat CNT in lowering blood pressure in a similar target population of patients who have been indicated for, and recently received, a cardiac pacemaker implant. The strategic collaboration with Medtronic will provide Orchestra BioMed with development, clinical, and regulatory support for this planned global study. Upon regulatory approval, Medtronic will have the global rights to commercialize BackBeat CNT-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the BackBeat CNT-enabled pacing systems.

About Virtue SAB and the Strategic Collaboration with Terumo

Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. Virtue SAB demonstrated positive three-year clinical data in coronary in-stent restenosis (ISR) in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device designation by the U.S. Food and Drug Administration for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.

Under the terms of their collaboration agreement, Orchestra BioMed and Terumo plan to execute a global clinical program in an effort to gain regulatory approval for commercial sale of Virtue SAB in multiple markets and indications. Terumo made an upfront payment of $30 million to Orchestra BioMed and Terumo will potentially make additional future clinical and regulatory milestone payments. Orchestra BioMed will share meaningfully in future commercial revenues of Virtue SAB through royalties and per unit payments as the exclusive supplier of SirolimusEFR. Orchestra BioMed retains the rights to develop and license SirolimusEFR and other technologies used in Virtue SAB for clinical applications outside of coronary and peripheral vascular interventions.

About Orchestra BioMed

Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s flagship product candidates include BackBeat Cardiac Neuromodulation Therapy™ (CNT™) for the treatment of hypertension, a significant risk factor for death worldwide, and Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo Corporation, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing, and organic development. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn and Twitter.

References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.

Forward-Looking Statements

Certain statements included in this document that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and 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 relating to the sufficiency of our long-term capital resources to execute pivotal studies for our two lead programs, the expected runway of our current cash and cash equivalents, the potential efficacy of our product candidates, the timing of our planned pivotal trials, and the ability of our partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this document, and on the current expectations of 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 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 may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; failure to realize the anticipated benefits of the business combination; risks related to regulatory approval of the Company’s product candidates; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed in Part II, “Item 1A. Risk Factors” of our quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission on May 12, 2023.

The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.

References

  1. Company estimates based on published sources, including National Inpatient Survey (NIS) and National Health and Nutrition Examination Survey (NHANES).
ORCHESTRA BIOMED HOLDINGS, INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
 
  March 31,     December 31,  
  2023     2022  
ASSETS          
CURRENT ASSETS:          
Cash and cash equivalents $ 18,695     $ 19,784  
Marketable securities   108,438       63,915  
Strategic investments, current portion   100       86  
Accounts receivable, net   76       96  
Inventory   232       276  
Prepaid expenses and other current assets   2,339       533  
Total current assets   129,880       84,690  
Property and equipment, net   1,453       1,489  
Right-of-use assets   2,032       2,187  
Strategic investments, less current portion   2,495       2,495  
Deposits and other assets   421       4,711  
TOTAL ASSETS $ 136,281     $ 95,572  
LIABILITIES AND STOCKHOLDERS’ EQUITY              
CURRENT LIABILITIES:              
Accounts payable $ 2,765     $ 3,968  
Accrued expenses and other liabilities   3,256       5,376  
Operating lease liability, current portion   711       697  
Warrant liability         2,089  
Deferred revenue, current portion   5,325       6,436  
Total current liabilities   12,057       18,566  
Deferred revenue, less current portion   13,195       13,103  
Loan payable, less current portion   9,527       9,490  
Operating lease liability, less current portion   1,500       1,683  
Other long-term liabilities   249       196  
TOTAL LIABILITIES   36,528       43,038  
               
STOCKHOLDERS’ EQUITY              
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at March 31, 2023 and December 31, 2022.          
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 31,741,147 and 20,187,850 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively.   3       2  
Additional paid-in capital   310,459       252,274  
Accumulated other comprehensive loss   (35 )     (8 )
Accumulated deficit   (210,674 )     (199,734 )
TOTAL STOCKHOLDERS’ EQUITY   99,753       52,534  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 136,281     $ 95,572  

ORCHESTRA BIOMED HOLDINGS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
 
  Three Months Ended
March 31,
 
  2023     2022  
Revenue:          
Partnership revenue $ 1,019     $ 716  
Product revenue   145       150  
Total revenue   1,164       866  
Expenses:              
Cost of product revenues   44       42  
Research and development   8,254       3,474  
Selling, general and administrative   4,411       2,478  
Total expenses   12,709       5,994  
Loss from operations   (11,545 )     (5,128 )
Other income (expense):              
Interest income (expense), net   885       (236 )
Loss on fair value adjustment of warrant liability   (294 )     (145 )
Gain (loss) on fair value of strategic investments   14       (220 )
Total other income (expense)   605       (601 )
Net loss $ (10,940 )   $ (5,729 )
Net loss per share              
Basic and diluted $ (0.40 )   $ (0.62 )
Weighted-average shares used in computing net loss per share, basic and diluted   27,643,549       9,225,058  



Investor Contact:
Bob Yedid
LifeSci Advisors
(516) 428-8577
[email protected]

Media Contact:

Kelsey Kirk-Ellis
Orchestra BioMed
(484) 682-4892
[email protected] 



West Virginia Virtual Academy Students to Receive Prestigious Golden Horseshoe Award

West Virginia Virtual Academy Students to Receive Prestigious Golden Horseshoe Award

CHARLESTON, W.V.–(BUSINESS WIRE)–
Two eighth grade students enrolled at West Virginia Virtual Academy (WVVA) will receive the prestigious Golden Horseshoe Award during this year’s Golden Horseshoe ceremony June 13.

This is the first year WVVA students have participated in the test, and after receiving high scores on the test, which focuses on West Virginia history, eighth graders Ky’Aira Anderson from Martinsburg, WV, and Kingston Digman from Frametown, WV will be recognized as Knights of the Golden Horseshoe Society.

Administered each year since 1931, the Golden Horseshoe test is the longest running program of its kind nationwide, not just in West Virginia. The program’s origins date back to 1716, when governor of the Virginia colony Alexander Spotswood recognized a delegation of men who explored the land west of the Allegheny Mountains, most of which is now West Virginia. To commemorate their bravery during the expedition, Spotswood presented them each with a small golden pin in the shape of a horseshoe, much like what students receive today, according to the WVDE.

“Having two Golden Horseshoe winners is a testament to the outstanding instruction and opportunities that WVVA provides our students,” Cheryl Stahle, principal of WVVA, said. “As a first-year public charter school, this is another example of how WVVA supports the needs of students and challenges all students, not just our Golden Horseshoe winners, to excel in the classroom.”

This win cements a year of building and creating to support the families of West Virginia, Stahle said.

“Our entire faculty, including our eighth grade history teacher, excel in the classroom, and students are reaping the success of the educational quality that they are being provided,” Stahle said. “The Golden Horseshoe is the oldest state history test in the nation and is an honor that will follow the students throughout their academic careers,” she continued. “Doing well on the Golden Horseshoe test demonstrates a depth of knowledge about our state that ranks among the top of all eighth graders from the 55 counties.”

WVVA eighth grader Ky’Aira Anderson enjoys learning about West Virginia history and is excited to receive the Golden Horseshoe.

“I really enjoyed this class; it was super fun, and Ms. Godfrey was super patient with me when I was struggling with certain assignments, which was really helpful,” Anderson said. “I believe this achievement will further help me to get into colleges, and it would help me to find a good career.”

The West Virginia Department of Education (WVDE) will recognize 226 eighth grade students from across the state as Knights of the Golden Horseshoe at the Golden Horseshoe Ceremony Tuesday, June 13, 2023 at the West Virginia Culture Center, located at 1900 Kanawha Boulevard, East, Charleston, West Virginia, 25305. For more information about the ceremony, contact Dustin Lambert at [email protected]. A complete list of winners can be found on the WVDE website.

About West Virginia Virtual Academy

West Virginia Virtual Academy (WVVA) is a full-time, tuition-free public school for grades K-10. WVVA provides an online learning program for students statewide, giving families the choice to access the curriculum provided by K12, a Stride, Inc. company. For more information about WVVA, visit https://wvva.k12.com/.

Jason Hager, [email protected], (304) 951-7156

Ken Schwartz: [email protected]

KEYWORDS: West Virginia United States North America

INDUSTRY KEYWORDS: Teens Parenting Other Education Family Technology Consumer Education Other Technology

MEDIA:

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Momentus Signs Launch Service Agreement with SpaceX

Momentus Signs Launch Service Agreement with SpaceX

Flights now available to customers on all SpaceX Transporter Missions in 2024

SAN JOSE, Calif.–(BUSINESS WIRE)–
Momentus Inc. (NASDAQ: MNTS) (“Momentus” or the “Company”), a U.S. commercial space company that offers orbital transportation and in-space infrastructure services, signed a contract with SpaceX to reserve a port on its Transporter-12 mission targeted for launch no earlier than October 2024.

With this agreement, Momentus is planning on flying on three missions with SpaceX in 2024, inclusive of every Transporter rideshare mission slated for next year:

  • Transporter-10 mission targeting launch no earlier than January 2024

  • Transporter-11 mission targeting launch no earlier than June 2024

  • Transporter-12 mission targeting launch no earlier than October 2024

“This launch schedule enables us to meet the anticipated demand for our services,” said Momentus Chief Commercial Officer Chris Kinman. “Providing mission management and integration services is just the starting point for the work Momentus does, and we’re happy to accommodate our customers with speed, affordability, and flexibility both in getting to space and in executing their missions once in orbit.”

In less than a year, Momentus has earned flight heritage with three missions in orbit, a key factor that customers evaluate in determining a partner to take their satellites and other payloads to specific orbits in space. Yesterday, the Company announced its recent business highlights, including:

  • Being selected for funding from the Space Development Agency for a Small Business Innovation Research Phase 2 award, which SDA is collaborating to complete with the Air Force Research Lab Technology Directorate AFWERX.

  • Signing a Memorandum of Understanding with Axient, a well-established company with a strong track record in defense and classified work for the Defense Department.

  • Signing a services agreement with repeat customer, FOSSA Systems, to place its latest generation of satellites into Low-Earth Orbit. This agreement represents initial progress toward Momentus’ first large-scale constellation deployment.
  • Signing a services agreement with FOSSA Systems to fly a picosatellite deployer with the capacity for eight pocketqube satellites as part of its launch brokerage capabilities and services. This deployer will house several satellites serving different IoT, Earth Observation, and demonstration platforms for yet-to-be-announced customers.
  • Signing a services agreement with Hello Space to provide hosted payload service for a deployer carrying four pocketqubes. These pocketqube satellites mark the first tranche of an 80-satellite constellation set by Hello Space.
  • Signing a services agreement with Lunasonde to deliver a cubesat to orbit from the Vigoride-7 mission targeted for launch in October on the SpaceX Transporter-9 mission.

  • Signing a services agreement with SatRev for the delivery of a cubesat to Low-Earth Orbit also on the Vigoride-7 mission.

  • Signing a services agreement with a yet-to-be-named customer for the orbital delivery of the first tranche of picosats for a 100-satellite planned constellation.

  • Teaming with Astroscale U.S. to respond to NASA’s Hubble Reboost RFI in a joint proposal. The mission’s objectives include safe relocation of Hubble and removal of nearby threatening debris from the celebrated space telescope’s new orbit.

About Momentus

Momentus is a U.S. commercial space company that offers in-space infrastructure services, including in-space transportation, hosted payloads and in-orbit services. Momentus believes it can make new ways of operating in space possible with its planned in-space transfer and service vehicles that will be powered by an innovative water plasma-based propulsion system.

Forward-Looking Statements

This press release contains certain statements which may constitute “forward-looking statements” for purposes of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding Momentus or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and are not guarantees of future performance. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Momentus’ control. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to risks and uncertainties included under the heading “Risk Factors” in the Annual Report on Form 10-K filed by the Company on March 8, 2023, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (the “SEC”), accessible on the SEC’s website at www.sec.gov and the Investor Relations section of our website at investors.momentus.space. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and, except as required by law, the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Media:

[email protected]

Investors:

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Technology Aerospace Manufacturing Satellite

MEDIA:

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ZyVersa Therapeutics Reports First Quarter 2023 Corporate and Financial Results

Key Highlights

:

  • Continued progress has been made in advancing an investigator-initiated clinical trial to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200 in patients with renal disease
  • Announced publication of several peer-reviewed journal articles supporting ASC inhibition as a promising therapeutic target – data continue to demonstrate that multiple types of inflammasomes are activated in various conditions (Alzheimer’s disease, traumatic brain injury, and injury from intracortical implants), and substantiate that extracellular release of ASC specks to neighboring cells heighten and perpetuate damaging inflammation leading to disease progression in conditions such as Parkinson’s disease and alcoholic hepatitis
  • Added three internationally recognized experts in the field of glomerular disease to Renal Scientific Advisory Board, and an internationally recognized authority in the field of innate immunity to our Inflammatory Disease Scientific Advisory Board
  • Enhanced our Board of Directors with addition of three biopharmaceutical leaders with impeccable credentials and a proven track record of success

WESTON, Fla., May 12, 2023 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, provides a corporate update and reports financial results for the first quarter of 2023 ending March 31, 2023.

“This is a very exciting time in the growth and evolution of ZyVersa as we seek to build shareholder value through development of first-in-class drugs at the forefront of innovation for renal and inflammatory diseases,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa. “We are currently advancing a dynamic pipeline of drug candidates with multiple programs built around our two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases and Inflammasome ASC Inhibitor IC 100 for treatment of multiple CNS and other inflammatory diseases. We believe that both technologies have transformative potential, enabling development of drugs for patients who have limited or no therapeutic options.”

Mr. Glover continued: “Highlighting our Inflammasome ASC Inhibitor IC 100, ZyVersa expects to complete IC 100’s preclinical program this year, with an Investigational New Drug (“IND”) submission anticipated in second quarter of 2024. We were pleased to report publication of data in several peer-reviewed journal articles demonstrating the role of ASC specks in heightening and perpetuating damaging inflammation in neurological conditions (Alzheimer’s disease, Parkinson’s disease, and traumatic brain injury), and in alcoholic hepatitis. These data support the therapeutic potential of inhibiting ASC and ASC specks with IC 100 to control inflammation associated with various inflammatory diseases.”

“Regarding Cholesterol Efflux Mediator™ VAR 200, ZyVersa continues to leverage relationships with experts in the field of renal disease,” stated Mr. Glover. “To that end, we welcomed three new members to our Renal Disease Scientific Advisory Board. We look forward to benefitting from their decades of experience as we advance our investigator-initiated trial to evaluate VAR 200 in patients with renal disease, expected to begin in the fourth quarter of 2023.”

FIRST QUARTER AND RECENT PROGRAM UPDATES

Targeting Renal Disease with Phase 2a-Ready Cholesterol Efflux Mediator™ VAR 200

  • Continued progress is being made to launch an investigator-initiated clinical trial in patients with renal disease to gain human proof-of-concept for Cholesterol Efflux Mediator™ VAR 200, with trial initiation expected in the fourth quarter of 2023
  • Added to ZyVersa’s Renal Scientific Advisory Board (1) Dr. Daniel C. Cattran, Professor of Medicine, University of Toronto; (2) Dr. Fernando C. Fervenza, Professor of Medicine, Mayo Graduate School of Medicine and Director of the Nephrology Collaborative Group; and (3) Dr. Richard J. Glassock, Professor Emeritus, David Geffen School of Medicine, UCLA

Inflammasome ASC Inhibitor IC 100: Targeting Inflammation Associated with Multiple CNS and Other Inflammatory Diseases

  • On track to complete IND-enabling preclinical studies by end of year, with the goal of filing an IND application with the U.S. Food and Drug Administration in the second quarter of 2024
  • Highlighted peer-reviewed journal articles supporting the potential of ASC inhibition to control damaging inflammation associated with numerous diseases, including Alzheimer’s disease, Parkinson’s disease, traumatic brain injury, and alcohol induced hepatitis
  • Added to ZyVersa’s Inflammatory Disease Scientific Advisory Board Dr. Douglas Golenbock, The Neil and Margery Blacklow Chair in Infectious Diseases and Immunology, and Professor and Chief, Division of Infectious Diseases and Immunology at the UMass Chan Medical School

FIRST QUARTER FINANCIAL RESULTS

Since its inception in 2014 through March 31, 2023, ZyVersa has not generated any revenue and has incurred significant operating losses and negative cash flows from its operations. Based on our current operating plan, we expect our cash of $1.3 million as of March 31, 2023, will only be sufficient to fund our operating expenses and capital expenditure requirements on a month-to-month basis. ZyVersa will need additional financing to support its continuing operations. ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.

Research and development expenses were consistent at approximately $1.1 million for the three months ended March 31, 2023 (“Successor Period”), with an immaterial decrease of $11 thousand or 1.0% from the three months ended March 31, 2022 (“Predecessor Period”).

General and administrative expenses were $3.5 million for the three months ended March 31, 2023, an increase of $1.2 million or 53.7% from $2.3 million for the three months ended March 31, 2022. The increase is primarily attributable to an increase of $0.4 million in director and officer insurance, a $0.4 million increase in marketing costs for investor and public relations, and $0.4 million in payments for the Effectiveness Failure related to the PIPE shares.

Net losses were approximately $3.5 million for the three months ended March 31, 2023, with an improvement of $0.2 million or 5.5% compared to a net loss of approximately $3.7M, for the three months ended March 31, 2022. Net losses for the three months ended March 31, 2023 benefited from a $1.0 Million deferred tax benefit compared to none for the year earlier period.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact

Karen Cashmere
Chief Commercial Officer
[email protected]
786-251-9641

Media Contacts

Tiberend Strategic Advisors, Inc.

Casey McDonald
[email protected]
646-577-8520

Dave Schemelia
[email protected]
609-468-9325

ZYVERSA THERAPEUTICS, INC.  
CONDENSED CONSOLIDATED BALANCE SHEETS  
             
   
      Successor  
      March 31,   December 31,  
        2023       2022    
      (Unaudited)      
Assets            
             
Current Assets:        
  Cash   $ 1,278,073     $ 5,902,199    
  Prepaid expenses and other current assets   1,321,551       225,347    
  Vendor deposits   235,000       235,000    
    Total Current Assets   2,834,624       6,362,546    
Equipment, net   14,733       17,333    
In-process research and development   100,086,329       100,086,329    
Goodwill     11,895,033       11,895,033    
Security deposit   46,659       46,659    
Operating lease right-of-use asset   76,324       98,371    
             
    Total Assets $ 114,953,702     $ 118,506,271    
             
Liabilities, Temporary Equity and Stockholders’ Equity        
             
Current Liabilities:        
  Accounts payable $ 6,381,086     $ 6,025,645    
  Accrued expenses and other current liabilities   2,112,812       2,053,559    
  Operating lease liability   84,507       108,756    
    Total Current Liabilities   8,578,405       8,187,960    
Deferred tax liability   9,276,932       10,323,983    
    Total Liabilities   17,855,337       18,511,943    
             
Commitments and contingencies        
             
  Successor redeemable common stock, subject to possible redemption,        
  0 and 65,783 shares outstanding as of March 31, 2023 and        
  December 31, 2022, respectively         331,331    
Stockholders’ Equity:        
  Successor preferred stock, $0.0001 par value, 1,000,000 shares authorized:        
  Series A preferred stock, 8,635 shares designated, 8,635 shares issued        
  and outstanding as of March 31, 2023 and December 31, 2022, respectively   1       1    
  Series B preferred stock, 5,062 shares designated, 5,062 shares issued        
  and outstanding as of March 31, 2023 and December 31, 2022, respectively   1       1    
  Successor common stock, $0.0001 par value, 110,000,000 shares authorized; 9,211,922      
  and 9,016,139 shares issued and outstanding as of March 31, 2023 and   922       902    
  December 31, 2022, respectively        
  Additional paid-in-capital   105,562,569       104,583,271    
  Accumulated deficit   (8,465,128 )     (4,921,178 )  
             
    Total Stockholders’ Equity   97,098,365       99,662,997    
             
    Total Liabilities, Temporary Equity and Stockholders’ Equity $ 114,953,702     $ 118,506,271    
             

ZYVERSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
               
               
      Successor     Predecessor  
      For the Three     For the Three  
      Months Ended     Months Ended  
      March 31,     March 31,  
        2023         2022    
Operating Expenses:          
  Research and development $ 1,055,943       $ 1,066,962    
  General and administrative   3,536,136         2,301,369    
               
    Total Operating Expenses   4,592,079         3,368,331    
               
    Loss From Operations   (4,592,079 )       (3,368,331 )  
               
Other (Income) Expense:          
  Interest (income) expense   (1,078 )       168,064    
  Change in fair value of derivative liabilities           212,100    
               
    Pre-Tax Net Loss   (4,591,001 )       (3,748,495 )  
    Income tax benefit   1,047,051            
    Net Loss $ (3,543,950 )     $ (3,748,495 )  
               
               
    Net Loss Per Share          
    – Basic and Diluted $ (0.39 )     $ (0.16 )  
               
    Weighted Average Number of          
    Common Shares Outstanding          
    – Basic and Diluted   9,128,488         24,167,257    
               



IGM Biosciences Announces First Quarter 2023 Financial Results and Provides Corporate Update

– Randomized clinical trial of IGM-8444 plus FOLFIRI and bevacizumab in second line metastatic colorectal cancer underway –

– Plans to present additional non-randomized clinical data for 3 mg/kg of IGM-8444 plus FOLFIRI, with and without bevacizumab, in the middle of 2023 –

– Plans to begin clinical testing of imvotamab in severe systemic lupus erythematosus and

severe rheumatoid arthritis –

MOUNTAIN VIEW, Calif., May 12, 2023 (GLOBE NEWSWIRE) — IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the first quarter ended March 31, 2023 and provided an update on recent developments.

“We are pleased to be underway in our randomized clinical trial of IGM-8444 in combination with standard of care FOLFIRI chemotherapy and bevacizumab in second line metastatic colorectal cancer patients, and we look forward to presenting additional clinical data in the middle of 2023 from our non-randomized Phase 1 clinical study of 3 mg/kg of IGM-8444 plus FOLFIRI, with and without bevacizumab,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “We are also looking forward to the start of clinical testing of imvotamab in autoimmune diseases, where we believe the clinical safety and efficacy profile of imvotamab positions us very well for the exciting new area of treating autoimmune disease with T cell engagers.”

Pipeline Updates

IGM-8444 (DR5)

  • Clinical development of IGM-8444 advances. The Company continues to advance the clinical development of IGM-8444, the Company’s IgM agonist antibody targeting death receptor 5 (DR5).

    • Dosing ongoing in the randomized colorectal cancer clinical trial. The Company is currently treating patients in a randomized clinical trial of IGM-8444 plus FOLFIRI and bevacizumab in second line metastatic colorectal cancer. The Company plans to assess both the 3 mg/kg and 10 mg/kg dose levels of IGM-8444 with a primary endpoint of progression free survival and secondary endpoints of overall response rate and overall survival as compared to the current standard of care treatment arm.
    • Dosing ongoing in the venetoclax combination. The Company is currently treating patients with acute myeloid leukemia in its IGM-8444 plus venetoclax and azacytidine Phase 1 combination cohort.
    • Dosing ongoing in the fifth birinapant dose cohort. The Company is also currently treating patients in its fifth birinapant Phase 1 combination dose escalation cohort.
    • Additional clinical data expected in middle of 2023. The Company plans to present additional clinical data from the 3 mg/kg of IGM-8444 plus FOLFIRI cohort, with and without bevacizumab, of its non-randomized Phase 1 clinical trial in the middle of 2023.
  • Presented preclinical data. In April 2023, the Company presented preclinical data on IGM-8444 at the American Association for Cancer Research (AACR) Annual Meeting. The data was featured in a poster presentation titled “Characterization of the synergistic tumor cytotoxicity of agonist DR5 IgM antibody IGM-8444 with chemotherapeutic agents”.

Imvotamab (CD20 x CD3)

  • Advancing into multiple autoimmune clinical trials. The Company is planning to begin clinical testing of imvotamab in severe systemic lupus erythematosus and severe rheumatoid arthritis, subject to IND clearance.
  • Presented preclinical data. In April 2023, the Company presented preclinical data on imvotamab at the American Association for Cancer Research (AACR) Annual Meeting. The data was featured in a poster presentation titled “Depletion of tissue-resident B cells by a CD20xCD3 IgM bispecific T cell engager in cynomolgus monkeys demonstrates effective tissue penetration and potent target cell killing”.

IGM-7354 (IL-15 x PD-L1)

  • Phase 1 trial. The Company continues enrolling patients in a Phase 1 clinical trial exploring the safety, efficacy and biomarker activity of IGM-7354, an IgM targeted immunostimulatory IL-15 cytokine, in the treatment of patients with solid tumors.
  • Presented preclinical data. In April 2023, the Company presented preclinical data on IGM-7354 at the American Association for Cancer Research (AACR) Annual Meeting. The data was featured in a poster presentation titled “IGM-7354, an immunocytokine with IL-15 fused to an anti-PD-L1 IgM, induces NK and CD8+ T cell-mediated cytotoxicity of PD-L1-positive tumor cells”.

IGM-2644 (CD38 x CD3)

  • Phase 1 trial. The Company is initiating a clinical trial exploring the safety and efficacy of IGM-2644, a CD38 x CD3 IgM T cell engaging antibody, in patients with recurrent or refractory multiple myeloma.
  • Presented preclinical data. In April 2023, IGM presented preclinical data evaluating IGM-2644 at the American Association for Cancer Research (AACR) Annual Meeting. The data was featured in a poster presentation titled “Novel CD38xCD3 Bispecific IgM T Cell Engager, IGM-2644, Potently Kills Multiple Myeloma Cells Though Complement and T Cell Dependent Mechanisms”.

First Quarter 2023 Financial Results 

  • Cash and Investments: Cash and investments as of March 31, 2023 were $373.4 million, compared to $427.2 million as of December 31, 2022.
  • Collaboration Revenue: For the first quarter of 2023, collaboration revenues were $0.5 million, compared to no revenue for the same period in 2022.
  • Research and Development (R&D) Expenses: For the first quarter of 2023, R&D expenses were $50.9 million, compared to $38.9 million for the same period in 2022.
  • General and Administrative (G&A) Expenses: For the first quarter of 2023, G&A expenses were $13.0 million, compared to $13.1 million for the same period in 2022.
  • Net Loss: For the first quarter of 2023, net loss was $59.3 million, or a loss of $1.33 per share, compared to a net loss of $51.9 million, or a loss of $1.53 per share, for the same period in 2022.

2023 Financial Guidance

The Company expects full year 2023 GAAP operating expenses of $275 million to $285 million, including estimated non-cash stock-based compensation expense of approximately $45 million, and full year collaboration revenue of approximately $3 million related to the Sanofi agreement. The Company expects to end 2023 with a balance of more than $200 million in cash and investments, and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024.

About IGM Biosciences, Inc.

IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, autoimmune and inflammatory diseases and infectious diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to the Company’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding, the Company’s technology platform and its IgM antibodies and product candidates, including IGM-8444, imvotamab, IGM-7354 and IGM-2644; the Company’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of IGM-8444, imvotamab, IGM-7354 and IGM-2644, including the timing of initiation of clinical trials, patient enrollment and release of clinical data; the Company’s expectations regarding its financial position and guidance, including collaboration revenue, operating expenses, stock-based compensation expense, ending 2023 cash and investments and projected cash runway; and statements by the Company’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: the Company’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; the Company’s ability to demonstrate the safety and efficacy of its product candidates; the Company’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; the Company’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of collaborations with third parties; the Company’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for the Company’s product candidates, and the progress and success of alternative therapeutics currently available or in development; the Company’s ability to obtain additional capital to finance its operations, if needed; uncertainties related to the projections of the size of patient populations suffering from the diseases the Company is targeting; the Company’s ability to obtain, maintain and protect its intellectual property rights; developments relating to the Company’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; and other risks and uncertainties, including those more fully described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2023 and in the Company’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact:

Argot Partners
David Pitts
212-600-1902
[email protected]

IGM Biosciences, Inc.
Selected Statement of Operations Data
(unaudited)
(in thousands, except share and per share data)
 
    Three Months Ended  
    March 31,  
    2023     2022  
Collaboration revenue   $ 522     $  
             
Operating expenses:            
Research and development (1)     50,894       38,875  
General and administrative (1)     13,002       13,081  
Total operating expenses     63,896       51,956  
Loss from operations     (63,374 )     (51,956 )
             
Other income (expense):            
Interest income     4,172       54  
Other income (expense)     (20 )     8  
Total other income (expense)     4,152       62  
Loss before income tax expense     (59,222 )     (51,894 )
Income tax expense     (87 )      
Net loss   $ (59,309 )   $ (51,894 )
             
Net loss per share, basic and diluted   $ (1.33 )   $ (1.53 )
Weighted-average common shares outstanding, basic and diluted     44,466,764       33,838,895  

(1) Amounts include stock-based compensation expense as follows:
Research and development   $ 6,439     $ 6,607  
General and administrative     4,608       4,892  
Total stock-based compensation expense   $ 11,047     $ 11,499  

IGM Biosciences, Inc.
Selected Balance Sheet Data
(unaudited)
(in thousands)
 
    March 31,     December 31,  
    2023     2022  
Cash and investments   $ 373,396     $ 427,162  
Total assets     462,742       513,499  
Accounts payable     3,972       2,512  
Accrued liabilities     29,637       33,621  
Deferred revenue     148,409       148,931  
Total liabilities     223,312       226,236  
Accumulated deficit     (634,135 )     (574,826 )
Total stockholders’ equity     239,430       287,263  



The First National Bank of Long Island Names New Senior Vice President and Middle Market Team Leader

MELVILLE, N.Y., May 12, 2023 (GLOBE NEWSWIRE) — The First National Bank of Long Island, the subsidiary of The First of Long Island Corporation (Nasdaq: FLIC), announced today that Kenneth Ruland has been promoted to Senior Vice President and Middle Market Team Leader. Ken joined the Bank in 2019 as a Middle Market Relationship Manager. In his new role, Ken contributes to middle-market business development, engaging a team to identify, understand and prioritize clients’ financial needs.

Christopher Hilton, Executive Vice President and Chief Lending Officer, said, “Ken is a significant contributor to growing our Middle Market business across our footprint. His continued success supports our corporate strategies.”

The First National Bank of Long Island is a local bank founded in 1927 in Glen Head, New York. Through its online presence and branch network branded as First National Bank LI, the Bank focuses on business and consumer needs on Long Island and in New York City. We offer a broad set of lending, deposit, investment, and digital products. First National Bank LI is known for its culture of delivering extraordinary service and a “Customer First” banking experience to small and middle market businesses, professional service firms, not-for-profits, municipalities and consumers. The Bank’s tagline “Go First. Go Far.®” communicates the benefits of its employees’ commitment to helping customers reach their financial goals. For more information about the Bank and Corporation, visit fnbli.com.

To connect with the Lending team, call (516) 671-4900 or visit https://www.fnbli.com/commercial-lending-team.

For More Information Contact:
Carrie Genoino, First VP
(516) 671-4900, Ext. 7272



Bit Origin Ltd Announces Production and Operation Update for April 2023

NEW YORK, May 12, 2023 (GLOBE NEWSWIRE) — Bit Origin Ltd (NASDAQ: BTOG) (“Bit Origin” or the “Company”), an emerging growth company engaged in the crypto mining business with diversified expansion strategies, today provided its production and operation update for April 2023.

  • Operation Update

As of April 30, 2023, the total mining hash rate stands at 403 PH/s with 4,250 miners installed in the Indiana facility, representing all miners the Company has purchased.

  • Bitcoin Production and Revenue

The Company mined 27.0 Bitcoins and achieved a revenue of US$778,640 in April 2023.

   

  • Mining Sites Development

As of April 30, 2023, the Company has one hosting mining site in operation and one mining site under development. The Company ceased its operation in the mining facility in Georgia from December 31, 2022.

Site One – Marion, IN, 5.3 Megawatts
(
“MW”)

On June 8 and July 11, 2022, the Company announced that it entered into two hosting service agreements to increase mining capacity by 3 MW and 2.3 MW, respectively. Based on mutual understanding and arrangements, the Company further expanded its capacity in the Indiana mining facility, and as of April 30, 2023, 4,250 miners at this site have been deployed.

Site Two – Cheyenne, WY, 45MW

On June 15, 2022, the Company announced that it entered into a set of definitive agreements with a private cryptocurrency mining investment fund (the “Fund”). The Fund is investing in a mining site (the “Project”) in Wyoming, U.S. with a capacity of up to 75 MW.

Phase I of the Project of a capacity of up to 45MW for the mining facility in Wyoming was energized in March 2023, and construction of Phase II of 25MW is expected to commence in mid-May 2023.   

About Bit Origin Ltd

Bit Origin Ltd, formerly known as China Xiangtai Food Co., Ltd., is an emerging growth company operating in the United States and engaged in the cryptocurrency mining business. The Company is also actively deploying blockchain technologies alongside diversified expansion strategies. For more information, please visit https://bitorigin.io.


Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results.

Company Contact

Bit Origin Ltd
Mr. Lucas Wang, Chairman and Chief Executive Officer
Email: [email protected]

To keep updated on Bit Origin’s news releases and SEC filings, please subscribe to email alerts at https://bitorigin.io/contact

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bea8fc46-e61b-4dbb-aab9-d16a8d39a679



Liquid Media Announces Adjournment of Special Meeting

VANCOUVER, British Columbia, May 12, 2023 (GLOBE NEWSWIRE) — Liquid Media Group Ltd. (the “Company”, “Liquid Media” or “Liquid”) (Nasdaq: YVR) is announcing the adjournment of the special meeting of shareholders previously scheduled for May 12, 2023 (the “Special Meeting”), to rather be held on May 26, 2023 at 2:00pm PT at Suite 401, 750 West Pender Street, Vancouver, BC V6C 2T7 Canada.

About Liquid Media Group Ltd.

Liquid Media Group Ltd. (Nasdaq: YVR) is an entertainment company empowering independent IP creators. Liquid’s end-to-end solution enables professional video (film/TV and streaming) creation, packaging, financing, delivery, and monetization, empowering IP creators to take their professional content from inception through the entire process to monetization.

Additional information is available at www.LiquidMediaGroup.co.

Further information:

Investor / Business

Justin Kulik
CORE IR
[email protected]

Cautionary Note Regarding Forward-Looking Statements

This news release includes statements containing certain “forward-looking information” within the meaning of applicable securities law (“forward-looking statements”). Forward-looking statements are typically identified by words such as: “believe”, “expect”, “anticipate”, “intend”, “estimate”, “potentially” and similar expressions, or are those, which, by their nature, refer to future events. Forward-looking information in this news release includes, but is not limited to, the proposed timing of the Special Meeting. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such factors include, but are not limited to: developments related to the COVID-19 pandemic, regulatory actions, market prices, continued availability of capital and financing, and general economic, market or business conditions, as well as additional risks disclosed in the Company’s annual and quarterly financial reports available at www.sedar.com. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. The Company is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.



Clearmind Medicine Announces IRB Approval to Conduct Clinical Trial on Alcohol Use Disorder

IMCA medical center’s ethics committee approves clinical trial using proprietary CMND-100 treatment in
Israel

Tel Aviv, Israel / Vancouver, Canada, May 12, 2023 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the “company”), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, has received Ethics Committee approval for its CM-CMND-001 Phase I/II clinical trial of its MEAI-based CMND-100 compound for the treatment of alcohol use disorder (“AUD”) at Israel’s IMCA center.

CM-CMND-001 is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic Study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan. The company intends to have two additional sites in the United States, for this study, subject to signing an agreement with local sites.

The primary end point of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary end point is to evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving, in individuals with moderate-to-severe AUD. Oral capsules will be administered once daily, for ten consecutive days. The patients will report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.

“Ethics Committee approval of the study marks a key step forward in beginning the first-in-human clinical trial of CMND-100,” said Clearmind’s Chief Executive Officer, Dr. Adi Zuloff-Shani. “According to Research Nester, the alcohol treatment market is estimated to be USD 35 billion per year market in the U.S. alone, where the estimated number of people diagnosed with AUD total approximately 35 million people each year. Despite a significant addressable market and the fact AUD is a leading cause of death, current therapies often fall short due to limited efficacy, relapse rates, side effects and other factors. CMND-100 was shown to cause a significant and immediate reduction of alcohol cravings and consumption in pre-clinical studies with a high safety profile. As a result, we believe that CMND-001 holds tremendous potential as an alternative to current approaches. Moreover, CMND-100 is intended as a once-a-day oral capsule that can be taken from the privacy of one’s home. With CMND-100, we aim to revolutionize AUD treatment and improve patients’ compliance to therapy compared to other marketed pharmacotherapies”.

The Ethics Committee (which is the European and Israeli equivalent of the Institutional Review Board (IRB)), of the IMCA center, operating under the Declaration of Helsinki regulations and other international conventions concerning medical experiments on humans, is designated to authorize, review and monitor medical research and trials involving human subjects. The committee reviews research protocols and related materials (such as informed consent documents and investigator brochures) to ensure protection of the rights and welfare of the participants.


About


 


Clearmind


 


Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The company’s intellectual portfolio currently consists of fourteen patent families. The company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq and the Canadian Securities Exchange under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY.”

For further information visit: https://www.clearmindmedicine.com or contact:

Investor Relations
[email protected]
Telephone: (604) 260-1566

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FORWARD-LOOKING STATEMENTS:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the services to be performed by IMP and the benefit to the company therefrom, the timing of clinical trials, and the market size for AUD treatment and expected growth. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F filed with the SEC on February 6, 2023. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.