Market Newsdesk

IGALMI™ (dexmedetomidine) commercial momentum accelerating with doubling of formulary wins, unlocking more than $55 million in targeted market opportunity, and an additional $255 million scheduled to vote

Top-line data from pivotal SERENITY III Phase 3 trial (Part 1) for BXCL501 in bipolar or schizophrenia-associated agitation for at-home use expected in May 2023

Top-line data from repeat dosing of BXCL501 in Phase 1b trial for Major Depressive Disorder program in healthy volunteers expected in May 2023

Top-line data from pivotal TRANQUILITY II Phase 3 trial for BXCL501 for acute treatment of agitation associated with Alzheimer’s disease expected in June 2023

Company to host conference call at 8:00 a.m. ET today

NEW HAVEN, Conn., May 08, 2023 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced its financial results for the first quarter ended March 31, 2023, and provided an update on key strategic initiatives.

“The first quarter marked a strong start to the year with numerous advancements in our clinical programs and continued commercial focus building the agitation market for our new therapeutic option in a historically underdiagnosed and underserved medical condition,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “We are gearing up to announce top-line data readouts in agitation from two Phase 3 pivotal trials as well as BXCL501 potential as an adjunctive treatment for chronic use in our MDD program. In addition, IGALMI’s launch momentum is expanding our reach into addressable market opportunities. We believe the second quarter of 2023 represents a defining moment for the Company as we expand the full potential of BXCL501 in agitation for at-home use and long-term care settings, and in depression. These upcoming catalysts may have a transformational impact for patients in need and all our stakeholders.”

Company Highlights

Neuroscience Franchise

IGALMI™ (dexmedetomidine) sublingual film

IGALMI is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
¹
Up to an estimated 16 million institutional episodes occur annually within these two patient populations in the U.S.
^2
–
4
*

Key Commercial Parameters

• IGALMI launch is accelerating with continued deployment of integrated commercial team in 2023:
  • Secured more than 130 hospital formulary wins to date, which have doubled in the last two months; equates to $55 million of addressable market with Integrated Delivery Network (IDN) formulary approvals.
  • Six hundred additional Pharmacy & Therapeutics (P&T) Committee votes scheduled and approximately 25% of target IDN beds representing an additional $255 million of addressable market scheduled to vote.
  • More than half of all ordering hospitals have reordered; repeat orders demonstrate real-world utility and growing health care provider (HCP) interest.
  • Sales team has reached over 75% of 1,700 targeted hospitals with focus on deepening advocacy and driving demand.  
  • Group Purchasing Organization (GPO) process largely complete with nearly 80% of targeted beds under contract.
  • Amplifying IGALMI awareness through multi-channel approach including digital and print media, peer influence initiatives, and Free Trial Program.

Medical Affairs

• Medical Science Liaison and Medical Managed Care teams engaging in scientific dialogue with HCPs ahead of IDN and hospital formulary reviews.
  • Observed a 73% increase in medical community requests for IGALMI clinical information over prior quarter.
  • Conducted a real-world survey of early-adopter HCPs; results expected to be presented at the American Society of Health-System Pharmacists Annual Meeting in June 2023.
  • Continuing extensive medical education initiatives through multiple clinical and scientific publications and presentations.

Development Pipeline  
BXCL501, an investigational proprietary, sublingual film formulation of dexmedetomidine, has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.

• Alzheimer’s Disease-related Agitation: TRANQUILITY program is designed to evaluate BXCL501 for the acute treatment of Alzheimer’s-related agitation; up to 100 million Alzheimer’s-related agitation episodes are estimated to occur in the U.S. annually.^2*
  • TRANQUILITY II: Trial is fully enrolled, and all patients have completed the study in assisted living facilities (ALFs) and residential care settings.
    • Data cleaning and verification in progress.
    • Top-line data from pivotal trial expected in June 2023.
  • TRANQUILITY III: Continuing enrollment of patients with moderate to severe dementia in long-term-care facilities.
• Bipolar or Schizophrenia-related Agitation (At-Home Use): SERENITY III program is designed to evaluate BXCL501 for at-home use, where up to 23 million bipolar or schizophrenia-related agitation episodes are estimated to occur in the U.S. annually.^2–4*

SERENITY III consists of two parts:

• Part 1: Assessing the efficacy and safety of 60 mcg dose in acute treatment of agitated patients with bipolar I or II disorder or schizophrenia.
  • Data cleaning and verification in progress.
  • Top-line efficacy data from pivotal trial expected in May 2023.
• Part 2: Evaluating the safety of 60 mcg dose, and a second 60 mcg dose is allowed if required, at-home.
  • Expect to initiate Part 2 in Q2 2023.

• Adjunctive Treatment for Major Depressive Disorder (MDD) for At-Home Use: Phase 1b Multiple Ascending Dose (MAD) trial was designed to test safety and tolerability of daily dosing of BXCL501 for seven days in healthy volunteers to inform proof-of-concept (POC) trial dose selection. In Phase 2 program, treatment in MDD patients will be evaluated with BXCL501 in combination with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRIs or SNRIs, respectively) to assess rapid antidepressant response. Over 300 million antidepressant prescriptions are filled annually in the U.S.,^5* and current treatments are limited by slow onset of action and incomplete responses.
  • Data cleaning and verification in progress.
  • Top-line results are expected in May 2023.

OnkosXcel Therapeutics

OnkosXcel Therapeutics is a subsidiary of BioXcel Therapeutics focused on the sustained growth of the Company’s immuno-oncology (I-O) franchise, including BXCL701, its most advanced I-O program. BXCL701 is an investigational, oral innate immune activator in development for the treatment of aggressive forms of prostate cancer and other solid and liquid tumors.

• Continuing to actively evaluate strategic options for OnkosXcel Therapeutics:
  • Small Cell Neuroendocrine Prostate Cancer (SCNC) Program:  In 2023, it is estimated there will be 288,300⁶ new prostate cancer patients in the U.S., with approximately 11,500 patients progressing to SCNC.⁷
    • Planned Phase 2b potential pivotal study for BXCL701 monotherapy and in combination with KEYTRUDA® (pembrolizumab) in SCNC expected to initiate in 2H 2023, subject to further discussions with FDA.
  • Predictive Biomarker for BXCL701: Additional findings on DPP9 overexpression, a potential actionable biomarker for BXCL701 response, expected to be presented at an upcoming medical meeting.
  • Investigator-Sponsored Trials at Top Academic Centers: BXCL701 to be studied in combination with KEYTRUDA® (pembrolizumab) at Georgetown Lombardi Cancer Center and Dana-Farber Cancer Institute in pancreatic cancer and AML, respectively.

First Quarter 2023 Financial Results

Net Revenue: Net revenue was approximately $206,000 for the quarter, in line with the fourth quarter. The Company expects to see a notable uptick in revenues in the second half of the year in connection with additional formulary approvals.

Research and Development (R&D) Expenses: R&D expenses were $27.8 million for the first quarter of 2023, compared to $18.6 million for the same period in 2022. The increased expenses were primarily attributable to multiple clinical trials and CMC costs related to the upcoming three data readouts.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $23.6 million for the first quarter of 2023, compared to $12.9 million for the same period in 2022. The increased expenses were primarily attributable to personnel and sales, market access, and marketing costs associated with the commercialization of IGALMI in the U.S.

Net Loss: BioXcel Therapeutics had a net loss of $52.8 million for the first quarter of 2023, compared to a net loss of $31.5 million for the same period in 2022.

Cash and cash equivalents totaled $165.5 million as of March 31, 2023. BioXcel Therapeutics believes that full execution of its strategic financing with Oaktree and Qatar Investment Authority, and IGALMI revenues, would result in a cash runway into 2025.

Anticipated Milestones

• Top-line Clinical Trial Data Readouts
  • Pivotal SERENITY III Phase 3 trial (Part 1): May 2023
  • Phase 1b MAD trial for MDD program: May 2023
  • Pivotal TRANQUILITY II Phase 3 trial: June 2023
• Expected Clinical Trial Initiations
  • Pivotal SERENITY III Phase 3 trial (Part 2): Q2 2023
  • Phase 2b potential pivotal study of BXCL701 in SCNC: 2H 2023

Conference Call

BioXcel Therapeutics will host a conference call and webcast on May 8 at 8:00 a.m. ET to discuss its first quarter 2023 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through August 8, 2023. 

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the “Email Alerts” option under the News/Events menu of the Investors & Media section of its website. 

About IGALMI™ (dexmedetomidine) sublingual film

INDICATION

IGALMI™ (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

IGALMI can cause serious side effects, including:

• Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
• Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
• Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
• Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.

The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.

These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.

Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.

Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected].

Please see full
Prescribing Information.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. The Company’s commercial product, IGALMI™ (developed as BXCL501), is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. For more information, please visit igalmi.com and also see the IGALMI full Prescribing Information. BXCL501 is under evaluation for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for acute treatment of agitation associated with probable Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The safety and efficacy of BXCL501 for these uses have not been established. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia. Under its subsidiary, OnkosXcel Therapeutics, the Company is developing BXCL701, an investigational, oral systemic innate immune activator for the treatment of aggressive forms of prostate cancer and other solid and liquid tumors. The safety and efficacy of BXCL502 and BXCL701 have not been established. For more information, please visit bioxceltherapeutics.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s expected timing of, and data results from, trials and clinical studies involving its product candidates; its ongoing marketing, commercialization and expansion efforts, plan and strategy for IGALMI; strategic options for OnkosXcel; the Company’s participation in upcoming events and presentations; and the Company’s future financial and operational results, including future revenue growth. The words “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its significant indebtedness and other contractual obligations; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502 BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; impacts from the COVID-19 pandemic; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; its ability to commercialize its product candidates; and the other important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as such factors may be updated from time to time in its other filings with the SEC, including without limitation, its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Website Disclosure

We announce material financial and operational information to our investors using press releases, SEC filings and public conference calls webcasts, as well as the Investors & Media section of our website at www.bioxceltherapeutics.com. We may use our website as a distribution channel of material information about the Company. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the “Email Alerts” option under the News / Events menu of the Investors & Media section of our website at www.bioxceltherapeutics.com.

Contact Information

Corporate

BioXcel Therapeutics
Erik Kopp
1.203.494.7062
[email protected]

Investor Relations

BioXcel Therapeutics
Brennan Doyle
1.475.355.8462
[email protected]

Media

Russo Partners
David Schull or Scott Stachowiak
1.858.717.2310
[email protected]
[email protected]

Source: BioXcel Therapeutics, Inc.

IGALMI is a trademark of BioXcel Therapeutics, Inc. All other trademarks are the properties of their respective owners. Copyright © 2023, BioXcel Therapeutics, Inc. All rights reserved.

References and Notes

*Prevalence estimates show prominent variability and gradients

1. IGALMI™ (dexmedetomidine) [package insert]. New Haven, CT. BioXcel Therapeutics, Inc.; 2022.
2. Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540.
3. National Institute of Mental Health. Bipolar Disorder. Accessed April 5, 2022. https://rb.gy/lqz4rn.
4. UN Population Prospectus. Retrieved May 6, 2021. https://population.un.org/wpp.
5. IQVIA, 2021.
6. American Cancer Society. About Prostate Cancer. Accessed March 7, 2023.   https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
7. B.R. Alabi, S. Liu and T. Stoyanova, Current and emerging therapies for neuroendocrine prostate cancer, Pharmacology and Therapeutics (2022), https://doi.org/10.1016/j.pharmthera.2022.108255.

 

BioXcel Therapeutics, Inc.
Statements of operations
(in thousands, except per share amounts)
	Three months ended March 31,
		2023				2022
Revenues	$	206			$	–
Operating expenses
Cost of goods sold	$	9			$	–
Research and development		27,800				18,559
Selling, general and administrative		23,595				12,921
Total operating expenses	$	51,404			$	31,480
Loss from operations	$	(51,198	)		$	(31,480	)
Other expense (income)
Interest expense		3,367				7
Interest income		(2,015	)			(15	)
Other expense, net		246				–
Net loss and comprehensive loss	$	(52,796	)		$	(31,472	)
Net loss per share – basic and diluted	$	(1.84	)		$	(1.12	)
Weighted average shares outstanding – basic and diluted		28,616				27,980
Condensed Balance Sheets
(in thousands)
		March 31, 2023				December 31, 2022
Cash and cash equivalents	$	165,521			$	193,725
Working capital	$	148,509			$	169,970
Total assets	$	180,103			$	205,853
Long-term liabilities	$	98,339			$	96,180
Total liabilities	$	127,098			$	129,078
Total stockholders’ equity	$	53,005			$	76,775

 

 

This news release constitutes a “designated news release” for purposes of the Company’s prospectus supplement dated August 16, 2021, to its short form base shelf prospectus dated August 12, 2021.

TORONTO and BROSSARD, Québec, May 08, 2023 (GLOBE NEWSWIRE) — Bitfarms Ltd. (NASDAQ: BITF//TSX: BITF), a global vertically integrated Bitcoin mining company, today announces that in six years of operations it has mined 21,000 BTC with renewable hydropower.

“On May 7^th, 2023, Bitfarms achieved an important milestone by producing its 21,000^th BTC mined with renewable power, representing 1/1,000 of all BTC to ever be mined,” said Geoff Morphy, CEO of Bitfarms. “Leading the industry, this accomplishment is a testament to the proven capabilities of our mining operations that have powered on average between 1% and 2% of the BTC network, and we are proud to have done so with sustainable hydropower.

Morphy continued, “Bitfarms recognized early on the advantages of hydropower as a renewable energy resource and its sustainable and consistent economics. Our hydropower contracts provide a low direct cost of production and deliver higher mining margins than if we prioritized exahash growth alone. Bitfarms strategic expansions into Washington state and Paraguay are similar to our initial operations in Quebec, as we take advantage of excess hydropower infrastructure that became available with the migration of heavy industry. We have harnessed sustainable power with favorable economics for our shareholders, while simultaneously revitalizing communities with new jobs, capital investment, incremental tax revenues, and upgrades to the local electrical infrastructure. We thank our shareholders, directors, and team members, past and present, who made this great achievement possible.”

BTC Network Protocol and 21 Million BTC Limitation

Bitcoin is a cryptocurrency that operates on a decentralized network of computers. One of its most distinctive features is that there is a maximum limit of 21 million BTC that can ever be created. This limit was built into the Bitcoin protocol from the beginning and is expected to be reached in the year 2140.

As of May 7^th, 2023, there were approximately 19.4 million BTC in circulation, with a total value of approximately $550 billion. The remaining 1.6 million BTC are expected to be mined over the next century or so, with the rate of new BTC creation slowing down over time due to a process known as the “halving”. The next halving event is expected to occur in the year 2024.

Having mined 21,000 BTC, Bitfarms has now produced one of every 1,000 BTC that will ever be created. With its extensive portfolio of hydro powered operations, it has achieved this using 100% renewable energy. This accomplishment has been permanently memorialized on the Bitcoin blockchain at block 788,607.

About Bitfarms Ltd.

Founded in 2017, Bitfarms is a global, publicly traded (NASDAQ/TSX: BITF) Bitcoin mining company. Bitfarms develops, owns, and operates vertically integrated mining farms with in-house management and company-owned electrical engineering, installation service, and multiple onsite technical repair centers. The Company’s proprietary data analytics system delivers best-in-class operational performance and uptime.

Bitfarms currently has 10 farms, which are located in four countries: Canada, the United States, Paraguay, and Argentina. Powered by predominantly environmentally friendly hydro-electric and long-term power contracts, Bitfarms is committed to using sustainable, locally based, and often underutilized energy infrastructure.

To learn more about Bitfarms’ events, developments, and online communities:

Website: www.bitfarms.com

https://www.facebook.com/bitfarms/

https://twitter.com/Bitfarms_io

https://www.instagram.com/bitfarms/

https://www.linkedin.com/company/bitfarms/

Glossary of Terms

• BTC BTC/day = Bitcoin or Bitcoin per day
• EH or EH/s = Exahash or exahash per second
• MW or MWh = Megawatts or megawatt hour
• PH or PH/s = Petahash or petahash per second
• TH or TH/s = Terahash or terahash per second
• w/TH = Watts per Terahash
• KWh = Kilowatt per hour
  

Cautionary Statement

Trading in the securities of the Company should be considered highly speculative. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein. Neither the Toronto Stock Exchange, Nasdaq, or any other securities exchange or regulatory authority accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking information”) that are based on expectations, estimates and projections as at the date of this news release and are covered by safe harbors under Canadian and United States securities laws. The forward-looking information includes, but is not limited to, information concerning: the intentions, plans and future actions of the Company, as well as Bitfarms’ ability to successfully mine digital currency, revenue increasing as currently anticipated, the ability to profitably liquidate current and future digital currency inventory, volatility of network difficulty and digital currency prices and the potential resulting significant negative impact on the Company’s operations, the construction and operation of expanded blockchain infrastructure as currently planned, and the regulatory environment for cryptocurrency in the applicable jurisdictions.

Any statements that involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information and are intended to identify forward-looking information.

This forward-looking information is based on assumptions and estimates of management of the Company at the time they were made, and involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others, risks relating to: the availability of financing opportunities, risks associated with economic conditions, dependence on management and conflicts of interest, the ability to service debt obligations and maintain flexibility in respect of debt covenants; economic dependence on regulated terms of service and electricity rates; the speculative and competitive nature of the technology sector; dependency on continued growth in blockchain and cryptocurrency usage; lawsuits and other legal proceedings and challenges; conflict of interests with directors and management; government regulations;
the global economic climate; dilution; the Company’s limited operating history; future capital needs and uncertainty of additional financing, including the Company’s ability to utilize the Company’s at-the-market equity offering program (the “ATM Program”) and the prices at which the Company may sell Common Shares in the ATM Program, as well as capital market conditions in general; risks relating to the strategy of maintaining and increasing Bitcoin holdings and the impact of depreciating Bitcoin prices on working capital; the competitive nature of the industry; currency exchange risks; the need for the Company to manage its planned growth and expansion; the effects of product development and need for continued technology change; the ability to maintain reliable and economical sources of power to run its cryptocurrency mining assets; the impact of energy curtailment or regulatory changes in the energy regimes in the jurisdictions in which the Company operates; protection of proprietary rights; the effect of government regulation and compliance on the Company and the industry; network security risks; the ability of the Company to maintain properly working systems; reliance on key personnel; global economic and financial market deterioration impeding access to capital or increasing the cost of capital; share dilution resulting from the ATM Program and from other equity issuances; and volatile securities markets impacting security pricing unrelated to operating performance. In addition, particular factors that could impact future results of the business of Bitfarms include, but are not limited to: the construction and operation of facilities may not occur as currently planned, or at all; expansion may not materialize as currently anticipated, or at all; the digital currency market; the ability to successfully mine digital currency; revenue may not increase as currently anticipated, or at all; it may not be possible to profitably liquidate the current digital currency inventory, or at all; a decline in digital currency prices may have a significant negative impact on operations; an increase in network difficulty may have a significant negative impact on operations; the volatility of digital currency prices; the anticipated growth and sustainability of hydroelectricity for the purposes of cryptocurrency mining in the applicable jurisdictions; the inability to maintain reliable and economical sources of power for the Company to operate cryptocurrency mining assets; the risks of an increase in the Company’s electricity costs, cost of natural gas, changes in currency exchange rates, energy curtailment or regulatory changes in the energy regimes in the jurisdictions in which the Company operates and the adverse impact on the Company’s profitability; the ability to complete current and future financings, any regulations or laws that will prevent Bitfarms from operating its business; historical prices of digital currencies and the ability to mine digital currencies that will be consistent with historical prices; an inability to predict and counteract the effects of COVID-19 on the business of the Company, including but not limited to the effects of COVID-19 on the price of digital currencies, capital market conditions, restriction on labour and international travel and supply chains; and, the adoption or expansion of any regulation or law that will prevent Bitfarms from operating its business, or make it more costly to do so. For further information concerning these and other risks and uncertainties, refer to the Company’s filings on

www.SEDAR.com

(which are also available on the website of the U.S. Securities and Exchange Commission at

www.sec.gov

), including the annual information form for the year-ended December 31, 2022, filed on March 21, 2023. The Company has also assumed that no significant events occur outside of Bitfarms’ normal course of business. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those expressed in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on any forward-looking information. The Company undertakes no obligation to revise or update any forward-looking information other than as required by law.

Contacts:

LHA Investor Relations

David Barnard
+1 415-433-3777
[email protected]

Actual Agency

Lisa Helfer
+1 646-373-9946
[email protected]

Québec Media: Tact

Louis-Martin Leclerc
+1 418-693-2425
[email protected]

VANCOUVER, British Columbia, May 08, 2023 (GLOBE NEWSWIRE) — In response to the devastating wildfires spreading throughout Alberta and its impact on children and families, TELUS, in partnership with TELUS Friendly Future Foundation, TELUS Indigenous Communities Fund, TELUS Agriculture & Consumer Goods and TELUS Health are making an initial commitment of $5 million in cash donations and in-kind contributions to local charities and organizations supporting relief efforts and first responders, including the Canadian Red Cross and Salvation Army.

“Our team is deeply saddened by the widespread wildfires across Alberta and our thoughts are with those impacted by this disaster,” said Darren Entwistle, President and CEO of TELUS. “We have a long-standing history of being there for Albertans, particularly in their time of need, and it is an honour to lend our support through an initial investment of $5 million, as wildfires continue to ravage many parts of our province. I am grateful to our team for continuing to demonstrate that when things are at their worst, Canadians can count on TELUS to be at its very best, offering our resources and human compassion to help our fellow citizens in need.”

TELUS technicians continue to work around the clock to maintain critical infrastructure and network connectivity under the most challenging of conditions to ensure Albertans and first responders stay connected. These efforts include ensuring emergency generators are running for cell sites to provide wireless coverage throughout the province. In partnership with Ralcomm Ltd., a portable cell tower was placed outside of Drayton Valley for evacuees and first responders to stay connected. TELUS is also deploying extra network technology to evacuation centres such as Smart Hubs and power banks so everyone can stay connected to their loved ones.

Donations and in-kind support to assist with wildfire relief efforts in Alberta include:

• TELUS Friendly Future Foundation, TELUS Edmonton and Northern Alberta Community Board, TELUS Calgary and Southern Alberta Community Board, TELUS Indigenous Communities Fund, TELUS Agriculture & Consumer Goods, and TELUS Health are committing $500,000 to help evacuees and Albertans in need through local relief efforts, mental health support, emergency care and providing food and supplies to affected areas.
• TELUS Health has initiated a free community crisis hotline available 24/7 to all Canadians at 1-844-751-2133 and is providing support through the Employee Assistance Program (EAP) help line for eligible employees of their clients.
• Notifying impacted TELUS and Koodo residential and business customers via SMS that we are waiving all domestic voice, text and data overage fees, helping them stay connected to loved ones.
• TELUS Health and TELUS Agriculture & Consumer Goods are providing complimentary mental health support for farmers and in-kind emergency veterinary care for cattle.
• TELUS Friendly Future Foundation has activated a text-to-donate fundraising campaign whereby TELUS customers can text DONATE to 41010 to give $20 to TELUS Friendly Future Foundation to support registered charities providing wildfire relief across the province.
• TELUS team members are contributing to TELUS Friendly Future Foundation which TELUS is triple matching in support of Alberta fire relief efforts.
• TELUS Community Ambassadors delivered disaster kits with essential items like bandages, USB car chargers and flashlights to support evacuees from Brazeau County and Drayton Valley.

In addition, TELUS is engaged with evacuated Indigenous communities to understand their needs and supply necessities such as water, diapers and non-perishable food items.

To support Albertans who may not be able to travel to see their doctor, TELUS Health MyCare is free to download and offers a robust suite of services, including those covered by provincial health insurance, such as access to licensed medical professionals in numerous languages, specialist referrals, mental health counsellors and registered dietitians. TELUS Health patients who were evacuated and usually receive their prescriptions by home delivery can contact: 1-877-796-7979 to re-route their prescription, if needed immediately, to another location or accessible pharmacy.

Customers in Alberta and B.C. can redeem their TELUS Rewards points for a $20 donation to TELUS Friendly Future Foundation in support of wildfire relief efforts. To learn more about TELUS Friendly Future Foundation, visit friendlyfuture.com.

About TELUS

TELUS (TSX: T, NYSE: TU) is a dynamic, world-leading communications technology company with more than $18 billion in annual revenue and 18 million customer connections spanning wireless, data, IP, voice, television, entertainment, video, and security. Our social purpose is to leverage our global-leading technology and compassion to drive social change and enable remarkable human outcomes. Our longstanding commitment to putting our customers first fuels every aspect of our business, making us a distinct leader in customer service excellence and loyalty. The numerous, sustained accolades TELUS has earned over the years from independent, industry-leading network insight firms showcase the strength and speed of TELUS’ global-leading networks, reinforcing our commitment to provide Canadians with access to superior technology that connects us to the people, resources and information that make our lives better.

Operating in 31 countries around the world, TELUS International (TSX and NYSE: TIXT) is a leading digital customer experience innovator that designs, builds, and delivers next-generation solutions, including AI and content moderation, for global and disruptive brands across strategic industry verticals, including tech and games, communications and media and eCommerce and fintech.

TELUS Health is a global health care leader, which provides employee and family primary and preventive health care and wellness solutions. Our TELUS team, along with our 100,000 health professionals, are leveraging the combination of TELUS’ strong digital and data analytics capabilities with our unsurpassed client service to dramatically improve remedial, preventive and mental health outcomes covering 67 million lives, and growing, around the world. As the largest provider of digital solutions and digital insights of its kind, TELUS Agriculture & Consumer Goods enables efficient and sustainable production from seed to store, helping improve the safety and quality of food and other goods in a way that is traceable to end consumers.
Driven by our determination and vision to connect all citizens for good, our deeply meaningful and enduring philosophy to give where we live has inspired TELUS and our team to contribute $1.5 billion, including 2 million days of service since 2000. This unprecedented generosity and unparalleled volunteerism have made TELUS the most giving company in the world. Together, let’s make the future friendly.
For more information about TELUS, please visit telus.com, follow us at @TELUSNews on Twitter and @Darren_Entwistle on Instagram.

For media inquiries, please contact:

Lena Chen
TELUS Public Relations
[email protected]