Announced Positive Top-Line Final Results from Phase 2 Randomized Clinical Trial of BX1000
Hosted Key Opinion Leader Webinar to Highlight Potential of BX1000 and Neuromuscular Blocking Agent Portfolio
Secured $4 Million in Gross Proceeds from Public Offering in May
MALVERN, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today reported financial results for the quarter ended March 31, 2023, and provided a business update.
“During the first quarter we made significant progress advancing our neuromuscular blocking agent (NMB) portfolio, announcing positive topline results from our Phase 2 randomized trial of BX1000 and continuing to enroll our Phase 1 dose escalation trial for BX2000,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “Positive top line results from our Phase 2 trial demonstrate that BX1000 was effective at all doses, and compares favorably to rocuronium, with predictable onset and offset. We believe that when BX 1000 is combined with our reversal agent BX3000, it may provide even faster control/reversal of neuromuscular paralysis for surgical patients. These very encouraging data and the potential of our NMB portfolio were highlighted in the Key Opinion Leader webinar we were pleased to host recently. The webinar featured distinguished anesthesiologists Drs. Todd M Bertoch and Harold S. Minkowitz, who shared their experiences with the current standard of care and perspectives on the unmet need for improved NMB and reversal agents and can be found on the Events pages of our website”.
“In addition to announcing Phase 2 topline results for BX1000, during the quarter we also continued to enroll our dose escalation study for BX2000, our ultrashort acting NMB,” continued Ms. Henwood. We expect to complete this study by approximately the end of 2023. BX3000, our NMB reversal agent, remains on track, and we expect to complete the nonclinical and manufacturing studies needed to support an IND filing for BX3000 in late summer of 2023.
“On May 1st, we closed a $4 million financing through a public offering. We also executed the asset transfer of ANJESO® to Alkermes, which included the elimination of further payment obligations to Alkermes. These events will allow us to progress development of product candidates for ambulatory surgery centers and other acute care settings, which we believe may represent important innovations in NMBs along with a proprietary reversal agent,” concluded Ms. Henwood.
First Quarter 2023 and Recent Business Highlights
NMB Portfolio
BX1000 Phase 2 Top-Line Data. The Company announced positive top-line results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. Results of the study showed that BX1000 met the primary endpoint of readiness for intubation (evaluated as “Good” or “Excellent”) at all dose levels assessed. No severe adverse events were observed in any dose regimen.
Results showed that all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds (see Table 1 and Table 2). There was evidence of a dose-response across the three doses of BX1000, and the degree of blockade for the highest dose group appears comparable to that of the “standard” dose of rocuronium (0.6 mg/kg) employed in the study. Study treatments were generally well tolerated, with no occurrence of severe or serious adverse events. The frequency and severity of adverse events was similar across all four dose groups, and no notable events were aggregated in any one dose group (See table 3).
A further patient safety follow-up at 28 days after surgery as well as additional analyses of EMG neuromuscular blockade data is anticipated in the coming weeks. The Company will be continuing the development program for BX 1000 with a target of submitting a New Drug Application (“NDA”).
The Company hosted a key opinion leader webinar to discuss the Phase 2 results and opportunity represented by BX1000 and its NMB portfolio. The event, titled Innovation in Anesthesia: BX1000 for Neuromuscular Blockade (NMB), features Dr. Todd M. Bertoch, Chief Executive Officer of JBR Clinical Research, and Dr. Harold S. Minkowitz, Associate Director for Clinical Research at The University of Texas MD Anderson Cancer Center Department of Anesthesiology and Perioperative Medicine and discusses in greater detail results from the Phase 2 trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. A recording of the presentation can be found on the Baudax Bio website under the Events section.
BX2000 (IV Ultra-short duration of action). Cohort enrollment is ongoing for the Phase I dose escalation study evaluating the safety, tolerability, and pharmacokinetics of BX2000 in intubated healthy volunteers. This study is comprised of likely seven or eight dosing cohorts and each cohort is planned to enroll eight patients. The first and second cohorts have been dosed and enrollment of the third cohort is underway. The Company expects to complete enrollment of the remaining cohorts in the study by the end of 2023.
BX3000 (Reversal agent). Baudax Bio expects to complete nonclinical studies and manufacturing data required to support the IND for BX3000 in late summer of 2023. Early single agent clinical trials of BX3000 will not require intubation and so would be expected to progress quickly once the IND is active, and trials are ready to initiate. The Company believes progress towards a reversal study using BX3000 in patients who have received BX1000 could begin before the end of 2023.
The Company believes the data from the ongoing clinical trials for BX1000 and BX2000 will contribute to decisions to move forward later in 2023.
Corporate and Financial
Closed $4 million public offering – On May 1, 2023, the Company closed a public offering of an aggregate of 3,478,262 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock purchase warrants, at a public offering price of $1.15 per share (or pre-funded warrant) and accompanying warrants. Each share of common stock (or pre-funded warrant) was sold in the offering together with one Series A-5 warrant to purchase one share of common stock at an exercise price of $1.15 per share and one Series A-6 warrant to purchase one share of common stock at an exercise price of $1.15 per share. The Series A-5 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-6 warrants are exercisable immediately and will expire eighteen months from the date of issuance. Gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $4 million. The Company intends to use the net proceeds from this offering for pipeline development activities and general corporate purposes.
Alkermes Asset Transfer Agreement – On March 29, 2023, the Company entered into an Asset Transfer Agreement with Alkermes Pharma Ireland Limited (“Alkermes”) (the “Transfer Agreement”). Under the terms of the Transfer Agreement, the Company transferred the rights to certain patents, trademarks, equipment, data and other rights related to ANJESO® (the “Assets”) to Alkermes. The Company withdrew the New Drug Application (“NDA”) related to ANJESO. Additionally, under the Transfer Agreement, the Company granted Alkermes a non-exclusive, perpetual and irrevocable, royalty-free and fully paid-up worldwide license, to the additional intellectual property owned by the Company necessary to or useful to exploit ANJESO®. In consideration of the transfer of the Assets, the parties agreed to the termination of (i) the Purchase and Sale Agreement, dated March 7, 2015 by and among Alkermes, the Company and the other parties thereto (as amended, the “PSA”), (ii) the Asset Transfer and License Agreement, dated April 10, 2015 by and among Alkermes, the Company and the other parties thereto (as amended, the “ATLA”); and (iii) the Development, Manufacturing and Supply Agreement, dated as of July 10, 2015 by and between the Company and Alkermes (as amended, the “Manufacturing Agreement”) between the parties related to ANJESO (the PSA, ATLA and Manufacturing Agreement, collectively, the “ANJESO Agreements”). In connection with the termination of the ANJESO Agreements, no further payments of any kind pursuant to the ANJESO Agreements will be payable by the Company to Alkermes.
Consent to Credit Agreement – On March 29, 2023 the Company entered into a Consent to Credit agreement by and among the Company, Baudax Bio N.A. LLC (“Baudax LLC”), Baudax Bio Limited, Wilmington Trust, National Association, solely in its capacity as administrative and collateral agent (the “Agent”) and the lenders party thereto (the “Lenders”). The Amendment amends that certain Credit Agreement, dated as of May 29, 2020, by and among the Company, the Agent, and the Lenders (as amended, the “Credit Agreement”). Pursuant to the terms of the Amendment, the Lenders consented to the transactions contemplated by the Transfer Agreement (as defined below) and agreed to release and discharge any liens granted or held by the Lenders in respect of the Assets (as defined below). Pursuant to the terms of the Transfer Agreement, the parties also agreed to, among other things, amend the minimum liquidity covenants under the Credit Agreement to require that the Company maintains $2.5 million of liquidity at all times.
Financial Results for the Three Months Ended March 31, 2023
As of March 31, 2023, Baudax Bio had cash and cash equivalents of $3.8 million.
Research and development expenses from continuing operations for the three months ended March 31, 2023 were $2.9 million compared to $0.7 million for the three months ended March 31, 2022. The increase of $2.2 million was primarily due to an increase in clinical and preclinical trials costs associated with our NMB program of $1.7 million and an increase in general expenses, including consulting and other outside service expenses, of $0.5 million.
Selling, general and administrative expenses from continuing operations for the three months ended March 31, 2023 were $1.8 million compared to $6.9 million for the same prior year period. The decrease of $5.1 million was primarily a result of a reduction in personnel costs of $3.5 million, a decrease in public company costs of $0.7 million, a decrease in consulting expenses of $0.5 million, and a decrease of $0.5 million in patent legal and other expenses.
Baudax Bio reported net loss from continuing operations of $(7.4) million, or $(3.19) per share, for the three months ended March 31, 2023. Net loss from continuing operations for the three months ended March 31, 2022 was $(8.2) million, or $(81.16) per share.
About Baudax Bio’s Neuromuscular Blocking Agents (NMBs)
Baudax Bio holds exclusive global rights to two novel NMBs, BX1000, an intermediate duration, clinical stage blocking agent, and BX2000, an ultra-short duration, clinical stage blocking agent, as well as a proprietary chemical reversal agent, BX3000, undergoing nonclinical studies intended to support an investigational new drug (IND) submission in 2023. BX3000 is a specific reversal agent that may rapidly reverse BX1000 and BX2000. All three agents are licensed from Cornell University. We believe these agents, when an NMB and BX3000 are administered in succession, allow for a rapid onset of centrally acting neuromuscular blockade, followed by a rapid reversal of the neuromuscular blockade with BX3000. These novel agents have the potential to meaningfully reduce time to onset and reversal of blockade and improve the reliability of onset and offset of neuromuscular blockade. This can potentially reduce time in operating rooms or post operative suites, or PACU, resulting in potential clinical and cost advantages, as well as valuable cost savings for hospitals and ambulatory surgical centers and has the potential for an improved clinical profile in terms of safety.
About Baudax Bio
Baudax Bio is a pharmaceutical company focused on innovative products for acute care and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one that recently completed a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in late summer of 2023. For more information, please visit www.baudaxbio.com.
Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements, including statements relating to the clinical development of Baudax Bio’s product candidates, reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market, economic and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.
CALGARY, AB, May 12, 2023 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) announces its financial and operating results for the three months ended March 31, 2023. InPlay’s condensed unaudited interim financial statements and notes, as well as Management’s Discussion and Analysis (“MD&A”) for the three months ended March 31, 2023 will be available at “www.sedar.com” and our website at “www.inplayoil.com“. Our corporate presentation will soon be available on our website.
First Quarter 2023 Financial & Operating Highlights
Achieved average quarterly production of 9,020 boe/d(1) (58% light crude oil and NGLs), an increase of 21% on a debt adjusted per share basis compared to 8,221 boe/d(1) (59% light crude oil and NGLs) in the first quarter of 2022.
Generated strong quarterly adjusted funds flow (“AFF”)(2) of $21.3 million ($0.24 per weighted average basic share(3)).
Maintained balance sheet strength with a low net debt(2) to earnings before interest, taxes and depletion (“EBITDA”)(3) ratio of 0.4 on a trailing twelve month basis down from 1.0 in the first quarter of 2022.
Executed the most active quarter in the Company’s history drilling four (3.2 net) extended reach horizontal (“ERH”) wells in Willesden Green, two (2.0 net) ERH wells in Pembina and two (0.3 net) non-operated Willesden Green ERH wells. InPlay also started the upgrade of an operated gas facility in Willesden Green providing additional capacity. One (0.95 net) additional Willesden Green well which was planned for the second quarter was drilled in March and drilling operations began on another one (0.95 net) Willesden Green well in the first quarter.
Returned $4.4 million in the quarter directly to shareholders through $4.0 million in dividends and $0.4 million of share repurchases under the Company’s Normal Course Issuer Bid.
Realized net income of $9.3 million ($0.11 per basic share; $0.10 per diluted share).
Financial capability to deliver consistent returns to shareholders with the dividend supportable at a $55 WTI pricing environment until 2025.
First Quarter 2023 Financial & Operations Overview:
InPlay’s capital program for the first quarter of 2023 was the Company’s most active quarter in our history. During the quarter, InPlay invested $29.6 million drilling, completing and equipping four (3.2 net) ERH wells in Willesden Green, two (2.0 net) ERH wells in Pembina and two (0.3 net) non-operated Willesden Green ERH wells. Completion operations on two wells were advanced into the quarter that were originally planned to occur in the second quarter to ensure these wells could be brought on production prior to spring breakup. InPlay also advanced the initiation of its second quarter capital program into the first quarter by drilling in Willesden Green an additional one (0.95 net) ERH well in March and beginning the drilling operations on another one (0.95 net) ERH well. During the quarter, the Company also started construction on the first of two planned natural gas facility upgrades in Willesden Green in 2023.
In one area of Pembina, as published in our March 15, 2023 press release, the Company had natural gas production curtailments beginning February 15th from a third party natural gas facility due to capacity constraints. This impacted production in the quarter by approximately 475 boe/d (68% natural gas). InPlay actively responded to mitigate the impact of this curtailment on revenue by shutting in wells with high gas weightings, maximizing oil production and AFF in the strong oil pricing environment. The impact of the constraints was also mitigated by the fact that due to expected weaker natural gas pricing in 2023, InPlay previously shifted 2023 drilling plans away from this prolific production area due to its higher gas weighted production, and its higher gas processing fees in comparison to our Willesden Green property.
In Willesden Green, two (1.6 net) ERH wells that were brought on production in early February had average initial production (“IP”) rates per well of 579 boe/d (73% light crude oil and NGLs) and 428 boe/d (70% light crude oil and NGLs) over their first 30 and 60 days respectively. The Company also brought on production another two (1.6 net) ERH Willesden Green wells in early March. The average IP rates for these wells was 722 boe/d (82% light crude oil and NGLs) and 564 boe/d (81% light crude oil and NGLs) per well over their first 30 and 60 days respectively. These four wells have delivered IP rates significantly above internal expectations and their high production rates led to increased back pressure in the area resulting in operated and non-operated curtailments of approximately 150 boe/d (57% light crude oil and NGLs) during the quarter due to temporarily backing out production from our older lower pressured offsetting wells. During April, InPlay completed the upgrade on the first of two natural gas processing facilities in the Willesden Green area which allowed curtailed production to be brought back online.
Production averaged 9,020 boe/d (58% light crude oil & NGLs) (1) in the first quarter of 2023 resulting in $21.3 million of AFF. The impact on production due to the two above mentioned curtailments was approximately 625 boe/d (48% light crude oil & NGLs) in the first quarter of 2023. During the quarter, InPlay increased light oil and NGLs weighting by approximately 1.5% over the fourth quarter of 2022, and this weighting is expected to continue to increase as the Company is focused on drilling in areas with higher oil weightings.
Outlook and Operations Update(5)
InPlay continues to be excited about 2023 as our drilling continues to outperform our expectations including the two oil focused wells drilled in Pembina in the first quarter and brought on production in April. The two (2.0 net) ERH wells had average IP rates over their first 25 days of 307 boe/d (89% light crude oil and NGLs) per well, exceeding our internal forecasts with a strong oil and liquids weighting. These wells are expected to remain at an elevated oil weighting and flat for a few months as we continue to see strong pressures, decreasing water cuts and the artificial lift equipment is operating at maximum pumping capacity.
Capital activity planned for the second quarter will include completing and bringing on production three (2.9 net) ERH wells in Willesden Green which commenced drilling in March and finished in April. These wells are expected to be completed in late May and brought on production in early June. Continued work on our second significant upgrade to an operated natural gas plant in Willesden Green is also planned for the quarter. This upgrade is expected to be online in the second half of July and provides InPlay with considerable increased operated natural gas capacity to facilitate continued development and growth in Willesden Green in the current and future years. Drilling activity is expected to resume in late June or early July but overall capital spending in the second quarter is expected to be significantly lower than the first quarter providing strong free adjusted funds flow(3).
A three week turnaround at the Company’s largest non-operated midstream natural gas facility is expected to occur in June. InPlay proactively secured capacity at alternative facilities for a significant amount of impacted gas production and the production of oil and NGLs in the second quarter of 2023 is not expected to be materially affected.
InPlay responded quickly and effectively to address the production curtailments impacting the Company in the first quarter. Natural decline of InPlay and other operators’ production in Pembina continues to reduce the impact of curtailed production, which is currently estimated at 825 boe/d (68% natural gas), compared to the 950 boe/d (68% natural gas) impact during the last half of the first quarter. We expect natural declines will continue to reduce the impact of curtailed production through the summer and alternative options to bring the remaining curtailed production fully back online are currently being evaluated. The Company anticipates all curtailed production to be back online early in the fourth quarter of 2023 which will be sold into the much higher future winter natural gas prices.
Strong fundamentals have InPlay continuing to focus on high oil weighted properties as we have a much more favorable outlook for oil prices versus natural gas prices, specifically in the second half of 2023. This focus is due to light oil and NGLs representing an estimated 86% of our overall forecasted corporate revenue in 2023. The 2023 capital program will remain flexible and the Company will revisit this program should commodity prices continue to remain volatile.
Similar to other operators, InPlay has had production in the Pembina region affected by the recent wildfires in Alberta. Our first priority was ensuring the safety of our employees, contractors, the community and our infrastructure, which to date has been accomplished. The Company started shutting in production and facilities late on May 4th and had concluded shutting in all affected wells and facilities by late in the day on May 5th. Affected production shut in peaked at approximately 3,400 boe/d (52% light oil and liquids). Since the weekend the fire hazard has somewhat diminished in the area. Production has started to be brought back on over the past few days and we will continue to restart the remaining production down as services allow. We will continue to monitor the hazards and act accordingly. The Company thanks its field employees for their diligent and quick action in safely shutting in operations.
Strong results from our 2023 drilling program to date has InPlay reiterating our previous production guidance of 9,500 – 10,500 boe/d(1). However, given the curtailments experienced to date in 2023 and their expected impact over the next few quarters, the Company is forecasting 2023 average production to be within the lower half of this guidance at 9,500 – 10,000 boe/d(1) but at the higher end of our light crude oil and NGLs weighting guidance at 59% – 61%.
The Company continues to expect near term volatility in commodity prices, specifically natural gas prices, but with the United States refined product inventory levels at five year lows, oil inventory at the five year average and refineries starting back up after maintenance downtime, we anticipate the second half of 2023 to have higher oil prices. The Company’s downside exposure to lower forward summer 2023 natural gas prices are protected with hedges put in place of 12,500 GJ/day swaps at $3.73 AECO per GJ for April to October 2023. InPlay forecasts 2023 AFF(2) of $117 to $123 million with FAFF(3) of $37 to $48 million. The Company’s leverage metrics are forecasted to remain at very low levels, with net debt to EBITDA(3) forecast to be 0.0x – 0.2x for 2023.
The Company continues to remain focused on providing strong returns to shareholders through the payment of our monthly dividend of $0.015/share (which is expected to be only 13%-14% of forecasted 2023 AFF), timely share repurchases under our normal course issuer bid and top-tier production per debt adjusted share growth. The Company’s strong debt position, disciplined and adaptable capital allocation, and high quality asset base provides InPlay with a competitive advantage to continue to provide strong returns to shareholders in a volatile commodity pricing environment. The Company forecasts our base monthly dividend to be sustainable in a scenario where WTI dropped to US $55/bbl through to the end of 2025.
On behalf of our employees, management team and Board of Directors, we would like to thank our shareholders for their support and look forward to updating you on our progress throughout the year.
Notes:
1.
See “Production Breakdown by Product Type” at the end of this press release.
2.
Capital management measure. See “Non-GAAP and Other Financial Measures” contained within this press release.
3.
Non-GAAP financial measure or ratio that does not have a standardized meaning under International Financial Reporting Standards (IFRS) and GAAP and therefore may not be comparable with the calculations of similar measures for other companies. Please refer to “Non-GAAP and Other Financial Measures” contained within this press release.
4.
Supplementary financial measure. See “Non-GAAP and Other Financial Measures” contained within this press release.
5.
See “Reader Advisories – Forward Looking Information and Statements” for key budget and underlying assumptions related to our previous and updated 2023 capital program and associated guidance.
Reader Advisories
Non-GAAP and Other Financial Measures
Throughout this press release and other materials disclosed by the Company, InPlay uses certain measures to analyze financial performance, financial position and cash flow. These non-GAAP and other financial measures do not have any standardized meaning prescribed under GAAP and therefore may not be comparable to similar measures presented by other entities. The non-GAAP and other financial measures should not be considered alternatives to, or more meaningful than, financial measures that are determined in accordance with GAAP as indicators of the Company performance. Management believes that the presentation of these non-GAAP and other financial measures provides useful information to shareholders and investors in understanding and evaluating the Company’s ongoing operating performance, and the measures provide increased transparency and the ability to better analyze InPlay’s business performance against prior periods on a comparable basis.
Non-GAAP Financial Measures and Ratios
Included in this document are references to the terms “free adjusted funds flow”, “operating income”, “operating netback per boe”, “operating income profit margin”, “Net Debt to EBITDA”, “Net Corporate Acquisitions”, “Debt adjusted production per share” and “EV / DAAFF”. Management believes these measures and ratios are helpful supplementary measures of financial and operating performance and provide users with similar, but potentially not comparable, information that is commonly used by other oil and natural gas companies. These terms do not have any standardized meaning prescribed by GAAP and should not be considered an alternative to, or more meaningful than “profit (loss) before taxes”, “profit (loss) and comprehensive income (loss)”, “adjusted funds flow”, “capital expenditures”, “corporate acquisitions, net of cash acquired”, “net debt”, “weighted average number of common shares (basic)” or assets and liabilities as determined in accordance with GAAP as a measure of the Company’s performance and financial position.
Free Adjusted Funds Flow
Management considers FAFF an important measure to identify the Company’s ability to improve its financial condition through debt repayment and its ability to provide returns to shareholders. FAFF should not be considered as an alternative to or more meaningful than AFF as determined in accordance with GAAP as an indicator of the Company’s performance. FAFF is calculated by the Company as AFF less exploration and development capital expenditures and property dispositions (acquisitions) and is a measure of the cashflow remaining after capital expenditures before corporate acquisitions that can be used for additional capital activity, corporate acquisitions, repayment of debt or decommissioning expenditures or potentially return of capital to shareholders. Refer below for a calculation of historical FAFF and to the “Forward Looking Information and Statements” section for a calculation of forecast FAFF.
Operating Income/Operating Netback per boe/Operating Income Profit Margin
InPlay uses “operating income”, “operating netback per boe” and “operating income profit margin” as key performance indicators. Operating income is calculated by the Company as oil and natural gas sales less royalties, operating expenses and transportation expenses and is a measure of the profitability of operations before administrative, share-based compensation, financing and other non-cash items. Management considers operating income an important measure to evaluate its operational performance as it demonstrates its field level profitability. Operating income should not be considered as an alternative to or more meaningful than net income as determined in accordance with GAAP as an indicator of the Company’s performance. Operating netback per boe is calculated by the Company as operating income divided by average production for the respective period. Management considers operating netback per boe an important measure to evaluate its operational performance as it demonstrates its field level profitability per unit of production. Operating income profit margin is calculated by the Company as operating income as a percentage of oil and natural gas sales. Management considers operating income profit margin an important measure to evaluate its operational performance as it demonstrates how efficiently the Company generates field level profits from its sales revenue. Refer below for a calculation of operating income, operating netback per boe and operating income profit margin.
Net Debt to EBITDA
Management considers Net Debt to EBITDA an important measure as it is a key metric to identify the Company’s ability to fund financing expenses, net debt reductions and other obligations. EBITDA is calculated by the Company as adjusted funds flow before interest expense. When this measure is presented quarterly, EBITDA is annualized by multiplying by four. When this measure is presented on a trailing twelve month basis, EBITDA for the twelve months preceding the net debt date is used in the calculation. This measure is consistent with the EBITDA formula prescribed under the Company’s Senior Credit Facility. Net Debt to EBITDA is calculated as Net Debt divided by EBITDA. Refer below for a calculation of Net Debt to EBITDA and to the “Forward Looking Information and Statements” section for a calculation of forecast Net Debt to EBITDA.
Net Corporate Acquisitions
Management considers Net corporate acquisitions an important measure as it is a key metric to evaluate the corporate acquisition in comparison to other transactions using the negotiated consideration value and ignoring changes to the fair value of the share consideration between the signing of the definitive agreement and the closing of the transaction. Net corporate acquisitions should not be considered as an alternative to or more meaningful than “Corporate acquisitions, net of cash acquired” as determined in accordance with GAAP as an indicator of the Company’s performance. Net corporate acquisitions is calculated as total consideration with share consideration adjusted to the value negotiated with the counterparty, less working capital balances assumed on the corporate acquisition. Refer below for a calculation of Net corporate acquisitions and reconciliation to the nearest GAAP measure, “Corporate acquisitions, net of cash acquired”.
Production per Debt Adjusted Share
InPlay uses “Production per debt adjusted share” as a key performance indicator. Debt adjusted shares should not be considered as an alternative to or more meaningful than common shares as determined in accordance with GAAP as an indicator of the Company’s performance. Debt adjusted shares is a non-GAAP measure used in the calculation of Production per debt adjusted share and is calculated by the Company as common shares outstanding plus the change in net debt divided by the Company’s current trading price on the TSX, converting net debt to equity. Debt adjusted shares should not be considered as an alternative to or more meaningful than weighted average number of common shares (basic) as determined in accordance with GAAP as an indicator of the Company’s performance. Management considers Debt adjusted share is a key performance indicator as it adjusts for the effects of capital structure in relation to the Company’s peers. Production per debt adjusted share is calculated by the Company as production divided by debt adjusted shares. Management considers Production per debt adjusted share is a key performance indicator as it adjusts for the effects of changes in annual production in relation to the Company’s capital structure. Refer below for a calculation of Production per debt adjusted share and to the “Forward Looking Information and Statements” section for a calculation of forecast Production per debt adjusted share.
EV / DAAFF
InPlay uses “enterprise value to debt adjusted AFF” or “EV/DAAFF” as a key performance indicator. EV/DAAFF is calculated by the Company as enterprise value divided by debt adjusted AFF for the relevant period. Debt adjusted AFF (“DAAFF”) is calculated by the Company as adjusted funds flow plus financing costs. Enterprise value is a capital management measures that is used in the calculation of EV/DAAFF. Enterprise value is calculated as the Company’s market capitalization plus working capital (net debt). Management considers enterprise value a key performance indicator as it identifies the total capital structure of the Company. Management considers EV/DAAFF a key performance indicator as it is a key metric used to evaluate the sustainability of the Company relative to other companies while incorporating the impact of differing capital structures. Refer to the “Forward Looking Information and Statements” section for a calculation of forecast EV/DAAFF.
Capital Management Measures
Adjusted Funds Flow
Management considers adjusted funds flow to be an important measure of InPlay’s ability to generate the funds necessary to finance capital expenditures. Adjusted funds flow is a GAAP measure and is disclosed in the notes to the Company’s financial statements for the three months ended March 31, 2023. All references to adjusted funds flow throughout this MD&A are calculated as funds flow adjusting for decommissioning expenditures and transaction and integration costs. Decommissioning expenditures are adjusted from funds flow as they are incurred on a discretionary and irregular basis and are primarily incurred on previous operating assets. Transaction costs are non-recurring costs for the purposes of an acquisition, making the exclusion of these items relevant in Management’s view to the reader in the evaluation of InPlay’s operating performance. The Company also presents adjusted funds flow per share whereby per share amounts are calculated using weighted average shares outstanding consistent with the calculation of profit per common share.
Net Debt / Working Capital
Net debt / working capital is a GAAP measure and is disclosed in the notes to the Company’s financial statements for three months ended March 31, 2023. The Company closely monitors its capital structure with a goal of maintaining a strong balance sheet to fund the future growth of the Company. The Company monitors net debt / working capital as part of its capital structure. The Company uses net debt / working capital (bank debt plus accounts payable and accrued liabilities less accounts receivables and accrued receivables, prepaid expenses and deposits and inventory) as an alternative measure of outstanding debt. Management considers net debt / working capital an important measure to assist in assessing the liquidity of the Company.
Supplementary Measures
“Average realized crude oil price” is comprised of crude oil commodity sales from production, as determined in accordance with IFRS, divided by the Company’s crude oil production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Average realized NGL price” is comprised of NGL commodity sales from production, as determined in accordance with IFRS, divided by the Company’s NGL production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Average realized natural gas price” is comprised of natural gas commodity sales from production, as determined in accordance with IFRS, divided by the Company’s natural gas production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Average realized commodity price” is comprised of commodity sales from production, as determined in accordance with IFRS, divided by the Company’s production. Average prices are before deduction of transportation costs and do not include gains and losses on financial instruments.
“Adjusted funds flow per weighted average basic share” is comprised of adjusted funds flow divided by the basic weighted average common shares.
“Adjusted funds flow per weighted average diluted share” is comprised of adjusted funds flow divided by the diluted weighted average common shares.
“Adjusted funds flow per boe” is comprised of adjusted funds flow divided by total production.
Forward-Looking Information and Statements This news release contains certain forward–looking information and statements within the meaning of applicable securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends”, “forecast” and similar expressions are intended to identify forward-looking information or statements. In particular, but without limiting the foregoing, this news release contains forward-looking information and statements pertaining to the following: the Company’s business strategy, milestones and objectives; the Company’s planned 2023 capital program including wells to be drilled and completed and the timing of the same and that the operated natural gas plant in Willesden Green is expected to be online in the second half of July; 2023 guidance based on the planned capital program and all associated underlying assumptions set forth in this press release including, without limitation, forecasts of 2023 annual average production levels, debt adjusted production levels, adjusted funds flow, free adjusted funds flow, Net Debt/EBITDA ratio, operating income profit margin, and Management’s belief that the Company can grow some or all of these attributes and specified measures; light crude oil and NGLs weighting estimates; expectations regarding future commodity prices; future oil and natural gas prices; future liquidity and financial capacity; future results from operations and operating metrics; future costs, expenses and royalty rates; future interest costs; the exchange rate between the $US and $Cdn; future development, exploration, acquisition, development and infrastructure activities and related capital expenditures, including our planned 2023 capital program; the amount and timing of capital projects; forecasted spending on decommissioning; that the Company has the financial capability to deliver consistent return to shareholders and the dividend is supportable at a $55 WTI pricing environment until 2025; that the Company’s light oil and NGLs weighting is expected to continue to increase as the Company is focused on drilling in areas with higher oil weightings; that the production profile of the two Pembina wells brought on production in April is expected to remain flat for a few months; the expectation that the second quarter will provide strong free adjusted funds flow; the expectation that all curtailed production will be back online in the fourth quarter of 2023; and methods of funding our capital program.
Without limitation of the foregoing, readers are cautioned that the Company’s future dividend payments to shareholders of the Company, if any, and the level thereof will be subject to the discretion of the Board of Directors of InPlay. The Company’s dividend policy and funds available for the payment of dividends, if any, from time to time, is dependent upon, among other things, levels of FAFF, leverage ratios, financial requirements for the Company’s operations and execution of its growth strategy, fluctuations in commodity prices and working capital, the timing and amount of capital expenditures, credit facility availability and limitations on distributions existing thereunder, and other factors beyond the Company’s control. Further, the ability of the Company to pay dividends will be subject to applicable laws, including satisfaction of solvency tests under the Business Corporations Act (Alberta), and satisfaction of certain applicable contractual restrictions contained in the agreements governing the Company’s outstanding indebtedness.
Forward-looking statements or information are based on a number of material factors, expectations or assumptions of InPlay which have been used to develop such statements and information but which may prove to be incorrect. Although InPlay believes that the expectations reflected in such forward looking statements or information are reasonable, undue reliance should not be placed on forward-looking statements because InPlay can give no assurance that such expectations will prove to be correct. In addition to other factors and assumptions which may be identified herein, assumptions have been made regarding, among other things: the impact of increasing competition; the general stability of the economic and political environment in which InPlay operates; the timely receipt of any required regulatory approvals; the ability of InPlay to obtain qualified staff, equipment and services in a timely and cost efficient manner; drilling results; the ability of the operator of the projects in which InPlay has an interest in to operate the field in a safe, efficient and effective manner; the ability of InPlay to obtain debt financing on acceptable terms; the timing and amount of purchases under the Company’s NCIB; the anticipated tax treatment of the monthly base dividend; field production rates and decline rates; the ability to replace and expand oil and natural gas reserves through acquisition, development and exploration; the timing and cost of pipeline, storage and facility construction and the ability of InPlay to secure adequate product transportation; future commodity prices; that various conditions to a shareholder return strategy can be satisfied; expectations regarding the potential impact of COVID-19 and the Russia/Ukraine conflict; currency, exchange and interest rates; regulatory framework regarding royalties, taxes and environmental matters in the jurisdictions in which InPlay operates; and the ability of InPlay to successfully market its oil and natural gas products.
The forward-looking information and statements included herein are not guarantees of future performance and should not be unduly relied upon. Such information and statements, including the assumptions made in respect thereof, involve known and unknown risks, uncertainties and other factors that may cause actual results or events to defer materially from those anticipated in such forward-looking information or statements including, without limitation: the continuing impact of the COVID-19 pandemic and the Russia/Ukraine conflict; inflation and the risk of a global recession; changes in our planned 2023 capital program; changes in our long range plan; changes in our approach to shareholder returns, including in relation to the Company’s NCIB and the timing and amount of any potential purchases thereunder; changes in commodity prices and other assumptions outlined herein; the risk that dividend payments may be reduced, suspended or cancelled; the potential for variation in the quality of the reservoirs in which we operate; changes in the demand for or supply of our products; unanticipated operating results or production declines; changes in tax or environmental laws, royalty rates or other regulatory matters; changes in development plans or strategies of InPlay or by third party operators of our properties; changes in our credit structure, increased debt levels or debt service requirements; inaccurate estimation of our light crude oil and natural gas reserve and resource volumes; limited, unfavorable or a lack of access to capital markets; increased costs; a lack of adequate insurance coverage; the impact of competitors; and certain other risks detailed from time-to-time in InPlay’s continuous disclosure documents filed on SEDAR including our Annual Information Form and our MD&A.
This press release contains future-oriented financial information and financial outlook information (collectively, “FOFI”) about InPlay’s financial and leverage targets and objectives, InPlay’s long-term forecast, and potential dividends and share buybacks, all of which are subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraphs. The actual results of operations of InPlay and the resulting financial results will likely vary from the amounts set forth in this press release and such variation may be material. InPlay and its management believe that the FOFI has been prepared on a reasonable basis, reflecting management’s reasonable estimates and judgments. However, because this information is subjective and subject to numerous risks, it should not be relied on as necessarily indicative of future results. Except as required by applicable securities laws, InPlay undertakes no obligation to update such FOFI. FOFI contained in this press release was made as of the date of this press release and was provided for the purpose of providing further information about InPlay’s anticipated future business operations and strategy. Readers are cautioned that the FOFI contained in this press release should not be used for purposes other than for which it is disclosed herein.
The internal projections, expectations, or beliefs underlying our Board approved 2023 capital budget and associated guidance, as well as management’s preliminary estimates and targets in respect of plans for 2024 and beyond (which are not based on Board approved budgets at this time), are subject to change in light of, among other factors, the impact of world events including pandemics and the Russia/Ukraine conflict, ongoing results, prevailing economic circumstances, volatile commodity prices, and industry conditions and regulations. InPlay’s financial outlook and guidance provides shareholders with relevant information on management’s expectations for results of operations, excluding any potential acquisitions or dispositions, for such time periods based upon the key assumptions outlined herein. In this document reference is made to the Company’s longer range 2024 and beyond internal plan and associated economic model. Such information reflects internal estimates and targets used by management for the purposes of making capital investment decisions and for internal long range planning and budget preparation. Readers are cautioned that events or circumstances could cause capital plans and associated results to differ materially from those predicted and InPlay’s guidance for 2023, and more particularly 2024 and beyond, may not be appropriate for other purposes. Accordingly, undue reliance should not be placed on same.
The forward-looking information and statements contained in this news release speak only as of the date hereof and InPlay does not assume any obligation to publicly update or revise any of the included forward-looking statements or information, whether as a result of new information, future events or otherwise, except as may be required by applicable securities laws.
Risk Factors to FLI
Risk factors that could materially impact successful execution and actual results of the Company’s 2023 capital program and associated guidance and long-term preliminary plans and estimates include:
volatility of petroleum and natural gas prices and inherent difficulty in the accuracy of predictions related thereto;
the extent of any unfavorable impacts of wildfires in the province of Alberta;
changes in Federal and Provincial regulations;
the Company’s ability to secure financing for the Board approved 2023 capital program and longer term capital plans sourced from AFF, bank or other debt instruments, asset sales, equity issuance, infrastructure financing or some combination thereof;
those additional risk factors set forth in the Company’s MD&A and most recent Annual Information Form filed on SEDAR
Key Budget and Underlying Material Assumptions to FLI
The key budget and underlying material assumptions used by the Company in the development of its current and previous 2023 guidance and preliminary estimates are as follows:
The change in the current 2023 guidance from prior guidance results from forecasted production to be within the lower half of guidance given the curtailments experienced to date in 2023 and their expected impact over the next few quarters as detailed in this press release.
The Company’s 2024 and 2025 preliminary plans remains the same as previously released January 18, 2023, with net debt (working capital) updated to reflect the updated 2023 ending net debt. The 2024 and 2025 preliminary plan guidance calculations which are impacted by this change and the change in assumed share price to $2.75 are outlined below.
See “Production Breakdown by Product Type” below
Quality and pipeline transmission adjustments may impact realized oil prices in addition to the MSW Differential provided above
Changes in working capital (net debt) are not assumed to have a material impact between the years presented above.
The assumptions above do not include potential future purchases through the Company’s NCIB.
Test Results and Initial Production Rates
Test results and initial production (“IP”) rates disclosed herein, particularly those short in duration, may not necessarily be indicative of long term performance or of ultimate recovery. A pressure transient analysis or well-test interpretation has not been carried out and thus certain of the test results provided herein should be considered to be preliminary until such analysis or interpretation has been completed.
Production Breakdown by Product Type
Disclosure of production on a per boe basis in this press release consists of the constituent product types as defined in NI 51–101 and their respective quantities disclosed in the table below:
References to crude oil, light oil, NGLs or natural gas production in this press release refer to the light and medium crude oil, natural gas liquids and conventional natural gas product types, respectively, as defined in National Instrument 51-101, Standards of Disclosure for Oil and Gas Activities (“Nl 51-101”).
BOE equivalent Barrel of oil equivalents or BOEs may be misleading, particularly if used in isolation. A BOE conversion ratio of 6 mcf: 1 bbl is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. Given that the value ratio based on the current price of crude oil as compared to natural gas is significantly different than the energy equivalency of 6:1, utilizing a 6:1 conversion basis may be misleading as an indication of value.
SOURCE InPlay Oil Corp.
For further information: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634
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.
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 kcashmere@zyversa.com 786-251-9641
Showcase to feature presentations by key opinion leaders Drs. Gaël Roué and Bhavana Pothuri
Showcase to take place on May 18, 2023 at 11:00 a.m. ET
NEWTOWN, Pa., May 12, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven M. Fruchtman, M.D., President & CEO of Onconova Therapeutics, will participate in a Ladenburg Thalmann virtual R&D showcase on Thursday, May 18, 2023, at 11:00 a.m. ET.
The R&D showcase will feature presentations by key opinion leaders Gaël Roué, Ph.D. (Josep Carreras Leukaemia Research Institute), and Bhavana Pothuri, M.D. (New York University Langone Health), who will discuss narazaciclib’s differentiated kinase inhibitory profile, the current treatment landscape in endometrial cancer, as well as Onconova’s planned Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). Presentations by the KOLs will be followed by remarks from Dr. Fruchtman as well as a question and answer session moderated by Ahu Demir, Ph.D., Managing Director, Senior Research Analyst, Ladenburg Thalmann & Co.
Dr. Gaël Roué leads the Lymphoma Translational Group at the Josep Carreras Leukaemia Research Institute, with a special focus on oncogenic signaling, B-cell receptor pathways and the role of intrinsic protein homeostasis in the control of lymphoma-stroma crosstalk. Dr. Roué obtained his Ph.D. in Molecular and Cellular Biology from the University of Caen. Dr Roué is co-author and lead author of a patent, two book chapters, and nearly 90 articles published in international peer-reviewed journals. He has led almost 20 national and international research projects. Dr Roué also serves as an ad-hoc reviewer for several journals in the fields of hematology and oncology, being an editorial board member for three of them, and is an external evaluator for different national and European funding agencies.
Dr. Bhavana Pothuri earned her medical degree from Jefferson Medical College at Thomas Jefferson University. She completed her residency in Obstetrics and Gynecology at the Jefferson Health System and a fellowship in Gynecologic Oncology at Memorial Sloan Kettering Cancer Center. She is a Professor in the Departments of Obstetrics and Gynecology and Medicine at the New York University (NYU) School of Medicine, Medical Director of Clinical Trials Office, Director of Gynecologic Oncology Clinical Trials, Director of Gynecologic Oncology Research, and Site Principal Investigator for the Perlmutter Cancer Center, NYU Langone Health. Dr. Pothuri is also the Principal Investigator for Onconova’s planned Phase 1/2a trial in endometrial cancer. In addition, her research focuses on using the PARP inhibitor, niraparib, as frontline maintenance treatment for ovarian cancer, as well as dostarlimab, a PD-1 inhibitor, in endometrial cancer.
About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications.
Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, and a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC).
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Star Buds Retailer Now Enters the Fort Collins and Garden City Markets in Colorado
DENVER, May 12, 2023 /CNW/ – Schwazze, (NEO: SHWZ) (OTCQX: SHWZ) (“Schwazze” or the “Company”), announced today that it closed the transaction to acquire certain assets of Cannabis Care Wellness Centers, LLC and Green Medicals Wellness Center #5, LLC (d/b/a “Smokey’s”). The transaction includes the recreational and medical use Smokey’s dispensaries located at 2515 7th Avenue in Garden City as well as 5740 S. College Avenue in Fort Collins. These two vibrant cannabis markets have limited licenses and present Schwazze with more opportunities to serve customers in northern Colorado. This acquisition continues Schwazze’s deliberate expansion in Colorado, bringing the Company’s total number of Colorado dispensaries to 27. The acquired assets included state and local retail marijuana licenses supporting the adult use dispensaries acquired in the transaction.
The consideration for the acquisition was US$7.5 million paid as a combination of cash and stock.
“As we continue to go deep in the state of Colorado, we’re excited to bring our Star Buds operations to both Garden City and Fort Collins. We will operate a store within a store concept to serve both recreational consumers as well as medical patients. By bringing our operating playbook to two key cities in northern Colorado, it allows us to deliver our brands, product assortment and dedicated service to customers in expanded areas throughout the state,” said Collin Lodge, Colorado Division President of Schwazze.
Since April 2020, Schwazze has acquired, opened, or announced the planned acquisition of 60 cannabis retail dispensaries (bannered as Star Buds, Emerald Fields, R. Greenleaf, Standing Akimbo, and Everest) as well as six operating cultivation facilities and three manufacturing plants across Colorado and New Mexico. In May 2021, Schwazze announced its Biosciences division, and in August 2021, it commenced home delivery services in Colorado.
About Schwazze
Schwazze (OTCQX: SHWZ) (NEO: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition.
Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth. To learn more about Schwazze, visit www.Schwazze.com.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intends,” “plans,” “strategy,” “prospects,” “anticipate,” “believe,” “approximately,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” or the negative of these terms or other words of similar meaning in connection with a discussion of future events or future operating or financial performance, although the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) regulatory limitations on our products and services and the uncertainty in the application of federal, state, and local laws to our business, and any changes in such laws; (ii) our ability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (iii) our ability to identify, consummate, and integrate anticipated acquisitions; (iv) general industry and economic conditions; (v) our ability to access adequate capital upon terms and conditions that are acceptable to us; (vi) our ability to pay interest and principal on outstanding debt when due; (vii) volatility in credit and market conditions; (viii) the loss of one or more key executives or other key employees; and (ix) other risks and uncertainties related to the cannabis market and our business strategy. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.
Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
2023-1Q results continued a steady upward production trend and biannual gas price resetting that has lead to higher revenues, fund flow from operations, and earnings. Results were generally in line with expectations. Although gas sales and prices were previously disclosed, total revenues were slightly below expectations due to lower natural gas liquid pricing. Royalty rates fell sharply due to a restructuring and lower natural gas prices.
Sale decline further explained. April volumes averaged 1,972 boepd vs. 2023-1Q production of 2,767 boepd. Management cited reduced demand and higher nominated volumes from its partner in the Cabure unit. Sales in the Cabure field are subject to a partnership agreement based on reserves in the ground. Alvopetro’s partner can then nominate the amount of reserves that are sold from its “piggy bank.” Bahia Gas, the consumer of Alvopetro’s gas supply, can take gas on a firm or interruptible basis. For a 7-10 day period, it took gas primarily from firm customers decreasing the demand for other customers.
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Tokens.com Corp is a publicly traded company that invests in Web3 assets and businesses focused on the Metaverse, NFTs, DeFi, and gaming based digital assets. Tokens.com is the majority owner of Metaverse Group, one of the world’s first virtual real estate companies. Hulk Labs, a wholly-owned Tokens.com subsidiary, focuses on investing in play-to-earn revenue generating gaming tokens and NFTs. Additionally, Tokens.com owns and stakes crypto assets to earn additional tokens. Through its growing digital assets and NFTs, Tokens.com provides public market investors with a simple and secure way to gain exposure to Web3.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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Results. Tokens.com reported revenue of $303,217 compared to $326,320 in the prior year. Driven by a $2.6 million digital asset revaluation gain, operating income was $1.9 million compared to a loss of $3.2 million last year. Net income for the quarter was $1.7 million, or diluted EPS of $0.02, compared to $7.8 million, or $0.07. We estimated revenue of $115,000, operating loss of $482,000, and breakeven EPS.
Macro Environment. Tokens.com noted that the ETH Shapella upgrade showed an increase in staking activity, which results in lower yields but is countered with the increase in crypto prices over the last few months. We expect that staking revenue will remain volatile for Tokens.com’s ETH and DOT but will have increases quarter-over-quarter, assuming prices stay level or increase.
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With more than 60 units, RCI Hospitality Holdings, Inc., through its subsidiaries, is the country’s leading company in adult nightclubs and sports bars/restaurants. Clubs in New York City, Chicago, Dallas-Fort Worth, Houston, Miami, Minneapolis, Denver, St. Louis, Charlotte, Pittsburgh, Raleigh, Louisville, and other markets operate under brand names such as Rick’s Cabaret, XTC, Club Onyx, Vivid Cabaret, Jaguars Club, Tootsie’s Cabaret, Scarlett’s Cabaret, Diamond Cabaret, and PT’s Showclub. Sports bars/restaurants operate under the brand name Bombshells Restaurant & Bar.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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Second Quarter Results. RCI reported revenue of $71.5 million, up 12.3% from last year. Net income was $7.7 million, or EPS of $0.83 compared to $11 million, or $1.15, last year due to a legal settlement expense, goodwill impairment, and SG&A expenses. Adjusted EPS was $1.30 versus $1.19. Adjusted EBITDA was at $21.7 million versus $19.9 million last year. We estimated revenue of $71 million, net income of $10.6 million, EPS of $1.15, and adjusted EBITDA of $21.3 million.
A Busy Quarter. The Baby Dolls-Chicas Locas acquisition was completed. The steakhouse and casino project continued to move forward. The Company purchased another Central City property for development of another potential future casino. The San Antonio Bombshells location was purchased and development moved forward on locations in Colorado and Texas. These investments will help drive results going forward.
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Largo has a long and successful history as one of the world’s preferred vanadium companies through the supply of its VPURE™ and VPURE+™ products, which are sourced from one of the world’s highest-grade vanadium deposits at the Company’s Maracás Menchen Mine in Brazil. Aiming to enhance value creation at Largo, the Company is in the process of implementing a titanium dioxide pigment plant using feedstock sourced from its existing operations in addition to advancing its U.S.-based clean energy division with its VCHARGE vanadium batteries. Largo’s VCHARGE vanadium batteries contain a variety of innovations, enabling an efficient, safe and ESG-aligned long duration solution that is fully recyclable at the end of its 25+ year lifespan. Producing some of the world’s highest quality vanadium, Largo’s strategic business plan is based on two pillars: 1.) leading vanadium supplier with an outlined growth plan and 2.) U.S.-based energy storage business support a low carbon future.
Michael Heim, Senior Vice President, Equity Research Analyst, Energy & Transportation, Noble Capital Markets, Inc.
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Quarterly results reviewed. As indicated in an earlier report, first-quarter results were generally in line with expectations. Revenues ran a bit above expectations on favorable pricing, but costs were higher than expected as well.
Production and sales guidance reductions. Management reduced production and sales guidance by roughly 20% due to drilling delays caused by wet weather. Management explained that vanadium production requires blending, and we believe regular drilling is needed to identify blending supplies. Drilling has resumed, and management should have a better idea what production and sales could look like for the rest of 2024 soon.
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Motorsport Games, a Motorsport Network company, combines innovative and engaging video games with exciting esports competitions and content for racing fans and gamers around the globe. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”). Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
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Q1 results disappoint. The company reported its first quarter results, which were disappointing, but not unexpected. With the lack of current franchise game releases, total company revenues declined 48% to $1.7 million. Given the continued investment in game development, EBITDA loss increased to $4.6 million, well above our $2.2 million loss estimate.
A tough situation. Management is trying to get to the finish line of launching new franchise motorsport games, which should provide a significant revenue lift and generate positive cash flow. The largest opportunity for that prospect would be in the second quarter 2024 when it launches its new IndyCar game.
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Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
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Strong Q1 results. The company reported strong quarterly results. Revenue grew 87% from Q1 22 to $21.2 million, beating our estimate of $17.1 million by 24%. Additionally, Adj. EBITDA of $0.5 million surpassed our estimate of negative $0.2 million. The better than expected results were a product of strength in both Buy-side and Sell-side segments.
Buy-side excels. The company’s higher margin Buy-side segment reported revenue of $7.4 million, beating our estimate of $6.1 million by 22%. While Buy-side only comprises 35% of revenues, its margins are much higher than Sell-side and contributes to cash flow in a more meaningful way. Management attributed the success of its Buy-side segment to existing clients spending 20% to 30% more, and increasing is client base by 3%.
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Codere Online refers, collectively, to Codere Online Luxembourg, S.A. and its subsidiaries. Codere Online launched in 2014 as part of the renowned casino operator Codere Group. Codere Online offers online sports betting and online casino through its state-of-the art website and mobile application. Codere currently operates in its core markets of Spain, Italy, Mexico, Colombia, Panama and the City of Buenos Aires (Argentina). Codere Online’s online business is complemented by Codere Group’s physical presence throughout Latin America, forming the foundation of the leading omnichannel gaming and casino presence in the region.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
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Beats Q1 expectations. The company reported strong Q1 results with net gaming revenue (NGR) of €39.5 million and an adj. EBITDA loss of €2.3 million, compared with our forecast of €33.5 million and a loss of €9.2 million, respectively. The company achieved the favorable results after lowering its marketing spend to streamline its path to profitability.
Performing well in Mexico. Despite lower marketing spend, net gaming revenue (NGR) in Mexico continued to grow in Q1. NGR of €17.6 million was up 75% while the adj. EBITDA loss of €2.0 million, compared with a €7.7 million loss in the prior year period. The strong results in Mexico were driven by a 42% increase in active users and higher spend per active user.
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For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
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Margins improve. The company reported $417.6 million in revenue, 1.9% below our estimate of $425.8 million. But, importantly, adj EBITDA in the quarter was negative $5.5 million, beating our estimate of a loss of $13.1 million by 57.5%. Improved margins in the quarter were attributed to reduced ocean freight costs and some commodity price decreases.
Raises fiscal 2023 adj. EBITDA guidance. Management provided full year fiscal 2023 guidance of revenue down 8% and adj. EBITDA to be in the range of $85 million to $90 million, an increase from its previous guidance of $75 million to $80 million. In addition, the company reiterated that it will exceed $75 million in free cash flow.
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