Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results. Zero revenue and a loss of CAD$1.0 million, or a loss of $0.02/sh for 1Q23, similar to the 4Q22 loss. We had forecast revenue of CAD$1,000 and a net loss of CAD$924,066, or $0.02 per share. Until MustGrow receives regulatory approval in at least one market, we anticipate similar quarterly results going forward.
Janssen Re-Ups. Last week, Janssen PMP, a unit of Janssen Pharmaceuticals, signed an extension to test and develop MustGrow’s biological mustard plant-based technologies for certain postharvest food preservation storage applications globally. According to Janssen, “In post-harvest, the need for technologies derived from nature remains very high. Janssen PMP sees a great potential in the use of the MustGrow technology in extending shelf life of fruits and vegetables. This is the reason why we decided to extend our global exclusive partnership with MustGrow…” We believe such actions reflect positively on MustGrow and its products.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Reported Full Year Fiscal 2023. Yesterday, ChitogenX reported a loss per share of $0.13 (currencies in Canadian $), versus our expected $0.12 loss per share. The difference was primarily due to a $768,000 charge on converting the $3 million non-convertible debt into a convertible debenture, taken during the fourth quarter. Operationally, fourth quarter expenses were lower at $1.09 million versus our estimate of $1.29 million, with lower than estimated R&D costs the biggest factor.
Subsequent News. At fiscal yearend, the Company reported $108,000 in cash and equivalents. Subsequent to the yearend, ChitogenX raised about $5.3 million giving the Company some runway to develop both orthopedic and non-orthopedic applications. As a reminder, ChitogenX also secured a $3.47 million 4-year grant in February 2023 for regenerative medicine development and to accelerate the commercial readiness of the ORTHO-R platform.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Data Puts TNX-601 ER In The Spotlight. Tonix will be presenting data from the Phase 2 UPLIFT study at the American Society of Clinical Psychopharmacology (ASCP) meeting from May 30 to June 2, 2023. The presentation will provide an update on the UPLIFT trial testing TNX-601 EP, including data on the mechanism of action and the development of TNX-4300, the purified (S)-isomer of tianeptine.
Phase 2 UPLIFT Trial In Major Depression Disorder. TNX-601 is an extended-release formulation of tianeptine hemioxalate, a drug used for depression in Europe for over 30 years. The Phase 2 UPLIFT trial is a placebo-controlled trial with 6 weeks of once-daily dosing. The primary endpoint is mean change from baseline in the MADRS (Montgomery-Asberg depression rating scale) at week 6. Top-line results expected in 4Q23.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
ASCO Abstracts Contain Positive Data Update. On Friday, May 26, abstracts for the Annual Meeting of the American Society of Clinical Oncology (ASCO) were released. As we expected, the data update from the Phase 2 VERSATILE-002 trial showed consistent or improved response rates, overall survival, and progression free survival, with continued safety and tolerability. We believe these data support our expectations of efficacy in the Phase 3 trial, expected to begin in late 2023.
Data Updates Confirm and Support Preliminary Findings. The abstract contains updated interim results from the Phase 2 VERSATILE-002 trial testing the combination of PDS0101 with Keytruda (an anti-PD-1 immune checkpoint inhibitor from Merck). The data presentation will include 34 patients that have reached the 12-month evaluation point, compared with the data from 17 patients evaluated after 9 months presented at ASCO 2022. These new data show strong improvements over ICI monotherapy, the current standard of care, as well as efficacy and strong duration of benefits.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Out of compliance with minimum stockholders’ equity requirement. Baudax Bio received notice on November 18, 2022 that the minimum $2.5 million requirement, under Listing Rule 5550(b), was not met for continued Nasdaq listing. The Company was granted an extension until May 15, 2023 to comply.
Delist determination letter. On May 17, 2023, the Company received a delist determination letter from Nasdaq that the extension terms were not met. Specifically, proposed transactions were not completed, and evidence of compliance was not received by the May 15, 2023 deadline. From the letter, Nasdaq indicated the Company’s securities would be suspended from Nasdaq trading at the open of business May 26, 2023.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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.
Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q Results. Schwazze reported revenue of $40 million, an increase from last year’s $31.8 million. We had estimated revenue of $41.5 million. Schwazze reported net income, before preferred dividends, of $1.7 million, compared to a loss of $26.8 million last year. After preferred dividends, net loss was $283,965, or a loss of $0.01/sh, versus a loss of $28.5 million, or a loss of $0.61/sh, last year. Adjusted EBITDA was $14.5 million, or a margin of 36.3%, compared to $7.9 million, or 24.7%, last year.
Retail Solid, Wholesale Taking Baby Steps. Retail sales rose 35% to $35.8 million. In the Colorado wholesale market, flower pricing remains compressed but has begun to show signs of stability. Quarter-over-quarter wholesale sales grew 29% from $3.2 million in the fourth quarter of 2022 to $4.1 million in the first quarter of this year.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Summary. PDS Biotech reported 1Q23 loss of $9.7 million or $(0.32) per share. The company ended the quarter with $65.2 million in cash, which it expects to be sufficient to fund operations through 3Q24. The Phase 3 trial testing PDS0101 is expected to begin in 4Q23, and additional data from the Phase 2 VERSATILE-002 trial has been accepted for presentation at the ASCO meeting June 2 through June 6. The data will be also included in an expert panel discussion on head and neck cancer.
Phase 3 Trial Expected To Begin In 4Q23. An amended IND is expected to be filed in 3Q23 to begin the Phase 3 trial for PDS0101 in 4Q23 in patients with recurrent or metastatic head and neck cancer. The trial is designed to test the combination of PDS0101 and Keytruda against Keytruda monotherapy with primary endpoints of Overall Survival and PFS. Two interim analysis points are planned, which we anticipate may be designed to permit discussion of early application for approval with the FDA.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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 two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Onconova Updates Clinical Progress With 1Q23 Financial Report. Onconova reported a loss of $5.8 million or $(0.28) per share, and gave updates on its clinical programs including Phase 1 testing narazaciclib and several Phase 2 studies testing rigosertib. The company ended 1Q23 with $34.2 million in cash, which it projects to last into 1Q24.
Rigosertib Could Become An Orphan Drug. Results from two patients in an Investigator Initiated Trial testing rigosertib in a rare disease (RDEB-associated SCC, or recessive dystrophic epidermolysis bullosa-associated squamous cell carcinoma) were reported at a meeting of the Society of Investigative Dermatology in Osaka, Japan. Both patients had complete clinical responses of all cancerous lesions following treatment. Since this is a fatal disease with no effective therapy, the company has requested an FDA Type B meeting to review the data and discuss a pivotal study. An announcement is expected in 3Q23.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Progress Continues In Influenza and COVID-19 Programs. Cocrystal has been using its proprietary structure-based drug discovery and protein engineering technology to develop novel antiviral drugs. Its lead programs in influenza and COVID-19 (the SARS-CoV-2 virus) have reported progress and have new clinical trials ahead in 2023. Other programs are continuing through preclinical development.
Influenza Phase 2a Expected Shortly. Cocrystal has presented preliminary data from its Phase 1 trial for CC-42344 in influenza in December 2022. A Phase 2a trial testing the drug in a human challenge study is expected to begin in 2Q23. This study uses controlled conditions to test efficacy in healthy human volunteers, allowing for a smaller trial with less variance.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q 2023 reported. Last Friday, the Company reported GAAP EPS of $4.91 per share, as compared to our estimate of $5.75 per share. With the announced asset transfer of ANJESO and write-off of contingent liabilities owed Alkermes, Baudax Bio re-classified the ANJESO operations as discontinued. While showing a net loss operationally, the positive EPS was due to the removal of the Alkermes contingent consideration liability.
Higher expenses in the quarter. The higher than expected expenses consisted primarily of a $2.1 million loss on extinguishment of debt related to the previously disclosed amended credit agreement, and remaining discontinued operation property and equipment write-offs. In addition, continuing operation expenses were $223,000 higher than our estimate, related to higher neuromuscular blocker R&D expenditures.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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1Q23 Reported Within Expectations. Tonix reported a 1Q23 loss of $33.0 million or $(0.52) per share, consistent with our expectations of a loss of $34.8 million or $(0.57) per share. During the quarter, the company reported a shift in pipeline priorities toward its CNS programs and discontinuation of some early-stage programs. There are several clinical data presentations expected during 2H23 that we see as potential drivers of the stock in 2H23. The company ended the quarter with $72.0 million in cash.
Looking Forward To Phase 3 Results In Fibromyalgia. Data was presented for the completed RELIEF Phase 3, the first of the two studies needed for an NDA. The interim analysis for the Phase 3 RESILIANT trial has been cancelled, avoiding the “statistical penalty” for the early analysis as well as saving time and money. The RESILIANT data announcement is expected in 4Q23.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
1Q23 Loss Reported With Progress Review. Maia Biotechnology announced a 1Q23 loss of $4.1 million or $(0.38) per share. Progress during the quarter included announcement of preliminary safety data from its lead trial in non-small cell lung cancer, THIO-101, and patient enrollment in Part B. Preclinical data was presented on THIO in liver cancer, an indication planned for the THIO-102 trial later in 2H23. Cash on March 31 was $7.6 million, excluding $5.75 million raised in a public offering completed in late April.
THIO-101 Part A Safety Results Were Presented. THIO-101 is the first trial testing THIO in combination with Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron. The data was from the Part A safety lead-in stage that tested a dose of 360 mg in 6 patients with advanced non-small cell lung cancer. There were no dose-limiting toxicities or safety issues reported. As of April 2023, the first two patients enrolled in Part A were still alive and reached survival endpoints of 10 and 9 months. Both patients have advanced Stage IV metastatic disease and had failed third and fourth line of therapy, with life expectancy of about 6 months.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
