Axcella Therapeutics (AXLA) – Down But Not Out After Restructuring


Friday, December 16, 2022

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Axcella Restructures and Reprioritizes Operations. Axcella has announced a corporate restructuring with changes to its development plans for AXA1125. The Phase 2b trial in NASH has been discontinued while the Long COVID Fatigue indication will move forward. Staff has been reduced by 85%. These actions should allow the operations to continue as strategic alternatives are evaluated.

Focus On Long COVID Fatigue. In August 2022, Axcella announced Phase 2a trial data for AXA1125 in Long COVID Fatigue patients, with data showing promising improvements in physical and mental fatigue. The company plans to continue discussions with the FDA and European regulators to design the next trial and requirements for an application for approval.


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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. 

Release – Genprex Receives Safety Review Committee Approval to Proceed to Final Cohort in Acclaim-1 Phase 1 Dose Escalation Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer

Research, News, and Market Data on GNPX

December 14, 2022

Recommendation to Advance to Increased Dose in Third and Final Cohort of Phase 1 Portion of Trial Indicates Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer

AUSTIN, Texas — (December 14, 2022) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the Safety Review Committee (SRC) has approved continuation to the third and final cohort in the dose escalation Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial of REQORSA® in combination with Tagrisso® (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC). In 2020, the combination of REQORSA and osimertinib received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.

Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Tagrisso (osimertinib) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso. 

The SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continues at the same dose or at a lower dose, that it escalates to a higher dose, or that the study be terminated altogether due to safety concerns.

“The SRC’s recommendation to increase the dosing of REQORSA is further confirmation of its favorable safety profile and it enables us to advance Acclaim-1 into the final cohort of the Phase 1 dose escalation portion of the study,” said Mark Berger, M.D., Chief Medical Officer of Genprex. “We look forward to completing enrollment of this final cohort in the first quarter of 2023.”

The Accaim-1 trial includes up to three sequential dose escalation cohorts that will treat study participants with REQORSA intravenously on Day 1 in addition to osimertinib 80 mg fixed dose oral daily tablet during 21-day treatment cycles until disease progression or unacceptable toxicity. The first group received REQORSA IV infusion at 0.06 mg/kg, the second group received 0.09 mg/kg, and the third group will receive 0.12 mg/kg.  

Following successful completion of the Phase 1 dose escalation portion of the Acclaim-1 study, the Company will advance into the dose expansion portion of the study, which will evaluate  the toxicity profile of REQORSA in combination with Tagrisso in patients with different eligibility criteria, and will also evaluate efficacy and other endpoints.

“The principal advantage of adding the dose expansion portion to Acclaim-1 is to gain efficacy data earlier than we would otherwise have received it from the Phase 2 portion of the study. We also will receive this data in the two distinct patient populations represented by the two expansion cohorts, which we believe will further increase the likelihood of a successful Phase 2 trial,” added Dr. Berger.  

About Acclaim-1

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso. Genprex expects the dose escalation Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients to determine the maximum tolerated dose of the combination.  The dose expansion Phase 1 portion of the study will then enroll 66 patients, half of whom will be patients who had received only prior Tagrisso treatment and the other half patients who had received prior Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort.   The Phase 2 portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or Tagrisso monotherapy. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 25 events.

About REQORSA® Immunogene Therapy

REQORSA Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC) uses Genprex’s unique, proprietary ONCOPREX® Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials. The plasmid portion of REQORSA contains the TUSC2 gene, a tumor suppressor gene. REQORSA consists of the TUSC2 gene containing plasmid encapsulated in a nanoparticle made from lipid molecules with a net positive electrical charge. REQORSA is injected intravenously and is preferentially taken up by cancer cells. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.

Tagrisso® is a registered trademark of AstraZeneca plc and its largest selling drug with 2021 sales of over $5 billion.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company’s lead product candidate, REQORSA® (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K for the year ended December 31, 2021.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships, including those with its third party manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex’s intellectual property and licenses. 

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

GNPX Investor Relations

investors@genprex.com

GNPX Media Contact

Kalyn Dabbs

media@genprex.com

DLH Holdings (DLHC) – Turbocharging Growth


Friday, December 09, 2022

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, Senior Research Analyst, 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.

Acquisition. Last night, DLH announced the acquisition of privately-held Grove Resource Solutions (GRSi). The acquisition broadens DLH’s digital transformation and IT modernization solutions, paving the way for new growth opportunities, in our view. GRSi provides a broad array of cloud-based enterprise modernization and cyber security solutions to numerous civilian and military federal agencies.

Details. Cost is $185 million, broken out to $178 million of cash and $7 million of DLH equity. Net cost after transaction-related tax benefits is $157.9 million. GRSi is expect to add $140 million of revenue and $18.5 million of EBITDA in year one and is expected to be accretive in fiscal 2024. The purchase price is approximately 10x 2023 projected EBITDA, or 8.5x after including tax benefits. The acquisition is being financed through an expansion of DLH’s credit facility.


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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. 

Release – Baudax Bio Initiates Phase II Clinical Trial Evaluating BX1000 in Patients Undergoing Surgery

Research, News, and Market Data on BXRX

December 08, 2022 8:00am EST

MALVERN, Pa., Dec. 08, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on innovative products for hospital and related settings, today announced the initiation of a clinical study evaluating the safety, tolerability profile, and intubation conditions of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.

This randomized, double-blind clinical trial will study BX1000 in approximately 80 adult patients, 18-65 years of age, who undergo elective surgery utilizing total intravenous anesthesia (TIVA) in an outpatient setting. Patients will undergo elective surgery with an intravenous (IV) line for anesthesia and study drug administration. Once anesthetized, neuromuscular monitoring will be initiated via electromyography (EMG), and approximately 3-5 minutes after induction of anesthesia, the randomized NMB treatment will be administered as an IV bolus. Intubation conditions will be assessed at 60 seconds after administration of the NMB dose and will be reassessed at 90 and 120 seconds if needed, with tracheal intubation performed when clinically acceptable conditions are identified. These “intubating conditions” represent the endpoint for NDA approval for NMB agents. Following successful tracheal intubation, patients will proceed to undergo their elective surgical procedures according to the standard practice of the investigator or surgical unit. Patients will be monitored post-surgery in the anesthesia recovery area and will be transferred to the inpatient facility where they will remain for at least 8 hours following NMB administration, to be discharged at the discretion of the investigator. There will be an in-person follow-up visit and several telephonic safety follow ups as well.

“The initiation of this Phase II clinical study in patients undergoing elective surgery is an important step for the overall NMB program, and we look forward to data on BX1000’s safety, tolerability, and neuromuscular blocking profile,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “We believe that BX1000, in combination with BX3000 (reversal agent), may permit precise control of the time patients are under neuromuscular paralysis. This could be significantly impactful for patients, surgeons, and anesthesiologists by enhancing safety, and possibly saving time and reducing costs related to delayed recovery from neuromuscular paralysis following surgical procedures. To date, no serious adverse events have been reported in the first group of patients enrolled and efficacy parameters have been recorded. We look forward to announcing the completion of the pre-planned first interim analysis of the BX1000 Phase 2 surgery trial early in 2023, with a target of completing full study enrollment by the end of March, 2023.”

About Baudax Bio’s Neuromuscular Blocking Agents (NMBs)

Baudax Bio holds exclusive global rights to two novel NMBs, BX1000, an intermediate duration, clinical stage agent, and BX2000, an ultra-short duration, clinical stage agent, as well as a proprietary chemical reversal agent, BX3000, undergoing nonclinical studies intended to support an IND filing in 2023. BX3000 is a specific reversal agent that rapidly reverses BX1000 and BX2000. All three agents are licensed from Cornell University. Used together, we believe these agents allow for a very rapid induction of neuromuscular blockade for surgical settings, followed by a rapid reversal of the neuromuscular blockade. These novel agents have the potential to meaningfully reduce procedure recovery time in operating rooms or post-acute care settings, resulting in valuable cost savings to hospitals and ambulatory surgical centers.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one in a Phase II study and an additional unique NMB in a dose escalation Phase I study, as well as a proprietary chemical reversal agent specific to these NMBs. Baudax Bio has received approval for and marketed ANJESO®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-opioid, non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. 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 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. Forward-looking statements may include, without limitation, statements regarding the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including Baudax Bio’s ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. 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, 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 comply with all listing requirements of 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.

CONTACT:

Investor Relations Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Source: Baudax Bio, Inc.

Released December 8, 2022

Ocugen (OCGN) – OCU400 Gene Therapy Trial Moving Forward With Highest Dose


Thursday, December 08, 2022

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

DSMB Recommends MTD and Further Treatment.  Ocugen has announced that patient data from the Phase 1/2 trial testing OCU400 in retinitis pigmentosa (RP) has been reviewed by its Data Safety and Monitoring Board (DSMB).  The highest dose of the three tested was determined to be the maximum tolerated dose (MTD).  The DSMB found no serious adverse events (SAEs) in the treated cohorts, and recommended treating patients in the expansion phase at the highest dose. 

Additional Patients To Be Treated. The OCU400 Phase 1/2 trial has treated patient cohorts at three dose levels. These patients have gene mutations associated with RP (NR2E3 and RHO) that control and regulate expression of genes that act in later pathways. A total of 10 patients have been treated, with an additional 8 patients to be added. A cohort of 3 patients with a different mutation, CEP290, associated with Leber congenital amaurosis (LCA) are also being added. Enrollment is expected to be complete by 1Q23.


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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 (BXRX) – Closing of $5 million Public Offering is Announced


Wednesday, December 07, 2022

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 Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Gross proceeds of nearly $5 million or net proceeds around $4.2 million.  The offering consisted of 1,042,087 shares of common stock (or Series C pre-funded warrants) combined with both a Series A-3 warrant to purchase 1,042,087 common shares and a Series A-4 warrant to purchase 1,042,787 common shares.  The combined unit was publicly offered at $4.795 per unit. The pre-funded warrants were offered to purchasers where the offering would result in beneficial ownership greater than 4.99% (or, at the election of the purchaser, 9.99%).

Warrants exercisable at $4.50 per share.  The Series C pre-funded warrants are exercisable at $0.01 per share. The Series A-3 warrants are exercisable immediately and will expire 5 years from date of issuance.  The Series A-4 warrants are exercisable immediately and expire 13 months from date of issuance.


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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. 

Release – Baudax Bio Announces Closing of $5 Million Public Offering

Research, News, and Market Data on BXRX

December 06, 2022 4:11pm EST

MALVERN, Pa., Dec. 06, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on innovative products for hospital and related settings, today announced the closing of its previously announced public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-4 warrants have an exercise price of $4.50 per share, are exercisable immediately upon issuance and will expire thirteen months from the date of issuance.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $5 million. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-268251), which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 2, 2022. The offering was made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 374,114 shares of common stock of the Company that were previously issued to an investor in November 2020, January 2021, June 2021, December 2021, March 2022, May 2022 and September 2022, at exercise prices ranging from $21.00 to $43.60 per share and expiration dates ranging from October 2023 to September 2027, were amended effective upon the closing of the offering so that the amended warrants have a reduced exercise price of $4.50 per share and will expire five years following the closing of the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one in a Phase II study and an additional unique NMB in a dose escalation Phase I study, as well as a proprietary chemical reversal agent specific to these NMBs. Baudax Bio has received approval for and marketed ANJESO®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-opioid, non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. 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 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. Forward-looking statements may include, without limitation, statements regarding the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including Baudax Bio’s ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. 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, 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 comply with all listing requirements of 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.

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com 

Source: Baudax Bio, Inc.

Released December 6, 2022

Schwazze (SHWZ) – A New Location


Tuesday, December 06, 2022

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, Senior Research Analyst, 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.

A New Dispensary. Yesterday, Schwazze announced the opening of a new dispensary in New Mexico. Located at 2245 Main Street in Los Lunas, the dispensary brings the total of New Mexico dispensaries to 14. The opening continues Schwazze’s expansion strategy within New Mexico, and we expect to see more opening and/or acquisitions in the future, especially near Albuquerque and the Texas-New Mexico border.

Being Positive. We hosted the Company’s CEO Justin Dye and CFO Nancy Huber in a series of Non-Deal Road Show meetings last week, and following are a couple of highlights from the meeting. Significantly, management noted the Company is one of only six MSOs to generate positive cashflow, of which the Company generated $14.5 million from operations LTM as of 3Q 2022.


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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. 

DLH Holdings (DLHC) – Reported Fourth Quarter and Full Year 2022 Results


Tuesday, December 06, 2022

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, Senior Research Analyst, 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.

4QFY22 Results. Revenue totaled $67.2 million, up from $66.4 million in 3Q22 and up from $65.2 million in the year ago period. The 3% top line growth, or 6% excluding 4Q21 FEMA revenue, reflects continued expansion of existing core contracts as the FEMA business has been completed. Earnings were $3.4 million, or $0.24 per diluted share, compared to $2.9 million, or $0.21 per diluted share last year. EBITDA was $6.6 million, or 9.8% of revenue, compared to $6.0 million and 9.3% last year. We had projected revenue of $67 million, EBITDA of $7.0 million, and EPS of $0.25.

Full Year FY2022. FY2022 results were positively impacted by the FEMA business. DLH reported full year revenue of $395.2 million, operating income of $33.3 million, net income of $23.2 million, EPS of $1.64, and EBITDA of $40.9 million. Excluding the FEMA contribution, for FY2022 DLH would have reported revenue of $269.4 million, operating income of $20.8 million, net income of $14.1 million, EPS of $0.99, and EBITDA of $28.5 million.


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Release – DLH Reports Fiscal 2022 Fourth Quarter Results

Research, News, and Market Data on DLH

 

December 5, 2022

PDF Version

Revenue of $67.2 Million for Quarter, $395.2 Million for Fiscal Year; Debt Reduced to $22.0 Million

ATLANTA, Dec. 05, 2022 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of innovative healthcare services and solutions to federal agencies, today announced financial results for its fiscal fourth quarter ended September 30, 2022.

Highlights

  • Fourth quarter revenue increased to $67.2 million in fiscal 2022 from $65.2 million in fiscal 2021, reflecting growth of 3% year-over-year
  • For the full fiscal year, revenue rose to $395.2 million from $246.1 million, reflecting the previously announced short term FEMA contracts to support Alaska, which contributed $125.8 million to revenue in the fiscal year
  • Excluding these short-term contracts, revenue grew to $269.4 million, an increase of 10% over the prior year, reflecting volume growth on existing contracts
  • Earnings were $3.4 million, or $0.24 per diluted share, for the fiscal 2022 fourth quarter versus $2.9 million, or $0.21 per diluted share, for the fourth quarter of fiscal 2021
  • Earnings for the full year were $23.3 million, or $1.64 per diluted share for fiscal 2022 as compared to earnings for fiscal 2021 of $10.1 million, or $0.75 per diluted share.
  • Excluding the FEMA contracts, earnings on a non-GAAP basis for the full fiscal year were $14.1 million, or $0.99 per diluted share, versus $10.0 million, or $0.74 per diluted share, for fiscal 2021
  • The Company’s secured term loan was reduced from $46.8 million to $22.0 million during the fiscal year
  • Contract backlog was $482.5 million as of September 30, 2022 versus $651.5 million at the end of the prior fiscal year, with approximately $85 million of the latter related to the FEMA contracts

Management Discussion
“Fiscal 2022 was a year that, once again, demonstrated the strength of our people, the ability of our platform to deliver excellent results and the agility of the Company’s advanced technological capabilities, driving us to record performance and positioning us well for the quarters to come,” said DLH President and Chief Executive Officer Zach Parker. “We begin fiscal 2023 with a healthy backlog of $482.5 million representing our diverse programs across numerous agencies in the markets we serve. In addition, we further paid down debt, leaving the Company with a solid balance sheet and the financial flexibility to fund business growth initiatives and invest in our people. As we look towards the future, I’d like to thank our employees for a standout year as you continue to support critical efforts and programs that support our nation. Given the longstanding demand for our services, broad bipartisan support in Congress, and our innovative, data-driven solutions, we remain optimistic about the quarters to come.”

Results for the Three Months Ended September 30, 2022
Revenue for the fourth quarter of fiscal 2022 was $67.2 million versus $65.2 million in the prior-year period. The 3% increase year-over-year reflects continued growth across the Company’s existing contracts.

Income from operations was $4.7 million for the quarter versus $4.0 million in the prior-year period and, as a percent of revenue, the Company reported an operating margin of 7.0% in fiscal 2022 fourth quarter versus 6.2% in same period in fiscal 2021. Income from operations increased due to higher revenue and improved program mix, offset by investments in the human capital and business development functions and increased compliance costs.

Interest expense was $0.5 million in the fiscal fourth quarter of 2022 versus $0.8 million in the prior-year period, reflecting the decrease of debt outstanding. Income before provision for income taxes was $4.2 million this year versus $3.2 million in fiscal 2021, representing 6.3% and 5.0% of revenue, respectively, for each period.

For the three months ended September 30, 2022 and 2021, respectively, DLH recorded a $0.8 million and $0.3 million provision for income taxes. The Company reported net income of approximately $3.4 million, or $0.24 per diluted share, for the fourth quarter of fiscal 2022 versus $2.9 million, or $0.21 per diluted share, for the fourth quarter of fiscal 2021. As a percent of revenue, net income was 5.1% for the fourth quarter of fiscal 2022 versus 4.4% for the prior year period.

On a non-GAAP basis, EBITDA for the three months ended September 30, 2022 was approximately $6.6 million versus $6.0 million in the prior-year period, or 9.8% and 9.3% of revenue, respectively.

Key Financial Indicators
For the 2022 fiscal year, DLH produced $1.2 million in operating cash, reflecting the impact of the $22.3 million deferred revenue on the previously-completed FEMA contracts, for which there were advance payments in the fourth quarter of fiscal 2021. The overall increase in accounts receivable versus the prior-year period reflects normal fluctuations in the timing of customer payments and growth in the overall business volume.

As of September 30, 2022, the Company had cash of $0.2 million and debt outstanding under its credit facilities of $22.0 million versus cash of $24.1 million and debt outstanding of $46.8 million as of September 30, 2021.

At September 30, 2022, total backlog was approximately $482.5 million, including funded backlog of approximately $98.9 million, and unfunded backlog of $383.5 million.

Conference Call and Webcast Details
DLH management will discuss fourth quarter results and provide a general business update, including current competitive conditions and strategies, during a conference call beginning at 10:00 AM Eastern Time today, December 5, 2022. Interested parties may listen to the conference call by dialing 888-347-5290 or 412-317-5256. Presentation materials will also be posted on the Investor Relations section of the DLH website prior to the commencement of the conference call.

A digital recording of the conference call will be available for replay two hours after the completion of the call and can be accessed on the DLH Investor Relations website or by dialing 877-344-7529 and entering the conference ID 3802471.

About DLH

DLH (NASDAQ:DLHC) delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,400 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH`s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. These statements reflect our belief and assumptions as to future events that may not prove to be accurate. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the impact of the novel coronavirus (“COVID-19”), including the measures to reduce its spread, and its impact on the economy and demand for our services, are uncertain, cannot be predicted, and may precipitate or exacerbate other risks and uncertainties; the risk that we will not realize the anticipated benefits of acquisitions; the challenges of managing larger and more widespread operations; contract awards in connection with re-competes for present business and/or competition for new business; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the ability to successfully integrate the operations of acquisitions; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.

Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.

CONTACTS:

INVESTOR RELATIONS
Contact: Chris Witty
Phone: 646-438-9385
Email: cwitty@darrowir.com

TABLES TO FOLLOW

DLH HOLDINGS CORP.
CONSOLIDATED STATEMENTS OF INCOME
(Amounts in thousands except per share amounts)

DLH HOLDINGS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands except par value of shares)

DLH HOLDINGS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)

Non-GAAP Financial Measures
The Company uses EBITDA and EBITDA as a percent of revenue as supplemental non-GAAP measures of performance. We define EBITDA as net income excluding (i) interest expense, (ii) provision for or benefit from income taxes and (iii) depreciation and amortization. EBITDA as a percent of revenue is EBITDA for the measurement period divided by revenue for the same period.

The Company is presenting additional non-GAAP measures to describe the impact from two short-term FEMA task orders on its financial performance for the three and twelve months periods ended September 30, 2022. The measures presented are revenue, operating income, net income, diluted earnings per share, and EBITDA for our enterprise contract portfolio less the respective performance on the FEMA task orders. These resulting measures present the remaining contract portfolio’s quarterly financial performance compared to results delivered in the prior year period. Definitions of these additional non-GAAP measures are set forth in the footnotes to the reconciliation table below.

These non-GAAP measures of performance are used by management to conduct and evaluate its business during its review of operating results for the periods presented. Management and the Company’s Board utilize these non-GAAP measures to make decisions about the use of the Company’s resources, analyze performance between periods, develop internal projections and measure management performance. We believe that these non-GAAP measures are useful to investors in evaluating the Company’s ongoing operating and financial results and understanding how such results compare with the Company’s historical performance.

(a): Revenue for the Company’s remaining contract portfolio less the FEMA task orders represents our consolidated revenues less the revenues generated from the FEMA task orders.

(b): Operating income attributable to the remaining contract portfolio less the FEMA task orders represents the Company’s consolidated operating income, determined in accordance with GAAP, less the operating income derived from the FEMA task orders. Similarly, for the year ended September 30, 2022 operating income for the FEMA task orders is derived by subtracting from the revenue attributable to the tasks orders of $125.8 million the following amounts associated with such task orders: contract costs $112.1 million and general & administrative costs of $1.2 million.

(c): Net income attributable to the remaining contract portfolio less the FEMA task orders represents the Company’s consolidated net income, determined in accordance with GAAP, less the net income derived from the FEMA task orders. For the year ended September 30, 2022 net income for the FEMA task orders is derived by subtracting from the revenue attributable to the tasks orders of $125.8 million the following amounts associated with such task orders: contract costs of $112.1 million, general & administrative costs of $1.2 million, and provision for income taxes of $3.2 million.

(d): Diluted earnings per share (diluted EPS) for the FEMA task orders is calculated using the net income attributable to such task orders as opposed to GAAP net income. Diluted EPS for the remaining contract portfolio (total contract portfolio excluding the FEMA task orders) is calculated by subtracting the diluted EPS for the FEMA task orders from the Company’s total diluted EPS.

(e): EBITDA attributable to the FEMA task orders of $12.5 million for the year ended September 30, 2022, is arrived at through the same calculation as operating income as there are not any depreciation and amortization costs attributable to the FEMA task orders. EBITDA for the remaining contract portfolio is calculated by subtracting the EBITDA attributable to the FEMA task orders from the Company’s total EBITDA.

MustGrow Biologics Corp. (MGROF) – Reports Third Quarter Results


Monday, December 05, 2022

Joe Gomes, Senior Research Analyst, 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.

3Q Results. MustGrow reported revenue of $1,308 (all figures in Canadian dollars) in the third quarter of 2022 versus our estimate of zero, as the Company is still in the pre-revenue stage. The Company reported a net loss of $2.13 million, or a loss of $0.04 per share, compared to our estimate of a net loss of $1.32 million or a loss of $0.03 per share. In the year ago period, MustGrow reported revenue of $12,869 and a net loss of $696,115, or a loss of $0.02 per share.

ExpensesThe increase in the net loss was driven by a large increase year-over-year in the stock-based compensation line, from $112,469 to $1.11 million, and higher than our estimate of $200,000. All other expenses were roughly in line with our expectations, although we note that the Company can experience fluctuations in expenses due to the regulatory approval processes.


Get the Full Report

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. 

GABY (GABLF) – Early Indications of Improving Operating Environment


Monday, December 05, 2022

GABY Inc. is a California-focused retail consolidator and the owner of Mankind Dispensary, one of the oldest licensed dispensaries in California. Mankind is a well-known, and highly respected dispensary with deep roots in the California cannabis community operating in San Diego, California. GABY curates and sells a diverse portfolio of products, including its own proprietary brands, Lulu’s™ and Kind Republic™ through Mankind, manufactures Kind Republic, and distributes all its proprietary brands through its wholly owned subsidiary, GABY Manufacturing. A pioneer in the industry with a multi-vertical retail foundation, and a strong management team with experience in retail, consolidation, and cannabis, GABY is poised to­­­ grow its retail operations both organically and through acquisition.

Joe Gomes, Senior Research Analyst, 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.

3Q22 Revenue. GABY reported third quarter revenue of $5.35 million (all figures in U.S. $), down from $7.6 million reported last year, although adjusted for the closure of the wholesale distribution business, revenue was down $1.3 million, or 20%. Net loss was $3.76 million, or a loss of $0.01 per share, compared to a loss of $3.41 million, or a loss of $0.01 per share, year-over-year. A still difficult operating environment due to lower pricing and reduced demand combined with increased competition and forex losses impacted results.

A Ray of Light? Notably, on a sequential basis, revenue was up $0.2 million, or 4%, from the second quarter of 2022, potentially indicating an upturn in the depressed California market. Gross margin increased to 46.5% from 43.2%, sequentially, and was up from 39.3% year-over-year. The Mankind dispensary experienced a 2.5% growth in the number of transactions to 74,331, with a consistent average transaction value of $70 when comparing 2Q22 with 3Q22. 


Get the Full Report

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. 

Release – Baudax Bio Announces Pricing of $5 Million Public Offering

Research, News, and Market Data on BXRX

December 02, 2022 2:46pm EST

MALVERN, Penn., Dec. 02, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the pricing of a public offering of an aggregate of 1,042,787 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-3 warrants to purchase up to 1,042,787 shares of common stock and Series A-4 warrants to purchase 1,042,787 shares of common stock, at a combined public offering price of $4.795 per share (or pre-funded warrant) and accompanying warrants. The Series A-3 warrants will have an exercise price of $4.50 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance, and the Series A-4 warrants will have an exercise price of $4.50 per share, will be exercisable immediately upon issuance and will expire thirteen months from the date of issuance. The closing of the offering is expected to occur on or about December 6, 2022, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5 million. The Company intends to use the net proceeds from this offering for working capital, pipeline development activities and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-268251), which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 2, 2022. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 374,108 shares of common stock of the Company that were previously issued to an investor in November 2020, January 2021, June 2021, December 2021, March 2022, May 2022 and September 2022, at exercise prices ranging from $21.00 to $43.60 per share and expiration dates ranging from October 2023 to September 2027, will be amended effective upon the closing of the offering so that the amended warrants will have a reduced exercise price of $4.50 per share and will expire five years following the closing of the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for hospital and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one in a Phase II study and an additional unique NMB in a dose escalation Phase I study, as well as a proprietary chemical reversal agent specific to these NMBs. Baudax Bio has received approval for and marketed ANJESO®, the first and only 24-hour, intravenous (IV) COX-2 preferential non-opioid, non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. 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 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. Forward-looking statements may include, without limitation, statements regarding the consummation of the offering, the satisfaction of the closing conditions of the offering and the use of net proceeds therefrom. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including Baudax Bio’s ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. 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, 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 comply with all listing requirements of 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.

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com 

Source: Baudax Bio, Inc.

Released December 2, 2022