Lineage Cell Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

Research, News, and Market Data on Lineage Cell Therapeutics

• Advanced RG6501 (OpRegen^®)
  Development in Partnership with Roche and Genentech
• Published OPC1 Phase 1/2a Clinical Study
  Results in Journal of Neurosurgery: Spine
• Completed Key Activities to Support Planned
  Regulatory Interactions for OPC1 and VAC2
• Expanded Collaboration with Advanced BioMatrix
  for HyStem^® Cell Drug Delivery Technology
• Cash, Cash Equivalents, and Marketable
  Securities of $72.0 Million as of June 30,
  2022 Expected to Provide Capital Through Q2 2024

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 11, 2022– Lineage Cell
Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the second quarter of 2022. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

“We are pleased with the progress on RG6501 (OpRegen) product development under our collaboration with Roche and Genentech. During the second quarter this year, we have made progress across multiple functional areas, including clinical, regulatory, and technology transfer activities,” stated Brian M. Culley, Lineage CEO. “As we continue to position Lineage as a leader in regenerative medicine through the transplant of specific cell types, our focus is on completing the necessary clinical, regulatory and related activities which can create value and reduce risk across our portfolio of five cell transplant assets. In particular, our efforts have been focused on preparing for OPC1 and VAC2 regulatory interactions to enable their next phases of clinical testing in spinal cord injury and oncology, respectively. In parallel, we are advancing our auditory neuron and photoreceptor programs through preclinical development activities which are necessary to support initial clinical testing. We believe our disciplined use of capital and our increased strategic business development activities can support multiple years of growth and the achievement of important milestones in the months and years to come.”

Second quarter milestones and activities included:

– RG6501 (OpRegen)

• Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including:
  • Conducting additional OpRegen manufacturing runs and supporting Chemistry Manufacturing and Controls (CMC) activities.
  • Continuing technology transfer activities.
  • Actively participating in both Joint Advisory and Joint Manufacturing Committees, forums for discussion and planning with respect to next steps in clinical development and related activities.
• Continuing long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
  • Enrolled patients have continued to do well, supporting multi-year durability of a treatment effect with RG6501 (OpRegen).

– OPC1

• Results from a Phase 1/2a clinical study in subacute cervical spinal cord injury were 
  published in the 
  Journal of Neurosurgery: Spine;
  • OPC1 has demonstrated an excellent safety profile, and at one-year post-treatment, 96% of patients had recovered one or more levels of neurological function on at least one side of their body, and 32% of patients had recovered two or more levels of neurological function on at least one side of their body.
• Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, has demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
• A majority of the verification and validation activities for the novel parenchymal spinal delivery (PSD) system, and its preclinical testing in support of a regulatory submission have been completed.
• Preclinical activities to support upcoming regulatory interactions are near completion.
• Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates, is underway.

– VAC2

• Following technology transfer of the program from Cancer Research UK (CRUK) to Lineage and improvement of manufacturing processes, production scale was increased and accordingly the cost of goods has been reduced significantly, along with marked improvements in the purity and functionality of the manufactured material.
• CRUK continues to follow patients on the Phase 1 NSCLC clinical study; Lineage has received all necessary clinical information from CRUK required to support U.S., or other, regulatory interactions.

– ANP1 & PNC1

• Preclinical activities are continuing, including thought leader engagement to support future preclinical testing.

– Business Development

• Broadened collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for the HyStem delivery technology to include clinical/commercial GMP (Good Manufacturing Practice) material, increasing the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.
• Continued work under our collaboration with our strategic partner, Immunomic Therapeutics (“ITI”); currently awaiting decision on next steps for ITI’s allogeneic cell-based cancer immunotherapy for the treatment of glioblastoma based on the VAC platform.

Some of the key upcoming milestones and activities anticipated
by Lineage include:

– Planned interaction with FDA in Q4 2022 to discuss an OPC1 IND amendment submission to enable clinical performance and safety testing of a novel PSD system.

– A pre-IND regulatory interaction in Q4 2022 to seek feedback on a VAC2 CMC, nonclinical, and clinical package to support U.S. clinical development; pre-IND briefing package submission in Q3 2022.

– Submission of a grant application to the California Institute for Regenerative Medicine (CIRM) for the continued support of the clinical development of OPC1.

– Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer (NSCLC) study, pending release from CRUK.

– Preclinical activities for both the ANP1 and PNC1 programs.

– Additional OPC1 publications, including preclinical study results utilizing a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process.

– An additional OPC1 manuscript from a Phase 1/2a clinical study in subacute cervical spinal cord injury, focused on MRI data.

– Evaluation of new partnership opportunities and/or expansion of existing collaborations.

– Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $72 million as of June 30, 2022, which is expected to support operations through Q2 2024.

Second Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended June 30, 2022 were approximately $4.6 million, a net increase of $4.0 million as compared to $0.5 million for the same period in 2021. The increase was primarily related to licensing fees recognized from deferred revenues in connection with the $50.0 million upfront licensing payment received in the first quarter of 2022 from Roche.

Operating Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A”) expenses. Total operating expenses for the three months ended June 30, 2022 were $8.6 million, an increase of $1.1 million as compared to $7.5 million for the same period in 2021.

R&D Expenses: R&D expenses for the three months ended June 30, 2022 were $3.3 million, a net increase of $0.4 million as compared to $2.9 million for the same period in 2021. The net increase was driven by $0.1 million in higher OpRegen related expenses to support the Roche Collaboration. Another $0.2 million and $0.1 million of the increase was related to R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.

G&A Expenses: G&A expenses for the three months ended June 30, 2022 were $5.3 million, a net increase of approximately $0.7 million as compared to $4.5 million for the same period in 2021. The increase was primarily attributable to $0.4 million in payroll and related benefits expense, and $0.5 million in share-based compensation, partially offset by $0.2 million in lower investor relations expense.

Loss from Operations: Loss from operations for the three months ended June 30, 2022 was $4.2 million, a decrease of $2.9 million as compared to $7.1 million for the same period in 2021.

Other Income/(Expenses), Net: Other income (expenses), net for the three months ended June 30, 2022 reflected other expense, net of ($2.5) million, compared to other income, net of $2.1 million for the same period in 2021. The net change was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries, as well as a decrease in the value of marketable equity securities, and partially offset by the gain on extinguishment of debt from Lineage’s Paycheck Protection Program loan forgiveness recognized in the prior year’s quarter.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2022 was $6.8 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $4.8 million, or $0.03 per share (basic and diluted), for the same period in 2021.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: our ability to support our operations for at least two years with our existing cash, cash equivalents and marketable securities; our ability to create value and reduce risk across our portfolio; our ability to support multiple years of progress and achieve important milestones; our collaboration and license agreement with Roche and Genentech and the potential to receive milestone and other consideration thereunder; the potential benefits of treatment with OpRegen; the potential future achievements of our clinical and preclinical programs; the timing of anticipated FDA interactions, preclinical activities, clinical trials, and clinical data updates related to our programs, and the submission of a grant application to the CIRM; plans and expectations regarding publications relating to our programs; plans and expectations regarding potential new partnership opportunities and existing collaborations; our ability to broaden awareness of our mission and accomplishments; plans and expectations regarding our products in development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that we may not establish new partnerships or expand existing collaborations; that we do not successfully broaden awareness of our mission or accomplishments; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005126/en/

 

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(
ir@lineagecell.com)
(442) 287-8963

Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

 

Baudax Bio Reports Second Quarter 2022 Financial Results and Business Highlights

Research, News, and Market Data on Baudax Bio

August 11, 2022 7:00am EDT

ANJESO^® Net Product Revenue Up 49% Year-Over-Year;
Vials Sold to End-Users Up 67% Year-Over-Year

Dosing Complete in the First Cohort of the Phase I BX2000 Study;
On Track to Complete Enrollment in Remaining Cohorts by Early 2023

MALVERN, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for acute care settings, today reported financial results for the three and six months ended June 30, 2022, provided key metrics around the ongoing commercialization of ANJESO (meloxicam) injection, updated status of the neuromuscular blocking (NMB) agent development program, and provided an overview of other corporate and financial developments.

“ANJESO continued its solid sales performance during the second quarter of 2022 with 49% growth year-over-year,” said Gerri Henwood, President and CEO of Baudax Bio. “The development programs for our neuromuscular blocking (NMB) agents continue to advance with the commencement of a Phase I clinical study evaluating BX2000, our ultra-short acting NMB, in healthy volunteers. We are on track to progress through the remaining dosing cohorts and expect to complete enrollment of the study by early 2023. We are also working toward initiation of a Phase II study evaluating our intermediate-acting NMB, BX1000, in surgical patients and we look forward to keeping you updated on our progress.”

Second Quarter 2022 and
Recent Business Highlights

ANJESO

• ANJESO
  U.S. Commercialization. ANJESO is indicated for the management of moderate to severe pain in adults, alone or in combination with other non-NSAID analgesics. For the second quarter of 2022, ANJESO achieved net product revenue of $0.3 million, reflecting 49% growth year-over-year. Vials sold to end-users increased by approximately 67% compared to the same prior year period. In terms of site of care usage of ANJESO, there was a 12% increase in vials sold to hospitals in the second quarter of 2022 compared to the first quarter of 2022. In the second quarter of 2022 the re-order rate from existing accounts was 72%.  

• Impacts
  from COVID-19. The newer Omicron variants of COVID-19 as well as hospital and ambulatory surgical center staffing issues, although beginning to stabilize, continued to impact the number of elective surgeries performed during the quarter. Cancellations of elective surgeries were primarily due to patients or ASC and hospital staff testing positive for COVID-19, as well as reduced availability of staff at ambulatory surgical centers and hospitals.

NMBs

• BX1000
  (IV Intermediate-action). A dose-escalation Phase I study evaluating BX1000 in 58 healthy volunteers was completed and results showed that BX1000 was generally well tolerated through the dosing range tested. Muscle paralysis was rapidly achieved along with complete spontaneous recovery. Baudax Bio is preparing the clinical study report for this dose-escalation study and expects to submit it to the U.S. Food and Drug Administration (FDA) in 2022. Additionally, the Company expects to begin enrollment in a Phase II study in surgical patients during 2022.

• BX2000
  (IV Ultra-short action). Dosing was completed for the first cohort of the Phase I dose escalation study evaluating the safety, tolerability and pharmacokinetics of BX2000 in healthy volunteers. This study is comprised of up to 10 dosing cohorts and each cohort is planned to enroll 8 patients. The Company expects to complete enrollment of the remaining cohorts in the study by early 2023.

• BX3000
  (Reversal agent). Additional work to enhance the formulation of the BX3000 reversal agent is complete and the Company believes this data, along with certain non-clinical data, which will be submitted to FDA by early 2023, will support and IND filing for a Phase I study in healthy volunteers the first half of 2023.

Corporate and Financial

• Secured
  $2.0 Million in Financing. In May, Baudax Bio completed a registered direct offering with institutional investors securing approximately $2.0 million, before deducting placement agent fees and other offering expenses. The financing was priced at-the-market and the Company issued and sold approximately 1.6 million shares of its common stock, at a purchase price of $1.215 per share. The Company also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to 1.6 million shares of its common stock.

Second Quarter 2022
Financial Results

As of June 30, 2022, Baudax Bio had cash and cash equivalents of $5.2 million.

Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the three months ended June 30, 2022 was $0.3 million. This compares to $0.2 million for the three months ended June 30, 2021, an increase of $0.1 million, or 49%, despite a decrease of approximately 80% of the field staff in the current year. While utilizing the title model of distribution, product revenue is recognized as shipments are made to the Company’s third-party logistics provider. The increase in net product revenue was attributable to increased demand at existing accounts as well as securing additional formulary approvals.

Cost of sales for the three months ended June 30, 2022 was $0.4 million, compared to $0.6 million for the three months ended June 30, 2021, a decrease of $0.2 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The decrease of $0.2 million was primarily a result of the reduction in manufacturing costs, including production and storage costs, in the current year compared to the prior year. Certain product costs of ANJESO units recognized as revenue during the three months ended June 30, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods. Baudax Bio expects that over time, product costs in cost of sales will modestly increase as sales increase and inventory associated with the units manufactured prior to FDA approval have been sold.

Research and development expenses for the three months ended June 30, 2022 and 2021 were $0.9 million.

Selling, general and administrative expenses for the three months ended June 30, 2022 were $4.0 million, of which $1.1 million was attributable to selling expense and $2.9 million was attributable to general and administrative expense. This compares to $10.6 million for the same prior year period, of which $5.0 million was attributable to selling expense and $5.6 million was attributable to general and administrative expense. Selling expenses decreased $3.9 million, primarily as a result of a reduction in personnel costs of $2.4 million and a decrease in marketing costs of $1.4 million. The decrease of $2.7 million in general and administrative costs was primarily a result of a decrease in personnel costs of $1.4 million, a decrease in public company costs of $0.9 million and a decrease in consulting costs of $0.3 million.

Baudax Bio reported a net loss of $7.5 million, or $(1.05) per share, including non-cash charges of $2.6 million, for the three months ended June 30, 2022. Adjusted net loss* was $4.9 million.

Six Months Ended June
30, 2022 Financial Results

Net product revenue related to sales of ANJESO in the U.S., recognized according to U.S. GAAP, for the six months ended June 30, 2022 was $0.7 million. This compares to $0.4 million for the six months ended June 30, 2021, an increase of $0.3 million. While utilizing the title model of distribution, product revenue is recognized as shipments are made to the Company’s third-party logistics provider. The increase in net product revenue was attributable to increased demand at existing accounts as well as securing additional formulary approvals.

Cost of sales for the six months ended June 30, 2022 was $1.0 million, compared to $1.4 million for the six months ended June 30, 2021, a decrease of $0.4 million, and consisted of product costs, royalty expense and certain fixed costs associated with the manufacturing of ANJESO, including supply chain and quality costs. The decrease of $0.4 million was primarily a result of the reduction in scrap expense recorded in the current year compared to the prior year of $0.2 million and a decrease in manufacturing costs, including reductions in production and storage costs, of $0.2 million. Certain product costs of ANJESO units recognized as revenue during the six months ended June 30, 2022 and 2021 were expensed prior to the FDA approval of ANJESO in February 2020, and therefore are not included in cost of sales during the related periods. Baudax Bio expects that over time, product costs in cost of sales will modestly increase as sales increase and inventory associated with the units manufactured prior to FDA approval have been sold.

Research and development expenses for the six months ended June 30, 2022 were $2.2 million compared to $2.0 million for the six months ended June 30, 2021. The increase of $0.2 million was primarily due to the initiation of the pediatric trial for ANJESO of $0.2 million.

Selling, general and administrative expenses for the six months ended June 30, 2022 were $18.2 million, of which $8.3 million was attributable to selling expense and $9.9 million was attributable to general and administrative expense. This compares to $22.7 million for the same prior year period, of which $10.1 million was attributable to selling expense and $12.6 million was attributable to general and administrative expense. Selling expenses decreased $1.8 million, primarily as a result of a decrease in marketing costs of $1.1 million and a reduction in personnel costs of $0.7 million. The decrease of $2.7 million in general and administrative was primarily a result of a decrease in public company costs of $1.4 million, a decrease in personnel costs of $0.9 million and a decrease in consulting costs of $0.4 million.

Baudax Bio reported net loss of $20.3 million, or $(3.63) per share, including net non-cash charges of $0.2 million, for the six months ended June 30, 2022. Adjusted net loss* was $20.1 million.

* Non-GAAP Financial
Measures

To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company is reporting certain non-GAAP information for its business, including adjusted net loss. Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, and stock-based compensation. The Company believes this non-GAAP financial measure is helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. This measure is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Please see the section of this press release titled “Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of non-GAAP adjusted net loss to its most directly comparable GAAP measure.

About ANJESO^®

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO^®, 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, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs. 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. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to future expenses, product costs, and the development of each of BX1000, BX2000, and BX3000, 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, 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.

CONTACTS:

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

BAUDAX BIO, INC.
Consolidated Balance Sheets
(Unaudited)
(amounts in thousands, except share and per share data)
Assets									June 30, 2022			December 31, 2021
Current assets:
	Cash and cash equivalents							$	5,210		$	15,891
	Accounts receivable, net								616			542
	Inventory								5,255			5,002
	Prepaid expenses and other current assets								1,398			2,059
					Total current assets			$	12,479		$	23,494
	Property, plant and equipment, net								4,941			5,015
	Intangible assets, net								20,390			21,678
	Goodwill								2,127			2,127
	Other long-term assets								897			963
					Total assets			$	40,834		$	53,277
Liabilities and Shareholders’ Equity
Current liabilities:
	Accounts payable								3,064			1,468
	Accrued expenses and other current liabilities								3,812			5,540
	Current portion of long-term debt, net								3,611			2,222
	Current portion of contingent consideration								7,694			6,416
					Total current liabilities				18,181			15,646
	Long-term debt, net								5,099			6,309
	Long-term portion of contingent consideration								12,692			17,446
	Other long-term liabilities								632			650
					Total liabilities				36,604			40,051
Shareholders’ equity:
	Preferred stock, $0.01 par value. Authorized, 10,000,000 shares;
		none issued and outstanding.							—			—
	Common stock, $0.01 par value. Authorized, 190,000,000 shares; issued and outstanding, 8,068,853 shares at June 30, 2022 and 2,807,239 shares at December 31, 2021								81			28
	Additional paid in-capital								156,578			145,287
	Accumulated deficit								(152,429	)		(132,089	)
					Total shareholders’ equity				4,230			13,226
					Total liabilities and shareholders’ equity			$	40,834		$	53,277

 

BAUDAX BIO, INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(amounts in thousands, except share and per share data)
						Three Months Ended						Six Months Ended
						June 30,						June 30,
						2022			2021			2022			2021
Revenue, net					$	300		$	201		$	722		$	399
Operating expenses:
	Cost of sales (excluding amortization of intangible assets)					361			586			1,009			1,407
	Research and development					912			857			2,205			1,965
	Selling, general and administrative					4,029			10,608			18,219			22,696
	Amortization of intangible assets					644			644			1,288			1,288
	Change in warrant valuation					(1	)		(59	)		(6	)		(41	)
	Change in contingent consideration valuation					1,327			3,881			(2,476	)		5,722
		Total operating expenses				7,272			16,517			20,239			33,037
		Operating loss				(6,972	)		(16,316	)		(19,517	)		(32,638	)
Other expense:
	Other (expense) income, net					(559	)		987			(823	)		397
	Net loss				$	(7,531	)	$	(15,329	)	$	(20,340	)	$	(32,241	)
Per share information:
Net loss per share of common stock, basic					$	(1.05	)	$	(7.17	)	$	(3.63	)	$	(16.43	)
Net loss per share of common stock, diluted					$	(1.05	)	$	(7.18	)	$	(3.63	)	$	(16.43	)
Weighted average common shares outstanding, basic						7,181,640			2,137,191			5,610,037			1,962,655
Weighted average common shares outstanding, diluted						7,181,640			2,138,100			5,610,037			1,962,655

BAUDAX BIO, INC.
Reconciliation of GAAP to Non-GAAP Measures
(Unaudited)

		For the Three Months Ended June 30,								For the Six Months Ended June 30,
(amounts in thousands)			2022				2021				2022				2021
Net loss (GAAP)		$	(7,531	)		$	(15,329	)		$	(20,340	)		$	(32,241	)
Stock-based compensation			337				903				858				3,207
Non-cash interest expense			223				229				449				458
Gain on extinguishment of debt			—				(1,553	)			—				(1,553	)
Depreciation expense			43				63				86				149
Amortization expense			644				644				1,288				1,288
Non-cash loss on retirement of fixed assets			8				—				8				—
Change in warrant valuation			(1	)			(59	)			(6	)			(41	)
Change in contingent consideration valuation			1,327				3,881				(2,476	)			5,722
Adjusted net loss (non-GAAP)		$	(4,950	)		$	(11,221	)		$	(20,133	)		$	(23,011	)

To supplement the Company’s financial results determined by U.S. generally accepted accounting principles (“GAAP”), the Company has disclosed in the tables below the following non-GAAP information about adjusted net loss.

Adjusted net loss is net loss as determined under GAAP, excluding the changes in fair values of contingent consideration and warrant valuations, gain on extinguishment of debt, interest, depreciation, amortization, and stock-based compensation.

The Company believes that non-GAAP financial measures are helpful in understanding its business as it is useful to investors in allowing for greater transparency of supplemental information used by management. Adjusted net loss is used by investors, as well as management in assessing the Company’s performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.

 

Source: Baudax Bio, Inc.

Released August 11, 2022

Avivagen Announces Receipt of Repeat Order from Asian Customer

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ August 11, 2022 /– Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that one of its most important customers in Asia has placed a new order for four tonnes of OxC-Beta™ Livestock to be used in Asia, in line with previous shipments fulfilled in 2021. “It’s encouraging to see one of our largest customers in Asia continue to place sizeable orders – which we view as a sign that they remain on target for economic recovery at a time where uncertainty is playing out elsewhere and also confirms the value of our product in economically challenging times,” says Kym Anthony, Chief Executive Officer of Avivagen Inc. “We are excited for the year ahead as we continue to build on existing and new relationships both in Asia and markets worldwide.” About Avivagen Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release. About OxC-beta™ Technology and OxC-beta™ Livestock Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia. Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics. Forward Looking Statements This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s outlook, Avivagen’s expectation that it will fulfill the order described above, the future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, worldwide demand for products sold by Avivagen may drop, orders may be cancelled, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. For more information: Avivagen Inc. Drew Basek Director of Investor Relations 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733 E-mail: d.basek@avivagen.com Kym Anthony Chief Executive Officer 100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164 Website: www.avivagen.com Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

 

PsyBio Therapeutics Expands International Patent Applications

Research, News, and Market Data on PsyBio

PsyBio is continuing to increase its psycho-targeted patent
portfolio, executing on its strategic priorities of innovation, development,
and technology optimization

PsyBio now has twenty patent applications in total

OXFORD, Ohio and DENVER, Aug. 8, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company focused upon discovery and development of novel, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health, today is announcing the filing of additional international patent applications in Europe, Africa, and Asia. This brings PsyBio’s total number of patent application submissions to twenty, making it one of the most robust portfolios in the sector.PsyBio Logo (CNW Group/PsyBio Therapeutics Corp.)

“Biosynthetic tryptamine production allows the development of psycho-targeted molecules as novel therapeutic candidates, with the goal to potentially help improve human health,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “Our IP strategy fosters the developmental processes and will allow us to develop these molecules as smoothly and rapidly as possible. Global patent submissions further expand PsyBio’s IP portfolio and support our ongoing plans for growth.”

The patent applications submitted comprise advancements concerning production methodology, host strains and processes of production that support and allow PsyBio’s novel production methodology to be globally protected. These filings demonstrate the Company’s commitment to value creation, while also promoting scientific and methodologic advancements in the field.

“PsyBio is dedicated to leading the development of psycho-targeted therapeutic candidates in our vision to potentially improve mental and neurological health,” stated Evan Levine, PsyBio’s Chief Executive Officer. “With these additional patent submissions, PsyBio continues to demonstrate its leadership in the biosynthetic development field by prioritizing intellectual property protection, which is necessary for us to achieve our business objectives and important for our current and future investors.”

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing new, bespoke, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof.  The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to build and protect its intellectual property portfolio of novel drug candidates; the ability of PsyBio to launch clinical trials; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more investigational new drug applications with the United States Food and Drug Administration (“FDA“); PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the “TSXV“) has
neither approved nor disapproved the contents of this news release. Neither the
TSXV nor its Regulation Services Provider (as that term is defined in the
policies of the TSXV) accepts responsibility for the adequacy or accuracy of
this release.

SOURCE PsyBio Therapeutics Corp.

Wednesday, August 10, 2022

PDS Biotechnology Corp (PDSB)
As PDS0101 Trials Continue, Preparations For Pivotal Studies Begin.

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

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

Quarterly Loss Was Less Than We Estimated.  PDS Biotech reported 2Q22 loss of $5.8 million or $(0.20) per share, beating our estimated loss of $8.8 million or $(0.34) per share. The differences were largely due to R&D expense of $3.7 million compared with our estimate of $5.3 million, as well as a $1.2 million tax benefit. The company ended the quarter with $53.0 million in cash.

As The Versatile-002 Trial Continues, Phase 3 Planning Begins.  The Phase 2 Versatile-002 trial, testing PDS0101 in combination with the checkpoint inhibitor Keytruda, received a positive opinion from its independent Data Safety Monitoring Board. The recommendation was to continue the trial to completion without any changes to the protocol.  In June, the combination of PDS0101 with Keytruda received Fast-Track designation from the FDA….

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. 

Tonix Pharmaceuticals to Present at the 2022 Virtual Q3 Investor Summit

Research, News, and Market Data on Tonix Pharmaceuticals

August 09, 2022 7:00am EDT

CHATHAM, N.J., Aug. 09, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the Virtual Q3 Investor Summit on Tuesday, August 16, 2022, at 9:30 a.m. ET.

Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator. A webcast of the presentation can be found 
here and will be available under the IR Events tab of the Tonix website at www.tonixpharma.com.

About Tonix Pharmaceuticals
Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’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 (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also 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 third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first half of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) 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 first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward
Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released
August 9, 2022

Tuesday, August 09, 2022

Tonix Pharmaceuticals (TNXP)
Second Quarter Saw Progress In Several Therapeutic Areas

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

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

2Q Reported With Product Milestones Ahead.  Tonix reported a loss of $27.4 million or $(1.22) per share compared with our estimated loss of $26.9 million or $(1.43) per share.  During the quarter the company raised $28.5 million in a private placement, ending with $145.5 million in cash on June 30.

Monkeypox Program Has Become A New Focus.  Tonix announced that it formed a collaboration with the Kenya Medical Research Institute for a Phase 1 trial to start in 1H2023.   Tonix has been developing TNX-801, a vaccine that has been shown to be effective against both smallpox and monkeypox in preclinical testing with non-human primates.  We have always seen the potential for TNX-801 as an improved smallpox vaccine that would be sold to the US government stockpile for use defense against bioterrorism.  Since Monkeypox has been declared a public health emergency, monkeypox prevention could bring additional sales beyond our estimates….

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 Engages CRO to Conduct Phase 2a Human Challenge Influenza A Clinical Trial with Novel, Broad-Spectrum Antiviral Candidate CC-42344

Research, News, and Market Data on Cocrystal Pharma

BOTHELL, Wash., Aug. 08, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organization (CRO), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally administered antiviral candidate CC-42344. This candidate represents a new class of investigational medicine designed to directly inhibit replication of the virus for the treatment of pandemic and seasonal influenza A.

“We are highly encouraged by the Phase 1 healthy volunteer trial results received so far and are committed to rapidly advancing this program into a human challenge Phase 2a trial in influenza A-infected subjects,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “The fact that influenza virus is constantly mutating against existing influenza antiviral drugs elevates an urgent need for effective antiviral therapeutics. CC-42344 is a broad-spectrum oral PB2 inhibitor that is highly active against drug-resistant influenza A strains. Further clinical development of CC-42344 offers an opportunity to address the need. Open Orphan is a world leader in conducting human challenge clinical trials with antiviral drug candidates, making it an ideal partner for conducting our Phase 2a trial.”

The single-center, double-blind, placebo-controlled Phase 2a human challenge trial is designed to evaluate safety, viral and clinical measures of orally administered 
CC-42344 to subjects challenged with influenza A. The trial is expected to be initiated in the second half of 2023, pending approval from the United Kingdom Medicines and Healthcare Products Regulatory Agency. This study will be conducted at hVIVO’s state-of-the-art facility in the United Kingdom.

Yamin “Mo” Khan, Open Orphan CEO, said, “We are pleased to be working with Cocrystal to evaluate its promising antiviral drug candidate for influenza A. A human challenge trial is an excellent option for Cocrystal, as it can rapidly provide efficacy data at a lower cost than traditional field trials.”

Cocrystal is conducting a Phase 1 study with CC-42344 in healthy subjects in Australia. The Company recently announced pharmacokinetic (PK) data supporting once-daily dosing from the single-ascending dose portion of this study. Enrollment in the multiple-ascending dose portion of the Phase 1 trial is ongoing, with full trial results expected in 2022.

About CC-42344 and
Influenza
CC-42344 is an oral PB2 inhibitor that blocks an essential step of viral replication. CC-42344 was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. 
CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains, including pandemic strains. In
vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu^® and Xofluza^®, while also demonstrating favorable pharmacokinetic and safety profiles.

The global influenza therapeutics market is projected to reach $9.5 billion by 2027, from $6.6 billion in 2020, growing at a 4.8% CAGR between 2021 and 2027, according to a report published by Precision Reports in June 2022.

About hVIVO and
Open Orphan plc
hVIVO, a subsidiary of Open Orphan plc, is a rapidly growing specialist contract research organization (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and longstanding client base of biopharma companies.

About Cocrystal
Pharma, Inc.
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.

Cocrystal Pharma Cautionary
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our collaboration with hVIVO to conduct a Phase 2a clinical trial for CC-42344 and the anticipated timeline for the study, the potential design and efficacy of CC-42344, and the demand for products designed to treat influenza and opportunities presented thereby. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the COVID-19 pandemic including in Australia, the Russian invasion of Ukraine, and/or inflation and Federal Reserve interest rate increases in response thereto on the global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs such as obtaining the requisite regulatory approvals including from the United Kingdom Medicines and Healthcare Products Regulatory Agency, the ability of the CRO to recruit patients into clinical trials, and the results of the studies for CC-42344. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100

jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378

Jabraham@jqapartners.com

# # #

Source: Cocrystal Pharma, Inc.

Released August 8,
2022

 

Tonix Pharmaceuticals Reports Second Quarter 2022 Financial Results and Operational Highlights

Research, News, and Market Data on Tonix Pharmaceuticals

Phase 1 Study
of TNX-801, a Vaccine in Development for the Prevention of Monkeypox and
Smallpox, Expected to Initiate in First Half 2023 in Kenya; the U.S. has
Declared Monkeypox a Public Health Emergency

U.S. National Institute of Drug
Abuse (NIDA) Grant Awarded for the Development of TNX-1300 for Cocaine
Intoxication; Phase 2 Study of TNX-1300 Expected to Initiate in Fourth Quarter
2022

Advanced Development Center in
Dartmouth, Mass. is Open and Expected to Imminently Conduct Process Development
and Clinical Trial Manufacturing of Live-Virus Vaccines

Cash and Cash Equivalents
Totaled Approximately $145 Million at June 30, 2022

CHATHAM, N.J., Aug. 08, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2022, and provided an overview of recent operational highlights.

“The rapidly expanding outbreaks of monkeypox in the U.S. and approximately 80 other countries outside of Africa have brought attention to our work on a novel monkeypox vaccine, TNX-801, which has already been shown to protect non-human primates against a challenge with lethal doses of monkeypox. The U.S. has declared monkeypox a public health emergency. In addition, we are excited by the many opportunities ahead for our pipeline of CNS, rare disease, immunology and infectious disease product candidates,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We are on track to have four CNS programs in the clinic by the end of 2022, including our most advanced program, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, which is in mid-Phase 3 development, Phase 2 studies of TNX-102 SL for Long COVID and PTSD and a Phase 2 study of TNX-1300 for cocaine intoxication.”

Recent
Highlights—Key Product Candidates*

Infectious
Disease Pipeline

TNX-801 (live
horsepox virus vaccine for percutaneous administration): vaccine against
smallpox and monkeypox designed as a single-administration vaccine to elicit T
cell immunity

• In July 2022, Tonix announced a collaboration with the Kenya Medical Research Institute (KEMRI) to plan, seek regulatory approval for and conduct a Phase 1 clinical study in Kenya to develop TNX-801 as a vaccine to protect against monkeypox and smallpox. The study is expected to start in the first half of 2023.
• Tonix presented data from a research collaboration with The University of Alberta in a poster presentation at the 4th Symposium of the Canadian Society for Virology. The poster titled, “Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox,” describes data from animals vaccinated with TNX-801 to protect against monkeypox. The poster presentation reports that all animals (n=8) vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox. The vaccinations with TNX-801 were well tolerated. Synthetic horsepox virus is the basis for the Company’s TNX-801 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2.
• Tonix announced the issuance of U.S. Patent for TNX-801 smallpox and monkeypox vaccine and Recombinant Pox Virus (RPV) platform technology. This patent is expected to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.

TNX-1850 (live
virus vaccine based on Tonix’s recombinant pox virus vector): COVID-19 vaccine
designed as single-administration vaccine to elicit T cell immunity

• Tonix announced the issuance of U.S. Patent for TNX-801 smallpox and monkeypox vaccine and Recombinant Pox Virus (RPV) platform technology (TNX-1850). This patent is expected to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.

TNX-2300: Live
virus vaccine based on a bovine parainfluenza virus vector to protect against
COVID-19

• In April 2022, Tonix extended a sponsored research agreement with Kansas State University to develop a vaccine candidate, TNX-2300, for the prevention of COVID-19 that utilizes a novel live virus vaccine vector platform based on bovine parainfluenza virus. The efficacy of co-expression of the CD40-ligand, also known as CD154, to stimulate T cell immunity will also be tested.
• Attenuated bovine parainfluenza virus has previously been shown to be an effective antigen delivery vector in humans. Notably and most importantly, following extensive testing in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children. The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally.

Central
Nervous System (CNS) Pipeline

TNX-102 SL
(cyclobenzaprine HCl sublingual tablet): small molecule for the management of
fibromyalgia (FM)

• Enrollment continues in the RESILIENT study, a double-blind, randomized, placebo-controlled, potentially pivotal Phase 3 study of TNX-102 SL for the management of fibromyalgia. The two-arm trial is expected to enroll approximately 470 participants in the U.S. Results from a planned interim analysis are expected in the first quarter of 2023.

TNX-102 SL for
the treatment of Long COVID, also known as Post-Acute Sequelae of COVID-19
(PASC)

• The Company continues to expect to start a Phase 2 clinical study with TNX-102 SL as a potential treatment for a subset of patients with Long COVID with multi-site pain in the third quarter of 2022.
• As previously announced, the results of a retrospective observational database study of over 50,000 adult U.S. patients with Long COVID showed that over 40% of patients had fibromyalgia-like multi-site pain. These findings support the feasibility of the planned Phase 2 study which will enroll Long COVID patients with multi-site pain.

TNX-102 SL for
the treatment of Posttraumatic Stress Disorder (PTSD)

• Tonix expects to begin enrolling a Phase 2 study of TNX-102 SL in police in Kenya in the third quarter of 2022.

TNX-1300
(recombinant double mutant cocaine esterase): biologic for life-threatening
cocaine intoxication

• In August 2022, Tonix announced that it received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300.
• The Company expects to initiate a new Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the fourth quarter of 2022, pending agreement with the U.S. Food and Drug Administration (FDA). The Phase 2 trial, which has the potential to be a pivotal study, is a single-blind, open-label, placebo-controlled, randomized study comparing the safety of a single 200 mg dose of TNX-1300 to standard of care alone in approximately 60 emergency department patients presenting with cocaine intoxication.
• A positive Phase 2a study of volunteer cocaine users in a controlled laboratory setting has been previously completed. TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

TNX-1900
(intranasal potentiated oxytocin): small peptide for migraine, craniofacial
pain, insulin resistance and related disorders, and obesity associated binge
eating disorder

• Tonix announced that U.S. Patent 11,389,473 issued in July 2022. The patent, entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use” claims methods and compositions for treating pain, including migraine headaches, using intranasal magnesium-containing oxytocin formulations. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until January 2036.
• Tonix announced the publication of a paper, entitled “Impact of Magnesium on Oxytocin Receptor Function,” in the journal Pharmaceutics, that described results from a research team led by Professor David Yeomans. The paper includes data showing the enhancing effects of magnesium (Mg²⁺) on the activity of intranasal oxytocin in an animal model of craniofacial pain. The Mg²⁺ potentiated formulation of intranasal oxytocin is the basis for the Company’s TNX-1900 drug candidate in development to prevent migraine headaches in chronic migraineurs. Professor Yeomans was the scientific founder of Trigemina, Inc. from which Tonix acquired rights to the Mg²⁺potentiated oxytocin technology. The potential clinical significance of these observations is that the formulation of oxytocin plus Mg²⁺ in Tonix’s TNX-1900 has the potential to enhance oxytocin efficacy for pain as well as for other uses.
• The Company expects to begin enrollment in a Phase 2 study of TNX-1900 for the prevention of migraine headache in chronic migraineurs the first half of 2023.

TNX-601 ER
(tianeptine hemioxalate extended-release tablets): small molecule for the
treatment of major depressive disorder (MDD), PTSD, and neurocognitive
dysfunction associated with corticosteroid use.

• In July 2022, Tonix announced development of a new extended release formulation of TNX-601, for the treatment of MDD. Tonix expects to initiate a Phase 2 study of TNX-601 ER for the treatment of MDD in the first quarter of 2023, pending FDA clearance of its Investigational New Drug (IND) application.

Rare Disease
Pipeline

TNX-2900
(intranasal potentiated oxytocin): small peptide for the treatment of
Prader-Willi syndrome (PWS)

• Tonix delivered a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome” at the World Orphan Drug Congress USA in July 2022.
• TNX-2900 has received Orphan Drug designation from the FDA for the treatment of PWS.

Immunology
Pipeline

TNX-1500
(anti-CD40L monoclonal antibody): third generation monoclonal antibody for
prophylaxis of organ transplant rejection and treatment of autoimmune
disorders.

• Tonix announced data from three oral presentations at the 2022 American Transplant Congress by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital for TNX-1500 targeting CD40-ligand (CD40L), which is also known as CD154.
• The presentations titled, “Long-Term
  Rejection Free Renal Allograft Survival with Fc-Modified Anti-CD154
  Antibody Monotherapy in Nonhuman Primates,” “TNX-1500, an Fc-modified Anti-CD154 Antibody,
  Prolongs Nonhuman Primate Cardiac Allograft Survival,” and “
  Novel Targetable Pathways in Costimulation Pathway
  Blockade” include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in a non-human primate cardiac allograft model without clinical thrombosis.
• A Phase 1 study of TNX-1500 is expected to start in the first half of 2023.

      *All of
Tonix’s product candidates are investigational new drugs or biologics and have
not been approved for any indication.

Recent
Highlights—Facilities and Corporate

• In July 2022, Tonix announced the appointment of Sina Bavari, Ph.D. as Executive Vice President, Infectious Disease Research and Development. In this role, Dr. Bavari will be responsible for leading Tonix’s development of its growing infectious disease pipeline and will serve as a key member of the Company’s executive leadership team.
• In June 2022, Tonix held a ribbon-cutting ceremony for its Advanced Development Center (ADC) located in the New Bedford Business Park in North Dartmouth, Massachusetts. The new facility is designed for accelerated research, development and analytical capabilities, as well as the production of clinical trial quality vaccines for infectious diseases, including monkeypox, smallpox and COVID-19 as well as other infectious diseases for pandemic preparedness. The ADC is open and expected to soon perform process development and clinical trial manufacturing of live-virus vaccines.

Recent
Highlights–Financial

As of June 30, 2022, Tonix had $145.5 million of cash and cash equivalents, compared to $178.7 million as of December 31, 2021. In June 2022, Tonix issued 2,500,000 shares of Series A convertible redeemable preferred stock and 500,000 shares of Series B convertible redeemable preferred stock to certain institutional investors in a private placement for gross proceeds of $28.5 million. The Company expects to use the proceeds to redeem the preferred stock.

Cash used in operations was approximately $21.2 million for the three months ended June 30, 2022, compared to $19.1 million for the same period in 2021. Capital expenditures were approximately $14.4 million for the three months ending June 30, 2022 compared to $1.4 million for the same period in 2021. The increase was primarily due to the continued buildout of the ADC in North Dartmouth, Mass.

Second Quarter 2022 Financial Results

Research and development (R&D) expenses for the three months ended June 30, 2022 were $16.6 million, compared to $18.1 million for the same period in 2021. The decrease is predominately due to decreased non-clinical expenses, offset by an increase in employee-related expenses. We continue to expect R&D expenses to increase during 2022 as we move our clinical development programs forward and invest in our development pipeline.

General and administrative (G&A) expenses for the three months ended June 30, 2022 were $6.8 million, compared to $5.4 million for the same period in 2021. The increase is primarily due to employee-related expenses.

Net loss available to common stockholders was $27.4 million, or $1.22 per share, basic and diluted, for the three months ended June 30, 2022, compared to net loss of $23.6 million, or $2.25 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for the three months ended June 30, 2022 was 22,404,371, compared to 10,483,112 shares for the same period in 2021.

About Tonix
Pharmaceuticals Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’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 (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also 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 third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is Phase 2 ready and has been granted Breakthrough Therapy designation by the FDA. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first half of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) 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 first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

^*All of Tonix’s product candidates are investigational
new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward
Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

TONIX PHARMACEUTICALS HOLDING
CORP.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
Thousands, Except Share and Per Share Amounts)
(unaudited)

		Three Months Ended June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
COSTS AND EXPENSES:
Research and development		$	16,579			$	18,133			$	35,001			$		33,460
General and administrative			6,757				5,429				14,771					10,838
			23,336				23,562				49,772					44,298
Operating Loss			(23,336	)			(23.562	)			(49,772	)				(44,298	)
Interest and other income, net			196				9				215					92
Net loss			(23,140	)			(23,553	)			(49,557	)				(44,206	)
Preferred stock deemed dividend			4,255				—				4,255					—
Net loss available to common stockholders		$	(27,395	)		$	(23,553	)		$	(53,812	)		$		(44,206	)
Net loss per common share, basic and diluted		$	(1.22	)		$	(2.25	)		$	(2.76	)		$		(4.49	)
Weighted average common shares outstanding, basic and diluted			22,404,371				10,483,112				19,462,280					9,843,309

TONIX PHARMACEUTICALS HOLDING
CORP.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
Thousands)
(Unaudited)

	June 30, 2022			December 31, 20211
Assets
Cash and cash equivalents	$	145,478		$	178,660
Restricted cash		31,500		—–
Prepaid expenses and other		14,769			10,389
Total current assets		191,747			189,049
Other non-current assets		84,418			51 ,851
Total assets	$	276,165		$	240,900
Liabilities and stockholders’ equity
Total liabilities	$	16,383		$	22,183
Temporary equity		31,500			–
Stockholders’ equity		228,282			218,717
Total liabilities and stockholders’ equity	$	276,165		$	240,900

¹The condensed consolidated balance sheet for the year ended December 31, 2021 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

Contacts

Jessica Morris
(corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com

(862) 799-8599

Olipriya Das,
Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo
(investors)
ICR Westwicke
peter.vozzo@westwicke.com

(443) 213-0505

 

Source: Tonix Pharmaceuticals Holding Corp.

Released
August 8, 2022

Monday, August 08, 2022

Ocugen (OCGN)
2Q22 Reported With New Pipeline Program Moving Forward

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.

Second Quarter Reflects Increases In Pipeline Activity.  Ocugen reported a loss of $19.5 million or $(0.09) per share, greater than our estimated loss of $16.7 million or $(0.07) per share.  The difference was due to higher expenses from clinical trials and increased headcount as the company added development staff.  The company ended the quarter with $115.0 million in cash.

Covaxin Clinical Studies Move Forward.  Ocugen is currently conducting a Phase 2/3 immuno-bridging study for US approval.  Discussions continue with Health Canada regarding additional information that may be required for Canadian approval.  In Mexico, Covaxin has received emergency use authorization for adults, with submission for pediatric use under review.  Due to the shortages of other COVID-19 vaccines in Mexico, this territory is a near-term opportunity for Covaxin….

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. 

Image Credit: Marco Verch (Flickr)

Biotech Earnings Reports and M&A Activity Contribute to Sector Strength

Biotech stocks that were on life support during the beginning of 2022 are now revived and not slowing down. Since mid-June, when many sectors turned around, the beaten-up biotechs became impressive outperformers. And, for good reasons. While they may have overshot on the high side during the pandemic, the post-pandemic selling may have also gone too far, currently, they are priced at levels that has generated a lot of interest among investors, both small and large.

The SPDR S&P Biotech ETF (XBI), which tracks the sector, is up 16.35% over the past three months and 45.14%% since the markets closed on June 14. XBI had fallen from the $110 range to the $60 range earlier this year, it is now around $92. Whether or not this represents a continued direction for the biotech sector remains to be seen, but the positive buzz and news stories surrounding biotech seem to be increasing.

Right Mixture

Merck (MRK) has been in the news as they’re in negotiations to acquire Seagen (SGEN). This has been a reminder that big pharma is flush with cash, so much that attractive small and mid-cap biotech companies can easily be purchased without a financial blink from the acquirer. These smaller companies are also finding it easier to develop financial and R&D partnerships with big companies. The financial strength of big pharma has been further highlighted in recent weeks as stock buybacks among large firms and merger activity seem to be growing. Market-moving drug-testing results are also being reported as the FDA is less distracted than it has been in years. Taken together, all of these factors would seem to be the right treatment to continue to heal and strengthen a depressed sector.

Source: Koyfin

The market is also being reminded of the potential profitability of the sector during this earnings
season. Companies like Regeneron Pharmaceuticals (REGN) climbed almost 6% after reporting earnings this week, and Gilead Sciences (GILD) financial reporting had a similar impact on its stock price. But these didn’t even come close to Moderna (MRNA) which gained 16% after reporting its earnings.

As for the smaller biotech names, both public and private are also deals being made. Gilead announced an agreement on Thursday to pick up a private U.K.-based biotech called MiroBio for $405 million in cash.

The sector has gained much of its strength of the sector in recent months from mid-caps that were weaker than their larger counterparts early in the year. Names like Therapeutics (BEAM), which started the year off poorly but is now up 104% since mid-June. Fate Therapeutics (FATE) is another mid cap that has been flying since mid-June and is currently up 77% during that period.

Take Away

Markets are cyclical, and the biotech sector, which was at the height of its cycle earlier this decade, may have recently passed the bottom of its cycle. Smaller names are now at attractive levels for cash-rich larger pharmaceutical companies to scoop up companies that operate in areas they are looking to strengthen their pipeline or offerings.

A great place to find and explore small biotechs is Channelchek. Simply click on Company
Data at the upper left of your screen, then healthcare, which leads you to a drop-down menu with biotech as one of the categories. Sign up for research on small and microcap companies from top-ranked analysts in biotech and other industries, delivered to your inbox each morning.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://www.barrons.com/articles/biotech-stocks-rally-bear-market-51657551507

https://www.barrons.com/articles/bull-market-biotech-stocks-51659620438?mod=hp_LEAD_2_B_2

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Ocugen Provides Business Update & Second Quarter 2022 Financial Results

Research, News, and Market Data on Ocugen

CONFERENCE CALL AND WEBCAST TODAY AT 8:30 A.M. ET

 

• Dosing
  patients in U.S. Phase 2/3 COVAXIN™ (BBV152) clinical trial
• Completed
  dosing of patients in Cohort 1 of OCU400 gene therapy product candidate
• Expanding
  product pipeline with the regenerative medicine cell therapy program
  NeoCart^®

MALVERN, Pa., Aug. 05, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today reported financial results for the quarter ended June 30, 2022, and provided a general business update.

“The second quarter was marked by several important milestones,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “On the vaccine front, we continued to work diligently with our co-development partner, Bharat Biotech, to ensure we execute our planned clinical and commercial objectives for COVAXIN™ – a whole-virion inactivated COVID-19 vaccine candidate.”

“We are also excited and encouraged by the positive momentum of our investigational modifier gene therapy platform, with the potential to address many different gene mutations in the retina and look forward to bringing hope to patients for whom no treatment options exist,” Dr. Musunuri added.

During the second quarter, Ocugen expanded its dynamic clinical product pipeline with the introduction of NeoCart^®, an innovative Phase 3-ready cell therapy platform. The U.S. Food and Drug Administration (FDA) recently granted NeoCart^® a Regenerative Medicine Advanced Therapy (RMAT) designation for the repair of full-thickness lesions of the knee cartilage in adults, and this candidate, if approved, offers the potential for a new therapeutic option in this area.

“With our diversified portfolio, Ocugen is well-positioned to advance our product development efforts and we look forward to sharing key data as these programs progress,” Dr. Musunuri concluded.

Clinical and Business
Updates

Vaccines

• COVAXIN™ Development in the
  United States – The Phase 2/3 immuno-bridging and broadening clinical trial, OCU-002, for COVAXIN™ is progressing well.
• The Company is actively engaged in planning for the initiation of an adult safety clinical trial this year.
• COVAXIN™ Data Published in
  Scientific Journals – In June 2022, positive pediatric Phase 2/3 study results in children aged 2-18 years were published in The Lancet Infectious Diseases. A study published in Nature
  Scientific Reports in July shows that COVAXIN™ (BBV152) generated a persistent cell mediated memory immune response for up to 12 months. Additionally, a booster dose is safe and ensures persistent immunity to minimize breakthrough infections of COVID-19.

Gene Therapies

• OCU400 Clinical Trial – Dosing of subjects with retinitis pigmentosa in Cohort 1 was completed. Previously, the Company reported “first patient, first dose” in late March 2022.
• The Independent Data and Safety Monitoring Board (DSMB) for the clinical trial recently completed a review of safety data based on dosing from Cohort 1 and recommends proceeding to dosing in Cohort 2. The Company expects to begin dosing in Cohort 2 this month.
• OCU410 Development Program – Ocugen is conducting IND-enabling studies as per discussions with the FDA. A clinical trial is scheduled to begin next year, and the Company is currently manufacturing materials to support the clinical trial.
• Improved Patent Estate – In June 2022, the Company announced that the United States Patent and Trademark Office issued U.S. Patent No. 11,351,225, which is directed to methods for preventing or treating an ocular disease or disorder associated with retinal degenerative disease. The patent covers the use of a nuclear hormone receptor gene, such as nuclear receptor subfamily 2 group E member 3 (NR2E3), RAR-related orphan receptor A (RORA), Nuclear Protein 1, Transcriptional Regulator (NUPR1), and Nuclear Receptor Subfamily 2 Group C Member 1 (NR2C1), in treating retinal degenerative diseases as well as reducing the risk of developing such diseases.

Cell Therapies

• Expansion of Product Candidate
  Pipeline with NeoCart^® – Ocugen added NeoCart^®, a Phase 3-ready cell therapy platform technology to its diverse product candidate pipeline. The Company originally acquired NeoCart^® as part of the Company’s reverse merger with Histogenics Corporation in 2019. Ocugen is currently working with the FDA to finalize the Phase 3 protocol necessary to advance the clinical development program of NeoCart^®. Also, the Company entered into a collaborative research agreement with Brigham and Women’s Hospital, Harvard Medical School, to support NeoCart^® development and explore expansion of the pipeline.

Other Business

• At-the-Market Stock Issuance – In June 2022, the Company announced it had entered into an At Market Issuance Sales Agreement relating to the sale of shares of Ocugen’s common stock having an aggregate gross sales price of up to $160.0 million. Proceeds will be used for general corporate purposes.
• Community Recognition – In June 2022, the Philadelphia Business
  Journal named Ocugen among the region’s “2022 Best Places to Work.”

Second Quarter 2022
Financial Results

• The Company’s cash, cash equivalents, and restricted cash totaled $115.0 million as of June 30, 2022, compared to $95.1 million as of December 31, 2021. The Company believes that its current cash and cash equivalents balance will enable it to fund its operations into the second quarter of 2023. The Company had 216.1 million shares of common stock outstanding as of June 30, 2022.
• Research and development expenses for the three months ended June 30, 2022, were $9.0 million compared to $18.9 million for the three months ended June 30, 2021. Research and development expenses for the three months ended June 30, 2021, included a $15.0 million upfront payment to Bharat Biotech for the right and license to COVAXIN™ development, manufacturing, and commercialization in Canada.  
• General and administrative expenses for the three months ended June 30, 2022, were $10.6 million compared to $6.8 million for the three months ended June 30, 2021.
• Ocugen reported a $0.09 net loss per share for the three months ended June 30, 2022, compared to a $0.13 net loss per share for the three months ended June 30, 2021.

Conference Call and
Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s executive management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 7036957
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 

Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995, which are subject to
risks and uncertainties. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or
other words that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Such forward-looking statements include, but
are not limited to, statements about the potential for NeoCart^® (autologous chondrocyte-derived neocartilage), if
approved, to provide an innovative new option for the repair of full-thickness
lesions of the knee cartilage in adults, as well as Ocugen’s intention to begin
dosing in Cohort 2 of the OCU400 clinical trial this month. Such statements are
subject to numerous important factors, risks, and uncertainties that may cause
actual events or results to differ materially from our current expectations.
These and other risks and uncertainties are more fully described in our
periodic filings with the Securities and Exchange Commission (SEC), including
the risk factors described in the section entitled “Risk Factors” in the
quarterly and annual reports that we file with the SEC. Any forward-looking
statements that we make in this press release speak only as of the date of this
press release. Except as required by law, we assume no obligation to update
forward-looking statements contained in this press release whether as a result
of new information, future events, or otherwise, after the date of this press
release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

(Tables to follow)

OCUGEN, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

 

OCUGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

Friday, August 05, 2022

Avivagen Inc. (VIVXF)
AB Vista Gets on the Board

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

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 Pathway Into Brazil. Avivagen’s management announced Wednesday that the Company has received a 1.2 tonne order of OxC-beta from AB Vista that will be shipped for use in Brazil. It will be used for ongoing trials with several large poultry and cattle producers. We believe that this is a stepping stone in Avivagen’s aggressive marketing in OxC-beta, as the order represents increased awareness of the product.

Brazil Market. As a reminder, AB Vista is the exclusive distribution partner for Avivagen in the United States, Brazil, and Thailand. Brazil is the third largest for animal feed behind China and the U.S., and produced 80.1mmt in 2021. We anticipate more deals coming from the Brazil market, as AB Vista has existing relationships and distribution partnerships it can use to further sales of the OxC-beta product….

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.