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Release – Cocrystal Pharma Reports Second Quarter 2023 Financial Results and Provides Updates on its Antiviral Drug Development Programs

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

AUGUST 14, 2023

  • On track to begin a Phase 2a trial in the second half of 2023 with CC-42344 for the treatment of pandemic and seasonal influenza A
  • Selected the novel protease inhibitor CDI-988 as development lead in the oral norovirus program
  • CDI-988, the first potential dual coronavirus-norovirus oral antiviral, was cleared by the Australian regulatory agency for evaluation in healthy volunteers

BOTHELL, Wash., Aug. 14, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) reports financial results for the three and six months ended June 30, 2023, and provides updates on its antiviral pipeline, upcoming milestones and business activities.

“This is an eventful time for Cocrystal with notable advancements in developing our pipeline of highly promising antivirals,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “With our novel oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A, we are building on the favorable data from our Phase 1 trial with the submission of an application for UK MHRA (Medicine and Healthcare Products Regulatory Agency) approval to begin a Phase 2a human challenge trial later this year.

“In our COVID-19 program, we received approval from the Australian regulatory agency in late May to begin a first-in-human trial with our novel, broad-spectrum oral protease inhibitor CDI-988. Earlier this month we announced the selection of CDI-988 as our lead oral norovirus candidate. This Phase I study is designed to access the safety, tolerability, and pharmacokinetics of CDI-988 for both our COVID-19 and our norovirus programs. We expect to report top-line data of CDI-988 Phase 1 study in 2024.”

“We have a number of significant near-term inflection points with our three leading antiviral programs including the commencement of multiple clinical trials,” said James Martin, CFO and co-CEO. “I’m pleased to report that under our cost-efficient business model, we believe our current cash position is sufficient to fund our planned operations for the next 12 months.”

Antiviral Product Pipeline Overview

We are developing therapeutics that inhibit the viral replication function of RNA viruses that cause acute and chronic diseases. Our drug discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. It differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes. By designing and selecting antiviral drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that are effective against both the virus and mutants of the virus, and also have reduced off-target interactions that may cause undesirable clinical side effects.

Influenza Programs

Influenza is a severe respiratory illness caused by the influenza A or B virus that results in disease outbreaks mainly during the winter months. The global seasonal influenza market including diagnostics, treatments and vaccines is projected to reach up to $27.95 billion by 2029, according to Data Bridge Market Research.

  • Pandemic and Seasonal Influenza A
    • Our novel oral PB2 inhibitor CC-42344 has shown excellent antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In March 2022 we initiated enrollment in a randomized, double-controlled, dose-escalating Phase 1 trial to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered CC-42344 in healthy adults.
    • In April 2022 we announced preliminary Phase 1 trial data demonstrating a favorable safety and PK profile in the first two cohorts in the single-ascending-dose portion of the study.
    • In July 2022 we reported PK results from the single-ascending-dose portion of the study that support once-daily dosing.
    • In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 trial.
    • We entered into an agreement with a UK-based clinical research organization to conduct a Phase 2a human challenge study to evaluate safety, and viral and clinical measures of orally administered CC-42344 in influenza A-infected subjects.
    • We submitted an application to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct the Phase 2a human challenge study and, pending clearance, we expect to initiate the study in the second half of 2023.
    • Preclinical development is underway with an inhaled formulation of CC-42344 as a potential treatment and prophylaxis for influenza A. We expect to complete active pharmaceutical ingredient (API) manufacturing in preparation for toxicity studies, and to begin the Phase 1 clinical trial in the first half of 2024.

  • Pandemic and Seasonal Influenza A/B Program


    • In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. (Merck) to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
    • In January 2021 we announced completion of all research obligations under the agreement, making Merck solely responsible for further preclinical and clinical development of these compounds.
    • In early 2023 Merck notified us of its intent to continue development of the proprietary compounds discovered under this agreement and of their filing on behalf of both companies of multiple U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.

COVID-19 and Other Coronavirus Programs

By targeting viral replication enzymes and protease, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.

  • Oral Protease Inhibitor CDI-988
    • In August 2023 we announced the selection of CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. Designed and developed using our proprietary structure-based drug discovery platform technology, CDI-988 targets a highly conserved region in the active site of SARS-CoV-2 3CL (main) protease required for viral RNA replication.
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern, and demonstrated a safety profile and PK properties that are supportive of once-daily dosing.
    • In May 2023 we announced approval of our application to the Australian regulatory agency for a planned randomized, double-blind, placebo-controlled Phase 1 trial in healthy volunteers.
    • We believe the FDA’s guidance for further development of our antiviral candidate CDI-45205 (described below) assists us in designing a subsequent Phase 2 trial for CDI-988.

  • Intranasal/Pulmonary Protease Inhibitor CDI-45205


    • CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor and was among the broad-spectrum viral protease inhibitors we obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in April 2020. We believe the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
    • CDI-45205 and several analogs showed potent in vitro activity against the main SARS-CoV-2 variants, surpassing the activity observed with the original Wuhan strain of the virus.
    • CDI-45205 demonstrated good bioavailability in mouse and rat PK studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
    • In January 2022 we received guidance from the FDA regarding further preclinical and clinical development of CDI-45205, which provides a clearer pathway for future development.
    • An IND-enabling study is ongoing with CDI-45205.
  • Replication Inhibitors
    • We are using our proprietary structure-based drug discovery platform technology to discover replication inhibitors for orally administered therapeutic and prophylactic treatments for SARS-CoV-2. Replication inhibitors hold potential to work with protease inhibitors in combination therapy regimens.

Norovirus Program

  • In August 2023 we announced our selection of the novel broad-spectrum 3CL protease inhibitor CDI-988 as our lead potential oral treatment for norovirus. CDI-988 is approved for evaluation in a first-in-human trial in healthy volunteers in Australia, and that trial is expected to serve as the Phase 1 trial for both our norovirus and our coronavirus programs.
  • With no approved treatments or vaccines, norovirus represents a significant unmet medical need. It is a highly contagious infection and is the most common cause of acute gastroenteritis, accounting for nearly one in five cases. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of $60 billion.

Hepatitis C Program

  • We are seeking a partner to advance development of CC-31244 following the successful completion of a Phase 2a trial. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a trial in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV).
  • HCV is a viral infection of the liver that causes both acute and chronic infection. The World Health Organization estimated that 58 million people worldwide had chronic HCV infection in 2019. 

Corporate Updates

  • In April we announced the appointment of Fred Hassan to our Board of Directors. Mr. Hassan’s distinguished 40-year career includes serving in senior executive and director positions at global pharmaceutical companies and leading investment firms. He currently is Chairman of the investment firm Caret Group and a Director of Warburg Pincus LLC, a global private equity firm.
  • In April we completed a $4.0 million private placement offering of common stock with Mr. Hassan and Phillip Frost, M.D., a Company co-founder and director, who currently is Chairman and CEO of OPKO Health.

Second Quarter Financial Results

Research and development (R&D) expenses for the second quarter of 2023 were $2.8 million, compared with $2.4 million for the second quarter of 2022. The increase was primarily due to preparations for a Phase 2a clinical trial with CC-42344 for pandemic and seasonal influenza A, and preparations for advancing CDI-988’s COVID-19 and norovirus programs toward a Phase 1 clinical trial.

General and administrative (G&A) expenses for the second quarter of 2023 were $1.5 million, compared with $1.4 million for the second quarter of 2022, with the increase primarily due to professional fees and general corporate cost increases.

The net loss for the second quarter of 2023 was $4.2 million, or $0.41 per share, compared with the net loss for the second quarter of 2022 of $24.4 million, or $3.00 per share. The second quarter of 2022 included a legal settlement of $1.6 million, which was returned to the Company in the third quarter of 2023 following a successful appeal of the trial court’s summary judgment ruling. In the second quarter of 2022, the Company also recorded a non-cash goodwill impairment of $19.1 million.

Six Month Financial Results

R&D expenses for the six months ended June 30, 2023 were $6.7 million, compared with $5.2 million for the first six months of 2022. G&A expenses for the six months ended June 30, 2023 and 2022 were unchanged at $2.7 million.

During the first six months of 2022, the Company recorded a $19.1 million non-cash goodwill impairment. There was no comparable impairment charge during the first six months of 2023.

The net loss for the six months ended June 30, 2023 was $9.4 million, or $1.03 per share. The net loss for the six months ended June 30, 2022 was $28.6 million, or $3.48 per share, and reflected the litigation expense and non-cash impairment charge described above.

Cocrystal reported unrestricted cash as of June 30, 2023 of $32.4 million, compared with $37.1 million as of December 31, 2022. Net cash used in operating activities for the first six months of 2023 was $8.7 million. The Company had working capital of $34.1 million and 10.2 million common shares outstanding as of June 30, 2023. During the second quarter of 2023, the Company raised $4.0 million in a private placement offering of common stock that was priced “at-the-market” under Nasdaq Listing Rules.

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), noroviruses and hepatitis C viruses. 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.

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 plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value-driving milestones in our programs, including, preparation, commencement and advancement of clinical studies for certain product candidates in 2023 and beyond, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to advance our programs and fund our planned operations, and our liquidity. 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 risks and uncertainties arising from the risks arising from interest rate increases in response to inflation, uncertainty in the financial markets, the possibility of a recession and the Ukraine war on our Company, our collaboration partners, and on the U.S., U.K., Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future CROs and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and the outcome of the ongoing litigation with the insurance company. 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, 2022. 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

Financial Tables to follow

 COCRYSTAL PHARMA, INC.

CONSOLIDATED BALANCE SHEETS
(in thousands)

  June 30, 2023  December 31, 2022 
   (unaudited)     
Assets        
Current assets:        
Cash $32,419  $37,144 
Restricted cash  75   75 
Tax credit receivable  1,207   716 
Prepaid expenses and other current assets  1,200   2,243 
Total current assets  34,901   40,178 
Property and equipment, net  305   342 
Deposits  46   46 
Operating lease right-of-use assets, net (including $72 and $99 respectively, to related party)  167   274 
Total assets $35,419  $40,840 
         
Liabilities and stockholders’ equity        
Current liabilities:        
Accounts payable and accrued expenses $1,421  $976 
Current maturities of finance lease liabilities  –   7 
Current maturities of operating lease liabilities (including $62 and $59 respectively, to related party)  166   233 
Total current liabilities  1,587   1,216 
Long-term liabilities:        
         
Operating lease liabilities (including $10 and $42 respectively, to related party)  10   57 
         
Total liabilities  1,597   1,273 
         
Commitments and contingencies        
         
Stockholders’ equity:        
Common stock, $0.001 par value; 150,000 shares authorized as of June 30, 2023, and December 31, 2022; 10,174 and 8,143 shares issued and outstanding as of June 30, 2023 and December 31, 2022  10   8 
Additional paid-in capital  341,957   337,489 
Accumulated deficit  (308,145)  (297,930)
Total stockholders’ equity  33,822   39,567 
Total liabilities and stockholders’ equity $35,419  $40,840 

COCRYSTAL PHARMA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)

  Three months ended
June 30,		  Six months ended
June 30,		 
  2023  2022  2023  2022 
Operating expenses:                
Research and development  3,661   2,361   7,568   5,233 
General and administrative  1,538   1,375   2,742   2,708 
Legal settlement  –   1,600   –   1,600 
Impairments  –   19,092   –   19,092 
Total operating expenses  5,199   24,428   10,310   28,633 
                 
Loss from operations  (5,199)  (24,428)  (10,310)  (28,633)
Other income (expense):                
Interest income (expense), net  140   –   140   (1)
Foreign exchange loss  33   (1)  (45)  (14)
Change in fair value of derivative liabilities  –   1   –   12 
Total other expense, net  173   –   95   (3)
Net loss $(5,026) $(24,428)  (10,215)  (28,636)
Net loss per common share, basic and diluted $(0.50) $(3.00)  (1.12)  (3.48)
Weighted average number of common shares outstanding, basic and diluted  10,065   8,143   9,109   8,143 

# # #

Source: Cocrystal Pharma, Inc.

Released August 14, 2023

Release – PDS Biotech Reports Second Quarter 2023 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

  • Successful submission of final clinical protocol and supporting CMC information to FDA to initiate Phase 3 VERSATILE-003 trial in the fourth quarter 2023
  • Biomarker data from VERSATILE-002 to be presented at ESMO 2023
  • Company to host conference call and webcast today at 8:00 AM EDT

PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, will discuss its financial results for the quarter ended June 30, 2023 and provide a business update on its conference call today.

Recent Business Highlights:
PDS0101 Lead Drug Candidate

  • VERSATILE-003: Submitted the final Phase 3 clinical protocol and supporting Chemistry, Manufacturing and Controls (CMC) information to the U.S. Food and Drug Administration (FDA) to enable initiation of the VERSATILE-003 randomized, controlled multicenter study of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer in the fourth quarter 2023
  • VERSATILE-002: Phase 2 open-label, multicenter study of PDS0101 in combination with KEYTRUDA® in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer
    • Announced clinical immune response data to be presented at upcoming European Society for Medical Oncology (ESMO) Congress 2023
      • Biomarker data highlighting HPV16-specific killer and helper T cell responses will be presented
    • Presented interim data at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, demonstrating a 12-month overall survival rate of 87%, with only 8% of patients experiencing Grade 3 treatment-related adverse events, and no reports of more severe Grade 4 or 5 adverse events
    • Achieved the efficacy threshold in Stage 2 of this clinical trial for the naïve patient arm
      • 14 patients in the immune checkpoint inhibitor (ICI) naïve arm experienced either a complete response or partial response on two consecutive scans 9-12 weeks apart, constituting a confirmed objective response. This result suggests that PDS0101 has a statistically significant additive effect over published results of ICI monotherapy
    • Completed enrollment in the ICI naïve arm and expect final data readout in mid-2024

PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)

  • PDS0301 + docetaxel: Phase 2, open label, single-arm trial of PDS0301 in combination with docetaxel in metastatic castration sensitive and castration resistant prostate cancer, led by the National Cancer Institute (NCI)
    • Announced selection of abstract for oral presentation by the NCI at the upcoming Cytokines 2023 Annual Meeting on October 15-18, 2023
    • The Phase 2 clinical trial is investigating the safety, immune responses, and clinical activity of the combination in metastatic prostate cancer patients
    • First clinical trial of an immunocytokine with docetaxel in prostate cancer patients

Business Highlights

  • PDS Biotech was added to the broad-market Russell 2000® and Russell 3000® Indexes in June 2023

“We continue to make significant strides with our lead candidate, PDS0101, specifically with the regulatory and clinical activities necessary to initiate the VERSATILE-003 trial, as well as with progression of the Phase 2 VERSATILE-002 clinical trial,” stated Dr. Frank Bedu-Addo, CEO of PDS Biotech. “In the second quarter, at ASCO 2023, we presented interim data from VERSATILE-002 which revealed an impressive estimated 12-month overall survival rate of 87% and a progression-free survival of 10.4 months, while maintaining a favorable safety profile when PDS0101 is combined with KEYTRUDA®. The reported 12-month overall survival rate for immune checkpoint inhibitors is 30-50%. These encouraging findings fuel our enthusiasm as we prepare to initiate the Phase 3 VERSATILE-003 clinical trial in which patient overall survival will be the primary trial outcome in the fourth quarter of 2023.”

Dr. Bedu-Addo further commented, “In addition to our enthusiasm for PDS0101, we are thrilled about the prospects of PDS0301 which we believe may potentially overcome some of the key safety and efficacy limitations of current cytokines. We are excited about the NCI’s abstract acceptance at the upcoming Cytokines 2023 annual meeting. We anticipate these results have the potential to offer valuable insights into the use of PDS0301 in conjunction with chemotherapy for various solid tumors, presenting a promising avenue for future development and commercialization possibilities.”

Second Quarter 2023 Financial Results

Net loss for the three months ended June 30, 2023 was approximately $11.5 million, or ($0.37) per basic share and diluted share, compared to a net loss of approximately $5.8 million, or ($0.20) per basic share and diluted share, for the three months ended June 30, 2022. The higher net loss this quarter was primarily due to costs incurred in connection with our research and development programs.

Research and development expenses increased to $8.0 million for the three months ended June 30, 2023 from $3.8 million for the three months ended June 30, 2022. The increase of $4.2 million is primarily attributable to an increase of $1.4 million in clinical trials, $0.5 million in personnel costs, including $0.2 million in non-cash stock-based compensation, and $2.3 million in manufacturing expenses.

General and administrative expenses increased to $4.7 million for the three months ended June 30, 2023 from $3.3 million for the three months ended June 30, 2022. The increase of $1.4 million is primarily attributable to an increase of $0.5 million in personnel costs, including $0.4 million in non-cash stock-based compensation and $0.9 million in professional fees.

Cash and cash equivalents as of June 30, 2023, totaled approximately $60.6 million. Based on the company’s cash resources, PDS Biotech believes this amount is sufficient to fund operations and research and development programs for 12 months following the filing of the Company’s June 2023 Quarterly Report on Form 10-Q which will be filed as of the date of this press release.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 AM EDT today, August 14, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13731437. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Versamune®
Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.

About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16 targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About PDS0301
PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. PDS0301 is given by a subcutaneous injection. PDS0301 is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
drandolph@pdsbiotech.com 

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
pdsb@cg.capital 

Media Contacts:
Tiberend Strategic Advisors, Inc.
Dave Schemelia
Phone: +1 (609) 468-9325
dschemelia@tiberend.com 

Eric Reiss
Phone: +1 (802) 249-1136
ereiss@tiberend.com

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Balance Sheets
 
 June 30, 2023 December 31, 2022
ASSETS(unaudited)  
Current assets:   
Cash and cash equivalents$60,624,991  $73,820,160 
Prepaid expenses and other assets 2,725,958   2,660,230 
Total current assets 63,350,949   76,480,390 
      
Property and equipment, net 143,600   – 
Financing lease right-to-use assets 220,213   374,888 
Operating lease right-to-use asset 39,488   152,645 
      
Total assets$63,754,250  $77,007,923 
      
LIABILITIES AND STOCKHOLDERS’ EQUITY     
Current liabilities:     
Accounts payable$4,414,905  $1,219,287 
Accrued expenses 3,376,325   8,313,708 
Financing lease obligation-short term 53,309   56,612 
Operating lease obligation-short term 59,650   231,429 
Total current liabilities 7,904,189   9,821,036 
      
Noncurrent liabilities:     
Note payable, net of debt discount 23,254,367   23,020,844 
Financing lease obligation-long term 151,505   164,013 
Total liabilities:$31,310,061  $33,005,893 
      
      
STOCKHOLDERS’ EQUITY     
Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2023
and December 31, 2022, 30,868,188 shares and 30,170,317 shares issued and
outstanding at June 30, 2023 and December 31, 2022, respectively		 10,188   9,956 
Additional paid-in capital 155,187,231   145,550,491 
Accumulated deficit (122,753,230)  (101,558,417)
Total stockholders’ equity 32,444,189   44,002,030 
      
Total liabilities and stockholders’ equity$63,754,250  $77,007,923 
 
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
 
 Three Months Ended June 30, Six Months Ended June 30,
  2023   2022   2023   2022 
Operating expenses:               
Research and development expenses$8,004,852  $3,761,646  $13,848,538  $8,922,961 
General and administrative expenses 4,691,321   3,331,006   8,270,049   6,648,913 
Total operating expenses 12,696,173   7,092,652   22,118,587   15,571,874 
                
Loss from operations (12,696,173)  (7,092,652)  (22,118,587)  (15,571,874)
                
Interest income (expenses), net               
Interest income 750,654   74,547   1,479,995   80,247 
Interest expense (995,397)  –   (1,962,242)  – 
Interest income (expenses), net (244,743)  74,547   (482,247)  80,247 
                
Loss before income taxes (12,940,916)  (7,018,105)  (22,600,834)  (15,491,627)
Benefit for income taxes 1,406,021   1,198,905   1,406,021   1,198,905 
Net loss and comprehensive loss (11,534,895)  (5,819,200)  (21,194,813)  (14,292,722)
                
Per share information:               
Net loss per share, basic and diluted$(0.37) $(0.20) $(0.69) $(0.50)
                
Weighted average common shares outstanding, basic,
and diluted		 30,802,498   28,451,579   30,616,310   28,450,104 

Release – PDS Biotech Announces Submission of Phase 3 Protocol to FDA to Initiate VERSATILE-003 Trial

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

VERSATILE-003 will evaluate PDS0101 in combination with KEYTRUDA® in recurrent or metastatic HPV16-positive head and neck cancer

PDS Biotech anticipates initiating the VERSATILE-003 trial in the fourth quarter of 2023

PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced the submission to the U.S. Food and Drug Administration (FDA) of an updated Chemistry, Manufacturing and Controls (CMC) package and a Phase 3 multicenter registrational protocol to the company’s Investigational New Drug (IND) submission to evaluate the combination of PDS0101 and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of recurrent or metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). The protocol was developed in accordance with guidance from the FDA on key elements of the Phase 3 program to support the eventual submission of a Biologics License Application (BLA).

The Phase 3 trial, named VERSATILE-003, is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in immune checkpoint inhibitor (ICI)-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003, per the protocol, is overall survival (OS). The Phase 3 study is expected to involve approximately 90-100 clinical sites globally. PDS Biotech anticipates initiating the VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.

“Submission of the protocol and supportive CMC documents for this Phase 3 registrational trial is an important milestone for PDS Biotech and our VERSATILE-003 program investigating PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent or metastatic HPV16-positive HNSCC,” stated Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “Interim data from our ongoing VERSATILE-002 Phase 2 clinical trial have been very encouraging, with impressive interim OS and PFS results. With VERSATILE-003, we have an opportunity to confirm the Phase 2 results from VERSATILE-002 in a controlled, Phase 3 clinical trial comparing the combination of PDS0101 and KEYTRUDA® to KEYTRUDA® monotherapy.”

About PDS0101 

PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggest PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

About VERSATILE-002 

VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.   

Interim efficacy and safety data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-naïve patients. Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed, and Grade 3 treatment related adverse events were observed in 8% of patients.

About VERSATILE-003 

VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.  

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

Forward Looking Statements 

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.    

Versamune® and Infectimune® are trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts: 
Deanne Randolph 
PDS Biotech 
Phone: +1 (908) 517-3613 
Email: drandolph@pdsbiotech.com 

Rich Cockrell 
CG Capital 
Phone: +1 (404) 736-3838 
Email: pdsb@cg.capital 
  
Media Contacts: 
Dave Schemelia 
Tiberend Strategic Advisors, Inc. 
Phone: +1 (609) 468-9325 
Email: dschemelia@tiberend.com 

Eric Reiss
Tiberend Strategic Advisors, Inc. 
Phone: +1 (802) 249-1136
Email: ereiss@tiberend.com 

Tonix Pharmaceuticals (TNXP) – Focus On CNS Transforms During 2Q23

Posted on by cpereira@noblefcm.com


Monday, August 14, 2023

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Two Product Acquisitions Plus Four Topline Clinical Trial Results Expected. Tonix reported a loss of $28.4 million or $(2.68) per share, and a cash balance of $25.6 million in cash on June 30, 2023. During the quarter, the company acquired two currently marketed products for migraine headache that turn it into an operating company with product sales. These products fit with its focus on CNS drugs and its four clinical trials that are expected to announce topline results before the end of 2023.

Two CNS Products Have Been Acquired. In June, Tonix acquired two migraine headache products containing sumatriptan with proprietary delivery technologies. Zembrace SymTouch is an injectable sumatriptan packaged with an autoinjector for ease of use. Tosymra is a sumatriptan nasal spray with a permeation enhancer. These products have sales estimated at about $30 million during the previous 12 months. In addition, they add a sales force and CNS customer base for Tonix’s future products.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Schwazze (SHWZ) – Navigating Through Industry Shoals

Posted on by cpereira@noblefcm.com


Monday, August 14, 2023

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

2Q Results. Schwazze reported revenue of $42.4 million, down from last year’s $44.3 million. We had estimated revenue of $44 million. Schwazze reported a net loss, before preferred dividends, of $6.6 million, compared to net income of $33.8 million last year, which was impacted by unrealized derivative gains. After preferred dividends, net loss was $8.96 million, or a loss of $0.15/sh, versus net income of $32.1 million, or $0.24/sh, last year. Adjusted EBITDA was $13.8 million, or a margin of 32.6%, compared to $15 million, or 33.9%, last year. We had projected a $3.4 million net loss, or $0.06/sh.

Playbook Protecting Margins. By implementing its “go deep” retail strategy in its Colorado and New Mexico markets, Schwazze has been able to capture market share while cost optimization and operating efficiencies are enabling the Company to protect margins, as seen in 2Q23 gross margin of 57.9% up from 56.8% in 2Q22.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

RCI Hospitality Holdings (RICK) – Reports Second Quarter Earnings; Lowering Price Target

Posted on by cpereira@noblefcm.com


Monday, August 14, 2023

With more than 60 units, RCI Hospitality Holdings, Inc., through its subsidiaries, is the country’s leading company in adult nightclubs and sports bars/restaurants. Clubs in New York City, Chicago, Dallas-Fort Worth, Houston, Miami, Minneapolis, Denver, St. Louis, Charlotte, Pittsburgh, Raleigh, Louisville, and other markets operate under brand names such as Rick’s Cabaret, XTC, Club Onyx, Vivid Cabaret, Jaguars Club, Tootsie’s Cabaret, Scarlett’s Cabaret, Diamond Cabaret, and PT’s Showclub. Sports bars/restaurants operate under the brand name Bombshells Restaurant & Bar.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Third Quarter Results. RCI reported revenue of $77.1 million, up 9% y-o-y and in-line with our $77.8 million estimate. Net income was $9.1 million, or EPS of $0.96 compared to $13.9 million, or $1.48, last year with 3Q23 results impacted by higher expenses and one-time costs. Adjusted EPS was $1.30 versus $1.60. Adjusted EBITDA was at $22.7 million versus $24.6 million last year. We estimated net income of $12.9 million, EPS of $1.34, and adjusted EBITDA of $24.9 million.

Tough Comps and a Tough Environment. We would note 3Q22 had one of the highest levels of operating leverage in the last five years, as the business benefitted from the COVID emergence, directly impacting y-o-y comparisons. A continued uncertain economic environment also impacted results to a degree.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Kelly Services (KELYA) – Lower Demand Environment but Still Underway with Transformation

Posted on by cpereira@noblefcm.com


Monday, August 14, 2023

Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

2Q Results. Kelly reported revenues of $1.22 billion, a 3.9% decrease, or down 4.5% in constant currency, from the prior year. Organic revenue was down 2.2% in constant currency. We estimated revenue at $1.24 billion.  GP rate was down 90 basis points to 19.8% primarily due to lower permanent placements fees. Net income was $7.5 million, or EPS of $0.20, compared to $2.2 million, or EPS of $0.06 last year. Adjusted EPS was $0.36 versus $0.45. We were at $0.44.

Transformation Plan. Kelly is moving quickly, already seeing benefits from its cost optimization and efficiencies programs. Next up will be a focus on growth, both organic, especially capturing a higher wallet share from existing clients, as well as a renewed inorganic focus.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Comstock Inc. (LODE) – Looking Ahead to a Catalyst-Rich Second Half 2023

Posted on by cpereira@noblefcm.com


Monday, August 14, 2023

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complimentary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.

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

Innovative feedstocks for renewable fuel producers. Comstock Fuels demonstrated the production of lignocellulosic bio-intermediates suitable for use in existing renewable fuel refineries at pilot scale and the capability for ongoing operations. A baseline lifecycle carbon analysis (LCA) model has also been developed with a third-party to validate industry-leading carbon intensity scores for fuel produced through its pathways. Management is engaged with multiple potential customers and partners for early adopter commercial agreements and expects one or more agreements to be completed this year.

Advancing toward commercialization. Comstock Metals has leased an operating facility in Silver Springs, Nevada and submitted all permits for operating its proprietary metal processing and recycling system. Comstock anticipates full deployment of its entire production system by the end of 2023 with operations commencing upon receipt of the permits. Comstock Metals has engaged suppliers to secure photovoltaic feedstocks and expects initial supply-revenue agreements in advance of production.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Was Michael Burry Wrong to Say, “I Was Wrong to Say Sell”?

Posted on by phoffman@channelchek.com

Michael Burry Has a Huge Bet According to His Just Filed SEC 13-F Report

It looks like Michael Burry has changed his mind, again. At the beginning of 2023, Burry,  the founder of Scion Asset Management, was not positive at all on the stock market. The market then moved up in an epic rally. By late March, he announced in a tweet, “I was wrong to say sell.” Over the coming months stocks that had been beaten down the prior year, moved up significantly.

In his quarterly SEC 13-F filing today, the hedge fund manager that was portrayed in the movie “The Big Short” reported that he is more than just short the S&P 500 and Nasdaq 100. Burry held a huge leveraged short position as of June 30th. The position represents 84% of Scion’s assets under management (AUM), and is in the form of an all-or-nothing marketable options trade.

Source: Koyfin

About His Position

Burry recognized losses during the second quarter. The long positions he had put on earlier were underwater when he sold. The only conclusion is that he must have switched again from bullish to bearish – at least on these specific stocks. He then, with a broad brush, shorted large-cap stocks using stock options on ETFs. As of quarter-end 51.05% of his portfolio held puts on SPY and 42.54% held puts on QQQ.

Burry manages $1.7 billion. The puts used to short the S&P 500 ETF (SPY) and Nasdaq 100 (QQQ) is a broad brush that shows a great deal of confidence that large-cap stocks are headed lower before the options expire. It is a huge bet, while a short using puts has less downside than a straight short that, if unmanaged, can move against the owner an infinite amount, options have a window when they can be sold or exercised. If the position doesn’t work out, losses can be 100%.

Take Away

A lot can be learned from celebrity investors and fund managers. The lesson that investors may glean from Michael Burry’s first six months of 2023 is that you don’t sit in a bad position. Or, changing your mind is okay. The new positions indicate a high degree of confidence that large-cap stocks will fall apart over the coming months. It is just two positions, but they speak volumes in terms of his market call.

Paul Hoffman

Managing Editor, Channelchek

https://whalewisdom.com/filer/scion-asset-management-llc

https://www.channelchek.com/news-channel/michael-burry-suggests-he-is-now-bullish

Is Gary Gensler on His Way Out at the SEC?

Posted on by phoffman@channelchek.com

The SEC May be Poised to Become more Accommodating to Cryptocurrency

In what is being reported as a developing story that can significantly impact securities and crypto regulation, rumors are circulating that SEC Chair Gary Gensler may be on the way out as head of the agency.  The reports are pointing to Hester Pierce as the most likely person to replace him. How would this impact public markets and the future state of cryptocurrency regulation? We discuss these questions and thoughts below.

Background

Whale (@whalechart) is a crypto news provider with an account on the microblogging platform X.  It is widely respected, with 363,000 followers. Whale announced this morning (August 14), “SEC Commissioner Hester Peirce is being considered to replace Gary Gensler as the head of the regulatory agency.”  This small post (or tweet) has triggered waves of speculation about the upcoming course of securities regulation for both registered products and cryptocurrencies like Bitcoin.

Ms. Peirce is known for her strong support of innovation and outside-the-box thinking. She has been a commissioner of the SEC since 2018, appointed by President Trump. Pierce is a former academic and lawyer who has specialized in securities law and financial regulation. She is known for her views on the regulation of cryptocurrencies and other emerging technologies.

What the SEC May Look Like Under Hester Pierce

Peirce, who has a reputation as being pro-innovation, has been a bold advocate for embracing disruptive technologies like cryptocurrencies and blockchain. If the rumors are accurate and she does find her way to the position of top securities cop, it could signal a shift towards a more accommodating regulatory stance, with a leader whose thoughts on fintech and digital assets are known.

If the days are indeed numbered for the SEC’s current head Gary Gensler, the traditional and digital asset markets would mainly view this as a positive. President Biden’s appointee, Gary Gensler, has been a catalyst behind the intensified scrutiny and rule-making within the overall cryptocurrency realm. His time in the position has led the SEC’s tightening its grip on digital asset exchanges and clamping down on many Initial Coin Offerings (ICOs).

Gensler has been acting to protect consumers, but many critics argue that the SEC under his lead, has been led to too much interference in free markets. With Peirce potentially in the drivers seat, the probability of the regulator embracing crypto assets in a less restrictive way increases dramatically.

Those impacted the most by a changed SEC head have weighed in already with diverse ideologies and opinions. Advocates assert that her penchant for innovation could sow the seeds for heightened financial growth. They contend that a friendlier regulatory outlook might be the medicine needed to embolden new ideas and investors to explore new opportunities – this, they say, could give the economy a lift.

Those opposed to a Hester Peirce nomination warn against a looser regulatory environment that could leave investors exposed to heightened risks. Their call is for the SEC to remain a vigilant guardian of investor interests, standing as a wall against potential deceit or market manipulation.

As the news regarding Peirce’s probable elevation continues to spread on social media and in articles like this, the pressing question many market participants are trying to discern is, will the SEC take a gentler road to new tech innovations or will it hold overly tight to its role concerning investor safety? If the change happens, there could be a celebratory bump in the value of crypto assets and others.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://publish.twitter.com/? Whale

https://foggymedia.in/blog/SEC%20Commissioner%20Hester%20Peirce%20Considered%20to%20Replace%20Gary%20Gensler/

https://cointelegraph.com/news/this-scenario-could-see-sec-gary-gensler-resign

https://coinmarketcap.com/community/articles/64d9f66a62115c7ccfb3c1ec

The Week Ahead –  SEC 13-F Filings, FOMC Minutes, Housing Numbers

Posted on by phoffman@channelchek.com

The Trading Week Ahead Could See Investors Continuing to Adjust to the Flattening Yield Curve

Bill Ackman says he’s short the U.S. Treasury long bond. Michael Burry, who tends to see things before others, had been short a derivative of Treasuries two summers ago, was he involved in interest rates this most recent quarter-end? We will get a glimpse into what these two, plus Warren Buffett and a host of others, as time runs out on their 13-F filing as of the close of business on Monday.

Last week many investors went from betting on a soft-landing a few weeks ago to now thinking interest rates along the curve are too low. The impetus for the shift was the CPI and PPI reports last week had provided nothing for the Fed to stop or slow down tightening. This concerns stock market investors. Higher rates, at a minimum, are beginning to provide an attractive alternative to a stock market that has already run up above average. This is because investors can now be choosier as their cash is far more productive, even after inflation, than it has been in years. Individual companies that have great prospects, rather index ETFs where you hold the good with the bad, would seem more prudent in the current scenario.

Monday 8/14

•             13-F Day is the SEC deadline for funds that manage more than $100 million in assets, that they must divulge positions held as of the end of the previous quarter. For example, Michael Burry’s Scion Asset Management hedge fund, Warren Buffett’s Berkshire Capital Holdings, and all U.S. asset managers of size have 45 days from quarter-end to file. A very large percentage choose to file on the 45th day, August 14th is 45 days from June 30th. Investors pour through the 13_f filings of top investors looking for insights.

Tuesday 8/15

•             8:30 AM ET, The consensus for Retail Sales for July is up 0.4% after an unexpectedly poor showing in June of a gain of 0.2%. Retail sales measure the total receipts at stores that sell merchandise and related services to final consumers. Sales are by retail and food services stores.

•             8:30 AM ET, Import and Export Prices are expected to show that import prices increased 0.2% in July after falling 0.2% in June. Export prices are expected to have increased 0.1% after dropping 0.9% in June. The underlying value of this report is the measure of global inflationary trends. Import price indexes are compiled for the prices of goods that are bought in the United States but produced abroad and export price indexes are compiled for the prices of goods sold abroad but produced within the U.S.

•             4:00 AM ET, Treasury International Capital is the tracking of who holds U.S. securities, or put another way, where in the world are U.S. Stocks, U.S. Treasuries, Agencies, and Corporate Bonds. TIC has recently been watched by a wider group as it is a measure of foreign demand for our assets. The prior number (May) showed net long-term transactions abroad of U.S. securities at $25.8 billion.

Wednesday 8/16

•             7:00 AM ET, The Mortgage Bankers Association (MBA) compiles data which indicates demand for mortgages. Data from the previous week indicate a drop in their Purchasing index of 2.7%, and a decline in its Refinance index of 4.0%.

•             8:30 AM ET, Housing Starts month over month for July are expected to have increased to 1.464 million from 1.44 million in June.

•             9:15 AM ET, Industrial Production had fallen 0.5 percent for two straight months; forecasters expect a rebound of 0.3 percent in July. After falling 0.3 and 0.2 percent, manufacturing output is seen as unchanged. Capacity utilization is expected to rise to 79.1 from 78.9 percent, still below what is considered inflationary.

•             10:30 PM ET,  The Energy Information Administration (EIA) provides weekly information on petroleum inventories in the U.S., whether produced here or abroad. The inventory level impacts prices for petroleum products.

•             2:00 PM ET,  FOMC minutes are from the meeting three weeks ago, where the Fed adjusted the overnight target upward. This report has recently been market-moving as it details the issues of debate and consensus among policymakers.

Thursday 8/17

•             8:30 AM ET, Initial Jobless Claims are expected to have fallen the week ended August 12th to 240,000 following a 21,000 jump to 248,000 last week, in the absence of inflation data, the market places adds emphasis on unexpected results in the labor market.

•             10:00 AM ET, E-Commerce Retail Sales for the second quarter are scheduled for release. During the first quarter, online retail transactions had increased by 3%.

•             4:30 AM ET, the weekly report on the Fed’s Balance Sheet is now awaited each week as it provides statistics on whether the Fed is fulfilling its quantitative tightening promise on schedule. It also  could provide an early tip-off if there is a problem within the banking system. The report from the week prior showed $8.208 trillion in assets, and bank reserve credit declining $18,685 billion.

Friday 8/18

•             10:00 AM ET, The Quarterly Services Survey is not usually a large focus, but it is the only economic number printing on what may very well be a lightly traded late summer Friday. The report includes industry information; professional, scientific, and technical services; administrative & support services; and waste management (NAICS 51, 54, and 56). Last quarter, these industries experienced 2.9% growth, or 9.7% year-on-year.

What Else

A press release dated Friday, August 11th, stated that Greg Steube, a Representative from Florida’s 17th district had filed “Articles of Impeachment Against Joseph Robinette Biden, Jr., President of the United States, For High Crimes and Misdemeanors.” What this could mean for markets, if the past is an indicator, is very little. There could be days where traders are largely distracted by news stories that may come from this, but the soundness of the U.S. or the global economy is not likely to be hanging in the balance on any outcome from the proceedings.

Paul Hoffman

Managing Editor, Channelchek

Sources

Steube.house.gov

https://www.econoday.com/articles/high-points-for-economic-data-scheduled-for-august-14-week/

https://thehill.com/homenews/house/4150478-florida-republican-rep-files-articles-of-impeachment-against-biden/

Steube.house.gov

Release – Tonix Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operational Highlights

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

August 10, 2023 4:30pm EDT

Download as PDF

Related Documents

Topline Results from Four CNS Clinical Trials Expected in the Third and Fourth Quarters of 2023

Fibromyalgia Topline Results Expected in the Fourth Quarter of 2023 for Phase 3 Potentially NDA-Enabling Study of the Centrally-Acting Non-Opioid Analgesic TNX-102 SL

Completed Strategic Acquisition of Two Marketed Acute Migraine Products: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray)

CHATHAM, N.J., Aug. 10, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced financial results for the second quarter ended June 30, 2023, and provided an overview of recent operational highlights.

“We have recently completed enrollment in four clinical trials for central nervous system (CNS) indications, representing our continuing progress towards bringing forth new treatments for serious CNS conditions that affect large patient populations,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We look forward to data readouts before year-end 2023 for fibromyalgia, fibromyalgia-type Long COVID, chronic migraine, and depression. The topline results from the Phase 3 fibromyalgia trial are of particular importance because we believe the RESILIENT trial, if successful, will be the final efficacy trial required for submitting a New Drug Application (NDA) for approval by the U.S. Food and Drug Administration (FDA).”  

On June 30, 2023, Tonix completed the acquisition of two marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both non-oral proprietary products indicated for the treatment of acute migraine with or without aura in adults. Zembrace SymTouch is the only branded sumatriptan autoinjector professionally promoted in the United States and is designed for ease of use and favorable tolerability with a low 3 mg dose. Tosymra is a novel intranasal sumatriptan product formulated with a permeation enhancer that provides rapid and efficient absorption of sumatriptan. Collectively, these products generated gross factory sales of approximately $30 million for the twelve months ended March 31, 2023. Zembrace SymTouch and Tosymra each may provide onset of migraine pain relief in as few as 10 minutes for some patients and currently have patent protection to 2036 and 2031, respectively.  

Seth Lederman continued, “The acquisition of these two marketed products is transformative for Tonix as we believe that we are on track to become a fully integrated pharmaceutical company and to expand our expertise in CNS disorders by interacting with health care providers and payers. The build out of our commercial capabilities is timely, given the potential 2025 launch of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, if results from the RESILIENT trial are positive. The two marketed acute migraine products also align strongly with our clinical product candidate TNX-1900 (intranasal potentiated oxytocin), in development as a preventive medication in chronic migraineurs.”

“We plan to submit an IND to study TNX-2900 (intranasal potentiated oxytocin) in Prader-Willi syndrome, for which Orphan Drug Designation has already been granted by the FDA,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Academic collaborators have initiated enrollment in three Phase 2 investigator-initiated trials studying TNX-1900 (intranasal potentiated oxytocin). The trials in adolescent obesity and binge eating disorder at Massachusetts General Hospital (MGH) have the potential to expand the use of TNX-1900 to the treatment of disorders of appetite, eating behaviors and weight. The trial in social anxiety at University of Washington has the potential to expand the use of TNX-1900 to the treatment of disorders of social functioning.”

Dr. Lederman continued, “During the second quarter of 2023, we also announced the prioritization of our clinical stage CNS programs and de-prioritization of our COVID-19 vaccine and related therapeutic programs, as well as certain other preclinical programs in order to reallocate cash and resources. We also streamlined several CNS studies by eliminating interim analyses and reducing enrollment targets to ensure data readouts this year. We incurred a one-time cash outlay related to our acquisition of Zembrace SymTouch and Tosymra in the second quarter.”

Recent Highlights—Marketed Products

On June 30, 2023, Tonix completed the acquisition of two currently marketed products from Upsher-Smith Laboratories, LLC (Upsher-Smith): Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are both indicated for the treatment of acute migraine with or without aura in adults.

Recent Highlights—Key Product Candidates*

Upcoming Data Readouts in Central Nervous System (CNS) Pipeline During 2023

Fibromyalgia (4Q): Phase 3 Potentially NDA-Enabling Study of TNX-102 SL

Fibromyalgia-Type Long COVID (3Q): Phase 2 Proof-of-Concept Study of TNX-102 SL

Chronic Migraine (4Q): Phase 2 Proof-of-Concept Study of TNX-1900

Depression (4Q): Phase 2 Proof-of-Concept Study of TNX-601 ER

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): once-daily at bedtime small molecule for the management of fibromyalgia (FM) – centrally-acting, non-opioid analgesic.

  • In August 2023, the Company announced that it completed enrollment of its potentially confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg in fibromyalgia. A total of 457 participants were randomized in the trial, which, if successful, may serve as the final, well-controlled efficacy trial required for submission of an NDA for approval by the FDA. RESILIENT is a registration-quality, double-blind, placebo-controlled study.
  • Topline results from the RESILIENT trial are expected in the fourth quarter of 2023

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

  • In August 2023, the Company announced it completed the clinical phase of the PREVAIL study, a Phase 2 proof-of-concept study of TNX-102 SL for fibromyalgia-type Long COVID, as the last patient completed their final study visit. PREVAIL is a registration-quality, double-blind, placebo-controlled study.
  • Topline results from the PREVAIL Phase 2 trial are expected in the third quarter of 2023.

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

  • Tonix has developed a formulation of intranasal oxytocin that contains magnesium (Mg2+) which is believed to potentiate the effects of oxytocin and may address the “inverted U” dose response of oxytocin. The company believes that if Mg2+ reduces the high dose inhibition of oxytocin alone, then the new formulation may improve consistency in clinical trials.
  • Enrollment has been completed in the proof-of-concept Phase 2 PREVENTION study of TNX-1900 for the prevention of migraine headache in chronic migraineurs with a total of 88 patients enrolled. PREVENTION is a registration-quality, double-blind, placebo-controlled study.
  • Topline results from the PREVENTION Phase 3 trial are expected in the fourth quarter of 2023.
  • In July 2023, Tonix announced that the first participant was enrolled in the investigator-initiated Phase 2 STROBE Study of TNX-1900 for the treatment of binge-eating disorder at the Massachusetts General Hospital (MGH) under the direction of Principal Investigator Elizabeth Lawson. Tonix is supporting the STROBE study through a clinical trial agreement with MGH.
  • In July 2023, Tonix announced that the first participant was enrolled in a Phase 2 investigator-initiated, proof-of-concept study of TNX-1900 for enhancing social safety learning in social anxiety disorder (SAD) under the direction of Principal Investigator Angela Fang. Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 in enhancing vicarious extinction learning in SAD, compared to healthy controls.
  • In July 2023, Tonix announced that the first participant was enrolled in the Phase 2 POWER study of TNX-1900 for the treatment of pediatric obesity with MGH under the direction of Principal Investigator Elizabeth Lawson. MGH is the sponsor of the National Institutes of Health-funded trial, being conducted under an investigator-initiated IND.
  • In May 2023, Tonix entered into a research collaboration agreement with the principal investigator of the study, Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology, Erasmus University Medical Center, to evaluate the effect of TNX-1900 on capsaicin- or electrical stimulation-induced forehead dermal blood flow in health female volunteers.

TNX-601 ER (tianeptine hemioxalate extended-release tablets): a once-daily orally administered small molecule for the treatment of major depressive disorder (MDD), posttraumatic stress disorder (PTSD), neurocognitive dysfunction associated with corticosteroid use, and potentially Alzheimer’s disease

  • Enrollment has been completed in the proof-of-concept Phase 2 UPLIFT study for the treatment of MDD, with 116 patients enrolled. UPLIFT is a registration-quality, double-blind, placebo-controlled study.
  • Topline results for the UPLIFT Phase 2 trial are expected in the fourth quarter of 2023.
  • Scientists at Tonix’s Research and Development Center (RDC) in Frederick, Md. established the molecular mechanism of action of tianeptine, the active ingredient of TNX-601 ER. The research supports a direct role for restoring neuroplasticity and neurogenesis, and upsets previously held beliefs about the significance of neurotransmitters in treating depression. It also provides clarity on why tianeptine does not cause sexual dysfunction, weight gain or several other treatment-limiting toxicities associated with traditional antidepressants.

TNX-4300 (estianeptine): small molecule oral therapeutic for MDD, bipolar disorder, Alzheimer’s disease and Parkinson’s disease

  • In July 2023, the Company announced that it would focus resources on the development of single isomer TNX-4300 as a first-in-class oral therapy for mood disorders, Alzheimer’s disease and other psychiatric and neurodegenerative conditions with memory deficits. The decision follows the Company’s announcement in May 2023 of the isolation and characterization of the (S)-isomer of tianeptine, which activates PPAR-β/δ, restores neuroplasticity in neuronal tissue culture and is free of µ-opioid receptor activity.

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

  • Tonix expects to initiate a potentially pivotal Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the third quarter of 2023. In 2022, Tonix was awarded 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.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

Rare Disease Pipeline

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

  • TNX-2900 has been granted Orphan Drug designation from the FDA for the treatment of PWS and the preparation of the IND is in process.
  •  TNX-2900 is in development to treat PWS and the planned clinical study will study its effects on hyperphagia, or pathological over-eating, in children and young adult patients with PWS.

Immunology Pipeline

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

  • In May 2023, the IND for prevention of organ rejection in patients receiving a kidney transplant was cleared by FDA. A first-in-human Phase 1 study is expected to start in the third quarter of 2023. The first indication for TNX-1500 will be prophylaxis of organ rejection in adult patients receiving a kidney transplant, but multiple additional indications are possible, including autoimmune diseases. Two peer reviewed publications described the work at the Massachusetts General Hospital on allogeneic transplants in animals.1,2

      *All of Tonix’s product candidates are investigational new drugs or biologics and none have been approved for any indication.

1Lassiter, G., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate renal allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.022

2Miura, S., et al. (2023). TNX-1500, a crystallizable fragment–modified anti-CD154 antibody, prolongs non-human primate cardiac allograft survival. American Journal of Transplantation. https://doi.org/10.1016/j.ajt.2023.03.025

      Recent Highlights—Financial

As of June 30, 2023, Tonix had approximately $25.6 million of cash and cash equivalents, compared to $120.2 million as of December 31, 2022. Subsequent to the end of the second quarter of 2023, Tonix raised $7.0 million in gross proceeds through a public offering of its common stock. Cash used in operations was approximately $56.3 million for the six months ended June 30, 2023, compared to $52.2 million for the same period in 2022. Cash used by investing activities for the six months ended June 30, 2023 was approximately $27.8 million, primarily driven by the purchase of certain assets from Upsher-Smith Laboratories, LLC.

The acquisition cost of Zembrace SymTouch and Tosymra was $15 million, consisting of $12 million up front and an additional deferred payment of $3.0 million. We also purchased inventory for $10.0 million and expect to pay an additional $1.3 million related to an inventory adjustment.

On April 8, 2020, the Company entered into a sales agreement with AGP of up to $320.0 million in at-the-market offerings sales. During the quarter ended June 30, 2023, the Company sold approximately 0.4 million shares of common stock under the sales agreement, for net proceeds of approximately $1.0 million.

On August 1, 2023, the Company sold in a public offering securities consisting of 2,530,000 shares of common stock, pre-funded warrants to purchase up to 4,470,000 shares of common stock, and accompanying common warrants to purchase 7,000,000 shares of common stock, at $1.00 per unit of common stock and common warrant, and $0.99 per pre-funded warrant and common warrant. The Company received net proceeds of approximately $6.2 million, after deducting underwriting discount and other offering expenses.

Second Quarter 2023 Financial Results

R&D expenses for the second quarter 2023 were approximately $22.0 million, compared to $16.6 million for the same period in 2022. As expected, R&D expenses have increased during 2023 due to progressing clinical development programs forward and investing in our preclinical development pipeline.

G&A expenses for the second quarter 2023 were $7.0 million, compared to $6.8 million for the same period in 2022.

Net loss available to common stockholders was $28.4 million, or $2.68 per share, basic and diluted, for the second quarter 2023, compared to net loss available to common stockholders of $27.4 million, or $7.64 per share, basic and diluted, for the same period in 2022. The basic and diluted weighted average common shares outstanding for the second quarter 2023 was 10,587,096 compared to 3,584,699 shares for the same period in 2022.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development 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, having completed enrollment in a potentially registration-enabling study, and with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), is a once-daily formulation being developed as a treatment for major depressive disorder (MDD). Enrollment is now complete in the UPLIFT trial of TNX-601 ER in MDD and topline results are expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. TNX-1900 (intranasal potentiated oxytocin), is in development for chronic migraine, and the PREVENTION study has completed enrollment with topline data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023. Tonix’s rare disease development 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 development 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 rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, classes of broad-spectrum small molecule antivirals.

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

Tonix Medicines has contracted to acquire the Zembrace SymTouch and Tosymra registered trademarks. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc.

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; risks related to the failure to successfully market any of our products; 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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,		 
  2023  2022  2023  2022 
COSTS AND EXPENSES:                
Research and development $21,976  $16,579  $48,487  $35,001 
General and administrative  7,026   6,757   14,417   14,771 
   29,002   23,336   62,904   49,772 
                 
Operating loss  (29,002)  (23,336)  (62,904)  (49,772)
                 
Interest and other income, net  646   196   1,543   215 
                 
Net loss  (28,356)  (23,140)  (61,361)  (49,557)
                 
Preferred stock deemed dividend  —   4,255   —   4,255 
                 
Net loss available to common stockholders $(28,356) $(27,395) $(61,361) $(53,812)
                 
Net loss per common share, basic and diluted $(2.68) $(7.64) $(5.88) $(17.28)
                 
Weighted average common shares outstanding, basic and diluted  10,587,096   3,584,699   10,428,678   3,113,965 

See the accompanying notes to the condensed consolidated financial statements 		 
TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands)
(Unaudited)

 June 30, 2023 December 31, 20221
Assets  
Cash and cash equivalents$25,617 $120,229
Inventory 13,700  –
Prepaid expenses and other 12,012  10,548
Total current assets 51,329  130,777
Other non-current assets 108,407  94,913
Total assets$159,736 $225,690
   
Liabilities and stockholders’ equity  
Total liabilities$19,273 $18,508
Stockholders’ equity 140,463  207,182
Total liabilities and stockholders’ equity$159,736 $225,690

1The condensed consolidated balance sheet for the year ended December 31, 2022 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

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

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Zembrace® SymTouch® (sumatriptan Injection):   IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age. 

Source:

Released August 10, 2023

Release – Onconova Therapeutics Reports Corporate Update And Announces Second Quarter 2023 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Aug 10, 2023

PDF Version

Anticipate topline results from the Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023

Plans are underway for a registrational trial with rigosertib in patients with RDEB-associated squamous cell carcinoma based on a constructive Type B FDA meeting held in June

Company to host conference call and webcast at 4:30 p.m. ET on Thursday, August 10, 2023

NEWTOWN, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today reported second quarter 2023 financial results and provided an update on recent pipeline progress. Management plans to host a conference call and live webcast at 4:30 p.m. ET today to discuss these results.

“We are very encouraged about the recent progress that the Onconova team has made for our two lead programs, narazaciclib, a differentiated multikinase CDK4/6 inhibitor targeting proteins involved in resistance pathways, and rigosertib, a cell signaling inhibitor, over the last few months, while effectively managing our financial resources. In addition, we are pleased that Victor Moyo, M.D., a highly experienced and successful clinical researcher and drug developer, has agreed to join the Company as Consulting Chief Medical Officer. We look forward to sharing several important updates in the coming months,” said Steve Fruchtman, M.D., President and Chief Executive Officer.

Dr. Fruchtman continued, “For narazaciclib, our efforts have been dedicated to completing a Phase 1 program and defining a recommended Phase 2 dose to support evaluation of narazaciclib in a randomized trial. Onconova believes this CDK4/6 compound has the potential to provide differentiated efficacy based on targeting proteins that have been implicated in resistance mechanisms and the potential for an improved safety profile. We are pleased to see target engagement based on an assay measuring proliferation. We expect to report the results from our Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023. The readout will include safety, pharmacokinetics and the definition of a recommended Phase 2 dose.”

Dr. Fruchtman concluded, “For rigosertib, we continue to believe this rigosertib’s unique action on cell signaling pathways, including K-RAS and PLK-1, combined with an acceptable safety profile, could position it as an attractive anti-cancer agent. In June, we had a constructive Type B meeting with the FDA for the use of rigosertib monotherapy in the lead, ultra-rare indication of RDEB-associated squamous cell carcinoma. Based on that meeting and the impressive clinical responses in previously refractory patients we have seen and presented at major medical meetings, we plan to design a registrational trial and will look to provide an update on next steps in H1 2024. In the meantime, we continue to support two investigator sponsored studies for rigosertib, underway in melanoma and KRAS mutated non-small cell lung cancer which includes any KRAS mutation that may be present.”

Second Quarter Financial Results
Cash and cash equivalents as of June 30, 2023, were $29.7 million, compared to $38.8 million as of December 31, 2022. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business into the second quarter of 2024.

Research and development expenses were $2.5 million for the second quarter of 2023, compared with $2.0 million for the second quarter of 2022.

General and administrative expenses were $2.2 million for the second quarter of 2023, compared with $2.1 million for the second quarter of 2022.

Net loss for the second quarter of 2023 was $4.3 million, or $0.20 per share on 21.0 million weighted shares outstanding, compared with a net loss of $4.0 million, or $0.19 per share for the second quarter of 2022 on 20.9 million weighted shares outstanding.

Conference Call and Webcast Information
Interested parties who wish to participate in the conference call may do so by dialing:

  • (800) 715-9871 for domestic and
  • (646) 307-1963 for international callers and
  • Using conference ID 9506701

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates include proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a Phase 1/2 combination trial with the estrogen blocker, letrozole, in advanced low grade endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

For more information, please visit www.onconova.com.

Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates and its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-sponsored trials, regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

ONCONOVA THERAPEUTICS, INC.   
Condensed Consolidated Balance Sheets   
(in thousands)   
 June 30, December 31,
  2023   2022 
Assets(unaudited)  
Current assets:   
Cash and cash equivalents$29,729  $38,757 
Receivables 17   29 
Prepaid expenses and other current assets 704   561 
Total current assets 30,450   39,347 
Property and equipment, net 17   24 
Other non-current assets 1   1 
Total assets$30,468  $39,372 
    
Liabilities and stockholders’ equity   
Current liabilities:   
Accounts payable$5,071  $3,860 
Accrued expenses and other current liabilities 3,369   3,960 
Deferred revenue 226   226 
Total current liabilities 8,666   8,046 
Deferred revenue, non-current 2,904   3,017 
Total liabilities 11,570   11,063 
    
Stockholders’ equity:   
Preferred stock –   – 
Common stock 210   209 
Additional paid in capital 492,424   491,816 
Accumulated other comprehensive loss (28)  (33)
Accumulated deficit (473,708)  (463,683)
Total stockholders’ equity 18,898   28,309 
Total liabilities and stockholders’ equity$30,468  $39,372 
    
ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
        
 Three Months Ended June 30, Six months months ended June 30,
  2023   2022   2023   2022 
        
Revenue$57  $57  $113  $113 
Operating expenses:       
General and administrative 2,211   2,139   4,324   4,325 
Research and development 2,456   2,038   6,536   4,040 
Total operating expenses 4,667   4,177   10,860   8,365 
Loss from operations (4,610)  (4,120)  (10,747)  (8,252)
        
Change in fair value of warrant liability –   –   –   – 
Other income, net 360   96   722   106 
Net loss (4,250)  (4,024)  (10,025)  (8,146)
Net loss per share of common stock, basic and diluted$(0.20) $(0.19) $(0.48) $(0.39)
Basic and diluted weighted average shares outstanding 20,979,766   20,904,085   20,970,022   20,904,085