Tuesday, August 16, 2022

BioSig Technologies (BSGM)
2Q 2022 released; No Big Surprises, But Looking Forward

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com). The Company’s first product, PURE EP(TM) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

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

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

2Q 2022 results were released. BioSig released second quarter results in its 10Q filing yesterday. As we previously removed second quarter PURE EP unit revenues (see note dated July 8, 2022), top-line reported in the quarter was no surprise.  The Company did generate $8,000 in service revenue in the quarter.

Expenses lower than expected. We had expected $6.8 million in operating expenses in the quarter, but BioSig reported $5.7 million due to General and Administrative expenses being $1.2 million lower. Diluted share count was 264k higher than our estimate at 39.823 million.  Net loss per share of $0.15 beat our estimate of a loss of $0.17….

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

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

Cocrystal Pharma Reports Second Quarter 2022 Financial Results and Provides Updates on its Antiviral Development Programs

Research, News, and Market Data on Cocrystal Pharma

• Planned Phase 2a study design with orally administered CC-42344 for the treatment of pandemic and seasonal influenza A
• Reported pharmacokinetic (PK) data from the single ascending dose portion of its Phase 1 study with CC-42344 supporting once-daily dosing
• Collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the potential of the Company’s COVID-19 protease inhibitors and subsequently expanded the collaboration to support a scale-up synthesis of these inhibitors
• Initiated API (Active Pharmaceutical Ingredient) synthesis and process chemistry development with the goal in 2022 of initiating two Phase 1 healthy volunteer studies evaluating intranasal and oral protease inhibitors for COVID-19

BOTHELL, Wash., Aug.
15, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the three and six months ended June 30, 2022, and provides updates on its antiviral pipeline, upcoming milestones and business activities.

“This quarter we advanced our compounds in the clinic and announced a significant research collaboration. We were excited to announce the design of our Phase 2a human challenge study with our oral PB2 inhibitor CC-42344, enabling us to quickly evaluate antiviral efficacy and tolerability of influenza-infected healthy volunteers. Human influenza challenge studies have proven important in advancing the development of approved influenza antivirals. Additionally, due to the small sample size, a human challenge study can be completed quickly,” said Sam Lee, Ph.D., President and co-interim CEO of Cocrystal. “Later this year we expect to report results from our Phase 1 study in healthy volunteers that is underway in Australia. Our plan is to then file with the UK regulatory agency in early 2023 to proceed with the Phase 2a study.

“We have initiated API synthesis and process chemistry development with our novel, broad-spectrum COVID-19 intranasal/pulmonary and oral protease inhibitors, as we prepare data to support Investigational New Drug (IND) applications with the goal of initiating two Phase 1 healthy volunteer studies evaluating these inhibitors for COVID-19 this year,” he added.

“We continue to be well positioned to execute on our clinical and regulatory goals given our clean capital structure, cost-efficient business model and a cash balance we believe is sufficient to fund planned operations into 2024,” said James Martin, CFO and co-interim CEO. “We chose to conduct the Phase 2a influenza A trial with PB2 inhibitor CC-42344 in the UK due to the efficiency and data we expect from a human challenge model, as opposed to a traditional clinical trial model. Under the human challenge model healthy adults will be deliberately infected with influenza virus under carefully controlled conditions, which we believe will hasten trial enrollment and ensure subjects are infected with influenza A. Our niche contract research partner, Open Orphan, is one of the premier specialists in providing this unique clinical model.”

Antiviral Pipeline Overview

Many antiviral drugs are effective only against certain strains of a virus and are less effective or not effective at all against other strains or variants. Cocrystal is developing drug candidates that specifically target proteins involved in viral replication. Despite the numerous strains that may exist or emerge, these enzymes are required for viral replication and are essentially similar (highly conserved) across all strains. By targeting these highly conserved regions of the replication enzymes, our antiviral compounds are designed and tested to be effective against major virus strains.

COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases 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.

In April 2022 we announced a collaboration with the NIAID to evaluate the potential of our COVID-19 3CL protease inhibitors for the treatment of COVID-19, with the NIAID responsible for in vitro and in
vivo studies evaluating the antiviral activity of the compounds. In June 2022 we expanded this collaboration by providing our proprietary process chemistry information for oral 3CL protease inhibitors to the NIAID to support scale-up synthesis of a key intermediate of these compounds.

• Intranasal/Pulmonary Protease
  Inhibitor CDI-45205
• CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor being developed as a potential treatment for COVID-19 and its variants.
• We have initiated scale-up synthesis and process chemistry development with CDI-45205 as we generate data to support an IND application with the goal of progressing to a first-in-human clinical trial in 2022.
• We received guidance from the FDA regarding further preclinical and clinical development of CDI-45205 that provides a clearer pathway for the Phase 1 study we plan to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.
• CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Omicron (Botswana and South Africa/BA.1), Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South Africa/B.1.351) variants, surpassing the activity observed with the original wild-type (Wuhan) strain.
• 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.
• CDI-45205 was among the broad-spectrum viral protease inhibitors 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.
• Oral Protease Inhibitors

• We are investigating novel antiviral drug candidates CDI-988 and CDI-873 for development as potential oral treatments for SARS-CoV-2. Both candidates were designed and developed using our proprietary structure-based drug discovery platform technology. These agents are chemically differentiated and exhibit superior in vitro potency against SARS-CoV-2, with activity maintained against current variants of concern. Both candidates demonstrated a favorable safety profile and PK properties that are supportive of daily dosing.
• Our goal is to initiate a Phase 1 study in 2022 with one of these candidates. We believe the FDA’s guidance for further development of CDI-45205 provides us with a clearer pathway for the clinical development of our oral COVID-19 program.
• Replication Inhibitors

• We are using our proprietary structure-based drug discovery platform technology to discover replication inhibitors as orally administered therapeutic and prophylactic treatments for SARS-CoV-2. Replication inhibitors hold potential to work with protease inhibitors in a combination therapy regimen.

Influenza Programs
Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in outbreaks of disease mainly during the winter months. According to a report published by Precision Reports in June 2022, the global influenza therapeutics market is projected to reach $9.5 billion by 2027, from $6.6 billion in 2020, growing at a 4.8% CAGR between 2021 and 2027. 

• Pandemic and Seasonal Influenza
  A
• A novel PB2 inhibitor, CC-42344 has shown excellent antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains resistant to Tamiflu^® and Xofluza
  ^®. CC-42344 also has favorable PK and drug-resistance profiles.
• In March 2022 we initiated enrollment in our Phase 1 study with orally administered 
  CC-42344 in healthy adults. This randomized, double-controlled, dose-escalating study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344.
• In April 2022 we announced preliminary data from our Phase 1 study with CC-42344, demonstrating a favorable safety and PK profile in the first two cohorts administered single ascending doses of 100 mg and 200 mg.
• In July 2022 we announced completion of the single ascending dose portion of the Phase 1 study and reported that PK results from this portion of the study support once-daily dosing.
• We expect to report full results from the Phase 1 clinical study in 2022.
• We entered into an agreement with a clinical research organization to conduct a human challenge Phase 2a study evaluating safety, viral and clinical measures in influenza A-infected subjects. The study is expected to be initiated in the second half of 2023.
• 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. Merck is now solely responsible for further preclinical and clinical development of compounds discovered under this agreement. Merck continues development activities with the compounds discovered under this agreement.

Norovirus Program

• We continue to develop certain proprietary broad-spectrum non-nucleoside polymerases for the treatment of human norovirus infections using our proprietary structure-based drug design technology platform and plan to conduct proof-of-concept animal studies.
• We also hold exclusive rights to norovirus protease inhibitors for use in humans under the KSURF license.
• Our goal is to select preclinical leads in the 2022-2023 timeframe.
• Norovirus is a global public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.

Hepatitis C Program

• We are seeking a partner to advance the development of CC-31244 following successful completion of a Phase 2a study. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a study 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. In June 2022, the World Health Organization estimates that 58 million people worldwide have chronic HCV infections. 

Second Quarter 2022 Financial
Results

Research and development (R&D) expenses for the second quarter of 2022 were $2.4 million compared with $2.6 million for the second quarter of 2021, with the decrease primarily due to the influenza A program transitioning from the preclinical discovery stage into a clinical trial. The Company is anticipating increased R&D expenses during the second half of 2022 as it prepares for additional clinical trials.

General and administrative (G&A) expenses for the second quarter of 2022 were $1.4 million compared with $1.3 million for the second quarter of 2021, with the increase primarily due to legal expenses and higher insurance costs.

The Company’s litigation with an insurer resulted in the insurance company obtaining a summary judgment during the second quarter of 2022 and accounted for a potential $1.6 million adverse award by expensing this amount in the second quarter of 2022. The Company filed an appeal in July 2022. Pending the outcome of the appeal, the Company paid $1.6 million into the registry of the court which stayed execution of the Judgment.

During the six months ended June 30, 2022, the Company saw a significant decrease in the price of its common stock resulting in an overall reduction in market capitalization and our recorded net book value exceeded its market capitalization as of June 30, 2022. The Company concluded that goodwill was impaired in its entirety and recorded a $19.1 million non-cash impairment during the second quarter of 2022.

The net loss for the second quarter of 2022 was $24.4 million, or $0.25 per share, and included a non-cash impairment charge of $19.1 million resulting from the significant decrease in the price of the Company’s common stock price and market capitalization. The net loss for the second quarter of 2021 of $3.8 million, or $0.04 per share.

Six Month Financial
Results

R&D expenses for the six months ended June 30, 2022 were $5.2 million compared with $4.0 million for the first six months of 2021. G&A expenses for the six months ended June 30, 2022 were $2.7 million compared with $2.6 million for the six months ended June 30, 2021.

As stated above, the Company accounted for a potential $1.6 million legal settlement by expensing this amount during the six months ended June 30, 2022 and the Company concluded that goodwill was impaired in its entirety and recorded a $19.1 million non-cash impairment during six months ended June 30, 2022.

The net loss for the six months ended June 30, 2022 was $28.6 million, or $0.29 per share, and reflected the non-cash impairment charge described above. The net loss for the six months ended June 30, 2021 was $6.6 million, or $0.08 per share.

The Company reported unrestricted cash of $51.0 million as of June 30, 2022 compared with $58.7 million as of December 31, 2021. Net cash used in operating activities for the first half of 2022 was $7.6 million. The Company reported working capital of $48.8 million as of June 30, 2022.

About Cocrystal
Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

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 goals of initiating two Phase 1 studies for our COVID-19 programs in 2022, our expectations of reporting data from the Phase 1 clinical study of our Influenza A product candidate later in 2022 and timeline for filing with the UK regulatory agency for a Phase 2a study in 2023, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the global market for therapeutics, our attempts to discover replication inhibitors, our ability to execute our clinical and regulatory goals, our development of antiviral treatments for norovirus including our plan to conduct a proof-of-concept animal study and select a preclinical lead in 2022 or 2023, our expectations concerning R&D expenses, the expected sufficiency of our cash balance to 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 arising from the impact of the COVID-19 pandemic and the Ukraine war on our Company, our collaboration partners, and on the national and global economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including and adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Contract Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the impact of inflation and Federal Reserve interest rate increases in response thereto on the economy, the ability of our current CRO to recruit volunteers for, and to proceed with, clinical studies, the results of our collaboration with NIAID relating to our 3CL protease inhibitors for the treatment of COVID-19, 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 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 our appeal of the summary judgment. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

jcain@lhai.com

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

Jabraham@jqapartners.com

 

Monday, August 15, 2022

Lineage Cell Therapeutics (LCTX)
OpRegen Collaboration Advances As Pipeline Products Move Toward INDs

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

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

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

Quarterly Revenues Include Revenue Recognition.  Lineage Cell Reported a loss of $6.8 million or $(0.04) per share, in-line with our estimate of $4.6 million or $(0.03) per share.  Progress on the OpRegen collaboration with Roche/Genentech accounted for revenue of $4.1 million out of $4.6 million total revenues.  The company ended the quarter with $72.0 million in cash.

OpRegen Progress Allowed Revenue Recognition.  The OpRegen collaboration with Roche/Genentech brought in net fees of about $29 million, after allocation of amounts due to its licensors.  The amount is being amortized over the course of the agreement, with revenue recognized as obligations under the agreement are met.  Lineage recognized $4.1 million under the agreement in 2Q22 and a total of $9.0 million for the year to date.  This reflects progress on Chemistry and Manufacturing Controls (CMC), technology transfers, and manufacturing milestones….

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. 

Monday, August 15, 2022

Axcella Therapeutics (AXLA)
2Q Included The First of Two Phase 2 Data Announcements

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

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

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

2Q Included Long COVID-19 Data Announcement and An Increase In Cash.  Axeclla reported a loss of $21.3 million or $(0.40) per share, compared with our estimate of $19.4 million or $(0.47) per share.  During the quarter, the company raised about $25 million through a direct stock offering, bringing cash and marketable securities to $44.4 million as of June 30.  The highlight of the quarter, in our opinion, was the announcement of Phase 2a data in Long COVID-19.

Phase 2a Data Was Encouraging.  The company recently announced positive data from its Phase 2a trial testing AXA1125 in Long COVID-19.  These data showed statistically significant improvements in several measures of physical and mental fatigue.  The company reiterated plans to meet with the FDA to discuss the design of the next clinical test during the coming months….

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. 

Ayala Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Corporate Update

Research, News, and Market Data on Ayala Pharmaceuticals

August 15, 2022

Interim data from Part A of the RINGSIDE study
demonstrated substantial initial anti-tumor activity for AL102 as a single
agent and supports continued development

More advanced and comprehensive data set from RINGSIDE to be
presented at ESMO

REHOVOT, Israel and WILMINGTON, Del., Aug. 15, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced second-quarter 2022 financial results and provided a corporate update.

“We continue to make considerable progress across our pipeline, and we were particularly excited to announce interim results from the ongoing Phase 2/3 RINGSIDE trial evaluating AL102 in desmoid tumors. Although early, the results showed substantial initial anti-tumor activity and a favorable side effect profile,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Based on these positive results, our efforts are focused on finalizing the Part A of the study shortly followed by immediate initiation of Part B. For AL101, we were pleased with the latest interim results from the ACCURACY trial presented at ASCO, which demonstrated anti-tumor monotherapy activity and evidence of improved progression-free survival (PFS) in patients with recurrent/metastatic ACC.”

Second-quarter 2022
and Recent Business Highlights

• In July, announced positive interim data
  from Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid
  tumors: Data showed tumor shrinkage in substantially all patients who were evaluable at 16 weeks. AL102 was well tolerated at all three dosing regimens with no dose-limiting toxicities and no Grade 4/5 adverse events. The results from Part A will be used to determine the dose of AL102 to be evaluated in Part B of RINGSIDE, the randomized portion of the study, which Ayala is on track to initiate in 3Q 2022. More advanced and comprehensive data from RINGSIDE is expected to be presented at ESMO.
• Data on AL101 in adenoid cystic carcinoma
  (ACC) presented at ASCO 2022 Annual Meeting: In a poster at ASCO, the company provided an update from the 4mg and 6 mg AL101 cohorts in the ACCURACY study of AL101, a selective gamma-secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations. An overall disease control rate of 66.7% was observed. The median PFS in each of the 4mg and 6mg dose cohorts was 3.7 months and 6.7 months among the patients who had a partial response.

Upcoming Milestones

• More
  advanced data from the RINGSIDE trial in desmoid tumors: Ayala expects to present a more comprehensive data set from Part A of the RINGSIDE trial of AL102 at ESMO.
• Initiation
  of Part B of the RINGSIDE trial: Part B will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The primary endpoint will be PFS with secondary endpoints including objective response rates, duration of response, and patient-reported quality of life measures.
• Initiate
  Phase 2 clinical trial evaluating AL102 in T-cell acute lymphoblastic
  leukemia (T-ALL): Ayala plans to begin an investigator-initiated Phase 2 clinical trial evaluating AL102 in R/R T-ALL around year-end.

Second-Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents were $20.1 million as of June 30, 2022.

Collaboration Revenue: Collaboration revenue was $38 thousand for the second quarter of 2022, as compared to $761 thousand for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $5.6 million for the second quarter of 2022, compared to $8.1 million for the corresponding quarter in 2021. The decrease is mainly due to the winding down of the ACCURACY study.

G&A Expenses: General and administrative expenses were $2.3 million for the second quarter of 2022, compared to $2.5 million for the second quarter of 2021.

Net Loss: Net loss was $8.2 million for the second quarter of 2022, resulting in basic and diluted net loss per share of $0.54. This compares with a net loss of $10.8 million for the second quarter of 2021 or basic and diluted net loss per share of $0.75 for that quarter.

For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended June 30, 2022, filed with the SEC on August 15, 2022.

About Ayala Pharmaceuticals

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including desmoid tumors, adenoid cystic carcinoma and T-cell acute lymphoblastic leukemia (T-ALL). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602

jallaire@lifesciadvisors.com 

Ayala Pharmaceuticals:
+1-857-444-0553

info@ayalapharma.com 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements relating to our development of AL101 and AL102, the promise and potential impact of our preclinical or clinical trial data, the timing of and plans to initiate additional clinical trials of AL101 and AL102, the timing and results of any clinical trials or readouts, our participation at scientific or medical conferences, the sufficiency of cash to fund operations, and the anticipated impact of COVID-19, on our business. These forward-looking statements are based on management’s current expectations. The words ”may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability; we will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of AL101 and AL102; we have identified conditions and events that raise substantial doubt about our ability to continue as a going concern; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability; we are heavily dependent on the success of AL101 and AL102, our most advanced product candidates, which are still under clinical development, and if either AL101 or AL102 does not receive regulatory approval or is not successfully commercialized, our business may be harmed; due to our limited resources and access to capital, we must prioritize development of certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business; the outbreak of COVID-19, may adversely affect our business, including our clinical trials; our ability to use our net operating loss carry forwards to offset future taxable income may be subject to certain limitations; our product candidates are designed for patients with genetically defined cancers, which is a rapidly evolving area of science, and the approach we are taking to discover and develop product candidates is novel and may never lead to marketable products; we were not involved in the early development of our lead product candidates; therefore, we are dependent on third parties having accurately generated, collected and interpreted data from certain preclinical studies and clinical trials for our product candidates; enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control; if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed and our business will be harmed; our product candidates may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales; the market opportunities for AL101 and AL102, if approved, may be smaller than we anticipate; we may not be successful in developing, or collaborating with others to develop, diagnostic tests to identify patients with Notch-activating mutations; we have never obtained marketing approval for a product candidate and we may be unable to obtain, or may be delayed in obtaining, marketing approval for any of our product candidates; even if we obtain FDA approval for our product candidates in the United States, we may never obtain approval for or commercialize them in any other jurisdiction, which would limit our ability to realize their full market potential; we have been granted Orphan Drug Designation for AL101 for the treatment of ACC and may seek Orphan Drug Designation for other indications or product candidates, and we may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity, and may not receive Orphan Drug Designation for other indications or for our other product candidates; although we have received Fast Track designation for AL101, and may seek Fast Track designation for our other product candidates, such designations may not actually lead to a faster development timeline, regulatory review or approval process; we face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively; we are dependent on a small number of suppliers for some of the materials used to manufacture our product candidates, and on one company for the manufacture of the active pharmaceutical ingredient for each of our product candidates; any future collaborations will be, important to our business. If we are unable to maintain our existing collaboration or enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected; enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates, if approved, and may affect the prices we may set; if we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our markets; we may engage in acquisitions or in-licensing transactions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources; and risks related to our operations in Israel could materially adversely impact our business, financial condition and results of operations.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2022 filed with the U.S. Securities and Exchange Commission (SEC) on August 15, 2022 and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

AYALA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts)
		June 30,				December 31,
		2022				2021
		(Unaudited)
CURRENT ASSETS:
Cash and Cash Equivalents		$	20,059			$	36,982
Short-term Restricted Bank Deposits			111				122
Trade Receivables			262				–
Prepaid Expenses and other Current Assets			2,322				2,636
Total Current Assets			22,754				39,740
LONG-TERM ASSETS:
Other Assets		$	231			$	267
Property and Equipment, Net			1,039				1,120
Total Long-Term Assets			1,270				1,387
Total Assets		$	24,024			$	41,127
LIABILITIES AND STOCKHOLDERS’ EQUITY:
CURRENT LIABILITIES:
Trade Payables		$	3,254			$	3,214
Other Accounts Payables			2,993				3,258
Total Current Liabilities			6,247				6,472
LONG TERM LIABILITIES:
Long-term Rent Liability			414				497
Total Long-Term Liabilities		$	414			$	497
STOCKHOLDERS’ STOCKHOLDERS’ EQUITY:
Common Stock of $0.01 par value per share; 200,000,000 shares authorized at
December 31, 2021 and June 30, 2022; 14,503,743 and 14,080,383 shares issued at June 30, 2022 and December 31, 2021, respectively; 13,984,662 and 13,956,035 shares outstanding at June 30, 2022 and December 31, 2021, respectively		$	139			$	139
Additional Paid-in Capital			146,602				145,160
Accumulated Deficit			(129,378	)			(111,141	)
Total Stockholders’ Equity			17,363				34,158
Total Liabilities and Stockholders’ Equity		$	24,024			$	41,127

 

AYALA PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share & per share amounts)
		For the Three Months Ended June 30,								For the Six Months Ended June 30,
		2022				2021				2022				2021
Revenues from licensing agreement and others		$	38			$	761			$	496			$	1,735
Cost of services			(38	)			(761	)			(406	)			(1,735	)
Gross profit			—				—				90				—
Operating expenses:
Research and development			5,580				8,121				13,083				15,046
General and administrative			2,260				2,536				4,701				4,839
Operating loss			(7,840	)			(10,657	)			(17,694	)			(19,885	)
Financial Income (Loss), net			(156	)			(22	)			(140	)			(114	)
Loss before income tax			(7,996	)			(10,679	)			(17,834	)			(19,999	)
Taxes on income			(214	)			(162	)			(403	)			(410	)
Net loss			(8,210	)			(10,841	)			(18,237	)			(20,409	)
Net Loss per share attributable to common stockholders, basic and diluted		$	(0.54	)		$	(0.75	)		$	(1.19	)		$	(1.46	)
Weighted average common shares outstanding, basic and diluted			15,312,766				14,417,423				15,306,823				13,954,676

 

PsyBio Therapeutics Strengthens IP Portfolio through Filing of Data to Support Previously Submitted Provisional Biosynthetic Production Patent Application

Research, News, and Market Data on PsyBio

Biosynthetic Production covers
Methylated Tryptamine Derivatives including DMT and 5-MeO-DMT

OXFORD, Ohio and DENVER, Aug. 11, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB), (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company focused upon discovery and development of novel, psycho-targeted therapeutics to potentially improve mental and neurological health, today is announcing the filing of data to support the conversion of a previously submitted provisional patent covering the biosynthetic production of methylated tryptamine derivatives including 
N,N-dimethyltryptamine (“DMT“) and 5-methoxy-N,N-dimethyltryptamine (”
5-MeO-DMT“) as well as other related products.

“We are proud of the strength of our intellectual property portfolio, safeguarding our advancement of biosynthetic production of psycho-targeted molecules. This most recent filing of data extends our coverage to include DMT and 5-MeO-DMT,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “While these methylated tryptamine derivatives are well known, this filing covers numerous novel compounds that we expect will allow us to proceed with clinical development and build on our work to potentially improve mental and neurological healthcare for patients.”

The patent information submitted includes data concerning host strains, production methodology, and processes of production that support and allow PsyBio’s novel methodology to be successful.

“PsyBio continues to demonstrate its leadership in the biosynthetic development field through our continued commitment to strengthen our intellectual property portfolio, while also promoting scientific and methodologic advancements in the field,” stated Evan Levine, PsyBio’s Chief Executive Officer. “Intellectual property protection is paramount for our Company and our shareholders.”

About PsyBio Therapeutics Corp.

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

Cautionary Note Regarding
Forward-Looking Statements

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

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: the filing will extend intellectual property protection coverage to include DMT and 5-MeO-DMT; the patent information submitted will support and allow PsyBio’s novel methodology to be successful; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more investigational new drug applications with the United States Food and Drug Administration (“FDA“); PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

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

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

SOURCE PsyBio Therapeutics Corp.

View original content to download multimedia: 
http://www.newswire.ca/en/releases/archive/August2022/11/c9503.html

 

 

Lineage to Present at H.C. Wainwright & Co. 2nd Annual Virtual Ophthalmology Conference

Research, News, and Market Data on Lineage Cell Therapeutics

CARLSBAD, Calif.–(
BUSINESS WIRE)–Lineage Cell
Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today Brian M. Culley, Lineage’s Chief Executive Officer, will present at the H.C. Wainwright
2nd Annual Ophthalmology Virtual Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Director of Research; Managing Director, Equity Research, H. C. Wainwright & Co. LLC. The fireside chat will be available to investors on demand, starting on August 17^th, 2022 at 7am ET.

Interested parties can register to view on-demand replay on the Events and
Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

About Lineage Cell Therapeutics, Inc.

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

Contacts

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

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

 

Ocugen CEO to Present at H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference

Research, News, and Market Data on Ocugen

August 12, 2022

MALVERN, Pa., Aug. 12, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen, will deliver a virtual presentation at the 
H.C. Wainwright 2^nd Annual Ophthalmology Virtual
Conference on August 17.

A video webcast of the presentation will be available on demand beginning at 7:00 a.m. ET on August 17, 2022 for those registered for the event and will be available on the events page of the Ocugen 
investor site. The webcast replay will be archived for 90 days following the event.

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

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995, which are subject to
risks and uncertainties. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or
other words that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Such statements are subject to numerous
important factors, risks, and uncertainties that may cause actual events or
results to differ materially from our current expectations. These and other
risks and uncertainties are more fully described in our periodic filings with
the Securities and Exchange Commission (SEC), including the risk factors
described in the section entitled “Risk Factors” in the quarterly and annual
reports that we file with the SEC. Any forward-looking statements that we make
in this press release speak only as of the date of this press release. Except
as required by law, we assume no obligation to update forward-looking
statements contained in this press release whether as a result of new
information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

 

 

Axcella Reports Second Quarter Financial Results and Provides Business Update

Research, News, and Market Data on Axcella Therapeutics

August 12, 2022 at 7:30 AM EDT

• Announced Statistically Significant Clinical
  Improvement in Fatigue in the Phase 2A Long COVID Trial Topline data

• NASH Trial interim Data
  Expected in Late Q3 2022

• Company to Host Conference Call
  at 8:30 a.m. ET today

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aug. 12, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the second quarter ended 
June 30, 2022 and provided a business update.

“Axcella has been a leader in clinical development in Long COVID. We continued this leadership through the second quarter as we advanced the development of our two clinical programs for AXA1125. Our Phase 2A trial of Long COVID in collaboration with 
Oxford University
 is now complete. The results were extremely encouraging and showed that administration of AXA1125 to patients significantly reduced mental and physical fatigue,” said  Bill Hinshaw , President and Chief Executive Officer of Axcella. “Since reporting our data last week, we have received extremely positive feedback from our community of physicians and patients regarding their excitement about the further development of this therapeutic and its potential to benefit patients once it reaches the clinic. In addition, we continue to participate in investors meetings to get the story of the company out to the wider investment community.”

Financial Results

Cash Position: As of 
June 30, 2022, cash, cash equivalents, and marketable securities totaled 
$44.4 million
, compared to 
$55.0 million
 as of 
December 31, 2021. In 
March 2022, the Company received approximately 
$25.0 million
 in gross proceeds from a registered direct offering of common stock. Axcella expects that its current cash balance will be sufficient to meet its operating needs into the first quarter of 2023, provided that, if the Company is unable to satisfy the cash covenants contained in its loan and security agreement with SLR Investment Corp., and SLR Investment Corp. seeks immediate repayment of the loan in full, the Company believes that its cash and cash equivalents will be sufficient to fund its operations into the fourth quarter of 2022.

R&D Expenses: Research and development expenses for the quarter and six months ended 
June 30, 2022 were 
$16.9 million
 and 
$30.4 million
, respectively. Research and development expenses for the same periods ended 
June 30, 2021 were 
$10.3 million
 and 
$20.5 million
, respectively. These increases are the result of the Company’s EMMPACT and Long COVID Phase 2 clinical trials, as well as closure costs for its EMMPOWER Phase 2 clinical trial.

G&A Expenses: General and administrative expenses for the quarter and six months ended 
June 30, 2022 were 
$3.8 million
 and 
$8.5 million
, respectively. General and administrative expenses for the same periods ended 
June 30, 2021 were 
$4.9 million
 and 
$9.2 million
. These decreases are primarily the result of lower non-cash stock-based compensation expenses.

Net Loss: Net loss for the quarter and six months ended 
June 30, 2022 was 
$21.3 million
, or 
$0.40 per basic and diluted share, and 
$40.3 million
, or 
$0.86 per basic and diluted share, respectively. This compares with a net loss of 
$15.9 million
, or 
$0.42 per basic and diluted share, and 
$31.1 million
, or 
$0.83 per basic and diluted share, for the quarter and six months ended 
June 30, 2021.

Internet Posting of
Information

Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, 
Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella
Therapeutics (Nasdaq: AXLA)

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

Forward-Looking
Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of the company’s clinical trial data readouts, its expected cash runway and the potential impact of the company’s recent clinical trial data readouts on market interest and acceptance of the company’s product candidates and investment interest in the company’s securities. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company’s clinical trial plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company’s target indications, and other risks identified in the company’s 
SEC filings, including Axcella’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the 
SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220812005033/en/

Ashley Robinson arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics

 

Friday, August 12, 2022

Onconova Therapeutics (ONTX)
All Trials Continue Toward Data Milestones

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China. Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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

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

2Q22 Onconova Reported Trial Progress. 2Q22 loss of $4.0 million or $(0.19) per share, compared with our estimated loss of $3.7 million or $(0.18) per share.  Several clinical trials for both narazaciclib and rigosertib are continuing as expected.  The company ended the quarter with $46.5 million in cash and cash equivalents.

Both Narazaciclib Phase 1/2 Trials Continue To Enroll Patients.  The two trials testing narazaciclib at different treatment schedules continue to treat patients.  The trial in China continues in its fifth cohort while the US trial recently begun dosing its fifth cohort.  Neither trial has reached its maximum tolerated dose and none of the toxicities associated with other CDK4/6 drugs have been reported.  We expect announcement of the dosing level selected for Phase 2 around 4Q22….

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. 

Friday, August 12, 2022

Baudax Bio (BXRX)
Baudax Bio reports 2Q 2022; Headwinds Persist

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

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

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

Baudax Bio, Inc. reported 2Q 2022 results yesterday.  While there was a revenue shortfall ($.3 million vs $.77 million expected), overall operating expenses of $7.8 million were below our estimate of $10.4 million due to lower severance costs primarily accrued in 1Q, and lower COGS and SG&A in 2Q, offset a bit by higher contingent consideration to Alkermes and a slight bump up in R&D from trial initiations. GAAP loss per share in 2Q was $(1.05) vs our expected $(1.27).

Feeling the impact of Covid.  Revenues came in light as Covid-related problems, including staffing shortages, continue to restrict usage at hospitals and ASCs, although 2Q hospital usage increased 12% as compared to 1Q 2022 and 2Q revenues increased 49% compared to the year ago period. Vials sold increased 67%. That said, in certain cases, procedure volumes are running as much as 50% below normal periods and are expected to not fully resolve until next year, at the earliest. An expected ramp in ANJESO is expected to be muted well into 2023….

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 Announces Second Quarter Results

Research, News, and Market Data on Schwazze

Record Quarterly Revenue and Adjusted EBITDA

Revenue Increases 44% to $44.3 Million Compared to $30.7 Million
in Q2 2021

Adjusted EBITDA of $15 Million, 33.9% of Revenue

Revised Guidance Driven by Short-Term, Challenging Colorado
Market Conditions
Q4 2022 Projected Revenue Annualized Run Rate: $175 Million – $200 Million
Q4 2022 Projected Adjusted EBITDA Annualized Run Rate: $60 Million – $72
Million

Conference Call & Webcast Scheduled for Today – 5:00 pm EDT

DENVER, Aug. 11, 2022 /PRNewswire/ – Schwazze, (OTCQX: SHWZ) (NEO: SHWZ) (“Schwazze” or the “Company”), today announced financial results for the second quarter ended June 30, 2022 (“Q2 2022”).

Q2 2022 Financial
Summary:

• Revenues of $44.3 million increased 44% compared to $30.7 million in second quarter ended June 30, 2021 (“Q2 2021”)
• Retail sales were $38.1 million up 77% when compared to Q2 2021
• Gross Margin of $25.2 million was up 69% compared to $14.9 million in Q2 2021, this quarter was affected by $0.2M in purchase accounting
• Net Income was $33.8 million compared to a Net Income of $4.4 million for the same period last year
• Adjusted EBITDA of $15 million was 33.9% of revenue, compared to $10 million for the same period last year
• Colorado two year stacked IDs for Q2 2022 compared to Q2 2021 and Q2 2020 for same store sales⁽¹⁾ were 1.8% and one year IDs⁽¹⁾ were (12.7%) comparing Q2 2022 to Q2 2021
• Average basket size ⁽¹⁾ for Q2 2022 was $59.98 down 4.1% compared to Q2 2021
• Recorded customer visits ⁽¹⁾ for Q2 2022 totaled 444,771 down 8.9%, compared to Q2 2021
• New Mexico two year stacked IDs for Q2 2022 compared to Q2 2021 and Q2 2020 for same store sales⁽¹⁾ were 41.0% and one year IDs⁽¹⁾ were 30.4% comparing Q2 2022 to Q2 2021
• Average basket size ⁽¹⁾ for Q2 2022 was $54.56 down 12.7% compared to Q2 2021
• Recorded customer visits ⁽¹⁾ for Q2 2022 totaled 209,591 up 49.4%, compared to Q2 2021

Accomplishments
Since December 2021, Schwazze has closed acquisitions adding 15 cannabis dispensaries, 10 in New Mexico and five in Colorado as well as four cultivation facilities in New Mexico and one in Colorado and one manufacturing asset in New Mexico.

• Closed Acquisition of Urban Health & Wellness Assets
• Listed Common Stock on the NEO Exchange
• Closed Acquisition of Brow 2 LLC Assets
• Closed Acquisition of Emerald Fields
• Added President of New Mexico Division
• Closed New Mexico Acquisition, Becoming a Regionally Focused MSO
• Added to Key Senior Leadership Team
• Closed Acquisition of Drift Assets

Justin Dye, Chairman and CEO of Schwazze stated
, “Similar to the rest of the country, the cannabis industry in
Colorado is also experiencing a slowdown in growth compared to the last couple
of years. Schwazze, however, is demonstrating that our regional strategy, built
on a customer first approach, developing significant scale, building brands and
leveraging data analytics and technology is not only sound but gaining momentum
as demonstrated by revenue and unit sales growth, customer loyalty and by once
again outpacing the legacy market growth by approximately 12%.  We believe
this model will travel well to other states as we find attractive
opportunities. Despite share price weakness driven by broader market
influences, we remain bullish on our business and have conviction that as
Schwazze continues to deliver superior operating results that our shareholders
will be rewarded.”

Justin continued, “As we look to
the future, we expect continued growth in Colorado and New Mexico through both
organic and inorganic means. Our operations continue to mature and gain
momentum, and we firmly believe that we are winning in our markets. Our team
will continue to focus on growing profitably and generating cash flow from
operations.  When positive federal legislation is passed, Schwazze will be
well-positioned as a market leader to take advantage of banking services and
institutional investment.”

Q2 2022 Revenue
Revenues for the three months ended June 30, 2022, totaled $44.3 million, including (i) retail sales of $38.1 million (ii) wholesale sales of $6.1 million and (iii) other operating revenues of $43,750, compared to revenues of $30.7 million, including (i) retail sales of $21.5 million, (ii) wholesale of $9.2 million, and (iii) other operating revenues of $16,844 during the three months ended June 30, 2021, representing an increase of $13.5 million or 44%. This increase was due to increased sale of our products as well as execution of our growth through acquisition initiatives. In the second quarter of 2022, the Company acquired one additional retail dispensary, which generated additional retail revenue. Additionally, recreational marijuana sales became legal in New Mexico in April 2022, which increased sales volume and revenues in New Mexico. Wholesale revenues in Colorado decreased due to increased cultivation capacity in the state resulting in an over-supply of wholesale cannabis materials.

Cost of goods and services for the three months ended June 30, 2022, totaled $19.1 million compared to cost of services of $15.8 million during the three months ended June 30, 2021, representing an increase of $3.3 million or 21%. The increase in cost of goods is driven by the increase in revenue, however not at the same rate. In the quarter, the Company experienced a reduction in costs driven by vertical integration and third-party price negotiations.

Gross profit increased to $25.2 million for Q2 2022 compared to $14.9 million during the same period in 2021. Gross profit margin increased as a percentage of revenue from 48.5% to 56.8%, and net of purchase accounting, the gross margin increased to 57.4%.  This positive result, net of purchase accounting continues to reflect our consolidated purchasing approach, the implementation of our retail playbook, and vertical product sales in New Mexico.

Operating expenses for the three months ended June 30, 2022, totaled $16.1 million, compared to operating expenses of $10.5 million during the three months ended June 30, 2021, representing an increase of $5.6 million or 54%. This increase is due to increased selling, general and administrative expenses, professional service fees, salaries, benefits, and related employment costs driven by growth from acquisitions.

Other income for the three months ended June 30, 2022, totaled $29.2 million compared to $0.2 million during the three months ended June 30, 2021, representing an increase in income of $29 million or 18,435%. The increase in other income is due to the revaluation of the derivative liability related to the Investor Notes, offset by higher interest payments.

The Company generated net income for the three months ended June 30, 2022, of $33.8 million, compared to net income of $4.4 million for the three months ended June 30, 2021.

Adjusted EBITDA for Q2 2022 was $15 million representing 33.9% of revenue, compared to $10 million and 32.6% of revenue for the same period last year. This is derived from Operating Income and adjusting one-time expenses, merger and acquisition and capital raising costs, non-cash related compensation costs, and depreciation and amortization. See the financial table for Adjusted EBITDA below adjustment for details. 

For six months ending June 30, 2022, the Company used cash for operations of ($8.0) million compared to generating cash of $1.4 million for the same period in 2021.  The Company has cash and cash equivalents of $33.9 million at the end of Q2 2022. 

Nancy Huber, CFO for Schwazze commented, ”
During Q2 we focused on completing integration of our acquisitions and
made sure that we used our resources effectively. We are focused on reducing
operating and SG&A expenses and judiciously investing growth capital to
ensure adequate liquidity and profitability despite difficult market conditions
in Colorado, which we believe to be transitory and temporary. Our balance sheet
remains strong, and we have ample liquidity.  We are focused on delivering
positive cash flow net of acquisition costs for the year while driving organic
growth and making smart acquisitions.”

2022 Guidance

The Company has revised its guidance for a fourth-quarter 2022 (Q4 2022) annualized run rate, which excludes transactions that are announced but not closed.  Q4 2022 revenue annualized run rate is projected to be $175 million to $200 million, and the Q4 2022 adjusted EBITDA annualized run rate is projected to be from $60 million to $72 million.  

NOTES:

(1)  Schwazze did not own all the assets and entities in part of 2021, 2020 and 2019 and is using unaudited numbers for this comparison.

Adjusted EBITDA represents income (loss) from operations, as reported, before
tax, adjusted to exclude non-recurring items, other non-cash items, including
stock-based compensation expense, depreciation, and amortization, and further
adjusted to remove acquisition and capital raise related costs, and other
one-time expenses, such as severance, retention, and employee relocation. The
Company uses adjusted EBITDA as it believes it better explains the results of
its core business. The Company has not reconciled guidance for adjusted EBITDA
to the corresponding GAAP financial measure because it cannot provide guidance
for the various reconciling items. The Company is unable to provide guidance
for these reconciling items because it cannot determine their probable
significance, as certain items are outside of its control and cannot be
reasonably predicted. Accordingly, a reconciliation to the corresponding GAAP
financial measure is not available without unreasonable effort.

Webcast – August 11,
2022 – 5:00 PM EDT
Investors and stakeholders may participate in the conference call by dialing 416 764 8650 or by dialing North American toll free 1-888-664-6383 or listen to the webcast from the Company’s website at https://ir.schwazze.com The webcast will be available on the Company’s website and on replay until August 18, 2022, and may be accessed by dialing 1-888-390-0541 / # 575833

Following their prepared remarks, Chief Executive Officer, Justin Dye and Chief Financial Officer, Nancy Huber will answer investor questions. Investors may submit questions in advance or during the conference call itself through the weblink: https://app.webinar.net/lwXbZbBZmKN  This weblink has been posted to the Company’s website and will be archived on the website. All Company SEC filings can also be accessed on the Company website at https://ir.schwazze.com/sec-filings

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

Forward-Looking
Statements
Such forward-looking statements may be preceded by the words “plan,” “will,” “may,” “continue,” “anticipate,” “become,” “build,” “develop,” “expect,” “believe,” “poised,” “project,” “approximate,” “could,” “potential,” or similar expressions as they relate to Schwazze. Forward-looking statements include the guidance provided regarding the Company’s Q4 2022 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and New Mexico and outside the states, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, (x) the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (xii) our ability to achieve the target metrics, including our annualized revenue and EBIDTA run rates set out in our Q4 2022 guidance. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.

 View original content to download multimedia:https://www.prnewswire.com/news-releases/schwazze-announces-second-quarter-results-301604597.html

SOURCE Schwazze

Released August 11,
2022

 

Onconova Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update

News and Market Data on Onconova Therapeutics

Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended June 30, 2022, and provided a business update.

Highlights for the second quarter of 2022 and recent weeks include:

• Safety data from the ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to be encouraging with the maximum tolerated dose not yet reached in either study. The trial in the United States is currently enrolling its fifth dose escalation cohort, with continuous dosing. The trial in China is also enrolling its fifth dose escalation cohort but once a day on days 1-21 of 28-day cycles. A protocol amendment to enable further dose escalation in the trial in China is being prepared.
• Data from 
  in
  vitro and cell-based assays that suggest narazaciclib’s inhibitory profile may provide safety and efficacy advantages over currently approved CDK4/6 inhibitors were featured in an abstract published at the American Society of Clinical Oncology (ASCO) Annual Meeting.
• Each of rigosertib’s investigator-sponsored trials continues to progress. A Phase 2 trial evaluating rigosertib plus pembrolizumab in patients with checkpoint inhibitor refractory metastatic melanoma is on schedule to be initiated in the second half of 2022. The expansion cohort of the Phase 1/2a trial of rigosertib plus nivolumab in patients with KRAS-mutated non-small cell lung cancer continues to enroll patients, with additional data from the trial expected in Q3 2022. The Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa also continues to enroll patients.
• Mark Guerin was appointed Chief Operating Officer in addition to his role as Chief Financial Officer and Dr. Adar Makovski Silverstein was promoted to Senior Director and Head of Corporate Development.
• Cash and cash equivalents at June 30, 2022 were $46.5 million, which the Company believes will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Management Commentary

“We saw sustained progress across our pipeline over the past months and are well positioned to complete our current Phase 1 trials as we move through the second half of the year,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Narazaciclib continues to show a favorable safety profile in its Phase 1 studies, which will be key to informing the design of future trials seeking to address the unmet needs posed by the limitations of currently available CDK4/6 inhibitors. These limitations stem from issues related to safety, tolerability, and primary and acquired drug resistance, which we believe narazaciclib’s differentiated inhibitory profile may overcome. We were pleased to publish preclinical data supporting this hypothesis at the most recent ASCO meeting and look forward to continued efforts to translate these promising findings to the clinic.”

Dr. Fruchtman continued, “Alongside narazaciclib’s advancement, we also made key progress in rigosertib’s investigator-sponsored studies. This includes a Phase 2 trial evaluating rigosertib combined with a PD-1 checkpoint inhibitor in checkpoint inhibitor refractory metastatic melanoma which is on schedule to open for enrollment in the second half of 2022. This study seeks to leverage rigosertib’s immunomodulatory effects and is supported by initial data from the ongoing trial of rigosertib plus anti-PD-1 therapy in KRAS-mutated NSCLC. These data provided strong evidence of the studied doublet’s activity in patients who previously failed checkpoint inhibitor therapy, which is a finding we aim to build upon with the presentation of additional data at a medical meeting later this quarter. Data has been presented, which will be updated, demonstrating that responses seen with rigosertib in this setting are agnostic to the type of KRAS mutation present. This upcoming milestone highlights how rigosertib’s investigator-sponsored studies enable the capital efficient pursuit of value creating opportunities to complement our lead narazaciclib program.”

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2022, were $46.5 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the second quarter of 2022, compared with $1.9 million for the second quarter of 2021.

General and administrative expenses were $2.1 million for the second quarter of 2022, compared with $2.9 million for the second quarter of 2021.

Net loss for the second quarter of 2022 was $4.0 million, or $0.19 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.2 million, or $0.27 per share for the second quarter of 2021 on 15.8 million weighted shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 289-0571 (domestic callers) or (856) 344-9290 (international callers) and using conference ID 3600715.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast 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 has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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 the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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,
		2022				2021
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	46,533			$	55,070
Receivables		28				28
Prepaid expenses and other current assets		1,472				332
Total current assets		48,033				55,430
Property and equipment, net		31				38
Other non-current assets		10				10
Total assets	$	48,074			$	55,478
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,003			$	2,757
Accrued expenses and other current liabilities		3,231				3,132
Deferred revenue		226				226
Total current liabilities		6,460				6,115
Deferred revenue, non-current		3,130				3,243
Total liabilities		9,590				9,358
Stockholders’ equity:
Preferred stock		–				–
Common stock		209				209
Additional paid in capital		491,181				490,644
Accumulated other comprehensive loss		(41	)			(14	)
Accumulated deficit		(452,865	)			(444,719	)
Total stockholders’ equity		38,484				46,120
Total liabilities and stockholders’ equity	$	48,074			$	55,478

 

ONCONOVA
THERAPEUTICS, INC.

Condensed
Consolidated Statements of Operations

(in
thousands, except share and per share amounts)

	Three Months Ended June 30,								Six months months ended June 30,
		2022				2021				2022				2021
Revenue	$	57			$	57			$	113			$	113
Operating expenses:
General and administrative		2,139				2,850				4,325				5,067
Research and development		2,038				1,852				4,040				3,789
Total operating expenses		4,177				4,702				8,365				8,856
Loss from operations		(4,120	)			(4,645	)			(8,252	)			(8,743	)
Change in fair value of warrant liability		–				427				–				(209	)
Other income (loss,) net		96				(13	)			106				6
Net loss		(4,024	)			(4,231	)			(8,146	)			(8,946	)
Net loss per share of common stock, basic and diluted	$	(0.19	)		$	(0.27	)		$	(0.39	)		$	(0.59	)
Basic and diluted weighted average shares outstanding		20,904,085				15,780,863				20,904,085				15,201,719