Tag: Health

BioSig Technologies (BSGM) – BioSig reports 3Q 2022; Lots of Activity; Target Price Reduced

Posted on by cpereira@noblefcm.com


Wednesday, November 16, 2022

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.

BioSig reported 3Q 2022 results.  The Company reported $135,000 of revenues in the quarter that recognized $127,000 in product sales and $8,000 in service revenue.  We were looking for $980,000 in product revenues and $49,000 in service revenue.  The third quarter EPS loss of $0.14 matched our expected loss per share.

Marketing activities are ramping up.  PURE EP technology was featured in a physician presentation at the Kansas City Heart Rhythm Symposium held August 20-21, 2022.  In late September 2022, the Company released its most advanced software, known as PURE EP Software Version 6 with ACCUVIZ Module. The new Version 6 software was introduced at the Cleveland Clinic Global EP Summit held September 23-24, 2022.  In addition, the Company was invited to attend and sponsor the Venice Arrhythmias 2022 Congress that met October 13-15 in Venice Italy.


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Schwazze (SHWZ) – Blocking and Tackling

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

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

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

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

3Q22 Results. Revenue was $43.2 million, up 36% y-o-y from $31.8 million. Adjusted EBITDA was $15.9 million, or 36.7% of revenue in the quarter, up from $8.8 million, or 26.7%, a year ago. Schwazze reported operating income of $11.1 million and net income of $25,124, or breakeven EPS, versus $3.8 million, $968,756 and $0.02 last year.

Quarterly Drivers. The most influential factor driving revenue increases in the third quarter  2022 was the inclusion of four consummated acquisitions in Colorado and revenue from R. Greenleaf. Revenue from wholesale sales decreased, due in large part to continued pricing pressure in the Colorado wholesale market as a result of supply saturation in flower and bulk distillate products.


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

PDS Biotechnology Corp. (PDSB) – PDS Bio Reports 3Q22 and Reviews Full SITC Data

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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

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

Financial Results Reported With Full Data. PDS Biotech reported a 3Q22 loss of $7.4 million or $(0.26) per share, with cash on September 30 of $71.6 million. PDS Management reviewed two presentations at last week’s Society for Immunotherapy of Cancer (SITC) meeting, providing additional information to the data published in the abstracts. These data continue to show improved efficacy for PDS0101 over current treatments.

Data From Two Studies Was Presented At SITC. As discussed in our Research Note on November 8, the response rate and patient survival for the Phase 2 IMMUNOCERV trial in cervical cancer exceeded the standard of care.  Data presented from the Phase 2 Triple Therapy trial showed anti-tumor action by PDS0101, with increases in immune response markers against the tumors and decreases in markers of immune suppression.


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Onconova Therapeutics (ONTX) – Onconova Announces A New Trial With 3Q22 Results

Posted on by cpereira@noblefcm.com


Tuesday, November 15, 2022

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.

3Q22 Showed Continued Progress In Ongoing Trials. Onconova announced a loss of $5.4 million or $(0.26) per quarter for 3Q22, ending the quarter with $42.6 million in cash. In addition to updates on its current clinical trials, the company announced its intentions to start a new Phase 1/2a trial testing narazaciclib in low-grade endometrioid endometrial cancer (LGEEC). This new trial is expected to begin in 1Q23 with first data announced in 4Q23.

New Trial Planned In Endometrial Cancer. The Phase 1/2a trial will test the combination of narazaciclib with letrozole (Femara, an aromatase inhibitor from Novartis) in recurrent low-grade endometrioid endometrial cancer (LGEEC). The trial will start with safety cohorts testing the combination, with a 200 mg dose of narazaciclib with the standard 2.5 mg dose of letrozole. This is the narazaciclib dose that is in its fifth cohort in the Phase 1 trial for solid tumors.


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Baudax Bio (BXRX) – Feeling the Pain; Focus on NMBs

Posted on by cpereira@noblefcm.com


Thursday, November 10, 2022

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

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

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

Baudax reported 3Q 2022 results. 3Q revenues reported of $0.238 million were well below our expectation of $0.965 million.  While vials sold increased year-over-year approximately 16%, much of the 3Q volume was discounted into 340B hospitals causing revenues to decline 15% from the prior year.

Feeling the pain. In the Covid environment that doesn’t seem to go away, hospitals face financial pressures as they struggle to curtail costs. For a single product company like Baudax Bio, the hospital issues have inflicted continued pain that is difficult to overcome. Hospitals look for less expensive alternatives in pain management. Recognizing that Covid-related issues facing hospitals now could continue into and through 2023, the Company eliminated the remaining commercial team in September 2022.


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

Ocugen (OCGN) – 3Q22 Reported With Pipeline Updates

Posted on by cpereira@noblefcm.com


Wednesday, November 09, 2022

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

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

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

Financial Results Met Expectations. Ocugen reported a 3Q loss of $21.9 million or $(0.10) per share, close to our estimates of $21.2 million and $(0.10) for the quarter. Cash on hand at September 30, 2022 was $101.6 million, which the company expects to last through 2023. 

COVID-19 Programs Are Moving Forward. The Phase 2/3 immuno-bridging study for COVAXIN has completed enrollment with data release expected in early 2023. This study is testing COVAXIN to determine the immune response in the current US population, providing a “bridge” for comparability with the Phase 3 trial conducted in India. The study enrolled patients who were unvaccinated and patients that received mRNA vaccines to determine both initial and booster efficacy. Once completed, Ocugen plans to work with government agencies for support and funding for regulatory approval of its COVID-19 products.


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PDS Biotechnology Corp (PDSB) – SITC Abstracts Released For Two Studies

Posted on by cpereira@noblefcm.com


Tuesday, November 08, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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

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

Data To Be Presented At SITC.  PDS Biotechnology released two PDS0101 abstracts to be presented at the SITC (Society for Immunotherapy of Cancer) meeting later this week. Data will be from the Phase 2 IMMUNOCERV trial in cervical cancer in combination with chemotherapy and radiation and the trial known as the Triple Combination Study or NCI Study, testing PDS0101 in combination with two immunomodulating agents. We believe both studies show positive results that are consistent with our expectations. 

IMMUNOCERV Trial Highlights. The Phase 2 IMMUNOCERV trial is testing PDS0101 in combination with standard-of-care chemotherapy in advanced cervical cancer. Out of 17 patients enrolled in the study, 8 had been reached the 170-day status evaluation for by PET CT. Complete responses (CR) were seen in 7 out of 8 (87.5%) of the patients. One year survival was all 8 out of 8 (100%), with 7 out of 8 disease free (87.5%). One patient who only received 3 out of 5 doses showed signs of residual disease. The study is still ongoing.


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

Ocugen (OCGN) – R&D Day Highlights Gene Therapy and COVID Programs

Posted on by cpereira@noblefcm.com


Wednesday, November 02, 2022

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

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

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

Gene Therapy In The Spotlight.  Ocugen held an R&D Day to highlight its programs in gene therapy and COVID-19.  The presentations discussed the novel mechanisms behind its gene therapy products and the nature of the ophthalmic disease indications in development.  While the company has been best known for COVAXIN and COVID-19, we have always seen the gene therapy indications as highly promising and underappreciated.

Modifier Gene Therapy Platform.  The first presentations discussed the company’s novel approach to gene therapy.  In contrast to other approaches that seek to transfer a functional copy of a gene to replace a gene that has mutated or become dysfunctional, Ocugen’s Modifier Gene Therapy targets a “master control gene” that controls the expression of multiple gene pathways, allowing products to be developed for diseases caused by downstream gene pathways and combinations of genetic mutations.


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

Axcella Therapeutics (AXLA) – 3Q22 Reported After An Eventful Quarter

Posted on by cpereira@noblefcm.com


Wednesday, November 02, 2022

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

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

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

Financial Results.  Axcella reported a 3Q22 loss of $17.8 million or $(0.34) per share, compared with our estimate of a loss of $21.7 million or $(0.43) per share.  The company sold convertible notes raising $6.0 million to end the quarter with $25.4 million in cash and equivalents.  After the quarter ended, it added $28.2 million in cash through a direct offering of common stock.  Based on our 4Q22 estimate of a loss of $18.1 million, we project the cash balance at YE22 to be around $35.5 million.

Long COVID Study Results Were Encouraging.  Results from a Phase 2a study testing AXA1125 in Long COVID were announced in early August, as discussed in our note from August 3. The data showed statistically significant improvements in both physical and mental fatigue symptoms.  We believe this is clinically relevant for an estimated 20% to 30% of the people who have been infected with COVID-19.  Axcella is in currently in discussions with regulatory authorities to design the next study, planned to begin in 2023.


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

PDS Biotechnology Corp (PDSB) – KOL Event Held To Discuss Head and Neck Cancer

Posted on by cpereira@noblefcm.com


Thursday, October 27, 2022

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

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

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

Roundtable Discussion of Head and Neck Cancer.  PDS Biotech held a Head and Neck Cancer Roundtable with KOLs to discuss treatments and PDS0101.  Although no new data was released, there was a discussion of the cancer, its prognosis, the drugs, and adverse events that showed the need for a new treatment like PDS0101.

Head and Neck Cancer Discussion Included Incidence and Market Size.  The presentations discussed the patient population, current drugs, survival and recurrence rates.  Newly diagnosed cases of head and neck cancer are often associated with HPV, in contrast to previous generations when it was associated with tobacco and alcohol.  Although vaccinations against HPV have  been introduced, millions have been already been exposed so that incidence is expected to rise in the coming decades.


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

Avivagen Inc. (VIVXF) – Securing More Financing

Posted on by cpereira@noblefcm.com


Tuesday, October 25, 2022

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

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

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

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

Issuing New Shares. Last Friday, Avivagen announced the closing of a first tranche of a non-brokered private placement of shares. The total amount of common shares issued in the first tranche was 2.15 million for approximately $430,000, or $0.20 per share. The total amount of the placement financing is up to $1 million. We expect the Company to issue the full amount in the private placement.

Use of Financing. The use of the funds will be for funding research and development expenses, sales and marketing costs, product registration, interest expense, working capital, and general corporate purposes. We anticipate the use of the funding will be for product expansion as the Company is continuing to work towards a No Objection Letter in the U.S., targeting an expansion in the European Union, and is seeing increased interest in South America.


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

Release – BioSig Signs Master Research Agreement with Cleveland Clinic to Explore Expanded Applications for its Digital Signal Processing Technology

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BSGM

October 24, 2022

Westport, CT, Oct. 24, 2022 (GLOBE NEWSWIRE) —

  • Medical Center of Excellence to leverage the Company’s PURE EP™ System to further its research and educational objectives as a leader in cardiac electrophysiology
  • Clinical investigations conducted by Cleveland Clinic could expand clinical parameters of BioSig’s digital signal processing technology for arrhythmia care

BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP™ System, today announced that it will sponsor a research agreement with Cleveland Clinic Foundation (CCF) to investigate expanded clinical applications for the intracardiac signals acquired by its PURE EP™ System.

Under the terms of the research agreement, Cleveland Clinic will conduct physician initiated scientific research investigating PURE EP™’s potential to address common limitations of signal processing and signal use expansion during— but not limited to— electrophysiology ablation procedures. Results from this research could elucidate new clinical workflow methods impacting the ablation process for numerous arrhythmia types.

The Company has selected Cleveland Clinic, a leading medical center of excellence, based on their world-class physician faculty, research competency, and mutual interest in leveraging digital signal processing technology to further advance the field of cardiac electrophysiology. 

“As a non-profit, research, education, and healthcare institution, Cleveland Clinic has a long legacy of innovation in cardiovascular disease, and specifically in the field of electrophysiology. At BioSig, we embody their commitment to clinical discovery and ensuring that optimal treatments are made available to patients with efficiency and efficacy,” said Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. “We are honored to align ourselves with Cleveland Clinic’s expertise as we discover new ways to positively impact procedural workflows by leveraging digital signal processing technology.”

BioSig’s PURE EP™ System is currently under evaluation at both Main and Fairview campuses of Cleveland Clinic’s Heart, Vascular & Thoracic Institute.  

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. As a leader in arrhythmia treatment and diagnosis, Cleveland Clinic medical centers include state-of-the-art electrophysiology laboratories, world-class physicians and researchers, and the latest cutting-edge technologies and protocols deployed for the treatment of heart abnormalities. To learn more, visit clevelandclinic.org.

About BioSig Technologies

BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias. Through collaboration with physicians, experts, and healthcare leaders across the field of electrophysiology (EP), BioSig is committed to addressing healthcare’s biggest priorities — saving time, saving costs, and saving lives.

The Company’s first product, the PURE EP™ System, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization allowing physicians to perform insight-based, highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

The PURE EP™ System is currently in a national commercial launch and an integral part of well-respected healthcare systems, such as Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic, and Kansas City Heart Rhythm Institute. In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology, electrophysiologists rated PURE EP™ as equivalent or superior to conventional systems for 93.6% of signal samples, with 75.2% earning a superior rating.

The global EP market is projected to reach $16B in 2028 with a 11.2% growth rate.[1]

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future 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 and consequently, actual 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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) difficulties in securing regulatory approval to market our products and product candidates. 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.

1 Global Market Insights Inc. March 08, 2022.

Andrew Ballou

BioSig Technologies, Inc.

Vice President, Investor Relations

55 Greens Farms Road, 1st Floor

Westport, CT 06880

aballou@biosigtech.com

203-409-5444, x133

Source: BioSig Technologies, Inc.

Released October 24, 2022

Ayala Pharmaceuticals (AYLA) – Ayala Announces Merger With Advaxis

Posted on by cpereira@noblefcm.com


Thursday, October 20, 2022

Ayala Pharmaceuticals, Inc. is 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. 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 Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). 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) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.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.

Merger Combines Cash And Phase 2/3 Product.  Ayala has agreed to merge with Advaxis, Inc. (ADXS, $2.37, Not Rated), with Ayala shareholders owning 62.5% and Advaxis shareholders owning 37.5% of the newly combined company.  Importantly, Advaxis had $28.2 million on July 31, 2022, which we believe will allow continuation of the RINGSIDE Phase 2/3 trial in desmoid tumors.

Combined Company Will Have A Late Stage Product and An Immunotherapy Technology.  The new company will have funding to move AL102 forward and to continue development of Advaxis’ proprietary Lm platform for antigen delivery.  This platform is based on its proprietary technology using a modified bacteria, Listeria monocytogenes, for delivering antigens to stimulate the immune system against tumors.  Advaxis ADXS-504 is in a dose-finding Phase 1 study for prostate cancer.


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