PsyBio Therapeutics Develops Commercial Purification Process for Second Generation Psycho-Targeted Compound

Research, News, and Market Data on PsyBio

PsyBio Therapeutics Further
Expands Scalable Manufacturing Process Development

OXFORD, Ohio and COCONUT CREEK, Fla., May 16, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), a fully integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today reported that it has achieved a commercially scalable purification method for one of its second generation compounds. This manufacturing process achievement is expected to enable the commercial scale purification of bioreactor produced products utilizing state of the art manufacturing methodology to further expand PsyBio’s portfolio of compounds that can be more readily and rapidly developed than competitive methods. This purification process methodology is a necessary component for the Chemistry, Manufacturing and Controls section (“CMC”) for this second-generation candidates Investigational New Drug (“IND”) application with the US Food and Drug Administration (“FDA”).

“Developing adequate and scalable methodology for the purification of pipeline compounds will allow PsyBio to enable bench scale technology to be adapted to modern biotechnological production efficiency.  This technology is necessary to produce reliable and predictable purity which allows more rapid development of large scale lots of material,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “This is expected to facilitate effective in vitro and in
vivo testing, moving towards additional clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health.”

PsyBio retains the global, exclusive, and perpetual right to license a platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale.    Commercial purification process development furthers the ability to manufacture compounds with predictable and reproducible purity.

“PsyBio continues to make significant progress in the manufacturing arena, developing effective and scalable techniques to enhance the ability to produce an ever-growing number of psycho-targeted therapeutic candidates in a rapid and highly cost-efficient manner,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The development of this type of manufacturing processes improves PsyBio’s capability to develop and rapidly manufacture novel therapeutic agents. PsyBio remains one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds as most of the landscape appears to rely on third party providers.”

About
PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company developing new, bespoke, fully approved, 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, specifically because they are already known to have an effect within the brain.

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 impact of this manufacturing process achievement on commercial scale purification; the impact of this manufacturing process achievement on the CMC section of PsyBio’s IND application with the FDA; PsyBio’s ability to develop compounds more readily and rapidly than competitive methods; PsyBio’s plans for filing IND applications with the FDA; the impact of this new manufacturing on potential 
in vitro and in
vivo testing; PsyBio’s plans to move towards additional clinical trials for psycho-targeted therapeutics intended to potentially improve mental and neurological health; PsyBio’s ability to develop novel therapeutic agents; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s ability to launch clinical trials; PsyBio’s ability to build its intellectual property portfolio of novel drug candidates; PsyBio’s ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and PsyBio’s ability 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: this manufacturing process will enable commercial scale purification of bioreactor produced products; this manufacturing process will have a positive impact on potential 
in vitro and in
vivo testing; this manufacturing process will have a positive impact on progress toward the filing of IND applications with the FDA; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining IND applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; 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.

Tuesday, May 17, 2022

Ayala Pharmaceuticals (AYLA)
Data Milestones Reiterated With 1Q22 Financial Report

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.

1Q22 Reported With Clinical Updates.   Ayala Pharmaceuticals reported a 1Q22 loss of $10.0 million or $(0.66) per share.  Interim results from the Phase 2/3 RINGSIDE trial testing AL102 in desmoid tumors are expected to be announced in mid-2022, unchanged from previous guidance.  The company also expected to provide updates from the Phase 2 ACCURACY trial testing AL102 in adenoid cystic carcinoma (ACC), and plans to begin a trial in acute lymphoblastic leukemia (ALL) later in 2022.  The company ended the quarter with $27.4 million in cash.

Looking Forward To Phase 2/3 Ringside Data.  The RINGSIDE trial is testing AL102 for treatment of desmoid tumors, a rare tumor of the connective tissue.  In February, Ayala announced that Part A of the trial had completed enrollment of 42 patients to evaluate the safety and tolerability, as well as tumor shrinkage at 16 weeks.  Upon completion of Part A, the double-blind placebo-controlled Part B will begin testing efficacy with a target enrollment of 156 patients….

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. 

PDS Biotech to Participate at Upcoming Investor Conferences

Research, News, and Market Data on PDS Biotech

FLORHAM PARK, N.J., May 17, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced that its management will present at the H.C. Wainwright Global Investment Conference and the LD Micro Invitational and will participate at the UBS Healthcare Virtual One-on-One Day. 

H.C. Wainwright Global Investment Conference
Date: Tuesday, May 24, 2022
Time: 7:00 AM EDT
Investors can register for the conference here

UBS Healthcare Virtual One-on-One Day
Date: Wednesday, June 1, 2022

LD Micro Invitational Conference
Date: Wednesday, June 8, 2022
Time: 7:30 AM PDT
Virtual Viewers: Livestream

Following the conferences, a webcast replay of the presentations will be available on the Investor section of the company’s website, PDS Biotechnology. 

About PDS Biotechnology
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.

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Investor
Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838

pdsb@cg.capital

Image Credit: US Food and Drug Administration (Flickr)

FDA Breakthrough Devices Program Could Aid Investors to Find Opportunities

The FDA Breakthrough Devices Program may be a starting point for investors exploring the medical space. It’s designed to create a quicker path for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversible conditions. There are significant benefits for the companies granted access to the program. Lists of devices after the companies have been granted a marketing authorization are available on the FDA
website.

While new pharmaceuticals tend to grab headlines quicker than devices, investors looking for public companies, that may be uncorrelated to the pace of US economic growth or the financial markets, may visit the website and then research the companies on Channelchek.

Benefits of the Breakthrough Devices Program

The purpose of the Breakthrough Devices Program is to provide patients and health care providers with timely access to novel medical devices by speeding up their development, assessment, and review. At the same time, it preserves the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Manufacturers have the opportunity to interact with the FDA’s experts through several different program options to efficiently address issues that present themselves during the FDA premarket review phase. This feedback from the FDA helps shorten the agreement phase. The company can also expect a prioritized review of its submission. This can have the effect of speeding the product to market with less cost and fewer problems.

How this Works

Pulling an example from the Channelchek library of
videos from NobleCon18, we can use Perimeter
Medical Imaging AI (PYNKF) to understand what a candidate looks like and how it may bring value to the patient, medical provider, and possibly investors.

Perimeter is an early-stage medical device company that expects its flagship product to address unmet cancer treatment needs. Initially, the device is expected to change the way breast cancer is treated and evaluated to improve outcomes and minimize the chance of recurrence or having to reoperate. In order to apply for the FDA designation, Perimeter’s device was indicated for breast cancer. However, the applications are expected to extend well beyond and into other major cancers in the $3.7 billion total market.

This FDA designation makes for a much more clear regulatory pathway. Perimeter meets the first guideline in that its product has unique technology (breakthrough) that is solving problems with a different method on a scalable platform. The procedures are expected to reduce the cost to patients, minimize the need for repeat surgery and be self-funding from the hospitals’ standpoint. This is because about 20 to 25% of cancer patients now need to return for a re-operation that costs approximately $16,000. Hospitals that adopt the Perimeter AI technology could serve patients better and stand to recover their costs while reducing overall patient costs on average.

Take-Away

There are many ways to uncover companies that are “on the move.” Reviewing those the FDA is likely to help along toward a full “go-ahead” is just one of them. For a more detailed look at Perimeter, their unique business model,  and technology, watch the 20-minute video below. For more on understanding the FDA Breakthrough Device Program in order to uncover companies that could change medicine, go to FDA.gov .

To evaluate small and growing companies, explore Channelchek beginning here.

Paul Hoffman

Managing Editor, Channelchek

Suggested Content

Understanding the FDA Medical Device Approval Pathways Helps Investors

The FDA’s CBD and CDP Data Acceleration Program

Perimeter Medical Imaging AI (PYNKF) NobleCon18 Presentation Replay

BioSig Technologies (BSGM) NobleCon18 Presentation Replay

Sources

https://pink.pharmaintelligence.informa.com/PS144170/Half-Of-US-FDAs-Breakthrough-Therapy-Designations-Have-Resulted-In-Approval

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program

Stay up to date. Follow us:

Tonix Pharmaceuticals Announces 1-for-32 Reverse Stock Split

Research, News, and Market Data on Tonix Pharmaceuticals

CHATHAM, N.J., May 16, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it will effect a 1-for-32 reverse stock split of its outstanding common stock. This will be effective for trading purposes as of the commencement of trading on May 17, 2022.

The reverse stock split was previously approved by the Board of Directors of Tonix in accordance with Nevada law, under which no stockholder approval is required, and is intended to increase the per share trading price of Tonix’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market (Rule 5550(a)(1)). Tonix’s common stock will continue to trade on the NASDAQ Capital Market under the symbol “TNXP” and under a new CUSIP number, 890260862. As a result of the reverse stock split, every thirty-two pre-split shares of common stock outstanding will become one share of common stock. The reverse stock split will also proportionately reduce the number of shares of authorized common stock from 1,600 million to 50 million shares. The reverse split will also apply to common stock issuable upon the exercise of Tonix’s outstanding warrants and stock options.

Tonix’s transfer agent, VStock Transfer LLC, which is also acting as the exchange agent for the reverse split, will provide instructions to shareholders regarding the process for exchanging share certificates. Any fractional shares of common stock resulting from the reverse stock split will be rounded up to the nearest whole post-split share and no shareholders will receive cash in lieu of fractional shares.

About Tonix
Pharmaceuticals Holding Corp.¹

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally, TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the second half of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All of Tonix’s
product candidates are investigational new drugs or biologics and have not been
approved for any indication.

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

Forward
Looking Statements

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

Contacts

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

(862) 799-8599

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

(646) 942-5588

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

(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

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

Research, News, and Market Data on Ayala Pharmaceuticals

Interim data from Part A of RINGSIDE study of AL102 expected
mid-2022

REHOVOT, Israel and WILMINGTON, Del., May 16, 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 first-quarter 2022 financial results and provided a corporate update.

“We continued to execute on advancing our clinical programs during the first quarter of 2022,” said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. “Our highest immediate priority is completing Part A of the RINGSIDE study evaluating AL102 in desmoid tumors and we are on target to announce initial interim data around mid-year. This will be followed by initiation of Part B, the randomized portion of the study, immediately thereafter. We are very encouraged by the positive feedback received from investigators in the study and by early signs of anti-tumor activity. Other important milestones expected this year include clinical updates from the ongoing ACCURACY trial of AL101 in adenoid cystic carcinoma and the planned initiation of a Phase 2 trial of AL102 in T-ALL.”

First-quarter 2022 and Recent Business Highlights

• Completed
  enrollment of Part A of the Phase 2/3 RINGSIDE study of AL102 in desmoid
  tumors: 42 patients have been enrolled in Part A of the RINGSIDE study, which is evaluating the safety and tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Three dosing regimens of AL102 are being tested to determine the optimal dose regimen to advance forward.

• Initiated “Window
  of Opportunity” study of AL101 in adenoid cystic carcinoma (ACC): The study, which is being conducted in collaboration with M.D. Anderson Cancer Center and the Adenoid Cystic Carcinoma (ACC) Research Foundation, is focused on determining the effects of AL101 for the treatment of ACC and other cancers. The goals of the study are to better understand the mechanism of AL101, determine the best treatment regimen and generate data for the future development strategy.

Upcoming Milestones

• Initial interim
  data from pivotal Phase 2/3 RINGSIDE trial in desmoid tumors: Ayala expects to report an initial interim data read-out from Part A of Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors around mid-2022. Part B of the study will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression free survival with secondary endpoints including objective response rates, duration of response and patient reported quality of life measures.
• Clinical data from
  Phase 2 ACCURACY trial of AL101 in ACC: The Phase 2 ACCURACY clinical trial is an open-label, single-arm, multi-center study to assess the clinical activity of AL101 using radiographic assessments of patients with R/M ACC demonstrating disease progression within 6 months prior to dosing. A poster at the 2022 ASCO Annual Meeting is expected to feature safety, efficacy, pharmacokinetics, and pharmacodynamics data from the 6mg AL101 cohort in the trial.
• Initiate Phase 2
  clinical trial evaluating AL102 in T-cell acute lymphoblastic leukemia
  (T-ALL): Ayala plans to begin a Phase 2 clinical trial evaluating AL101 in R/R T-ALL in the second half of 2022.

First-Quarter 2022
Financial Results

Cash Position: Cash and cash equivalents were $27.4 million as of March 31, 2021, as compared to $37.3 million at December 31, 2021.

Collaboration Revenue: Collaboration revenue was $0.4 million for the first quarter of 2022, as compared to $1.0 million for the corresponding quarter in 2021.

R&D Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.9 million for the corresponding quarter in 2021.

G&A Expenses: General and administrative expenses were $2.4 million for the first quarter of 2022, compared to $2.3 million for the first quarter of 2021.

Net Loss: Net loss was $10.0 million for the first quarter ended March 31, 2022, resulting in basic and diluted net loss per share of $0.66. This compares with a net loss of $9.6 million for the first quarter ended March 31, 2021, or basic and diluted net loss per share of $0.74.

For further details on the company’s financial results, refer to form Quarterly Report on Form 10-Q for the three months ended March 31, 2022, filed with the SEC on May 16, 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 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, 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.

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, including the 2022 ASCO Annual Meeting, 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; our existing collaboration with Novartis is, and 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 March 31, 2022 filed with the U.S. Securities and Exchange Commission (SEC) on May 16, 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
(Unaudited)
(In thousands, except share and per share amounts)

AYALA
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

(In thousands, except share & per share amounts)

Friday, May 13, 2022

Avivagen Inc. (VIVXF)
The China Road Is Now Open

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.

China Approval. Avivagen’s oxidized carotenoid-based feed additive, OxC-beta, has received approval for use in China. This is a significant accomplishment for Avivagen and should have a positive impact on operating results going forward. China marks the second key market, along with Vietnam, in which OxC-beta has received approval this year. With China and Vietnam approvals and the land-mark eight-year deal with AB Vista for exclusive distribution of OxC-beta for use with poultry, swine, ruminants (dairy and beef), and aquaculture in the U.S., Brazil, and Thailand, we believe Avivagen is on the cusp of significant revenue growth.

Number 1. China is the world’s largest feed market. According to Alltech Agri-Food Outlook, the country will produce over 261 million metric tons of feed in 2022. In addition, the country also experienced the largest increase in feed production by tonnage during 2021, as the country’s feed industry continues to consolidate and modernize. China has been a leader in efforts to reduce antibiotic use with livestock nationwide, in an effort to reduce antimicrobial-resistance in the region, which plays directly into OxC-beta’s strengths….

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, May 13, 2022

Lineage Cell Therapeutics (LCTX)
1Q22 Reported With Clinical Program Review

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.

Lineage Reported 1Q22.  Lineage Cell Therapies reported a loss of $7.1 million or $(0.04) per share.  Revenues included recognition of a portion of the payment from the Roche/Genentech collaboration, with revenue to be recognized each quarter as obligations under the agreement are completed. Total Operating Expenses included a $3.5 million accrual for a legal settlement.  Cash at the end of the quarter was $78.1 million.

Payment Under The OpRegen Collaboration Will Be Amortized Over The Course Of The Agreement.  In December 2021, Lineage made a collaborative agreement with Roche/Genentech for development and commercialization of OpRegen, its RPE cell transplant for age-related macular degeneration (dry AMD).  Lineage received $50 million in signing fees in January, with a portion going to its early collaborators and licensors.  Lineage will be recognizing the fee as revenue as its obligations under the agreement are met.  We expect uneven, milestone-driven recognition over the next several quarters….

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. 

Thursday, May 12, 2022

Cocrystal Pharma (COCP)
Influenza Trial Continues With New Clinical Trials Planned For COVID-19

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.

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.

Cocrystal Reported 1Q22 With Pipeline Updates.  Cocrystal reported a 1Q22 loss of $4.2 million or $(0.04) per share.  The company reviewed its recent clinical progress, including its ongoing Phase 1 study of CC-42344 in influenza and plans to initiate two Phase 1 studies of CC-45205 in COVID-19.  Cash at the end of 1Q22 was $54.8 million.

Influenza programs.  Cocrystal reported Phase 1 data from the CC-42344, its oral PB2 inhibitor for pandemic and seasonal influenza A.  The first two cohorts of healthy adults receiving escalating doses of 100 mg and 200 mg, reported positive safety and pharmacokinetic data.  This Phase 1 dose escalation trial began in March 2022 in Australia, with additional cohorts continuing enrollment.  Additional data is expected during 2022….

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. 

Thursday, May 12, 2022

Onconova Therapeutics (ONTX)
Clinical Trials Progressing As Expected As 1Q22 Reported

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.

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.

Onconova Reported 1Q22.  Onconova reported a loss of $4.1 million or $(0.20) per share and gave updates to its clinical trial progress.  The Phase 1 dose escalation trials for narazaciclib in solid organ tumors continue to treat patients.  The trial in China continues to treat its fifth cohort, while the US trial continues to treat its fourth cohort. Rigosertib trials in non-small cell lung cancer and RDEB continue, with a new Phase 2 rigosertib trial in metastatic melanoma expected to begin during 2Q22.

Narazacliclib Data To Be Presented At ASCO.  An abstract on narazaciclib is scheduled for publication at the American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for June 3 to 7.  We expect the data to include its action on CDK4, CDK6 and inhibition of targets in the pathways of cell proliferation, invasion, metastasis, and drug resistance.  The studies will also show comparisons with the three approved CDK4/6 inhibitor drugs….

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. 

Thursday, May 12, 2022

PDS Biotechnology Corp (PDSB)
Clinical Progress Continues As 1Q22 Results Were Within Expectations

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.

PDS Biotechnology Reported 1Q22.  PDS Biotechnology reported a loss of $8.5 million or $(0.32) per share for 1Q22, consistent with our expectations.  The company also gave updates on its clinical trials and pipeline products, and has two  upcoming poster presentations scheduled to provide clinical data updates from PDS0101 trials in trials for HPV-associated cancers.  Cash on hand at the end of the quarter was $58.9 million.

PDS0101 Has Four Trials For HPV-Associated Cancer.    The lead product is PDS0101, a cancer therapy that uses the Versamune technology to deliver the HPV16 antigen. There are four trials in progress that test the drug in HPV-associated cancers found in any tissue or location, and at different stages of disease, and in combination with other drugs. Two clinical updates are scheduled for the American Society of Clinical Oncology (ASCO) from June 3-7….

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. 

Avivagen Announces Approval in China, the World’s Largest Commercial Feed Production Market

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ May 12, 2022 /– Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that Avivagen’s oxidized carotenoid-based feed additive product has received approval for use in China.

“Core to our success to date has been the strong inroads we’ve made across key Asian feed markets, and we’re thrilled to now have regulatory approval to bring OxC-betaTM to feed producers and commercial operations across China,” says Kym Anthony, Chief Executive Officer, Avivagen. “Having direct access to the world’s largest feed market at a time of continued growth has the potential to be transformative for Avivagen and help drive greater adoption and growth in Asia and worldwide.”

The approval comes as a result of Avivagen working closely with COFCO Biotech, a state-owned multi-billion-dollar company, and follows successful trials across numerous species.

China was ranked as the number one feed-producing country in the world in the 2022 Alltech Agri-Food Outlook, producing 261.4mmt in 2021. The country also experienced the largest increase in feed production by tonnage during the year, as the country’s feed industry continues to consolidate and modernize . The country has been a leader in efforts to reduce antibiotic use with livestock nationwide, in an effort to reduce antimicrobial-resistance in the region.

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

About OxC-beta™
Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking
Statements
This
news release includes certain forward-looking statements that are based upon
the current expectations of management. Forward-looking statements involve
risks and uncertainties associated with the business of Avivagen Inc. and the
environment in which the business operates. Any statements contained herein
that are not statements of historical facts may be deemed to be
forward-looking, including those identified by the expressions “aim”,
“anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”,
“if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”,
“potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and
similar expressions.

Statements set out in
this news release relating to the potential impacts on Avivagen from this
regulatory approval, future growth and prospects for Avivagen and the
possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds
as growth promoters are forward-looking statements. These forward-looking
statements are subject to a number of risks and uncertainties that could cause
actual results or events to differ materially from current expectations. For
instance, Avivagen’s products may not gain market acceptance or regulatory
approval in new jurisdictions or for new applications and may not be widely
accepted as a replacement for antibiotics as growth promoters in livestock
feeds due to many factors, many of which are outside of Avivagen’s control.
Readers are referred to the risk factors associated with the business of
Avivagen set out in Avivagen’s most recent management’s discussion and analysis
of financial condition available at www.SEDAR.com. Except as required by law,
Avivagen assumes no obligation to update the forward-looking statements, or to
update the reasons why actual results could differ from those reflected in the
forward-looking statements.

Neither TSX Venture
Exchange nor its Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for the adequacy
or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164

Website: www.avivagen.com
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.