Image Credit: Karolina Grabowska (Pexels)

When Stocks in a Sector are Trading for Less than Their Cash on Hand, it May be Time to Bargain Hunt

If you’re shopping for a wallet and one comes complete with $100 worth of cash inside and is priced at $60, would you think there is value to this purchase? A situation similar to this has evolved in many biotech stocks. Their balance sheet cash and cash equivalents exceed their market value. Whether the broader market recognizes the value in these companies and pushes prices up, or large-pharma, currently flush with cash, swoops in to own more than their purchase price, remains to be seen. But, the value many of these firms offer is more than just their R&D, patents, or product pipeline. It is also measurable assets in excess of where the market currently values the company.

Background

The Nasdaq Small-Cap Biotech Index did well beginning March 20, 2020.  At the time the race was on for a vaccine for the novel coronavirus and attention was being paid to these smaller, more nimble firms. The index rose from a low on March 20 of 2,667 to reach a high of 7,052 on February 5, 2021, just after vaccines began being distributed. That’s a 164% increase in 10 months. During that period, if you were a biotech firm, raising capital was easier than it had been in years.

From February 2021, the index began a long slide and is actually cheaper than it had been before the initial run-up. The index is now at 2,437 (May 25).

Valuations

Number crunchers at Noble Capital Markets created a list of all Nasdaq-listed biotech companies with Market Caps below $160 million. They then netted the market cap from the corporate cash position on each. The results are surprising. The list of companies is 267 long, and more than half (135), held cash and equivalents that exceeded their market value.

While a full evaluation of any company, including its cash burn rate, and future prospects is necessary, by this one measure, there are a number of potential positive outcomes for these seemingly undervalued companies.  

First, investors could begin to recognize value. As institutional and retail investors begin to become aware of the value in this sector, they may begin allocating more to small-cap biotechs.

The second is that big pharma is flush with cash. Their cumulative position is now over $300 billion. The entire group of companies with more cash than market cap has a combined market cap of $6.5 billion (values shown in green on the linked
spreadsheet). (Note: the linked spreadsheet is available exclusively for Channelchek members. Registration is free)

Third, the FDA has more free time. The pandemic put the arm of the FDA that reviews and approves new drugs and vaccines under more pressure than normal. Those resources are presumably more available now to review and approve non-pandemic-related applications.

Fourth medicine and therapies are largely recession-proof. Keeping money out of the stock market exposes investors to the erosion of an 8% inflation rate. Money in the market exposes investors to stocks that are still, by many measures overvalued. The biotech sector is not guaranteed to be revived anytime soon, but the case that it is overvalued is a tough one to make in light of the assets vs. price of these corporations.

Examples

While there are 267 companies that met the criterion, 135 had cash exceeding market value. Below are three examples as a demonstration of what is included on the spreadsheet:

 Eledon (ELDN) has a market value of 57% of its cash position. In actual dollar amounts, it has a market cap of $43.6 million, and current cash assets of $76.7 million. ELDN is a clinical-stage pharmaceutical company focusing on developing medicines for patients living with autoimmune diseases and requiring an organ or cell-based transplant.

ELDN is currently trading at $3.11 per share.

Tonix Pharmaceuticals (TNXP) has a market value of $39.9 million. According to its March 31, 2022 10-Q, Tonix has $140.4 million in cash and equivalents. This causes cash to be 350% of market value. Tonix is a clinical-stage biopharmaceutical company. It focuses on discovering, acquiring, developing, and licensing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering.

TNXP is currently trading at $1.94 per share.

Sigilon Therapeutics (SGTX)  has a market value of $25.8 million. The company’s cash position is $107.1 million which is 314% of the market value. Sigilon is a clinical-stage biopharmaceutical company. It’s developing a new class of therapeutics and functional cures for patients with chronic diseases by providing stable and durable levels of therapeutic molecules.

SGTX is currently trading at $0.74 per share.

 

Take-Away

For a brief moment in 2020, oil prices were so low that oil futures were negative – you could actually get paid to own an oil contract. Some months after this situation, the entire energy sector became the best performing industry. It still is. Small-cap biotech may now be experiencing its own oversold conditions.

An investment in some companies is backed by more cash and other assets than it would cost the investor or acquirer. There are four companies on the linked list trading at a level where the net cash is four times the market cap.

The biotech sector appears ripe for attention by bottom-pickers.

Paul Hoffman

Managing Editor, Channelchek

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Sources

https://channelchek.com/news-channel/Nasdaq_Listed_Biotech_Companies_Under_$160M_Market_Cap

www.channelchek.com

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Tuesday, May 24, 2022

Tonix Pharmaceuticals (TNXP)
Monkeypox Cases Attract Attention To The Tonix Vaccine Programs

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

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

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

Cases Of Monkeypox Infection Have Been Reported in US.  Monkeypox infections have recently been reported in the US and around the globe.  Although rarely seen outside of parts of Africa, an estimated 190 cases have been reported in 16 countries outside of territories where it is normally found.  Although there is little chance of widespread infection in the US, the outbreak has drawn attention to companies developing vaccines for monkeypox, smallpox, and biodefense programs.

Tonix Has A Proprietary Vaccine Program For Monkeypox and Smallpox.  Although smallpox has been eradicated, it has been identified as one of several viruses that could be used for bioterrorism. There is an approved smallpox vaccine (Jynneos, from Bavarian Nordic), although it has safety and tolerability concerns including pain, swelling, severe allergic reactions.  TNX-801 is in development to be an effective and better tolerated smallpox vaccine….

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. 

Ocugen Announces New Cell Therapy Program Following FDA Regenerative Medicine Advanced Therapy (RMAT) Recognition

Research, News, and Market Data on Ocugen

NeoCart^® (autologous chondrocyte-derived neocartilage) receives regulatory designation intended to help expedite development of new regenerative medicines

MALVERN, Pa., May 24, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, today announced that it is diversifying its innovative pipeline by introducing a Phase 3, cell therapy platform technology called NeoCart^® (autologous chondrocyte-derived neocartilage). Recently, the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to NeoCart^® for the repair of full-thickness lesions of the knee cartilage in adults.

NeoCart^® is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes – the cells responsible for maintaining cartilage health – derived from the patient on a unique scaffold. NeoCart^® has the potential to accelerate healing and reduce pain by rebuilding a patient’s damaged knee cartilage. It treats pain at the source, creating a similar, functional joint surface as it was before the injury. Ultimately, the goal is to prevent a patient’s progression to osteoarthritis. NeoCart^® was acquired as a part of Ocugen’s reverse merger with the original developer of the therapy, Histogenics, in 2019.

“We’re excited that NeoCart^® has received this RMAT designation, an important regulatory milestone, especially as we view this product as an enabling technology in cell and regenerative therapy for orthopedic indications. Our next step will be working with the FDA to construct the Phase 3 program to bring this innovation to this emerging treatment area,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder, Ocugen, Inc. “People living with articular cartilage lesions literally have holes in their knees that are extremely difficult to heal, and without proper treatment, they’re at high risk of getting osteoarthritis. We believe that NeoCart^® offers the potential for an innovative new option where treatments in this area are still limited and results are not optimal.”

The Regenerative Medicine Advanced Therapy (RMAT) designation is part of the 21^st Century Cures Act. The program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition. Receiving an RMAT designation offers sponsor companies all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA. Ocugen is working with the FDA to finalize the Phase 3 protocols necessary to advance the clinical development program of NeoCart^® required for eventual market authorization.

        

Articular cartilage lesions are a serious and often mobility-limiting condition. When the cartilage is healthy, it makes movement easy, allowing the bones to glide over each other with very little friction, but it can be damaged by injury or normal wear and tear. Cartilage that is damaged can, over time, cause pain and reduce one’s ability to function. Small articular lesions have a limited capacity to self-repair, and full thickness injuries have no ability to naturally heal. There are no blood vessels or nerves to support healing, and as cartilage matures, chondrocytes have limited ability to replicate. Untreated damage eventually can lead to osteoarthritis.

Details of the NeoCart^® development program will be shared at a future date.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995, which are subject to
risks and uncertainties. Ocugen may, in some cases, use terms such as
“predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should,” or other words that convey uncertainty of future events or outcomes
to identify these forward-looking statements. Such forward-looking statements
include, but are not limited to, statements about Ocugen’s intention to work
with the U.S. Food and Drug Administration (“FDA”) to finalize the Phase 3
protocols necessary to advance the clinical development program of NeoCart^® (autologous chondrocyte-derived neocartilage) required for
eventual market authorization. Such statements are subject to numerous
risks and uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements, including, among other
things, the uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, ability to timely enroll clinical
trial participants, commencement and/or completion dates for clinical trials,
regulatory submission dates, regulatory approval dates and/or launch dates,
Ocugen’s ability to utilize accelerated FDA review designations, such as the
Regenerative Medicine Advanced Therapy designation, which does not guarantee an
accelerated pathway or timeline for regulatory approval of any such product
candidates, including NeoCart^® (autologous
chondrocyte-derived neocartilage), or increase the likelihood of any such approvals,
and the other risks and uncertainties more fully described in our periodic
filings with the Securities and Exchange Commission (the “SEC”), including the
risk factors described in the section entitled “Risk Factors” in the quarterly
and annual reports that we file with the SEC. Any forward-looking statements
that we make in this press release speak only as of the date of this press
release. Except as required by law, we assume no obligation to update
forward-looking statements contained in this press release whether as a result
of new information, future events or otherwise, after the date of this press
release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
ken.inchausti@ocugen.com

For investor-related inquiries: IR@Ocugen.com

Monday, May 23, 2022

BioSig Technologies (BSGM)
1Q Short Of Expectations But Signal Strength Improving

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.

Company filed 1Q 2022. Last week BioSig released its 10-Q for 1Q 2022.  The company recorded no PURE EP unit sales in the quarter, below our expectations of three units.  The Company received strong signals from facilities, but contracts were not signed by the end of the quarter. We expect agreements in the second quarter.  Total expenses, reduced by overhead reduction, ran higher than our expected levels as the company added back staff as part of its commercial buildout and official June 1^st rollout. 

ATM agreement filed. In preparation for the commercial buildout for PURE EP, and general corporate purposes, BioSig also filed an At-The-Market (ATM) agreement for up to $10 million in common stock. We had expected a capital raise in the second half of 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. 

Ocugen Announces FDA Removes Clinical Hold on Phase 2/3 Clinical Trial for COVAXIN™ (BBV152)

Research, News, and Market Data on Ocugen

DOSING TO RESUME
IMMEDIATELY

MALVERN, Pa., May 23, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Company’s Phase 2/3 clinical trial, OCU-002, for COVAXIN™ (BBV152).

“We’re extremely pleased that we can proceed with our clinical trials for COVAXIN™, our whole virus inactivated COVID-19 vaccine candidate. The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc. “Thank you to our clinical trial partners and site collaborators for their ongoing support. Ocugen will now work with study sites to fully resume this clinical development program immediately.”

People interested in learning about how to participate in this clinical
trial (NCT05258669) can visit the clinical trials section of Ocugen.com.

About
COVAXIN™ (BBV152)
COVAXIN™ (BBVI52) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 350 million doses having been administered to adults outside the U.S., COVAXIN™ is currently approved for adults in India and authorized under emergency use in 25 countries. Applications for emergency use authorization are pending in more than 60 other countries. COVAXIN™ is listed by the World Health Organization (WHO) as authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™. The trade name, COVAXIN™, has not been evaluated by the FDA.

About
Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary
Note on Forward-Looking Statements

This press release contains forward-looking statements
within the meaning of The Private Securities Litigation Reform Act of 1995,
which are subject to risks and uncertainties. Ocugen may, in some cases, use
terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should,” or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements. Such forward-looking
statements include, but are not limited to, statements about Ocugen’s intention
to begin dosing patients in its Phase 2/3 immune-bridging and broadening trial for COVAXIN™ in the coming weeks, and are
subject to risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements, including, among
other things, the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, ability to timely enroll
clinical trial participants, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates and/or launch
dates; the risk that Health Canada does not accept its New Drug Submission
(“NDS”) for COVAXIN™ or that Ocugen may not be able to adequately resolve the
deficiencies noted by Health Canada with respect to its NDS, for which Ocugen
has provided responses that are currently under review by Health Canada; the
risk that Ocugen may not be able to successfully commercialize COVAXIN™ in
Mexico for adults over the age of 18 pursuant to Ocugen’s agreement with Bharat
Biotech and the risk that Ocugen does not obtain emergency pediatric use for
COVAXIN™ in Mexico for children between two and 18 years of age on a timely
basis, if at all; the risk that Ocugen’s Phase 2/3 immuno-bridging and
broadening clinical trial for COVAXIN™ is not completed on a timely basis, if
at all; or that the U.S. Food and Drug Administration places a new clinical
hold on such trial in the future, for any reason; risks associated with
preliminary and interim data, including the possibility of unfavorable new
clinical trial data and further analyses of existing clinical trial data; the
risk that the results of in-vitro studies will not be duplicated in human
clinical trials; the risk that clinical trial data is subject to differing
interpretations and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory authorities;
whether and when data from Bharat Biotech’s clinical trials will be published
in scientific journal publications and, if so, when and with what
modifications; whether the data and results from the preclinical and clinical
studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will
be accepted by regulatory authorities or otherwise sufficient to support
Ocugen’s submissions for regulatory approvals or authorizations in the United
States, Canada or Mexico; the size, scope, timing and outcome of any additional
clinical trials or studies that Ocugen may be required to conduct to support
regulatory approvals or authorizations; any additional chemistry,
manufacturing, and controls information that Ocugen may be required to submit
to regulatory authorities ; whether and when a Biologics License Application
for COVAXIN™ will be submitted to or approved by the FDA; the risk that Ocugen
may not be able to successfully negotiate and execute definitive transaction
agreements for the acquisition of the manufacturing site on acceptable terms,
if at all, and the ultimate terms and timing for closing of the transactions
contemplated thereby; the risk that Ocugen will not be able to successfully
close the acquisition of the manufacturing site; risks associated with the
planned development and refurbishing of the manufacturing site, including that
the expected costs for such development may be greater than currently
contemplated or that the planned development may take longer than expected or
fail to be completed on a timely basis, if at all; and the risk that Ocugen
will not be able to scale production for such manufacturing site to adequately
support manufacturing of its product candidates or the other products that may
in the future be manufactured at such manufacturing site; whether developments
with respect to the COVID-19 pandemic will affect the regulatory pathway
available for vaccines in the United States, Canada, Mexico or other
jurisdictions; market demand for COVAXIN™ in the United States, Canada or
Mexico; decisions by the regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could affect the
availability or commercial potential of COVAXIN™ in the United States, Canada
or Mexico, including development of products or therapies by other companies. Such
 statements are subject to numerous
important factors, risks and uncertainties that may cause actual events or
results to differ materially from our current expectations, such as market and
other conditions. These and other risks and uncertainties are more fully
described in our periodic filings with the Securities and Exchange Commission
(the “SEC”), including the risk factors described in the section entitled “Risk
Factors” in the quarterly and annual reports that we file with the SEC. Any
forward-looking statements that we make in this press release speak only as of
the date of this press release. Except as required by law, we assume no
obligation to update forward-looking statements contained in this press release
whether as a result of new information, future events or otherwise, after the
date of this press release.

Ocugen
Contact:
Ken Inchausti
Head, Investor Relations & Communications
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

 

Image Credit: Frequency Therapeutics

Reversing Hearing Loss with Regenerative Therapy

Zach Winn | MIT
News Office

Most of us know someone affected by hearing loss, but we may not fully appreciate the hardships that lack of hearing can bring. Hearing loss can lead to isolation, frustration, and a debilitating ringing in the ears known as tinnitus. It is also closely correlated with dementia.

The biotechnology company Frequency Therapeutics (FREQ) is seeking to reverse hearing loss — not with hearing aids or implants, but with a new kind of regenerative therapy. The company uses small molecules to program progenitor cells, a descendant of stem cells in the inner ear, to create the tiny hair cells that allow us to hear.

Hair cells die off when exposed to loud noises or drugs including certain chemotherapies and antibiotics. Frequency’s drug candidate is designed to be injected into the ear to regenerate these cells within the cochlea. In clinical trials, the company has already improved people’s hearing as measured by tests of speech perception — the ability to understand speech and recognize words.

“Speech perception is the No. 1 goal for improving hearing and the No. 1 need we hear from patients,” says Frequency co-founder and Chief Scientific Officer Chris Loose PhD ’07.

In Frequency’s first clinical study, the company saw statistically significant improvements in speech perception in some participants after a single injection, with some responses lasting nearly two years.

The company has dosed more than 200 patients to date and has seen clinically meaningful improvements in speech perception in three separate clinical studies. Another study failed to show improvements in hearing compared to the placebo group, but the company attributes that result to flaws in the design of the trial.

Now Frequency is recruiting for a 124-person trial from which preliminary results should be available early next year.

The company’s founders, including Loose, MIT Institute Professor Robert Langer, CEO David Lucchino MBA ’06, Senior Vice President Will McLean PhD ’14, and Harvard-MIT Health Sciences and Technology affiliate faculty member Jeff Karp, are already gratified to have been able to help people improve their hearing through the trials. They also believe they’re making important contributions toward solving a problem that impacts more than 40 million people in the U.S. and hundreds of millions more around the world.

“Hearing is such an important sense; it connects people to their community and cultivates a sense of identity,” says Karp, who is also a professor of anesthesia at Brigham and Women’s Hospital. “I think the potential to restore hearing will have enormous impact on society.”

From the Lab to Patients

In 2005, Lucchino was an MBA student in the MIT Sloan School of Management and Loose was a PhD candidate in chemical engineering at MIT. Langer introduced the two aspiring entrepreneurs, and they started working on what would become Semprus BioSciences, a medical device company that won the MIT $100K Entrepreneurship Competition and later sold at a deal valued at up to $80 million.

“MIT has such a wonderful environment of people interested in new ventures that come from different backgrounds, so we’re able to assemble teams of people with diverse skills quickly,” Loose says.

Eight years after playing matchmaker for Lucchino and Loose, Langer began working with Karp to study the lining of the human gut, which regenerates itself almost every day.

With MIT postdoc Xiaolei Yin, who is now a scientific advisor to Frequency, the researchers discovered that the same molecules that control the gut’s stem cells are also used by a close descendant of stem cells called progenitor cells. Like stem cells, progenitor cells can turn into more specialized cells in the body.

“Every time we make an advance, we take a step back and ask how this could be even bigger,” Karp says. “It’s easy to be incremental, but how do we take what we learned and make a massive difference?”

Progenitor cells reside in the inner ear and generate hair cells when humans are in utero, but they become dormant before birth and never again turn into more specialized cells such as the hair cells of the cochlea. Humans are born with about 15,000 hair cells in each cochlea. Such cells die over time and never regenerate.

In 2012, the research team was able to use small molecules to turn progenitor cells into thousands of hair cells in the lab. Karp says no one had ever produced such a large number of hair cells before. He still remembers looking at the results while visiting his family, including his father, who wears a hearing aid.

“I looked at them and said, ‘I think we have a breakthrough,’” Karp says. “That’s the first and only time I’ve used that phrase.”

The advance was enough for Langer to play matchmaker again and bring Loose and Lucchino into the fold to start Frequency Therapeutics.

The founders believe their approach — injecting small molecules into the inner ear to turn progenitor cells into more specialized cells — offers advantages over gene therapies, which may rely on extracting a patient’s cells, programming them in a lab, and then delivering them to the right area.

“Tissues throughout your body contain progenitor cells, so we see a huge range of applications,” Loose says. “We believe this is the future of regenerative medicine.”

Advancing Regenerative Medicine

Frequency’s founders have been thrilled to watch their lab work mature into an impactful drug candidate in clinical trials.

“Some of these people [in the trials] couldn’t hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying,” Langer says. “It’s so meaningful to them. Obviously more needs to be done, but just the fact that you can help a small group of people is really impressive to me.”

Karp believes Frequency’s work will advance researchers’ ability to manipulate progenitor cells and lead to new treatments down the line.

“I wouldn’t be surprised if in 10 or 15 years, because of the resources being put into this space and the incredible science being done, we can get to the point where [reversing hearing loss] would be similar to Lasik surgery, where you’re in and out in an hour or two and you can completely restore your vision,” Karp says. “I think we’ll see the same thing for hearing loss.”

The company is also developing a drug for multiple sclerosis (MS), a disease in which the immune system attacks the myelin in the brain and central nervous system. Progenitor cells already turn into the myelin-producing cells in the brain, but not fast enough to keep up with losses sustained by MS patients. Most MS therapies focus on suppressing the immune system rather than generating myelin.

Early versions of that drug candidate have shown dramatic increases in myelin in mouse studies. The company expects to file an investigational new drug application for MS with the FDA next year.

“When we were conceiving of this project, we meant for it to be a platform that could be broadly applicable to multiple tissues. Now we’re moving into the remyelination work, and to me it’s the tip of the iceberg in terms of what can be done by taking small molecules and controlling local biology,” Karp says.

For now, Karp is already thrilled with Frequency’s progress, which hit home the last time he was in Frequency’s office and met a speaker who shared her experience with hearing loss.

“You always hope your work will have an impact, but it can take a long time for that to happen,” Karp says. “It’s been an incredible experience working with the team to bring this forward. There are already people in the trials whose hearing has been dramatically improved and their lives have been changed. That impacts interactions with family and friends. It’s wonderful to be a part of.”

 

Reprinted with permission of MIT News (http://news.mit.edu/)

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Wednesday, May 18, 2022

Baudax Bio (BXRX)
Offering Raise Helps Cash Needs Near-Term

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.

Stock and Warrants.  Yesterday Baudax Bio announced a registered direct at-the-market offering to institutional investors for the sale and issuance of 1,646,091 shares of common stock at a price of $1.215 per share, raising close to $2 million. In conjunction, the investors, in a private placement will be issued 1,646,091 private placement warrants at an exercise price of $1.09 per share.

Timing was unexpected.  The Company had previously issued common shares in a public offering in late February 2022, so the cash need was not great at the present time.  We had expected capital raises later in 2022, even with the reduced cash burn outlook….

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. 

Baudax Bio Announces $2.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Research, News, and Market Data on Baudax Bio

MALVERN, Pa., May 17, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for acute care settings, today announced that it has entered into a definitive agreement with certain institutional investors for the issuance and sale of 1,646,091 shares of its common stock, at a purchase price of $1.215 per share, in a registered direct offering priced at-the-market under Nasdaq rules. The Company also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to 1,646.091 shares of its common stock.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.09 per share, will be exercisable immediately upon issuance and will expire five years from the date of issuance. The closing of the offering is expected to occur on or about May 19, 2022, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $2.0 million before deducting placement agent fees and other offering expenses. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

The shares of common stock described above (but not the warrants or shares of common stock underlying the warrants) are being offered by the Company in a registered direct offering pursuant to an effective “shelf” registration statement on Form S-3 (Registration No. 333-253117), including an accompanying base prospectus previously filed with the Securities and Exchange Commission (the “SEC”) on February 16, 2021 which became effective on September 2, 2021. The offering of such shares of common stock is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 1002, by phone at (212) 856-5711 or e-mail at 
placements@hcwco.com.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About
Baudax Bio

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.

Forward
Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding the expected completion and use of proceeds of the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site, including statements relating to the expected completion and use of proceeds of the registered direct offering, and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:

Investor Relations Contact:
Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com 

Tonix Pharmaceuticals Extends Research Collaboration with the University of Alberta to Develop Antiviral Drugs Against SARS-CoV-2

Research, News, and Market Data on Tonix Pharmaceuticals

Tonix Exercises Option to License Antiviral Technology Platform

NEW YORK, May 18, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has entered into a license agreement and extended a research collaboration with the University of Alberta, a leading Canadian research university, focused on identifying and testing broad-spectrum antiviral drugs against future variants of SARS-CoV-2 and other emerging viruses.

“We are excited to extend our collaboration with Tom Hobman, Ph.D., Professor, Department of Cell Biology, University of Alberta, and to have exercised an option to license the technology,” said Seth Lederman, M.D., President and Chief Executive Officer. “Antiviral therapeutics are needed to mitigate the effects of SARS-CoV-2 and future coronavirus outbreaks, and Professor Hobman’s work is designed to facilitate the identification and testing of novel broad-spectrum antiviral drugs. SARS-CoV-2 is very sensitive to interferon (IFN) treatment and therefore, drugs that upregulate IFN production and/or signaling may reduce virus replication.”

“The research collaboration is focused on the development and testing of Wnt/?-Catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses,” said Professor Tom Hobman. “During the first phase of the sponsored research, we showed that small molecules that inhibit this pathway also decrease replication of SARS-CoV-2 genomic RNA and dramatically reduce infectious viral titers. Drugs in this class seem to work by inducing peroxisome biogenesis, which in turn enhance production of Type I and III IFNs when cells detect viral genetic material. Peroxisomes are key antiviral signaling platforms that are important for IFN induction and antiviral defense. We believe this work has the potential to lead to drugs that limit the spread and disease burden of SARS-CoV-2 and other RNA viruses, which will support the goal of pandemic preparedness.”

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 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

Baudax Bio to Present at the H.C. Wainwright Annual Global Life Sciences Conference

Research, News, and Market Data on Baudax Bio

MALVERN, Pa., May 18, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on innovative products for acute care settings, today announced that Gerri Henwood, the Company’s President and Chief Executive Officer, will present at the H.C. Wainwright Annual Global Life Sciences Conference, taking place in Miami, Florida on Wednesday, May 25, 2022, at 1:30 p.m. Eastern Time.

A webcast of the presentation will be available on the “Events” page within the investors section of the Baudax Bio website at 
https://www.baudaxbio.com/news-and-investors. The webcast will be archived on the company’s website for 90 days following the event.

About Baudax Bio

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.

CONTACT:

Investor Relations Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Cocrystal Pharma to Present at the H.C. Wainwright Global Investment Conference

Research, News, and Market Data on Cocrystal Pharma

BOTHELL, Wash., May 18, 2022 (GLOBE NEWSWIRE)
— Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that James Martin, Chief Financial Officer and co-interim Chief Executive Officer, will present a Company overview at the H.C. Wainwright Global Investment Conference on Wednesday, May 25, 2022 at 10:00 a.m. Eastern Time. The hybrid in-person and virtual conference is being held at the Fontainebleau Miami Beach Hotel in Miami Beach.

A webcast of the presentation will be available live on the IR Calendar of the Company website and will be archived for 90 days following the event.

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

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

jcain@lhai.com

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

Jabraham@jqapartners.com

PDS Biotechnology Appoints Seasoned Business Development Executive Sanjay Zaveri as Senior Vice President, Business Development

Research, News, and Market Data on PDS Biotech

Reports An Inducement Grant
Under NASDAQ Listing Rule 5635(c)(4)

FLORHAM PARK, N.J., May 18, 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 Sanjay Zaveri has joined PDS Biotech as Senior Vice President, Business Development. Mr. Zaveri has extensive partnering experience having completed licenses and acquisitions between leading biotechnology and pharmaceutical companies. As PDS Biotech’s Senior Vice President of Business Development, he is responsible for business strategy, and managing the Company’s potential licensing and partnering opportunities in support of PDS Biotech’s pipeline. Prior to joining PDS Biotech he held the position of Head of Business Development and Corporate Strategy at Strongbridge Biopharma, leading their business development, licensing and partnership strategy prior to its acquisition by Xeris Pharmaceuticals. Before Strongbridge, he held biotechnology consulting positions with Guidehouse, formerly Navigant Consulting, and IQVIA. Mr. Zaveri holds a Bachelor of Science in Pharmacy from Massachusetts College of Pharmacy and a Master of Business Administration from the University of Minnesota, Carlson School of Management.

“We are pleased to have Sanjay join the PDS Biotech management team. He brings a great depth of experience successfully conducting business development in the life science industry,” said PDS Biotech Chief Executive Officer, Frank Bedu-Addo. “As we demonstrate proof-of-concept for PDS0101 and our Versamune® and Infectimune™ platforms, Sanjay’s proven ability to execute a sound business development strategy will be an asset to PDS Biotech.”

Additionally, PDS Biotech granted Mr. Zaveri nonstatutory stock options to purchase 150,000 shares of PDS’s common stock as a material inducement to his employment with PDS Biotech in accordance with Nasdaq Listing Rule 5635(c)(4) and PDS Biotech’s 2019 Inducement Plan, as amended. PDS Biotech’s 2019 Inducement Plan, as amended, provides for the granting of equity awards to new employees of PDS Biotech. The stock option award has an exercise price of $5.35, the closing price of PDS Biotech’s common stock on May 17, 2022. The option award vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date (May 17, 2023) and then monthly over the following 36 months, subject to continued employment with the company through the applicable vesting dates.

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.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™-based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

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.