Lineage Cell Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update

• Reported RG6501 (OpRegen^®)
  Clinical Results at 2022 ARVO Meeting; Outer Retinal Structure Improvement
  Observed in Five Dry AMD Patients
• Expanded Pipeline with Two New Cell Therapy
  Development Programs; Auditory Neurons and Photoreceptors
• Announced Completion of Enrollment in VAC2
  Phase 1 NSCLC Study by Cancer Research UK
• Cash and Cash Equivalents of $78.1
  Million as of March 31, 2022

CARLSBAD, Calif.–(BUSINESS WIRE)–May 12, 2022– Lineage Cell
Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the first quarter of 2022. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2022 financial and operating results and to provide a business update.

“The first quarter of this year was highlighted by the rapid launch of new cell therapy programs in hearing loss and vision disorders and conducting tech transfer activities to support our alliance with Roche and Genentech for our dry AMD program,” stated Brian M. Culley, Lineage CEO. “Our broad strategic plan is to position Lineage as a leader in regenerative medicine through the transplant of specific cell types to treat significant unmet medical needs. As part of that plan, we have expanded our cell therapy pipeline to five distinct programs, each offering an opportunity to impact various diseases. We believe our ability to, in just a matter of months, advance from a product concept to generating new intellectual property to support the manufacture of specific cell types, is not only illustrative of the power and efficiency of our platform but also a competitive advantage compared to others in this field. Looking forward, our focus is on clinical and regulatory execution across our portfolio. We are working to advance OPC1 and VAC2 into their next phases of clinical testing, in spinal cord injury and oncology, respectively, as well as advancing our auditory neuron and photoreceptor programs through preclinical development and toward pre-IND meetings with FDA. We believe the combination of our disciplined use of capital and current balance sheet will support multiple years of progress, during which we anticipate reaching significant events with each of our clinical and preclinical programs.”

Recent
milestones include:

• Reported RG6501 (OpRegen) Phase 1/2a clinical results at 2022 Association for Research in Vision and Ophthalmology, Inc. (ARVO) annual meeting: 12-month primary endpoint data support the potential for OpRegen to slow, stop or reverse disease progression in geographic atrophy (GA) secondary to age-related macular degeneration (AMD); outer retinal structure improvement observed in five dry AMD patients;
• Announced expansion of pipeline with addition of new cell therapy program: allogeneic photoreceptor neural cell (PNC1) transplants for the treatment of diseases which may lead to blindness; dynamic culturing process offers path to clinical- and industrial-scale production of photoreceptors; data generated further demonstrated that a single cell suspension of photoreceptor precursor cells has the potential to survive and mature post-transplantation in a rodent model of retinal degeneration;
• Announced completion of patient enrollment in Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer (NSCLC) by Cancer Research UK; Lineage has now assumed responsibility for further clinical development of VAC2 and any future development opportunities derived from the VAC platform; and
• Announced expansion of pipeline with addition of new cell therapy program: auditory neuronal cells (ANP1) for the treatment of hearing loss; intellectual property filed covering composition and methods for generating auditory neuronal progenitors.

Some of
the events and milestones anticipated by Lineage in the rest of 2022 include:

• Investigational New Drug (“IND”) amendment submission to enable clinical performance and safety testing of a novel parenchymal spinal delivery system for OPC1, in Q4 2022;
• FDA interaction to discuss recent manufacturing improvements made to OPC1, anticipated in Q4 2022;
• Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer study; anticipated from CRUK in 2H 2022;
• An IND submission for VAC2 to support US-based clinical testing in 2H 2022;
• Preclinical activities for both ANP1 and PNC1 programs; ongoing throughout 2022;
• Additional OPC1 publications, including full clinical study results from the SCiStar clinical study and an MRI findings paper; anticipated in 2H 2022;
• Continued development of a cell-based therapeutic for glioblastoma with our strategic partner, Immunomic Therapeutics; ongoing throughout 2022;
• Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens; ongoing throughout 2022;
• Evaluation of new funded partnership opportunities and/or expansion of existing collaborations; ongoing throughout 2022; and
• Continued participation in numerous investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.

Balance
Sheet Highlights

Cash and cash equivalents totaled $78.1 million as of March 31, 2022.

First
Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three months ended March 31, 2022 were $5.2 million, an increase of $4.8 million as compared to $0.4 million for the same period in 2021. The increase was primarily related to licensing fees recognized from deferred revenues in connection with the $50.0 million upfront licensing payment received in the first quarter of 2022 from Roche.

Operating
Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A”) expenses. Total operating expenses for the three months ended March 31, 2022 were $11.5 million, an increase of $4.2 million as compared to $7.3 million for the same period in 2021, primarily attributable to a $3.5 million non-recurring expense related to the potential settlement of the litigation concerning our 2019 acquisition of Asterias (“Asterias Litigation”).

R&D
Expenses: R&D expenses for the three months ended March 31, 2022 were $3.0 million, a decrease of $0.4 million as compared to $3.4 million for the same period in 2021. The decrease was driven by $0.7 million in lower expenses for the OPC1 program, partially offset by $0.2 million and $0.1 million in higher expenses to support the VAC program and OpRegen related expenses to support the Roche Collaboration, respectively. Another $0.1 million of the offsetting increase was related to initial costs to support the new auditory neuron cell therapy program.

G&A
Expenses: G&A expenses for the three months ended March 31, 2022 were $8.5 million, an increase of $4.6 million as compared to $3.9 million for the same period in 2021. The increase was primarily attributable to the $3.5 million non-recurring expense related to the potential settlement of the Asterias Litigation, and $0.5 million in share-based compensation.

Loss
from Operations: Loss from operations for the three months ended March 31, 2022 was $6.4 million, a decrease of $0.7 million as compared to $7.1 million for the same period in 2021.

Other
Income/(Expenses), Net: Other income (expenses), net for the three months ended March 31, 2022 reflected other expense, net of ($0.7) million, compared to other income, net of $5.6 million for the same period in 2021. The net change of ($6.3) million was primarily related to the gain on sale of marketable securities in the prior year.

Net
Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2022 was $7.1 million, or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $1.4 million, or $0.01 per share (basic and diluted), for the same period in 2021.

Conference
Call and Webcast

Interested parties may access today’s conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 20, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1875641.

About Lineage
Cell Therapeutics, Inc.

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

Forward-Looking
Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the collaboration and license agreement with Roche and Genentech, activities expected to occur thereunder, the potential to receive upfront, milestone and royalty consideration payable to Lineage thereunder; the potential benefits of treatment with OpRegen; the power and efficiency of Lineage’s platform and its competitive advantages; the ability of Lineage’s resources to support multiple years of progress; the potential future achievements of Lineage’s clinical and preclinical programs; the timing of potential FDA interactions, and of anticipated clinical trials and clinical data updates; and plans and expectations of Lineage’s products in development. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that competing alternative therapies may adversely impact the commercial potential of OpRegen; the risk that Roche and Genentech may not be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; the risk that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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

Solebury
Trout IR Justin Frantz (
jfrantz@soleburytrout.com )
(617) 221-9100

Russo
Partners – Media Relations Nic Johnson or David Schull Nic.johnson@russopartnersllc.com

David.schull@russopartnersllc.com

(212) 845-4242

Source:
Lineage Cell Therapeutics, Inc.

BioSig Technologies, Inc. Issues Shareholder Letter with Corporate Update on Recent Achievements

News and Market Data on BioSig Technologies

Westport, CT, May 11, 2022 (GLOBE NEWSWIRE) —

• To date,
  Company’s FDA 510(k) cleared PURE EP(TM) system has completed over
  2,200 patient cases with 75 physicians at 17 hospitals across the United
  States

• The Company adds
  new executives to accelerate sustained commercial momentum developing
  a national installed base of the PURE EP systems

BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today issued a Letter to Shareholders providing highlights on the Company’s recent developments and updates.

Recent Company highlights include:

• The growth of its PURE EP(TM) System from its first-in-human surgical procedures in 2019 to completing over 2,200 patient cases with 75 physicians at 17 hospitals across the United States.

• BioSig strengthened its management with a new commercialization team led by industry veteran Gray Fleming, Chief Commercial Officer, who spent 18 years with St. Jude Medical.

• The rollout of a two-phase approach for purchase, lease, or rental options for PURE EP and a new go-to-market strategy for commercialization.

• Launch of its new NOVA-5 software at the Heart Rhythm Society Convention on April 29, 2022. NOVA-5 offers greater customization and smarter workflows with the aim of further driving clinical adoption.

• Recapped the successful completion of its first blinded clinical trial in 2021 and published those results in a leading peer-reviewed journal. Titled “Evaluation
  of a novel cardiac signal processing system for electrophysiology
  procedures: The PURE EP 2.0 study,” the study was conducted at three leading medical centers across the United States: St. David’s Medical Center (TCAI), Mayo Clinic, and Massachusetts General Hospital.

• A snapshot into Biosig’s financing included no debt and positioning in a global electrophysiology device market which, according to Grand View Research, could reach $12.2 billion by 2026 and expand at a growth rate of approximately 12%.

“We have made great strides on multiple fronts and felt it was an important time to communicate to our shareholders the strength of our business and the initiatives we are executing that have served as the foundation for our growth trajectory,” said Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. “We strongly believe in the value of our technology and are now supported with both peer-reviewed clinical data and third-party economic data, proving the value of what we have built. We are eager to continue working on our new commercialization strategy, seeing the impact of our new NOVA-5 software has, and all our initiatives we are undertaking to drive shareholder value and expand PURE EP.”

To view the Company’s Shareholder Letter in its entirety, please visit: Presentations :: BioSig
Technologies, Inc. (BSGM).

The PURE EP(TM) is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2,200 patient cases with the PURE EP(TM) System.

Clinical data acquired by the PURE EP(TM) System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(TM) signals over conventional sources.

About
BioSig Technologies
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 electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking
Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social, and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise.

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

Research, News, and Market Data on Cocrystal Pharma

• Reported favorable preliminary data from the two initial cohorts in its Phase 1 study with CC-42344 for the treatment of pandemic and seasonal influenza A
• Announced a collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the Company’s COVID-19 protease inhibitors
• Initiated scale-up synthesis and process chemistry development in preparation to begin a Phase 1 study with oral and inhalation inhibitors for the treatment of COVID-19

BOTHELL, Wash., May 11, 2022 (GLOBE NEWSWIRE)
— Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the three months ended March 31, 2022, and provides updates on its antiviral pipeline, upcoming milestones and business activities.

“I am pleased to be reporting progress and important developments with our antiviral programs for the treatment of influenza and COVID-19,” said Sam Lee, Ph.D., President and co-interim CEO of Cocrystal. “With our oral PB2 inhibitor, CC-42344 for the treatment of pandemic and seasonal influenza A, we announced favorable preliminary safety and pharmacokinetic data from the first two cohorts of healthy adults in our dose-escalation Phase 1 study underway in Australia. Enrollment in the remaining cohorts is ongoing.

“We are also advancing toward the start of a Phase 1 study with our novel, broad-spectrum inhalation SARS-CoV-2 3CL (main) protease inhibitor CDI-45205 for the treatment of COVID-19. Scale-up synthesis and process chemistry development are ongoing as we prepare data to support an IND application,” Dr. Lee added.

“Among our goals this year is to complete the 
CC-42344 Phase 1 influenza study and to initiate two Phase 1 COVID-19 studies with CDI-45205 and a novel, broad-spectrum orally administered protease inhibitor designed and developed using our proprietary structure-based drug discovery platform technology,” said James Martin, CFO and co-interim CEO. “We are well positioned to execute on these goals in the current challenging economic environment, given our clean capital structure and a cash balance we believe is sufficient to fund planned operations through 2023.”

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

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

• Intranasal/Pulmonary Protease
  Inhibitor CDI-45205
• CDI-45205 is our novel SARS-CoV-2 3CL (main) protease inhibitor being developed as a potential treatment for COVID-19 and its variants via intranasal/pulmonary delivery.
• We have initiated scale-up synthesis and process chemistry development with CDI-45205 as we assemble data to support an IND application with the goal of progressing to a first-in-human clinical trial in 2022.
• We received guidance from the FDA regarding further preclinical and clinical development of CDI-45205 that provides a clearer pathway for the Phase 1 study we plan to initiate in 2022, as well as directives for designing a subsequent Phase 2 study.
• CDI-45205 and several analogs showed potent in
  vitro activity against the SARS-CoV-2 Omicron (Botswana and South Africa/BA.1), Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South Africa/B.1.351) variants, surpassing the activity observed with the original wild-type (Wuhan) strain.
• CDI-45205 demonstrated good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
• CDI-45205 was among the broad-spectrum viral protease inhibitors obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in 2020. We believe the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
• Oral Protease Inhibitors

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

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

Influenza Programs
Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in outbreaks of disease mainly during the winter months. The global market for influenza therapeutics is expected to reach nearly $6.5 billion annually by 2022, according to a report published by BCC Research in May 2018.

• Pandemic and Seasonal Influenza
  A
• A novel PB2 inhibitor, CC-42344 has shown excellent antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains resistant to Tamiflu^® and Xofluza
  ^®. CC-42344 also has favorable pharmacokinetic and drug-resistance profiles.
• In March 2022 we initiated enrollment in our Phase 1 study with orally administrated antiviral CC-42344 in healthy adults. This randomized, double-controlled, dose-escalating study is designed to assess the safety, tolerability and pharmacokinetics of 
  CC-42344.
• In April 2022 we announced preliminary data from our Phase 1 study with CC-42344, demonstrating a favorable safety and pharmacokinetic profile in the first two cohorts administered single-ascending doses of 100 mg and 200 mg. We expect to report full results from the Phase 1 clinical study in 2022.

• Pandemic and Seasonal Influenza
  A/B program
• In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
• In January 2021 we announced completion of all research obligations under the agreement. Merck is now solely responsible for further preclinical and clinical development of compounds discovered under this agreement.
• Merck continues development activities with the compounds discovered under this agreement.

Norovirus Program

• We are developing certain proprietary broad-spectrum protease and replication inhibitors for the treatment of norovirus infections.
• We plan to select preclinical leads in the 2022-2023 timeframe.
• Norovirus is a global public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.

Hepatitis C Program

• We are seeking a partner to advance the development of CC-31244 following successful completion of a Phase 2a study. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV).
• HCV is a viral infection of the liver that causes both acute and chronic infection. The 2017 World Health Organization Global Hepatitis Report estimates that 71 million people worldwide have chronic HCV infections.

First Quarter 2022 Financial Results
Research and development (R&D) expenses for the first quarter of 2022 were $2.9 million compared with $1.6 million for the first quarter of 2021, with the increase primarily related to COVID-19 and influenza programs. The Company expects R&D expenses to increase during 2022 due to the advancement of its influenza A program into the clinic and progress with preclinical COVID-19 programs toward clinical development. General and administrative expenses for the first quarter of 2022 were $1.3 million compared with $1.2 million for the first quarter of 2021, with the increase primarily due to insurance costs and reduced by the conclusion of certain previously reported legal matters.

The net loss for the first quarter of 2022 was $4.2 million, or $0.04 per share, compared with a net loss for the first quarter of 2021 of $2.7 million, or $0.04 per share.

The Company reported unrestricted cash of $54.8 million as of March 31, 2022, compared with $58.7 million as of December 31, 2021. Net cash used in operating activities for the first quarter of 2022 was $3.9 million. The Company reported working capital of $53.8 million as of March 31, 2022.

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

Cautionary Note Regarding Forward-Looking
Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our goals of initiating two Phase 1 studies for our COVID-19 programs in 2022, our expectations of reporting data from the Phase 1 clinical study of our Influenza A product candidate later in 2022, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the global market for influenza therapeutics, our attempts to discover replication inhibitors, our development of antiviral treatments for norovirus, our expectations concerning R&D expenses, the expected sufficiency of our cash balance to fund our planned operations and our liquidity. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from the impact of the COVID-19 pandemic and the Ukraine war on our Company, our collaboration partners, and on the national and global economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including and adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Clinical Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the impact of inflation and Federal Reserve interest rate increases in response thereto on the economy, the ability of our current CRO to recruit volunteers for, and to proceed with, clinical studies, possible delays resulting from future lockdowns in Australia, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

jcain@lhai.com

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

Jabraham@jqapartners.com

PDS Biotech Provides Business Update and Reports First Quarter 2022 Financial Results

Research, News, and Market Data on PDS Biotech

Company to host
conference call and webcast today, May 11, 2022, at 8:00 AM EDT

FLORHAM PARK, N.J., May 11, 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, will discuss its financial results for the quarter ended March 31, 2022, and provide a business update on its conference call today.

“2022 is shaping up to be an incredibly productive year for PDS Biotech,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. “As we continue to make significant clinical progress on our lead oncology candidate, PDS0101, we’re looking ahead to presentations of preliminary data from our two most advanced Phase 2 clinical trials at this year’s ASCO meeting in early June. We believe ASCO’s selection of the preliminary data from both trials for presentation at the June meeting is a testament to the quality of work being done by our team and our partners, as well as the potential demonstrated by PDS0101 in treating advanced HPV-associated cancers. We look forward to sharing these efficacy and safety data in the near term. In addition, we continue to leverage our proprietary platforms to advance our pre-clinical pipeline into clinical studies, focused on a variety of cancer targets and infectious diseases. Lastly, due to our partnering model and our financial discipline, we finished the quarter with a strong cash balance which we project to fund our current operations into 2024.”

Recent Business Highlights:

• Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7 in Chicago:
• The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
• The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2 clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.
• In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.
• Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.

First Quarter 2022
Financial Results
PDS Biotech reported a net loss of approximately $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022 compared to a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021.

Research and development (R&D) expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributable to an increase of $1.8 million in manufacturing services and quality costs, $1.04 million in clinical study and regulatory costs, $0.8 million in personnel costs and $0.06 million in facilities.

General and administrative expenses increased to approximately $3.3 million for the three months ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributable to an increase of $1.0 million in personnel costs, $0.6 million in legal fees and $0.1 in marketing expenses.

Total operating expenses increased to approximately $8.5 million for the three months ended March 31, 2022 from approximately $3.0 million for the three months ended March 31, 2021 for the reasons described above. 

PDS Biotech’s cash balance as of March 31, 2022 was approximately $58.9 million.

Conference Call and
Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, May 11, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13728184. To access the webcast, please use the following link PDS Biotech Earnings Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months. 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of 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.

KEYTRUDA^® is a registered trademark of Merck Sharp and Dohme Corp. a subsidiary of Meck & Co., Inc. Kenilworth, NJ USA.

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

PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
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Comprehensive Loss
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PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
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