On May 13, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported first quarter 2021 results and provided a corporate update (Press release, aTyr Pharma, MAY 13, 2021, View Source [SID1234580043]).

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"During the first quarter, we remained focused on advancing our lead therapeutic candidate, ATYR1923. We are tracking towards the readout from our Phase 1b/2a proof-of-concept study in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, which is expected in the third quarter of this year," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "We have key mechanistic insights regarding ATYR1923’s anti-inflammatory effects in patients from our Phase 2 study in COVID-19 related respiratory complications. This clinical data is consistent with what we have seen preclinically for key anti-inflammatory cytokines that are implicated in sarcoidosis and other ILD."

"Furthermore, we generated additional preclinical data for ATYR2810, our lead anti-Neuropilin-2 (NRP2) antibody and IND candidate, including research presented at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating tumor inhibitory effects in triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC), as both a single agent and in combination with chemotherapy and the targeted agent bevacizumab. Our manufacturing agreement with Lonza for the production of this antibody reflects our commitment to this program. We are off to a strong start in 2021 and look forward to building upon this progress throughout the year."

First Quarter 2021 and Subsequent Period Highlights

Progressed its Phase 1b/2a multiple-ascending dose, placebo-controlled study of ATYR1923 in 37 patients with pulmonary sarcoidosis. Data is expected in the third quarter of this year.

Reported positive results from its Phase 2 study of ATYR1923 in COVID-19 patients with severe respiratory complications, which provided proof-of-mechanism for ATYR1923. The study met its primary safety endpoint and demonstrated signals of clinical activity. Biomarker data showed that ATYR1923 reduced levels of several inflammatory cytokines and chemokines, including those that are implicated in sarcoidosis and other ILD, which is consistent with findings from animal models.

Appointed leading sarcoidosis advocate Andrea Wilson as a patient advisor to the company. Ms. Wilson, Co-Founder and former member of the Board of Directors for the Foundation for Sarcoidosis Research (FSR), will advise the company on patient strategies related to its clinical program for ATYR1923 in pulmonary sarcoidosis.

Participated in a Virtual Town Hall on Steroids and Sarcoidosis in collaboration with the FSR to discuss the burden of steroid treatment for patients with sarcoidosis and the need for new treatments.

Presented two posters at the AACR (Free AACR Whitepaper) Annual Meeting related to preclinical research for ATYR2810 in conjunction with the company’s scientific advisor Dr. Arthur Mercurio and his lab at the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School. In models of TNBC, ATYR2810 administered in combination with widely used anti-cancer therapeutics, including chemotherapy or the targeted VEGF antibody bevacizumab, increased the anti-tumor effects of each agent. ATYR2810 also down-regulated epithelial-mesenchymal transition genes, which may be a mechanism that mediates its anti-tumor effects. In animal models of NSCLC, ATYR2810 inhibited tumor growth when administered both as a single agent and in combination with chemotherapy.

Entered into an agreement with Lonza, a leading contract development and manufacturing organization, for the manufacture of ATYR2810 to support the progression of ATYR2810 to clinical stage development.

Pangu BioPharma, the company’s Hong Kong subsidiary, together with the Hong Kong University of Science and Technology, achieved the milestones of the first year of a two-year project funded in part by the Hong Kong Government’s Innovation and Technology Commission to develop a high-throughput platform for the development of bispecific antibodies targeting NRP2.

Promoted Leslie Nangle, Ph.D., to Vice President, Research. Dr. Nangle will serve as a member of the company’s executive leadership team, managing research and scientific operations.
First Quarter 2021 Financial Results

Total revenues were $0 and $8.1 million for the three months ended March 31, 2021 and 2020, respectively. Revenues for the three months ended March 31, 2020 consisted primarily of license and collaboration agreement revenues under company’s license agreement with Kyorin. Research and development expenses were $4.5 million and $3.6 million for the three months ended March 31, 2021 and 2020, respectively. The increase was due primarily to manufacturing costs related to ATYR1923, increased research and development expenses related to ATYR2810 and increased expenses related to the research program between Pangu BioPharma, Hong Kong University and the Government of the Hong Kong Special Administration Region. General and administrative expenses were consistent between periods at $2.7 million and $2.6 million for the three months ended March 31, 2021 and 2020, respectively.

During the first quarter of 2021, the company raised gross proceeds of $9.9 million through its at-the-market offering program with H.C. Wainwright & Co., LLC and $15.3 million through its common stock purchase agreement with Aspire Capital Fund, LLC. As of March 31, 2021, aTyr had $50.6 million in cash, cash equivalents and investments.

The company expects its expenses to continue to increase in 2021 as research and development of ATYR1923 and ATYR2810 progress.

Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 6867948. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About ATYR1923

aTyr is developing ATYR1923 as a potential therapeutic for patients with inflammatory lung disease. ATYR1923, a fusion protein comprised of the immuno-modulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory disease states. aTyr recently completed enrollment in a proof-of-concept Phase 1b/2a trial evaluating ATYR1923 in patients with pulmonary sarcoidosis. This Phase 1b/2a study is a multi-ascending dose, placebo-controlled, first-in-patient study of ATYR1923 that has been designed to evaluate the safety, tolerability, steroid sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923. In response to the COVID-19 pandemic, aTyr completed a Phase 2 clinical trial with ATYR1923 in COVID-19 patients with severe respiratory complications. This Phase 2 study was a randomized, double blind, placebo-controlled study that was designed to evaluate the safety and preliminary efficacy of a single dose of ATYR1923.

On May 13, 2021 Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported first quarter 2021 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAY 13, 2021, View Source [SID1234579924]).

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Recent Events & Highlights

Provided update on the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3.0 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 17 clinical sites in the United States
Published Phase 2b ORCA-1 safety, efficacy, and compliance results in Nicotine and Tobacco Research
Announced the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to Achieve’s Board of Directors
Published RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix (varenicline) in Addiction
"In the first quarter, we’ve seen great interest and increased momentum in the ORCA-2 trial and look forward to completing enrollment by the middle of the year," commented John Bencich, Chief Executive Officer of Achieve. "We will continue to focus our efforts on execution of the Phase 3, ensuring all required NDA-enabling activities remain on track, and furthering our discussions with potential strategic partners to prepare for cytisinicline commercialization."

Phase 3 ORCA-2 Trial
The Phase 3 ORCA-2 trial continues to enroll at 17 clinical sites in the United States. Approximately 750 adult smokers will be randomized to one of three study arms to determine the efficacy and safety of cytisinicline administered for either six or twelve weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the six and twelve-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. The trial is expected to complete enrollment by the middle of 2021.

ORCA-1 Results Published in Nicotine and Tobacco Research
Results from the Phase 2b ORCA-1 trial were published in the scientific journal Nicotine and Tobacco Research. ORCA-1 evaluated the efficacy and safety of cytisinicline across various dosing and administration schedules in 254 smokers in the United States. The publication reported that subjects treated with cytisinicline, regardless of dose or schedule, had statistically significantly higher (p<0.001) end of treatment abstinence rates compared to those treated with placebo. Participants in the 3.0 mg cytisinicline 3 times daily (TID) arm, were five times more likely to quit smoking than those in the placebo arm (OR of 5.04, 95% CI: 1.42, 22.32, p<0.001). Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported.

Appointment of Drs. Martell and Jacobs to Board of Directors
Achieve announced the appointment of two new members to Achieve’s Board of Directors, Dr. Bridget Martell and Dr. Cindy Jacobs. Dr. Martell is board certified in both Internal and Addiction Medicine and is an experienced executive leader in the pharmaceutical industry. Dr. Jacobs serves as Achieve’s President and Chief Medical Officer, and in addition to her Board of Directors duties, will continue in her current role leading Achieve’s regulatory and clinical development efforts for cytisinicline.

RAUORA Trial Results Published in Addiction
Results from the Phase 3 RAUORA trial were published in the scientific journal Addiction. RAUORA evaluated the effectiveness and safety of cytisinicline compared to Chantix (varenicline) as a smoking cessation aid in 679 indigenous New Zealanders (Māori). The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint, and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), and a 55% improvement in quit rates at six months in favor of cytisinicline when compared to Chantix. A Bayesian analysis of the primary efficacy outcome is ongoing. Additionally, statistically significant fewer overall AEs were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001) including a significantly lower rate of nausea when compared to subjects on Chantix.

Financial Results
As of March 31, 2021, the company’s cash, cash equivalents, and restricted cash was $29.7 million. Total operating expenses for the three months ended March 31, 2021 was $8.0 million. Total net loss for the three months ended March 31, 2021 was $8.0 million.

As of May 13, 2021, Achieve had 6,164,360 shares outstanding.

Conference Call Details
Achieve will host a conference call at 4:30 pm Eastern time today, Thursday, May 13, 2021. To access the webcast, log on to the investor relations page of the Achieve website at View Source Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6096445. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On May 13, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported financial results for the first quarter ended March 31, 2021, and provided an update on its clinical and preclinical programs (Press release, Synlogic, MAY 13, 2021, View Source [SID1234579940]).

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"We are building momentum and executing on our plans to demonstrate the clinical potential of our Synthetic Biotic platform in 2021," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "With proof of mechanism established in our two lead metabolic programs and a strengthened balance sheet, we are well positioned to deliver proof of concept readouts for both SYNB1618 in Phenylketonuria (PKU) and SYNB8802 in Enteric Hyperoxaluria later this year."

Quarter Highlights

The Metabolic Portfolio:

Continued development of Synthetic Biotic medicines for the treatment of PKU.

Enrollment of the SynPheny-1 Phase 2 trial is on track with data expected in the second half of 2021. SynPheny-1 is designed to evaluate plasma phenylalanine (Phe) lowering of a solid oral formulation of SYNB1618 in adult PKU patients who do not benefit from, or do not tolerate, existing therapies such as KUVAN (sapropterin dihydrochloride) or PALYNZIQ (pegvaliase-pqpz).

Data on the solid oral formulation of SYNB1618 was presented at the American College of Medical Genetics meeting in April 2021.

Continued development of SYNB1934, an evolved Synthetic Biotic medicine in the PKU portfolio, which may provide increased Phe lowering efficacy, lower dosing, or both, relative to SYNB1618. SYNB1934 is progressing through IND enabling studies.
SYNB1618 and SYNB1934 are orally administered Synthetic Biotic medicines being developed as potential treatments for PKU. They are intended to address the needs of patients of all age groups through the consumption of Phe in the gastrointestinal (GI) tract, which has the potential to lower blood Phe levels and enable the consumption of more natural protein in the diet.

Demonstration of proof of mechanism of SYNB8802, a Synthetic Biotic medicine being developed for the treatment of Enteric Hyperoxaluria.

In an ongoing Phase 1 study, SYNB8802 demonstrated safety and urinary oxalate lowering in healthy volunteers consuming a high oxalate diet.

Urinary oxalate lowering by SYNB8802 was dose-dependent. The 3e11 dose was chosen for further evaluation in the second part of the Phase 1 study in patients with Enteric Hyperoxaluria. This dose was well-tolerated and resulted in a 28.6% (90% CI: -42.4 to -11.6) reduction in urinary oxalate as measured by a change from baseline compared to placebo.

The second part of the Phase 1 study is continuing with the evaluation of SYNB8802 in patients with Enteric Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery. Data from the second part of the study is anticipated in the second half of 2021.
SYNB8802 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for Enteric Hyperoxaluria. Enteric Hyperoxaluria results in dangerously high urinary oxalate levels causing progressive kidney damage, kidney stone formation, and nephrocalcinosis. Enteric Hyperoxaluria has no approved treatment options. SYNB8802 is designed to consume oxalate in the GI tract to prevent the increased absorption of oxalate in patients with Enteric Hyperoxaluria.

The Immunomodulation Portfolio:

Progression of SYNB1891 in combination arm dosing with PDL1 checkpoint inhibitor in an ongoing Phase 1 clinical study in patients with advanced solid tumors or lymphoma.

SYNB1891 is currently being evaluated in a Phase 1 study that has two parts:

Part A is a monotherapy arm that has enrolled six dose cohorts to date. The maximum tolerated dose has not been reached and dose escalation continues.

Part B is a combination arm and dosing has been completed in two cohorts to date with SYNB1891 and the PD-L1 checkpoint inhibitor atezolizumab to establish a recommended Phase 2 dose for the combination regimen.

Data from this study was presented at the American Association of Cancer Research meeting in April 2021.
SYNB1891 is an intratumorally administered Synthetic Biotic medicine engineered to act as a dual innate and adaptive immune activator. Data from both arms of the Phase 1 study will continue to be reported over the course of 2021, with mature combination therapy data expected by the end of the year.

Corporate Update:

Synlogic strengthens Balance Sheet.

On April 20th, subsequent to the end of the first quarter, Synlogic completed an underwritten public offering of 11.5 million shares. Net proceeds from the offering were $32.6 million, bringing Synlogic’s cash balance to approximately $127 million.
Synlogic advances strategic partnerships and expands manufacturing capabilities.

Synlogic plans to expand its manufacturing footprint by more than 50% to support continued advancement of its pipeline and late-phase development of its lead metabolic programs.

Synlogic will invest to expand fermentation and lyophilization capacity to support scale up efforts, enabling potential late stage development of SYNB1618 and SYNB8802.

Construction and build out anticipated to take place in the second half of 2021.

Synlogic and the MIT Voigt Lab are collaborating with the Air Force Research Laboratory (AFRL) and the Department of Defense (DoD) to engineer novel investigational medicines to address battle fatigue.

Synlogic and Ginkgo Bioworks continue to advance their long-term strategic platform collaboration that provides expanded synthetic biology capabilities to Synlogic with multiple undisclosed metabolic programs now in preclinical stages of development.
First Quarter 2021 Financial Results

As of March 31, 2021, Synlogic had cash, cash equivalents and short-term investments of $94.4 million.

For the three months ended March 31, 2021, Synlogic reported a consolidated net loss of $15.0 million, or $0.36 per share, compared to a consolidated net loss of $15.8 million, or $0.46 per share, for the corresponding period in 2020.

Research and development expenses were $11.2 million for the three months ended March 31, 2021 compared to $12.7 million for the corresponding period in 2020.

General and administrative expenses for the three months ended March 31, 2021 were $3.9 million compared to $3.8 million for the corresponding period in 2020.

There was no revenue for the three months ended March 31, 2021 compared to $0.1 million for the corresponding period in 2020. Revenue for the prior period was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of Inflammatory Bowel Disease which was terminated in May 2020.

Financial Outlook

Based upon its current operating plan, balance sheet as of March 31st, 2021 and proceeds from the recent public offering in April 2021, Synlogic expects to have sufficient cash to be able to fund the base operating plan into the second half of 2023.

Conference Call & Webcast Information

Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, May 13, 2021. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 2526209. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

On May 13, 2021 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported on its results for the first quarter ended March 31, 2021 (Press release, CytRx, MAY 13, 2021, View Source [SID1234579957]). In addition, CytRx highlighted developments pertaining to its agreements with Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme") and ImmunityBio, Inc. (NASDAQ:IBRX) ("ImmunityBio") as well as Centurion Biopharma. The Company’s 10-Q was filed on May 13, 2021.

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Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, stated:

"CytRx continues to execute on its strategic plan to cut costs, maintain a stable capital position, and nimbly manage a portfolio of high-potential licensing agreements and strategic assets. We are very excited about the quarters ahead now that Orphazyme is preparing for prospective regulatory approvals for arimoclomol in the treatment of Niemann-Pick disease Type C and ImmunityBio is expanding its scope of clinical trials involving aldoxorubicin to treat advanced pancreatic cancer. We also continue to pursue viable partnership opportunities that can bring Centurion Biopharma’s platform into the clinical testing phase."

First Quarter Financial Overview

CytRx concluded the quarter ended March 31, 2021 with cash on hand of approximately $9.3 million, which management believes is sufficient to fund ongoing operations for the foreseeable future.
The Company recorded a net loss of $1.3 million for the quarter ended March 31, 2021, compared to a net loss of $1.2 million for the same period in 2020.
General and administrative expenses were $1.3 million for the quarter, compared with $1.2 million for the same period in 2020.
Based on a current projection of expenditures, the Company’s monthly cash burn rate is estimated to be approximately $430,000 per month. This number is largely unchanged from the close of the fourth quarter of fiscal year 2020.
Year-to-Date Highlights

Orphazyme Highlights

CytRx’s agreement with Orphazyme can deliver up to approximately $100 million in potential milestone payments and future single digit royalties paid on sales of arimoclomol.
CytRx is positioned to receive up to $10 million in potential milestone payments in 2021 based on possible U.S. and European approvals for arimoclomol to treat Niemann-Pick disease Type C ("NPC").
During the past quarter, multiple analysts issued notes that conveyed optimism regarding Orphazyme’s ability to obtain potential regulatory approvals for arimoclomol in the treatment of NPC.
Recently, Orphazyme announced the appointment of Christophe Bourdon as its new Chief Executive Officer, effective as of April 1, 2021.
As reported by Orphazyme, Mr. Bourdon has successfully launched a variety of products in demanding environments, making him an ideal individual to lead Orphazyme as it prepares for a potential commercial launch of arimoclomol.
He joins from Amgen, Inc., where he held the role of Senior Vice President, General Manager for the U.S. Oncology Business. He was leading commercialization planning and execution for several products.
Previously, Mr. Bourdon was Senior Vice President of Europe, Middle East, Africa and Canada at Alexion Pharmaceuticals Inc. as the company launched two breakthrough ultra-orphan drugs and negotiated payor access across the United Kingdom, Germany, France, Italy and Canada. He holds an MBA from IMD business school (Switzerland) and a BA from ISG (France).
Recently, Orphazyme also announced MIPLYFFA as the global brand name for arimoclomol and expanded its NPC Early Access Program in the U.S. and opened similar programs in France and Germany.
ImmunityBio Highlights

In January 2021, ImmunityBio and NantKwest announced that their ongoing Phase 2 clinical trials of a novel combination immunotherapy – which includes aldoxorubicin – for locally advanced or metastatic pancreatic cancer had produced early indications of increased survival rates for patients with no other approved treatment options.
Interim results of the three-cohort trials, known as QUILT 88, showed median survival rates of more than double that of the historic rate in patients with advanced metastatic pancreatic cancer (for which no other FDA approved treatment exists).
Recently, ImmunityBio and NantKwest announced the closing of their merger, with ImmunityBio now trading on the NASDAQ under ticker symbol IBRX.
Additional Corporate Highlights

In February 2021, CytRx announced that it is now a part of the LD Micro Index (the "Index").
The Index is designed to give the most accurate representation of the intraday activity of microcap stocks in North America.
In March 2021, CytRx participated in the H.C. Wainwright Global Life Sciences Conference and the Virtual 33rd Annual ROTH Conference.
Mr. Kriegsman’s presentation may be accessed on the News and Events page of our website.
With respect to Centurion Biopharma, Mr. Kriegsman and Lead Director Louis Ignarro, PhD have continued pursuing third-party financing and strategic partnership opportunities to advance clinical testing for the platform’s high-potential assets. Discussions with prospective partners are ongoing. There are no formal partnership updates to report at this time.
CytRx maintains federal and state net operating loss ("NOL") carryforwards of $327.6 million and $252.6 million, respectively, available to offset against future taxable income. Of this amount, $258.3 million of federal NOLs and $252.6 million of state NOL’s are unrestricted.

On May 13, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that it will discuss its financial results for the quarter ended March 31, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 13, 2021, View Source [SID1234579982]).

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Recent Business Highlights:

National Cancer Institute to present interim efficacy and safety data of PDS0101 Phase 2 clinical trial in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting on June 7, 2021. This trial is evaluating PDS0101 with two clinical stage immunotherapies from EMD Serono, a first in class bifunctional checkpoint inhibitor Bintrafusp Alfa (M7824) and an antibody conjugated cytokine M9241 (NHS-IL12), in patients with all types of advanced HPV-associated cancers, whose cancer has returned or spread after treatment.
COVID-19 consortium received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund up to approximately US$60 million to support the clinical development and commercialization of a Versamune-based COVID-19 vaccine by Farmacore in Brazil.
"We look forward to the presentation of preliminary efficacy and safety data from the National Cancer Institute (NCI)-led Phase 2 combination study of PDS0101 at the ASCO (Free ASCO Whitepaper) conference in early June. ASCO (Free ASCO Whitepaper) provides an important opportunity to present the potential of PDS0101 and the Versamune platform in oncology to the research and medical community," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech, "The presentation of the human clinical efficacy data at ASCO (Free ASCO Whitepaper) is an important milestone both for PDS0101 and our entire Versamune-based oncology pipeline."

First Quarter 2021 Financial Results
PDS Biotech reported 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 compared to a net loss of approximately $4.0 million, or $0.39 per basic share and diluted share, for the three months ended March 31, 2020.

Research and development (R&D) expenses decreased 28% to approximately $1.4 million for the three months ended March 31, 2021 from approximately $2.0 million for the three months ended March 31, 2020. The decrease of approximately $0.6 million in 2021 was primarily attributable to a decrease of $0.3 million in professional services and $0.3 million in clinical studies.

General and administrative expenses decreased 21% to approximately $1.6 million for the three months ended March 31, 2021 from approximately $2.1 million for the three months ended March 31, 2020. The decrease of approximately $0.5 million is primarily attributable to a decrease in professional services of approximately $0.7 million which includes legal fees of approximately $0.2 million, offset by an increase of approximately $0.2 million in personnel costs.

Total operating expenses decreased 24% to approximately $3.0 million for the three months ended March 31, 2021 from approximately $4.0 million for the three months ended March 31, 2020.

PDS Biotech’s cash balance as of March 31, 2021 was approximately $25.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Thursday, May 13, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotech. Participants can also access the conference call via webcast on the investor relations page of the Company’s corporate website (link).

The event will be archived in the investor relations section of PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13716518.