On November 10, 2021 Recursion (Nasdaq : RXRX), a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering, reported business updates and financial results for its third quarter ending September 30, 2021 (Press release, Recursion Pharmaceuticals, NOV 10, 2021, View Source [SID1234595223]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In Q3, our team made progress towards our vision to industrialize drug discovery. We are now harvesting the efforts of the past few years to build a map of human cellular biology through the continued refinement and increased usage of our inference-based approach to drug discovery. With the power of our Recursion Map illuminating new and exciting relationships in biology, we are now deeply focused on extending our chemistry capabilities to significantly improve, scale and speed up new chemical entity development to address the plethora of novel biological relationships we are discovering," said Recursion Co-Founder & CEO Chris Gibson, Ph.D. "In addition, our rapidly growing development team is preparing for our four clinical-stage programs to initiate Phase 2 or Phase 2/3 studies in the first half of 2022, including two of the programs that we expect will enroll their first patients in early 2022. To facilitate our broad ambition, we continue to rapidly grow our workforce while nurturing Recursion’s culture and community."

Recursion finished the third quarter of 2021 with a portfolio of 4 clinical stage programs, 4 preclinical programs, 7 late discovery programs, and 41 early discovery programs. Additionally, Recursion continued scaling the total number of executed phenomic experiments to approximately 95 million, the size of its proprietary data universe to over 11 petabytes, and the number of biological inferences to approximately 200 billion. Data have been generated on the Recursion OS across 38 human cell types, an in-house chemical library of over 717 thousand compounds, and an in silico library of 12 billion small molecules, by a growing team of more than 330 Recursionauts that is balanced between life scientists and computational and technical experts.

Summary of Business Highlights

Clinical Programs
Neurofibromatosis type 2 (NF2) (REC-2282): In early October we received Fast Track Designation for REC-2282 from the FDA for the potential treatment of NF2 meningiomas. We plan to initiate a parallel group, two stage, Phase 2/3, randomized, multicenter study in early 2022.
Cerebral cavernous malformation (CCM) (REC-994): We plan to initiate a Phase 2, double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this candidate in early 2022.
Familial adenomatous polyposis (FAP) (REC-4881): In September we received Orphan Drug Designation for REC-4881 from the FDA for the potential treatment of Familial Adenomatous Polyposis. We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and efficacy in the first half of 2022.
GM2 gangliosidosis (REC-3599): We plan to initiate a Phase 2 study of this candidate in the first half of 2022.
Preclinical Programs
Clostridium difficile colitis (REC-3964): We expanded our medicinal chemistry team and digital chemistry tools and made progress in IND-enabling studies for REC-3964, which is the most advanced New Chemical Entity developed by the Recursion OS.
Bayer AG Partnership: We continue to advance our collaboration with Bayer to discover small molecule drug candidates with the potential to treat fibrotic diseases. We have multiple programs progressing simultaneously with our partner.
Recursion OS
Biological Contexts: We advanced our capabilities to model diseases in multiple biological contexts, including new types of biological perturbations beyond CRISPR-based knockouts, complex cell type onboarding, and organoid model systems. Moreover, we made progress on multiple maps in iPSC-derived neural cell types.
Mechanisms of Action: We improved our computational methods to identify mechanisms of action and used this technology to increase our ability to screen out compounds with potentially toxic effects for multiple programs earlier than is possible with traditional approaches. We believe that such methods will better enable us to advance the most promising novel chemical compounds through discovery.
Transcriptomics Validation: We made significant improvements to our transcriptomics protocols to enable increases in throughput. Additionally, we have been optimizing our ability to use transcriptomics signatures for compound characterization.
Facilities and Manufacturing: We continued to make progress in expanding our current headquarters and creating a chemistry, manufacturing and controls (CMC) site in Salt Lake City. These spaces are designed with flexibility in mind to enable next-generation automated workflows and instruments for compound, tissue culture, and biobank management to further industrialize the drug discovery and development process.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $578.9 million as of September 30, 2021.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.5 million for the third quarter of 2021, compared to $1.0 million for the third quarter of 2020. The increase was due to revenue recognized from our collaboration with Bayer.
Research and Development Expenses: Research and development expenses were $33.2 million for the third quarter of 2021, compared to $16.5 million for the third quarter of 2020. The increase in research and development expenses was primarily due to an increased number of experiments run on the Recursion OS, an increased number of assets being validated, and increased clinical costs as studies progressed.
General and Administrative Expenses: General and administrative expenses were $15.7 million for the third quarter of 2021, compared to $7.0 million for the third quarter of 2020. The increase in general and administrative expenses was due to the growth in size of the company’s operations, including an increase in salaries and wages of $3.7 million, equipment costs, human resources-related costs, facilities costs, and other administrative costs associated with operating a high-growth company.
Net Loss: Net loss was $47.4 million for the third quarter of 2021, compared to a net loss of $23.9 million for the third quarter of 2020.
Additional Corporate Updates

Operations in Canada: Jordan Christensen joined Recursion as Vice President, Engineering and also became our Toronto Site Lead. Additionally, we opened our Montreal office and hired multiple machine learning research scientists.
Translational Biology: Alison O’Mahony, Ph.D., joined Recursion as Vice President, Discovery Platform and will be responsible for continued scaling and improvement of Recursion’s orthogonal validation and bespoke validation assays to continue driving down the time from initial discovery to clinical development. Dr. O’Mahony previously served as Vice President, Translational Biology at Eurofins Discovery.
Information Security: Ganesh Jagannathan joined Recursion as Chief Information Security Officer & Vice President, Information Technology and will be responsible for all strategic, innovative and operational aspects of Information Security and Information Technology. Mr. Jagannathan previously served as Chief Information Security Officer at Jazz Pharmaceuticals.
CEO Rule 10b5-1 Plans: Chris Gibson, Ph.D., the company’s Co-Founder and CEO, established personal stock trading plans in the second quarter of 2021 in accordance with Rule 10b5-1 under the Securities and Exchange Act of 1934 and Recursion’s insider trading policy. Under the plans, all outstanding stock options may be exercised and we anticipate shares representing up to approximately 4% of Dr. Gibson’s holdings may be sold or transferred to donor-advised philanthropic funds. We anticipate the Rule 10b5-1 transactions may take place over the next 13 months. Any such transactions will be disclosed through public filings as required by the SEC.

On November 10, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, NOV 10, 2021, View Source [SID1234595222]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This past quarter, Zentalis continued to execute on its clinical development strategy, and we are pleased with the progress we have made to advance our lead program, ZN-c3, a potentially best-in-class WEE1 inhibitor," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Most recently, we initiated a Phase 1/2 trial with ZN-c3 in combination with gemcitabine in patients with osteosarcoma, further supporting the broad potential of ZN-c3 in combination therapy settings. Before year-end, we plan to have a total of six ongoing trials investigating our WEE1 inhibitor and look forward to initiating our potentially registrational biomarker-driven Phase 2 trial shortly. Additionally, the foundational research on the discovery of ZN-c3 was published in the peer-reviewed Journal of Medicinal Chemistry, which reviews our objectives for designing ZN-c3 as a potentially safer and more selective WEE1 inhibitor and in turn, overcoming limitations seen with other candidates in development."

Continued Dr. Sun, "We remain on track with our anticipated clinical milestones and are eager to provide future updates on these efforts. Looking ahead, we are excited to host a virtual R&D Day on December 16, during which our management team and key opinion leaders will provide a review of new preclinical science across multiple programs and share clinical updates on ZN-d5 and ZN-e4."

Program Highlights:

In September 2021, Zentalis dosed the first patient in the Phase 1/2 study of ZN-c3 in combination with gemcitabine, a chemotherapy used to treat certain malignant tumors, in patients with relapsed or refractory osteosarcoma. Zentalis recently received orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA) for pediatric osteosarcoma. Zentalis expects to report initial results from this trial in the second half of 2022.
Enrollment is ongoing in the potentially registrational Phase 2 trial of ZN-c3 in women with recurrent or persistent USC. Following an end-of-Phase 1 meeting in July 2021, the FDA agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 study design in USC.
In September 2021, research on the discovery of ZN-c3 was published in the Journal of Medicinal Chemistry. The paper reviews Zentalis’ objectives in designing ZN-c3 as a potentially safer and more selective WEE1 inhibitor, overcoming limitations seen with other WEE1 inhibitors.
In September 2021, Zentalis presented six poster presentations on the candidates: ZN-c3, a WEE1 inhibitor; ZN-c5, an oral selective SERD and ZN-d5, a BCL-2 inhibitor at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.
Zentera Highlights:

In August 2021, Zentera, a Shanghai-based clinical-stage biopharmaceutical company formed by Zentalis, announced the completion of a $75 million Series B financing. Zentera plans to use the proceeds to advance the clinical development in China of three of Zentalis’ product candidates (ZN-c3, ZN-c5 and ZN-d5), as well as expand its pipeline through additional business development opportunities for China and global development.
Zentera received CTA acceptances in China for ZN-c3, ZN-c3 in combination, ZN-c5 and ZN-d5 and four clinical trials are ongoing.
Corporate Highlights:

In July 2021, Zentalis closed an underwritten follow-on offering of 3,565,000 shares of its common stock at a public offering price of $48.50 per share. The total net proceeds were approximately $162.2 million, after deducting underwriting discounts and commissions and offering expenses payable by Zentalis.
Third Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of September 30, 2021, Zentalis had cash, cash equivalents and marketable securities of $366.8 million. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2021 will be sufficient to fund our operating expenses and capital expenditures requirements into the third quarter of 2023.
Research and Development Expenses: Research and development expenses for the three months ended September 30, 2021 were $54.0 million, compared to $24.7 million for the three months ended September 30, 2020. The increase of $29.3 million was primarily due to increases in external research and development expenses related to our clinical product candidates, as we advanced our clinical pipeline.
General and Administrative Expenses: General and administrative expenses for the three months ended September 30, 2021 were $8.9 million, compared to $10.1 million during the three months ended September 30, 2020. This decrease of $1.2 million was primarily attributable to a decrease of $0.6 million in legal fees and an increase in allocable overhead expenses to research and development expenses of $1.7 million, offset by an increase of $1.1 million of facilities and related permits/fees and licenses expenses.
Net Loss: Net loss was $10.5 million for the three months ended September 30, 2021, compared to $34.7 million for the three months ended September 30, 2020. The $24.2 million decrease in net loss was primarily the result of the gain on deconsolidation of Zentera recognized during the three months ended September 30, 2021, partially offset by increases in research and development expenses discussed above.

On November 10, 2021 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the third quarter ended September 30, 2021 (Press release, Century Therapeutics, NOV 10, 2021, View Source [SID1234595221]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to deepen investments in cellular reprogramming, genetic engineering, and manufacturing, in order to advance our iPSC platforms, with an ultimate goal of developing therapies that can meaningfully advance cancer care," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We are making tangible progress in advancing our lead candidate, CNTY-101, into the clinic, with our IND filing on track for mid-2022. Additionally, through our recently announced collaboration with Outpace Bio, we are further investing in new technologies as we execute on our vision of building a next-generation cell therapy platform. We expect to provide scientific updates on our programs later this year and at our upcoming virtual research and development update."

Business Highlights

Entered into a research collaboration agreement with Outpace Bio to explore Outpace’s protein solutions for cell therapy to potentially enhance the functionality of Century’s iPSC platform. The collaboration’s initial program will focus on hematological malignancies with an option to expand to additional candidates.
Included in the small-cap Russell 2000 Index as a part of the 3Q21 Russell Indexes IPO additions.
Upcoming Milestones

Pre-clinical data from the Company’s CNTY-101 program and CAR-iT platform to be presented in two posters at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on December 11-14, 2021 in Atlanta, Georgia, and virtually.
Virtual research and development update to be held on Thursday, December 16, 2021 from 8:00-9:30 AM EST. Century’s management team will discuss an update on the Company’s iPSC technology platform and pipeline. Eduardo Sotomayor, M.D., Director of the Cancer Institute at Tampa General Hospital, will discuss the current treatment paradigm for B-cell malignancies. For additional information on how to access the event, please visit the Events & Presentations section of Century’s website.
Current Good Manufacturing Practice (cGMP) manufacturing facility expected to be operational in early 2022.
CNTY-101 IND filing remains on track for mid-2022.
Third Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $400.3 million as of September 30, 2021, as compared to $440.0 million as of June 30, 2021.
Research and Development (R&D) expenses: R&D expenses were $19.5 million for the three months ended September 30, 2021, compared to $10.8 million for the same period in 2020. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s research and development capabilities, costs for preclinical studies, costs for laboratory supplies, and facility costs.
General and Administrative (G&A) expenses: G&A expenses were $6.3 million for the three months ended September 30, 2021, compared to $2.3 million for the same period in 2020. The increase was primarily due to an increase in personnel related expense due to an increase in employee headcount and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company.
Net loss: Net loss was $26.0 million for the three months ended September 30, 2021, compared to $13.1 million for the same period in 2020.

On November 10, 2021 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the third quarter ended September 30, 2021 and provided an update on key strategic initiatives (Press release, BioXcel, NOV 10, 2021, View Source [SID1234595220]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have made tremendous progress advancing our neuroscience and immuno-oncology franchises," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "With our PDUFA date for BXCL501 less than two months away, we are excited that our commercial and launch readiness planning is progressing well. We are equally excited about initiating our Phase 3 program for BXCL501 for acute treatment of agitation associated with dementia in Alzheimer’s patients, the most prevalent type of dementia in the United States, which has a high unmet medical need and we believe would mark the first orally available FDA-approved therapy. Furthermore, adding major depressive disorder as a potential indication for BXCL501 and introducing BXCL502 as a candidate for chronic treatment of agitation in dementia strengthens our pipeline and expands our market opportunity."

Dr. Mehta added, "Our immuno-oncology program is also advancing, with positive interim results from our Phase 2 trial of BXCL701 in heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC) demonstrating encouraging efficacy and a favorable safety profile. We believe BXCL701 shows considerable potential as an investigational, orally administered, systemic innate immune activator."

Company Highlights

Neuroscience Franchise

BXCL501 is an investigational, proprietary, orally dissolving, thin film formulation of the adrenergic receptor agonist dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. BXCL501 has received FDA Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and FDA Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders I and Il, and dementia.

·BXCL501 for Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II: On track with FDA review of BXCL501 NDA for acute treatment of agitation associated with schizophrenia and bipolar disorders I and II; Marketing Authorization Application to European Medicines Agency of BXCL501 expected to be submitted in 1H 2022.

·BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer’s Disease: Following multiple meetings with FDA and alignment on key design features, on track to initiate Phase 3 program in Q4 2021. Alzheimer’s disease is the most prevalent type of dementia in the U.S. and is expected to double from 5.8 million patients in 2020 to 11.8 million patients by 2040.1 The Company remains interested in exploring BXCL501 for other dementia subtypes as part of future development.

·BXCL501 for Major Depressive Disorder (MDD): Held pre-Investigational New Drug (IND) meeting with FDA for use of BXCL501 as an adjunctive treatment for MDD, with Selective Serotonin Reuptake Inhibitors (SSRIs) and serotonin-norepinephrine reuptake Inhibitors (SNRIs), and to align on key design features; preparing to submit IND and expect to initiate a clinical trial in 1H 2022.

·BXCL502 for Chronic Treatment of Agitation in Patients with Dementia: Formulation and clinical development planning underway for BXCL502 as a potential monotherapy and in combination with BXCL501 for chronic treatment of agitation in patients with dementia; designed to be a potent and selective antagonist for a GPCR target affecting serotonergic signaling in the cerebral cortex.

AI-driven Drug Discovery & Development

·Hosted a Virtual R&D Day in September highlighting the Company’s innovative approaches to leveraging its proprietary artificial intelligence platform to expand current neuroscience portfolio, including identification of the Company’s newest product candidate, BXCL502, and to broaden the addressable market for lead program, BXCL501, in MDD.

1. Alzheimer’s Association.

Immuno-Oncology Franchise

BXCL701 is an investigational, orally administered, systemic innate immune activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

·Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Presented positive interim data from Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA (pembrolizumab) for heavily pre-treated mCRPC patients with adenocarcinoma at the 2021 European Society for Medical Oncology Congress in September. Following this data, announced expansion of ongoing Phase 1b/2 trial of BXCL701 in mCRPC patients with either de novo or treatment-emergent small-cell neuroendocrine carcinoma (SCNC).

·Solid Tumors Program (Checkpoint Naïve and Refractory): Expect to present additional efficacy data from MD Anderson-led open-label Phase 2 basket trial of BXCL701 and KEYTRUDA in 1H 2022.

·Peer-Reviewed Journal Findings Published on BXCL701 Mechanism of Action: Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) reported data findings, on November 4, 2021, suggesting BXCL701 may enhance immunotherapy efficacy in ‘cold’ tumor types such as pancreatic cancer. These findings also highlight the potential importance of natural killer (NK) cells along with T cells in regulating pancreatic cancer tumor growth.

Commercial and Launch Readiness Progress

·Expanded Sales Leadership: onboarded a Vice President of Sales and Regional Sales Directors; continuing to recruit sales force across key territories.

·Optimizing Market Access and Pricing Strategy for BXCL501: through evidence-based market research.

·Fully Launched Unbranded Disease Education Campaign (Including partnersincalm website): to promote awareness of acute agitation in schizophrenia and bipolar disorders.

Medical Affairs Progress

·Medical Science Liaison and Medical Managed Care Teams Fully Deployed: actively engaged with healthcare professionals and payers to provide key insights and support potential BXCL501 commercial launch, including participation and presentations at:

oNeuroscience Education Institute Congress in November

oPsych Congress, American College of Emergency Physicians conference and Academy of Managed Care Pharmacy conference in October

oEmergency Nurses Association Annual Meeting in September

Third Quarter 2021 Financial Results

Research and Development Expenses: Research and development expenses were $11.9 million during the third quarter of 2021, as compared to $16.3 million for the same period in 2020. The decreased expenses were primarily attributable to a reduction in BXCL501 clinical trial costs offset in part by increased BXCL701 trial costs. In addition, the Company experienced greater professional and consulting fees primarily related to BXCL501 development.

General and Administrative Expenses: General and administrative expenses were $14.9 million for the third quarter of 2021, as compared to $8.5 million for the same period in 2020. The increase was primarily due to higher stock-based compensation and personnel costs due to continued expansion of teams, increased marketing and commercial costs related to the potential launch of BXCL501 in the U.S., as well as increased legal and professional fees, and insurance costs.

Net Loss: BioXcel Therapeutics reported a net loss of $26.8 million for the third quarter of 2021, compared to a net loss of $24.8 million for the same period in 2020.

As of September 30, 2021, cash and cash equivalents totaled approximately $252.9 million.

Conference Call

BioXcel Therapeutics will host a conference call and webcast today at 8:30 a.m. EDT to discuss its third quarter 2021 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through at least December 11, 2021.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News/Events menu of the Investors & Media section of its website.

On November 10, 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 September 30, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, NOV 10, 2021, View Source [SID1234595219]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Business Highlights:

Achieved several milestones in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
Achievement of the preliminary safety benchmark for the first 12 patients
Completion of enrollment for the first stage of the checkpoint inhibitor naïve arm (1st line treatment of recurrent or metastatic head and neck cancer).
Initiated enrollment of the second arm of the study addressing checkpoint inhibitor refractory patients (2nd line treatment of recurrent or metastatic head and neck cancer)
Completed a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary T-cell receptor gamma alternate reading frame protein (TARP) tumor antigen for use in PDS0102.
PDS0102 is being developed to treat prostate cancer, breast cancer and acute myeloid leukemia or AML.
PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells in preclinical studies.
Entered agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia for use in the development of PDS0202, a novel Versamune-based universal flu vaccine.
Announced temporary administrative suspension of enrollment into the NCI-led study of the PDS0101 triple combination. PDS Biotech continues to be in contact with the NCI. Treatment of already enrolled patients has continued without interruption.
Announced the hiring of Matthew Hill as Chief Financial Officer, who has more than 25 years of experience in finance and operational leadership roles for life sciences companies.
"PDS Biotech has continued to build on its momentum from the interim data of the last quarter in 2nd and 3rd line treatment of HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We have achieved numerous clinical milestones, and formalized agreements with development partners to continue to progress both our Versamune-based oncology pipeline and our Versamune-based infectious diseases pipeline. We also welcomed Matthew Hill as our new Chief Financial Officer. Matt has decades of experience as a financial leader in publicly traded life sciences companies and will be a key player in our next phase of growth. The groundwork has been laid for the execution of multiple pipeline development milestones in 2022 and into 2023."

Third Quarter 2021 Financial Results

PDS Biotech reported a net loss of approximately $7.0 million, or $(0.24) per basic and diluted share, for the three months ended September 30, 2021, compared to a net loss of approximately $3.9 million, or $(0.21) per basic and diluted share, for the three months ended September 30, 2020.

Research and development expenses increased to approximately $3.7 million for the three months ended September 30, 2021 from approximately $2.1 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to an increase of $0.7 million in personnel costs of which $0.5 million was stock compensation costs, and $0.9 million in costs related to clinical studies.

General and administrative expenses increased to approximately $3.2 million for the three months ended September 30, 2021 from approximately $1.8 million for the three months ended September 30, 2020. The increase of $1.4 million is primarily attributable to an increase in personnel costs of $1.6 million, of which $1.0 million was stock compensation costs and $0.4 million was severance, partially offset by a decrease in professional fees of $0.2 million.

PDS Biotech’s cash and cash equivalents as of September 30, 2021, were approximately $69.7 million.

Conference Call and Webcast

The conference call is scheduled to begin at 8:00 am ET on Wednesday, November 10, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.

After the live webcast, the event will be archived on 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 13722558.