On May 15, 2023 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that its recent accomplishments and financial results for the quarter ended March 31, 2023 (Press release, Soligenix, MAY 15, 2023, View Source [SID1234631746]).

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"We recently completed a public offering with gross proceeds of approximately $8.5 million, which will allow us to continue to move our rare disease pipeline forward," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently we announced positive clinical results from a compatibility study evaluating HyBryte (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL). The purpose of the study was to establish that any light device capable of producing visible light of an appropriate and consistent wavelength (500 to 650 nm) was suitable for use with HyBryte and to extend the pharmacokinetic profile using a recently developed, more sensitive hypericin assay. Additionally, the United States (U.S.) Food and Drug Administration (FDA) has granted our Type A Meeting request to initiate formal discussions regarding the design of a second, confirmatory Phase 3 pivotal study evaluating HyBryte in the treatment of early stage CTCL, where it has successfully demonstrated statistically significant results in the first Phase 3 clinical trial. We also continue to evaluate synthetic hypericin (SGX302) in mild-to-moderate psoriasis where we anticipate the clinical study results in the second half of 2023."

Dr. Schaber continued, "From a business strategy perspective, we recently announced two important additions. We entered into an exclusive option agreement with Silk Road Therapeutics, a privately-held company, pursuant to which we have the right to evaluate and acquire a novel topical formulation of Pentoxifylline (PTX), a non-biological anti-TNF-alpha inhibitor, for the treatment of mucocutaneous ulcers in patient’s suffering from Behçet’s Disease (BD). This has the potential to expand our already robust rare disease pipeline. We also added Timothy R. Coté, MD, to our Board of Directors. Dr. Coté comes with extensive regulatory and orphan drug development expertise, having served as the Director of the FDA Office of Orphan Products Development where he implemented the U.S. Orphan Drug Act and personally signed decisions on more than 1,400 orphan drug designation applications. With approximately $10.3 million in cash at March 31, 2023, not including our non-dilutive government funding and the recent financing, which increases are partially offset by the recent $5.0 repayment under our credit facility, we continue to manage cash burn very carefully to achieve our near-term milestones, as we continue to assess all strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On May 11, 2023, the Company announced the U.S. FDA had granted our Type A meeting request to discuss the design of a second, Phase 3 pivotal study evaluating HyBryte in the treatment of early stage CTCL. To view this press release, please click here.
On May 9, 2023, the Company announced the closing of its public offering of 6,538,500 shares of common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to 6,538,500 shares of common stock at a combined public offering price of $1.30 per share and accompanying warrant having a $1.50 per share exercise price for aggregate gross proceeds of approximately $8.5 million, before deducting placement agent fees and other offering expenses. To view this press release, please click here.
On May 4, 2023, the Company announced positive clinical results from a compatibility study evaluating HyBryte in the treatment of CTCL using the commercially ready Daavlin Series 7 visible light device. To view this press release, please click here.
On May 3, 2023, the Company announced the appointment of Timothy R. Coté, M.D., M.P.H. to its Board of Directors. To view this press release, please click here.
On May 1, 2023, the Company announced that it had entered into an exclusive option agreement with Silk Road Therapeutics, a privately-held company. To view this press release, please click here.
On April 14, 2023, the Company announced the outcome of the Type A Meeting with the U.S. FDA to discuss the contents of a refusal to file letter previously issued for its new drug application for HyBryte in the treatment of early stage CTCL. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2023

Soligenix’s revenues for the quarter ended March 31, 2023 were $0.3 million as compared to $0.2 million for the quarter ended March 31, 2022. Revenues primarily relate to third party licensing and the government contracts and grants awarded in support of RiVax, its ricin toxin vaccine candidate; SGX943, its therapeutic candidate for treatment of emerging and/or antibiotic-resistant infectious diseases; and CiVax, its vaccine candidate for the prevention of COVID-19.

Soligenix’s net loss was $1.0 million, or ($0.36) per share, for the quarter ended March 31, 2023, as compared to $4.3 million, or ($1.52) per share, for the quarter ended March 31, 2022. The decrease in net loss was primarily due to a decrease in operating expenses in addition to the recognition of an income tax benefit resulting from the sale of its 2021 net operating loss (NOL) carryforwards during the three months ended March 31, 2023.

Research and development expenses were $0.9 million as compared to $1.7 million for the quarters ended March 31, 2023 and 2022, respectively. The decrease was primarily due to the decrease in costs associated with the Oral Mucositis Phase 3 clinical trial as well as a decrease in manufacturing costs associated with the HyBryte NDA filing.

General and administrative expenses were $1.2 million and $2.5 million for the quarters ended March 31, 2023 and 2022, respectively. This decrease in general and administrative expenses is primarily attributable to a reduction in legal and consulting expenses associated with the arbitration against Emergent and certain of its subsidiaries.

As of March 31, 2023, the Company’s cash position was approximately $10.3 million.

On May 15, 2023 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Ocuphire Pharma, MAY 15, 2023, View Source [SID1234631745]).

"Ocuphire made significant progress across both our APX3330 and Nyxol programs throughout the first quarter," said Rick Rodgers, Interim Chief Executive Officer. "Based on the efficacy and safety data from the ZETA-1 Phase 2 trial of APX3330, we are preparing for an End-of-Phase 2 meeting with the FDA to confirm Phase 3 registration endpoints and study parameters. If approved, APX3330 has the potential to be a non-invasive, oral, early intervention treatment for millions of DR patients at risk of progressing to vision-threatening complications. For Nyxol, we look forward to the September 2023 PDUFA date in its first indication in RM. With a strong cash position and our partner Viatris funding the Nyxol program, we are well positioned to advance both APX3330 and Nyxol programs."

Key Anticipated Future Milestones

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APX3330: End of Phase 2 meeting with FDA to confirm Phase 3 regulatory path for Oral APX3330 in DR (2H 2023)
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Nyxol: PDUFA date for Nyxol in RM. FDA approval in RM would trigger a $10 million milestone payment to Ocuphire (September 28, 2023)
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Nyxol: Topline results from VEGA-2 Phase 3 pivotal trial of Nyxol in Presbyopia (Late 2023)

Recent Business Highlights

Clinical and Regulatory Updates

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In January 2023, the Company announced topline results from the ZETA-1 Phase 2 trial of oral APX3330 for the treatment of diabetic retinopathy (DR). Oral APX3330 achieved statistical significance on a key pre-specified secondary endpoint of binocular ≥ 3-step worsening of DRSS and demonstrated favorable safety and tolerability. This binocular secondary endpoint is a potential Phase 3 registration endpoint. The Company plans an End-of-Phase 2 FDA meeting in the second half of 2023 to formally confirm this endpoint and other clinical trial parameters.

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In February 2023, the Company announced that the FDA has accepted for review a New Drug Application (NDA) for Nyxol in RM and set a PDUFA date of September 28, 2023. FDA approval in RM would trigger a $10 million milestone payment to Ocuphire.

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Topline results from the VEGA-2 Phase 3 pivotal trial of Nyxol in presbyopia are expected in late 2023. Nyxol clinical programs in presbyopia and dim light disturbances (DLD) continue to progress as planned.

Presentations, Publications, and Conferences

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From January 2023 through May 2023, several papers, posters, and panel talks were presented at medical and industry conferences with updates on APX3330 in DR and Nyxol in RM, DLD and presbyopia. Highlights include:

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Results from ZETA-1 Phase 2 trial of APX3330 in DR were presented for the first time to the medical community at the 20th Angiogenesis, Exudation, and Degeneration 2023 Meeting in February 2023.

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Results from LYNX-1 Phase 3 trial of Nyxol in DLD were presented for the first time to the medical community at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in April 2023, and at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in May 2023.

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Previously announced results from ZETA-1 Phase 2 trial of APX3330 in DR were presented to the medical community at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in May 2023.

Corporate

In April, Ocuphire announced the appointment of Rick Rodgers as Interim President and Chief Executive Officer. Mr. Rodgers is a seasoned operating executive with 20 years of experience in biopharmaceutical management.

First Quarter ended March 31, 2023 Financial Highlights

As of March 31, 2023, Ocuphire had cash and cash equivalents of approximately $39.0 million. The Company has no debt. Based on current projections, management believes the present cash on hand will be sufficient to fund operations into 2025.

License and collaborations revenue was $1.7 million for the three months ended March 31, 2023. There was no revenue recorded in the three months ended March 31, 2022. Revenue during the first quarter of 2023 was derived from the reimbursement of research and development services under the Nyxol License Agreement.

General and administrative expenses for the three months ended March 31, 2023 were $2.3 million, compared to $1.7 million for the three months ended March 31, 2022. The increase was primarily attributable to an increase in stock-based compensation, professional services fees, legal support, and business development activities, offset in part by a decrease in payroll and insurance costs on a net basis. General and administrative expenses included $0.5 million and $0.3 million in stock-based compensation expense during the three months ended March 31, 2023, and 2022, respectively.

Research and development expenses for the three months ended March 31, 2023 were $5.6 million, compared to $4.8 million for the three months ended March 31, 2022. The increase was primarily attributable to increased manufacturing activities for Nyxol and APX3330 period over period as well as increased payroll and consulting costs during the current period. Research and development expenses also included $0.3 million and $0.1 million in stock-based compensation expense during the three months ended March 31, 2023, and 2022, respectively.

The loss from operations for the quarter ended March 31, 2023 was $6.1 million, compared to $6.5 million for the quarter ended March 31, 2022.

Net loss for the quarter ended March 31, 2023 was $5.8 million or ($0.28) per share, compared to $6.6 million or ($0.35) per share for the quarter ended March 31, 2022.

For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 to be filed with the Securities and Exchange Commission.

On May 15, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of cancers, reported financial results for the first quarter ended March 31, 2023 (Press release, Renovorx, MAY 15, 2023, View Source [SID1234631744]).

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"We are off to a strong start in 2023, as we build upon the recent positive interim data analysis announced at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) from our open-label Phase III TIGeR-PaC clinical trial with RenovoGem," said Shaun Bagai, CEO, RenovoRx. "Results of the analysis highlight a trend in median overall survival by 24-weeks and reduced side effects for patients with locally advanced pancreatic cancer (LAPC) with RenovoGem versus systemic chemotherapy. We’re also thrilled to welcome industry veteran Robert J. Spiegel to our Board of Directors, and, clinical trials expert, Leesa Gentry, as our new Senior Vice President of Clinical Operations. We are well positioned to build on our success and momentum, and plan to advance our pipeline of innovative therapies to address unmet medical needs for patients with solid tumor cancers."

Operational Highlights for the First Quarter Ended March 31, 2023:

● Announced positive new data from Phase III clinical trial interim analysis. Data suggests a 60% survival benefit and greater than 65% reduction in side effects compared to systemic chemotherapy.
● Announced initial results in pharmacokinetic (PK) substudy: data on RenovoGem supports potential for the RenovoTAMP therapy platform to increase local gemcitabine (chemotherapy) delivery and decrease side effects of pancreatic cancer treatment.
● Issued 8th U.S. patent extending the intellectual property coverage of the RenovoTAMP therapy platform.
● Acceptance of four clinical data abstracts at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium.

Highlights Subsequent to the First Quarter Ended March 31, 2023:

● Appointed Robert J. Spiegel, MD, FACP, former Chief Medical Officer of Schering-Plough, to the Board of Directors.
● Appointed Leesa Gentry as Senior Vice President of Clinical Operations.
● Presented Phase III interim analysis data of the TIGeR-PaC study at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Orlando, Florida.
● Closed $5 million registered direct offering.

Financial Highlights for the First Quarter Ended March 31, 2023:

● Cash and cash equivalents as of March 31, 2023, were $3.7 million.
● Research and development expenses were $1.3 million for the quarter ended March 31, 2023, compared to $1.3 million, relatively flat compared to the quarter ended March 31, 2022. Clinical consulting support for the ongoing Phase III clinical trial increased $0.1 million, which was offset by a decrease in our Phase III clinical trial costs of $0.1 million primarily due to suspending the European Phase III clinical trial.
● General and administrative expenses were $1.9 million for the quarter ended March 31, 2023, compared to $1.7 million for the quarter ended March 31, 2022. The increase was primarily due to higher employee and related benefit costs of $0.3 million, and an increase in professional and consulting fees of $0.2 million. This increase was partially offset by an increase of $0.2 million in allocated general and administrative expenses to research and development including other miscellaneous general and administrative costs of $0.1 million.
● Net loss was $3.3 million for the quarter March 31, 2023, compared to net loss of $3.0 million for year ended March 31, 2022.
● As of March 31, 2023, the Company had 9,097,701 common shares outstanding.

On May 15, 2023 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that patient dosing is now underway in its Phase 1b ADVANCED-1EXP expansion trial evaluating TARA-002, the Company’s investigational cell-based therapy, for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ (CIS) (Press release, Protara Therapeutics, MAY 15, 2023, View Source [SID1234631743]).

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"Following positive preliminary results from the ADVANCED-1 trial, we are pleased to have dosed the first patients in our ADVANCED-1EXP trial," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. "We believe TARA-002 has the potential to play a meaningful role in the NMIBC treatment landscape, as there continues to be limited treatment options for this highly recurrent disease. We look forward to gaining additional clinical experience with TARA-002 in NMIBC patients with CIS."

ADVANCED-1EXP is a Phase 1b open-label expansion trial, which is evaluating intravesical TARA-002 at the 40KE1 dose in 12 CIS patients, including Bacillus Calmette-Guérin (BCG)-naïve, BCG-unresponsive and BCG-inadequately treated patients. Trial participants will receive six once-weekly intravesical instillations of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and signs of anti-tumor activity of TARA-002, and the planned primary endpoint is the complete response (CR) rate at three months.

In April 2023 at the American Urological Association Annual Meeting, the Company announced positive preliminary results from the Phase 1a dose-escalation component of the ADVANCED-1 clinical trial of TARA-002 for the treatment of patients with high-grade NMIBC. The clinical data indicate that TARA-002 was generally well tolerated and anti-tumor activity was observed, including tumor regression in all three evaluable patients with CIS, including one heavily pre-treated BCG-unresponsive patient who achieved a CR.

Based on these results, Protara plans to initiate ADVANCED-2, a Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with CIS. The Phase 1b trial is expected to enroll 27 patients with CIS (± Ta/T1), BCG-Naïve or BCG-exposed who have not received intravesical BCG for at least 24 months prior to CIS diagnosis. The Phase 2 trial is expected to enroll 75 patients with BCG-unresponsive CIS (± Ta/T1). ADVANCED-2 is expected to initiate in the second half of 2023.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA). TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and approved in Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha are secreted by immune cells to induce a strong inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On May 15, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that it will discuss its financial results for the quarter ended March 31, 2023, and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 15, 2023, View Source [SID1234631742]).

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First Quarter and Recent Business Highlights:

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PDS0101 Lead Drug Candidate

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VERSATILE-002 Phase 2 open-label, multicenter study of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer

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Announced poster presentation of updated data from VERSATILE-002 trial during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and its selection as a featured poster to be reviewed by an expert panel during the Head and Neck Cancer discussion session

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Announced plan to initiate the Phase 3 VERSATILE–003 trial, for PDS0101 in combination with KEYTRUDA in head and neck cancer in the fourth quarter of 2023

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Presented initial data on T cell activation and functionality for PDS0101 in combination with KEYTRUDA (pembrolizumab) at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2023

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National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers

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Reported successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)

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PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)

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Hosted Key Opinion Leader (KOL) event focused on the potential use of IL-12 immunocytokine in oncology and the clinical results demonstrated to date with PDS0301

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Announced clinical study of PDS0301 monotherapy published by the NCI in peer-reviewed journal, International Immunopharmacology, linking induced changes in immune responses with clinical outcomes in advanced cancer patients

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Infectimune Platform

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Publication of preclinical Infectimune study in the peer-reviewed journal Viruses showed complete protection against influenza infection in animal studies with PDS0202, a novel investigational recombinant protein-based universal flu vaccine

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A second preclinical Infectimune publication in the peer-reviewed journal Viruses showed induction of higher levels of multifunctional influenza-specific CD4 T cells compared to leading commercial vaccine technologies

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Business Highlights

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Received $1.4 million from the net sale of net operating loss tax benefits through the New Jersey economic development program

"PDS Biotech had another productive quarter progressing toward initiation of the upcoming Phase 3 trial, VERSATILE-003, for PDS0101 in combination with KEYTRUDA in HPV16-positive head and neck cancer patients," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We look forward to initiating our Phase 3 trial in the fourth quarter of this year and to provide an update on interim data from our VERSATILE-002 Phase 2 clinical trial this June at ASCO (Free ASCO Whitepaper). Additionally, the NCI-led triple combination, IMMUNOCERV, and Mayo Clinic neoadjuvant Phase 2 trials continue to progress. Furthermore, we continue to develop our novel antibody-conjugated IL-12 asset PDS0301 and look forward to providing an update on ongoing investigator-initiated Phase 2 trials at the NCI in several solid tumor indications."

First Quarter 2022 Financial Results
Reported net loss was approximately $9.7 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2023, compared to a net loss of $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022. The increase was due to personnel, clinical studies, medical affairs, and manufacturing expenses.

Research and development expenses increased to approximately $5.8 million for the three months ended March 31, 2023, from $5.2 million for the three months ended March 31, 2022. The increase of $0.6 million in 2023 was primarily attributable to an increase of $0.2 million in clinical studies and medical affairs, $0.8 million in personnel costs and $0.1 million in professional fees offset by a decrease of $0.5 million in manufacturing expenses.

General and administrative expenses increased to approximately $3.6 million for the three months ended March 31, 2023, from approximately $3.3 million for the three months ended March 31, 2022. The increase of $0.3 million is primarily attributable to an increase of $0.8 million in personnel, which is offset by a decrease of $0.5 million in professional fees.

Total operating expenses increased to approximately $9.4 million for the three months ended March 31, 2023 from $8.5 million for the three months ended March 31, 2022.

Cash and cash equivalents as of March 31, 2023, totaled approximately $65.2 million. Based on the Company’s cash resources with the anticipated initiation of one registrational trial in 2023, PDS Biotech believes this balance is sufficient to fund the Company’s operations and research and development programs into the third quarter of 2024.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET on Monday, May 15, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13738216. 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.