On March 15, 2024 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 its recent accomplishments and financial results for the year ended December 31, 2023 (Press release, Soligenix, MAR 15, 2024, View Source [SID1234641206]).

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"Our primary focus in 2024 continues to be advancing our multiple clinical programs in our rare disease pipeline," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Our collaborative discussions continue with the U.S. Food and Drug Administration (FDA) regarding the design of a second, confirmatory Phase 3 pivotal study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL), where we successfully demonstrated statistically significant results in the first Phase 3 clinical trial. We also continue to engage in discussions with the European Medicines Agency to explore potential marketing approval and partnership in Europe. Recently, we shared successful preliminary top-line results of our ongoing Phase 2a clinical trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. Following the clearance of the Investigational New Drug (IND) application for a Phase 2a clinical trial with SGX945 (dusquetide) in Behçet’s Disease and the recent receipt of "Fast Track" designation from the FDA, we anticipate initiating this study in the second half of 2024. Under our Public Health Solutions business segment, we recently announced publication of the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. The published paper describes the potency of the bivalent formulation against both lethal viruses, demonstrating 100% protection in the most rigorous non-human primate (NHP) challenge models."

Dr. Schaber continued, "With approximately $8.4 million in cash at December 31, 2023, not including our non-dilutive government funding, we are managing cash burn very carefully in order to achieve our near-term milestones. We recently received $0.6 million, net of transaction costs, from the state of New Jersey’s (NJ) Technology Business Tax Certificate Transfer Program. This is our fourteenth year participating in the program, over that time we have received approximately $9.4 million in non-dilutive capital. We continue to evaluate a number of strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On February 8, 2024, the Company announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance to the Company as it advances the clinical development of SGX945 (dusquetide) for the treatment of Behçet’s Disease. To view this press release, please click here.
On January 8, 2024, the Company announced its SGX945 development program for the treatment of oral lesions of Behçet’s Disease has received "Fast Track" designation from the FDA. To view this press release, please click here.
On January 4, 2024, the Company announced positive preliminary top-line results of its ongoing Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis. To view this press release, please click here.
On January 2, 2024, the Company announced publication describing the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both SUDV and MARV infections in NHP models. This vaccine candidate had been previously demonstrated to be stable to high temperature storage for at least 2 years at 40 degrees Celsius (104 degrees Fahrenheit). To view this press release, please click here.
On December 1, 2023, the Company announced publication of an article describing the potential use of HyBryte in the treatment of CTCL in Frontiers in Drug Discovery. To view this press release, please click here.
On November 30, 2023, the Company announced the FDA had cleared the IND application for a Phase 2a clinical trial entitled, "Pilot Study of SGX945 (Dusquetide) in the Treatment of Aphthous Ulcers in Behçet’s Disease." To view this press release, please click here.
Financial Results – Year Ended December 31, 2023

Soligenix’s revenues for the year ended December 31, 2023 was $0.8 million as compared to $0.9 million for the year ended December 31, 2022. Revenues primarily relate to government contracts and grants awarded in support of HyBryte, our therapeutic candidate for early-stage CTCL; SGX943, our therapeutic candidate for treatment of emerging and/or antibiotic-resistant infectious diseases; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s net loss was $6.1 million, or ($0.79) per share, for the year ended December 31, 2023, as compared to $13.8 million, or ($4.81) per share, for the year ended December 31, 2022. The decrease in net loss was primarily due to decreases in operating expenses and interest expense and an increase in other income.

Research and development expenses were $3.3 million as compared to $7.9 million for the years ended December 31, 2023 and 2022, respectively. The decrease was primarily due to the decrease in manufacturing and regulatory costs associated with the HyBryte new drug application filing.

General and administrative expenses were $4.5 million and $6.7 million for the years ended December 31, 2023 and 2022, respectively. This decrease in general and administrative expenses is primarily attributable to a reduction in legal and consulting expenses.

As of December 31, 2023, the Company’s cash position was approximately $8.4 million.

On March 15, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has entered into definitive agreements with two existing institutional investors for the purchase and sale of 13,029,316 shares of its common stock (or common stock equivalents in lieu thereof) in a registered direct offering and warrants to purchase up to an aggregate of 13,029,316 shares of common stock in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $1.535 per share and accompanying warrant, priced at-the-market under Nasdaq rules (Press release, Sellas Life Sciences, MAR 15, 2024, View Source [SID1234641205]). The warrants will have an exercise price of $1.41 per share, will be immediately exercisable upon issuance and will expire 5.5 years from issuance.

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The closing of the Offering is expected to occur on or about March 19, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $20 million, before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds from the Offering for research and development activities, working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.

The registered direct offering of the shares of common stock (or common stock equivalents in lieu thereof) is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-255318) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed Offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624- 2060, or by email at [email protected].

The private placement of the warrants will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

On March 15, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will participate in a virtual fireside chat on the Treatment Landscape & New Treatment Options for Prostate Cancer (Press release, Oncternal Therapeutics, MAR 15, 2024, View Source [SID1234641204]).

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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

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Oncternal’s President and CEO, James Breitmeyer, M.D., Ph.D. will join Oppenheimer Senior Research Biotech Analyst, Hartaj Singh and a prostate cancer Key Opinion Leader on Tuesday, March 19th, 2024 at 11:00 AM ET. Dr. Breitmeyer will discuss the development of Oncternal’s novel dual-acting androgen receptor inhibitor, ONCT-534, the ongoing Phase 1/2 clinical trial ONCT-534-101, and the potential positioning of ONCT-534 within the treatment paradigm of advanced prostate cancer.

To join this call, please contact your Oppenheimer institutional salesperson. A replay of the event will be available online at investor.oncternal.com and it will be archived there for at least 30 days.

On March 15, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) met its primary endpoint of overall survival (OS) for the treatment of newly diagnosed patients with high-risk locally advanced cervical cancer (Press release, Merck & Co, MAR 15, 2024, View Source [SID1234641202]).

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At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent CRT showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.

As previously reported, KEYNOTE-A18 met its other primary endpoint of progression-free survival (PFS) in 2023. These PFS data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 and supported the U.S. Food and Drug Administration’s approval of KEYTRUDA in combination with CRT for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer in January 2024.

"This is the first Phase 3 trial in which an immunotherapy-based regimen has shown a statistically significant and clinically meaningful improvement in overall survival compared to chemoradiotherapy alone," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "Building on the positive progression-free survival findings from this study, these results underscore our commitment to exploring the role of KEYTRUDA across different types of cancers in earlier stages of disease, where there is a greater potential for better outcomes."

"These findings are important for patients and the medical community alike and reinforce previous data from the KEYNOTE-A18 trial, now showing this regimen has the potential to extend the lives of patients with locally advanced cervical cancer," said Prof. Domenica Lorusso, the study’s overall principal investigator, lead investigator for ENGOT, and professor of Obstetrics and Gynecology at Humanitas University.

In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test; and as a single agent, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

About KEYNOTE-A18/ENGOT-cx11/GOG-3047

KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT04221945) sponsored by Merck and conducted in collaboration with the European Network for Gynecological Oncology Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG) investigating KEYTRUDA in combination with CRT (cisplatin and external beam radiotherapy [EBRT] followed by brachytherapy [BT]) compared to placebo plus concurrent CRT for the treatment of newly diagnosed high-risk (stage IB2-IIB with lymph node-positive disease, and stage III-IVA with and without lymph node-positive disease) locally advanced cervical cancer where patients are treated with definitive intent. The primary endpoints are PFS and OS, and secondary endpoints include complete response rate, objective response rate and safety. The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer. Patients were randomized (1:1) to receive either:

KEYTRUDA (200 mg intravenously [IV]) every three weeks (Q3W) for five cycles concurrent with cisplatin (40 mg/m2 IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by KEYTRUDA (400 mg IV) every six weeks (Q6W) for 15 cycles;
Placebo IV Q3W for five cycles concurrent with cisplatin (40 mg/m2 IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by placebo IV Q6W for 15 cycles.
About cervical cancer

Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. All women are at risk for cervical cancer, and it is most frequently diagnosed between the ages of 35 and 44. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most common cancer in women globally. In the U.S., it is estimated there will be approximately 13,820 new patients diagnosed with invasive cervical cancer and about 4,360 deaths from the disease in 2024.

On March 15, 2024 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, reported financial results for the fourth quarter and full year of 2023 (Press release, Ensysce Biosciences, MAR 15, 2024, View Source [SID1234641200]).

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Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We are proud of the significant progress Ensysce has made in 2023 both operationally and clinically for our lead pain therapeutic, PF614, and our overdose protection product, PF614-MPAR. Our advancements were particularly instrumental in providing a foundation for our constructive end of Phase 2 meeting with the U.S. Food & Drug Administration (FDA) for PF614. We believe the FDA’s guidance positioned Ensysce favorably and solidified the PF614 Phase 3 clinical study designs to initiate enrollment in the second half of 2024, ultimately reducing regulatory risks that could impede our commercialization plan. Especially encouraging was the FDA grant of Breakthrough Therapy designation to PF614-MPAR in January 2024, acknowledging its unique advantage over current opioids. Breakthrough Therapy, an exclusive designation applied to less than 300 drugs historically, offers Ensysce the opportunity to accelerate our clinical programs and go-to market plans."

"Importantly, the collective empirical data we’ve received from four completed clinical studies verify PF614’s bioequivalence to commercially available opioids but with reduced abuse potential, and reaffirms our belief that Ensysce’s PF614 will provide a "next generation" opioid family with the added value proposition of safer products with overdose protection. We have many reasons to remain optimistic on our path to regulatory approval as we advance through our Phase 3 clinical trials beginning in the second half of 2024. Progress in 2023 and early 2024 has provided further evidence that our innovative analgesics will provide prescribers and patients in severe pain with an alternative, effective option with safety advantages to address the opioid epidemic in the United States," concluded Dr. Kirkpatrick.

TAAPTM (Opioid Abuse Deterrent Program) Updates

Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential "next generation" analgesic for severe pain. The Company’s TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification. PF614’s TAAPTM modification makes it inactive until it is swallowed, following which it is activated or ‘turned on’ to release oxycodone by the body’s own trypsin, an enzyme in the small intestine. Ensysce recently completed a Phase 2 clinical trial for PF614, received FDA guidance on the strategy and design of its Phase 3 clinical program and expects to commence enrollment for the Phase 3 clinical trial in the second half of 2024. Ensysce believes it has a body of evidence showing that PF614 works as designed, has a good safety profile and is bioequivalent to OxyContin providing strong efficacy, yet reduced abuse potential.

As a reaffirmation of the Company’s belief in the efficacy of PF614, on February 15, 2024, the Company announced the online publication of its manuscript entitled, "Clinical evaluation of PF614, a novel TAAPTM prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers" by the open-access medical journal Clinical and Translational Science (CTS) sponsored by the American Society of Clinical Pharmacology and Therapeutics (ASCPT). The results from the two-part PF614‑102 study demonstrate a clear dose relationship between PF614 and oxycodone, which is the foundation for the FDA submission.

As previously mentioned, on January 31, 2024, the Company completed a successful End of Phase 2 meeting with the FDA regarding PF614 and received guidance on its non-clinical development approach and clinical development plans.

Instrumental to the meeting was the PF614-201 study, "A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects" that concluded in December 2023. This study measured the time-of-onset of pain-relief in healthy volunteers and showed that Ensysce’s TAAPTM chemical approach delivers effective analgesia. This study was a meaningful component of the Company’s Phase 3 clinical protocol design and a driver of the positive outcome with the FDA.

MPAR (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR is a combination product of the TAAP prodrug PF614 with a trypsin inhibitor, designed to treat severe pain while providing overdose protection. MPAR (Multi-Pill Abuse Resistance) reduces or ‘turns off’ the release of the opioid to prevent an overdose, providing an additional layer of protection to Ensysce’s TAAP medications. Over the past year, clinical data demonstrated that the MPAR technology reduces release and absorption of oxycodone from PF614 when consumed in more than a prescribed dose.

Importantly, in January 2024, Ensysce received notice from the FDA that it had granted Breakthrough Therapy designation for PF614-MPAR, acknowledging the potential impact of the innovative MPAR overdose protection technology. Breakthrough Therapy is an elite designation that expedites the development and review of drugs that are intended to treat a serious condition where the drug may demonstrate substantial improvement over available therapies.

In February, the Company received additional productive guidance from the FDA to aid the design of our PF614-MPAR programs to efficiently move toward a new drug application (NDA) submission and approval to bring this innovative drug to market.

Financial Results

Cash – Cash and cash equivalents were $1.1 million as of December 31, 2023, as compared to $1.5 million as of September 30, 2023. After year end, the Company received cash proceeds of $2.1 million from the exercise of warrants, originally issued in the fourth quarter of 2023, to purchase 1.3 million shares of common stock. Additionally, in February 2024, the Company received gross proceeds of $4.7 million, prior to deducting placement agent fees and offering expenses, from the exercise of warrants to purchase 3.6 million shares of common stock originally issued in May 2023.

Federal Grants – Funding under federal grants totaled to $0.5 million for the fourth quarter of 2023 compared to $1.4 million in the comparable year ago quarter. For the full year of 2023, funding from federal grants was $2.2 million compared to $2.5 million for the full year of 2022. The decreases are due to the timing of research activities eligible for funding, particularly relative to the MPAR program.

Research & Development Expenses – R&D expenses were $2.2 million for the fourth quarter of 2023 compared to $6.4 million for the same period in 2022. For the full year of 2023, R&D expenses were $7.6 million compared to $19.8 million for the full year of 2022. The decreases were primarily the result of reduced external research and development costs related to the clinical programs for PF614 and PF614-MPAR, particularly regarding bioequivalence and human abuse potential studies for PF614.

General & Administrative Expenses – G&A expenses were $1.4 million in the fourth quarter of 2023, a slight increase compared to $1.2 million for the same period of 2022. For the full year of 2023, G&A expenses were $5.4 million, a decrease compared to $6.9 million for the full year of 2022. The quarterly increase from the same prior year period was primarily a result of higher non-cash stock-based compensation, while the full year decrease resulted from reduced consulting, legal, liability insurance and employee bonus expenses.

Other Income (Expense) – Total other income (expense), net was an expense of $0.3 million for the fourth quarter of 2023 compared to income of $0.7 million for the same period of 2022. For the full year, total other income (expense), net was income of $91,912 in 2023 compared to income of $14,410 in 2022. The changes in other expenses were primarily due to non-cash fair value adjustments for convertible notes and warrants.

Net Loss – Net loss attributable to common stockholders for the fourth quarter of 2023 was $3.5 million compared to $5.5 million for the fourth quarter of 2022. For the full year of 2023, net loss was $10.6 million compared to $25.1 million for the full year of 2022. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.

Corporate Update Conference Call

Ensysce CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. William Schmidt, will host a conference call on Thursday, March 21, 2024, at 11:00am ET to provide a corporate update and review recent company milestones. The call will conclude with Q&A from participants. An accompanying updated presentation will be posted prior to the call to the Company’s investor relations website.

Date: Thursday, March 21, 2024
Time: 11:00am ET
U.S/ Dial-in: 1-877-407-0792
International Dial-in: 1-201-689-8263
Webcast: ENSC Corporate Update Call

Please dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through Thursday, April 4, 2024. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay pin number 13744594.