On August 12, 2024 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the three months ended June 30, 2024, and provided a business update (Press release, Azitra, AUG 12, 2024, View Source [SID1234645748]).

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Q2 2024 and Recent Business Highlights

●
Completed a follow-on offering of $10 million in gross proceeds expected to provide cash runway into 2025. With the recent financing, the company anticipates announcing multiple clinical milestones

● Strengthened global intellectual property portfolio with newly granted and allowed patents

● Exhibited positive preclinical data from ATR-04 at the Society of Investigative Dermatology Annual Meeting

● Presented positive preclinical data of ATR-12 and clinical design in Netherton Syndrome at the ASGCT (Free ASGCT Whitepaper) Annual Meeting

● Opened a Phase 1b clinical trial for ATR-12 for recruitment

Francisco Salva, CEO of Azitra commented:

"Azitra is poised to achieve significant milestones in the second half of 2024 and beyond, propelling our pipeline forward. In Q3 2024, we expect to dose the first Netherton syndrome patient with ATR-12. Additionally, we anticipate filing and clearing an Investigational New Drug (IND) application for ATR-04, targeting epidermal growth factor receptor inhibitor (EGFRi) rash, a condition with high unmet need. This milestone will expand our clinical pipeline to two clinical-stage programs.

Approximately year-end 2024, we anticipate reporting initial safety data from the ATR-12 Phase 1b trial in Netherton syndrome patients and providing an update on our Bayer license agreement. We expect to initiate a first-in-human clinical trial with ATR-04 for EGFRi rash this fall.

Looking ahead to mid-2025, we eagerly anticipate reporting topline data from the ATR-12 Phase 1b trial, a defining moment as we aim to demonstrate biological proof of concept of our innovative approach in addressing this severe, rare skin disorder.

With a clear roadmap, strong financial position, and dedicated team, Azitra is well-positioned to execute these milestones, deliver transformative therapies to patients in need, and ultimately maximize shareholder value."

Pipeline and Upcoming Milestones

○ Q3 2024: First Netherton syndrome patient dosed with ATR-12

○ Q3 2024: New investigational new drug (IND) application filed and cleared with the FDA for a Phase 1/2 clinical study of ATR-04 in patients with dermal toxicity undergoing treatment with EGFR inhibitors ("EGFRi rash")

○ YE 2024: Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial

○ YE 2024: First patient dosed with ATR-04 for EGFRi rash by year end 2024

○ YE 2024: Bayer collaboration continues with update on license agreement expected by year end

○ Mid 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected

Financial Results for the Three Months Ended June 30, 2024

● Service Revenue – Related Party: The Company generated $7,500 service revenue during the quarter ended June 30, 2024, compared to $172,000 for the comparable period in 2023.

● Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2024, were $1.1 million compared to $0.8 million for the comparable period in 2023.

● General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2024, were $1.5 million compared to $0.8 million for the comparable period in 2023.

● Net Loss was $2.6 million for the quarter ended June 30, 2024, compared to $5.1 million for the comparable period in 2023.

● Cash and cash equivalents: As of June 30, 2024, the Company had cash and cash equivalents of $0.8 million.

About ATR-12

ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately 20,000 patients globally. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial that is actively recruiting adult Netherton syndrome patients (NCT06137157). Azitra has identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints.

About ATR-04

ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derived S. epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFR inhibitor ("EGFRi") associated rash, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi rash in the United States. Azitra plans to initiate a Phase 1/2 clinical study in patients undergoing EGFRi rash by year end 2024.

On August 12, 2024 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and announced financial results for the fiscal quarter ended June 30, 2024 (Press release, Erasca, AUG 12, 2024, View Source [SID1234645727]).

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"This second quarter 2024 was transformative for Erasca, driven by the successful in-licensing of a RAS-targeting franchise of potentially best-in-class and first-in-class molecules along with initiating our SEACRAFT-2 Phase 3 registrational trial for naporafenib; in addition, we strengthened our balance sheet and significantly extended our cash runway from multiple equity financings and prioritization decisions," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Naporafenib plus trametinib has shown clinically meaningful and differentiated progression free survival and overall survival benefits across Phase 1 and 2 trials in patients with NRAS-mutant (NRASm) melanoma. We may also have the opportunity to expand treatment options for patients with various RAS Q61X solid tumors based on the initial Phase 1b combination data from SEACRAFT-1 expected in the fourth quarter of the year."

Dr. Lim continued, "Our bolstered pipeline includes an exciting RAS-targeting franchise, including a pan-RAS molecular glue ERAS-0015 and a pan-KRAS inhibitor ERAS-4001, that exhibit complementary RAS inhibitory mechanisms, differentiated preclinical profiles, and the potential to expand treatment options across RAS-driven tumors. We are well-positioned to continue advancing our pipeline through multiple catalysts and deliver on our mission to develop therapies that shut down RAS-driven cancers for the benefit of patients."

Research and Development (R&D) Highlights

•
Initiated SEACRAFT-2 Pivotal Phase 3 Trial: In June 2024, Erasca announced the initiation of the global SEACRAFT-2 Phase 3 trial evaluating the pan-RAF inhibitor naporafenib in combination with the MEK inhibitor trametinib (MEKINIST) in patients with NRASm melanoma. The two-stage design is expected to provide a randomized data readout of naporafenib plus trametinib against single agent trametinib in 2025 in Stage 1 and inform the randomized Phase 2 dose for the combination. In Stage 2, the trial is expected to compare the combination against physician’s choice of chemotherapy or a single agent MEK inhibitor using dual primary endpoints of progression free survival and overall survival for regulatory approval.

Corporate Highlights

•
In-Licensed Potential Best-in-Class and First-in-Class RAS-Targeting Franchise: In May 2024, Erasca announced exclusive license agreements for two preclinical RAS programs—a potential best-in-class pan-RAS molecular glue (ERAS-0015) and a potential first-in-class pan-KRAS inhibitor (ERAS-4001). ERAS-0015 and ERAS-4001 are potent, orally bioavailable molecules with complementary RAS inhibitory mechanisms that have the potential to address unmet needs in approximately 2.7 million patients who are diagnosed annually globally with RAS-mutant (RASm) tumors, of which over 2.2 million patients are diagnosed with KRAS-mutant (KRASm) tumors.
•
Extended Cash Runway with $229 Million in Equity Financings: In March 2024, Erasca entered into a $45 million oversubscribed private placement financing led by high-quality new and existing healthcare-focused investors. Additionally, in May 2024, Erasca entered into a $184 million oversubscribed underwritten offering led by high-quality new and existing healthcare-focused investors. Together, these equity financings extended Erasca’s expected cash runway into the first half of 2027.

Key Upcoming Milestones

•
SEACRAFT-1: Phase 1b trial for naporafenib (pan-RAF inhibitor) plus trametinib in patients with RAS Q61X solid tumors
o
Initial Phase 1b combination signal-seeking efficacy data in relevant tumor types expected to be reported in Q4 2024
•
SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
o
Phase 3 Stage 1 randomized dose optimization data expected to be reported in 2025
•
AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RASm solid tumors
o
IND filing expected in H1 2025
o
Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026
•
BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRASm solid tumors
o
IND filing expected in Q1 2025
o
Initial Phase 1 monotherapy data in relevant tumor types expected to be reported in 2026

Second Quarter 2024 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $460.2 million as of June 30, 2024, compared to $322.0 million as of December 31, 2023. In April 2024, Erasca completed a $45 million private placement, raising net proceeds of $43.6 million after deducting placement agent fees and expenses. In May 2024, Erasca completed a $184 million underwritten offering, raising net proceeds of $174.4 million after deducting underwriting discounts and commissions, and offering costs. Erasca expects its current cash, cash equivalents, and marketable securities balance of $460.2 million to fund operations into the first half of 2027.

Research and Development (R&D) Expenses: R&D expenses were $33.0 million for the quarter ended June 30, 2024, compared to $26.2 million for the quarter ended June 30, 2023. The increase was primarily driven by an impairment charge on operating lease assets and property and equipment, and increases in expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, personnel costs primarily due to termination benefits in connection with a reduction in force, facilities-related expenses and depreciation, and outsourced services and consulting fees. Erasca also recorded $22.5 million of in-process R&D expense during the quarter ended June 30, 2024 for upfront payments under Erasca’s ERAS-0015 and ERAS-4001 license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $12.3 million for the quarter ended June 30, 2024, compared to $9.8 million for the quarter ended June 30, 2023. The increase was primarily driven by an impairment charge on operating lease assets and property and equipment, and an increase in legal fees.

Net Loss: Net loss was $63.2 million, or $(0.29) per basic and diluted share, for the quarter ended June 30, 2024, compared to $31.8 million, or $(0.21) per basic and diluted share, for the quarter ended June 30, 2023.

On August 13, 2024 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported business updates for the company’s top strategic priorities and provided financial results for the second quarter of 2024 (Press release, Boundless Bio, AUG 12, 2024, View Source [SID1234645749]).

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"At Boundless, we’re on a bold mission to pioneer a new category of cancer treatment for patients with oncogene amplified cancer who are in dire need of new therapeutic options," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "In the second quarter of 2024, we continued to advance our first clinical-stage ecDTx, BBI-355, began dosing patients with our second ecDTx, BBI-825, and completed the analytical validation and received IRB approval of our novel ecDNA diagnostic, ECHO, for deployment as a clinical trial assay in our BBI-355 POTENTIATE trial. Though we have made progress toward our goals, the number of patients enrolled thus far in the combination cohorts of the BBI-355 POTENTIATE trial is lower than originally projected. While we implement measures to accelerate enrollment, we have chosen to scale back our early discovery efforts and streamline our operations to extend our runway and help ensure we have the necessary capital for our core ecDTx programs. Moving forward, we believe we are well-positioned to move our lead programs through initial clinical proof-of-concept data readouts and remain steadfast in advancing this innovative approach for patients with high unmet need."

Strategic Priorities for Core Programs

Boundless Bio has outlined its core portfolio priorities to support the achievement of potential near-term catalysts and long-term patient impact. Through 2025, the company’s core strategic priorities remain:

•
Executing the ongoing Phase 1/2 POTENTIATE (Precision Oncology Trial Evaluating Novel Therapeutic Interrupting Amplifications Tied to ecDNA) clinical trial of its lead ecDNA directed therapeutic candidate (ecDTx), BBI-355, a novel, oral CHK1 inhibitor, to generate initial proof-of-concept in solid tumor cancer patients with driver oncogene amplifications;
•
Executing the ongoing Phase 1/2 STARMAP (Study Targeting Acquired Resistance: MAPK Amplifications) clinical trial of its second ecDTx, BBI-825, a novel, oral RNR inhibitor, to generate initial proof-of-concept in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance oncogene amplifications;
•
Advancing the company’s third ecDTx program, directed to a novel, previously undrugged kinesin target essential for ecDNA segregation, into IND-enabling studies; and
•
Deploying its proprietary ecDNA diagnostic in the clinic to identify ecDNA+ patients who are most likely to benefit from its ecDTx therapeutics.

In alignment with its strategic priorities, Boundless Bio has narrowed its discovery research work and, as a result, modestly reduced its workforce. The company believes the combination of these operational efficiencies and its cash, cash equivalents, and short-term investments of $179.3 million as of June 30, 2024, provides an operating runway into the fourth quarter of 2026.

BBI-355, a novel, oral, potent, selective CHK1 inhibitor targeting replication stress for cancer patients with driver oncogene amplifications

•
The company presented preclinical and clinical pharmacodynamic data on BBI-355 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024.
•
Enrollment is progressing in the Phase 1/2 POTENTIATE clinical trial evaluating BBI-355 as a single agent and in combination with targeted therapies in patients with locally advanced or metastatic solid tumors with oncogene amplifications.
•
To date, no new safety signals have been observed, and there has been no evidence of combinatorial toxicity in the dose escalation cohorts evaluating BBI-355 in combination with either the EGFR inhibitor erlotinib or the FGFR inhibitor futibatinib.
•
The initial pace of enrollment in the combination cohorts has been slower than anticipated. The company has recently implemented multiple initiatives to help accelerate enrollment, including engaging with next-generation sequencing vendors to identify patients, adding new clinical sites in the US, and preparing for the initiation of ex-US sites.
•
Based on its current projections, the company now anticipates reporting initial clinical proof-of-concept data from POTENTIATE in the second half of 2025.

BBI-825, a novel, oral, potent, selective RNR inhibitor targeting ecDNA assembly and repair for cancer patients with resistance oncogene amplifications

•
In April 2024, the company announced the first patient had been dosed with BBI-825 in the Phase 1/2 STARMAP clinical trial.
•
Multiple dose levels have been completed in the single-agent, dose-escalation portion of the STARMAP clinical trial and, to date, BBI-825 has demonstrated oral bioavailability and has been generally well-tolerated. Initial clinical proof-of-concept data from the trial are expected in the second half of 2025.

ecDTx 3, a novel kinesin program involved in ecDNA segregation

•
The company’s third ecDTx program, directed to a previously undrugged kinesin target essential for ecDNA segregation whose inhibition is synthetic lethal to ecDNA-enabled cancer cells, is currently advancing through lead optimization.

ECHO, a proprietary diagnostic for detection of ecDNA amplified oncogenes

•
The company’s proprietary ecDNA diagnostic, referred to as ECHO (ecDNA Harboring Oncogenes), is designed to detect ecDNA in patient tumor specimens. ECHO was previously determined by the FDA to be a non-significant risk device for use as a clinical trial assay (CTA) in the BBI-355 POTENTIATE trial.
•
ECHO has now been analytically validated and institutional review board (IRB)-approved for use as a CTA in the BBI-355 POTENTIATE trial.

Second Quarter 2024 Financial Results

•
Cash Position: Cash, cash equivalents, and short-term investments totaled $179.3 million as of June 30, 2024.
•
R&D Expenses: Research and development (R&D) expenses were $14.7 million for the second quarter of 2024 compared to $11.1 million for the same period in 2023.
•
G&A Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2024 compared to $2.9 million for the same period in 2023.
•
Net Loss: Net loss totaled $17.0 million for the second quarter of 2024 compared to $12.4 million for the same period in 2023.

About BBI-355

Boundless Bio’s lead ecDTx, BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing, first-in-human, Phase 1/2 POTENTIATE clinical trial (NCT05827614) in cancer patients with oncogene amplifications. CHK1 is a master regulator of cells’ response to replication stress (RS). RS is elevated in cancer cells with oncogene amplification, including on ecDNA, and, because of this, represents a key vulnerability of those cells. BBI-355 was designed to exploit the elevated RS in ecDNA-enabled oncogene amplified cancer cells by disrupting proper CHK1 function in regulating RS and thereby facilitating catastrophic RS to preferentially kill cancer cells relative to healthy cells.

About BBI-825

Boundless Bio’s second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing, first-in-human, Phase 1/2 STARMAP clinical trial (NCT06299761) in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance gene amplifications. In preclinical studies, BBI-825 demonstrated low double digit nanomolar RNR inhibition and tumor growth inhibition, including regressions, in both the prevention and treatment of amplification-mediated resistance in mitogen-activated protein kinase (MAPK) pathway-activated tumors. RNR is the rate-limiting enzyme responsible for cellular de novo synthesis of deoxynucleotide triphosphates (dNTPs), the building blocks of DNA, and is essential to the assembly and repair of ecDNA. BBI-825 was shown to dysregulate ecDNA-reliant cancer cell dNTP pools, deplete ecDNA, and was synthetic lethal in multiple oncogene amplified preclinical cancer models.

On August 11, 2024 Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") reported two upcoming oral presentations of ivonescimab (PD-1/VEGF bispecific antibody) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer ("WCLC24"), taking place in San Diego, USA from September 7-10, 2024 (Press release, Akeso Biopharma, AUG 11, 2024, View Source [SID1234645701]). Among these is a late-breaking Presidential Symposium presentation featuring results from the HARMONi-2/AK112-303 study, which evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS ≥1%).

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The late-breaking result of HARMONi-2/AK112-303 will be presented by Professor Zhou Caicun, the principal investigator of HARMONi-2 and director in the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University.

Presentations during WCLC 2024

Abstract Title

Presentation Details

Phase 3 Study of Ivonescimab (AK112) vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: Primary Analysis of HARMONi-2

Session: PL02 Presidential Symposium 1 (LIVESTREAMED)

Form: Plenary oral

Presenter: Caicun Zhou, MD. Ph.D, China Shanghai Pulmonary Hospital

Abstract release time: embargoed until the presentation day

A Phase 2 Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer

Session: Perioperative Strategies 1—Early-Stage Non-Small Cell Lung Cancer

Sunday, September 8, 2024, 11:17 AM-11:27 AM

Form: Oral

Presenter: Xiaoliang Zhao, MD, China Tianjin Medical University Cancer Institute & Hospital

Abstract release time: August 14, 2024

Akeso will also participate as an exhibitor, actively engaging with professionals from diverse fields.

Milestones of ivonescimab:

May 2024:
Ivonescimab was granted marketing approval for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"), making it the world’s first approved PD-1/VEGF bi-specific antibody.

May 31:
At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

June 01:
Interim result of the Phase III study of ivonescimab combined with platinum-doublet chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR-TKIs treatment (HARMONi-A ), was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and the study was ranked as the top report on the TOP 10 list of lung cancer at ASCO (Free ASCO Whitepaper) by OncoAlert, an international cancer support organization. On the same day, the research findings were also published simultaneously in the JAMA journal.

July 25:
Akeso’s partner, Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit,") announced a strategic five-year collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for the purpose of accelerating the development in certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer.

July 29:
The supplemental New Drug Application (sNDA) for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA). This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study.

August 02:
The supplemental New Drug Application (sNDA) for ivonescimab monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic NSCLC was accepted by China NMPA with priority review.

About Ivonescimab (AK112/SMT112)
Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’ license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

On August 9, 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 quarter ended June 30, 2024 (Press release, Soligenix, AUG 9, 2024, View Source [SID1234645693]).

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"This is a pivotal time for Soligenix with a great deal of clinical activity and upcoming milestones," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "While we prepare for the upcoming initiation of our confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease, we are incredibly encouraged by the recent positive clinical results from our comparability study evaluating HyBryte against Valchlor (mechlorethamine gel), which demonstrated a three-fold higher response rate over a 12-week treatment period and more favorable safety profile for HyBryte in the treatment of CTCL. These findings, coupled with the promising interim data from the ongoing open-label, investigator-initiated study evaluating extended HyBryte treatment, reinforce our excitement about the future of HyBryte as a potential front-line treatment option for patients with early-stage CTCL. Additionally, we will be initiating a Phase 2 study with SGX945 (dusquetide) in Behçet’s disease later this year with top-line results expected in the first half of 2025, along with top-line results expected during the same timeframe from our ongoing SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate psoriasis."

Dr. Schaber continued, "With approximately $9.1 million in cash at June 30, 2024, exclusive of the approximately $4.1 million in net proceeds from recent warrant exercises, we continue to prioritize resource allocation to achieve our goals. We have a clear vision for the future, and we are actively pursuing strategies to create long-term value for our shareholders, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On July 24, 2024, the Company received a letter from Nasdaq confirming that the Company had regained compliance with the Minimum Bid Price Rule. Accordingly, the Nasdaq Hearings Panel determined to continue the listing of the Company’s common stock and closed the matter.
On July 9, 2024, the Company announced an interim update on the open-label, investigator-initiated study evaluating extended HyBryte treatment for up to 12 months in patients with early-stage CTCL. To view this press release, please click here.
On June 25, 2024, the Company announced positive clinical results from a comparability study evaluating HyBryte versus Valchlor in the treatment of CTCL. To view this press release, please click here.
On May 16, 2024, the Company announced the publication of results of its compatibility study evaluating HyBryte for the treatment of CTCL in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. To view the publication, please click here. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2024

Soligenix’s revenues for the quarter ended June 30, 2024 were less than $0.1 million as compared to $0.2 million for the quarter ended June 30, 2023. Revenues primarily relate to government contracts and grants awarded in support of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; development of CiVax, our vaccine candidate for the prevention of COVID-19, and evaluation of HyBryte for expanded treatment in patients with early-stage CTCL.

Soligenix’s net loss was $1.6 million, or ($1.31) per share, for the quarter ended June 30, 2024, as compared to $1.6 million, or ($3.56) per share, for the quarter ended June 30, 2023. The increase in net loss was primarily due to decreases in gross profit and tax credits as well as an increase in operating expenses, offset by increases in interest income and changes in the fair value of debt during the three months ended June 30, 2024.

Research and development expenses were $0.5 million as compared to $0.8 million for the quarters ended June 30, 2024 and 2023, respectively. The decrease was primarily due to adjustment of estimated accruals for completed clinical trials offset by preliminary costs associated with the anticipated initiation of our Phase 2 study in Behçet’s Disease and the second Phase 3 CTCL trial.

General and administrative expenses were $1.2 million and $0.9 million for the quarters ended June 30, 2024 and 2023, respectively. The increase in general and administrative expenses for the three months ended June 30, 2024 was primarily attributable to an increase in legal and professional fees associated with the 2024 annual meeting of stockholders, the April 2024 public offering and the June 2024 reverse stock split of our issued and outstanding shares of common stock.

As of June 30, 2024, the Company’s cash position, exclusive of the approximately $4.1 million in net proceeds from recent warrant exercises, was approximately $9.1 million.