On February 27, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported it has entered into securities purchase agreements with new and existing healthcare focused institutional investors as well as participation from certain directors of the Company, for the purchase and sale of 7,330,121 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,330,121 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules (the "Offering") at a combined purchase price of $1.50 for the institutional investors and $1.66 for certain directors of the Company (Press release, PDS Biotechnology, FEB 27, 2025, View Source [SID1234650752]). The warrants will have an exercise price of $1.50 per share, will be immediately exercisable upon issuance and will expire 5 years from issuance. Approximately $11 million will be funded in full upon the closing of the Offering, and up to an additional $11 million may be funded upon full cash exercise of the warrants.

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The closing of the Offering is expected to occur on or about February 28, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds from the Offering are expected to be approximately $11 million.

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

The Company intends to use the net proceeds from the Offering for research and development expenses and general corporate purposes.

The Offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333- 267041) which was declared effective by the Securities and Exchange Commission (the "SEC") on September 2, 2022. The offering is made only by means of a prospectus which is part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus 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].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 26, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter and year ended December 31, 2024 (Press release, Corcept Therapeutics, FEB 26, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2024 [SID1234650625]).

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Financial Results

"Once again, we had a record number of new Korlym prescribers and a record number of patients receiving Korlym in the quarter. Physicians are increasingly aware of hypercortisolism’s true prevalence and the poor health outcomes for patients who go untreated. Screening is becoming more common and the number of patients receiving appropriate care continues to increase. We are confident that our Cushing’s syndrome business will grow for many years," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s fourth quarter 2024 revenue was $181.9 million, compared to $135.4 million in the fourth quarter of 2023. Revenue for the full year was $675.0 million, compared to $482.4 million in 2023.

Net income was $30.7 million in the fourth quarter, or $0.26 diluted net income per common share, compared to net income of $31.4 million, or $0.28 diluted net income per common share, in the fourth quarter of 2023. Net income was $141.2 million for the full year, or $1.23 diluted net income per common share, compared to net income of $106.1 million, or $0.94 diluted net income per common share, in 2023.

Cash and investments were $603.2 million at December 31, 2024 compared to $425.4 million at December 31, 2023. In 2024, Corcept paid $38.0 million to purchase its common stock pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants.

Clinical Development

"We made substantial progress in all of our clinical development programs in 2024," added Dr. Belanoff. "We submitted a New Drug Application (NDA) for our proprietary, selective cortisol modulator, relacorilant, as a treatment for hypercortisolism, based on compelling results from our GRACE, GRADIENT, long-term extension and Phase 2 studies. Our CATALYST study demonstrated that hypercortisolism is much more common than previously assumed in patients with difficult-to-control diabetes and that treatment with a cortisol modulator can significantly improve their glucose control. We expect data from ROSELLA, our pivotal study in women with platinum-resistant ovarian cancer, this quarter."

Hypercortisolism (Cushing’s Syndrome)

Relacorilant for patients with hypercortisolism – NDA submitted in December 2024
GRACE – Pivotal Phase 3 trial of relacorilant in 152 patients with all etiologies of hypercortisolism – primary endpoint achieved in randomized withdrawal phase; open-label phase demonstrated clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms; relacorilant was well-tolerated, consistent with its known safety profile, with no cases of endometrial hypertrophy or drug-induced vaginal bleeding, relacorilant-induced hypokalemia, adrenal insufficiency or QT prolongation
GRADIENT – Supportive data for NDA – Patients treated with relacorilant exhibited clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms in randomized, double-blind, placebo-controlled, Phase 3 trial in 137 patients with hypercortisolism caused by adrenal gland pathology; relacorilant was well-tolerated, consistent with its known safety profile, including no cases of endometrial hypertrophy or drug-induced vaginal bleeding, relacorilant-induced hypokalemia, adrenal insufficiency or QT prolongation
Phase 3 long-term extension study – Supportive data for NDA – clinically meaningful and durable cardiometabolic improvements exhibited in 116 patients who completed the GRACE, GRADIENT or Phase 2 relacorilant studies, with no new or notable safety signals observed; treatment duration of up to six years
CATALYST Part 1 – Of 1,057 patients with difficult-to-control type 2 diabetes, 23.8 percent were found to have hypercortisolism
CATALYST Part 2 – Primary endpoint met in randomized, double-blind, placebo-controlled study of 136 patients identified with hypercortisolism in CATALYST Part 1; patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, with a decrease from baseline of 1.47 percent compared to a decrease of 0.15 percent in patients who received placebo (p-value: < 0.0001); safety profile of Korlym in this study was consistent with the medication’s label; no new adverse events were observed
MOMENTUM – 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension to begin this quarter
"The positive results from our pivotal GRACE study, and confirmatory evidence from our GRADIENT, long-term extension and Phase 2 studies, provide powerful support for relacorilant’s NDA in hypercortisolism. Patients in these studies experienced clinically significant improvements in a wide array of hypercortisolism’s signs and symptoms, without the off-target effects and toxicities that accompany currently available treatments. Relacorilant’s strong efficacy and safety profile positions it to become the new standard of care for patients with hypercortisolism," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

"CATALYST is a landmark study that will change the way physicians treat some of their sickest patients. Its findings are striking: One-in-four patients whose type 2 diabetes resists treatment with the best available medications have hypercortisolism and hyperglycemia in these patients responds powerfully to treatment with a cortisol modulator," added Dr. Guyer. "We plan to build on these findings. Our MOMENTUM study will establish the prevalence of hypercortisolism in patients with resistant hypertension."

Oncology

ROSELLA – Results expected this quarter from pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer
Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
"If ROSELLA replicates the positive results of our large, controlled, Phase 2 study, it will constitute a major medical advance and serve as the basis for relacorilant’s next NDA. We expect progression-free survival results this quarter," said Dr. Guyer. "Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer."

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – In a randomized, double-blind, placebo-controlled Phase 2 study in 249 patients with ALS, dazucorilant did not meet its primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R); a statistically significant improvement in overall survival at week 24 was observed; an open-label, long-term extension study is ongoing and one-year overall survival results are expected in the second quarter
"ALS is a devastating disease, with few good treatment options. In DAZALS, patients who received dazucorilant did not show improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R), which was the study’s primary endpoint. An improvement in overall survival was observed at week 24 of the study – no deaths (0 of 83 patients) were observed in the 300 mg dazucorilant arm, compared to 5 deaths (5 of 82 patients) in the placebo group (p-value: 0.02). The open-label, long-term extension study is ongoing and we expect one-year overall survival results in the second quarter," said Dr. Guyer.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment continues in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in 120 patients with biopsy-confirmed MASH and in 75 patients with presumed MASH
"In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our MONARCH study," said Dr. Guyer.

Conference Call

We will hold a conference call on February 26, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

On February 26, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported the presentation of a compilation of data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) IO Conference (Press release, Sonnet BioTherapeutics, FEB 26, 2025, View Source [SID1234650641]).

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As part of the conference, Dr. Sant Chawla, Principal Investigator at the Sarcoma Oncology Center in Santa Monica, California, presented a poster entitled, "Combination immunotherapy with an albumin-binding interleukin-12 fusion protein that extends cytokine half-life, targets the tumor microenvironment, and enhances therapeutic efficacy." This is the first time the overall strategy of Sonnet’s Fully Human Albumin Binding (FHAB) platform has been compiled with existing data and presented in a poster. The presented poster is now available on the Publications page of the Company’s website.

SON-1010 is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using genetic fusion to the FHAB platform, which extends the half-life and bioactivity of the IL-12 component due to binding native albumin in the serum. Albumin binding to FcRn, GP60, and SPARC results in an improved PK profile, decreased toxicity risk, and a broader therapeutic index preclinically, with significant targeting of the tumor microenvironment and increases in activated NK, NKT, Th1, and cytotoxic CD8 T cells, as well as marked repolarization of pro-tumor M2 MDSCs to inflammatory M1 APCs.

"Recombinant interleukins have generally had limited clinical success due to inefficient tumor targeting, short half-lives, and off-target toxicity. As previously disclosed, our novel FHAB platform has demonstrated the potential for us to design product candidates that safely extend the half-life of cytokines and deliver them to the tumor, where they can convert the immunological response from ‘cold’ to ‘hot’ and potentially realize the promise of immunotherapy. We are pleased to share the compilation of data in this poster presentation and look forward to announcing additional data from our ongoing studies evaluating our SON-1010 platform in 2025," commented Pankaj Mohan, Ph.D., Founder and Chief Executive Officer of Sonnet.

Key Highlights:

● A platform strategy was developed that links cytokines to the FHAB as mono- or bifunctional fusions to bind native albumin at both physiologic and acidic pH, taking advantage of albumin’s long serum half-life and concentration in tumors, allowing delivery to and accumulation of the drug in the TME. IL-12 is a potent cytokine that stimulates the innate and adaptive immune responses, functioning in combination with other cytokines, like IL-15 and IL-18. Several approaches are currently being studied in humans, such as:

○ SON-1010 monotherapy at the highest dose is continuing in patients with advanced solid tumors. In December 2024, the Company disclosed clinical benefit in 48% of patients, including a partial response at the highest dose in a patient with clear cell sarcoma. The poster reflects the current status of this trial.

○ Co-administration with a checkpoint inhibitor (atezolizumab) to activate local immune cells and upregulate PD-L1 in the TME. Safety has been monitored at each dose escalation step and the most common adverse events at each dose level have been updated for the results currently available.

○ SON-1010 is being administered alternating with an immunoreactive chemotherapy drug (trabectedin) to enhance its ability to activate a pro-inflammatory phenotype in the TME.

○ Alternating administration with a potent chemotherapeutic regimen (NALIRIFOX) will be done in front-line patients with pancreatic ductal adenocarcinoma (PDAC) to enhance their response.

● Each setting has the potential to augment the effects of the licensed therapy in populations that continue to have high unmet needs for an improved outcome. Immunotherapy allows greater flexibility in selecting potentially synergistic combinations for rational implementation.

● SON-1010 and SON-1210 address paramount safety and tolerability factors, which have traditionally hindered the use of therapeutic cytokines in the treatment of solid tumors, by extending the cytokine half-life and improving the therapeutic index that may result in better patient outcomes.

SON-1010 is being evaluated in a Phase 1b/2a dose-escalation and proof-of-concept study (SB221) in combination with SON-1010 and atezolizumab (Tecentriq) (in collaboration with Genentech, a member of the Roche Group), which is focused on platinum-resistant ovarian cancer (PROC) (NCT05756907). The extended PK of SON-1010, along with its ability to induce IFNγ in the TME causing upregulation of PD-L1, creates an opportunity for synergistic activity. Enrollment remains ongoing and an update on safety at the MTD in that trial is expected in Q1 calendar year 2025. Another trial evaluating dose escalation of SON-1210 (IL12-FHAB-IL15), followed by its combination with NALIRIFOX in patients with metastatic pancreatic cancer, is expected to begin later this calendar year.

About SON-1010

SON-1010 is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. This single-chain antibody fragment was selected to bind albumin both at normal pH, as well as at the acidic pH typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only IL-12, but a variety of potent immunomodulators that can be linked using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), several types of cancer, such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant to this approach. SON-1010 is designed to deliver IL-12 to local tumor tissue, turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.

On February 26, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA," the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, FEB 26, 2025, View Source [SID1234650657]). Following successful outcomes to date in THIO-101, the expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy.

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The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo (cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia.

MAIA recently announced an amended clinical supply agreement with Regeneron to include the expansion portion of THIO-101. Under terms of the amended agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients including the additional patients in the expansion and potentially, the registration studies.

"We are excited to start the expansion arm of our THIO-101 trial which is designed to determine overall response rates in third line NSCLC. We expect to have new patients enrolled in the coming weeks," said Vlad Vitoc, M.D., CEO of MAIA. "Through THIO-101 to date, THIO has delivered unprecedented disease control, response, and survival results. Continued efficacy and safety data generated by our study could support an FDA NDA submission directly, particularly as we plan to seek an accelerated approval of THIO in the U.S.

"We have multiple milestones that we believe are attainable for 2025 and we look forward to keeping our shareholders and investors well informed of our progress on value creation," Dr. Vitoc added.

As of January 15, 2025, data indicated that Median Overall Survival (OS) in third-line treatment was reached at 16.9 months, with a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months). The treatment has been generally well-tolerated to date in this heavily pre-treated population1.

Details on safety can be found on the previously announced SITC (Free SITC Whitepaper) 2024 presentation available on MAIA’s website.

About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On February 26, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 10:30 a.m. ET (Press release, CRISPR Therapeutics, FEB 26, 2025, View Source [SID1234650626]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.