On June 16, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has closed the third $5 million tranche of the previously announced Standby Equity Purchase Agreement (the "SEPA") with YA II PN, Ltd. ("Yorkville"), an investment fund managed by Yorkville Advisors Global, LP (Press release, FibroBiologics, JUN 16, 2025, View Source [SID1234653918]). The agreement allows FibroBiologics, subject to customary conditions, to sell up to $25 million in the aggregate of its common stock to Yorkville over the course of two years.

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Yorkville agreed to advance to FibroBiologics the first $15 million available under the SEPA in three equal tranches to be evidenced by convertible promissory notes. The first tranche in the amount of $5 million was funded upon entry into the SEPA and the second tranche of $5 million was funded after the filing of a registration statement covering the resale of the shares issuable to Yorkville under the promissory notes. The third tranche of $5 million was funded following the effectiveness of the registration statement and receipt of shareholder approval in satisfaction of certain Nasdaq rules. FibroBiologics can sell an additional $10 million of its common stock to Yorkville, subject to Yorkville’s consent and other conditions, while the convertible promissory notes remain outstanding.

The net proceeds of the financing are expected to be used for general corporate purposes, including funding for research and development programs and supporting the upcoming Phase 1/2 diabetic foot ulcer clinical trial expected to begin in the second half of 2025.

For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected]. For more information on the SEPA, including important terms and conditions, please see FibroBiologics’ filings with the Securities and Exchange Commission, including its Current Reports on Form 8-K filed with the Securities and Exchange Commission from time to time.

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

D. Boral Capital LLC acted as the exclusive placement agent in connection with the SEPA.

On June 16, 2025 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, reported that the company is participating in the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts (Press release, Enveric Biosciences, JUN 16, 2025, View Source [SID1234653917]).

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During the conference, CEO and Director of Enveric, Joseph Tucker, Ph.D., will conduct one-on-one meetings with registered investors and potential partners, showcasing the company’s business and development strategy, recent corporate achievements, and anticipated milestones.

On June 16, 2025 Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DSB2455, its next-generation, CNS-active selective PARP1 inhibitor, for the treatment of patients with brain metastases originating from primary triple-negative breast cancer (TNBC) tumors harboring BRCA1/2 and/or homologous recombination repair (HRR) alterations (Press release, Duke Street Bio, JUN 16, 2025, View Source [SID1234653916]).

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DSB2455 is a potentially best-in-class agent within the PARP1-selective inhibitor space, offering a differentiated profile that may expand therapeutic possibilities in hard-to-treat indications. The compound is a next-generation, highly PARP1-selective inhibitor with demonstrated brain penetrance and potent anti-tumour activity in preclinical models of homologous recombination-deficient cancers, including brain metastases.

The Fast Track designation is intended to facilitate the development of new therapies for serious conditions where there is significant unmet medical need. It allows for more frequent interactions with the FDA, eligibility for rolling review of an NDA, and potential consideration for Priority Review or Accelerated Approval.

"Receiving Fast Track designation for DSB2455 represents an important milestone in our mission to develop more targeted and effective therapies for patients with limited treatment options," said Alan Wise, Chief Executive Officer of Duke Street Bio. "Next-generation PARP1-selective inhibitors such as DSB2455 are expected to offer a wider therapeutic window than earlier PARP inhibitors, potentially enabling broader use both as monotherapy and in combination with other anti-cancer agents across a range of tumors."

"DSB2455’s ability to achieve therapeutically relevant concentrations in the CNS represents a key differentiator," added Dónal Landers, Chief Medical Officer of Duke Street Bio. "This could offer a new treatment option for patients with secondary HRD brain metastases, where clinical need remains high and current therapeutic choices are limited."

About Fast Track Designation
The FDA’s Fast Track program is designed to accelerate the development and review of new drugs for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Companies granted this designation benefit from more frequent communication with the FDA and eligibility for rolling submissions and other expedited review processes.

On June 16, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that it will host an in-person and virtual R&D Day in New York on Thursday, June 26, 2025, from 9:00 AM to 12:00 PM ET (Press release, Crinetics Pharmaceuticals, JUN 16, 2025, View Source [SID1234653915]).

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The event will provide an update including data on Crinetics’ early-stage pipeline assets, next steps, and portfolio strategy to drive long-term value. Key topics will include:

NETs and beyond – NDC platform with CRN09682
Graves’ disease and thyroid eye disease (TED) – TSH antagonist
Autosomal polycystic kidney disease (ADPKD) – SST3 agonist
A live question-and-answer session will follow the formal presentations.

On June 16, 2025 Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC) (Press release, Circle Pharma, JUN 16, 2025, View Source;utm_medium=rss&utm_campaign=circle-pharma-receives-fda-orphan-drug-designation-for-cid-078-for-the-treatment-of-small-cell-lung-cancer [SID1234653914]).

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Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression2.

"The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options," said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. "We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices."

The FDA’s Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants4.

Circle Pharma has initiated a Phase 1 clinical trial (NCT06577987) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program
CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients.