On September 23, 2025 Monopar Therapeutics Inc. (Nasdaq: MNPR) ("Monopar Therapeutics", "Monopar", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, reported the pricing of an underwritten registered offering of 1,034,433 shares of its common stock at an offering price of $67.67 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 960,542 shares of common stock at the purchase price of $67.669 per pre-funded warrant, which represents the offering price per share for the common stock less a $0.001 per share exercise price (Press release, Monopar Therapeutics, SEP 23, 2025, View Source [SID1234656171]).

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The gross proceeds to Monopar from the offering net of the anticipated Stock Repurchase (as defined below), but before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $100 million. Monopar intends to use such remaining net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

Monopar Therapeutics intends to use up to $35 million of the proceeds from the offering to purchase shares of its common stock held by Tactic Pharma, LLC in a privately negotiated transaction at $63.6098 per share, which is the same price per share as the price at which the shares are being sold to investors in the offering, less underwriting discounts and commissions (the "Stock Repurchase").

The offering is expected to close on or about September 25, 2025, subject to customary closing conditions.

Morgan Stanley, Leerink Partners and Barclays are acting as the lead book-running managers for the offering.

The securities in the registered offering are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-289947), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on August 29, 2025, and declared effective on September 9, 2025. A prospectus supplement and accompanying prospectus describing the terms of the registered offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered offering, when available, may also be obtained by contacting Morgan Stanley & Co. LLC at Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email: [email protected]; Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Barclays Capital Inc., Attn: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, 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 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 jurisdiction.

On September 23, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM) demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint (Press release, Bristol-Myers Squibb, SEP 23, 2025, View Source [SID1234656170]). In accordance with the trial design and based on the recommendation from the Data Monitoring Committee, the trial will continue without changes to evaluate the other dual-primary endpoint of progression-free survival (PFS), and the key secondary endpoint of overall survival and safety. The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.

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"This result builds on our significant experience in both targeted protein degradation and developing new treatment options for patients living with multiple myeloma," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy. "Iberdomide represents the first of a novel class of medicines, called CELMoDs, which has the potential to create a new foundation for multiple myeloma treatment that may be combined with other therapies."

The company plans to discuss these results with health authorities.

About EXCALIBER-RRMM
EXCALIBER-RRMM (NCT04975997) is a Phase 3, multicenter, two-stage, randomized, open-label study evaluating the efficacy and safety of iberdomide in combination with daratumumab and dexamethasone (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma (RRMM). The study is designed to assess dual-primary endpoints of minimal residual disease (MRD) negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), and health-related quality of life (HR-QoL). Stage 1 of the study identified 1.0 mg iberdomide as the optimal dose based on safety, pharmacokinetics, and efficacy data. In Stage 2, approximately 664 patients were randomized to receive either IberDd or DVd.

About Minimal Residual Disease (MRD)
Minimal residual disease (MRD) refers to the small number of cancer cells that may remain in a patient’s body after treatment and are undetectable using conventional diagnostic methods. In multiple myeloma, MRD assessment has emerged as a highly sensitive and clinically meaningful tool for evaluating treatment response. MRD negativity does not necessarily mean all cancer cells are gone, but it may predict improved clinical outcomes, including longer remission and survival.

Modern MRD detection methods, such as next-generation sequencing (NGS) and next-generation flow cytometry (NGF), can identify one malignant cell among 100,000 (threshold for MRD) to 1,000,000 normal cells, offering unprecedented precision in measuring disease burden. MRD is increasingly being used in clinical trials as a surrogate endpoint for progression-free survival (PFS) and is gaining recognition from regulatory authorities for its role in accelerating therapeutic development.

About Targeted Protein Degradation and Novel CELMoD Agents
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered "undruggable." We are the only company that has successfully developed and commercialized protein degrader agents – immunomodulatory drugs (IMiD) which helped establish the current standard of care in the treatment of multiple myeloma. We are building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD agents, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach allows us to match the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb.

On September 23, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech"), alongside its artificial intelligence ("AI") company InstaDeep Ltd. ("InstaDeep"), reported it will host its second AI Day, an edition of BioNTech’s "Innovation Series", at 09:00 a.m. EDT (3:00 p.m. CEST) on Wednesday, October 1, 2025, in London, United Kingdom (Press release, BioNTech, SEP 23, 2025, View Source [SID1234656169]). The event will provide an overview of BioNTech’s AI strategy and capabilities, and the application of AI in BioNTech’s pipeline and internal processes.

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The live webcast of the event will be available via this link.

Participants may also access the slides and a recording of the event via the "Events & Presentations" page in the Investor Relations section of BioNTech’s website at www.BioNTech.com. The recording will be available shortly after the event’s conclusion and archived on BioNTech’s website for one year thereafter.

On September 23, 2025 SEED Therapeutics, Inc. ("SEED"), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, reported the successful completion of its $30 million Series A-3 financing, alongside U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its lead program targeting RBM39 (Press release, Seed Therapeutics, SEP 23, 2025, View Source [SID1234656168]). The company anticipates entering first-in-human clinical trials of ST-01156 in Q1 2026.

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The $30 million Series A-3 financing consists of a $24 million first close completed in August 2024 and a $6 million second close completed in August 2025. In addition, SEED has received close to $60 million in equity, as well as collaboration upfront and milestone payments combined, from its partnerships with Eli Lilly and Eisai reflecting strong partner validation of its scientific platform.

Lan Huang, Ph.D., SEED Co-Founder, Chairman, and Chief Executive Officer, said:
"FDA clearance of our IND is a defining milestone for SEED, marking our transition into a clinical-stage company. ST-01156 represents the first of a new generation of rationally designed molecular glue degraders. We continue to translate innovation into meaningful therapies for patients."

Bill Desmarais, SEED Chief Financial Officer and Chief Business Officer, added:
"Our equity financing, together with collaboration payments from Eli Lilly and Eisai, supplement our resources to move confidently into the clinic and to continue building a broad pipeline. We have the partners, capital, and momentum to deliver on SEED’s strategy."

SEED Therapeutics is a TPD 2.0 company that integrates structure-based drug design, computational chemistry, and chemical biology to discover molecular glues that reprogram the ubiquitin-proteasome system to degrade disease-causing proteins. Its proprietary RITE3 platform has generated a growing pipeline of nine programs spanning oncology, neurodegeneration, immunology, and virology.

On September 23, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next generation targeted protein degradation (TPD) medicines, reported first data on its TEAD oncology therapeutic program including unveiling a new mechanism of action for the degradation of TEAD that is differentiated from cereblon- or VHL-based PROTACs (Press release, Amphista Therapeutics, SEP 23, 2025, View Source [SID1234656167]). Amphista’s novel TEAD Targeted Glues, which are inherently smaller and more drug like molecules than conventional PROTAC binders, have demonstrated:

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Novel mechanism of degradation: Amphista’s pan-TEAD Targeted Glue series induces degradation via functional recruitment of the E3 ligase FBXO22 (F-Box Protein 22), a mechanism of degradation that has not previously been described for TEAD.
Highly specific degradation of TEAD:Global proteomics demonstrates complete, and statistically significant, selective, degradation of TEAD vs >7000 other proteins.
Deep target degradation via oral dosing: Leveraging high-resolution cryo-EM, Amphista has designed sub-nM degraders of TEAD which induce >95% degradation of TEAD in vivo after a single oral dose.
Exceptional degradation dynamics: Amphista’s Targeted Glues achieve >90% TEAD degradation within 2 hours (the first time point measured) of single dosing, sustained at >70% through to at least 72 hours,
Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "Soon after disclosing initial details of our SMARCA2 oncology program, the first unveiling of a completely novel mechanism of action for the degradation of TEAD, represents another significant milestone for Amphista, as well as the wider targeted protein degradation field. The development of potent, rapid, orally bioavailable Targeted Glue degraders of TEAD that work via FBXO22 is testament to the power of our Eclipsys platform and our brilliant multidisciplinary team. What is particularly exciting are the structural insights that we are gaining from our technology as we build our cryo-EM datasets. Not only are these helping Amphista generate differentiated, higher quality molecules with the properties that will enable them to become medicines, but they are also unlocking mechanistic insights into the development and optimisation of Amphista’s Targeted Glues which operate through diverse ligases. The progress we have made across our portfolio this year, which includes the disclosure of two completely novel mechanisms for the degradation of therapeutically relevant targets is exceptional. I am looking forward to sharing further data and updates as we look to select our clinical candidates for TEAD and SMARCA next year."

Amphista plans to present data from its TEAD Targeted Glue program at a key forthcoming TPD scientific conference.

This news on Amphista’s TEAD Targeted Glue program follows an announcement by the Company on 17 September 2025, which disclosed first data on its SMARCA2 program including demonstrating exquisite selectivity of its sequentially bifunctional Targeted Glues for SMARCA2 over the closely related homolog, SMARCA4.