On March 3, 2025, Viridian Therapeutics, Inc. (the "Company") reported to have entered into an Open Market Sale Agreement (the "Sale Agreement") with Jefferies LLC, as sales agent (the "Sales Agent"), pursuant to which the Company may offer and sell from time to time through the Sales Agent, shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), having an aggregate offering price of up to $300,000,000 (the "Shares") (Filing, Viridian Therapeutics, MAR 3, 2025, View Source [SID1234650886]). The Company intends to use the net proceeds from the offering, if any, to further the clinical development of the Company’s product candidates and prepare for commercialization of any of the Company’s product candidates that receive regulatory approval, including veligrotug, as well as for working capital and general corporate purposes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3ASR (File No. 333-267351) (the "Registration Statement"), which the Company filed with the U.S. Securities and Exchange Commission (the "SEC") on September 9, 2022 and which became effective upon filing. The Company filed a prospectus supplement, dated March 3, 2025, to the Registration Statement with the SEC in connection with the entry into the Sale Agreement.

Subject to the terms and conditions of the Sale Agreement, the Sales Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has provided the Sales Agent with customary indemnification and contribution rights, and the Sales Agent will be entitled to a commission of up to 3.0% of the gross proceeds of Shares sold pursuant to the Sale Agreement.

Sales of the Shares, if any, under the Sale Agreement may be made in privately negotiated transactions with the consent of the Company, as block transactions, or by any other method permitted by law deemed to be an "at the market offerings" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Shares and may at any time suspend sales under the Sale Agreement. The Sale Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the Sale Agreement and (ii) the termination of the Sale Agreement as permitted therein. The Company and the Sales Agent may each terminate the Sale Agreement at any time upon ten days’ prior notice.

The foregoing description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the Sale Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference.

The legal opinion of Ropes & Gray LLP relating to the Shares being offered pursuant to the Sale Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

On March 3, 2025 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported the acceptance of two abstracts for poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Spring Scientific Meeting taking place March 12-14, 2025, in San Diego, C.A (Press release, Adicet Bio, MAR 3, 2025, View Source [SID1234650863]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Details of the poster presentation are as follows:

Abstract Title: ADI-270, an Armored Allogeneic Anti-CD70 γδ CAR T Cell Therapy, Demonstrates Improved Efficacy and Safety in Preclinical Models Compared to Conventional αβ CAR Benchmarks
Poster/Abstract Number: 39
Presenting Author: Shon Green, Ph.D.
Date/Time: Wednesday, March 12, 2025, from 5:10 p.m. – 6:45 p.m. PT

Abstract Title: A Phase 1/2 First in Human Study of ADI-270, an Armored Allogeneic Anti-CD70 Chimeric Antigen Receptor γδ T Cell Therapy, in Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)
Poster/Abstract Number: 136
Presenting Author: Gregory Vosganian, M.D.
Date/Time: Thursday, March 13, 2025, from 5:00 p.m. – 6:30 p.m. PT

On March 3, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported the first preclinical data on SOT109, a novel antibody-drug conjugate (ADC) targeting cadherin-17 (CDH17) (Press release, SOTIO, MAR 3, 2025, View Source [SID1234650862]). The data highlight SOT109’s promising activity and tolerability profile across multiple disease models, reinforcing its potential to become a best-in-class therapeutic for the treatment of colorectal cancer and other gastrointestinal (GI) cancers. The findings were presented at the 15th World ADC London 2025, taking place from March 3 to 6 at Novotel London West, London, UK.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited to share groundbreaking data on SOT109, an innovative ADC designed to treat colorectal cancer and other GI malignancies," said Martin Steegmaier, Ph.D., chief scientific officer of SOTIO. "CDH17 has long been recognized as a highly compelling therapeutic target, yet previous non-ADC and ADC approaches have faced significant obstacles. Our cutting-edge design overcomes these challenges, utilizing state-of-the-art linker-payload technology and an optimized antibody backbone to enhance efficacy and tumor selectivity. Preclinical data indicate that our candidate not only delivers potent tumor cell killing but does so with an excellent safety profile and high therapeutic index. We believe this represents a major advancement in ADC development for GI cancers, and we look forward to filing an Investigational New Drug (IND) application for this program in Q2 2026."

CDH17 is a highly promising target homogenously overexpressed in more than 90% of colorectal cancers (CRC) and abundantly expressed in other GI cancers, including gastric, pancreatic, and esophageal cancers. In contrast, its expression in normal adult tissues is largely restricted to the GI tract, reducing the risk of off-target toxicity.

As CDH17 is an abundantly expressed and rapidly internalizing transmembrane protein on GI cancer cells, CDH17 is ideally suited for an ADC-mediated drug delivery approach. SOT109 is a fully human and highly specific ADC with exceptional binding and internalization properties against CDH17. SOT109 utilizes Synaffix’s clinically validated ADC platform, incorporating the SYNtecan E proprietary linker-payload system that contains an exatecan payload (DAR=4). For the treatment of CRC, SOT109’s exatecan payload is expected to demonstrate superior activity, reduced susceptibility to resistance, and an enhanced bystander effect due to its high cell permeability, setting it apart from other ADC payloads utilized to date.

In preclinical studies presented at World ADC London, SOT109 exhibited strong anti-tumor activity across multiple mouse xenograft models, including complete responses. It demonstrated favorable tolerability in an exploratory mouse study at doses up to 150 mg/kg. Furthermore, data from a subsequent toxicity study in non-human primates (NHPs) revealed that SOT109 displays a favorable therapeutic index underscoring its potential as a transformative therapy for GI cancers.

On March 3, 2025 Laekna (2105.HK) reported that the U.S. Food and Drug Administration (FDA) has approved the IND for LAE120, an internally discovered USP1 inhibitor, for the treatment of advanced solid tumors (Press release, Laekna Therapeutics, MAR 3, 2025, View Source [SID1234650861]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

LAE120 is a novel, allosteric and highly potent USP1 inhibitor, displaying monotherapy potency and combination activity with PARP inhibitor in HRD (homologous recombination deficiency) cancers. It has a unique chemical structure differentiated from all the other disclosed USP1 inhibitors and is expected to induce a different conformational change in USP1. LAE120 shows robust tumor inhibitory activity across various xenograft models such as MDA-MB-436 and K562 as a single agent and exhibits synergistic effect in combination with PARP inhibitors. It also demonstrates good therapeutic windows in GLP long-term toxicology study. Laekna is actively exploring partnerships to accelerate the clinical development of LAE120.

"Leveraging our deep know-how and extensive expertise in drug discovery, Laekna has developed a distinctive portfolio of innovative drug candidates through the close collaboration of our Med Chem, Biology and AIDD (AI-driven Drug Discovery) teams, continuously advancing preclinical drug candidates into clinical stage. Laekna has also significantly accelerated the progress of drug discovery by utilizing cutting-edge artificial intelligence tools," said Dr. Justin Gu, Chief Scientific Officer of Laekna. "We look forward to bringing novel drugs to patients as swiftly as possible," he added.

Advancing Diversified Pipelines

Laekna is actively advancing preclinical drug candidates. In the fourth quarter of 2024, another internally discovered anti-tumor drug candidate, LAE118, a potentially best-in-class, mutant-selective PI3Kαinhibitor, has advanced to IND-enabling study. PI3Kα mutations are prevalent in patients with breast, colorectal, lung, endometrial, and numerous other cancers. However, the first-generation drugs targeting PI3Kα inhibit the wild-type and mutant PI3Kα with equal potency, which raises concerns of tolerability and therapeutic efficacy.

As a novel allosteric inhibitor, LAE118 demonstrates excellent potency and selectivity towards various PI3Kα mutants. With superior anti-cancer efficacy and tolerability than other current PI3Kα inhibitors, LAE118 is potentially the best-in-class pan-mutant-selective PI3Kα inhibitor. Laekna has presented the preclinical characterization of LAE118 at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. LAE118 is in IND-enabling studies and IND is expected to be filed in the fourth quarter of 2025.

Strategic Partnerships to Accelerate Globalization

"We will continue to advance and expand our product portfolio in the therapeutic areas where we have accumulated tremendous experience and extensive know-how," said Dr. Chris Lu, Chief Executive Officer of Laekna. "In November 2024, the Group has entered into a clinical collaboration agreement with Lilly (NYSE:LLY) to support and accelerate global clinical development of LAE102 for the treatment of obesity. We plan to pursue strategic partnerships with global leading pharmaceutical companies to accelerate clinical development and commercialization of our drug candidate assets. We keep advancing and expanding our pipeline and are committed to bringing life-changing medicines to more people around the world," he added.

On March 3, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard) (Press release, Nuvation Bio, MAR 3, 2025, View Source [SID1234650860]). The transaction comprises a royalty interest financing of $150 million and a senior term loan of up to $100 million. These financings strengthen Nuvation Bio’s balance sheet to fully fund commercialization of taletrectinib in the U.S., if approved, and development of the Company’s current clinical-stage pipeline. The transaction also provides Nuvation Bio with a path to potential profitability without the need to raise additional capital.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This transaction is a significant milestone for Nuvation Bio as we prepare to bring taletrectinib to the U.S. market, subject to FDA approval, in mid-2025," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "With these financings, we are well positioned to launch taletrectinib and drive continued development of our clinical-stage pipeline—all without the need for additional fundraising. This also improves our flexibility to pursue strategic opportunities to deploy our capital. We are thrilled to have support from Sagard and appreciate their shared confidence in taletrectinib and Nuvation Bio as we continue toward our goal of improving outcomes for patients with cancer."

Subject to the approval of taletrectinib by the U.S. Food and Drug Administration (FDA) on or prior to September 30, 2025, Sagard will provide Nuvation Bio with an upfront cash payment of $150 million. In return, Sagard will receive tiered royalties on U.S. net sales of taletrectinib, including 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. Nuvation Bio will retain all annual U.S. net sales above $1 billion. Payments to Sagard will cease upon the earliest occurrence of total royalties reaching 1.6 times its investment by June 30, 2031, 1.75 times its investment by June 30, 2034, or 2.0 times its investment thereafter.

"We are excited to partner with Nuvation Bio, an organization with deep oncology expertise and a commitment to delivering transformative therapies," said Raja Manchanda, Partner at Sagard Healthcare Partners. "We believe taletrectinib has the potential to redefine the treatment landscape for patients with ROS1-positive non-small cell lung cancer, and we are pleased to provide a structured financing that supports both potential near-term commercialization and long-term growth."

In addition to the royalty financing, Sagard has committed to a 5-year, senior secured term loan of up to $100 million, with $50 million to be funded upon U.S. FDA approval of taletrectinib on or prior to September 30, 2025. The second tranche of $50 million is available at Nuvation Bio’s option until June 30, 2026, as long as Nuvation Bio has achieved first U.S. commercial sale of taletrectinib. The term loan will bear interest at SOFR + 6.00%, subject to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, with all outstanding principal due at maturity.

TD Cowen served as financial advisor and Cooley LLP served as legal advisor to Nuvation Bio. Sidley Austin LLP served as legal advisors to Sagard.