On June 12, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX) ("Quince" or the "Company"), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants ("Warrants") that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses (Press release, Quince Therapeutics, JUN 12, 2025, View Source [SID1234653847]).

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The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash.

At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions.

Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement.

The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

This news release does not constitute an offer to sell or the solicitation of an offer to buy 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 June 12, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) in Milan, Italy (Press release, ADC Therapeutics, JUN 12, 2025, View Source [SID1234653863]). The Company will host a conference call and webcast featuring LOTIS-7 trial principal investigator and EHA (Free EHA Whitepaper) presenting author, Juan Alderuccio, MD, Clinical Site Disease Group Leader, Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine today at 8:00 a.m. ET to discuss the results. To access the conference call, please register here.

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"The data seen in this study with the combination of ZYNLONTA and glofitamab has shown a manageable safety profile along with strong efficacy data from patients with relapsed or refractory DLBCL, with complete responses observed regardless of prior therapy, including CAR-T," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "The combination of these two anti-cancer agents holds significant promise for advancing the treatment landscape and addressing unmet need in patients with these hard-to-treat lymphomas."

The presentation highlights updated data as of April 14, 2025, in which r/r LBCL patients received dose levels of 120 µg/kg or 150 µg/kg of ZYNLONTA plus the bispecific antibody glofitamab, with 41 patients evaluable for safety and 30 patients evaluable for efficacy.

Key highlights of the LOTIS-7 data presentation are as follows:

Best overall response data among the 30 efficacy evaluable patients shows overall response rate (ORR) of 93.3% (28/30 pts) as assessed by Lugano Criteria
Complete response (CR) rate of 86.7% (26/30 pts)
Of these, 25/26 patients achieving CR remain in CR as of the data cut-off
Median time to CR in 120 µg/kg = 80 days
Median time to CR in 150 µg/kg = 42 days
12 patients converted from stable disease (SD) or partial response (PR) to CR over time (1 and 11 pts respectively)
Of the 6 patients previously treated with CAR-T and undergoing response assessment, 5 achieved a CR
Among the 41 safety evaluable patients, the combination was generally well tolerated with a manageable safety profile and no DLTs across dose levels
Grade 3 or higher treatment emergent adverse events (TEAEs) observed in > 5% of patients included neutropenia (24.4%), anemia (9.8%), AST increased (7.3%), GGT increased (7.3%), and thrombocytopenia (7.3%)
In the 150 µg/kg dose, cytokine release syndrome (CRS) (23.8%), all of which were Grade 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) (4.8%), with one case of Grade 2, were observed
In the 120 µg/kg dose, CRS all grades (55%), all of which were Grade 1/2 except one case of Grade 3, and ICANS (10%), with one case of Grade 1 and one case of Grade 2, were observed
TEAEs leading to discontinuation included 3 each for ZYNLONTA and glofitamab
There were no Grade 5 TEAEs observed
"We believe these new data are differentiating and further reinforce the potential of ZYNLONTA plus the bispecific glofitamab to improve outcomes for DLBCL patients who need it most," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "This early safety and efficacy data support the ongoing expansion of this study to 100 patients at the 150 µg/kg dose of ZYNLONTA plus glofitamab. We look forward to discussing the results with Dr. Alderuccio during our conference call today in addition to the presentation of the data set across two key conferences."

This data will be shared at EHA (Free EHA Whitepaper)2025 during a poster presentation on June 14 at 6:30 p.m. CEST and also as an oral encore presentation at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20 at 9:00 a.m. ET. The Company plans to share additional data before the end of 2025.

Conference Call Information
To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

About LOTIS-7
LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L/2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab). Primary endpoints of the study include safety and tolerability. Secondary efficacy endpoints include ORR, DOR, CRR, PFS, RFS, and OS as well as pharmacokinetics and immunogenicity.

For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901).

About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On June 11, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors (Press release, Oncolytics Biotech, JUN 11, 2025, View Source [SID1234653815]).

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Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law.

"Mr. Kelly’s vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of Oncolytics’ Board of Directors and outgoing Interim CEO. "We believe Mr. Kelly’s well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics’ potential to deliver transformative outcomes for patients and exceptional value for investors."

Mr. Kelly added, "Pelareorep’s clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders."

Pelareorep, an intravenously-administered immunotherapeutic agent, has been granted FDA Fast Track designation by the U.S. Food and Drug Administration (FDA) in metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). It has delivered compelling results in mPDAC, a high-value indication with significant unmet need. In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep has delivered a >60% objective response rate in tumor evaluable patients in the most recent study, which is more than double the benefit observed in historical control trials, and, separately, two-year survival rates 4-6 times those observed in control patients or against the benchmark in prior studies.

In mBC, pelareorep recorded a meaningful survival benefit in two randomized Phase 2 studies of over 100 combined mBC patients, IND-213 and BRACELET-1. Phase 2 objective response rate data in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients continue to exceed historical data for treatment with a checkpoint inhibitor alone. These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships. Pelareorep also has a well-defined and favorable safety profile based on data from >1,100 patients across multiple tumor types.

As a material inducement to Mr. Kelly’s appointment as Chief Executive Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Kelly has been awarded an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares with an exercise price of CAD$0.57, which will vest upon the achievement of certain financing objectives. All stock option grants have a term of 5 years from the date of grant. The Company also granted Mr. Kelly restricted stock units, which will entitle him to receive that number of Common Shares equal to 2% of the Company’s then outstanding common shares upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. Each of these awards is intended to align Mr. Kelly’s long-term incentives with the creation of shareholder value.

On June 11, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that it has entered into a definitive agreement with a single institutional investor for the purchase and sale in a registered direct offering of 739,000 shares of its common stock (or common stock equivalents), at an offering price of $6.25 per share of common stock (or common stock equivalent) (Press release, Tempest Therapeutics, JUN 11, 2025, View Source [SID1234653817]). The closing of the offering is expected to occur on or about June 12, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering primarily for supporting the previously announced strategic alternative process and for working capital and general corporate purposes.

The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333- 280918) that was filed with the Securities and Exchange Commission (the SEC), on July 19, 2024, as amended on January 24, 2025, which was declared effective by the SEC on January 27, 2025. The offering of the securities in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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 June 11, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported a poster presentation with positive, updated data from a Phase 1/2a trial of the tetraspecific T-cell engager MP0533 in relapsed/refractory acute myeloid leukemia (AML), at the 30th EHA (Free EHA Whitepaper) (European Hematology Association) Congress, taking place in Milan on June 12–15, 2025 (Press release, Molecular Partners, JUN 11, 2025, View Source [SID1234653818]).

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The poster, Updated Results from the Ongoing Phase 1/2a Study of MP0533, a Tetra-Specific Designed Ankyrin Repeat Protein (DARPin; CD33 x CD123 x CD70 x CD3), in Patients with Relapsed/Refractory AML or MDS/AML, outlines the impact of accelerated step-up dosing regimen (steeper and faster) of MP0533 on exposure and clinical responses in cohort 8, providing the rationale for further optimization to the dosing regimen implemented in the ongoing cohort 9.

Data from cohort 8 show that 3 of 8 evaluable patients (> 30%) achieved a clinical response after the first cycle, with one patient achieving a complete response and two patients a complete response with partial hematologic recovery as best overall response. Two patients maintained a response for more than 3 months and one patient remains on treatment, maintaining a response beyond 6 months at the time of data cutoff (14 April 2025). Cohort 8 implemented a higher starting dose than cohorts 1-7, and the inclusion of an additional day of dosing, reaching the target dose by day 12, as opposed to day 15 previously.

Cohort 8 data indicate that patients maintained exposure to MP0533 for a longer period of time within the predicted therapeutic range through the accelerated step-up dosing scheme, within the first cycle. Data show that patients reached over 4 days of relevant exposure, with 5 out of 8 patients displaying > 50% blast reduction. MP0533 shows an acceptable safety profile after adjustment of the target dose in cohort 8.

"I am encouraged by the number and level of responses observed in the most recent cohort and have started to include patients with the new ‘dense administration’ schedule aiming to establish the full potential of this product for our R/R AML patients," said Pierre Bories, MD, PhD, Principal Investigator at Institut Universitaire du Cancer Toulouse – Oncopole, France.

In cohorts 1-7, where step-up dosing reached target dose by day 15, exposure to predicted therapeutic doses was limited to roughly 2 days in the first cycle, most likely due to target-mediated-drug deposition. This prior treatment protocol, despite demonstrating initial blast reductions in ~30% of patients, resulted in limited responses.

Based on the encouraging antitumor activity observed in cohort 8, the amended protocol for cohort 9 and beyond includes further acceleration of the step-up dosing to reach therapeutically-relevant doses faster, increased frequency of dosing for higher cumulative MP0533 exposure, and the introduction of anti-CD20 premedication to mitigate loss of exposure, with the objective to further increase the depth and duration of responses in patients.

Cohort 9 is currently dosing patients and initial data from the amended dosing scheme are expected in H2 2025. Additionally, future study cohorts will evaluate the combination of azacitidine/venetoclax with MP0533.

Details of the presentation:

Updated Results from the Ongoing Phase 1/2a Study of MP0533, a Tetra-Specific
Designed Ankyrin Repeat Protein (DARPin; CD33 x CD123 x CD70 x CD3), in Patients with
Relapsed/Refractory AML or MDS/AML
Time: June 13, 18:30 – 19:30 CEST (Poster Session 1)