Entry into a Material Definitive Agreement

On April 1, 2025 Citius Pharmaceuticals, Inc. (the "Company") entered into a securities purchase agreement (the "Purchase Agreement") with a certain institutional investor for the issuance and sale, in a registered direct offering by the Company (the "Offering"), of 465,000 shares of the Company’s common stock, par value $0.001 per share (the "Shares"), and pre-funded warrants to purchase up to 1,274,131 shares of common stock (the "Pre-funded Warrants") at an offering price of $1.15 and $1.1499, respectively (Filing, 8-K, Citius Pharmaceuticals, APR 1, 2025, View Source [SID1234651752]). The Offering closed on April 2, 2025.

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 Pre-funded Warrants are exercisable immediately at an exercise price of $0.0001 per share and shall remain valid and exercisable until all the Pre-funded Warrants are exercised in full. A holder of a Pre-funded Warrant will not have the right to exercise any portion of its warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or 9.99% at the election of the holder prior to the date of issuance) of the number of shares of common stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided that in no event shall the Beneficial Ownership Limitation exceed 9.99%. The exercise price and number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price.

H.C. Wainwright and Co., LLC ("Wainwright") acted as the Company’s exclusive placement agent in connection with the Offering. In connection with the Offering, the Company agreed to pay Wainwright a cash fee of 7.0% of the gross proceeds the Company received in the Offering. The Company agreed to also reimburse Wainwright up to $25,000 for fees and expenses of legal counsel, $10,000 for non-accountable expenses and $10,000 for a clearing fee. In addition, the Company granted placement agent warrants to Wainwright, or its designees, to purchase up to 121,739 shares of the common stock (the "Placement Agent Warrants").

The Placement Agent Warrants have an exercise price equal to $1.4375 per share, are exercisable six months after issuance and will expire five years from the commencement of sales in the Offering. The exercise price and number of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and the exercise price. If there is no effective registration statement for the resale of the shares issuable upon exercise of the Placement Agent Warrants, holders of the Placement Agent Warrants may elect a "cashless" exercise, whereby they would receive the net number of shares of common stock determined according to a formula set forth in the Placement Agent Warrants. On the expiration date of the Placement Agent Warrants, any Placement Agent Warrants outstanding and unexercised will be automatically exercised via cashless exercise.

The net proceeds to the Company from the Offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by the Company. The Company anticipates using the net proceeds to support the commercial launch of LYMPHIR and general corporate purposes.

Pursuant to the Purchase Agreement, the Company agreed for a period of 30 days following the closing of the Offering not to issue, enter into an agreement to issue or announce the issuance or proposed issuance of the shares or any other securities convertible into, or exercisable or exchangeable for, shares of common stock, subject to certain exceptions.

The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-277319), which was previously declared effective by the Securities and Exchange Commission (the "SEC") on March 1, 2024, including a prospectus supplement filed with the SEC on April 1, 2025.

The Purchase Agreement contains customary representations and warranties and agreements of the Company and the investors and customary indemnification rights and obligations of the parties. The representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties to the Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the SEC.

The foregoing descriptions of the Purchase Agreement, the Pre-funded Warrants and the Placement Agent Warrants are qualified in their entirety by reference to the forms of the Purchase Agreement, the Pre-funded Warrants and the Placement Agent Warrants, copies of which are attached hereto as Exhibits 10.1, 4.1 and 4.2, respectively, and are incorporated herein by reference. A copy of the opinion of Wyrick Robbins Yates & Ponton LLP relating to the legality of the issuance and sale of the Shares, the Pre-funded Warrants and the Placement Agent Warrants in the Offering is attached as Exhibit 5.1 hereto.

enGene to Present at the Stifel 2025 Virtual Targeted Oncology Forum

On April 1, 2025 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, Chief Executive Officer, will present at the Stifel 2025 Virtual Targeted Oncology Forum, on Tuesday, April 8, 2025, at 4:00 p.m. ET (Press release, enGene, APR 1, 2025, View Source [SID1234651738]).

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!

A live webcast of the presentation can be accessed under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

BBOT Announces First Patient Dosed with BBO-11818, a PanKRAS Dual Inhibitor, in the Phase 1 KONQUER-101 Trial for Advanced Solid Tumors

On April 1, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT" or the "Company"), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported that the first patient has been dosed with BBO-11818 in the Phase 1 KONQUER-101 trial for advanced solid tumors (Press release, BridgeBio Oncology Therapeutics, APR 1, 2025, View Source [SID1234651737]). BBO-11818 is an orally bioavailable small molecule dual inhibitor that directly binds to both the "ON" and "OFF" states of KRAS. KONQUER-101 will enroll patients globally with certain KRAS mutations.

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 dosing of the first patient is a major milestone in assessing BBO-11818’s potential benefit for patients with tumors driven by mutant KRAS," said Dr. Ignacio Garrido-Laguna, MD, PhD, Principal Investigator at Huntsman Cancer Institute at the University of Utah. "We are committed to bringing cutting-edge therapies to patients with advanced cancer in the Mountain Region. BBO-11818 has the potential to safely achieve optimal target inhibition and combine with other targeted therapies. We look forward to evaluating it in the KONQUER-101 trial."

BBO-11818 was designed to non-covalently bind both the inactive GDP-bound "OFF" and active GTP-bound "ON" forms of KRASG12D and KRASG12V. In cellular assays, EC50 values for pERK inhibition in selected KRAS G12D and G12V-mutant cell lines range from sub-nanomolar to single-digit nanomolar potency. BBO-11818 is similarly effective in reducing cell viability in KRASG12D, KRASG12V, and KRASG12C-mutant cell lines. Further, NRAS and BRAF mutant cell lines show insensitivity to BBO-11818, and the molecule exhibits more than 500-fold selectivity for KRAS over H- and NRAS.

"There is a great need for new therapies that can safely treat patients with tumors driven by KRAS mutations, as the current standard of care lacks satisfactory options as monotherapy or to enable combinations of KRAS targeted therapies with other targeted agents," said Yong (Ben) Ben, MD, Chief Medical and Development Officer of BBOT. "BBO-11818 marks the third molecule entering the clinic for BBOT, further proving our capability to advance novel programs into the clinic. Of note, our portfolio is uniquely positioned to deliver the combination of MAPK (BBO-8520 and BBO-11818) and PI3Kα/AKT (BBO-10203) co-inhibition, with a therapeutic index. We hope this will bring unprecedented benefit to patients with RAS-driven cancers."

The discovery of BBO-11818 was the result of a collaboration between the RAS Initiative at Frederick National Laboratory, Lawrence Livermore National Laboratory, and BBOT.

Amneal Launches BORUZU™, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma

On April 1, 2025 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and Shilpa Medicare Limited ("Shilpa") reported the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration (Press release, Amneal Pharmaceuticals, APR 1, 2025, View Source [SID1234651736]). This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.

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!

BORUZU (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code.

"As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the U.S. launch of BORUZU in our oncology portfolio. This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement. Our commitment remains steadfast in delivering differentiated oncology products that enhance patient care and access," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology.

"This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool," said Vishnukant Bhutada, Managing Director of Shilpa Medicare.

The most commonly reported adverse reactions for BORUZU in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.

RenovoRx Reports Initial Revenues from RenovoCath® Commercialization, and Provides Update on Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial

On April 1, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business updates for the fourth quarter and full year ended December 31, 2024 (Press release, Renovorx, APR 1, 2025, View Source [SID1234651735]).

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 fourth quarter of 2024 marks a significant milestone in our company history as we have generated our first revenue from sales of our proprietary RenovoCath device on a standalone basis, with expectations for meaningful revenue growth going forward. Importantly, we believe our current commercial strategy can be accomplished without a material increase in our capital expenditures, regardless of whether we self-commercialize or choose to partner with a larger organization and use their existing sales force and channels. Further, we believe that the gross proceeds from our February 2025 public offering of $12.1 million together with our cash on hand of $7.2 million at year end fully funds our current operational plan as we look to scale RenovoCath revenues and progress our Phase III TIGeR-PaC clinical trial towards key milestones. Moreover, we expect that growing RenovoCath revenues will reduce our burn rate as we prudently deploy our cash on hand to drive shareholder value," said Shaun Bagai, CEO of RenovoRx.

"Based on our internal analysis with current clinical applications, we believe that our initial total addressable market (TAM) for RenovoCath represents an estimated $400 million peak annual U.S. sales opportunity. Beyond this, there are expansion opportunities across other indications that could create the potential for a several billion-dollar U.S. TAM for RenovoCath over time," continued Mr. Bagai. "We expect revenue to increase to the low six figure range for the first quarter of 2025 followed by sequential quarter-over-quarter increases for the remainder of the year."

RenovoCath Commercialization Update

In December 2024, RenovoRx received first commercial purchase orders for its RenovoCath device, which resulted in revenue generation of approximately $43,000 for the fourth quarter of 2024.

RenovoRx is seeing strong organic demand for RenovoCath. More than ten medical institutions have initiated the process for RenovoCath purchase orders, and purchase orders have already been received from several esteemed, high volume National Cancer Institute-designated centers. Additionally, utilization of RenovoCath devices by initial customers has led to repeat purchase orders. Moreover, RenovoRx believes the twenty cancer centers that have used RenovoCath as part of its TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment later this year.

RenovoRx has identified its initial target market for RenovoCath to be approximately $400 million in peak annual U.S. sales, based on the Company’s internal assumptions1. Moreover, expansion opportunities across other clinical indications could create a several billion-dollar total addressable market potential for RenovoCath over time. It’s management’s belief that the Company can achieve meaningful market penetration with a small commercial team targeting the top 200 high-volume treatment centers.

Importantly, there is a current reimbursement code with the Centers for Medicare and Medicaid Services covering procedures utilizing specialty pressure-mediated delivery catheters, which creates incentives for hospitals to adopt more advanced technology, like RenovoCath.

Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial Update

During the fourth quarter 2024, RenovoRx added several additional renowned clinical oncology sites to participate in the TIGeR-PaC study. The initiation of these sites allows for new patient enrollment at the Sarah Cannon Research Institute Oncology Partners in Nashville, TN and at the Northwell Health Cancer Institute Clinical Site in New Hyde Park, NY which are key additions to the number of clinical sites to support RenovoRx’s path to completing patient enrollment for the trial. RenovoRx is continuing to target additional clinical oncology sites, with the expectation that the study will achieve full enrollment during 2025.

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 28, 2025, 90 patients have been randomized with 50 events having occurred. A second interim analysis will be triggered by the 52nd event.

The timing required to analyze the data after the 52nd event is expected to take several months and includes a full review with recommendations by the TIGeR-PaC Data Monitoring Committee. RenovoRx currently anticipates the 52nd event to occur during the second quarter of 2025. The key recommendation from the Data Monitoring Committee on whether or not to continue the study based on the data reviewed is expected to be announced in the second half of 2025.

Fireside Chat Strategic Update

RenovoRx will host a fireside chat with Shaun Bagai, Chief Executive Officer, on Thursday, April 3, 2025, at 12:00 p.m. ET. During the event, Mr. Bagai will discuss the momentum of RenovoRx’s commercialization efforts for its RenovoCath device, including an update on initial revenues generated, and continued progress on the ongoing Phase III TIGeR-PaC clinical trial. Additionally, one of RenovoCath’s initial customers, Gregory Tiesi, MD, FACS, FSSO, Medical Director of Hepatobiliary Surgery, Division of Surgical Oncology, Hackensack Meridian Jersey Shore University Medical Center, will join Mr. Bagai. He will share his insights on the Trans-Arterial Micro-Perfusion (TAMP) therapy platform and its impact on patient care. Hackensack Meridian Jersey Shore University Medical Center began using the RenovoCath device with oncology patients in December 2024.

Fireside Chat Details:
Date: Thursday, April 3, 2025
Time: 12:00 p.m. ET
Webcast: View Source

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.