Immutep to Participate in September Investor Conferences

On September 6, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapiesfor cancer and autoimmune disease, reported that its management will participate in the following upcoming investor conferences in September (Press release, Immutep, SEP 6, 2023, View Source [SID1234634915]):

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• The 18th Annual Citi Biopharma Conference in Boston, MA on Thursday, September 7.
• Bell Potter Emerging Ideas Leaders Conference on September 12. Presentation at 3:30 p.m. AEST.
• Baird’s 2023 Global Healthcare Conference in New York City, NY on September 12. Fireside chat at 3:45 p.m. ET.
• E&P Small Cap Healthcare Conference in Sydney, NSW. Presentation on September 13 at 4:25 p.m. AEST.
• 2023 Cantor Global Healthcare Conference in New York City, NY on September 26.

Panel presentation at 2:45 p.m. ET. Further information about upcoming conferences and events that Immutep’s management will be attending is available at the Events page within the Investors & Media section of Immutep’s website.

Entry into a Material Definitive Agreement

On September 5, 2023, Cellectar Biosciences, Inc. (the "Company") reported to have entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited investors (the "Investors"), pursuant to which the Company agreed to issue and sell, in a private placement (the "Offering"), (i) 1,225 shares of Series E-1 Convertible Voting Preferred Stock, par value $0.0001 per share (the "Series E-1 Preferred Stock"), (ii) Tranche A Warrants (the "Tranche A Warrants") to acquire shares of Series E-3 Convertible Voting Preferred Stock, par value $0.00001 per share (the "Series E-3 Preferred Stock") and (iii) Tranche B Warrants (the "Tranche B Warrants," together with the Tranche A Warrants, the "Warrants") to acquire shares of Series E-4 Convertible Voting Preferred Stock, par value $0.00001 per share (the "Series E-4 Preferred Stock" and together with the Series E-3 Preferred Stock, the "Warrant Shares") for an aggregate offering price of $24.5 million (Filing, 8-K, Cellectar Biosciences, SEP 5, 2023, View Source [SID1234635025]).

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Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of Series E Convertible Voting Preferred Stock, which is filed as Exhibit 3.1 to this Current Report on Form 8-K (the "Certificate of Designation"), each share of Series E-1 Preferred Stock is, subject to the Stockholder Approval (as defined below), automatically convertible into shares of common stock, par value $0.00001 per share, of the Company (the "Common Stock") and/or, if applicable, shares of Series E-2 Preferred Stock, par value $0.00001 per share, of the Company (the "Series E-2 Preferred Stock"), in lieu of Common Stock.

The aggregate exercise price of the Tranche A Warrants is approximately $44.1 million, exercisable for an aggregate of 2,205 shares of Series E-3 Preferred Stock commencing on the Exercisability Date (as defined in the Tranche A Warrant) until the earlier of (i) ten (10) trading days following the date of the Company’s public announcement of Positive Topline Data from its CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) and (ii) September 8, 2026.

The aggregate exercise price of the Tranche B Warrants is approximately $34.3 million, exercisable for an aggregate of 1,715 shares of Series E-4 Preferred Stock commencing on the Exercisability Date (as defined in the Form of Tranche B Warrant) until the earlier of (i) ten (10) Trading Days following the date of the Company’s public announcement of its receipt of written approval from the FDA of its New Drug Application for iopofosine I 131 and (ii) September 8, 2028.

Subject to the terms and limitations contained in the Certificate of Designation, the Series E-1 Preferred Stock issued in the Offering will not become convertible until the Company’s stockholders approve (i) the issuance of all Common Stock issuable upon conversion of the Series E Preferred Stock and (ii) the issuance of the Warrant Shares upon exercise of the Warrants (collectively, the "Stockholder Approval"). On the first (1st) Trading Day (as defined in the Certificate of Designation) following the announcement of the Stockholder Approval, each share of Series E-1 Preferred Stock shall automatically convert into Common Stock, at the conversion price of $1.82 per share, and/or, if applicable, shares of Series E-2 Preferred Stock, in lieu of Common Stock, in each case subject to the terms and limitations contained in the Certificate of Designation. Subject to the limitations set forth in the Certificate of Designation, at the option of the holder, each share of Series E-2 Preferred Stock, Series E-3 Preferred Stock or Series E-4 Preferred Stock shall be convertible into Common Stock, at the conversion price of $1.82 per share, $3.185 per share and $4.7775 per share, respectively, rounded down to the nearest whole share, and in each case subject to the terms and limitations contained in the Certificate of Designation.

The closing of the Offering took place on September 8, 2023. The gross proceeds of the Offering are estimated to be approximately $24.5 million, before deducting fees paid to the Placement Agent (as defined below) and financial advisors of the Offering and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for working capital purposes and general corporate purposes, subject to certain limitation described in the Purchase Agreement.

Pursuant to the Purchase Agreement, as soon as practicable following the filing of the Definitive Proxy Statement in connection with the Stockholder Approval (and in any event no later than seven (7) days thereafter), the Company shall file a registration statement on Form S-3 providing for the resale by the Investors of the Common Stock issuable upon conversion of the Registrable Shares (as defined in the Purchase Agreement) and to use commercially reasonable efforts to have the registration statement declared effective as soon as practicable following receipt of the Stockholder Approval (but no later than ten (10) days following the receipt of Stockholder Approval (or, in the event that the staff of the Securities and Exchange Commission reviews and has oral or written comments to such registration statement, within forty (40) days following the receipt of Stockholder Approval). The Company further agreed to take all steps necessary to keep such registration statement effective at all times until all Registrable Shares have been resold, or there remains no Registrable Shares.

The Purchase Agreement contains certain representations and warranties, covenants and indemnities customary for similar transactions. 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.

Additionally, pursuant to the Purchase Agreement and subject to customary conditions, the Company shall appoint a director designated by the purchasers purchasing a majority of the securities being sold under the Purchase Agreement and an additional director designated by the purchasers purchasing a majority of the securities being sold under the Purchase Agreement if an existing director on the Company’s Board of Directors is not removed on or before the annual meeting of the Company immediately following this Offering.

The securities issued in the Offering have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and until so registered the securities may not be offered or sold absent registration or availability of an applicable exemption from registration. There is no established public trading market for the Series E-1 Preferred Stock, Series E-2 Preferred Stock, Warrants, or Warrant Shares and the Company does not intend to list such securities on any national securities exchange or nationally recognized trading system.

The Offering was conducted pursuant to a Placement Agency Agreement, dated September 7, 2023 (the "Placement Agency Agreement"), between the Company and Oppenheimer & Co. Inc. (the "Placement Agent"). The Placement Agent has no obligation to purchase any of the securities or to arrange for the purchase or sale of any specific number or dollar amount of securities. The Company has agreed to pay: (i) the Placement Agent and certain financial advisors a cash fee equal in total to an aggregate of 7.0% of the gross proceeds raised in the offering from sales of the Series E-1 Preferred Stock, (ii) the Placement Agent a cash fee equal in total to 3.0% of the gross proceeds raised in the offering from the exercise, if any, of the Tranche A Warrants and the Tranche B Warrants, and (iii) reimbursement for certain expenses, including counsel to the Placement Agent and counsel to investors, up to an aggregate of $212,500.

The form of each Tranche A Warrant, the Tranche B Warrant and the Purchase Agreement are filed as Exhibits 4.1, 4.2 and 10.1, respectively, to this Current Report on Form 8-K. The foregoing summaries of the terms of the Certificate of Designation, the Series E-1 Preferred Stock, the Series E-2 Preferred Stock, the Warrants and the Warrant Shares and the terms of the Purchase Agreement are subject to, and qualified in their entirety by, the full text of such documents, where applicable, which are incorporated herein by reference.

Theratechnologies Announces Certain Preliminary Q3 2023 Financial Highlights

On September 05, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that the Company expects to report positive adjusted EBITDA1 for its third quarter ended August 31, 2023 (Press release, Theratechnologies, SEP 5, 2023, View Source [SID1234635018]). Additionally, as at August 31, 2023, Theratechnologies estimates that its cash, bonds and money market funds, stood at US$22.9 million.

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"Theratechnologies’ commitment to investors at the beginning of 2023 has been to remain steadfast in delivering on key financial objectives, particularly to achieve positive adjusted EBITDA by the end of the current fiscal year," said Philippe Dubuc, Senior Vice President and Chief Financial Officer at Theratechnologies. "With second quarter headwinds firmly behind us, we are pleased to announce these positive results in advance of our upcoming earnings call and look forward to sharing our complete financial results."

The Company is in the process of preparing its third quarter 2023 financial results and currently expects to release financial results and accompanying documents before the end of September. Earnings conference call details will be shared closer to this date.

Sermonix Pharmaceuticals Shares Encore ELAINE-2 Poster Presentation at 2023 Metastatic Breast Cancer Research Conference

On September 5, 2023 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, reported it shared an encore poster presentation at the 10th annual Metastatic Breast Cancer Research Conference (MBCRC) highlighting the results of its Phase 2 ELAINE-2 clinical study (Press release, Sermonix Pharmaceuticals, SEP 5, 2023, View Source [SID1234634994]).

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The poster, "Lasofoxifene plus abemaciclib for treating ER+/HER2-, ESR1-mutated, metastatic breast cancer after progression on prior therapies: ELAINE-2 update," was presented Wednesday, Aug. 30.

"Sermonix welcomed the opportunity to share these important ELAINE-2 findings with researchers at MBCRC, who are highly focused experts in the metastatic breast cancer arena, in addition to the patient advocates who play such a vital role," said Dr. David Portman, Sermonix founder and chief executive officer. "We also were pleased to discuss our plans for ELAINE-3, a registrational Phase 3 trial that if positive could bring lasofoxifene closer to becoming available as a potential new option to improve the lives of those confronted with this terrible disease."

ELAINE-2 (NCT04432454), an open-label Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study of Sermonix’s lead investigational drug, lasofoxifene, in combination with Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib, evaluated 29 heavily pre-treated women with ER+/HER2- locally advanced or metastatic breast cancer and an ESR1 mutation. Results were initially shared at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and updated in June at ASCO (Free ASCO Whitepaper) 2023.

The primary endpoint was safety/tolerability, with secondary endpoints including progression-free survival (PFS) and overall response rate (ORR). With patient follow-up through Jan. 31, 2023, the combination of lasofoxifene and abemaciclib continued to be well-tolerated, with clinically meaningful efficacy in women with ER+/HER2- metastatic breast cancer and an ESR1 mutation. The PFS, a median of 13 months, and ORR of 56% were promising.

The results led Sermonix to initiate ELAINE-3, a global registrational study of 400 patients assessing the efficacy of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib, with enrollment planned to begin in the second half of 2023.

To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit View Source To learn more about the ELAINE studies, visit View Source

About Lasofoxifene
Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

Guardant Health Receives Regulatory Approval in Japan for Guardant360® CDx as Companion Diagnostic to ENHERTU® for Treatment of Non-Small Cell Lung Cancer Patients with HER2 Mutations

On September 5, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Guardant360 CDx liquid biopsy test as a companion diagnostic to select patients with unresectable (inoperable) advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy for treatment with ENHERTU (trastuzumab deruxtecan) (Press release, Guardant Health, SEP 5, 2023, View Source [SID1234634925]). ENHERTU is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo.

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Mutations in the HER2 gene are responsible for approximately 2-4% of non-squamous NSCLC, which represents about 70% of NSCLC cases.1,2 Overall, NSCLC accounts for about 80-85% of all lung cancer,3 the leading cause of cancer death for men and women worldwide.4 Guardant360 CDx is a next-generation sequencing-based assay that detects genomic alterations using circulating tumor DNA from blood. The approval for use of the test as a companion diagnostic with ENHERTU in Japan is an expansion of the approval received from the U.S. Food and Drug Administration (FDA) for the same indication in August 2022.

"The ministry’s approval of Guardant360 CDx as a companion diagnostic for ENHERTU is great news for patients with metastatic non-small cell lung cancer with HER2 mutations," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "Oncologists in Japan now have the first blood-based companion diagnostic to determine if their patients are eligible to receive the first HER2 directed therapy approved to treat this specific condition. This is another step forward in achieving Guardant Health’s mission to conquer cancer globally."

In March 2022, the MHLW approved the Guardant360 CDx test for comprehensive genomic profiling in patients with advanced solid tumors, and in July 2023, the test received national reimbursement approval in Japan. The MHLW also previously approved the test as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab), patients with MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab), and patients with metastatic NSCLC who may benefit from treatment with LUMAKRAS (sotorasib).

About Guardant360 CDx

For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced, Guardant360 has become widely accepted for blood-based comprehensive genomic profiling with more than 400 peer-reviewed publications. It has been used by more than 12,000 oncologists, with more than 400,000 tests performed to date, and is broadly covered by Medicare and private payers, insuring over 300 million people.