On June 11, 2024 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent Product Development Platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported the publication of Phase 2 clinical data of its DNA damage repair inhibitor drug candidate, TRC102, in patients with glioblastoma in Clinical Cancer Research (Press release, Tracon Pharmaceuticals, JUN 11, 2024, View Source [SID1234644262]). The article, entitled, "Evaluating the Base Excision Repair Inhibitor TRC102 and Temozolomide for patients with Recurrent Glioblastoma in the Phase 2 Adult Brain Tumor Consortium Trial BERT," highlights the activity of TRC102 given in combination with Temodar chemotherapy in patients with recurrent glioblastoma: View Source

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TRC102 was evaluated in a Phase 2 trial in combination with Temodar in 19 patients with progressive or recurrent glioblastoma following surgical resection, Temodar and external beam radiotherapy. Extended survival was observed in two patients (progression-free survival ≥ 17 months and overall survival > 32 months), both of whom demonstrated significantly enriched signatures of DNA damage response (DDR), chromosomal instability, and cellular proliferation by RNA sequencing prior to initiating treatment with Temodar and TRC102. The study was completed by the Adult Brain Tumor Consortium and led by Manmeet Alhuwalia, MD while he was Chair of Neuro-Oncology at Cleveland Clinic prior to his appointment as Chief of Medical Oncology, Chief Scientific Officer, and Deputy Director of the Miami Cancer Institute. The authors concluded the study findings confirm the safety and feasibility of TRC102 given with Temodar for recurrent glioblastoma patients and warrant further evaluation of combination therapy in biomarker-enriched trials enrolling glioblastoma patients with baseline hyperactivated DDR pathways.

"We believe that the data generated to date provides a strong rationale for studying TRC102 in combination with Temodar and radiotherapy in newly diagnosed patients with malignant glioma," said James Freddo, M.D., Chief Medical Officer of TRACON. "The Clinical Cancer Research publication supports prior data published in Cancer Cell (View Source) that patients whose cancers demonstrate activation of DDR pathways may be particularly sensitive to the pharmacologic effects of TRC102."

Based on a 100% response rate (including a 20% complete response rate) in a Phase 1 clinical trial combining TRC102 with pemetrexed, cisplatin and radiation therapy in 15 patients with stage III non-squamous non-small cell lung cancer (View Source), TRC102 is currently being studied in a randomized Phase 2 clinical trial in combination with chemotherapy (pemetrexed, cisplatin or carboplatin) and radiation therapy for stage III non-squamous non-small cell lung cancer (NCT05198830: View Source;rank=6). This trial is sponsored by the National Cancer Institute (NCI) through a Cooperative Research and Development Agreement (CRADA). Determination of the primary endpoint of progression free survival is expected in 2025. TRACON and the NCI have a longstanding history of partnership to develop TRC102, whereby the NCI has funded six Phase 1 or Phase 2 trials through the CRADA.

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple randomized Phase 2 clinical trial entitled Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (NCT05198830) that is sponsored by the NCI through a CRADA. TRC102 was granted orphan drug designation by the US FDA for the treatment of malignant glioma in 2020. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical-trials.

About Malignant Glioma and Glioblastoma
Glioblastoma (GBM) is a rapidly growing malignant glioma that develops from glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is the most invasive type of glial tumors, rapidly growing and commonly invading into nearby brain tissue. The National Cancer Institute estimates that approximately 22,850 adults are diagnosed with brain and other nervous system cancers annually in the U.S. and approximately 15,320 of these diagnoses will result in death. GBM has an incidence of two to three per 100,000 adults per year in the U.S., and accounts for 52 percent of all primary brain tumors.

On June 11, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated biopharmaceutical company, reported that it intends to offer and sell shares of its common stock (or pre-funded warrants in lieu thereof) (Press release, TONIX Pharmaceuticals, JUN 11, 2024, View Source [SID1234644261]). All of the securities to be sold in the offering are to be offered by Tonix. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.

Dawson James Securities, Inc. is the sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-266982) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a prospectus supplement and accompanying prospectus. The preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Tonix has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Tonix and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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 June 11, 2024 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 and Orano Med, a clinical stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), reported the debut of their lead Radio-DARPin therapy (RDT) candidate MP0712, targeting DLL3, in an oral presentation (Press release, Molecular Partners, JUN 11, 2024, View Source [SID1234644260]). The data presented today provide strong support for MP0712’s clinical development in small-cell lung cancer (SCLC) and other DLL3+ neuroendocrine tumors. MP0712 features 212Pb as a potent therapeutic payload. The data were presented today at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8-11 in Toronto, Canada.

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"Three years ago, we started our venture into the radiotherapy space. We have made tremendous progress with our Radio-DARPins and are proud to present MP0712, our first RDT development candidate targeting DLL3 delivering and 212Pb to kill the tumor, in partnership with Orano Med," said Patrick Amstutz, Ph.D., Molecular Partners’ Chief Executive Officer. "We have made key learnings how to reduce kidney accumulation and increase tumor uptake. We are now exploiting the long-known DARPin advantages to a full pipeline of candidates addressing high medical need. Kudos to both the Orano Med and Molecular Partners team for advancing the science to make this happen."

"We are extremely excited with the first preclinical results of the MP0712 program, which confirm the potential of the combination between Molecular Partners’ targeting technology and 212Pb, an isotope perfectly suited for targeted alpha therapy. We eagerly anticipate advancing the drug’s development and initiating clinical trials to provide solutions for patients with unmet medical needs," said Julien Dodet, CEO of Orano Med.

MP0712 is the first high-affinity DLL3-targeting RDT combining the advantages of DARPins as small protein-based delivery vectors and the short-lived alpha particle-emitting radioisotope 212Pb. DLL3 is expressed in >85% of SCLC patients and in other neuroendocrine tumors, while its expression in healthy tissues is low, making it a priority target for radiopharmaceutical therapy. SCLC is an aggressive form of lung cancer, with a poor five-year survival prognosis and a high unmet need for patients.

The preclinical package presented at SNMMI includes in vivo data demonstrating strong and homogeneous tumor uptake of 212Pb-DLL3 RDT, as well as significant and durable inhibition of tumor growth at clinically-relevant doses. The safety results seen across the tested dosing levels in mice suggest a favorable safety profile and potential for clinical use. 212Pb-DLL3 RDT candidates were engineered by tuning their biophysical properties to achieve an optimal safety/antitumor activity profile in vivo. The selected lead candidate, MP0712, demonstrated a promising biodistribution profile in mouse xenograft tumor models, with close to 60% of injected dose detectable in the tumor and encouraging tumor to kidney ratios over two. The replicable DARPin learnings from the development of MP0712, as well as additional platform improvements, are being taken forward to the broader RDT portfolio.

The intrinsic properties of DARPins, such as small size, high affinity and selectivity, and a broad range of potential targets, make them ideal vector candidates for radiopharmaceutical therapeutics. Historically, small protein-based vectors faced challenges with kidney accumulation and toxicity, as well as suboptimal tumor uptake. Molecular Partners has evolved its RDT platform to address these limitations with its half-life extension technologies and surface engineering approaches, while preserving the advantages of the small protein format. In addition, Molecular Partners’ DARPin candidates have been clinically validated with over 2500 patients treated worldwide and multiple DARPin mechanisms have been demonstrated as biologically active in for different indications, contributing to validation of the drug class and Molecular Partners as leader in the field of DARPin engineering and development.

Details of the presentation summarizing the MP0712 preclinical data at the SNMMI 2024 Annual Meeting can be found below. The presentation will be made available on Molecular Partners’ website after the presentation.

Presentation Title: Lead-212 Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) shows promising preclinical antitumor efficacy and tolerability in small cell lung cancer (SCLC)
Session: IS09 Integrated Session: Radionuclides (CMIIT/RPSC);
Timing: 11 June 2024; 8:00–9:15 am EDT

On June 11, 2024 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conference this month (Press release, MacroGenics, JUN 11, 2024, View Source [SID1234644259]):

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Goldman Sachs 45th Annual Global Healthcare Conference (Miami Beach). MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will provide a corporate presentation on Thursday, June 13, 2024, at 10:00am ET. MacroGenics’ management will also participate in one-on-one meetings.

A webcast of the above presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of this webcast on its website for 30 days after the conference.

On June 11, 2024 Flerie AB[1] ("Flerie" or the "Company") reported the completion of the acquisition of all shares in Flerie Invest AB through an issue in kind (the "Acquisition") (Press release, InDex Pharmaceuticals, JUN 11, 2024, View Source [SID1234644256]). Through the Acquisition, Flerie Invest AB will become a wholly-owned subsidiary of Flerie. As previously announced, Flerie intends to raise capital through a directed share issue and have therefore appointed Carnegie Investment Bank AB (publ) ("Carnegie") and DNB Markets, a part of DNB Bank ASA, Sweden branch ("DNB Markets)" as joint bookrunners (the "Joint Bookrunners") to investigate the conditions for carrying out a directed issue of ordinary shares of up to approximately SEK 600 million through a bookbuilding procedure (the "Capital Raise"), of which approximately SEK 520 million is pre-committed. The Capital Raise is intended to be primarily directed to Swedish and international institutional investors.

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Summary

As separately announced yesterday, on 10 June 2024, Flerie’s acquisition of all shares in Flerie Invest AB has been completed. The Acquisition was approved by an Extraordinary General Meeting held earlier on the same date (the "EGM"). The EGM also approved the issue in-kind of consideration shares for the Acquisition (the "Consideration Shares"), the authorization to issue shares for the Capital Raise, the election of new Board members and new auditor, as well as other matters that follow from the Acquisition.
Through the Capital Raise, the Company will raise at least approximately SEK 520 million as per pre-commitments from a number of institutional investors (see further below), prior to transaction costs. The total number of newly issued ordinary shares in the Capital Raise will be determined through a bookbuilding procedure, which will commence immediately following the announcement of this press release and is expected to end before trading commences on Nasdaq First North Growth Market on 14 June 2024.
The subscription price in the Capital Raise will be the same as for the Consideration Shares, i.e. SEK 0.506 per ordinary share. Flerie intends to use the net proceeds from the Capital Raise to fulfil its capital commitments, make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity.
As per 31 May 2024, the net asset value (NAV) per share of Flerie Invest AB was SEK 32.37[2], and hence, the net asset value (NAV) per share of Flerie was approximately SEK 0.60[3].
A number of institutional investors, including the Company’s existing shareholders the Fourth Swedish National Pension Fund, HBM Healthcare Investments, Linc AB and SEB Stiftelsen, have undertaken to subscribe for new shares in the Capital Raise, and the aggregate pre-commitments received from investors amount to approximately SEK 520 million (the "Pre-Commitments"). Those investors who have provided the Pre-Commitments will receive full allocation.

Background

As previously announced, on 20 May 2024, InDex Pharmaceuticals Holding AB (publ) ("InDex Pharmaceuticals"), whose name will be changed to Flerie AB, entered into an agreement to acquire all shares in Flerie Invest AB. The consideration was to be made through an issue in kind of 6,073,952,948 new shares in the Company, following which Flerie Invest AB’s shareholders will initially hold approximately 91.9 per cent of the shares and the existing shareholders will initially hold approximately 8.1 per cent of the shares in InDex Pharmaceuticals.

Flerie Invest AB was valued at approximately SEK 3,073 million in the Acquisition, based on reported net asset value as of 31 March 2024 with a discount of 10 per cent, and InDex Pharmaceuticals was valued at approximately SEK 269 million, which corresponded to InDex Pharmaceuticals estimated cash position after closing costs with a premium of 20 per cent. These valuations entailed a subscription price in the Acquisition of approximately SEK 0.506 per Consideration Share. As further announced on 10 June 2024, the EGM approved the Acquisition and the Acquisition was completed. As per 31 May 2024, the net asset value (NAV) per share of Flerie Invest AB was SEK 32.37, and hence, the net asset value (NAV) per share of Flerie was approximately SEK 0.60.

Capital Raise

Flerie’s intention is to carry out the Capital Raise with deviation from the shareholders’ preferential rights, based on the authorization granted by the EGM. The subscription price in the Capital Raise will be SEK 0.506, which is the same as the subscription price of the Consideration Shares.

The total number of newly issued shares in the Capital Raise will be determined through a bookbuilding procedure, which will commence immediately following the announcement of this press release and is expected to end before trading commences on Nasdaq First North Growth Market on 14 June 2024. The bookbuilding procedure may close earlier or later and may be cancelled at any point in time without prior notification. Flerie will announce the outcome of the Capital Raise through a press release after the closing of the bookbuilding procedure.

The purpose of the Capital Raise, and the reasons for the deviation from the shareholders’ preferential right, is to diversify the shareholder base of the Company in order to meet the liquidity requirements for a listing on, initially, Nasdaq First North Growth Market and, subsequently, Nasdaq Stockholm (for more information, please see section "Admission to trading on Nasdaq Stockholm"), to ensure continued financing of Flerie in immediate connection to the implementation of the Acquisition, and to have flexibility to make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity, as well as, strengthen the shareholder base with Swedish and international institutional investors. With the above considered, the Board of Directors of Flerie has made the assessment that a directed issue of ordinary shares with deviation from the shareholders’ preferential rights is the most favourable alternative for the Company to carry out the capital raising and is in the best interest of the Company’s shareholders. The Board of Directors thus considers that the reasons outweigh the main rule that new share issues are to be carried out with preferential rights for the shareholders.

Since the subscription price in the Capital Raise corresponds to the subscription price for the Consideration Shares, which was based on a valuation of InDex Pharmaceuticals as standalone listed entity (i.e. prior to the Acquisition) that has been subject to arm’s-length negotiations with the sellers of Flerie Invest AB, the Board of Directors of Flerie considers that the subscription price in the Capital Raise is market-based.

Through the Capital Raise, the Company will raise at least approximately SEK 520 million as per the Pre-Commitments, prior to transaction costs. Flerie intends to use the net proceeds from the Capital Raise to fulfil its capital commitments, make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity.

A number of institutional investors, including the Company’s existing shareholders the Fourth Swedish National Pension Fund, HBM Healthcare Investments, Linc AB and SEB Stiftelsen, have undertaken to subscribe for new shares in the Capital Raise, and the aggregate pre-commitments received from investors amount to approximately SEK 520 million. Those investors who have provided the Pre-Commitments will receive full allocation.

Investors in the Capital Raise are required to undertake not to utilise the right as a shareholder in the Company to request conversion of ordinary shares into shares of series C in the Company under the redemption program until 2026 (for more information, please see section "Voluntary share redemption program" below).

Lock-up

Flerie will undertake towards the Joint Bookrunners, for a period of 360 days from and including today, 11 June 2024, not to, without Carnegie’s approval, propose or take measures that entail an increase in the share capital, new share issues and similar measures, with certain exceptions, for example in connection with acquisitions or establishment of incentive programs. Thomas Eldered’s directly and indirectly wholly-owned companies T&M Förvaltning AB and T&M Participation AB (the "Major Shareholders"), as well as Flerie’s Board and management will undertake towards the Joint Bookrunners not to, without Carnegie’s approval, sell or otherwise transfer or dispose of their shares in Flerie, subject to certain exceptions. This lock-up period will last for 360 days from completion of the Acquisition for the Major Shareholders, and 180 days from completion of the Acquisition for Flerie’s Board and management.

Admission to trading on Nasdaq Stockholm

The Company intends to carry out an uplisting from Nasdaq First North Growth Market to Nasdaq Stockholm. Provided that Nasdaq Stockholm approves the Company’s application for admission to trading, the first day of trading on Nasdaq Stockholm is planned to take place around 27 June 2024.

Voluntary share redemption program

The Company has established an annual voluntary share redemption program from and including 2025 in order to increase the liquidity of the shares of Flerie. Through the redemption program, shareholders are proposed to have the right during an annual conversion period, to occur during the last week of March, to request the conversion of their ordinary shares into a new class of shares, convertible and redeemable class C shares. Conversion can take place of up to five (5) per cent of the total number of outstanding shares. If the number of ordinary shares notified for conversion exceeds this limit, distribution shall be made in proportion to the number of ordinary shares that each shareholder has requested for conversion.

As soon as possible following announcement of the interim report for the first quarter, Flerie shall redeem all outstanding class C shares at a redemption amount per share corresponding to the net asset value (NAV) per share as of 31 March. During 2025, certain different time periods will apply for the redemption program.

The Major Shareholders and investors that have provided Pre-Commitments have undertaken not to exercise the redemption program prior to 2029 and 2026, respectively, and any additional investors in the Capital Raise will, by subscribing for shares in the Company, undertake not to exercise the redemption program prior to 2026.

Advisors

Carnegie is Sole Global Coordinator and Joint Bookrunner and DNB Markets is Joint Bookrunner in connection with the Capital Raise. Setterwalls Advokatbyrå is legal advisor to Flerie in connection with the Capital Raise. White & Case is legal advisor to Carnegie and DNB Markets in connection with the Capital Raise.