Outlook Therapeutics® to Present at the H.C. Wainwright 25th Annual Global Investment Conference

On September 5, 2023 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported that Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 25th Annual Global Investment Conference being held in New York, NY on Wednesday, September 13, 2023 at 9:30 AM ET (Press release, Outlook Therapeutics, SEP 5, 2023, View Source [SID1234634905]).

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In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A live video webcast of the presentation will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). A webcast replay will be archived for 90 days following the event.

Olema Oncology Announces Combined Financing for Up to $180 Million

On September 5, 2023 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported that it has entered into a stock purchase agreement for a private placement of approximately $130 million of common stock (the "Private Placement") to selected institutional and accredited investors, as well as a new senior secured credit facility with an aggregate principal amount of up to $50 million (the "Credit Facility") (Press release, Olema Oncology, SEP 5, 2023, View Source [SID1234634904]). The Private Placement is expected to close on September 12, 2023, subject to customary closing conditions.

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The Private Placement was led by Paradigm BioCapital Advisors, with participation by Lightspeed Venture Partners, Deep Track Capital, BVF Partners L.P., Cormorant Asset Management, Vivo Capital, Logos Capital, and Woodline Partners LP. Pursuant to the terms of the stock purchase agreement, Olema will issue 13,211,382 shares of common stock at a purchase price of $9.84 per share, for gross proceeds of approximately $130 million, before deducting offering expenses. The Private Placement is being conducted in accordance with applicable Nasdaq rules and was priced using the average closing price of Olema’s common stock for the five trading days ended September 1, 2023.

The Credit Facility is provided by Silicon Valley Bank, a division of First-Citizens Bank & Trust Company ("SVB"), and is a four-year senior secured credit facility with an aggregate principal amount of up to $50 million, of which $25 million will be available upon the closing of the Private Placement ("Closing"), and the remaining $25 million may be made available upon approval by SVB in its discretion. The Company does not anticipate drawing on the Credit Facility at Closing.

"We are very pleased to announce this combined equity and debt financing." said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "With the support of both existing and new equity investors as well as SVB, we are now well positioned to execute on our planned monotherapy pivotal Phase 3 trial, OPERA-01, which we expect to initiate in the fourth quarter of this year."

Olema intends to use the net proceeds from the proposed financing to fund research and development of palazestrant (OP-1250) and other ongoing research programs, and for working capital and general corporate purposes. The proceeds from these financings, combined with current cash, cash equivalents and marketable securities, is expected to be sufficient to fund the current operating plan into 2027.

The securities described above have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state’s securities laws, and are being issued and sold pursuant to an exemption from registration provided for under the Securities Act. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Olema has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued and sold in the Private Placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

NUCLIDIUM to Present Data from Three Clinical-Ready Precision Oncology Programs at the 36th Annual EANM Congress

On September 5, 2023 NUCLIDIUM reported the presentation of pre-clinical and clinical translation data from three of the company’s precision oncology programs targeting epithelial tumours (KaliosTM), neuroendocrine tumours (TraceNETTM) and prostate cancer (NuriProTM) at the upcoming 36th Annual Congress of the European Association of Nuclear Medicine (EANM), 09-13 September 2023 (Press release, NUCLIDIUM, SEP 5, 2023, View Source [SID1234634903]). The full pre-clinical data packages demonstrate the company’s progress in the selection of diagnostic lead candidates for the KaliosTM and NuriProTM programs, as well as the successful establishment of a clinical-scale production process for the diagnostic component of its TraceNETTM program. The data, presented in two oral presentations and a poster presentation, support the advancement of these three programs into clinical translation. The programs are part of NUCLIDIUM’s comprehensive pipeline of copper-based radiotheranostics based on its flexible CuTraceTM platform.

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"More than 50% of cancer patients are misdiagnosed which significantly impacts their survival chances. We aim to address this challenge with our theranostic approach leveraging the advantageous properties of copper isotopes to reduce side effects and increase the precision and efficacy of radiopharmaceuticals. The positive pre-clinical data for the diagnostic candidates from three of our programs and the preparation for clinical translation represent an important step for NUCLIDIUM. Our rapid progress towards clinical evaluation will help us establish a new standard in precision oncology and offer patients better access to highly effective and safe diagnostics and treatment options," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM.

Presentation Information:

Oral presentation on the development of diagnostic candidates from the KaliosTM program targeting Fibroblast Activation Protein (FAP)-expressing tumours such as breast and lung cancer

Title: Enhancing the tumor-to-background ratio of FAP-positive PET/CT scans with the novel 61Cu-Kalios derivatives: synthesis, in vitro and in vivo characterization

Session: New Roads Towards FAP-directed Theranostics

Presenter: Jacopo Millul, PhD, Postdoctoral Scientist at University Hospital Basel

Date & Time: September 11th, 3 pm CEST

Summary:
The presentation will detail the development and characterization of a 61Cu-based diagnostic to more efficiently visualize epithelial tumours. These types of tumours make up the majority of all cancer cases and often overexpress Fibroblast Activation Protein (FAP), making FAP a promising target for cancer diagnostics and therapies. The data demonstrate the successful synthesis of four new FAP-targeting ligands with high hydrophilicity and affinity against FAP that were conjugated with 61Cu via the NODAGA chelator. In vivo analyses showed that two of the diagnostic KaliosTM conjugates are particularly promising for delayed time-point imaging, with superior tumour-to-background ratios at 4 hours. To select the best candidate for clinical translation, these two diagnostic KaliosTM conjugates will be directly compared to a 68Ga-based standard FAP-radiodiagnostic.

Oral presentation on NUCLIDIUM’s successfully established 61Cu production and on the labelling method for the diagnostic lead candidate from the TraceNETTM program targeting somatostatin-receptor-expressing neuroendocrine tumours (NETs)

Title: Radiopharmaceutical Production of [61Cu]Cu-NODAGA-LM3 Injection Solution

Session: Efficient Radiolabelling: Key for Clinical Translation

Presenter: Manuel Alejandre-Lafont, PhD, Head QC/QA Radiopharmaceutical Chemistry at University Hospital Basel

Date & Time: September 11th, 4:45 pm CEST

Summary:
The presentation will highlight NUCLIDIUM’s 61Cu production process, which was developed together with the University Hospital Zurich, and the labelling method and clinical transfer for the TraceNETTM lead diagnostic candidate, which was developed at the University Hospital Basel. TraceNETTM is designed to improve the visualization of somatostatin-receptor-expressing neuroendocrine tumours (NETs). The established technology allows to produce 61Cu in high yields and purity in a cyclotron and efficient labelling of the tumour-targeting molecule. Due to its favourable half-life properties, 61Cu enables a wide distribution radius, potentially broadening the patient population that can get access to 61Cu-based radiodiagnostics. The successfully established process enables clinical-scale production of the diagnostic candidate.

Poster presentation on the development and selection of the lead diagnostic candidate from the NuriProTM prostate cancer program

Title: 61Cu-PSMA PET in prostate cancer: development and selection of the first radioligand for clinical translation

Session: New Imaging Agents

Presenter: Prof. Melpomeni Fani, PhD, Division Head Radiopharmaceutical Chemistry at University Hospital Basel

Date & Time: September 13th, 9:45 am CEST

Summary:
The poster presentation will describe the development and lead candidate selection of the NuriProTM program’s 61Cu-based diagnostic to improve the visualization of prostate cancer. Two newly developed 61Cu-based diagnostic conjugates targeting Prostate-Specific Membrane Antigen (PSMA) with either DOTAGA or NODAGA as the chelator were compared preclinically against two currently used standard prostate cancer diagnostics based on 68Ga and 18F, respectively. In these, the NODAGA-conjugated NuriProTM diagnostic candidate exhibited superior biodistribution and pharmacokinetics than the DOTAGA-conjugate. In comparison to the standard diagnostics, the NODAGA-conjugated candidate showed a similar biodistribution but better results for delayed imaging due to improved tumour-to-background ratio in the imaging scan. Based on these findings, the NODAGA-conjugated variant was selected as the lead diagnostic candidate for translation into clinical trials.

Monopar to Participate in the H.C. Wainwright 25th Annual Global Investment Conference

On September 5, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported that Chandler D. Robinson, MD, Monopar’s Chief Executive Officer, will present at the H.C. Wainwright 25th Annual Global Investment Conference(Press release, Monopar Therapeutics, SEP 5, 2023, https://ir.monopartx.com/news/detail/77/monopar-to-participate-in-theh-c-wainwright-25th-annual-global-investment-conference [SID1234634902]). The Company’s presentation will be webcast beginning on Monday, September 11, 2023 at 7:00 a.m. ET. In person one-on-one meetings will take place at the Lotte New York Palace, NY, NY from September 11 – 13, 2023.

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Moleculin to Present at the H.C. Wainwright 25th Annual Global Investment Conference

On September 5, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported that Walter Klemp, Chairman and Chief Executive Officer of Moleculin will present at the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023 in New York, NY and virtually (Press release, Moleculin, SEP 5, 2023, https://moleculin.com/moleculin-to-present-at-the-h-c-wainwright-25th-annual-global-investment-conference/ [SID1234634901]).

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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

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 11 at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (moleculin.com). The webcast replay will be archived for 90 days following the event.