On April 23, 2023, Applied Therapeutics, Inc. (the "Company") reported to have entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") for a private placement (the "Private Placement") with a select group of accredited investors (collectively, the "Purchasers") (Filing, 8-K, Applied Therapeutics, APR 24, 2023, View Source [SID1234630409]). Pursuant to the Securities Purchase Agreement, the Purchasers have agreed to purchase 9,735,731 shares of the Company’s common stock, par value $0.0001 per share (the "Shares") at a purchase price of $0.946 per share, and 22,000,000 pre-funded warrants to purchase common stock at a purchase price of $0.945, which equals the purchase price per share of common stock less the $0.001 per share exercise price of each pre-funded warrant (the "Pre-Funded Warrants" and together with the Shares the "Securities"). The Pre-Funded Warrants are immediately exercisable from the date of issuance and do not have an expiration date. Holders may not exercise any Pre-Funded Warrants that would cause the aggregate number of shares of common stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding common stock immediately after exercise. The Pre-Funded Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Pre-Funded Warrants will be entitled to receive, upon exercise of the Pre-Funded Warrants, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such transaction. The Pre-Funded Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of common stock are entitled.

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The Private Placement is expected to occur on or about April 26, 2023, subject to the satisfaction of customary closing conditions. The Company anticipates receiving gross proceeds from the Private Placement of approximately $30 million before deducting fees to the placement agent and other offering expenses payable by the Company. The Company intends to use the net proceeds to fund research and development and registration of its pipeline candidates, and for working capital and general corporate purposes.

The foregoing description of the Securities Purchase Agreement and Pre-Funded Warrants issued under the Purchase Agreement does not purport to be complete and is qualified in its entirety by references to the full text of (i) the Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference herein and (ii) the form of Pre-Funded Warrant issued under the Purchase Agreement, a copy of which is attached to this report as Exhibit 4.1 and is incorporated by reference herein.

Registration Rights Agreement

In connection with the Private Placement, the Company also entered into a registration rights agreement, dated April 23, 2023 (the "Registration Rights Agreement") with the Purchasers requiring the Company to register the resale of the Shares and the shares underlying the Pre-Funded Warrants. The Company is required to prepare and file a registration statement with the Securities and Exchange Commission (the "SEC") as soon as reasonably practicable, but in no event later than 30 days following the closing of the Private Placement (the "Filing Deadline"), and to use commercially reasonable efforts to have the registration statement declared effective within 30 days of the Filing Deadline, subject to extension under the terms of the Registration Rights Agreement.

The Company has granted the Investors customary indemnification rights in connection with the Registration Rights Agreement. The Investors have also granted the Company customary indemnification rights in connection with the Registration Statement.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by references to the full text of such agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated by reference herein.

On April 24, 2023 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported the closing of a $38 million Series A+ financing (Press release, Adcentrx Therapeutics, APR 24, 2023, View Source [SID1234630408]). The round was led by Eight Roads Ventures, with participation from F-Prime Capital, ABio-X, Delta Capital, Trinity Innovation Fund, and other strategic investors. Life Venture Partners and Lighthouse Capital acted as Adcentrx’s financial advisors. Adcentrx intends to use the proceeds from the financing to advance its proprietary ADC therapeutic pipeline into the clinic.

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ADCs are a class of therapies that combine the target specificity of antibodies with the potency of conventional chemotherapy drugs. This class has revolutionized the treatment landscape in oncology with the potential to positively impact other serious diseases. Adcentrx differentiates itself by leveraging its team’s industry-leading experience in ADC drug development as well as deep expertise in chemistry and biology. The team has pioneered the development of an ADC technology toolbox addressing key components of protein conjugate design to solve challenges that arose in previous generations of ADCs. Adcentrx implements this optimized approach to fuel the development of a robust pipeline of first-in-class and best-in-class therapies. The company’s lead candidate, ADRX-0706, is anticipated to enter a first-in-human Phase 1 clinical trial in the second half of 2023. Adcentrx is developing additional candidates in parallel with the goal of advancing at least one into the clinic each year.

"We are thrilled to have Eight Roads and our investors supporting our mission to bring innovative treatments to patients," said Hui Li, Ph.D., Founder and CEO of Adcentrx. "Over the last two years, we have made significant progress advancing our emerging therapeutic pipeline that implements our proprietary and differentiated technology platform. This new round of funding from our investors will enable Adcentrx to quickly advance our safer and more efficacious conjugate therapies for patients in need. This year will be pivotal for Adcentrx, when we transition from the discovery stage into a clinical stage company."

"ADCs as a therapeutic modality have flourished in recent years with a transformative inflow of active investment and strategic transactions. Adcentrx has demonstrated good potential of developing differentiated ADCs for unmet medical needs" commented Tao Huang, Ph.D., Principal of Eight Roads Ventures. "We are very excited to lead this round of financing to empower Adcentrx to accelerate its work in bringing new hope to patients in need."

"Through its innovative work in the ADC field, Adcentrx exemplifies the type of company that ABio-X was designed to support as a global platform for developing the next generation healthcare companies. We are pleased to join together with other quality investors in this financing round and look forward to continuing our support of Adcentrx through the platform and board representation," added Jeff Jonas, President and CEO of ABio-X.

"Adcentrx has made significant progress in building its preclinical pipeline and platform technology since our initial investment," said Meng Jiang, Head, Venture Capital at CBC Group. "Together with our ABio-X colleagues, we are pleased to reaffirm our commitment to support the company’s continued growth and development."

"As an innovation company with a global vision, Adcentrx leverages its technology platform to address the challenges of ADC drug development," commented Lei Hong, Executive Director of Lighthouse Capital. "It is a privilege to participate in this round of financing that attracted investment from renowned funds and industry players, indicating the company’s growing prominence within the industry. We look forward to Adcentrx’s continued progress of advancing its novel ADCs into the clinic."

For more information about Adcentrx and its innovative ADC technology, please visit View Source

On April 24, 2023 AB Science S.A. (the "Company" or "AB Science", NYSE Euronext – FR0010557264 – AB), reported the success of its capital increase through the issuance of new ordinary shares with attached warrants, with a waiver of preferential subscription rights, via a private placement for a final amount of 15.0 million euros (the "Capital Increase") (Press release, AB Science, APR 24, 2023, View Source [SID1234630407]).

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Alain Moussy, Chief Executive Officer of AB Science, states:

« AB Science is satisfied with the success of this capital increase, through which AB Science’s historical shareholders have had the opportunity to renew their confidence in AB Science and to show their support for its new strategy announced on April 21. »
AB Science has decided to focus its development strategy as follows:

– Allocation of current resources primarily to the development of masitinib for the treatment of amyotrophic lateral sclerosis and the development of the microtubule destabilizer agents (MDA) platform, with the clinical development of AB8939 in refractory acute myeloid leukemia and the initiation of regulatory preclinical development of a new oral molecule in the same microtubule class for sarcoma and solid tumors. We want to focus the majority of our clinical resources on the development of rare diseases with masitinib, on the development of the microtubule platform with AB8939 and future molecules of the same family due to the very encouraging first results.

– Acceleration of the process of seeking a license for masitinib in non-rare disease indications, with priority given to progressive forms of multiple sclerosis and Alzheimer’s disease.

This acceleration is possible now that the confirmatory Phase 3 studies have been approved by the FDA in the United States and the major European agencies. To this end, the Company has retained the services of a leading investment bank.

This license search is a priority in the Company’s strategy, given the number of clinical studies already conducted and the maturity of the pipeline, and given the additional investments required to complete the clinical program, up to market authorizations. We want to highlight that the duration of this license search is not predictable and that the realization of a license is dependent on a number of factors and is not guaranteed. However, the milestones reached at this stage are essential factors that contribute to the feasibility of this strategy.

As a result of the focus strategy, AB Science has decided to adapt its organization, which should lead to a significant reduction in costs. This strategic focus reinforces and sustains the existing agreement between certain shareholders of AB Science and Alain Moussy.

Terms of the Capital Increase

The Capital Increase consisted of a private placement pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code and has been carried out with a waiver of preferential subscription rights, pursuant to the delegation of authority granted to the Board of Directors under the 20th resolution of the Combined General Shareholders’ Meeting of June 29, 2022. The Capital Increase has taken the form of the issuance of 2,608,686 actions new ordinary shares (the "New Shares") to each of which are attached a share subscription warrant (the "Warrants").
The Capital Increase was made through a cash contribution of approximately EUR 11.5 million and by offsetting existing receivables, i.e. approximately EUR 3.0 million (receivables related to the pre-financing of the research tax credit for the 2020 financial year and maturing in 2023, as well as approximately EUR 500,000 in interest accrued to date on the convertible bonds issued in February 2022).

Two warrants giving the right to subscribe to one ordinary share, all of the 2,608,686 New Shares and all of the 1,304,343 new shares that would be issued upon exercise of the warrants, i.e. a total of 3,913,029 shares in the Company, represent 7.36% of the Company’s current share capital.

The issue price of the New Shares has been set at 5.75 euros (0.01 euro par value and 5.74 euros issue premium) and the exercise price of the Warrants at 8.625 euros, representing a total fundraising of approximately EUR 15.0 million (taking into account the exercise of the warrants, the maximum amount of the Capital Increase could be increased by an amount of 26.3 million euros).

The Warrants may be exercised from January 1st, 2025 to December 31, 2030, will be immediately detached from the New Shares upon their issuance and will not be listed.

The settlement-delivery of the new ordinary shares to be issued in the context of the Capital Increase and their listing on Euronext Paris are expected to occur on April 28, 2023 at the latest. The new shares will bear current dividend rights and will be listed on the regulated market on Euronext Paris under ISIN code: FR0010557264 – AB.

The proceeds of the Capital Increase will provide AB Science with the additional resources necessary to finance its activities over the next twelve months. In particular, the raised funds will be used for the clinical development of masitinib in amyotrophic lateral sclerosis and other orphan indications and for the development of the AB Science microtubule destabilizer agents platform. The Capital Increase will also support the strategy communicated on April 21.

Shareholding structure of the Company after the Capital Increase

After the Capital Increase (excluding the exercise of the Warrants), the share capital of the Company will amount to 558,081.39 euros, and will be composed of 55,808,139 shares with a nominal value of 0.01 euro each (all share classes included). By way of illustration, a shareholder holding 1% of the Company’s share capital (including all categories of shares) prior to the Capital Increase and who did not participate in the Capital Increase will hold 0.95% of the Company’s share capital after the Capital Increase and 0.93% in the event that all the Warrants are exercised. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan 3

The table below reflects the shareholding to the best of the Company’s knowledge.

Shareholders Before the Capital Increase After the Capital Increase (before exercise of the warrants) After the Capital Increase and exercise of the warrants Ordinary shares % Ordinary shares % Ordinary shares % A. Moussy 7 058 068 13,27% 7 058 068 12,65% 7 058 068 12,36% AMY SAS 12 273 000 23,07% 12 273 000 21,99% 12 273 000 21,49% Agreement (excluding A. Moussy and AMY SAS) 2 183 696 4,10% 2 673 442 4,79% 2 918 315 5,11% Other investors 31 684 689 59,56% 33 803 629 60,57% 34 863 099 61,04% Total 53 199 453 100,00% 55 808 139 100,00% 57 112 482 100,00%

Information available to the public

The Capital Increase will not be subject to a prospectus approved by the French Financial Market Authority (the "AMF"). AB Science draws the attention of the public to the risk factors relating to the Company and its business described in its annual management reports and press releases, which are available free of charge on the Company’s website (www.ab-science.com).

In addition, the main risks specific to securities are as follows: – The existing shareholders who do not participate in the Capital Increase will see their shareholding in the share capital of AB Science diluted, and this shareholding may also be diluted in the event of exercise of the Warrants, as well as in the event of new securities transactions.

– The volatility and liquidity of AB Science shares could fluctuate significantly. The sale of Company shares may occur on the secondary market, after the Capital Increase, and have a negative impact on the Company share price.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that targets mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Due to its unique mode of action, masitinib can be developed in a wide range of diseases, including oncology, inflammatory diseases, and certain central nervous system diseases. In oncology, through its immunotherapy activity, masitinib may have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the symptoms associated with certain inflammatory and central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug. Preclinical data show that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has strong potential to be developed in numerous oncology indications.

On April 24, 2023 – 3B Pharmaceuticals GmbH (3BP), a private German biotechnology company developing targeted radiopharmaceutical drugs and diagnostics for oncology indications, reported that it has entered into an amended and restated licensing agreement with Novartis Innovative Therapies AG (Novartis) for 3BP’s FAP-targeting peptide technology (Press release, 3B Pharmaceuticals, APR 24, 2023, View Source [SID1234630406]).

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The agreement gives Novartis exclusive worldwide rights to develop and commercialize therapeutic and imaging applications for 3BP’s FAP-targeting peptide technology, including FAP-2286. FAP-2286 targets fibroblast activation protein (FAP), a promising theranostic target with expression across a majority of cancers. FAP-2286 was the first peptide-targeted radioligand therapy (PT-RLT) targeting FAP to enter clinical development together with the respective imaging agent, making it the most advanced radioligand therapy in its class. It is currently being tested in a phase 1 clinical trial (LuMIERE).

Under the terms of the agreement, 3BP receives an initial payment of $40 million as well as up to $425 million in development, regulatory, and commercial milestone payments, in addition to tiered royalties on net sales. 3BP retains certain rights to develop its FAP-targeting imaging technology for diagnostic purposes.

3BP entered into a license and collaboration agreement in 2019 with Clovis Oncology focusing on the development of a peptide-targeted radiotherapy and imaging agent targeting FAP. The new agreement with Novartis encompasses 3BP’s entire FAP-targeting peptide technology and worldwide rights.

"We are grateful to our partner Clovis Oncology for the excellent translation and early clinical development of FAP-2286. We believe the new agreement with Novartis is an ideal partnership for the further clinical development of FAP-2286 for the benefit of patients with many different types of cancer," said Dr. Christiane Smerling, Head of Nuclear Medicine & Imaging at 3BP.

"We have focused for many years on developing a peptide technology platform to create innovative radiopharmaceuticals and this agreement validates the value of 3BP’s platform," added Dr. Ulrich Reineke, Managing Director of 3BP. "This partnership will allow us to continue to expand our core competencies and dedicate resources to the further development of our pipeline."

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use.

On April 23, 2023, IDEAYA Biosciences, Inc. (the "Company") reported interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients, its trial design for the Phase 2/3 clinical trial evaluating darovasertib and crizotinib in first-line HLA-A2 negative MUM patients, and interim results for darovasertib as neoadjuvant therapy in primary uveal melanoma (UM), from an ongoing investigator sponsored trial (IST) evaluating darovasertib in (neo)adjuvant uveal melanoma, from compassionate use protocol(s) and from the Company’s Phase 1/2 clinical trial evaluating darovasertib as monotherapy and in combination with crizotinib (Press release, Ideaya Biosciences, APR 23, 2023, View Source [SID1234630428]).

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Clinical Data Update – Darovasertib and Crizotinib Combination in MUM

The Company observed encouraging clinical activity in the Phase 2 clinical trial evaluating the darovasertib and crizotinib combination in first-line and any-line MUM patients. The reported Phase 2 clinical data are based on 20 evaluable first-line and 63 evaluable any-line patients enrolled as of September 22, 2022 in the darovasertib and crizotinib combination study at the expansion dose of 300 mg twice-a-day darovasertib and 200 mg twice-a-day crizotinib. Reported data are preliminary and based on investigator review from an unlocked database as of the data analyses cutoff date of March 8, 2023. Enrollment in the darovasertib and crizotinib combination expansion dose cohort of the Phase 2 clinical trial is ongoing.

In the 20 evaluable first-line MUM patients in the expansion cohort, the investigator-reviewed data by RECIST 1.1 include:

45% confirmed Overall Response Rate (ORR) in first-line MUM: 9 of 20 evaluable patients had a confirmed partial response (PR)

90% Disease Control Rate (DCR) in first-line MUM: 18 of 20 evaluable patients showed disease control, including 9 confirmed PRs, 1 unconfirmed PR and 8 stable disease

~7 months median progression free survival (PFS) in first-line MUM

In the 63 evaluable any-line MUM patients at the expansion dose, the investigator-reviewed data by RECIST 1.1 include:

30% confirmed ORR in any-line MUM: 19 of 63 evaluable patients had a confirmed PR; the any-line MUM patients were heavily pre-treated, with 63% of patients having received one or more prior lines of treatment and 43% of patients having received two or more prior lines of treatment in the metastatic setting

87% DCR in any-line MUM: 55 of 63 evaluable patients showed disease control, including 19 confirmed PRs, 4 unconfirmed PRs and 32 stable disease

~7 months median PFS in any-line MUM

Observed median PFS increased versus median PFS of ~5 months previously reported in September 2022 with 35 evaluable any-line MUM patients

There were 20 evaluable hepatic-only MUM patients, including first-line and pre-treated patients with only hepatic metastases, for whom the investigator-reviewed data by RECIST 1.1 include:

35% confirmed ORR in hepatic-only MUM: 7 of 20 evaluable patients had a confirmed PR

100% DCR in hepatic-only MUM : 20 of 20 evaluable patients showed disease control, including 7 confirmed PRs, 1 unconfirmed PR and 12 stable disease

~11 months median PFS in hepatic-only MUM

These data demonstrate robust clinical efficacy of the darovasertib and crizotinib combination in first-line and any-line MUM patients.

The darovasertib and crizotinib combination has a manageable adverse event profile in MUM patients (n=68), with a low rate of drug-related serious adverse events (SAEs). Patients reported predominantly Grade 1 or 2 drug-related adverse events (AEs): 31% of patients reported at least one Grade 3 AE; no patients observed a Grade 4 AE; and one patient observed a Grade 5 AE. Four (6%) patients discontinued treatment with either darovasertib or crizotinib due to a drug-related adverse event.

FDA Guidance in Type C Meeting Supports Initiation of Potential Registrational Trial

The Company is targeting to initiate a potential registration-enabling Phase 2/3 clinical trial in Q2 2023 in first-line HLA-A2 negative MUM patients. The Phase 2/3 clinical trial design incorporates guidance and feedback from the FDA following a recent Type C meeting.

The protocol includes an integrated Phase 2/3 open-label study-in-study design in first-line MUM patients with an HLA-A*02:01 negative serotype. The clinical trial design employs a Phase 2 portion with median PFS as a primary endpoint for potential accelerated approval. Patients enrolled in Phase 2 will continue on treatment within the same clinical trial and will be considered together with additional enrolled patients to evaluate overall survival (OS) in support of a potential Phase 3 registrational trial.

In the Phase 2 portion of the clinical trial, approximately 230 patients will be randomized on a 2:1 basis for treatment with the darovasertib and crizotinib combination in the treatment arm or investigators choice in the control arm, selected from a combination of ipilimumab (ipi) and nivolumab (nivo), PD1-targeted monotherapy or DTIC. The treatment arm of the Phase 2 portion includes a nested study to confirm the move forward combination dose for the integrated Phase 2/3 clinical trial – including cohorts at the Phase 2 expansion doses of (i) darovasertib 300 mg BID + crizotinib 200 mg BID and (ii) darovasertib 200 mg BID + crizotinib 200 mg BID. Under the nested study design, patients enrolled in the cohort at the move forward dose will be included within the Phase 2/3 registrational clinical trial. The Phase 2 portion of the clinical trial contemplates an efficacy and safety data set of approximately 200 patients randomized 2:1 with the treatment arm at the move forward dose to support a potential accelerated approval based on median PFS by blinded independent central review (BICR) as a primary endpoint.

Patients enrolled in Phase 2 at the selected dose would continue on treatment and be included in the Phase 3 study analysis, supplemented by enrollment of approximately 120 additional patients into the Phase 3 portion of the clinical trial with 2:1 randomization on the same basis as the Phase 2 portion. Efficacy data from the Phase 3 could support potential approval using median OS as a primary endpoint.

Clinical Data Update – Darovasertib in (Neo)Adjuvant Primary UM

The Company observed further evidence of encouraging clinical activity for darovasertib as neoadjuvant therapy in primary UM, including responses in primary ocular tumor lesions. Data was reported from an ongoing IST evaluating darovasertib in (neo)adjuvant UM, from compassionate use protocol(s) and from the Company’s Phase 1/2 clinical trial evaluating darovasertib as monotherapy and in combination with crizotinib. Best ocular tumor response is reported based on maximal percentage reduction in measured apical height or longest basal diameter.

Collectively, these data further substantiate clinical proof of concept (POC) for the use of darovasertib in the (neo)adjuvant uveal melanoma setting:

Ocular tumor shrinkage by investigator review in 9 of 9 (100%) UM (n=6) or MUM (n=3) patients treated as monotherapy or in combination with crizotinib, including a neoadjuvant UM patient treated with darovasertib with a partial response at one month, and a second neoadjuvant UM patient treated with the darovasertib and crizotinib combination with ~80% ocular tumor shrinkage at four months who was spared enucleation, as described below.

A UM patient who was already blind in one eye from vascular disease developed a large uveal melanoma lesion in his other eye and sought neoadjuvant treatment with a goal to avoid enucleation and potentially preserve vision in the affected eye to prevent blindness. This patient, who remains on therapy, was treated with darovasertib and crizotinib combination under a compassionate use protocol. The preliminary clinical data showed:

observed ~80% ocular tumor shrinkage after four months of treatment and remains on therapy

avoided enucleation of the affected eye, which we believe to be the first reported case of systemic neoadjuvant therapy resulting in eye preservation

prompt responsiveness to treatment, including progressive tumor shrinkage, as determined by investigator measurement of tumor apical height, over each month of treatment, including approximately 30% ocular tumor shrinkage after one month, with ocular lesion size reduced to approach threshold for plaque brachytherapy, and further ocular tumor shrinkage to ~50% after two months, ~70% after three months and ~80% after four months of treatment

improved vision following course of treatment and treatment of a severe cataract: pretreatment vision score was 6/120, where 6/60 is legally blind; post-treatment vision score was 6/5, reflecting a greater than 20-fold improvement and resulting in better than normal vision. Vision scoring was based on AU meter measurement system: 6/6 m = 20/20 ft (normal vision).

The Company is initiating a company-sponsored clinical trial to evaluate darovasertib as monotherapy in (neo)adjuvant UM and is evaluating potential near-term clinical neoadjuvant endpoints such as organ preservation (avoiding enucleation) for large ocular tumors and reduction in radiation dose and/or vision preservation for small or medium ocular tumors.

The Company is also supporting St. Vincent’s Hospital Sydney Limited, which has initiated an ongoing IST captioned as "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM) (NCT05187884), to evaluate darovasertib monotherapy in a neoadjuvant and adjuvant setting in primary UM patients.

Addressable Patient Population in MUM and UM

The potentially addressable patient population for metastatic uveal melanoma is estimated to include approximately 4,500 patients across the United States and Europe, based on estimated annual incidence, and approximately 14,000 patients in total prevalence in the United States and Europe. (Neo)Adjuvant UM represents a significant expansion opportunity for darovasertib given the potential annual incidence of approximately 8,700 patients aggregate in the United States and Europe, and approximately 100,000 patients in total prevalence in the United States and Europe.