On September 15, 2025, BullFrog AI Holdings, Inc. (the "Company") reported to have entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park committed to purchase up to $10.0 million of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement (Filing, 8-K, Bullfrog AI, SEP 15, 2025, View Source [SID1234655993]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the "Purchase Shares"). Such sales of Common Stock by the Company, if any, will be subject to certain limitations set forth in the Purchase Agreement, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase Agreement are satisfied, including that a registration statement covering the resale by Lincoln Park of shares of Common Stock that have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company agreed to file with the U.S. Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (the date on which all of such conditions are satisfied, the "Commencement Date").

From and after the Commencement Date, provided the last closing sale price of Common Stock is not below $0.50 at or immediately prior to the time of sale, the Company may, by written notice, direct Lincoln Park to purchase up to 30,000 shares of our Common Stock, which amount may be increased depending on the last closing sale price of Common Stock at or immediately prior to the time of sale, subject to a maximum commitment of $500,000 on such business day (or the purchase date) at a purchase price per share that will be determined in accordance with the Purchase Agreement at the time the Company delivers such written notice to Lincoln Park (a "Regular Purchase"). The purchase price per share for each Regular Purchase will be based on prevailing market prices of the Common Stock at or prior to the time of sale as computed in accordance with the terms set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock under the Purchase Agreement.

If the Company directs Lincoln Park to purchase the maximum number of shares of Common Stock that the Company may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park to purchase additional shares of Common Stock in an "accelerated purchase" (each, an "Accelerated Purchase") and an "additional accelerated purchase" (each, an "Additional Accelerated Purchase") (including multiple Additional Accelerated Purchases on the same trading day) as provided in the Purchase Agreement. The purchase price per share for each Accelerated Purchase and Additional Accelerated Purchase will be based on market prices of the Common Stock on the applicable purchase date for such Accelerated Purchases and such Additional Accelerated Purchases.

The Company will control the timing and amount of any sales of Common Stock to Lincoln Park pursuant to the Purchase Agreement. Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions set forth in the Purchase Agreement.

Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, general market conditions, the trading price of the Company’s Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital, capital expenditures and general corporate purposes.

In the case of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 2,048,936 shares (subject to adjustment as described above) of the Common Stock (which is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) stockholder approval is obtained to issue Purchase Shares above the Exchange Cap, or (ii) at the time the Company has issued shares of Common Stock equal to the Exchange Cap and at all times thereafter, the average price per share of Common Stock for all shares of Common Stock sold by the Company to Lincoln Park under the Purchase Agreement equals or exceeds $1.4053 per share (which represents the lower of (A) the official closing price of our Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and (B) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, in each case as adjusted under applicable Nasdaq rules to take into account the issuance of shares of Common Stock to Lincoln Park for non-cash consideration as payment of the commitment fee described below so that the Exchange Cap limitation would not apply to issuances and sales of Common Stock under the Purchase Agreement pursuant to the rules and regulations of Nasdaq).

In all cases, the Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder), would result in Lincoln Park beneficially owning more than 4.99% of the then total outstanding shares of Common Stock.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, except the Company is prohibited (with certain specified exceptions set forth in the Purchase Agreement) from effecting or entering into an agreement to effect an "equity line of credit" or other substantially similar offering whereby an investor is irrevocably bound to purchase securities over a period of time from the Company at a price based on the market price of the Common Stock at the time of each such purchase. Lincoln Park has agreed not to engage in or effect, directly or indirectly, for its own principal account or for the principal account of any of its affiliates, any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during the term of the Purchase Agreement.

Pursuant to the terms of the Purchase Agreement, the Company will issue 147,682 shares of Common Stock (the "Commitment Shares") to Lincoln Park as consideration for its commitment to purchase shares of Common Stock under the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time with one business day notice, at no cost or penalty. Following the Commencement Date, if any "Suspension Event", as defined in the Purchase Agreement, occurs, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such Suspension Event is cured.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are summaries and are qualified in their entirety by reference to the full texts of the Purchase Agreement and Registration Rights Agreement, which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On September 15, 2025 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported that ADC therapeutics developer, Tubulis has exercised an exclusive license for the global development and commercialization of a fully human antibody developed by Biocytogen (Press release, Biocytogen, SEP 15, 2025, View Source [SID1234655985]). The antibody will be applied in a novel ADC candidate proprietary to Tubulis. It is part of a previously signed research collaboration and option agreement to discover and advance antibody components for the development and commercialization of ADC products based on Biocytogen’s antibody discovery engine.

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The antibody was generated using Biocytogen’s proprietary RenMice platform and features high affinity, low immunogenicity, and favorable developability. Tubulis will apply its proprietary linker and payload technologies to develop innovative ADC therapies based on this antibody, aiming to address areas of high unmet clinical need in cancer treatment.

Dr. Yuelei Shen, President and CEO of Biocytogen, said, "We are very pleased that Tubulis has exercised its option, which reflects the international competitiveness and translational potential of our fully human antibody discovery platform. We look forward to seeing this antibody advance through Tubulis’ powerful ADC development engine and into clinical development to benefit patients around the world."

Jonas Helma-Smets, PhD, CSO and co-founder of Tubulis, stated: "Our goal is to drive innovation in ADC development and deliver uniquely positioned ADC therapeutics that can improve treatment outcomes to patients with solid tumors. The R&D collaboration with Biocytogen has yielded an antibody candidate that we believe fits well with our ADC technology platforms and that may support us in the development of a novel therapeutic candidate."

Under the terms of the agreement, Biocytogen will receive an upfront payment and is eligible for certain development, regulatory, and commercial milestone payments, and single-digit royalties on net sales.

On September 15, 2025 Novocure (NASDAQ: NVCR) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy (Press release, NovoCure, SEP 15, 2025, View Source [SID1234655984]).

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"With the Ministry of Health, Labour and Welfare approval granted to Optune Lua, we now have a new treatment option available to patients with advanced non-small cell lung cancer," said Dr. Tetsuya Mitsudomi, President, Izumi City General Hospital. "The Phase 3 LUNAR trial showed that use of Optune Lua resulted in improved overall survival rates without severe side effects, resulting in a significant benefit for patients with this aggressive disease."

Optune Lua is a wearable, portable medical device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cancer cell death.

"Lung cancer is the leading cause of cancer-related death worldwide, and unfortunately, in Japan the number of cases continue to increase, which is why we see an urgent need for innovative treatment options for this disease," said Frank Leonard, President, Novocure. "Novocure is focused on launching Optune Lua as quickly as possible in Japan so that patients with non-small cell lung cancer experiencing a progression after initial platinum-based treatment have access to our therapy."

Data Supporting the Optune Lua Approval

The MHLW approval was supported by the Phase 3 LUNAR trial, a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel (experimental arm) to PD-1/PD-L1 inhibitors or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy.

The primary endpoint of the study was achieved demonstrating a statistically significant and clinically meaningful 3.3-month (P=0.04) extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n=145).

The group treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2 months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9 months (95% CI, 8.2 to 12.2 months) in the PD-1/PD-L1 inhibitor or docetaxel treated group (n=146).

The LUNAR study included two pre-specified powered secondary endpoints. The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua concurrently with docetaxel versus docetaxel alone.

Patients randomized to receive Optune Lua and a PD-1/PD-L1 inhibitor (n=70) demonstrated a median OS of 19.0 months (95% CI, 10.6 to 28.2 months) compared to a median OS of 10.8 months (95% CI, 8.3 to 17.6 months) in patients treated with a PD-1/PD-L1 inhibitor alone (n=71), which was a statistically significant extension in median OS of more than 8.0 months (P=0.02).

Patients randomized to receive Optune Lua and docetaxel (n=75) had a median OS of 11.1 months (95% CI, 8.2 to 13.9 months) compared to a median OS of 8.9 months (95% CI, 6.5 to 11.3 months) in patients treated with docetaxel alone (n=75). This 2.2-month extension in median OS did not provide a statistically significant demonstrated benefit but did show a positive trend.

Device-related adverse events (AEs) occurred in 63.1% of patients (n=89), these were skin-related disorders under the transducer arrays. The majority of these events were low grade (Grade 1 – 2), with only 4% (n=6) experiencing Grade 3 skin toxicity that required a break from treatment. There were no Grade 4 or Grade 5 toxicities related to Optune Lua, and no device-related AEs that caused death.

Baseline patient characteristics were well balanced between cohorts: median age was 65 years (range, 22-86); 66% male, 34% female; 96% of patients had an ECOG performance status of 0-1. PD-L1 expression data were collected from 83% of patients (69 of 83 patients) enrolled at U.S. sites and were well balanced across the four cohorts.

Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the most common cause of cancer-related death worldwide1, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. It is estimated that approximately 120,000 patients are diagnosed with NSCLC each year in Japan.2

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced NSCLC. Certain immune checkpoint inhibitors, including both PD-1 and PD-L1 inhibitors, have been approved for the first-line treatment of NSCLC and the standard of care in this setting continues to evolve rapidly.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On September 15, 2025 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported it has received regulatory approval from the Medical Device Division of Israel’s Ministry of Health ("AMAR") for its next-generation single cryoprobe cryoablation system, the XSense System and CryoProbes (Press release, IceCure Medical, SEP 15, 2025, View Source [SID1234655982]).

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As of mid-2024, XSense and its cryoprobes have also received regulatory clearance in the United States from the U.S. Food and Drug Administration ("FDA") for all of the indications for which ProSense, the Company’s flagship cryoablation system, has already received from the FDA.

"We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure’s leadership position in liquid-nitrogen based cryoablation," stated IceCure’s Chief Executive Officer, Eyal Shamir. "The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients."

"We are particularly pleased with the breast cancer indication approval in Israel, as we believe the growing body of evidence on cryoablation as a minimally invasive option for breast cancer supports accelerated commercial adoption," Shamir added.

XSense is now approved in Israel for all indications for which ProSense has already received approval in Israel, including general surgery, dermatology, neurology, including cryoanalgesia, thoracic surgery, ENT (ear, nose, throat), gynecology, oncology (including benign and malignant breast tumors), proctology and urology.

On September 15, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) (Press release, Akeso Biopharma, SEP 15, 2025, View Source [SID1234655980]). The trial will evaluate cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab.

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COMPASSION-36 is the first global registrational Phase III trial of cadonilimab, currently ongoing in China, the U.S. and Europe. Its advancement represents a significant milestone in the global development and registration of cadonilimab, reflecting Akeso’s commitment to advancing cancer immunotherapy and addressing the limited survival benefits associated with single-target therapies.

Additional global multicenter registrational/Phase III clinical trials for cadonilimab are currently being prepared. Going forward, Akeso will continue to pursue a dual strategy of in-house development and open collaboration, leveraging high-quality global resources to accelerate the internationalization of cadonilimab and offer patients worldwide improved and more accessible treatment options.

Currently, immune checkpoint inhibitor (IO) combination therapies have become the standard first-line treatment for various advanced malignancies. However, for patients worldwide whose disease progresses after IO combination therapy, there is a lack of effective second-line treatment options. The very limited second-line treatment options for advanced malignancies drive the critical need to explore new therapeutic strategies. Cadonilimab-based combination therapies have shown substantial potential in overcoming IO resistance across multiple tumor types.

Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, with approximately 865,000 new cases of liver cancer reported globally in 2022. The combination of atezolizumab and bevacizumab (A+T regimen) is the standard first-line therapy for advanced HCC, as recommended by the NCCN guidelines. However, for patients whose disease progresses after first-line A+T treatment, there is currently no FDA-approved second-line therapy available in the U.S., and also no approved treatment options from the NMPA in China. This creates a significant unmet need in the clinical management of these patients.

The potential of cadonilimab for the treatment of HCC has been validated in multiple studies. The promising data from the combination of cadonilimab and pulocimab (anti-VEGFR-2) in treating IO-resistant lung cancer was recently presented as an oral presentation at WCLC 2025, generating widespread attention within the industry. At the 2023 ESMO (Free ESMO Whitepaper) Asia Congress, a study was presented demonstrating that cadonilimab, combined with FOLFOX-HAIC as neoadjuvant therapy, achieved a 100% disease control rate (DCR) in patients with resectable multinodular HCC. Data presented at the 2023 ESMO (Free ESMO Whitepaper) Congress revealed that the combination of cadonilimab and lenvatinib as first-line treatment for advanced HCC shows superior antitumor activity.

Akeso’s exploration of combination therapies with cadonilimab in the treatment of HCC offers a broad and effective approach to disease management. These combinations address both early and advanced stages of HCC and provide promising therapeutic options for a wide range of patients.

In addition to the international multicenter Phase II registrational study COMPASSION-36, patient enrollment for the Phase III clinical trial of cadonilimab as adjuvant therapy for high-risk recurrence following curative surgery for HCC has been completed. Furthermore, a Phase III registrational study of cadonilimab combined with lenvatinib and transarterial chemoembolization (TACE) for the treatment of intermediate to advanced unresectable HCC is currently ongoing.