On August 13, 2025 MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value-added drug products, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, AUG 13, 2025, View Source [SID1234655200]). This novel oral formulation was developed using MAA’s proprietary NanoCont technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.

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This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.

"We are extremely pleased to receive IND clearance from the FDA for our third consecutive clinical-stage asset, following Methotrexate and Nintedanib," said Anjani Jha, Founder and CEO of MAA Laboratories. "This achievement is a testament to the versatility and potential of our NanoCont platform to deliver advanced oral drug formulations with meaningful clinical, regulatory, and development advantages."

Key Highlights

IND clearance granted for Dasatinib Nanoparticle Tablets
505(b)(2) regulatory pathway confirmed for a Phase I BA/BE study in healthy volunteers
Developed using NanoCont, an FDA-recognized Emerging Technology
Designed to optimize systemic exposure and patient experience across both oral and subcutaneous reference formulations
Marks MAA’s third consecutive IND approval utilizing NanoCont technology
About Dasatinib Nanoparticle Tablets

MAA’s next-generation Dasatinib Nanoparticle Tablets are designed to address pharmacokinetic and patient-experience limitations associated with conventional Dasatinib formulations. By leveraging the NanoCont platform, the product aims to enhance absorption, achieve consistent dose proportionality across multiple strengths, and improve systemic exposure—supporting a modernized, patient-friendly approach to oral oncology formulation development.

On August 13, 2025 bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported that it has entered into securities purchase agreements with several institutional and accredited investors (the "Purchasers") for the purchase and sale of 990 shares of the Company’s Series B Convertible Preferred Stock (the "Preferred Stock") and warrants (the "Private Placement Warrants") to purchase approximately 6.7 million shares of common stock (the "Private Placement") (Press release, BioAffinity Technologies, AUG 13, 2025, View Source [SID1234655222]).

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The shares of Preferred Stock have a stated value of $1,000 per share and are initially convertible into an aggregate of approximately 4.3 million shares of common stock at a conversion price of $0.23 per share. The Private Placement Warrants will be exercisable following the date on which the Company obtains stockholder approval of the exercise thereof at an initial exercise price of $0.352 per share and expire five years from the original exercise date.

The Company also announced today it has entered into a warrant exercise agreement with an existing accredited investor to exercise (i) outstanding warrants to purchase 450,000 shares of the Company’s shares of common stock that were issued in August 2024 (the "August Warrants") and (ii) outstanding warrants to purchase 650,000 shares of the Company’s common stock that were issued in October 2024 (the "October Warrants" and together with the August Warrants, the "Existing Warrants"), which reduced the exercise prices of the August Warrants from $1.50 to $0.23 per share and the October Warrants from $1.25 to $0.23 per share and provided for the issuance to such investor of new unregistered warrants (the "New Warrants") to purchase up to an aggregate of 1.43 million shares of the Company’s common stock in consideration for the immediate exercise in full of the Existing Warrants for gross cash proceeds to the Company of approximately $253,000 (the "Warrant Inducement"). The New Warrants will have an exercise price of $0.352 per share and will be initially exercisable on the date that stockholder approval of the exercise of the New Warrants is obtained and will expire five years from the date of such approval.

The closing of the Private Placement and Warrant Inducement is expected to occur on or about August 14, 2025, subject to the satisfaction of customary closing conditions.

The expected aggregate proceeds (before expenses) of the Private Placement and Warrant Inducement will be approximately $1.2 million. The Company shall use the net proceeds from the Private Placement and Warrant Inducement for working capital and general corporate purposes.

WallachBeth Capital LLC is acting as the sole placement agent for the Private Placement and financial advisor for the Warrant Inducement.

The securities described above will be offered in a private placement exempt from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and in a transaction not involving a public offering and have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock underlying the Preferred Stock, the Private Placement Warrants and New Warrants within 15 calendar days after the closing date.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On August 13, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Mersana Therapeutics, AUG 13, 2025, View Source [SID1234655201]).

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"During the second quarter, we were excited to have Emi-Le clinical data presented in oral sessions at both ASCO (Free ASCO Whitepaper) 2025 and ESMO (Free ESMO Whitepaper) Breast Cancer 2025. These presentations highlighted Emi-Le’s encouraging clinical activity in patients with TNBC post-topo-1 treatment and those with adenoid cystic carcinoma type 1 (ACC-1)," said Martin Huber, M.D., President and Chief Executive Officer of Mersana Therapeutics. "Our team has continued to make important progress in recent months, as evidenced by the strong pace of enrollment in the two ongoing dose expansion cohorts in our Phase 1 clinical trial of Emi-Le. We look forward to reporting initial clinical data from these expansion cohorts later this year."

Emiltatug Ledadotin (Emi-Le; XMT-1660)
Mersana has continued to advance the development of Emi-Le, the company’s B7-H4-directed Dolasynthen ADC.

Medical Congress Presentations: During the second quarter of 2025, clinical data as of a March 8, 2025 data cut-off from dose escalation and backfill cohorts in the Phase 1 clinical trial of Emi-Le were included in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (ASCO 2025) in Chicago, IL and the European Society for Medical Oncology Breast Cancer 2025 Annual Congress (ESMO Breast Cancer 2025) in Munich, Germany. The ASCO (Free ASCO Whitepaper) 2025 presentation included data for patients across all enrolled tumor types, and the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 presentation focused primarily on patients with post-topo-1 TNBC. These presentations can be accessed by visiting the Publications section of the Mersana website at www.mersana.com.

Expansion Update: Mersana continues to enroll patients with TNBC who have received one to four prior lines of therapy, including at least one topo-1 ADC. This stage of the trial is enrolling patients in two cohorts:

A "Dose A" cohort, in which patients are receiving 67.4 mg/m2 of Emi-Le every four weeks (Q4W), and
A "Dose B" cohort, in which patients are receiving 80 mg/m2 Q4W following a loading dose of 44.5 mg/m2 on days 1 and 8 of the first four-week cycle.
Collectively, more than 45 patients with TNBC have been enrolled across the two cohorts. Mersana plans to report initial clinical data from the expansion portion of its Phase 1 clinical trial in the second half of 2025.

XMT-2056
The dose escalation portion of Mersana’s Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope, is ongoing. Additionally, in July 2025, Mersana achieved a $15 million development milestone under its agreement with GSK plc, which has an exclusive global license option to co-develop and commercialize XMT-2056. Payment of the milestone is due in the third quarter of 2025. Mersana expects to present initial clinical pharmacodynamic STING activation data for XMT-2056 in the second half of 2025.

Collaborations
Mersana continues to support its collaborations with both Johnson & Johnson (Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

Reverse Stock Split
A 1-for-25 reverse stock split of the issued and outstanding shares of Mersana’s common stock (the Reverse Stock Split) became effective at 5:00 p.m. ET on July 25, 2025, and the company’s common stock began trading on a split-adjusted basis on July 28, 2025. The Reverse Stock Split reduced the number of outstanding shares of the company’s common stock from approximately 124.8 million shares to approximately 5.0 million shares. The shares outstanding and per share amounts below have been adjusted to reflect the Reverse Stock Split.

On August 11, 2025, the company received formal notification from The Nasdaq Stock Market, LLC (Nasdaq) confirming that the company has regained compliance with Nasdaq’s minimum bid price requirement. The regaining of compliance is a result of the closing bid price per share of the company’s common stock being at least $1.00 for a minimum of 10 consecutive business days prior to the August 25, 2025 compliance deadline, as described in the initial notice from Nasdaq to the company dated February 25, 2025.

Second Quarter 2025 Financial Results and Recent Updates

Net cash used in operating activities for the second quarter of 2025 was $22.6 million, which included $2.4 million in severance-related payments.

Cash and cash equivalents as of June 30, 2025 were $77.0 million.

In July 2025, Mersana made a payment of approximately $17.9 million to satisfy in full its indebtedness and obligations under the company’s previous loan and security agreement. The company continues to expect that its capital resources will be sufficient to support its current operating plan commitments into mid-2026.
Collaboration revenue for the second quarter of 2025 was $3.1 million, compared to $2.3 million for the same period in 2024. The year-over-year change was primarily related to increased revenue recognized under the company’s collaboration and license agreements with Johnson & Johnson and Merck KGaA, Darmstadt, Germany, partially offset by reduced revenue recognized under its agreement with GSK.

Research and development (R&D) expense for the second quarter of 2025 was $16.2 million, compared to $17.2 million for the same period in 2024. Included in the second quarter of 2025 R&D expense was $0.9 million in non-cash stock-based compensation expense. The year-over-year change in R&D expense was primarily related to lower headcount and related employee compensation costs, partially offset by an increase in costs related to Emi-Le and XMT- 2056 clinical development activities and manufacturing activities associated with the company’s collaborations.
General and administrative (G&A) expense for the second quarter of 2025 was $7.4 million, compared to $10.5 million during the same period in 2024. Included in the second quarter of 2025 G&A expense was $1.1 million in non-cash stock-based compensation expenses. The year-over-year change in G&A expense was primarily related to lower headcount and related employee compensation costs and a reduction in consulting and professional services fees.
Mersana incurred $3.9 million in restructuring expenses for the second quarter of 2025 related primarily to severance and benefit payments, outplacement services and related expenses.

Net loss for the second quarter of 2025 was $24.3 million, or $4.87 per share, compared to a net loss of $24.3 million, or $4.96 per share, for the same period in 2024.

Conference Call Reminder

Mersana will host a conference call today at 8:00 a.m. ET to discuss business updates and its financial results for the second quarter of 2025. To access the call, please dial 833-255-2826 (domestic) or 412-317-0689 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

On August 13, 2025 CEL-SCI Corporation (NYSE American: CVM) reported that a Breakthrough Medicine Designation application has been filed with the Saudi Food and Drug Authority (SFDA) for Multikine* (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies (Press release, Cel-Sci, AUG 13, 2025, View Source [SID1234655223]). CEL-SCI has signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3rd quarter of 2025.

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Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Following the granting of Breakthrough Medicine Designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia.

The Saudi pharma company is well positioned to procure reimbursement and to accelerate Multikine’s sale and commercial launch.

Several leading Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and a potential joint venture to serve the wider Middle East and North Africa (MENA) market. CEL-SCI is working closely with First Berlin of Germany and its Saudi representatives to advance its commercialization program for Multikine.

Martin Bailey, Managing Director and Founder of First Berlin, the lead advisor, commented, "CEL-SCI’s prospective new partner is a prominent and innovative leader that has rendered many valuable healthcare services to the Kingdom. The Saudi pharma company’s keen interest in Multikine to make patients’ first cancer treatment more curative is very much in line with their forward-thinking approach and fits well with Saudi Arabia’s Vision 2030 and the National Biotechnology Strategy. We look forward to facilitating the signing of a final partnership agreement and making Multikine available to patients as quickly as possible."

"This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine’s global regulatory, patient access/sale and commercial roll out," stated CEL-SCI CEO, Geert Kersten. "We’ve had a highly productive working relationship with this prestigious Saudi pharma company, First Berlin, and the SFDA and hope to see Multikine improve longevity and well-being for head and neck cancer patients in Saudi Arabia."

About the SFDA’s Breakthrough Medicine Program

The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. The program is voluntary and based on early dialogue with drug developers to optimize development plans and speed up evaluation. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines’ benefits justify their risks.

Eligibility includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation:

Target serious debilitating or life-threatening conditions with unmet medical need.
The medicinal product is likely to offer major advantages over methods currently used.
The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
The product is not registered at any regulatory authority at the time of submission of the designation request.

On August 13, 2025 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, reported its second quarter 2025 financial results and provided a corporate update (Press release, Instil Bio, AUG 13, 2025, View Source [SID1234655144]).

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Recent Highlights:

In June, announced the appointment of Jamie Freedman, M.D., Ph.D., as Chief Medical Officer
In July, announced the Investigational New Drug (IND) application for ‘2510 was cleared by the U.S. FDA
In July, ImmuneOnco, Instil’s collaborator, announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of ‘2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco
In August, ImmuneOnco announced that an abstract has been accepted for poster presentation at IASLC’s 2025 World Conference on Lung Cancer (September 6th-9th, 2025), which will provide updated results from additional patients with relapsed/refractory squamous-NSCLC treated with ‘2510 as monotherapy
Second Quarter 2025 Financial and Operating Results:

As of June 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $103.6 million, which consisted of $7.7 million in cash and cash equivalents, approximately $0.2 million in restricted cash, $84.1 million in marketable securities, and $11.7 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024, consisting of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities. Instil expects that its cash, cash equivalents, marketable securities and long-term investments as of June 30, 2025 will enable it to fund its operating plan beyond 2026.

In-process research and development expenses were $10.0 million for both the three and six months ended June 30, 2025, compared to nil for both the three and six months ended June 30, 2024.

Research and development expenses were $6.7 million and $12.1 million for the three and six months ended June 30, 2025, respectively, compared to $2.9 million and $10.2 million for the three and six months ended June 30, 2024, respectively.

General and administrative expenses were $6.2 million and $15.3 million for the three and six months ended June 30, 2025, respectively, compared to $10.7 million and $23.1 million for the three and six months ended June 30, 2024, respectively.

Restructuring and impairment charges were $0.5 million and $16.6 million for the three and six months ended June 30, 2025, respectively, compared to $0.5 million and $4.8 million for three and six months ended June 30, 2024, respectively.

Net loss per share, basic and diluted were $3.24 and $7.55 for the three and six months ended June 30, 2025, respectively, compared to $2.29 and $6.03 for the three and six months ended June 30, 2024, respectively. Non-GAAP net loss per share, basic and diluted, were $2.88 and $4.21 for the three and six months ended June 30, 2025, respectively, compared to $1.57 and $3.95 for the three and six months ended June 30, 2024, respectively.