On October 8, 2026 bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW) a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, reported that it has entered into a definitive agreement with an institutional investor to sell shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $6.122 (or $6.115 per pre-funded warrant), in a registered direct offering priced at-the-market under Nasdaq rules.

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Additionally in a concurrent private placement the Company will sell warrants to purchase up to an aggregate 980,072 shares of common stock at an exercise price of $6.122 per share. The pre-funded warrants will have an exercise price of $0.007 per share of common stock, and the warrants will have an exercise price of $6.122 per share, will be exercisable following stockholder approval, and will expire five years from the date of stockholder approval. The closing of the offering is expected to occur on or about October 9, 2026, subject to the satisfaction of customary closing conditions.

WallachBeth Capital, LLC is acting as sole placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $4 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital, to support expected growing sales for CyPath Lung, its noninvasive test for lung cancer, and general corporate purposes.

The common stock described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-275608) previously filed with the U.S. Securities and Exchange Commission ("SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective by the SEC on November 27, 2023. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement describing the terms of the proposed registered direct offering and accompanying prospectus will be filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting WallachBeth Capital, LLC, via email at [email protected], by calling +1-646-237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

(Press release, BioAffinity Technologies, OCT 8, 2026, View Source/Archives/edgar/data/1712762/000149315226046548/ex99-1.htm [SID1234673303])

On October 8, 2026 Thyme Companies, a family of businesses purpose-built to solve problems across the cancer care landscape, reported the launch of Thyme Therapeutics, a new business focused on driving reductions in the cost of oncology drugs. The company will work closely with oncologists, health plans, and manufacturers to commercialize oncology biosimilars. Its model will help patients access more affordable care, make lower-cost treatments easier for oncologists to adopt, and reduce overall healthcare costs.

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Biosimilars have already offered promising saving opportunities in cancer care, but unstable prices and other market dynamics have limited those savings. Even when lower-cost options are covered and prescribed, pricing can shift significantly from quarter to quarter, keeping drug spend high and unpredictable. Thyme Therapeutics is built to align incentives across manufacturers, payers, and providers so the savings from lower-cost biosimilars reach patients and hold up over time.

"Few challenges in oncology are more urgent to solve right now than the rising cost of cancer drugs," said Robin Shah, executive chairman of Thyme Companies. "With Thyme Therapeutics, we have an opportunity to rethink how value moves through the system so that more of the savings created by biosimilars can ultimately benefit patients and the healthcare system as a whole."

Thyme Therapeutics plans to launch its first asset in 2027 and is actively engaging leading oncology groups, biosimilar manufacturers, and health plans as it builds its initial portfolio. Thyme Therapeutics will build on Thyme Care’s mission to transform cancer care in a way that reduces costs for patients in partnership with both payers and providers as it works to bring additional biosimilars to market.

This launch comes at a critical inflection point for cancer care. U.S. oncology drug spending reached approximately $84 billion in 2025, an increase of roughly 20% in a single year, while several of the industry’s highest-cost cancer therapies are approaching loss of exclusivity. That opportunity could meaningfully reset the economics of cancer care, but only if lower-cost products achieve broad and sustained adoption. Thyme Therapeutics was built to help turn that opportunity into more predictable, durable savings.

Thyme Therapeutics is the first new business launched by Thyme Companies following its formation in September 2026, alongside its Series E financing, and will initially focus on biosimilar medications. Thyme Companies was established to build independent businesses that address distinct challenges across the cancer care ecosystem, with Thyme Therapeutics as the next such business alongside Thyme Companies’ first venture, Thyme Care. To learn more about the company and the team, visit thymetherapeutics.com.

On October 8, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported that the U.S. Food and Drug Administration (the "FDA") granted Fast Track Designation for the development of PSV359 for adult patients with locally advanced unresectable and/or metastatic fibroblast activation protein (FAP)-positive solitary fibrous tumors (SFTs).

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SFT is a rare cancer for which patients with locally advanced unresectable or metastatic disease have limited treatment options. [²¹²Pb]PSV359 is an investigational FAP-targeted alpha-particle therapy being evaluated in an ongoing Phase 1/2a study in patients with advanced FAP-positive solid tumors. Published clinical imaging research has demonstrated FAP-targeted tracer uptake in SFTs, supporting the biological rationale for evaluating a FAP-directed therapy in this disease.1 Early human imaging data for PSV359 support strong tumor uptake and fast renal clearance.

The FDA’s Fast Track program is intended to facilitate development and expedite the review of therapies for serious conditions with unmet medical needs.2 Programs that receive Fast Track Designation may benefit from more frequent interactions with the FDA regarding the development program. A Fast Track-designated product may also qualify for rolling review, Accelerated Approval, or Priority Review if the applicable requirements for those programs are met.2 FDA treats these as distinct expedited programs with separate qualifying criteria.

"FAP-α is a particularly compelling target because of its broad expression across solid tumors and within the tumor microenvironment, creating the potential for PSV359 to address a substantial patient population across multiple cancer types," said Markus Puhlmann, Perspective’s Chief Medical Officer. "There are currently no approved therapies specifically targeting FAP-α, despite its association with aggressive cancers and tumor environments that can limit drug penetration and suppress immune activity. Imaging FAP-α expression before treatment allows us to pair patient selection with targeted alpha radiopharmaceutical therapy and pursue that broad opportunity with precision."

"Fast Track designation for FAP-positive solitary fibrous tumors is an important step in advancing the broader PSV359 program and our strategy of engineering targeted radiopharmaceutical therapy based on the alpha-generating isotope 212Pb to optimize the therapeutic window in oncology," said Thijs Spoor, Perspective’s Chief Executive Officer. "We look forward to working with the FDA and the medical community to define an efficient development path for PSV359 in this rare and serious disease."

About FAP

FAP is a cell-surface protein expressed predominantly by cancer-associated fibroblasts (CAFs) in the stroma, an important component of the tumor microenvironment (TME) in many epithelial cancers. FAP may also be expressed directly by certain cancer cells, including sarcomas and mesotheliomas.3,4,5,6 Higher FAP-α expression has been found to be associated with poor prognosis in a number of solid tumors such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, stomach cancer, mesothelioma, head and neck cancer, esophageal cancer, and ovarian cancer.7,8,9,10,11,12 FAP-α expression is generally limited in healthy tissues.5,6

About PSV359

PSV359 was designed to target and deliver 212Pb to tumor sites expressing FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga (known as PSV377) to detect FAP-α expression in individual patients. Preclinical imaging and therapy, as well as early human imaging results, have demonstrated that Perspective’s proprietary targeting ligand improves target engagement and uptake in tumors and reduces retention in healthy tissues, which may result in a desirable therapeutic index.

Perspective is conducting a multi-center, open-label, dose-finding and dose-expansion study (clinicaltrials.gov identifier NCT06710756) of [212Pb]PSV359 in patients with advanced solid tumors that express FAP-α as determined by imaging with [203Pb]PSV359. The primary objective of the dose-finding phase of the study is to assess the safety and tolerability of various doses of [212Pb]PSV359 in order to inform selection of the recommended Phase 2 dose for use in the expansion phase. Antitumor activity may be evaluated as an additional primary outcome in the expansion portion of the study.

(Press release, Perspective Therapeutics, OCT 8, 2026, View Source [SID1234673300])

On October 8, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company, reported that the United States Patent and Trademark Office ("USPTO") has granted a new Method of Use patent for certepetide [U.S. Patent No. 12,751,991] for the treatment of pancreatic cancer and other solid tumors, expiring May 2041.

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The newly issued patent, titled "Methods for Treating Pancreatic Cancer and Other Solid Tumors," expands Lisata’s intellectual property protection for certepetide. The patent covers administering the Company’s proprietary cyclic peptide in combination with at least one anti-cancer agent or therapy to treat pancreatic cancer and other solid tumors, including metastatic, refractory, and drug-resistant cancers, by treating, inhibiting, and/or reducing tumor volume.

"This patent granted by USPTO secures important protection for the broad use of certepetide and provides added market exclusivity into November 2043, which is essential to support its continued development," stated David J. Mazzo, Ph.D., Chief Executive Officer of Lisata.

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer.

(Press release, Lisata Therapeutics, OCT 8, 2026, View Source [SID1234673299])

On October 8, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported that the first patient has been dosed in its pivotal Phase 2 study of CLN-049, a novel, investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia (AML).

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"Patients with relapsed or refractory AML continue to face poor outcomes and limited treatment options, underscoring the urgent need for new treatment approaches that can benefit a broad range of patients," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "We believe CLN-049 has the potential to offer a novel immunotherapeutic approach for patients with AML. With this Phase 2 study now underway, we look forward to further evaluating the potential role of CLN-049 for this difficult-to-treat disease."

The Phase 2 study is designed to evaluate CLN-049 in patients with relapsed/refractory AML who have received up to two lines of prior therapy. Following a successful End-of-Phase 1 meeting with the U.S. FDA, the potentially registrational study incorporates a brief dose-optimization phase evaluating two target dose levels of CLN-049, followed by seamless advancement to a single-arm expansion cohort at the recommended Phase 2 dose. The study also includes an exploratory cohort evaluating CLN-049 in patients with newly diagnosed TP53-mutated AML. The company expects to provide an update from the Phase 1 dose escalation study of CLN-049 in patients with relapsed/refractory AML in December.

In parallel, the company is initiating a Phase 1/2 study evaluating the combination of CLN-049, azacitidine, and venetoclax in patients with newly diagnosed AML.

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1/2, open-label, multicenter, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996).

CLN-049 is also being studied in a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and PD of IV-administered CLN-049 in combination with azacitidine and venetoclax in patients with newly diagnosed AML (NCT07722767).

CLN-049 has received Orphan Drug designation and Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.2 Each year in the U.S., approximately 23,000 people are diagnosed with AML, and about half as many lives are lost to the disease.3 Globally, AML affects an estimated 145,000 people annually, with approximately 130,000 deaths.4

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.5 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.6,7 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.7 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

(Press release, Cullinan Oncology, OCT 8, 2026, View Source [SID1234673298])