On August 2, 2024 Agilent Technologies Inc., (NYSE: A) reported that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy (Press release, Agilent, AUG 2, 2024, View Source [SID1234645311]).

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MAGE-A4 (melanoma-associated antigen A4) is a cancer-testis antigen overexpressed in various cancers, including synovial sarcoma. MAGE-A4 IHC 1F9 pharmDx is an immunohistochemistry (IHC) assay used to detect MAGE-A4 expression in formalin-fixed paraffin-embedded (FFPE) synovial sarcoma tissue. MAGE-A4 positivity in synovial sarcoma is a biomarker of eligibility for treatment with TECELRA. MAGE-A4 IHC 1F9 pharmDx is the first IVD for MAGE-A4 available on the market.

"MAGE-A4 plays a significant role in cancer research and holds promise as a therapeutic target. The FDA’s approval of Agilent’s MAGE-A4 IHC 1F9 pharmDx will expand treatment options for individuals diagnosed with synovial sarcoma," stated Lou Welebob, vice president and general manager of Agilent’s Pathology Division. "This endorsement amplifies Agilent’s pioneering role in shaping companion diagnostics for groundbreaking cancer therapies."

TECELRA, is a prescription medicine approved for advanced MAGE-A4 positive synovial sarcoma in adults with certain HLA types who have received prior chemotherapy. TECELRA is the first FDA-approved engineered TCR T-Cell therapy for a solid tumor cancer.

On August 2, 2024 bioAffinity Technologies, Inc. (NASDAQ: BIAF and BIAFW) reported that it has entered into warrant exercise agreements with three existing accredited investors to exercise certain outstanding warrants to purchase an aggregate of 1,041,667 of the Company’s shares of common stock (the "Existing Warrants"). In consideration for the immediate exercise in full of the Existing Warrants for gross cash proceeds of approximately $1,302,083, the exercising holders received in a private placement new unregistered warrants (the "New Warrants") to purchase up to an aggregate of 1,302,083 shares of common stock (equal to 125% of the shares of common stock issued in connection with the exercise of the Existing Warrants) with an exercise price of $1.50 per share and are 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 (Press release, BioAffinity Technologies, AUG 2, 2024, View Source [SID1234645310]). In connection with the exercise of the Existing Warrants, the Company agreed to reduce the exercise price of the Existing Warrants from $1.64 to $1.25 per share. The exercise of the Existing Warrants and the issuance of the New Warrants are expected to occur on August 5, 2024.

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The Company also announced today it has entered into a securities purchase agreement with an institutional investor for the purchase and sale of 360,000 shares of common stock in a registered direct offering and, in a concurrent private placement, common warrants (the "Private Warrants") to purchase up to 450,000 shares of common stock (together with the registered direct offering) at a combined purchase price of $1.25. The Private Warrants will have an exercise price of $1.50 per share, are initially exercisable on the date that stockholder approval of the exercise of the warrants is obtained and will expire five years from the date of such approval.

The closing of the offering is expected to occur on or about August 5, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $450,000, excluding any proceeds that may be received upon the exercise of the Private Warrants and before deducting placement agent fees and other offering expenses payable by the Company.

WallachBeth Capital is acting as sole placement agent for the registered direct offering and private placement and financial advisor for the warrant inducement transaction.

The common stock will be issued in a registered direct offering pursuant to an effective 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 Nov. 27, 2023. The Private Warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered pursuant to an exemption from the registration requirements of the Securities Act of under Section 4(a)(2) thereof and Regulation D promulgated thereunder and have not been registered under the Securities Act or applicable state securities laws. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and available on the SEC’s website located at View Source Electronic copies of the prospectus supplements may be obtained, when available, from 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.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

About CyPath Lung

CyPath Lung uses 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, TCPP, 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 cancer can improve outcomes and increase patient survival.

On August 2, 2024 Immunovia (Nasdaq Stockholm: IMMNOV), the pancreatic cancer diagnostics company, reported the company has filed a US provisional patent application to protect the intellectual property embodied in its next-generation test to detect stage 1 and 2 pancreatic cancer (Press release, Immunovia, AUG 2, 2024, View Source [SID1234645308]).

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The patent application claims methods of diagnosing pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The company is seeking patent protection for the unique combination of five specific biomarkers used in its test, as well as the method for combining these biomarkers to generate a positive or negative test result.

Immunovia filed the provisional patent application with the Patent and Trademark Office (PTO) in the United States of America, the first market for commercializing the company’s new test. In coming months, the company expects to submit additional clinical data to the USPTO bolster the patent application.

Immunovia also plans to file a single PCT (Patent Cooperation Treaty) application within the next year, enabling the company to seek patent protection for its invention across dozens of countries at one time. Immunovia will later pursue patents in specific high-value commercial markets outside the US.

"Our scientists have invented a breakthrough approach to detecting pancreatic cancer and it’s vital we protect that invention," said Jeff Borcherding, CEO of Immunovia.

As previously announced, Immunovia has completed development of its next-generation test to detect stage 1 and 2 pancreatic cancer. Immunovia will conduct a large, independent clinical validation study in fourth quarter 2024 to confirm the accuracy of the Immunovia test. The company is on track to launch the new test in the US in 2025.

On August 2, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported that Chief Medical Officer Dr. Thomas Heineman will participate in a fireside chat at Canaccord Genuity’s 44th Annual Growth Conference, which is taking place August 13-15, 2024 at the InterContinental Boston Hotel in Boston, MA (Press release, Oncolytics Biotech, AUG 2, 2024, View Source [SID1234645307]). Additional details on the fireside chat can be found below.

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Date: Tuesday, August 13, 2024
Time: 8:30 a.m. ET
Location: InterContinental Boston, Hutchinson Room
Webcast Link: Available by clicking here

Company management will also be participating in one-on-one investor meetings at the conference. To schedule a meeting, please submit a request on the conference website, contact your Canaccord representative, or email [email protected].

A live webcast of the Company’s presentation will also be available on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months.

On August 2, 2024 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the third quarter of fiscal 2024 ended June 30, 2024 (Press release, Twist Bioscience, AUG 2, 2024, View Source [SID1234645306]).

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"We once again surpassed our revenue guidance, ending the quarter with $81.5 million in revenue, and exceeded our targets for both cash burn and gross margin," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We saw strength in NGS as well as growth driven by our SynBio product line with sequential growth for our Express Genes portfolio. Recently, we leveraged the Express workflow and infrastructure to introduce new products, including our Express Antibodies, CHO and HEK293, as well as Multiplexed Gene Fragments, with direct synthesis of up to 500 base pairs in length."

Dr. Leproust continued, "We continue to employ disciplined execution and commercial prowess to expand our portfolio of products and services as we progress on our path to profitability and move toward an adjusted EBITDA loss of $20 million in the fiscal fourth quarter of 2024. We are encouraged by the continued increase in margin with approximately 900 basis point increase over the same period last year to 43.3% and we are moving toward a gross margin over 50% by the end of fiscal 2025."

See "Non-GAAP Information" below for a discussion of the measure adjusted EBITDA.

FISCAL 2024 THIRD QUARTER FINANCIAL RESULTS

•Orders: Total orders received for the third quarter of fiscal 2024 grew to $85.3M compared to $63.8M for the same period of fiscal 2023.
•Revenue: Total revenues for the third quarter of fiscal 2024 grew to $81.5 million compared to $63.7 million for the same period of fiscal 2023.
◦SynBio revenue grew to $33.0 million for the third quarter of fiscal 2024 compared to $25.9 million for the same period of fiscal 2023.
◦NGS revenue grew to $43.4 million for the third quarter of fiscal 2024 compared to $33.2 million for the same period of fiscal 2023.
◦Biopharma revenue was $5.1 million for the third quarter of fiscal 2024 compared to $4.6 million in the same period of fiscal 2023.
•Cost of Revenues: Cost of revenues for the third quarter of fiscal 2024 was $46.2 million compared to $41.8 million for the same period of fiscal 2023.
•Gross Margin: Gross margin for the third quarter of fiscal 2024 increased to 43.3% compared to 34.4% for the same period of fiscal 2023.
•Research and Development Expenses: Research and development expenses for the third quarter of fiscal 2024 were $22.5 million compared to $24.5 million for the same period of fiscal 2023.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of fiscal 2024 were $56.8 million compared to $46.1 million for the same period of fiscal 2023.
•Net Loss: Net loss attributable to common stockholders for the third quarter of fiscal 2024 was $85.6 million, or $1.47 per share, compared to $57.4 million, or $1.01 per share, for the same period of fiscal 2023. On a non-GAAP basis and excluding approximately $45.0 million for an impairment related to Biopharma assets, net loss attributable to common stockholders for the third quarter of fiscal 2024 was $40.6 million.
•Adjusted EBITDA: Adjusted EBITDA for the third quarter of fiscal 2024 was $(22.0) million compared to $(29.6) million for the same period of fiscal 2023. See the table included in this release for a reconciliation between our adjusted EBITDA and net loss attributable to common stockholders, the most directly comparable GAAP financial measure.
•Cash Position: As of June 30, 2024, the company had $289.4 million in cash, cash equivalents and short-term investments, a reduction of approximately $4 million from the March 31, 2024 balance of approximately $293 million.

Recent Highlights:

•Shipped products to approximately 2,300 customers in the third quarter of fiscal 2024, compared to approximately 2,200 customers in the third quarter of fiscal 2023.
•Shipped approximately 212,000 genes during the third quarter of fiscal 2024, compared with approximately 171,000 genes during the third quarter of fiscal 2023.
•Launched Twist Multiplexed Gene Fragments, pools of directly synthesized dsDNA up to 500bp in length with no limit on sequence number, to enable high throughput screening applications.
•Added Cloned Oligo Pools up to 300 nucleotides with no limit to pool size, to Twist’s ecommerce platform.

•Expanded high-throughput antibody portfolio with the launch of Twist Express Antibodies, CHO, complementing Twist’s HEK293 antibody offering.
•Announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405, the first antibody discovered using Twist synthetic antibody libraries to be evaluated in patients.
•Published preclinical data detailing the discovery of TB206-001, a first-in-class antibody that could enhance cancer immunotherapy by targeting adenosine A2A receptor and alleviating the suppressive tumor microenvironment.
•Launched a synthetic RNA control for H5N1, one of the causes of Highly Pathogenic Avian Influenza (HPAI).
•Joined the U.S. AI Safety Consortium, a group established by the Department of Commerce’s National Institute of Standards and Technology to support the development and deployment of trustworthy and safe AI.

Updated Fiscal 2024 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2024, including the fourth quarter of fiscal 2024. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2024, Twist provided the following updated financial guidance:

•Total revenue is expected to be approximately $310 million to $311 million compared to previous guidance of $300 million to $304 million, indicating year over year growth of approximately 27%, and includes the following:
◦SynBio revenue is expected to be approximately $121 million compared to the previous estimate of $118 million to $120 million, indicating year over year growth of 23%
◦NGS revenue is expected to be in the range of $169 million to $170 million compared to the previous estimate of $162 million to $164 million, indicating year over year growth of 36% to 37%
◦Biopharma revenue is expected to be approximately $20 million, no change to prior estimates and indicating year over year decrease of approximately 13%
•Gross margin is expected to be approximately 42.0% for fiscal 2024, the high end of the previous guidance range of 41.5% to 42%
•Loss from operations before taxes of approximately $227 million to $230 million, inclusive of the approximately $45 million impairment charge; on a non-GAAP basis excluding the impairment charge, loss from operations is expected to be in the range of $182 million to $185 million, a slight decrease from our previous guidance of $183 to $188 million
◦Capital expenditure of approximately $13 million, a decrease of $2 million compared to prior guidance of $15 million
◦Ending cash, cash equivalents and short-term investments at September 30, 2024 of more than $255 million, an increase of $10 million over previous guidance of more than $245 million.

For the fourth quarter of fiscal year 2024, Twist provided the following financial guidance:

•Total revenue of approximately $82 million to $83 million compared to the previous estimate of $77 million to $80 million
•Gross margin of approximately 44% compared to the previous estimate of 43-44%
•Adjusted EBITDA loss of $20 million