On August 4, 2023, iBio, Inc. (the "Company") reported to have agreed to amend the exercise price with certain holders of the Series A Warrants and Series B Warrants that were acquired from the Company in the underwritten public offering that was completed in December 2022 (Filing, 8-K, iBioPharma, AUG 4, 2023, View Source [SID1234633874]). Under the amended warrants, the Company agreed to amend existing Series A warrants to purchase up to 3,475,916 shares of common stock and existing Series B warrants to purchase up to 2,058,000 shares of common stock that were previously issued in December 2022 to the certain investors in the public offering, with exercise prices of $1.04 per share (the "Existing Warrants"), to lower the exercise price of the Existing Warrants to $0.50 per share.

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On August 4, 2023 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, reported that it has made equity grants to two newly hired employees under its 2022 Inducement Plan (the "Inducement Plan") (Press release, Inovio, AUG 4, 2023, View Source [SID1234633835]).

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The Compensation Committee of INOVIO’s Board of Directors has approved the award of restricted stock units ("RSUs") covering an aggregate of 10,000 shares of common stock and options to purchase an aggregate of 50,000 shares of common stock, with a grant date of July 31, 2023 (the "Grant Date"), to two newly hired employees in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over a three-year period, with one-third of the shares vesting on each of the first, second and third anniversaries of the Grant Date. The stock options have an exercise price of $0.53, the closing price of INOVIO’s common stock on the Grant Date. The stock options will vest and become exercisable with respect to one-fourth of the shares underlying the stock options vested on the Grant Date, and an additional one-fourth of the shares underlying the stock options on the first, second, and third anniversaries of the Grant Date. The vesting of the RSUs and stock options will be subject to the employees’ continued employment with INOVIO on the applicable vesting dates. Each of these awards is subject to the terms and conditions of a stock option agreement and RSU award agreement, as applicable, under the Inducement Plan.

On August 4, 2023 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 2023 ended June 30, 2023 (Press release, Twist Bioscience, AUG 4, 2023, View Source [SID1234633830]).

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"We reported record revenue again this quarter, with our core business, comprised of SynBio and NGS, delivering very strong results," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Significantly, our Wilsonville site manufactured and shipped the vast majority of our genes, gene fragments and oligo pools, with the new team performing well. We continued to expand our NGS portfolio with the launch of our RNA sequencing portfolio targeting the substantial research market."

Dr. Leproust continued, "As we look forward, we expect continued growth in the core business, driven by taking market share, an increasing customer base and expanding product portfolio. For Biopharma Solutions, we will continue to focus on hiring the right commercial leaders, serving our customers, and closing new deals both with existing and new partners while keeping a keen eye on evaluating, analyzing and managing this business to ensure value creation in the short, medium and long term. In data storage, we remain on track to demonstrate an end-to-end gigabyte Century Archive workflow by the end of calendar 2023."

FISCAL 2023 THIRD QUARTER FINANCIAL RESULTS

Orders: Total orders received for the third quarter of fiscal 2023 were $63.8 million compared to $59.7 million for the same period of fiscal 2022.
Revenue: Total revenues for the third quarter of fiscal 2023 were $63.7 million compared to $56.1 million for the same period of fiscal 2022.
Cost of Revenues: Cost of revenues for the third quarter of fiscal 2023 was $41.8 million compared to $31.0 million for the same period of fiscal 2022.
Research and Development Expenses: Research and development expenses for the third quarter of fiscal 2023 were $24.5 million compared to $36.8 million for the same period of fiscal 2022.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of fiscal 2023 were $46.1 million compared to $53.7 million for the same period of fiscal 2022.
Net Loss: Net loss attributable to common stockholders for the third quarter of fiscal 2023 was $57.4 million, or $1.01 per share, compared to $60.5 million, or $1.08 per share, for the same period of fiscal 2022.
Cash Position: As of June 30, 2023, the company had $357.1 million in cash, cash equivalents and investments.
Recent Highlights:

Shipped products to approximately 2,200 customers in the third quarter of fiscal 2023, versus approximately 1,900 in the third quarter of fiscal 2022.
Shipped approximately 171,000 genes during the third quarter of fiscal 2023, compared with approximately 163,000 in the third quarter of fiscal 2022.
Expanded the executive leadership team with the appointments of Robert Werner as chief accounting officer and Chet Gandhi as chief information officer.
Announced Jim Thorburn, chief financial officer (CFO), will transition to a new role supporting commercial scaling, operational leverage and DNA data storage once a new CFO is hired.
Entered into a new market with the launch of a portfolio of RNA sequencing tools to enable targeted or whole transcriptome research across fields including precision medicine, biomarker discovery and immuno-oncology research.
Entered into a collaboration with Cancer Research Horizons, the innovation arm of Cancer Research UK, by which Cancer Research Horizons will license the entire Twist Biopharma Solutions Library of Libraries.
Published preclinical data supporting the potential use of the highly potent and optimized GLP-1R antagonist antibody, TB-222-023, as a treatment for congenital hyperinsulinism in the journal Diabetes.
Presented at Imec Technology Forum (ITF) World 2023 on how industry growth could be fueled by using CMOS-based chips for high-density DNA synthesis for data storage applications.
Fiscal 2023 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2023. 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 2023, Twist provided the following updated financial guidance:

Revenue is expected to be approximately $241 million to $242 million, compared to previous guidance of $235 million to $238 million
SynBio revenue is expected to be approximately $98 million, at the high end of the previous guidance of $96 million to $98 million
NGS revenue is expected to be approximately $120 million, compared to previous guidance of $113 million to $114 million
Biopharma revenue is estimated to be approximately $23 million to $24 million compared to previous guidance of $26 million
Gross margin for fiscal 2023 is expected to be 36%, at the high end of the range of previous guidance of 35-36%
Operating expenses including R&D and SG&A are expected to be approximately $308 million, compared to previous guidance of $313 million to $319 million
R&D expense is expected to be approximately $109 million, compared to previous guidance of $112 million to $114 million
SG&A expense is expected to be $189 million, compared to previous guidance of $197 million to $200 million
Mark to market of contingent consideration and indemnity holdbacks is projected to be a credit of $6 million, compared to previous guidance of $5 million
Restructuring costs are expected to be approximately $14 million, which includes approximately $4 million of asset and lease hold impairment charges related to the transition of SynBio operations from South San Francisco to Wilsonville, compared to previous guidance of $9 million to $11 million
Other income and expense for the year is projected to be approximately $12 million
Operating loss is expected to be approximately $220 million inclusive of one-time charges for restructuring of $14 million, compared to our previous guidance of $230 million to $234 million and includes the following:
Stock-based compensation is expected to be approximately $32 million, compared to our previous guidance of $43 million
Depreciation and amortization are expected to be approximately $29 million, unchanged from previous guidance
Operating expenses for DNA data storage is expected to be approximately $40 million, unchanged from previous guidance
Capital expenditure is expected to be approximately $35 million, compared to previous guidance of $40 million
FY23 Year End Cash is projected to be $325 million, compared to previous guidance of $320 million
For the fourth quarter of fiscal 2023, Twist provided the following financial guidance:

Revenue is expected to be approximately $63 million to $64 million, compared to previous guidance of $62 to $63 million
Gross margin is expected to be approximately 36%
R&D expense is expected to be approximately $26 million
SG&A expense is expected to be approximately $47 million
Restructure expense is expected to be approximately $1 million
Fiscal 2024 Financial Guidance

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

Twist expects to exit fiscal 2024 with adjusted EBITDA breakeven for its core (SynBio, NGS) business in the fourth quarter
Operating expenses for DNA data storage are expected to be $40 million
Fiscal year end cash is projected to be $220 million
Twist expects to be delayed in reaching its initial timeline in achieving adjusted EBITDA breakeven for its biopharma business exiting the fourth quarter of fiscal 2024.

On August 4, 2023 Aptevo Therapeutics Inc. (NASDAQ:APVO) ("Aptevo" or the "Company"), a clinical stage biotechnology company focused on developing novel immuno-oncology therapeutics, reported the closing of its previously announced public offering of 2,221,550 shares of common stock at a purchase price of $0.62 per share, Pre-Funded Warrants to purchase up to an aggregate of 5,842,967 shares of common stock at a purchase price of $0.619 per Pre-Funded Warrant, Series A Warrants to purchase up to an aggregate of 8,064,517 shares of common stock and Series B Warrants to purchase up to an aggregate of 8,064,517 shares of common stock (Press release, Aptevo Therapeutics, AUG 4, 2023, View Source [SID1234633829]). The Pre-Funded Warrants have an exercise price of $0.001, are immediately exercisable and may be exercised at any time until exercised in full. The Series A and Series B Warrants have an exercise price of $0.62 per share, are immediately exercisable and expire in August 2028 and February 2025, respectively.

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Gross proceeds from the offering were approximately $5 million before deducting placement agent fees and other estimated offering expenses. The Company intends to use the net proceeds of this offering for the continued clinical development of its product candidates and for working capital purposes.

A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

The securities described above were offered pursuant to a registration statement on Form S-1, as amended (File No. 333-273067) previously filed with the Securities and Exchange Commission (SEC) which became effective on August 1, 2023. The offering was made only by means of a prospectus forming part of the effective registration statement. A final prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained on the SEC’s website located at View Source and may also be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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.

On August 4, 2023 Vivesto AB, an oncology-focused research and development company, reported early termination of patient enrollment in the Docetaxel micellar advanced prostate cancer Phase 1b study with the Swiss Group for Clinical Cancer Research (SAKK) (Press release, Vivesto, AUG 4, 2023, View Source [SID1234633828]).

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The open-label, multicenter, single-stage Phase 1b study has closed its accrual after enrollment of 11 of the planned 18 patients, since Vivesto believes that the data generated will be sufficient ahead of switching into development with a new formulation based on its improved XR-18 micelle technology platform.

Docetaxel micellar has shown good tolerability at doses considered standard for conventional docetaxel formulations, as well as signs of clinical activity. Docetaxel micellar has been well received by investigators of the SAKK 67/20 and by participating prostate cancer patients.

"We are grateful for the general positive feedback from the principal investigators. Particularly, Docetaxel micellar was safely administered with no infusion reactions and without the requirement for steroid premedication. A thorough analysis of the data, including pharmacological aspects, is pending, and we will await its completion to gain a comprehensive understanding of the outcomes," said Heidi Ramstad, Vivesto’s CMO. "We are grateful to the enrolled patients and for the effort put in by SAKK and investigators in search for better treatment options for prostate cancer."

Vivesto’s Docetaxel micellar is a solvent-free formulation of docetaxel developed to avoid the need for the solubility enhancers in a solvent-based docetaxel and the mandatory high-dose steroid premedication. Patients treated with other existing formulations of docetaxel require steroid administration to avoid certain serious adverse events related to the formulations with solvent. The administration of steroids can lead to marked bone fragility, exacerbated by cancer metastases in the bone, or steroid-related metabolic issues.

Vivesto has progressed in the development of its XR-18 drug delivery platform and intends to use this next-generation improved technology in future development of Docetaxel micellar.