On November 7, 2023 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 107.3 million in the third quarter of 2023 (Q3 2022: NOK 96.9 million), and an EBITDA of NOK 3.3 million (NOK 4.7 million) for the company (Press release, PhotoCure, NOV 7, 2023, View Source [SID1234637188]). Photocure refines its guidance ranges for 2023: The Company continues to expect 65-75 new Saphira blue light tower installations assuming delivery of an anticipated large purchase order in Q4; consolidated product revenue growth in the range of 17-20% including the impact of FX and the ongoing flexible BLC phase down; and positive EBITDA anticipated in the range of NOK 45-50 million excluding BD spending.

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"In the third quarter, Hexvix/Cysview revenue increased 11% year-over-year and we delivered NOK 3.3 million in EBITDA while progressing numerous initiatives to advance our business. We also announced successful Phase III clinical trial outcomes for two assets with our partner Asieris: Cevira for the treatment of pre-cervical cancer and Hexvix, our core product to be commercialized by Asieris in China," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 107.5 million in the third quarter of 2023 (NOK 106.8 million), and an EBITDA* of NOK 3.3 million (NOK 4.7 million), driven by a combination of price increases and a benefit from foreign exchange, partially offset by lower unit volumes in the U.S. The Hexvix/Cysview revenues ended at NOK 107.3 million in the quarter (Q3 2022: NOK 96.9 million). The EBIT was NOK -3.9 million (NOK -1.4 million). In the prior-year period, Photocure received a NOK 9.3 million milestone payment from Asieris. The cash balance at the end of the period was NOK 255.1 million.

At the end of the third quarter of 2023, the installed base of rigid blue light cystoscopy (BLC) systems in the U.S. was 342, an increase of 23%, or 65 towers, since the third quarter of 2022. These figures do not include the approximately 30 remaining active flexible cystoscopy towers in the U.S.

"The installed base of rigid blue light capital equipment continued to grow, with 21 new Saphira towers readied for use in the third quarter. New high definition Saphira cystoscope systems now represent more than a third of the installed base of rigid BLC towers in the U.S. Currently, there are more than 100 quotes for new Saphira towers issued, with Karl Storz extending its promotional program through year-end. As a result, we believe that both new placements and upgrades to high-definition blue light equipment in the U.S. will continue to be strong in Q4, as we work to offset the loss of active towers in the surveillance segment," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care, although the phase down of flexible equipment represents challenges in near to intermediate term.

Photocure today refined its 2023 guidance ranges: The Company continues to expect 65-75 new Saphira blue light tower installations assuming delivery of an anticipated large purchase order in Q4; consolidated product revenue growth in the range of 17-20% including the impact of FX and the ongoing flexible BLC phase down; and positive EBITDA anticipated in the range of NOK 45-50 million excluding BD spending.

"I am proud that in 2023 alone, Photocure has worked with blue light equipment manufacturers to open a total of 56 new accounts and upgrade components or full towers in over 150 accounts internationally. We believe that reclassification of BLC equipment from Class 3 to Class 2 in the U.S. will open a regulatory pathway facilitating the entry of equipment manufacturers eager to access the U.S. market to expand BLC use, as indicated by Stryker Corporation’s recent supportive public comment on the pending Citizen’s Petition. Simultaneously, we are actively pursuing a global strategy to reintroduce flexible blue light cystoscopy equipment with the intention to rebuild the larger surveillance segment of the market worldwide. Given our plans to reaccelerate growth, a strong balance sheet and the potential for additional milestones and sales royalties from our partner Asieris, I remain confident that Photocure is in a solid position to deliver value for our patients and shareholders," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the third quarter 2023 financial report on page 23.

The quarterly report and presentation will be published at 08:00 CET and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CET.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20231108_3/

The presentation is scheduled to conclude at 14:45 CET.

On November 7, 2023 Celldex Therapeutics, Inc. ("Celldex" or the "Company") (Nasdaq: CLDX) reported that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Celldex Therapeutics, NOV 7, 2023, View Source [SID1234637187]). Celldex expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares of common stock are being offered by the Company. Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of barzolvolimab, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies and Leerink Partners are acting as the joint book-running managers for the proposed offering.

The securities described above will be offered pursuant to a shelf registration statement on Form S-3 (File No. 333-275300), which was previously filed with the Securities and Exchange Commission ("SEC") and became automatically effective on November 3, 2023. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source(opens in a new tab), copies of which may be obtained, when available, for free by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388 or by e-mail at [email protected](opens in a new tab); or Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105 or by email at [email protected](opens in a new tab).

The offering will be made only by means of a prospectus. This press release does not constitute an offer to sell or the 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.

On November 7, 2023 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the third quarter ended September 30, 2023 and provided a business update (Press release, iTeos Therapeutics, NOV 7, 2023, View Source [SID1234637186]).

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"We have seen great progress over the third quarter with the initiation of GALAXIES H&N-202, a Phase 2 trial evaluating the belrestotug and dostarlimab doublet as well as novel IO combinations including a triplet in head and neck squamous cell carcinoma, enrollment completion of the belrestotug monotherapy arm in the Phase 2 TIG-007 trial, and enrollment completion of the first dose cohort in the Phase 1 trial of EOS-984," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Furthermore, we remain encouraged that the belrestotug + dostarlimab doublet represents a high quality TIGIT:PD-1 combination. Belrestotug demonstrated meaningful clinical benefit as a monotherapy in solid tumors in the Phase 1 trial and data presented at ESMO (Free ESMO Whitepaper) this year from GSK’s PERLA trial showed dostarlimab and pembrolizumab had similar efficacy in 1L metastatic non-squamous NSCLC, with a positive numerical trend in OS outcomes favoring dostarlimab plus chemotherapy compared to pembrolizumab plus chemotherapy. With this continued progress across our programs, our ambitions are high and we look forward to providing updates on data readouts in 2024, including the Phase 2 GALAXIES LUNG-201, Phase 2 TIG-006 HNSCC, Phase 2 A2A-005 and EOS-984’s Phase 1 trial."

Program Highlights

Belrestotug (EOS-448/GSK4428859A):

In collaboration with GSK, multiple combination studies evaluating late-stage development of belrestotug as a potential next-generation immuno-oncology (IO) agent are progressing as expected.
Trial updates include:
Initiation of GALAXIES H&N-202, a Phase 2 platform study assessing the belrestotug + dostarlimab doublet and novel IO combinations including a CD96 triplet in first-line patients with PD-L1 positive recurrent / metastatic head and neck squamous cell carcinoma (HNSCC).
Completed enrollment of monotherapy dose escalation arm in a Phase 1/2 trial evaluating belrestotug and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
Preparation underway for Phase 3 registrational studies that will evaluate the belrestotug + dostarlimab doublet combination.
Ongoing randomized GALAXIES LUNG-201 Phase 2 platform trial assessing the belrestotug + dostarlimab doublet and CD96 in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Ongoing Phase 2 TIG-006 expansion study assessing the belrestotug + dostarlimab doublet in first line PD-L1 positive advanced or metastatic HNSCC.
Ongoing Phase 1b TIG-006 expansion study assessing the triplet of belrestotug, dostarlimab, and chemotherapy in previously untreated advanced / metastatic NSCLC.
Continued advancement of Phase 1b trials exploring the addition of two novel triplets in selected advanced solid tumors: belrestotug with dostarlimab and GSK’s investigational anti-CD96 antibody, and belrestotug with dostarlimab and GSK’s investigational anti-PVRIG antibody.
Adenosine Pathway

Inupadenant (EOS-850):

Continued progression of the two-part A2A-005 Phase 2 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC. Topline data from Phase 2 A2A-005 are anticipated in late 2024.
EOS-984:

Completed enrollment of the first dose cohort and continued advancement in the dose escalation of the Phase 1 trial in advanced malignancies. Topline data from the Phase 1 trial are anticipated in late 2024.
Third Quarter 2023 Financial Results

Cash and Investment Position: The Company’s cash, cash equivalents, and investments position was $644.9 million as of September 30, 2023, as compared to $752.2 million as of September 30, 2022. The Company continues to expect its cash balance to provide runway through 2026.
Research and Development (R&D) Expenses: R&D expenses were $30.6 million for the quarter ended September 30, 2023, as compared to $23.9 million for the same quarter of 2022. The increases in each comparative period were primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs.
General and Administrative (G&A) Expenses: G&A expenses were $12.6 million for the quarter ended September 30, 2023, as compared to $10.8 million for the same quarter of 2022. The increases were primarily due to increases in headcount and related costs compared to the same quarter and nine months last year.
Net Income/Loss: Net loss attributable to common shareholders was $32.2 million, or net loss of $0.90 per basic and diluted share for the quarter ended September 30, 2023, as compared to a net income of $1.0 million, or a net income of $0.03 per basic and diluted share for the same quarter of 2022.

On November 7, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, reported that it will participate in three investor conferences this November, the Stifel Healthcare Conference, to be held in New York from November 14-15, the Jefferies London Healthcare Conference, to be held in London from November 14-16, and the Piper Sandler Annual Healthcare Conference, to be held in New York from November 28-30 (Press release, Cue Biopharma, NOV 7, 2023, View Source [SID1234637185]).

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During the presentations and fireside discussions, Cue Biopharma will provide a corporate overview including recent data highlights from its lead clinical programs, CUE-101 and CUE-102, representative of the IL-2-based CUE-100 series of selective T cell engagers.

Presentation Details
Stifel Healthcare Conference
Date and Time: Tuesday, November 14 from 1:50 p.m. EST–2:20 p.m. EST
Webcast Link: View Source
Presenter: Daniel Passeri, M.Sc., J.D., chief executive officer, Cue Biopharma

Jefferies London Healthcare Conference
Date and Time: Thursday, November 16 from 11:00 a.m. GMT–11:25 a.m. GMT
Webcast Link: View Source
Presenter: Daniel Passeri, M.Sc., J.D., chief executive officer, Cue Biopharma

Piper Sandler 35th Annual Healthcare Conference
Date and Time: Wednesday, November 29 at 4:00 p.m. EST–4:25 p.m. EST
Webcast Link: View Source;tp_key=a3f15c0417
Presenter: Daniel Passeri, M.Sc., J.D., chief executive officer, Cue Biopharma

Live and archived webcasts of the presentations and fireside chats will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcasts will be archived for 30 days.

On November 7, 2023 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update and its financial position for the quarter ending September 30, 2023 (Press release, Transgene, NOV 7, 2023, View Source [SID1234637184]).

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During the third quarter of 2023, Transgene’s clinical-stage immunotherapy portfolio continued to advance. Notable progress included the treatment of the first patient in the Part B of Phase I trial assessing the novel oncolytic virus BT-001 in combination with KEYTRUDA (pembrolizumab) (NCT: 04725331).

In the next 12 months, key expected catalysts include:

– Updated data from the ongoing Phase I trial of the neoantigen cancer vaccine TG4050 in the adjuvant treatment of head and neck cancer in H1 2024 and the launch of a randomized Phase II trial in 2024,
– Data read out from ongoing randomized Phase II trial of TG4001 in HPV+ anogenital cancers in 2024,
– Completion of the Phase I trial of TG6050 administered intravenously in non-small cell lung cancer,
– The inclusion of the last patient in the Part B of the Phase I study of BT-001 in solid tumors in H1 2024.

Operating income

First Nine Months

Q3

In millions of euros

2023

2022

2023

2022

Revenue from collaborative and licensing agreements

1.2

3.0

–

0.7

Government financing for research expenditures

4.8

5.2

1.3

1.5

Other income

0.2

0.2

0.1

0.1

Operating revenue

6.2

8.4

1.4

2.3

During the first nine months of 2023, operating revenue amounted to €6.2 million compared to €8.4 million in the same period in 2022. They are mainly derived from the research tax credit (€4.8 million for the first nine months of 2023, compared to €5.2 million for the same period in 2022) and Transgene’s collaboration agreement with AstraZeneca on the Invir.IO program.

Revenue from collaborative and licensing agreements amounted to €1.2 million in the first nine months of 2023, compared with €3 million in the same period in 2022. In the first half of 2023, AstraZeneca informed Transgene of its decision to end the collaboration.

Cash, cash equivalents and other financial assets

Cash, cash equivalents and other financial assets stood at €16.4 million as of September 30, 2023, compared to €26.8 million as of December 31, 2022. In the first nine months of 2023, Transgene’s cash burn amounted to €13.8 million compared to a cash burn of €13.3 million for the same period in 2022.

During the reporting period, the Company reached an agreement for the sale of its remaining shares held in Tasly BioPharmaceuticals for a total amount of US$15.3 million (€14 million). The transaction was closed in July 2023 upon receipt of the funds.

On September 20, 2023, the Company signed a current account advance agreement with Institut Mérieux (TSGH) for a maximum of €36 million. The credit facility has a 24-month term and Transgene is able to draw on and repay the facility at its discretion. As of September 30, 2023, the Company had drawn €3.4 million on this facility.

This non-dilutive credit facility extends Transgene’s financial visibility until the end of 2024, enabling the Company to deliver significant milestones on key portfolio projects in the next 12 months.