On November 7, 2023 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the quarter ended September 30, 2023 and highlighted recent corporate progress (Press release, Tyra Biosciences, NOV 7, 2023, View Source [SID1234637190]).

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"From the start, TYRA has focused on developing precision therapies that target large opportunities that exist in FGFR biology, and we continue to follow the data. We continue to advance TYRA-300, our oral FGFR3-selective inhibitor, as we dose expand and escalate in our SURF301 oncology study and strengthen our preclinical data package in achondroplasia," said Todd Harris, CEO of TYRA. "Before the end of the year, we expect to update our guidance on the timing and design of our planned Phase 2 study in achondroplasia and the dosing of our first patient with TYRA-200."

Third Quarter 2023 and Recent Corporate Highlights

TYRA-300

SURF301 Phase 1/2 Study for Oncology Continued to Advance. SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) is a multi-center, open label study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. Enrollment is ongoing in Part A and Part B and dose escalation is ongoing in Part B in Phase 1 of the study at multiple clinical sites in the U.S., Europe, and Australia. In this study, multiple doses and schedules of TYRA-300 will be evaluated to inform dosing decisions in future metastatic urothelial carcinoma (mUC), non-muscle invasive bladder cancer (NMIBC) and achondroplasia studies.

Presented Positive Preclinical Data for Achondroplasia at ASBMR and ASH (Free ASH Whitepaper)G Meetings. In October and early November 2023, TYRA presented additional preclinical results on TYRA-300 in achondroplasia at the American Society for Bone and Mineral Research (ASBMR) and the American Society of Human Genetics (ASHG) 2023 annual meetings, respectively. In preclinical mice models of achondroplasia conducted at The Imagine Institute in Paris, TYRA-300 increased bone growth, improved the shape of the skull, improved the shape of the foramen magnum, restored the architecture of the growth plate, and increased chondrocyte proliferation and differentiation.

Granted Orphan Drug Designation for Achondroplasia from FDA. In July 2023, TYRA-300 was granted Orphan Drug Designation (ODD) for the treatment of achondroplasia from the U.S. Food and Drug Administration (FDA).
TYRA-200

Phase 1 Study on Track to be Initiated by YE ’23. TYRA continued to advance activities to support the initiation of the planned Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA remains on track to dose the first patient in this trial before year-end 2023.
SNÅP Platform and Pipeline

TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions including FGF19+/FGFR4-driven cancers and others.
Third Quarter 2023 Financial Results

Third quarter 2023 net loss was $21.2 million compared to $12.5 million for the same period in 2022.
Third quarter 2023 research and development expenses were $19.3 million compared to $10.9 million for the same period in 2022.
Third quarter 2023 general and administrative expenses were $4.7 million compared to $2.7 million for the same period in 2022.
As of September 30, 2023, TYRA had cash and cash equivalents of $215.7 million that are expected to support TYRA’s important clinical and operational milestones over at least the next two years.
About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias, including achondroplasia. In oncology, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was designed to determine the optimal and MTD and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, and the Company expects to submit an IND for the initiation of a Phase 2 clinical study in pediatric achondroplasia in 2024. In July 2023, TYRA-300 was granted Orphan Drug Designation for the treatment of achondroplasia from the FDA.

On November 7, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported that it will host its 2023 R&D Day on November 17, 2023, to update the medical and investor communities on the company’s progress with its R&D programs. The session will feature three KOL sessions, and discussions about the data of Antengene’s key drugs in clinical development, including ATG-031 (anti-CD24 monoclonal antibody), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor); and updates on its proprietary R&D pipeline and upcoming development for 2024 (Press release, Antengene, NOV 7, 2023, View Source [SID1234637189]).

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Three guest experts will participate in the presentations and discussions at the event, they are: Dr. Adnan Khattak, M.D., Ph.D (One Clinical Research, Australia) who will discuss CD73 inhibitors; Dr. Anthony J. Olszanski, M.D., RPh(Fox Chase Cancer Center, the United States) who will discuss tumor immunotherapy, including targeting the PD-L1/4-1BB pathways; and Dr. Shehara Mendis, M.D., M.S. (Cabrini Health, Australia) who will discuss Claudin 18.2-targeting molecules.

Speakers from Antengene’s management team:

Jay Mei, M.D., Ph.D. – Founder, Chairman, and CEO
Amily Zhang, M.D. – Chief Medical Officer
Bo Shan, Ph.D. – Chief Scientific Officer
Godfrey Guo, M.D. – Executive Director, Clinical Development
Bing Hou, Ph.D. – Executive Director, Drug Discovery
A live question and answer session will follow the presentation.

The virtual event will be held in English at 8:30 AM, November 17, 2023, Eastern Time/ 9:30 PM, Beijing Time.

To attend the session, please register at View Source;tp_key=6683586ef4.
For participants in the Mainland of China, please register at View Source;tp_key=6683586ef4
A Hybrid Chinese session will also be held in-person at the Antengene Shanghai Office and virtually at 8:30 AM, November 17, 2023, Beijing Time.

To attend the event virtually, please register at View Source
For in-person attendance, please register at View Source or contact Antengene’s Investor Relations Team at [email protected].

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.