On November 12, 2025 Cogent Biosciences, Inc. ("Cogent") (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the pricing of its previously announced underwritten public offering of 9,677,420 shares of its common stock at a public offering price of $31.00 per share (such offering, the "Equity Offering") and its underwritten public offering of $200.0 million aggregate principal amount of its 1.625% convertible senior notes due 2031 (the "Convertible Notes" and such offering, the "Convertible Notes Offering"). The Equity Offering was upsized from the previously announced offering size of $200.0 million of shares of common stock.

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Cogent estimates that the net proceeds from the Equity Offering and the Convertible Notes Offering will be approximately $475.3 million, after deducting underwriting discounts and commissions and Cogent’s estimated offering expenses. In addition, Cogent has granted the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,451,613 shares of its common stock, on the same terms and conditions, and granted the underwriters of the Convertible Notes Offering a 30-day option to purchase up to an additional $30.0 million aggregate principal amount of Convertible Notes, solely to cover over-allotments in the Convertible Notes Offering, on the same terms and conditions.

The Equity Offering is expected to close on November 13, 2025, while the Convertible Notes Offering is expected to close on November 18, 2025, in each case, subject to satisfaction of customary closing conditions. The closing of neither the Equity Offering nor the Convertible Notes Offering is conditioned upon the closing of the other offering.

The Convertible Notes will be general, unsecured, senior obligations of Cogent. The Convertible Notes will accrue interest payable semi-annually in arrears on May 15 and November 15 of each year, beginning on May 15, 2026, at a rate equal to 1.625% per year. The Convertible Notes will mature on November 15, 2031, unless earlier converted, redeemed or repurchased by Cogent.

Before August 15, 2031, noteholders may convert their Convertible Notes at their option only in certain circumstances. At any time from, and including, August 15, 2031 until the close of business on the scheduled trading day immediately before the maturity date, the Convertible Notes will be convertible at the option of the holders. Cogent will settle conversions by paying or delivering, as applicable, cash, shares of its shares of its common stock, or a combination of cash and shares of its common stock, at Cogent’s election. The initial conversion rate is 22.2469 shares of its common stock, per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $44.95 per share of common stock and represents a conversion premium of approximately 45.0% above the public offering price per share of common stock in the Equity Offering. If a "make-whole fundamental change" (as defined in the indenture that will govern the Convertible Notes) occurs, then Cogent will in certain circumstances increase the conversion rate for a specified period of time.

The Convertible Notes will be redeemable, in whole or in part (subject to certain limitations), at Cogent’s option at any time, and from time to time, on a redemption date on or after November 20, 2029 and on or before the 26th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price for the Convertible Notes on (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date Cogent sends the related redemption notice; and (2) the trading day immediately before the date Cogent sends such notice.

If a "fundamental change" (as defined in the indenture that will govern the Convertible Notes) occurs, then, subject to certain exceptions, noteholders may require Cogent to repurchase their Convertible Notes at a cash repurchase price equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

Cogent intends to use the net proceeds from the Equity Offering and the Convertible Notes Offering to repay $50 million of loans outstanding under its existing term loan facility, plus accrued interest and associated fees, and the remainder for development and regulatory activities relating to bezuclastinib and other product candidates, the anticipated commercial launch and commercialization of bezuclastinib, as well as for working capital and general corporate purposes.

J.P. Morgan, Jefferies, Leerink Partners and Guggenheim Securities are acting as joint-book running managers for the Equity Offering. LifeSci Capital is acting as lead manager and Raymond James is acting as co-manager for the Equity Offering.

Jefferies and J.P. Morgan are acting as joint book-running managers for the Convertible Notes Offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-291384), which was filed with the Securities and Exchange Commission ("SEC") on November 7, 2025 and automatically became effective upon filing.

Preliminary prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each offering were filed with the SEC on November 10, 2025 and are expected to be available on the SEC’s website on November 12, 2025. Final prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. 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 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 jurisdiction. The offerings can be made only by means of prospectus supplements and accompanying base prospectuses, copies of which may each be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

(Press release, Cogent Biosciences, NOV 12, 2025, View Source [SID1234659753])

On November 12, 2025 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the third quarter ended September 30, 2025.

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"This quarter, we continued to execute across a diverse pipeline spanning multiple, potentially high impact projects in infectious diseases and oncology, leveraging our boron chemistry platform to address areas of high unmet need. These programs reflect our commitment to delivering transformative therapies, each having potential to meaningfully add shareholder value within our cash runway," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Our program studying oral AN2-502998 for Chagas disease is progressing through a Phase 1 first-in-human clinical trial, and planning for a subsequent Phase 2 proof-of-concept study is underway with our collaborators at Drugs for Neglected Diseases initiative (DNDi). In oncology, we expect our two lead programs to enter development in 2026, each with the potential to meaningfully impact solid-tumor cancers. We’ve also entered into a collaboration with GSK focused on TB, where our work is supported by a third year of funding from the Gates Foundation. This initiative reflects our commitment to applying boron chemistry to a disease that continues to impact a quarter of the world’s population."

Third Quarter & Recent Business Updates:

Chagas Disease

Advancing Phase 1 first-in-human clinical trial of oral AN2-502998

The Company is progressing through a Phase 1 first-in-human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. Oral AN2-502998 is under development for chronic Chagas disease, an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. and over 100,000 in Europe. AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in nonhuman primates (NHP) with long-term, naturally acquired chronic infections of diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, this efficacy data may be more predictive of efficacy in human clinical trials than other animal models. The Company anticipates Phase 1 data in the first quarter of 2026 and initiation of a Phase 2 proof-of-concept study in patients with chronic Chagas disease in 2026, depending upon the outcome and timing of completion of the Phase 1 study. Through the Company’s collaboration with DNDi, the company will leverage DNDi’s extensive clinical trial network and expertise in Chagas disease to rapidly advance the clinical development of AN2-502998. There are no FDA approved treatments for adults with chronic Chagas disease.
Boron Chemistry Pipeline

Continuing to advance boron chemistry compounds in oncology

The Company is pursuing a number of oncology targets where we believe boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and with strong oral pharmacokinetics. The Company anticipates advancing the first oncology compound into development in early 2026 with potential clinical proof-of-concept data within the Company’s current cash runway. The Company expects to advance its second oncology compound into development in mid-2026.
Nontuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus

M. abscessus program advancing through investigator-initiated trial (IIT)

Building on the microbiological and safety data from the Company’s prior NTM study, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult to treat NTM infections for which no FDA-approved therapies exist. The Company is supporting the design of an IIT expected to begin enrollment in early 2026, pending finalization of the trial protocol and regulatory allowance to proceed. The Company anticipates that data from this potential study, if positive, could provide the clinical evidence of human proof of concept in M. abscessus and inform the design of a subsequent pivotal trial. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of which 10–15% are caused by M. abscessus.
Melioidosis

Preparing for epetraborole’s next phase of development in acute melioidosis, a highly lethal bacterial infection and recognized biothreat

AN2 is developing epetraborole for the treatment of acute melioidosis, a highly lethal bacterial infection and recognized biothreat. The Company completed enrollment in a 200-patient observational trial (non-epetraborole treatment) in October 2024, and in June 2025 announced key insights from the trial, which reinforce the high mortality of the disease, despite standard of care. This study provided critical data which will allow the Company to optimize the design of upcoming clinical studies. Discussions are underway with the U.S. government to fund Phase 2 development of epetraborole in acute melioidosis. Melioidosis has a 90-day mortality rate approaching 40%, despite standard of care (SOC) drugs, including ceftazidime or meropenem. The aim of the program is to meaningfully lower the expected mortality rate by dosing epetraborole on top of standard of care. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S.
Global Health

Research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting TB; AN2 awarded third year funding from Gates Foundation

In November 2025, the Company announced a collaboration with the global biopharma company GSK to develop new therapies for TB. As part of this effort, the Gates Foundation will provide a third year of funding to support AN2’s work within the collaboration. TB continues to pose a major global health challenge, affecting more than a quarter of the world’s population and causing over 1.25 million deaths annually.
Selected Third Quarter Financial Results

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $7.0 million, compared to $8.3 million for the same period during 2024 due to decreased clinical trial expenses, personnel-related expenses, chemistry manufacturing and controls expenses, and consulting and outside services, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities in August 2024. These decreases were partially offset by increases in preclinical and research studies and expenses related to start-up activities of the Phase 1 trial in Chagas disease and facility and other expenses.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $3.0 million, compared to $3.5 million for the same period during 2024 due to decreased personnel-related expenses, professional and outside services expenses, and other expenses.
Restructuring Charges: There were no restructuring charges in the third quarter of 2025. Restructuring charges for the third quarter of 2024 were $2.2 million due to severance payments and other employee termination-related expenses.
Interest Income: Interest income for the third quarter of 2025 was $0.7 million, compared to $1.3 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024.
Net Loss: Net loss for the third quarter of 2025 was $9.4 million, compared to $12.7 million for the same period during 2024.
Cash Position: The Company had cash, cash equivalents and investments of $65.1 million at September 30, 2025. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2028 under the current operating plan.

(Press release, AN2 Therapeutics, NOV 12, 2025, View Source [SID1234659803])

On November 12, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported updated Phase 1a dose escalation data from both product candidates in its TCR Bispecifics (TCER) pipeline, IMA402 PRAME Bispecific and IMA401 MAGEA4/8 Bispecific, as well as next steps for clinical development.

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"Our off-the-shelf TCR Bispecifics have a proprietary next-generation format with half-life extension that is designed to combine optimized tolerability and potent anti-tumor activity while supporting patient-convenient dosing," said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. "We have now achieved clinical proof-of-concept for both product candidates and seen their potential to make a meaningful impact on patients with limited treatment options through deep and durable responses. We look forward to continuing to drive the development of our bispecifics to advance accessible, innovative therapies that can reach more patients and make a lasting difference in cancer care."

"Today marks the beginning of a new phase for Immatics, expanding our reach beyond cell therapy and establishing a leading position in the TCR Bispecifics field, with a clear commitment to advancing the clinical development of our bispecifics pipeline," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "Building on these data, we are excited to evaluate our IMA402 PRAME Bispecific now across multiple targeted cancer patient populations with significant unmet treatment needs and in potentially synergistic combinations. We are especially enthusiastic about the potential for profound benefit by combining IMA402 with IMA401, our MAGEA4/8 Bispecific, in patients with squamous non-small cell lung cancer, a large, highly underserved and difficult-to-treat indication."

Carsten Reinhardt, M.D., Ph.D., and Harpreet Singh, Ph.D., will present the complete TCR Bispecifics dataset and next development steps during a conference call and webcast today, November 12, at 8:30 am EST/2:30 pm CET. The presentation is accessible on the ‘Events & Presentations’ page on the Investors & Media section of the Company’s website.

IMA402 PRAME Bispecific Phase 1a Dose Escalation Data Summary

Patient Population: Advanced metastatic solid tumors with no available treatment options

As of the data cutoff on September 26, 2025, 80 heavily pre-treated patients (median of three prior systemic treatments) with recurrent and/or refractory solid tumors1 were treated with escalating dose levels of IMA402 monotherapy ranging from 0.02 mg to 30 mg. The safety population includes all 80 patients treated with IMA402. 29 patients received doses in the recommended Phase 2 dose (RP2D range) (10 to 30 mg) and, thereof, 20 patients were efficacy-evaluable2, including 14 patients with melanoma (12 cutaneous, 1 uveal, 1 unknown primary), 3 patients with ovarian carcinoma and 3 patients with other solid cancers3.

Safety: Treatment with IMA402 showed favorable tolerability

IMA402 showed favorable tolerability across a wide dose range in the 80 patients treated. The most frequent treatment-related adverse events (AEs) were expected and transient lymphopenia, consistent with the mechanism of action, and low-grade cytokine release syndrome (CRS): Grade 1: 33%, Grade 2: 5%, Grade 3: 0%, Grade 4: 1%. No ICANS or IMA402-related Grade 5 events occurred. Tolerability across all doses was consistent with tolerability at the RP2D range.

Phase 1a dose escalation in the monotherapy setting has been completed. The maximum tolerated dose (MTD) has not been reached. The provisional RP2D range has been identified at 10 to 30 mg. The Phase 1b dose expansion is ongoing at two distinct doses within the RP2D range, and the evaluation of IMA402 in combination with an immune checkpoint inhibitor has been initiated.

Anti-tumor Activity and Durability: Deep and durable responses observed at RP2D range

IMA402 showed a clear dose-response relationship across three different dose groups.

Deep and durable responses at RP2D range (RECIST 1.1)

All
Indications Melanoma Ovarian
Carcinoma

cORR 30% (6/20) 29% (4/14) 2/3
mDOR,
mFU month Not reached
4.2 Not reached
7.3 Not reached
2.2
Tumor shrinkage 55% (11/20) 57% (8/14) 2/3
DCR (at week 6) 65% (13/20) 71% (10/14) 2/3
mDOR: median duration of response; mFU: median follow-up; DCR: disease control rate

For patients across all indications treated within the RP2D range early, promising progression-free survival (PFS) and overall survival (OS) were observed:

Median PFS was 4.8 months at a mFU of 6.8 months; 6-month PFS rate was 45%
Median iPFS4 was not reached at a mFU of 6.3 months; 6-month iPFS rate was 58%
Median OS was not reached at a mFU of 5.4 months; 1-year OS rate was 94%

Clinical Development Opportunities for IMA402 PRAME Bispecific

Based on the promising Phase 1a dose escalation data, Immatics is advancing its IMA402 PRAME Bispecific into Phase 1b dose expansion at two distinct doses to determine the final RP2D, both as a monotherapy and in combination with an immune checkpoint inhibitor with a focus on melanoma and gynecologic cancers in 2026. Depending on the outcomes of these Phase 1b cohorts, the Company would seek to convert existing Phase 1b cohorts into Phase 2 trials, which will then have the potential to become registration-directed. As part of its strategy to maximize the IMA402 opportunity, the Company is also exploring the option to initiate additional Phase 1b cohorts in 2026 to determine the monotherapy and combination potential of IMA402 with immune checkpoint inhibitors and standard of care in late as well as earlier treatment lines. As an additional opportunity, the Company is exploring the potential combination of IMA402 with IMA401 MAGEA4/8 in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

IMA401 MAGEA4/8 Bispecific Phase 1a Data Summary

Patient Population: Heavily pre-treated patients with a broad range of tumor types with no available treatment options

As of the data cutoff on September 26, 2025, 55 heavily pretreated patients (median of four prior systemic treatments) with recurrent and/or refractory solid tumors5 were treated with escalating dose levels of IMA401 ranging from 0.0066 mg to 2.5 mg with or without an immune checkpoint inhibitor (ICI, pembrolizumab). The safety population includes all 55 patients treated with IMA401 as a monotherapy (n=46) or in combination with pembrolizumab (n=9). 44 patients were treated with doses from 1 to 2.5 mg, and thereof 38 were evaluable for efficacy6. All efficacy-evaluable patients treated with IMA401 in combination with pembrolizumab (n=4) had progressed on prior immune checkpoint inhibitor treatments.

Safety: Treatment with IMA401 showed favorable tolerability at RP2D

The most frequent and relevant treatment-related adverse events (AEs) across all 55 patients treated with IMA401 were low-grade cytokine release syndrome (CRS) (24% G1, 11% G2, no ≥ Grade 3), mostly at the first step dose, expected and transient lymphopenia, consistent with the mechanism of action, as well as neutropenia, which was mostly transient, not re-occurring after resolution under continued treatment and well-manageable at the RP2D range of 1-2 mg. Notably, no ICANS was observed. The tolerability of IMA401 in combination with pembrolizumab is consistent with the tolerability of IMA401 monotherapy.

The maximum tolerated dose (MTD) has not been reached; three dose-limiting events were observed at 2.5 mg. The Phase 1a dose escalation has been completed, and the provisional RP2D range has been identified at 1-2 mg. At RP2D, the tolerability profile was favorable.

Anti-tumor Activity and Durability: Promising clinical activity and deep and durable responses were observed in patients with head and neck cancer, melanoma and lung cancer treated at ≥1 mg

Patients in three focus indications treated with ≥1 mg of IMA401 as a monotherapy or in combination with pembrolizumab demonstrated clinical activity:

Head and neck cancer: cORR of 25% (2/8), disease control rate of 63% (5/8)
Melanoma: cORR of 29% (2/7), disease control rate of 57% (4/7)
Squamous non-small-cell lung cancer: 1 partial response at first scan for a heavily pre-treated, ICI-resistant patient, 1 patient with stable disease for >4 months and overall survival of approximately 16 months, 1 patient with progressive disease with shrinkage of liver target lesions

The duration of all confirmed responses was longer than 6 months post treatment, with the longest response ongoing over 2 years in a patient with advanced cutaneous melanoma.

Clinical Development Opportunity for IMA401 MAGEA4/8 Bispecific

Consistent with Immatics’ focus on advancing its PRAME franchise, the Company is exploring IMA401 in combination with IMA402, starting with squamous non-small cell lung cancer (sqNSCLC). Based on the clinical proof-of-concept of both bispecific candidates, including the initial promising activity of IMA401 in head and neck cancer and sqNSCLC, as well as preclinical proof-of-concept data, Immatics is well-positioned to assess the synergistic potential of combining two different bispecifics, IMA402 targeting PRAME and IMA401 targeting MAGEA4/8, with and without a checkpoint inhibitor. As over 90% of patients with sqNSCLC are positive for PRAME and/or MAGEA4/8, a potential IMA402 and IMA401 combination treatment could provide broad treatment coverage for this patient population. Approximately 60% of patients with sqNSCLC are positive for both targets, which could boost anti-tumor activity and counteract potential tumor escape mechanisms. The current addressable patient population for metastatic sqNSCLC in the United States and EU5 includes an estimated 40,000 patients per year.

(Press release, Immatics, NOV 12, 2025, View Source [SID1234659819])

On November 12, 2025 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"With our achievements in the third quarter and year to date, Ascendis is making great progress toward achieving Vision 2030. The ongoing strong global launch of YORVIPATH is transforming our financial profile and, based on positive feedback from physicians and patients, we expect to continue to build on this momentum," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "With TransCon CNP now under FDA and EMA review, we are on the verge of bringing our third high-value medicine to patients, and we expect our engine for future innovation to drive sustainable growth for years to come."

Select Highlights & Anticipated 2025 Milestones

TransCon PTH:
(palopegteriparatide, marketed as YORVIPATH)
YORVIPATH revenue for the third quarter of 2025 totaled €143.1 million, including a negative foreign currency impact of €3.6 million compared to the previous quarter.
Continued uptake from YORVIPATH in the U.S., with more than 4,250 unique patient enrollments and more than 2,000 prescribing health care providers as of September 30, 2025.
Outside the U.S., YORVIPATH is available commercially or through named patient programs in more than 30 countries.
Our strategic partner Teijin announced that YORVIPATH is now commercially available for prescription in Japan, expanding global access. In the third quarter, we recognized €12.9 million in milestone revenue related to the approval.
PaTHway60 trial, is ongoing as a single-arm safety and efficacy trial in adults with hypoparathyroidism to enable dose titration up to 60 mcg/day and is intended to support U.S. label expansion of YORVIPATH.
PaTHway Adolescent trial is planned to begin during the fourth quarter and is intended to support U.S. label expansion of YORVIPATH for the treatment of children with hypoparathyroidism, 12 to less than 18 years of age.
Presented pooled analysis of 3-year data from PaTHway and PaTH Forward trials at the American Society of Nephrology (ASN) Kidney Week 2025, reinforcing that treatment with TransCon PTH led to rapid and sustained improvements in kidney function in adults with hypoparathyroidism.

TransCon hGH:
(lonapegsomatropin, marketed as SKYTROFA)
SKYTROFA revenue for the third quarter of 2025 totaled €50.7 million, including a negative foreign currency impact of €1.6 million compared to the previous quarter.
The FDA approved our first label expansion for SKYTROFA in adult growth hormone deficiency, which represents the first of multiple additional label expansions we expect to pursue.
We initiated a basket trial for several established growth-hormone indications including idiopathic short stature (ISS), short stature homeobox-containing gene deficiency (SHOX deficiency), Turner syndrome, and small for gestational age (SGA).

TransCon CNP:
(navepegritide, FDA NDA and EMA MAA filed)
We recently completed our late-cycle meeting with the FDA, who accepted for priority review the New Drug Application (NDA) for the treatment of children with achondroplasia; Prescription Drug User Fee Act (PDUFA) goal date is November 30, 2025.
In Europe, our Marketing Authorisation Application (MAA) has been submitted and validated by the Committee for Medicinal Products for Human Use (CHMP) and is under review.
At the annual meeting of the American Society for Bone and Mineral Research (ASBMR), we presented new analyses from the pivotal ApproaCH Trial showing that children treated with TransCon CNP had improvements in the Physical Functioning domain of the Achondroplasia Child Experience Measure (ACEM-PF), with greatest benefits in younger children who had more severe genu varum (≥5°) at baseline, supporting benefits beyond linear growth.

TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)

Following a successful end-of-Phase 2 meeting with FDA, we plan to initiate a Phase 3 trial of TransCon CNP in combination with TransCon hGH this quarter.
Anticipate presenting 52-week data from the COACH Phase 2 trial of TransCon CNP + TransCon hGH in early 2026.
During the fourth quarter of 2025, we plan to submit an Investigational New Drug (IND) or similar to investigate TransCon CNP alone and in combination with TransCon hGH for the treatment of hypochondroplasia.

TransCon IL-2 β/γ
(onvapegleukin alfa)

In our IL-Believe trial, 70 patients with late-stage platinum-resistant ovarian cancer (PROC) (median 4 prior lines of therapy; 67% previously treated with at least 2 lines of taxane-containing therapy) have been enrolled. Data continued to suggest that TransCon IL-2 β/γ dosed every three weeks in combination with weekly paclitaxel is generally well-tolerated, with the majority of TransCon IL-2 β/γ-related treatment-emergent adverse events (TEAEs) being Grade 1 or 2 in severity.
We expect to provide median overall survival (OS) data for this cohort of 70 patients in the first quarter of next year as the dataset continues to mature.

Financial Update
Based on the continued growth of YORVIPATH, we achieved operating profitability. In the third quarter we recorded an operating profit of €11.0 million.
During the third quarter, our cash balance increased €45 million from €494 as of June 30, 2025, to €539 million as of September 30, 2025.

Third Quarter 2025 Financial Results
Total revenue for the third quarter of 2025 was €213.6 million, compared to €57.8 million during the same period in 2024. The year-over-year increase in revenue was primarily attributable to an increase in product revenue, which reflected a contribution of €134.6 million from YORVIPATH.

Total Revenue

(In EUR’000s) Three Months Ended
September 30,
Nine Months Ended
September 30,

2025
2024
2025
2024

Revenue
Commercial products 193,790 55,710 443,480 153,598
Rendering of services and clinical supply 6,134 1,272 13,228 9,637
Licenses 788 851 3,002 26,490
Milestones 12,922 — 12,922 —
Total revenue 213,634 57,833 472,632 189,725

Commercial Products Revenue

(In EUR’000s) Three Months Ended
September 30,
Nine Months Ended
September 30,

2025
2024
2025
2024

Revenue from commercial products
SKYTROFA 50,701 47,249 152,745 138,455
YORVIPATH 143,089 8,461 290,735 15,143
Total revenue from commercial products 193,790 55,710 443,480 153,598

Research and development costs for the third quarter of 2025 were €66.9 million, compared to €73.5 million during the same period in 2024. The decrease was driven by the completion of clinical trials and development activities within our Endocrinology Rare Disease pipeline.

Selling, general, and administrative expenses for the third quarter of 2025 were €113.4 million, compared to €69.8 million during the same period in 2024. The increase was primarily due to the continued impact from global commercial expansion, including launch activities for YORVIPATH.

Total operating expenses for the third quarter of 2025 were €180.3 million, compared to €143.4 million during the same period in 2024.

Operating profit for the third quarter of 2025 was €11.0 million primarily attributable to higher revenue from the launch of YORVIPATH in the U.S., partly offset by higher operating expenses.

Net finance expense for the third quarter of 2025 was €60.9 million, including non-cash remeasurement loss of financial liabilities of €47.2 million, compared to €2.9 million net finance income during the same period in 2024.

For the third quarter of 2025, Ascendis Pharma reported a net loss of €61.0 million, or €1.00 per share basic and diluted compared to a net loss of €99.2 million, or €1.72 per share basic and diluted for the same period in 2024.

As of September 30, 2025, Ascendis Pharma had cash and cash equivalents totaling €539 million compared to €560 million as of December 31, 2024. As of September 30, 2025, Ascendis Pharma had 61,695,211 ordinary shares outstanding, including 597,055 ordinary shares represented by ADSs held by the company.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its third quarter 2025 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

(Press release, Ascendis Pharma, NOV 12, 2025, View Source [SID1234659839])

On November 12, 2025 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported favorable preclinical results supporting the development of SOT106, its antibody-drug conjugate for the treatment of sarcoma, at the Connective Tissue Oncology Society (CTOS) Annual Meeting taking place November 12-15, 2025, in Boca Raton, FL.

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Data presented in SOTIO’s poster indicate that SOT106 is a potent and well-tolerated LRRC15-targeted ADC, showing strong potential for the treatment of sarcomas and other LRRC15-positive malignancies.

Specific results include:

SOT106 induces potent, antigen-specific cytotoxicity in vitro with nanomolar activity and a pronounced bystander effect.
In vivo, SOT106 drives dose-dependent tumor regression, including complete responses at 1 mg/kg, and surpasses benchmarks in both soft tissue sarcoma and osteosarcoma patient-derived xenograft (PDX) models, including those with low-to-medium LRRC15 expression and in orthotopic osteosarcoma.
In an exploratory non-human primate (NHP) study, SOT106 had a favorable pharmacokinetic profile and a high therapeutic index; dose-limiting toxicities aligned with known MMAE effects.
"Sarcomas continue to represent a significant unmet medical need, with limited therapeutic progress over the past several decades. LRRC15 is a clinically validated target broadly expressed across sarcoma subtypes, making it an ideal candidate for a differentiated ADC approach," said Amy Jensen-Smith, chief scientific officer of SOTIO. "These NHP data reinforce our confidence in SOT106’s therapeutic potential and mark a critical step toward delivering a novel treatment option for patients facing these aggressive diseases."

SOTIO is advancing SOT106 through IND-enabling studies toward an anticipated IND filing in Q4 2026. The company has additionally developed and validated a proprietary, highly sensitive, and specific LRRC15 immunohistochemistry assay to guide patient selection in upcoming clinical trials.

Poster presentation and Q&A details:

Poster Title: "Targeting leucine-rich repeat-containing protein 15 (LRRC15): SOT106 antibody-drug conjugate for soft tissue sarcoma and osteosarcoma treatment"
Presenter: Lenka Palova Jelinkova, Ph.D.
Date & Time: Thursday, Nov. 13, 2025, 5:30-6:30pm EST
Location: Grand Ballroom, The Boca Raton

Presentation materials will be available upon request following the live presentations.

(Press release, SOTIO, NOV 12, 2025, View Source [SID1234659858])