Tag: GlobeNewswire

Developers of advanced therapies using PluriFreeze during preclinical stages can seamlessly scale to clinical manufacturing and cross-reference the Drug Master File in FDA submissions

HOLLISTER, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), and Pluristyx, Inc. (“Pluristyx”), today announced that Pluristyx is completing a Type II Drug Master File (DMF) for the PluriFreeze™ cryopreservation system for submission to the U.S. Food and Drug Administration (FDA). The DMF will support drug makers seeking to incorporate PluriFreeze into their clinical development and manufacturing programs. Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, and is the exclusive manufacturer and distributor of PluriFreeze in the United States and Canada. Pluristyx is a leading provider of advanced induced pluripotent stem cell (iPSC) technologies and proprietary, genetically engineered solutions for drug discovery and the development of advanced therapies.

Developers who utilize PluriFreeze in preclinical stages can now request a letter of authorization (LOA) from Pluristyx and cross-reference the PluriFreeze DMF in their Investigational New Drug (IND) applications and Biologics License Applications (BLA). The comprehensive regulatory submission details chemistry, manufacturing, and controls (CMC) for the PluriFreeze system, helping to streamline regulatory submissions and accelerate the development of next-generation therapies.

“The PluriFreeze DMF gives advanced therapy developers more to build on than strong product performance: a documented regulatory position for their cryopreservation system, ready when they need it,” said Stephen Gunstream, Teknova’s President and Chief Executive Officer. “As the cell therapy industry has matured, and as more novel therapies move into clinical trials, our customers want to know that the reagents they’ve built their processes around can support them through clinical development and into commercialization. This file puts that documentation on record with the FDA, so they can seamlessly scale with confidence.”

“Cryopreservation is a critical manufacturing step in cell therapy, but it is often overlooked during process development,” said Dr. Jason Carstens, Chief Operating Officer and Co-Founder of Pluristyx. “PluriFreeze was designed for both cryopreservation performance and manufacturability, with a low-viscosity formulation that is easier to handle and scale as process volumes increase. That focus on low viscosity and manufacturing scalability is an important point of differentiation from other cryopreservation media, and the DMF now provides the regulatory documentation to support its use as programs advance toward the clinic.”

Purpose-built for scalable manufacturing of cell-based products, the PluriFreeze system is a biopreservation media used to protect cells – from intermediate holds during manufacturing through long-term cryopreservation – helping cells remain viable and functional throughout the product lifecycle. Entirely synthetic and animal-origin-free, the system pairs a protective wash with a freezing medium: PluriFreeze Base is a cellular wash that mimics intracellular space and provides metabolic support across the workflow, while PluriFreeze PF10 is a low viscosity freezing medium with 10% dimethyl sulfoxide (DMSO) that simplifies scale-up and process automation. Both products are available for research use and GMP manufacturing applications and can be further customized to support specific cell types and workflow requirements.

In studies comparing PluriFreeze with an industry reference, PluriFreeze PF10 supported similar post-thaw viability, recovery, doubling times, expansion, and surface marker expression across multiple pluripotent stem cell lines and Natural Killer (NK) cells. The PluriFreeze system is stable for up to two years at 2 – 8 °C.

The DMF, which Pluristyx holds, builds on the companies’ collaboration announced in March 2025, through which Teknova became the exclusive manufacturer and distributor of the PluriFreeze product line in the United States and Canada and subsequently contributed the manufacturing and quality content required to support the file. PluriFreeze products are manufactured at Teknova’s ISO 13485 certified facilities in Hollister, California, on the same modular manufacturing platform that supports the Company’s industry-leading turnaround times across research- and GMP-grade reagents.

For product specifications, quality documentation, and ordering information for PluriFreeze Base and PF10, visit teknova.com/pluristyx, email info@teknova.com, or call 1-800-209-4488. A Letter of Authorization can be requested directly from Pluristyx at info@pluristyx.com.

ABOUT TEKNOVA

Teknova makes solutions possible. Since 1996, Teknova has been innovating the manufacture of critical reagents for the life sciences industry to accelerate the discovery and development of novel breakthroughs that will help people live longer, healthier lives. We offer fully customizable solutions for every stage of the workflow, supporting industry leaders in genomics, molecular diagnostics, and emerging therapeutic modalities. Our fast turnaround of high-quality agar plates, microbial culture and cryopreservation media, buffers and reagents, and water helps our customers scale seamlessly from RUO to GMP. Headquartered in Hollister, California, with over 180,000 square feet of state-of-the-art facilities, Teknova’s modular manufacturing platform was designed by our team of scientists, engineers, and quality control experts to efficiently produce the foundational ingredients for the discovery and commercialization of next-generation therapies.

ABOUT PLURISTYX

Pluristyx is the leading provider of advanced iPSC-based solutions for the cell and gene therapy industry, delivering a comprehensive platform designed to accelerate therapeutic development with unmatched speed, safety, and scalability. Leveraging proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable, engineerable, and highly expandable cells. The company’s portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and safety and immune-evasion technologies, including the FailSafe^® safety switch and iACT^® immune cloaking system. Beyond cell sourcing, Pluristyx supports the full development continuum, from organoid-based disease modeling and high-throughput drug screening to GMP-scale manufacturing, helping therapeutic developers streamline workflows, reduce risk and accelerate the path to clinic. For more information, visit www.pluristyx.com.

CONTACTS

Investor Contact (Teknova)
Matt Lowell
Chief Financial Officer
matt.lowell@teknova.com
+1 831-637-1100

Media Contact (Teknova)
Jennifer Henry
Senior Vice President, Marketing
jenn.henry@teknova.com
+1 831-313-1259

Investor and Media Contact (Pluristyx)
Priya Baraniak
Chief Commercial and Development Officer
priya@pluristyx.com

This press release was published by a CLEAR® Verified individual.

Developers of advanced therapies using PluriFreeze during preclinical stages can seamlessly scale to clinical manufacturing and cross-reference the Drug Master File in FDA submissions

HOLLISTER, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), and Pluristyx, Inc. (“Pluristyx”), today announced that Pluristyx is completing a Type II Drug Master File (DMF) for the PluriFreeze™ cryopreservation system for submission to the U.S. Food and Drug Administration (FDA). The DMF will support drug makers seeking to incorporate PluriFreeze into their clinical development and manufacturing programs. Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, and is the exclusive manufacturer and distributor of PluriFreeze in the United States and Canada. Pluristyx is a leading provider of advanced induced pluripotent stem cell (iPSC) technologies and proprietary, genetically engineered solutions for drug discovery and the development of advanced therapies.

Developers who utilize PluriFreeze in preclinical stages can now request a letter of authorization (LOA) from Pluristyx and cross-reference the PluriFreeze DMF in their Investigational New Drug (IND) applications and Biologics License Applications (BLA). The comprehensive regulatory submission details chemistry, manufacturing, and controls (CMC) for the PluriFreeze system, helping to streamline regulatory submissions and accelerate the development of next-generation therapies.

“The PluriFreeze DMF gives advanced therapy developers more to build on than strong product performance: a documented regulatory position for their cryopreservation system, ready when they need it,” said Stephen Gunstream, Teknova’s President and Chief Executive Officer. “As the cell therapy industry has matured, and as more novel therapies move into clinical trials, our customers want to know that the reagents they’ve built their processes around can support them through clinical development and into commercialization. This file puts that documentation on record with the FDA, so they can seamlessly scale with confidence.”

“Cryopreservation is a critical manufacturing step in cell therapy, but it is often overlooked during process development,” said Dr. Jason Carstens, Chief Operating Officer and Co-Founder of Pluristyx. “PluriFreeze was designed for both cryopreservation performance and manufacturability, with a low-viscosity formulation that is easier to handle and scale as process volumes increase. That focus on low viscosity and manufacturing scalability is an important point of differentiation from other cryopreservation media, and the DMF now provides the regulatory documentation to support its use as programs advance toward the clinic.”

Purpose-built for scalable manufacturing of cell-based products, the PluriFreeze system is a biopreservation media used to protect cells – from intermediate holds during manufacturing through long-term cryopreservation – helping cells remain viable and functional throughout the product lifecycle. Entirely synthetic and animal-origin-free, the system pairs a protective wash with a freezing medium: PluriFreeze Base is a cellular wash that mimics intracellular space and provides metabolic support across the workflow, while PluriFreeze PF10 is a low viscosity freezing medium with 10% dimethyl sulfoxide (DMSO) that simplifies scale-up and process automation. Both products are available for research use and GMP manufacturing applications and can be further customized to support specific cell types and workflow requirements.

In studies comparing PluriFreeze with an industry reference, PluriFreeze PF10 supported similar post-thaw viability, recovery, doubling times, expansion, and surface marker expression across multiple pluripotent stem cell lines and Natural Killer (NK) cells. The PluriFreeze system is stable for up to two years at 2 – 8 °C.

The DMF, which Pluristyx holds, builds on the companies’ collaboration announced in March 2025, through which Teknova became the exclusive manufacturer and distributor of the PluriFreeze product line in the United States and Canada and subsequently contributed the manufacturing and quality content required to support the file. PluriFreeze products are manufactured at Teknova’s ISO 13485 certified facilities in Hollister, California, on the same modular manufacturing platform that supports the Company’s industry-leading turnaround times across research- and GMP-grade reagents.

For product specifications, quality documentation, and ordering information for PluriFreeze Base and PF10, visit teknova.com/pluristyx, email info@teknova.com, or call 1-800-209-4488. A Letter of Authorization can be requested directly from Pluristyx at info@pluristyx.com.

ABOUT TEKNOVA

Teknova makes solutions possible. Since 1996, Teknova has been innovating the manufacture of critical reagents for the life sciences industry to accelerate the discovery and development of novel breakthroughs that will help people live longer, healthier lives. We offer fully customizable solutions for every stage of the workflow, supporting industry leaders in genomics, molecular diagnostics, and emerging therapeutic modalities. Our fast turnaround of high-quality agar plates, microbial culture and cryopreservation media, buffers and reagents, and water helps our customers scale seamlessly from RUO to GMP. Headquartered in Hollister, California, with over 180,000 square feet of state-of-the-art facilities, Teknova’s modular manufacturing platform was designed by our team of scientists, engineers, and quality control experts to efficiently produce the foundational ingredients for the discovery and commercialization of next-generation therapies.

ABOUT PLURISTYX

Pluristyx is the leading provider of advanced iPSC-based solutions for the cell and gene therapy industry, delivering a comprehensive platform designed to accelerate therapeutic development with unmatched speed, safety, and scalability. Leveraging proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable, engineerable, and highly expandable cells. The company’s portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and safety and immune-evasion technologies, including the FailSafe^® safety switch and iACT^® immune cloaking system. Beyond cell sourcing, Pluristyx supports the full development continuum, from organoid-based disease modeling and high-throughput drug screening to GMP-scale manufacturing, helping therapeutic developers streamline workflows, reduce risk and accelerate the path to clinic. For more information, visit www.pluristyx.com.

CONTACTS

Investor Contact (Teknova)
Matt Lowell
Chief Financial Officer
matt.lowell@teknova.com
+1 831-637-1100

Media Contact (Teknova)
Jennifer Henry
Senior Vice President, Marketing
jenn.henry@teknova.com
+1 831-313-1259

Investor and Media Contact (Pluristyx)
Priya Baraniak
Chief Commercial and Development Officer
priya@pluristyx.com

This press release was published by a CLEAR® Verified individual.

CARLSBAD, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced that on September 28, 2026, it granted stock options to purchase 180,137 shares of the Company’s common stock and 89,286 time-based restricted stock units (“RSUs”) to Richard Heppenstall, the Company’s newly-hired Chief Financial Officer, as a material inducement to his employment.

The Company further announced that on October 1, 2026, it granted stock options to purchase 132,464 shares of the Company’s common stock and 63,735 time-based RSUs to Anthony Jarc, the Company’s newly-hired Chief Product and AI Officer, as a material inducement to his employment.  

The stock options have a per share exercise price equal to the fair market value of the underlying shares on the respective date of grant and vest, subject to the respective employee’s continued service with the Company, over a four-year period (25% on the one-year anniversary of the applicable grant date and the remainder in 12 equal quarterly installments thereafter). The RSUs will vest in three equal annual installments beginning on the first anniversary of the applicable grant date, in each case subject to each respective employee’s continued service with the Company.

The stock options and RSUs were approved by the Company’s Compensation Committee, which is comprised solely of independent directors, and were granted outside the Company’s equity incentive plan as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

About Carlsmed, Inc.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in Carlsmed’s Annual Report on Form 10-K on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations
IR@Carlsmed.com

Media
media@Carlsmed.com

Developers of advanced therapies using PluriFreeze during preclinical stages can seamlessly scale to clinical manufacturing and cross-reference the Drug Master File in FDA submissions

HOLLISTER, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Alpha Teknova, Inc. (“Teknova”) (Nasdaq: TKNO), and Pluristyx, Inc. (“Pluristyx”), today announced that Pluristyx is completing a Type II Drug Master File (DMF) for the PluriFreeze™ cryopreservation system for submission to the U.S. Food and Drug Administration (FDA). The DMF will support drug makers seeking to incorporate PluriFreeze into their clinical development and manufacturing programs. Teknova is a leading producer of critical reagents for the discovery, development, and commercialization of novel therapies, vaccines, and molecular diagnostics, and is the exclusive manufacturer and distributor of PluriFreeze in the United States and Canada. Pluristyx is a leading provider of advanced induced pluripotent stem cell (iPSC) technologies and proprietary, genetically engineered solutions for drug discovery and the development of advanced therapies.

Developers who utilize PluriFreeze in preclinical stages can now request a letter of authorization (LOA) from Pluristyx and cross-reference the PluriFreeze DMF in their Investigational New Drug (IND) applications and Biologics License Applications (BLA). The comprehensive regulatory submission details chemistry, manufacturing, and controls (CMC) for the PluriFreeze system, helping to streamline regulatory submissions and accelerate the development of next-generation therapies.

“The PluriFreeze DMF gives advanced therapy developers more to build on than strong product performance: a documented regulatory position for their cryopreservation system, ready when they need it,” said Stephen Gunstream, Teknova’s President and Chief Executive Officer. “As the cell therapy industry has matured, and as more novel therapies move into clinical trials, our customers want to know that the reagents they’ve built their processes around can support them through clinical development and into commercialization. This file puts that documentation on record with the FDA, so they can seamlessly scale with confidence.”

“Cryopreservation is a critical manufacturing step in cell therapy, but it is often overlooked during process development,” said Dr. Jason Carstens, Chief Operating Officer and Co-Founder of Pluristyx. “PluriFreeze was designed for both cryopreservation performance and manufacturability, with a low-viscosity formulation that is easier to handle and scale as process volumes increase. That focus on low viscosity and manufacturing scalability is an important point of differentiation from other cryopreservation media, and the DMF now provides the regulatory documentation to support its use as programs advance toward the clinic.”

Purpose-built for scalable manufacturing of cell-based products, the PluriFreeze system is a biopreservation media used to protect cells – from intermediate holds during manufacturing through long-term cryopreservation – helping cells remain viable and functional throughout the product lifecycle. Entirely synthetic and animal-origin-free, the system pairs a protective wash with a freezing medium: PluriFreeze Base is a cellular wash that mimics intracellular space and provides metabolic support across the workflow, while PluriFreeze PF10 is a low viscosity freezing medium with 10% dimethyl sulfoxide (DMSO) that simplifies scale-up and process automation. Both products are available for research use and GMP manufacturing applications and can be further customized to support specific cell types and workflow requirements.

In studies comparing PluriFreeze with an industry reference, PluriFreeze PF10 supported similar post-thaw viability, recovery, doubling times, expansion, and surface marker expression across multiple pluripotent stem cell lines and Natural Killer (NK) cells. The PluriFreeze system is stable for up to two years at 2 – 8 °C.

The DMF, which Pluristyx holds, builds on the companies’ collaboration announced in March 2025, through which Teknova became the exclusive manufacturer and distributor of the PluriFreeze product line in the United States and Canada and subsequently contributed the manufacturing and quality content required to support the file. PluriFreeze products are manufactured at Teknova’s ISO 13485 certified facilities in Hollister, California, on the same modular manufacturing platform that supports the Company’s industry-leading turnaround times across research- and GMP-grade reagents.

For product specifications, quality documentation, and ordering information for PluriFreeze Base and PF10, visit teknova.com/pluristyx, email info@teknova.com, or call 1-800-209-4488. A Letter of Authorization can be requested directly from Pluristyx at info@pluristyx.com.

ABOUT TEKNOVA

Teknova makes solutions possible. Since 1996, Teknova has been innovating the manufacture of critical reagents for the life sciences industry to accelerate the discovery and development of novel breakthroughs that will help people live longer, healthier lives. We offer fully customizable solutions for every stage of the workflow, supporting industry leaders in genomics, molecular diagnostics, and emerging therapeutic modalities. Our fast turnaround of high-quality agar plates, microbial culture and cryopreservation media, buffers and reagents, and water helps our customers scale seamlessly from RUO to GMP. Headquartered in Hollister, California, with over 180,000 square feet of state-of-the-art facilities, Teknova’s modular manufacturing platform was designed by our team of scientists, engineers, and quality control experts to efficiently produce the foundational ingredients for the discovery and commercialization of next-generation therapies.

ABOUT PLURISTYX

Pluristyx is the leading provider of advanced iPSC-based solutions for the cell and gene therapy industry, delivering a comprehensive platform designed to accelerate therapeutic development with unmatched speed, safety, and scalability. Leveraging proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable, engineerable, and highly expandable cells. The company’s portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and safety and immune-evasion technologies, including the FailSafe^® safety switch and iACT^® immune cloaking system. Beyond cell sourcing, Pluristyx supports the full development continuum, from organoid-based disease modeling and high-throughput drug screening to GMP-scale manufacturing, helping therapeutic developers streamline workflows, reduce risk and accelerate the path to clinic. For more information, visit www.pluristyx.com.

CONTACTS

Investor Contact (Teknova)
Matt Lowell
Chief Financial Officer
matt.lowell@teknova.com
+1 831-637-1100

Media Contact (Teknova)
Jennifer Henry
Senior Vice President, Marketing
jenn.henry@teknova.com
+1 831-313-1259

Investor and Media Contact (Pluristyx)
Priya Baraniak
Chief Commercial and Development Officer
priya@pluristyx.com

This press release was published by a CLEAR® Verified individual.

CARLSBAD, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced that on September 28, 2026, it granted stock options to purchase 180,137 shares of the Company’s common stock and 89,286 time-based restricted stock units (“RSUs”) to Richard Heppenstall, the Company’s newly-hired Chief Financial Officer, as a material inducement to his employment.

The Company further announced that on October 1, 2026, it granted stock options to purchase 132,464 shares of the Company’s common stock and 63,735 time-based RSUs to Anthony Jarc, the Company’s newly-hired Chief Product and AI Officer, as a material inducement to his employment.  

The stock options have a per share exercise price equal to the fair market value of the underlying shares on the respective date of grant and vest, subject to the respective employee’s continued service with the Company, over a four-year period (25% on the one-year anniversary of the applicable grant date and the remainder in 12 equal quarterly installments thereafter). The RSUs will vest in three equal annual installments beginning on the first anniversary of the applicable grant date, in each case subject to each respective employee’s continued service with the Company.

The stock options and RSUs were approved by the Company’s Compensation Committee, which is comprised solely of independent directors, and were granted outside the Company’s equity incentive plan as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

About Carlsmed, Inc.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in Carlsmed’s Annual Report on Form 10-K on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations
IR@Carlsmed.com

Media
media@Carlsmed.com

CARLSBAD, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Carlsmed, Inc. (Nasdaq: CARL) (“Carlsmed” or the “Company”), a medical technology company pioneering AI-enabled personalized spine surgery solutions, today announced that on September 28, 2026, it granted stock options to purchase 180,137 shares of the Company’s common stock and 89,286 time-based restricted stock units (“RSUs”) to Richard Heppenstall, the Company’s newly-hired Chief Financial Officer, as a material inducement to his employment.

The Company further announced that on October 1, 2026, it granted stock options to purchase 132,464 shares of the Company’s common stock and 63,735 time-based RSUs to Anthony Jarc, the Company’s newly-hired Chief Product and AI Officer, as a material inducement to his employment.  

The stock options have a per share exercise price equal to the fair market value of the underlying shares on the respective date of grant and vest, subject to the respective employee’s continued service with the Company, over a four-year period (25% on the one-year anniversary of the applicable grant date and the remainder in 12 equal quarterly installments thereafter). The RSUs will vest in three equal annual installments beginning on the first anniversary of the applicable grant date, in each case subject to each respective employee’s continued service with the Company.

The stock options and RSUs were approved by the Company’s Compensation Committee, which is comprised solely of independent directors, and were granted outside the Company’s equity incentive plan as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

About Carlsmed, Inc.

Carlsmed is a medical technology company pioneering AI-enabled personalized spine surgery solutions with a mission to improve outcomes and decrease the cost of healthcare for spine surgery and beyond.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including such important factors as are set forth under the caption “Risk Factors” in Carlsmed’s Annual Report on Form 10-K on file with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Carlsmed’s views as of the date of this press release. Carlsmed anticipates that subsequent events and developments will cause its views to change. However, while Carlsmed may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Carlsmed’s views as of any date subsequent to the date of this press release.

Investor Relations
IR@Carlsmed.com

Media
media@Carlsmed.com

WESTLAKE VILLAGE, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the grant of an aggregate of 62,500 restricted stock units (RSUs) of Arcutis common stock to six newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of October 1, 2026, as a material inducement to the new employees in connection with their commencement of employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to each employee’s continued employment with Arcutis through the applicable vesting date.

Arcutis is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company delivering meaningful innovation to address the needs of individuals living with chronic inflammatory skin diseases. Over the past decade, Arcutis has successfully developed a robust portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases, driven by a commitment to solving the most persistent patient challenges in dermatology. Arcutis’ unique dermatology development platform, built on established scientific pathways and coupled with deep clinical dermatology and commercial expertise, enables us to efficiently develop, scale, and deliver our differentiated therapies while advancing a growing pipeline across a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations and are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, head of Investor Relations
ir@arcutis.com

WESTLAKE VILLAGE, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the grant of an aggregate of 62,500 restricted stock units (RSUs) of Arcutis common stock to six newly hired employees. These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of October 1, 2026, as a material inducement to the new employees in connection with their commencement of employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs will vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to each employee’s continued employment with Arcutis through the applicable vesting date.

Arcutis is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company delivering meaningful innovation to address the needs of individuals living with chronic inflammatory skin diseases. Over the past decade, Arcutis has successfully developed a robust portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases, driven by a commitment to solving the most persistent patient challenges in dermatology. Arcutis’ unique dermatology development platform, built on established scientific pathways and coupled with deep clinical dermatology and commercial expertise, enables us to efficiently develop, scale, and deliver our differentiated therapies while advancing a growing pipeline across a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations and are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, head of Investor Relations
ir@arcutis.com

MICHIGAN CITY, Ind., Oct. 02, 2026 (GLOBE NEWSWIRE) — (NASDAQ GS: HBNC) – Horizon Bancorp, Inc. (“Horizon” or the “Company”) will host a conference call at 7:30 a.m. CT on Thursday, October 22, 2026 to review its third quarter 2026 financial results.

The Company’s Third quarter 2026 news release will be published after markets close on Wednesday, October 21, 2026. It will be available at investor.horizonbank.com.

Participants may access the live conference call on October 22, 2026 at 7:30 a.m. CT (8:30 a.m. ET) by dialing 1-833-974-2379 from the United States and Canada, or 1-412-317-5772 from international locations and requesting the “Horizon Bancorp Call.” Please dial in approximately 10 minutes prior to the call.

A telephone replay of the call will be available approximately one hour after the end of the conference call through November 22, 2026. The telephone replay may be accessed by dialing 1-855-669-9658 from the United States and Canada, or 1-412-317-0088 from other international locations and entering the access code 1977515.

About Horizon Bancorp, Inc.

Horizon Bancorp, Inc. (NASDAQ: HBNC) is the $6.6 billion-asset (as of June 30, 2026) commercial bank holding company for Horizon Bank, which serves customers across diverse and economically attractive Midwestern markets through convenient digital and virtual tools, as well as its Indiana and Michigan branches. Horizon’s retail offerings include prime residential and other secured consumer lending to in-market customers, as well as a range of personal banking and wealth management solutions. Horizon also provides a comprehensive array of in-market business banking and treasury management services, as well as equipment financing solutions for customers regionally and nationally, with commercial lending representing over half of total loans. More information on Horizon, headquartered in Northwest Indiana’s Michigan City, is available at horizonbank.com and investor.horizonbank.com.

Contact:	John R. Stewart
	Chief Financial Officer
Phone:	219-814-5833

MICHIGAN CITY, Ind., Oct. 02, 2026 (GLOBE NEWSWIRE) — (NASDAQ GS: HBNC) – Horizon Bancorp, Inc. (“Horizon” or the “Company”) will host a conference call at 7:30 a.m. CT on Thursday, October 22, 2026 to review its third quarter 2026 financial results.

The Company’s Third quarter 2026 news release will be published after markets close on Wednesday, October 21, 2026. It will be available at investor.horizonbank.com.

Participants may access the live conference call on October 22, 2026 at 7:30 a.m. CT (8:30 a.m. ET) by dialing 1-833-974-2379 from the United States and Canada, or 1-412-317-5772 from international locations and requesting the “Horizon Bancorp Call.” Please dial in approximately 10 minutes prior to the call.

A telephone replay of the call will be available approximately one hour after the end of the conference call through November 22, 2026. The telephone replay may be accessed by dialing 1-855-669-9658 from the United States and Canada, or 1-412-317-0088 from other international locations and entering the access code 1977515.

About Horizon Bancorp, Inc.

Horizon Bancorp, Inc. (NASDAQ: HBNC) is the $6.6 billion-asset (as of June 30, 2026) commercial bank holding company for Horizon Bank, which serves customers across diverse and economically attractive Midwestern markets through convenient digital and virtual tools, as well as its Indiana and Michigan branches. Horizon’s retail offerings include prime residential and other secured consumer lending to in-market customers, as well as a range of personal banking and wealth management solutions. Horizon also provides a comprehensive array of in-market business banking and treasury management services, as well as equipment financing solutions for customers regionally and nationally, with commercial lending representing over half of total loans. More information on Horizon, headquartered in Northwest Indiana’s Michigan City, is available at horizonbank.com and investor.horizonbank.com.

Contact:	John R. Stewart
	Chief Financial Officer
Phone:	219-814-5833