Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants




Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) — Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the pricing of an underwritten public offering of 44,000,000 shares of its common stock at an offering price of $2.50 per share and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 6,000,000 shares of its common stock at a price of $2.4999 per pre-funded warrant. The gross proceeds from this offering are expected to be approximately $125.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Invivyd. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant. All of the shares and pre-funded warrants are being offered by Invivyd. In addition, Invivyd has granted the underwriters an option for a period of 30 days to purchase up to an additional 7,500,000 shares of Invivyd common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about November 19, 2025, subject to the satisfaction of customary closing conditions.

Cantor is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

Invivyd intends to use the net proceeds that it will receive from the offering, together with its existing cash and cash equivalents, for commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as respiratory syncytial virus (RSV) and measles, continued advancement of the Spike Protein Elimination and Recovery (SPEAR) Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes.

The securities described above are being offered by Invivyd pursuant to a shelf registration statement on Form S-3 (File No. 333-267643) filed with the U.S. Securities and Exchange Commission (SEC) on September 28, 2022 and declared effective by the SEC on October 5, 2022.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and free writing prospectus relating to the offering were filed with the SEC on November 17, 2025 and are available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may also be obtained from Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59^th Street, 6^th Floor, New York, New York 10022; or by e-mail at prospectus@cantor.com.

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the amount of proceeds from the offering, the timing of the closing of the offering, as well as the anticipated use of the net proceeds from the offering. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Invivyd’s actual results to be materially different than those expressed in or implied by Invivyd’s forward-looking statements. For Invivyd, this includes satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, political uncertainties, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market. Other factors that may cause Invivyd’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the preliminary prospectus supplement and the free writing prospectus relating to the offering filed with the SEC, in Invivyd’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC, and in Invivyd’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants




Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) — Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced the pricing of an underwritten public offering of 44,000,000 shares of its common stock at an offering price of $2.50 per share and, to certain investors, in lieu of common stock, pre-funded warrants to purchase 6,000,000 shares of its common stock at a price of $2.4999 per pre-funded warrant. The gross proceeds from this offering are expected to be approximately $125.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Invivyd. The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant. All of the shares and pre-funded warrants are being offered by Invivyd. In addition, Invivyd has granted the underwriters an option for a period of 30 days to purchase up to an additional 7,500,000 shares of Invivyd common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about November 19, 2025, subject to the satisfaction of customary closing conditions.

Cantor is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

Invivyd intends to use the net proceeds that it will receive from the offering, together with its existing cash and cash equivalents, for commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as respiratory syncytial virus (RSV) and measles, continued advancement of the Spike Protein Elimination and Recovery (SPEAR) Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes.

The securities described above are being offered by Invivyd pursuant to a shelf registration statement on Form S-3 (File No. 333-267643) filed with the U.S. Securities and Exchange Commission (SEC) on September 28, 2022 and declared effective by the SEC on October 5, 2022.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and free writing prospectus relating to the offering were filed with the SEC on November 17, 2025 and are available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may also be obtained from Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59^th Street, 6^th Floor, New York, New York 10022; or by e-mail at prospectus@cantor.com.

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the amount of proceeds from the offering, the timing of the closing of the offering, as well as the anticipated use of the net proceeds from the offering. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Invivyd’s actual results to be materially different than those expressed in or implied by Invivyd’s forward-looking statements. For Invivyd, this includes satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, political uncertainties, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market. Other factors that may cause Invivyd’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the preliminary prospectus supplement and the free writing prospectus relating to the offering filed with the SEC, in Invivyd’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC, and in Invivyd’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

Portsmouth Square, Inc. Reports Q1 FY2026 Results; Hotel KPIs Up, Continued Stabilization in San Francisco, and ~$10.1 Million in Cash & Restricted Cash




Portsmouth Square, Inc. Reports Q1 FY2026 Results; Hotel KPIs Up, Continued Stabilization in San Francisco, and ~$10.1 Million in Cash & Restricted Cash

Los Angeles, CA, Nov. 17, 2025 (GLOBE NEWSWIRE) — Portsmouth Square, Inc. (“Portsmouth” or the “Company”) reported results for the three months ended September 30, 2025. Management continues to conclude that the prior going-concern doubt was alleviated as of June 30, 2025 following the refinancing completed on March 28, 2025, and that no substantial doubt exists for at least twelve months from the issuance date of the Company’s financial statements.

Fiscal Q1 2026 Highlights (vs. Q1 FY2025)

• GAAP net loss: ($2,585,000) (vs. ($1,872,000)).
• Hotel revenue: $12,418,000 (vs. $11,820,000; +5.1% YoY).
• Hotel operating income before interest, depreciation & amortization: $1,937,000 (vs. $3,028,000).
• Hotel KPIs: ADR $218 (+3.8% YoY), occupancy 95% (-1 pt), RevPAR $207 (+2.5% YoY).
• See GAAP-to-non-GAAP reconciliation of Net loss to EBITDA below (presented with GAAP prominence).
• As presented in the Condensed Consolidated Statements of Cash Flows, cash, cash equivalents and restricted cash at September 30, 2025 totaled $10,131,000.

Hotel Revenues & Expenses Detail (Segment)

Hotel revenues (by category):

• Rooms: $10,428,000 (vs. $10,110,000; +3.1% YoY)
• Food & beverage: $912,000 (vs. $733,000; +24.4% YoY)
• Garage: $900,000 (vs. $875,000; +2.9% YoY)
• Other operating departments: $178,000 (vs. $102,000; +74.5% YoY)
• Total hotel revenues: $12,418,000 (vs. $11,820,000; +5.1% YoY)

Hotel expenses (segment):

• Operating expenses excluding depreciation & amortization: $10,481,000 (vs. $8,792,000; +19.2% YoY)
• Operating income before interest, depreciation & amortization (Non-GAAP OIBDA): $1,937,000 (vs. $3,028,000; -36.0% YoY)
• Interest expense — mortgage: $2,493,000 (vs. $2,824,000; -11.7% YoY)
• Interest expense — related party: $872,000 (vs. $824,000; +5.8% YoY)
• Depreciation & amortization: $874,000 (vs. $903,000; -3.2% YoY)
• Net loss from Hotel operations (GAAP): ($2,302,000) (vs. ($1,523,000); -51.2% YoY)

Note: OIBDA is a Non-GAAP measure. GAAP income from operations can be derived as OIBDA minus depreciation & amortization. OIBDA is not a substitute for GAAP and is provided for period-over-period comparability.

CEO & President Commentary

John V. Winfield, Chairman and Chief Executive Officer, said:

“We continue to see encouraging signs of stabilization across the San Francisco hospitality market, including improving convention calendars, tourism indicators, and business travel activity. While we remain attentive to macroeconomic and geopolitical risks, the overall trajectory for the city has stabilized compared with the prior year.”

David C. Gonzalez, President, added:

“This quarter reflects a degree of stabilization. Revenue grew ~5% year over year, with ADR up ~4% and RevPAR up ~2.5%, while occupancy was essentially steady (down ~1 point). We remain focused on rate discipline, targeted cost controls, and merchandising into the convention and group calendar as San Francisco demand normalizes.”

GAAP to Non-GAAP Reconciliation (presented with GAAP prominence)

Reconciliation of Net Loss (GAAP) to EBITDA (Non-GAAP) — Three months ended September 30 (in dollars)

Year-over-year change (EBITDA): -38.2%.

Informational note: Interest expense includes related-party interest payable to The InterGroup Corporation of $872,000 in Q1 FY2026 and $824,000 in Q1 FY2025. These amounts are included in GAAP interest expense and in the EBITDA reconciliation above.

Non-GAAP Cautionary Statement: EBITDA is a non-GAAP financial measure defined by the Company as net income (loss) before interest expense, income tax expense (benefit), and depreciation and amortization. Management uses EBITDA to evaluate operating performance and liquidity, to compare results period-over-period, and to benchmark against peers; however, it has limitations and should not be viewed as a substitute for GAAP. The most directly comparable GAAP measure is net income (loss), which is presented above with equal or greater prominence.

KPI definitions: ADR = average room rate paid; Occupancy = rooms sold ÷ rooms available; RevPAR = ADR × Occupancy.

Forward-Looking Statements

This press release contains forward-looking statements subject to risks and uncertainties, including hospitality market recovery in San Francisco, business travel trends, competitive dynamics, and macroeconomic factors. See “Forward-Looking Statements” and “Risk Factors” in the Company’s Form 10-Q for the quarter ended September 30, 2025 for additional information. The Company undertakes no obligation to update forward-looking statements except as required by law.

About Portsmouth Square, Inc.

Portsmouth Square, Inc. owns the Hilton San Francisco Financial District (558 rooms) with extensive meeting space, restaurant and lounge, and a five-level parking garage. The hotel operates under a franchise license with Hilton and is managed by Aimbridge Hospitality. The Company is headquartered in Los Angeles, California.

Investor Contact
Portsmouth Square, Inc.
1516 S. Bundy Drive, Suite 200
Los Angeles, CA 90025
(310) 889-2500

Artisan Therapeutics and Tulex Pharmaceuticals Announce Positive Phase 2a Results for ART-501, a Novel Oral Liquid Extended-Release Formulation for Autism Spectrum Disorder




Artisan Therapeutics and Tulex Pharmaceuticals Announce Positive Phase 2a Results for ART-501, a Novel Oral Liquid Extended-Release Formulation for Autism Spectrum Disorder

Artisan and Tulex Report Positive Phase 2a Results for Autism Drug ART-501

SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) — Artisan Therapeutics, Inc. (“Artisan”) and Tulex Pharmaceuticals (“Tulex”) today announced encouraging Phase 2a clinical results highlighting the potential of ART-501 for the treatment of autism spectrum disorder (“ASD”)-related conditions. In this pilot, proof-of-concept study, four out of six participants demonstrated meaningful signs of clinical benefit. ART-501 was generally well-tolerated, with adverse events reported as mostly mild and transient, and with no serious adverse events observed.

Behavioral improvements, as measured by the Aberrant Behavior Checklist – Second Edition (ABC-2), were observed in the majority of participants, with notable reductions seen in the ABC-2 subscales for irritability, lethargy/social withdrawal, stereotypic behaviors, and hyperactivity/non-compliance during low-dose ART-501 dosing compared to baseline. The ABC-2 irritability subscale is an established clinical measure that has served as a primary endpoint in FDA-approved therapies for irritability associated with ASD.

The pilot Phase 2a study was a multicenter trial conducted at two U.S. clinical sites that enrolled six adult participants with diagnostically confirmed ASD, five of whom completed treatment. The trial consisted of baseline assessments followed by an open-label period involving low-dose ART-501, then by a blinded, placebo-controlled, crossover period involving higher-dose ART-501.

Dr. Ann Childress, M.D., who was an investigator in the trial, stated, “Autism presents significant challenges for patients and their families, including repetitive behaviors, communication difficulties, and impaired social interactions.” Dr. Childress further commented, “It was very encouraging to see signals of efficacy in several of the participants in the ART-501 study, which supports continued exploration of this use of ART-501 in a larger Phase 2/3 study.”

Dr. Colleen Craig, M.D., Interim Chief Medical Officer (CMO) at Artisan Therapeutics stated, “We are deeply encouraged by the early signs of clinical benefit observed in this Phase 2a study of ART-501. These results highlight the therapeutic potential of our novel extended-release formulation in addressing core symptoms of ASD. At Artisan, our mission is to pursue science-driven innovation for underserved neurodevelopmental conditions, and this milestone represents an important step forward. We look forward to advancing ART-501 into further clinical development in collaboration with Tulex.”

About ART-501

ART-501, formerly known as ARD-501 or TLX-032 for Tulex, is a proprietary oral liquid extended-release formulation of an existing, well-tolerated opioid receptor modulating drug developed through a joint venture between Tulex and Artisan.

About Tulex Pharmaceuticals

Tulex Pharmaceuticals is a U.S. based pharmaceutical company focused on the development of NDA and ANDA products of existing molecules in new dosage forms or new routes of administration. Tulex is a wholly owned subsidiary of Easywell Biomedicals, a publicly listed company in Taiwan (TPEX: 1799.TWO).

About Artisan Therapeutics, Inc.

Artisan Therapeutics, Inc., is a wholly owned subsidiary of Aardvark Therapeutics, Inc. and is focused on the development of ART-501 through a joint venture with Tulex.

Forward-Looking Statements: Certain statements included in this press release that are not historical facts are forward-looking statements. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, Tulex’s belief that its unique expertise in developing oral liquid extended-release formulations enables the optimized delivery of an existing opioid receptor modulator offering a promising new approach for the prospective treatment of autism, the therapeutic potential of the novel extended-release formulation in addressing core symptoms of ASD and Artisan’s plans to advance ART-501 into further clinical development in collaboration with Tulex. These statements are based on current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact:

Carolyn Hawley

Carolyn.hawley@inizioevoke.com

Onco360 Has Been Selected as a National Specialty Pharmacy Partner for Komzifti™ (ziftomenib)




Onco360 Has Been Selected as a National Specialty Pharmacy Partner for Komzifti™ (ziftomenib)

LOUISVILLE, Ky. , Nov. 17, 2025 (GLOBE NEWSWIRE) — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Kura Oncology for Komzifti^™ (ziftomenib), indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.¹ This indication was approved based on the phase II, KO-MEN-001 study.²   

“Komzifti provides a new treatment option for adults with relapsed or refractory AML who have limited treatment options,” said Benito Fernandez, Chief Commercial Officer. “We are proud to partner with Kura Oncology to provide access to this important therapy and support patients and their caregivers throughout their treatment journey.”

Komzifti is a menin inhibitor that blocks the interaction of menin and lysine [K]-specific methyltransferase 2A (KMT2A). Pharmacologic disruption of the menin-KMT2A protein-protein interaction by Komzifti blocks the oncogenic activity of mutant NPM1, which induces differentiation of leukemic cells as evidenced by increased expression of differentiation markers. About 30% of all patients with AML have the NPM1 mutation.

The efficacy of Komzifti was evaluated in an open-label, single-arm, multicenter clinical trial (Study KO-MEN-001, NCT04067336), in 112 adult patients with relapsed or refractory AML with an NPM1 mutation identified using next-generation sequencing or polymerase chain reaction.² The study demonstrated a rate of complete remission (CR) plus CR with partial hematological recovery (CRh) of 21.4% (95% CI 14.2,30.2).¹

The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase, infection without an identified pathogen, decreased potassium, decreased albumin, increased alanine aminotransferase, decreased sodium, increased creatinine, increased alkaline phosphatase, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, increased bilirubin, increased potassium, differentiation syndrome, pruritus, febrile neutropenia, and increased transaminases.¹

Please see the full Prescribing Information for Komzifti.

About Onco360 Oncology Pharmacy
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.

Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.Fernandez@Onco360.com
516-640-1332

References:
¹Komzifti™ (ziftomenib) [Package Insert]. San Diego, CA. Kura Oncology, Inc. 2025.
² Eunice S. Wang et al. Ziftomenib in Relapsed or Refractory NPM1-Mutated AML. J Clin Oncol 43, 3381-3390(2025). DOI:10.1200/JCO-25-01694

Artisan Therapeutics and Tulex Pharmaceuticals Announce Positive Phase 2a Results for ART-501, a Novel Oral Liquid Extended-Release Formulation for Autism Spectrum Disorder




Artisan Therapeutics and Tulex Pharmaceuticals Announce Positive Phase 2a Results for ART-501, a Novel Oral Liquid Extended-Release Formulation for Autism Spectrum Disorder

Artisan and Tulex Report Positive Phase 2a Results for Autism Drug ART-501

SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) — Artisan Therapeutics, Inc. (“Artisan”) and Tulex Pharmaceuticals (“Tulex”) today announced encouraging Phase 2a clinical results highlighting the potential of ART-501 for the treatment of autism spectrum disorder (“ASD”)-related conditions. In this pilot, proof-of-concept study, four out of six participants demonstrated meaningful signs of clinical benefit. ART-501 was generally well-tolerated, with adverse events reported as mostly mild and transient, and with no serious adverse events observed.

Behavioral improvements, as measured by the Aberrant Behavior Checklist – Second Edition (ABC-2), were observed in the majority of participants, with notable reductions seen in the ABC-2 subscales for irritability, lethargy/social withdrawal, stereotypic behaviors, and hyperactivity/non-compliance during low-dose ART-501 dosing compared to baseline. The ABC-2 irritability subscale is an established clinical measure that has served as a primary endpoint in FDA-approved therapies for irritability associated with ASD.

The pilot Phase 2a study was a multicenter trial conducted at two U.S. clinical sites that enrolled six adult participants with diagnostically confirmed ASD, five of whom completed treatment. The trial consisted of baseline assessments followed by an open-label period involving low-dose ART-501, then by a blinded, placebo-controlled, crossover period involving higher-dose ART-501.

Dr. Ann Childress, M.D., who was an investigator in the trial, stated, “Autism presents significant challenges for patients and their families, including repetitive behaviors, communication difficulties, and impaired social interactions.” Dr. Childress further commented, “It was very encouraging to see signals of efficacy in several of the participants in the ART-501 study, which supports continued exploration of this use of ART-501 in a larger Phase 2/3 study.”

Dr. Colleen Craig, M.D., Interim Chief Medical Officer (CMO) at Artisan Therapeutics stated, “We are deeply encouraged by the early signs of clinical benefit observed in this Phase 2a study of ART-501. These results highlight the therapeutic potential of our novel extended-release formulation in addressing core symptoms of ASD. At Artisan, our mission is to pursue science-driven innovation for underserved neurodevelopmental conditions, and this milestone represents an important step forward. We look forward to advancing ART-501 into further clinical development in collaboration with Tulex.”

About ART-501

ART-501, formerly known as ARD-501 or TLX-032 for Tulex, is a proprietary oral liquid extended-release formulation of an existing, well-tolerated opioid receptor modulating drug developed through a joint venture between Tulex and Artisan.

About Tulex Pharmaceuticals

Tulex Pharmaceuticals is a U.S. based pharmaceutical company focused on the development of NDA and ANDA products of existing molecules in new dosage forms or new routes of administration. Tulex is a wholly owned subsidiary of Easywell Biomedicals, a publicly listed company in Taiwan (TPEX: 1799.TWO).

About Artisan Therapeutics, Inc.

Artisan Therapeutics, Inc., is a wholly owned subsidiary of Aardvark Therapeutics, Inc. and is focused on the development of ART-501 through a joint venture with Tulex.

Forward-Looking Statements: Certain statements included in this press release that are not historical facts are forward-looking statements. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, Tulex’s belief that its unique expertise in developing oral liquid extended-release formulations enables the optimized delivery of an existing opioid receptor modulator offering a promising new approach for the prospective treatment of autism, the therapeutic potential of the novel extended-release formulation in addressing core symptoms of ASD and Artisan’s plans to advance ART-501 into further clinical development in collaboration with Tulex. These statements are based on current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact:

Carolyn Hawley

Carolyn.hawley@inizioevoke.com

Avalo Therapeutics Announces Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(c)(4)




Avalo Therapeutics Announces Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(c)(4)

WAYNE, Pa., Nov. 17, 2025 (GLOBE NEWSWIRE) — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced the grant of inducement equity awards to three new employees. The Compensation Committee of the Board of Directors of Avalo approved the grants of nonstatutory stock options to purchase an aggregate of 114,000 shares of common stock (the “Options”) as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

The Options were granted on November 4, November 10, and November 17, 2025, and entitle the recipients to purchase 24,000 shares of common stock, 72,000 shares of common stock, and 18,000 shares of common stock, respectively, at an exercise price per share equal to the closing price on the respective date on which the Option was granted. The Options will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of each employee’s respective start date, and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Avalo through the applicable vesting dates. The Options are subject to the terms and conditions of Avalo’s 2025 Inducement Award Plan and the terms and conditions of an applicable stock option agreement covering the grant.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. 

About AVTX-009

AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.1 It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1β inhibition has proven effective in multiple immune-mediated inflammatory diseases.1-3

References:1Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2Kany S et al. Int J Mol Sci. 2019;20(23):6008. 3Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA.

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793

or

Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com

Portsmouth Square, Inc. Reports Q1 FY2026 Results; Hotel KPIs Up, Continued Stabilization in San Francisco, and ~$10.1 Million in Cash & Restricted Cash




Portsmouth Square, Inc. Reports Q1 FY2026 Results; Hotel KPIs Up, Continued Stabilization in San Francisco, and ~$10.1 Million in Cash & Restricted Cash

Los Angeles, CA, Nov. 17, 2025 (GLOBE NEWSWIRE) — Portsmouth Square, Inc. (“Portsmouth” or the “Company”) reported results for the three months ended September 30, 2025. Management continues to conclude that the prior going-concern doubt was alleviated as of June 30, 2025 following the refinancing completed on March 28, 2025, and that no substantial doubt exists for at least twelve months from the issuance date of the Company’s financial statements.

Fiscal Q1 2026 Highlights (vs. Q1 FY2025)

• GAAP net loss: ($2,585,000) (vs. ($1,872,000)).
• Hotel revenue: $12,418,000 (vs. $11,820,000; +5.1% YoY).
• Hotel operating income before interest, depreciation & amortization: $1,937,000 (vs. $3,028,000).
• Hotel KPIs: ADR $218 (+3.8% YoY), occupancy 95% (-1 pt), RevPAR $207 (+2.5% YoY).
• See GAAP-to-non-GAAP reconciliation of Net loss to EBITDA below (presented with GAAP prominence).
• As presented in the Condensed Consolidated Statements of Cash Flows, cash, cash equivalents and restricted cash at September 30, 2025 totaled $10,131,000.

Hotel Revenues & Expenses Detail (Segment)

Hotel revenues (by category):

• Rooms: $10,428,000 (vs. $10,110,000; +3.1% YoY)
• Food & beverage: $912,000 (vs. $733,000; +24.4% YoY)
• Garage: $900,000 (vs. $875,000; +2.9% YoY)
• Other operating departments: $178,000 (vs. $102,000; +74.5% YoY)
• Total hotel revenues: $12,418,000 (vs. $11,820,000; +5.1% YoY)

Hotel expenses (segment):

• Operating expenses excluding depreciation & amortization: $10,481,000 (vs. $8,792,000; +19.2% YoY)
• Operating income before interest, depreciation & amortization (Non-GAAP OIBDA): $1,937,000 (vs. $3,028,000; -36.0% YoY)
• Interest expense — mortgage: $2,493,000 (vs. $2,824,000; -11.7% YoY)
• Interest expense — related party: $872,000 (vs. $824,000; +5.8% YoY)
• Depreciation & amortization: $874,000 (vs. $903,000; -3.2% YoY)
• Net loss from Hotel operations (GAAP): ($2,302,000) (vs. ($1,523,000); -51.2% YoY)

Note: OIBDA is a Non-GAAP measure. GAAP income from operations can be derived as OIBDA minus depreciation & amortization. OIBDA is not a substitute for GAAP and is provided for period-over-period comparability.

CEO & President Commentary

John V. Winfield, Chairman and Chief Executive Officer, said:

“We continue to see encouraging signs of stabilization across the San Francisco hospitality market, including improving convention calendars, tourism indicators, and business travel activity. While we remain attentive to macroeconomic and geopolitical risks, the overall trajectory for the city has stabilized compared with the prior year.”

David C. Gonzalez, President, added:

“This quarter reflects a degree of stabilization. Revenue grew ~5% year over year, with ADR up ~4% and RevPAR up ~2.5%, while occupancy was essentially steady (down ~1 point). We remain focused on rate discipline, targeted cost controls, and merchandising into the convention and group calendar as San Francisco demand normalizes.”

GAAP to Non-GAAP Reconciliation (presented with GAAP prominence)

Reconciliation of Net Loss (GAAP) to EBITDA (Non-GAAP) — Three months ended September 30 (in dollars)

Year-over-year change (EBITDA): -38.2%.

Informational note: Interest expense includes related-party interest payable to The InterGroup Corporation of $872,000 in Q1 FY2026 and $824,000 in Q1 FY2025. These amounts are included in GAAP interest expense and in the EBITDA reconciliation above.

Non-GAAP Cautionary Statement: EBITDA is a non-GAAP financial measure defined by the Company as net income (loss) before interest expense, income tax expense (benefit), and depreciation and amortization. Management uses EBITDA to evaluate operating performance and liquidity, to compare results period-over-period, and to benchmark against peers; however, it has limitations and should not be viewed as a substitute for GAAP. The most directly comparable GAAP measure is net income (loss), which is presented above with equal or greater prominence.

KPI definitions: ADR = average room rate paid; Occupancy = rooms sold ÷ rooms available; RevPAR = ADR × Occupancy.

Forward-Looking Statements

This press release contains forward-looking statements subject to risks and uncertainties, including hospitality market recovery in San Francisco, business travel trends, competitive dynamics, and macroeconomic factors. See “Forward-Looking Statements” and “Risk Factors” in the Company’s Form 10-Q for the quarter ended September 30, 2025 for additional information. The Company undertakes no obligation to update forward-looking statements except as required by law.

About Portsmouth Square, Inc.

Portsmouth Square, Inc. owns the Hilton San Francisco Financial District (558 rooms) with extensive meeting space, restaurant and lounge, and a five-level parking garage. The hotel operates under a franchise license with Hilton and is managed by Aimbridge Hospitality. The Company is headquartered in Los Angeles, California.

Investor Contact
Portsmouth Square, Inc.
1516 S. Bundy Drive, Suite 200
Los Angeles, CA 90025
(310) 889-2500

Onco360 Has Been Selected as a National Specialty Pharmacy Partner for Komzifti™ (ziftomenib)




Onco360 Has Been Selected as a National Specialty Pharmacy Partner for Komzifti™ (ziftomenib)

LOUISVILLE, Ky. , Nov. 17, 2025 (GLOBE NEWSWIRE) — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Kura Oncology for Komzifti^™ (ziftomenib), indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.¹ This indication was approved based on the phase II, KO-MEN-001 study.²   

“Komzifti provides a new treatment option for adults with relapsed or refractory AML who have limited treatment options,” said Benito Fernandez, Chief Commercial Officer. “We are proud to partner with Kura Oncology to provide access to this important therapy and support patients and their caregivers throughout their treatment journey.”

Komzifti is a menin inhibitor that blocks the interaction of menin and lysine [K]-specific methyltransferase 2A (KMT2A). Pharmacologic disruption of the menin-KMT2A protein-protein interaction by Komzifti blocks the oncogenic activity of mutant NPM1, which induces differentiation of leukemic cells as evidenced by increased expression of differentiation markers. About 30% of all patients with AML have the NPM1 mutation.

The efficacy of Komzifti was evaluated in an open-label, single-arm, multicenter clinical trial (Study KO-MEN-001, NCT04067336), in 112 adult patients with relapsed or refractory AML with an NPM1 mutation identified using next-generation sequencing or polymerase chain reaction.² The study demonstrated a rate of complete remission (CR) plus CR with partial hematological recovery (CRh) of 21.4% (95% CI 14.2,30.2).¹

The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased aspartate aminotransferase, infection without an identified pathogen, decreased potassium, decreased albumin, increased alanine aminotransferase, decreased sodium, increased creatinine, increased alkaline phosphatase, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, increased bilirubin, increased potassium, differentiation syndrome, pruritus, febrile neutropenia, and increased transaminases.¹

Please see the full Prescribing Information for Komzifti.

About Onco360 Oncology Pharmacy
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.

Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.Fernandez@Onco360.com
516-640-1332

References:
¹Komzifti™ (ziftomenib) [Package Insert]. San Diego, CA. Kura Oncology, Inc. 2025.
² Eunice S. Wang et al. Ziftomenib in Relapsed or Refractory NPM1-Mutated AML. J Clin Oncol 43, 3381-3390(2025). DOI:10.1200/JCO-25-01694

Avalo Therapeutics Announces Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(c)(4)




Avalo Therapeutics Announces Inducement Grants to New Employees Under Nasdaq Listing Rule 5635(c)(4)

WAYNE, Pa., Nov. 17, 2025 (GLOBE NEWSWIRE) — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases, today announced the grant of inducement equity awards to three new employees. The Compensation Committee of the Board of Directors of Avalo approved the grants of nonstatutory stock options to purchase an aggregate of 114,000 shares of common stock (the “Options”) as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

The Options were granted on November 4, November 10, and November 17, 2025, and entitle the recipients to purchase 24,000 shares of common stock, 72,000 shares of common stock, and 18,000 shares of common stock, respectively, at an exercise price per share equal to the closing price on the respective date on which the Option was granted. The Options will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of each employee’s respective start date, and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employee’s continued service relationship with Avalo through the applicable vesting dates. The Options are subject to the terms and conditions of Avalo’s 2025 Inducement Award Plan and the terms and conditions of an applicable stock option agreement covering the grant.

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL-1β-based treatments for immune-mediated inflammatory diseases. Our lead asset, AVTX-009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com. 

About AVTX-009

AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a pro-inflammatory cytokine that plays a central role in the pathogenesis of a wide range of human diseases.1 It activates immune cells that generate proinflammatory cytokines, including IL-6, TNF-α, and IL-17. Dysregulated IL-1β signaling is a major driver of inflammation, contributing to the progression of autoimmune disorders. IL-1β inhibition has proven effective in multiple immune-mediated inflammatory diseases.1-3

References:1Dinarello CA. Immunol Rev. 2018;281(1):8-27. 2Kany S et al. Int J Mol Sci. 2019;20(23):6008. 3Kimball AB et al. Presented at: American Academy of Dermatology; March 8-12, 2024; San Diego, CA.

Forward-Looking Statements

This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Avalo’s control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “might,” “will,” “could,” “would,” “should,” “continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” or similar expressions (including their use in the negative), or by discussions of future matters such as: drug development costs, timing of trials and trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the war in Ukraine and the Middle East; and those other risks detailed in Avalo’s filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For media and investor inquiries
Christopher Sullivan, CFO
Avalo Therapeutics, Inc.
ir@avalotx.com
410-803-6793

or

Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com