On July 31, 2026 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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Recent Highlights:

Clinical Updates:

Initiation of patient dosing in the Company’s Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs).
Completed manufacturing of three batches of the CYWC628 drug product in accordance with FDA’s Good Manufacturing Practices (cGMP). Two of these batches have been released and the third batch will be released after it successfully passes all required safety and quality testing.
Financing:

Strengthened financial position through completion of a $9.0 million private placement with $3.0 million upfront and up to approximately $6.0 million of potential additional gross proceeds upon the exercise in full of warrants. Additionally, closed a $3.0 million public offering.
Preclinical Progress:

Reported preclinical results suggesting that topical treatment with human dermal fibroblast (HDF) spheroids may reprogram the burn wound environment by dampening harmful inflammation, reshaping immune cell behavior, and reducing markers of scar-forming activity, within just eight days of injury.
Patent Portfolio:

Received a notice of an allowance for a patent with the U.S. Patent and Trademark Office (USPTO) covering methods of treating and accelerating the healing of wounds by topically administering a composition comprising 3D spheroid fibroblasts together or with one or more fibroblast-derived materials.
Filed a provisional patent application with the USPTO covering oral delivery systems designed to protect fibroblast-based therapeutics through the stomach and enable targeted release in the gastrointestinal tract.
Conference Presentations:

Presented poster presentations on the novel thymus organoid platform at the Keystone Symposia on Aging and Immunity; and preclinical data from its CYPS317 program for psoriasis at the Society for Investigative Dermatology 2026 Annual Meeting.
Presented its proprietary thymus organoid technology to reboot the immune system and extend human life at the Alliance for Longevity Initiatives H-Span Summit in Washington DC.
Upcoming Milestones

Wound Healing:

Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients:
Expects to report interim results in the second half of 2026.
Anticipates completion and disclosure of primary safety and efficacy results by the end of 2026.
Psoriasis:

Anticipates IND clearance for the treatment of psoriasis with CYPS317, the Company’s fibroblast spheroid product candidate, in the fourth quarter of 2026.
Multiple Sclerosis:

Plans to submit an IND application with the U.S. Food & Drug Administration (FDA) for the treatment of multiple sclerosis with FibroBiologics’ fibroblast spheroid product candidate, CYMS101, in the fourth quarter of 2026.
Degenerative Disc Disease:

Plans to amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank.
Pete O’Heeron, CEO and Founder of FibroBiologics, said, "With the first patient dosed in our CYWC628 trial, FibroBiologics has entered an important stretch as a clinical-stage company. Every milestone ahead builds on this one, and every data point will speak to what fibroblasts can do for patients. We are positioned for the catalysts ahead and eager to share our initial findings this year."

Financial Highlights for the Quarter Ended June 30, 2026

Research and development expenses were approximately $1.7 million for the three months ended June 30, 2026, compared to approximately $2.0 million for the same period in 2025. The decrease was primarily due to decreased CRO costs of $0.3 million as clinical validation changed to manufacturing, and certain costs were capitalized to research and development supplies.
General and administrative expenses were approximately $2.4 million for both the three months ended June 30, 2026 and 2025. The primary areas of net change are decreased personnel expenses of $0.2 million; increased professional fees of $0.1 million for accounting, legal and marketing expenses; decreased facilities expenses of $0.1 million; and increased listing expenses of $0.1 million.
For the three months ended June 30, 2026, FibroBiologics reported a net loss of approximately $4.1 million. The net loss for the three months ended June 30, 2026, was primarily due to research and development expenses and general and administrative expenses discussed above.

Cash and cash equivalents totaled approximately $3.5 million at June 30, 2026.

(Press release, FibroBiologics, JUL 31, 2026, View Source [SID1234669585])

On July 31, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that a scientific manuscript detailing extensive preclinical studies of narmafotinib in pancreatic cancer has been made publicly available on the biology preprint server bioRxiv and can be accessed via this link.

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The manuscript describes research conducted by Professor Paul Timpson and colleagues at the Garvan Institute of Medical Research, Sydney, and provides further insight into the multiple mechanisms through which narmafotinib may act to improve outcomes in pancreatic cancer.

Key findings reported in the manuscript include:

*Reduction of tumour fibrosis, a hallmark of pancreatic cancer that contributes to treatment resistance and impaired drug delivery;

*Enhanced anti-tumour activity when combined with chemotherapy across multiple preclinical pancreatic cancer models;

*Reduced cancer dissemination and metastatic spread in a model of metastatic pancreatic cancer; and

*Downregulation of multiple genes associated with chemotherapy resistance, further supporting the biological rationale for combining narmafotinib with chemotherapy and other drugs

Dr Chris Burns, CEO and Managing Director of Amplia commented: "We are delighted that the extensive research conducted by Professor Timpson’s team at the Garvan Institute over recent years is now being shared with the broader scientific community. Importantly, these studies strengthen the scientific rationale for the clinical development of narmafotinib, and provides further insight into the multifaceted mechanisms through which narmafotinib can act in the treatment of this devastating disease."

The publication represents one of the most comprehensive preclinical evaluations of narmafotinib undertaken to date and further supports Amplia’s ongoing clinical development program in pancreatic cancer.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

(Press release, Amplia Therapeutics, JUL 31, 2026, View Source [SID1234669584])

On July 31, 2026 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the second quarter of 2026.

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"The second quarter marked another period of strong execution for Moderna as we advanced our pipeline and strengthened our financial profile with an improved 2026 operating expense outlook," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the second half of 2026, we are preparing for the potential approval of mFLUSIVA in the U.S., which would be our fifth approved product, and continue to anticipate important pivotal readouts for our intismeran in melanoma and propionic acidemia programs."

Commercial Updates

During the second quarter, Moderna continued to advance its multi-year revenue growth strategy by executing on strategic partnerships and key approvals. In Brazil, a collaboration was signed with a local manufacturer in support of a supply agreement for COVID vaccines. In the EU, the Company signed a joint procurement contract with the European Commission on behalf of six countries for up to 24 million doses of mRESVIA. Moderna also received regulatory approvals in Australia and Mexico for mRESVIA and in Japan and Taiwan for mNEXSPIKE, and its investigational seasonal influenza vaccine, mFLUSIVA, received a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ahead of an August 5 Prescription Drug User Fee Act (PDUFA) goal date in the U.S.

Second Quarter 2026 Financial Results

Revenue: Total revenue for the second quarter of 2026 was $145 million, compared to $142 million in the same period in 2025. Lower COVID vaccine sales in the U.S. and South America were offset by deliveries in the United Kingdom under a long-term strategic government partnership and higher stand-ready manufacturing and collaboration revenue. Revenue was $87 million in the U.S. and $58 million in international markets.

Cost of Sales: Cost of sales for the second quarter of 2026 was $93 million, including $41 million of inventory write-downs, $23 million of unutilized manufacturing capacity costs, and $11 million of third-party royalties. Cost of sales decreased by 22% compared to the same period in 2025, primarily reflecting lower unutilized manufacturing capacity costs resulting from continued manufacturing productivity improvements and operational efficiencies.

Research and Development Expenses: Research and development expenses for the second quarter of 2026 were $651 million, a 7% decrease compared to the same period in 2025. The decrease was primarily driven by lower clinical development costs following the wind-down of several late-stage programs.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of 2026 were $216 million, a 6% decrease compared to the same period in 2025. The decrease reflected continued discipline across the organization.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss was $(0.8) billion for the second quarter of 2026, an improvement of $43 million, or 5%, compared to the second quarter of 2025.

Loss Per Share: Loss per share was $(1.97) for the second quarter of 2026, compared to loss per share of $(2.13) for the second quarter of 2025.

Cash Position: Cash, cash equivalents and investments as of June 30, 2026, were $6.9 billion, compared to $7.5 billion as of March 31, 2026. The decrease primarily reflected cash used to fund operations, continued investment in research and development and advancement of the Company’s pipeline. The Company subsequently paid $950 million in July 2026 related to the litigation settlement announced in the first quarter of 2026.

2026 Financial Framework

Revenue: The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international. Moderna expects approximately 55% of its second half 2026 revenue to be recognized in the third quarter.

Cost of Sales: Cost of sales for 2026 is expected to be approximately $1.7 billion, lowered from approximately $1.8 billion, and including the $0.9 billion non-recurring litigation settlement charge.

Research and Development Expenses: Research and development expenses for 2026 are now anticipated to be approximately $2.9 billion, lowered from approximately $3.0 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion.

Income Taxes: The Company expects its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion.

Cash and Investments: Year-end cash and investments for 2026 are now projected to be $4.7 to $5.2 billion, an improvement of approximately $0.2 billion. This excludes any further drawdowns from the Company’s remaining $0.9 billion available under its credit facility.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Infectious disease vaccines:

Seasonal flu + COVID vaccine: Moderna has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. The Company is awaiting further guidance from the U.S. FDA on refiling the submission for its flu plus COVID combination vaccine.

Seasonal flu vaccine: The Company’s mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. The U.S. FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026

Norovirus vaccine: Moderna’s Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. The trial is ongoing and remains blinded as the Company works toward enrolling an additional cohort.

Oncology therapeutics:

Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with nine total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC announced last quarter.

Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026.

The Company recently presented positive five-year Phase 2b adjuvant melanoma data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.

mRNA-4359: Moderna’s Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company’s PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects potential data in 2026.

Methylmalonic acidemia (MMA) therapeutic: The Company deferred its decision on a pivotal trial for mRNA-3705 until PA registrational data readout.

Moderna Corporate Updates

Appointed Ester Banque to Chief Commercial Officer of Moderna, effective June 15, 2026.

Appointed Michael McDonnell, former Chief Financial Officer of Biogen, to Moderna’s Board of Directors, effective July 8, 2026.

Company Accolades

Moderna was ranked no. 1 by TIME on its list of the World’s Most Impactful Companies.

Key 2026 Investor and Analyst Event Dates

Analyst Day: November 12

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on July 31, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

(Press release, Moderna Therapeutics, JUL 31, 2026, https://feeds.issuerdirect.com/news-release.html?newsid=7044027068145026&symbol=MRNA [SID1234669583])

On July 31, 2026 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the second quarter ended June 30, 2026.

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"In the second quarter of 2026, as previously announced, Werewolf entered into an asset purchase agreement with Jazz Pharmaceuticals Ireland Limited ("Jazz") with respect to the JZP898 program previously licensed to Jazz, and repaid all amounts owed under its loan and security agreement with K2 HealthVentures LLC ("K2"). Together, these transactions, which included a $21.0 million payment to Werewolf, enabled the Company to explore multiple options for the continued development of its INDUKINE and INDUCER platforms and programs," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "In the second half of the year, we expect to provide additional updates on the strategic alternatives process that is being run with assistance from our exclusive financial advisor, Piper Sandler & Co. ("Piper Sandler"), as well as data updates on our clinical trials of WTX-124 and WTX-330."

Financial Results for the Second Quarter of 2026:

•Cash position: As of June 30, 2026, cash and cash equivalents were $22.0 million, compared to $46.5 million as of March 31, 2026. Based on its current operating plan, the Company expects to be able to fund its operations into the second quarter of 2027.
•Collaboration revenue: Collaboration revenue was $21.0 million for the second quarter of 2026, and consists of revenue recognized related the Company’s agreement to sell its JZP898 program to Jazz Pharmaceuticals Ireland Limited. No collaboration revenue was recognized during the second quarter of 2025.
•Research and development expenses: Research and development expenses were $6.2 million for the second quarter of 2026, compared to $13.1 million for the same period in 2025.
•General and administrative expenses: General and administrative expenses were $7.7 million for the second quarter of 2026, compared to $4.4 million for the same period in 2025.
•Net income (loss): Net income was $3.7 million for the second quarter of 2026, compared to a net loss of $18.0 million for the same period in 2025.

(Press release, Werewolf Therapeutics, JUL 31, 2026, View Source [SID1234669581])

On July 31, 2026 Sona Nanotech Inc. (CSE: SONA, OTCQB: SNANF) (the "Company", "Sona") reported that it plans to raise up to $2,400,000 through a private placement financing (the "Financing") of up to 8,000,000 common shares of Sona (each, a "Share") at a price of $0.30 per Share (the "Offering Price"). Insiders and certain other existing shareholders of Sona may also subscribe for Shares under the Financing.

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Sona intends to use the net proceeds of the Financing for advancing studies to support the clinical advancement and continuing research and development work on its Targeted Hyperthermia TherapyTM ("THT") oncology treatment, as well as for general working capital purposes.

Completion of the Financing is subject to the satisfaction of certain conditions as well as the approval of the Canadian Securities Exchange. All securities issued pursuant to the Financing will be subject to a hold-period of four months and a day commencing from the closing date.

(Press release, Sona Nanotech, JUL 31, 2026, View Source [SID1234669580])