On August 11, 2026 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported financial results for the second quarter ended June 30, 2026, and provided an update on recent corporate highlights.

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The Company is also updating its previous cash runway guidance. As of June 30, 2026, cash and cash equivalents were approximately $30 million, which are expected to fund operations into late-2027.

"The partnership with Sentynl Therapeutics which we announced earlier today marks a significant milestone for our alvelestat program and for the Company as a whole. We are now working together to refine the design of the global Phase 3 study for our potential first-in-class oral therapy for AATD-LD and look forward to a continued close collaboration during the short option period. Assuming exercise of the license option by Sentynl, we plan to initiate the Phase 3 trial in early 2027," said Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma. "Additionally, alongside our partner Ultragenyx, we have had initial regulatory interactions on setrusumab with the FDA and the MHRA and we expect to be in a position to provide an update on the potential path forward by the end of this year. We finished the quarter with approximately $30 million in cash. Thanks to our careful expense management, we now expect that this cash will provide runway into late-2027, exclusive of the potential $40 million in upfront and R&D payments that we are eligible to receive on exercise of the alvelestat option by Sentynl."

Second Quarter 2026 Highlights, Recent Developments, and Anticipated Milestones

Setrusumab (UX143)

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The Orbit and the Cosmic Phase 3 studies did not achieve statistical significance against the primary endpoints of reduction in annualized clinical fracture rate, however, both achieved high statistical significance against the key secondary endpoint of improvement in bone mineral density, as well as reductions in vertebral fractures and improvements in patient reported outcomes (PROs) associated with disease severity, pain / discomfort and daily activities, with these PRO improvements achieving statistical significance in the Orbit study. Setrusumab also achieved meaningful reductions in fractures in certain bones and in patients with higher fracture frequencies. Both studies demonstrated a safety profile consistent with that observed in previous trials.
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Mereo and its partner, Ultragenyx Pharmaceutical, Inc. ("Ultragenyx"), are engaged with regulatory agencies to determine a potential path forward for setrusumab in pediatric OI patients and, to-date, have held discussions with the regulators in the U.S. and the U.K. The FDA indicated openness to considering alternative approaches to fracture analysis, with additional conversations needed to further define what additional clinical data would be needed to support a potential BLA. In recent communications with the MHRA, they encouraged further dialogue on any future development proposal, and we plan to have further interactions following the FDA discussions.

Alvelestat (MPH-966)

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Mereo recently announced an option and license agreement with Sentynl Therapeutics, Inc. (Sentynl), a wholly owned subsidiary of Zydus Lifesciences Limited. Sentynl has the right to acquire a license for the U.S. commercial and global manufacturing rights to alvelestat for AATD-LD.
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Sentynl is a California-based, commercial-stage biopharmaceutical company with three currently approved products for rare diseases.
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Under the agreement, the companies will collaborate to refine the design of the planned global Phase 3 trial of alvelestat and to advance the manufacturing during the short option period.
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Mereo will receive a non-refundable option fee and, on option exercise, would also be eligible to receive $40 million in upfront and R&D payments, up to $435 million in regulatory and commercial milestone payments, as well as double-digit tiered royalties on U.S. net sales of alvelestat.

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Mereo will lead the global Phase 3 study and regulatory interactions until study completion and will retain rest-of-world commercial rights for alvelestat.
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On exercise of the option by Sentynl, the agreement provides funding for the global Phase 3 study, which could be initiated early in 2027.

Vantictumab (OMP18R5)

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āshibio, Inc. (āshibio), Mereo’s development and commercial partner for vantictumab, is continuing to advance toward initiation of a Phase 2 clinical trial in autosomal dominant osteopetrosis Type 2 (ADO2).
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āshibio is responsible for the global clinical development of vantictumab. Mereo has retained European commercial rights to the product, with āshibio holding commercial rights for the rest of the world.

Second Quarter 2026 Financial Results

Total research and development ("R&D") expenses decreased by $3.6 million, from $5.4 million in the second quarter of 2025 to $1.8 million in the second quarter of 2026. The decrease was primarily due to a reduction of $2.6 million in R&D expenses for setrusumab and $1.0 million for alvelestat. The decrease in program expenses for setrusumab was primarily driven by reduction of, and delays to, investment in manufacturing and ongoing activities, including medical affairs activities in Europe during the second quarter of 2026. The decrease in program expenses for alvelestat was primarily due to completion of activities undertaken in preparation for the potential Phase 3 study during 2025.

General and administrative ("G&A") expenses decreased by $0.3 million, from $5.5 million in the second quarter of 2025 to $5.2 million in the second quarter of 2026. The decrease was primarily due to reductions of approximately $2.2 million driven by delays to investment in pre-commercial activities to lay the foundation for the potential commercial launch of setrusumab in Europe and other realized cost savings. These decreases were partially offset by the recognition of a $1.9 million reduction in expenses in the second quarter of 2025 for amounts received from our depository to reimburse certain expenses incurred by us in respect of our ADR program, whereas the corresponding amount in the current year was recognized in the first quarter of 2026.

Net loss for the second quarter of 2026 was $7.0 million, compared to $14.6 million for the second quarter of 2025, primarily reflecting reductions in R&D and G&A expenses and a lower net foreign currency translation loss.

As of June 30, 2026, the Company had cash and cash equivalents of $30.1 million, compared to $41.0 million as of December 31, 2025. The Company expects, based on current operational plans, that its existing cash and cash equivalents balance will enable it to fund its currently committed clinical trials, operating expenses, and capital expenditure requirements into late 2027. This guidance does not include any future potential payments associated with business development activity around any of the Company’s programs.

Total ordinary shares issued as of June 30, 2026 were 798,093,044. Total ADS equivalents as of June 30, 2026 were 159,618,608, with each ADS representing five ordinary shares of the Company.

(Press release, Mereo BioPharma, AUG 11, 2026, View Source [SID1234669949])

On August 11, 2026 Apollomics Inc. (Nasdaq: APLM) ("Apollomics" or the "Company"), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, reported that it has entered into definitive subscription agreements (the "Subscription Agreements") for a private placement transaction (the "Private Placement") with certain accredited investors (the "Investors"), for an aggregate gross consideration of approximately $10.0 million. The Private Placement is expected to close on or about August 14, 2026, subject to the satisfaction of customary closing conditions.

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The Private Placement comprises the issuance of an aggregate of up to 700,001 Class A ordinary shares, par value $0.01 per share, of the Company (the "Class A Shares") under the following tranches:

Cash Investment: Cash subscriptions for an aggregate of 533,334 Class A Shares at a purchase price of $15.00 per share, generating aggregate gross cash proceeds of approximately $8.0 million before fees and expenses.

Note Conversion: The automatic conversion of the outstanding $2.0 million principal amount of that certain unsecured Convertible Promissory Note, dated March 30, 2026, held by Mr. Hung-Wen (Howard) Chen, the Company’s Chairman and Chief Executive Officer. Pursuant to the terms of the Note, the conversion price is set at $12.00 per share, representing 80% of the purchase price paid by cash investors in the PIPE Transaction, resulting in the issuance of 166,667 Class A Shares at closing.

The cash portion of the Private Placement includes participation from certain unaffiliated accredited investors, as well as several of the Company’s executive officers and directors (or their affiliates), including Chief Executive Officer Hung-Wen (Howard) Chen, Chief Financial Officer Peter Kuan-How Lin, and Maxpro Investment Co., Ltd. (an affiliate of Chief Operating Officer Yi-Kuei (Alex) Chen).

No placement agents or underwriters were utilized in connection with the Private Placement, and no finder’s fees or commissions are payable.

The Class A Shares to be issued in the Private Placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder, or under any state securities laws. The Company relied on this exemption from registration based in part on representations made by the Investors. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Investors have agreed that all Class A Shares issued at closing will be restricted securities subject to customary holding periods under Rule 144.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Apollomics Inc., 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.

(Press release, Apollomics, AUG 11, 2026, View Source [SID1234669972])

On August 11, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on developing targeted immunotherapies for cancer, reported a Letter to Shareholders from Frank Bedu-Addo, Ph.D., Chief Executive Officer and Director of PDS Biotech:

"Dear Fellow Shareholders,

Over the past several months, our Board of Directors and management team conducted a comprehensive review of our development portfolio, capital allocation priorities and long-term strategy. Following this review, we believe the best path to creating long-term shareholder value is to prioritize the advancement of PDS0301, our tumor-targeted immunocytokine, while pursuing strategic partnership opportunities for PDS0101.

The oncology treatment landscape is rapidly evolving with the emergence of various precision medicines. Despite these advances, treatment resistance and limited durability of response remain significant challenges for many patients with advanced solid tumors. Based on supportive preclinical and clinical data, we believe PDS0301 has the potential to address these challenges by precisely targeting and remodeling the tumor microenvironment, potentially enhancing the effectiveness and durability of current and emerging oncology therapies. To address this medical need, we have designed PDS0301 for use, in combination with other oncology therapies, to remodel the tumor microenvironment to potentially promote more effective anti-tumor responses in patients. We believe the remodeling of the tumor microenvironment is an important factor in addressing treatment resistance and reversing disease progression. Further, this mechanism could enable PDS0301 to complement a broad range of current and emerging oncology therapies, including RAS pathway inhibitors, bispecific antibodies, ADCs and radioligand therapies.

We concluded that our resources should be redirected toward PDS0301, where we believe the combination of encouraging clinical data, development opportunity and capital requirements provide a potentially more attractive path to long-term shareholder value.

Phase 2 mCRC Results

Patients with metastatic microsatellite stable (MSS) and mismatch repair-proficient (pMMR) colorectal cancer, particularly those with liver metastases, continue to face substantial unmet medical needs, and median overall survival is reported to be less than 10 months and objective response rates (ORR) less than 25%1. Clinical data generated in collaboration with the National Cancer Institute demonstrated encouraging and durable activity, including a 71% ORR at 6 months and an 80% 24-month survival rate in patients with metastatic MSS and pMMR colorectal cancer and liver metastases2. Together with safety observed in more than 380 treated patients, these findings strengthen our conviction that PDS0301 has the potential to address one of the more significant limitations of current oncology therapies.

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Strategic Partnering Opportunities for PDS0101

We have decided that we will cease further internal investment in the PDS0101 Phase 3 VERSATILE-003 trial, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intend to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. This decision follows a comprehensive assessment of the capital, time and resources required to complete the Phase 3 trial and support commercialization of PDS0101. This decision reflects our commitment to disciplined capital allocation rather than a change in our view of the underlying PDS0101 science and clinical data. We believe the strength of the Phase 2 clinical results allows us to preserve the potential value of PDS0101 through a strategic partnership.

Why We Believe PDS0301 Represents Our Greatest Opportunity

Our objective is to establish PDS0301 as a foundational component of next-generation oncology therapies for multiple difficult-to-treat solid tumors.

We believe PDS0301 offers several important differentiators:

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Encouraging efficacy as a single agent (monotherapy) in advanced, recurrent cancer.

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Encouraging efficacy with chemotherapy in difficult-to-treat metastatic colorectal cancer.

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More than 380 patients treated with an encouraging safety and tolerability profile.

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A mechanism designed to remodel the tumor microenvironment and to reshape the anti-tumor immune response in patients, leading to more effective and more durable or long-lasting therapy. The mechanism also has the potential to improve the durability of ADCs, bispecific antibodies, radioligands, targeted therapies and immunotherapies.

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Clinical activity and tolerability observed across multiple difficult-to-treat solid tumors as a single agent and in double and triple combinations.

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A Phase 2b development strategy designed to take into account feedback from the FDA.

Although metastatic colorectal cancer is our lead development program, our maturing clinical data in various solid tumors suggests that PDS0301 may have broader application. By targeting the tumor microenvironment rather than a single oncogenic pathway, PDS0301 appears to have applicability across multiple difficult-to-treat solid tumors which could result in several combination oncology therapy strategies.

Beyond colorectal cancer, PDS0301 is also being evaluated in recurrent prostate cancer, metastatic castration resistant prostate cancer, Kaposi sarcoma, HPV16-positive cancers, and other National Cancer Institute-sponsored clinical trials, providing additional opportunities to demonstrate the breadth of PDS0301.

Looking Ahead

A randomized Phase 2b trial with PDS0301 has been designed taking into account feedback received from the FDA and is intended to generate meaningful clinical data with disciplined capital investment.

Over the next 18 to 24 months, we expect to:

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Advance PDS0301 through a randomized Phase 2b development program.
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Identify and assess strategic partnering opportunities for PDS0101.

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Maintain disciplined capital allocation while delivering meaningful clinical and business milestones.

We believe PDS Biotechnology is well positioned at the intersection of one of oncology’s most important emerging trends: improving the effectiveness and durability of oncology therapies through precision remodeling of the tumor microenvironment. By focusing our resources on PDS0301, identifying strategic partnerships for PDS0101, and executing with financial discipline, we believe we can create meaningful long-term value for both patients and shareholders. We look forward to updating you on our progress as we move forward with this new strategy."

Sincerely,

Frank Bedu-Addo, Ph.D.
Chief Executive Officer, Director

PDS Biotechnology will announce its financial results for the quarter ending June 30, 2026, on August 13, 2026.

(Press release, PDS Biotechnology, AUG 11, 2026, View Source [SID1234669950])

On August 11, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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BBOT’s portfolio of RAS-pathway inhibitors is designed to enable direct dual inhibition of KRASG12C (BBO-8520), or KRASG12D/V (BBO-11818) in both its ON and OFF states as well as disruption of RAS-driven PI3Kα activation (BBO-10203) to achieve optimal target coverage of the most mutated driver oncogene in human cancer. Together, these assets uniquely position BBOT to achieve concurrent, high-level suppression of both the MAPK and PI3Kα pathways through a wholly-owned internal combination strategy.

"During the second quarter, we made meaningful progress in patient enrollment in our monotherapy and combination cohorts across each of our three clinical programs. Differentiated patient benefit in oncology is driven by optimal target coverage and the ability to combine with standard-of-care regimens. Therefore, we continue to focus heavily on advancing our combination development strategies," said Pedro J. Beltran, Ph.D., Chief Executive Officer of BBOT. "In addition, our wholly-owned portfolio is uniquely positioned to enable concurrent suppression of the MAPK and PI3Kα pathways through internal combination strategies of each of our KRAS inhibitors with BBO-10203. We are excited to have both combinations already underway in patients. With multiple near-term clinical milestones across all programs expected in the second half of 2026 and cash runway into 2028, we believe we are well positioned to execute our strategy and expand treatment options for patients with mutant KRAS-driven cancers."

Key Program Highlights and Updates

BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRASG12C.

Continued to enroll BBO-8520 plus pembrolizumab combination in patients with NSCLC carrying KRASG12C mutation.
Initiated BBO-8520 plus BBO-10203 combination in patients with G12C NSCLC.

BBO-11818: An orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states.

Continued to enroll BBO-11818 monotherapy across multiple dose levels.
Initiated dosing of BBO-11818 in combination with cetuximab.
Subsequent to the end of the quarter, initiated dosing of BBO-11818 in combination with BBO-10203.
Presented preclinical data at AACR (Free AACR Whitepaper) highlighting the potency of BBO-11818 in KRASG12D and KRASG12V CDX models, potent combination effect with cetuximab or BBO-10203, and complete tumor regressions through adaptive immunity in combination with anti PD-1 antibodies.

BBO-10203: An orally bioavailable small molecule with a novel mechanism of action designed to block the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors.

Continued to enroll HR+ BC, HER2+/HR- BC, and colorectal (CRC) combination cohorts.
Presented preclinical data at AACR (Free AACR Whitepaper) showing that BBO-10203 demonstrated strong in vivo combination effect with HER2 inhibitors tucatinib or trastuzumab in HER2amp tumor models.

Second Quarter 2026 Financial Results

Cash Position: As of June 30, 2026, BBOT had cash, cash equivalents and marketable securities totaling $344.1 million, which is expected to provide cash runway into 2028.
Research and development (R&D) expenses: R&D expenses were $49.2 million for the second quarter of 2026 compared to $27.4 million for the second quarter of 2025. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for BBO-8520, BBO-11818, and BBO-10203.
General and administrative (G&A) expenses: G&A expenses were $11.0 million for the second quarter of 2026 compared to $2.7 million for the second quarter of 2025. The increase in G&A expenses reflects the initiation of BBOT’s standalone operations, de-SPAC transaction, and one-time severance costs for former executives.
Net Loss: Net loss was $56.5 million for the second quarter of 2026 compared to $28.4 million for the second quarter of 2025.

(Press release, BridgeBio Oncology Therapeutics, AUG 11, 2026, View Source [SID1234669973])

On August 11, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company focused on the discovery and development of integrin-based therapeutics, reported a corporate update and announced second quarter 2026 financial results.

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"In the second quarter, we continued to execute across the portfolio, led by strong enrollment in FORTIFY," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "With the appointments of Flavia and Robert to the board, Pliant now has deep global oncology drug development and commercialization expertise at this important time for our oncology program. We continue to make progress on our proprietary integrin-targeted drug-delivery platform and look forward to sharing more information on the platform soon."
Oncology Program
PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to overcome checkpoint resistance by blocking TGF-β activation in the tumor microenvironment. Pliant is currently conducting FORTIFY, a Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT0670706), to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors.

•Enrollment continues in FORTIFY, a Phase 1b indication expansion trial. FORTIFY will enroll up to 102 patients across three cohorts including non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC) and tumors with high tumor mutational burden. Patients are treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab is added as combination therapy. Enrollment remains strong, progressing ahead of schedule. Interim data is expected in 2027.

•Oral presentation at AACR (Free AACR Whitepaper) of updated PLN-101095 Phase 1 data highlights monotherapy biomarker data showing a coordinated T-cell reactivation cascade in responders. In July, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) Drug Discovery and Development conference, the Company reviewed encouraging PLN-101095 Phase 1 monotherapy biomarker data. As previously reported, all responding patients showed large increases in plasma interferon gamma (IFN-γ), a modulator of anti-tumor immunity, after 14 days of monotherapy with PLN-101095. Updated data show that blocking of αvβ8 by PLN-101095 also resulted in increases in CXCL9, a recruiter of T cells, and granzyme-B, a marker for cytotoxic arming in responding patients. Increased IFN-γ, CXCL9 and granzyme-B after PLN-101095 monotherapy signals a shift in the tumor microenvironment that could potentially resensitize tumors to pembrolizumab. Importantly, no non-responders experienced increases in these biomarkers.

Integrin-Targeted Delivery Platform

•Utilizing cell-specific integrin receptors, Pliant has developed a platform to deliver drug payloads, including siRNAs, to selective tissue types. Current programs are focused on delivering siRNAs to skeletal muscle cells and other tissues. Preclinical proof-of-concept studies are currently ongoing. The Company believes this integrin-targeting drug-delivery platform has the potential for broad applicability across multiple disease areas utilizing a variety of drug payloads. Pliant plans to provide additional detail on the platform and path forward, including initial treatment indications, in the second half of 2026.

Corporate Highlights
•Appointed Flavia Borellini, Ph.D. and Robert Iannone, M.D., M.S.C.E. to the Company’s Board of Directors. Dr. Borellini brings more than 25 years of executive management experience in the biopharmaceutical industry with a focus on the global development of targeted oncology drugs from preclinical to commercial stage. Dr. Iannone, who currently serves as Executive Vice President, Research and Development and Chief Medical Officer at Jazz Pharmaceuticals, brings more than two decades of executive drug development and regulatory leadership, including the approval of several targeted and immuno-oncology medicines.

Second Quarter 2026 Financial Results
•Research and development expenses were $16.7 million, as compared to $32.2 million for the prior-year quarter. The decrease was primarily due to completing close-out activities for BEACON-IPF, a Phase 2b/3 study of bexotegrast, in 2025 and reduced personnel-related expenses, including stock based compensation, driven by decreased headcount compared to prior year.
•General and administrative expenses were $7.1 million, as compared to $13.4 million for the prior-year quarter. The decrease was primarily due to personnel-related expenses, including stock-based compensation, driven by decreased headcount compared to prior year.
•Net loss was $22.4 million as compared to $43.3 million for the prior-year quarter. The decrease was primarily due to significantly lower operating expenses following the termination of bexotegrast development in IPF in 2025 and decreased personnel-related expenses, including stock-based compensation, driven by reduced headcount compared to prior year.
•As of June 30, 2026, the Company had cash, cash equivalents and short-term investments of $159.6 million which the Company expects to be sufficient to fund operations into the second half of 2028.

(Press release, Pliant Therapeutics, AUG 11, 2026, View Source [SID1234669951])