Curis to Release Fourth Quarter 2022 Financial Results and Hold Conference Call on March 9, 2023

On March 2, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter 2022 financial results on Thursday, March 9, 2023, after the close of U.S. markets. Management will host a conference call on the same day at 4:30 p.m. ET (Press release, Curis, MAR 2, 2023, View Source,-2023 [SID1234628055]).

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To access the live conference call, please dial (888)-346-6389 from the United States or (412)-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

On March 2, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that the U.S. Food and Drug Administration ("FDA") has accepted for filing the Biologics License Application ("BLA") for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody, as a treatment for patients with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or radiation (Press release, Checkpoint Therapeutics, MAR 2, 2023, View Source [SID1234628054]). The FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned

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The filing acceptance of our BLA is a major milestone for Checkpoint and our promising cosibelimab development program," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We look forward to continuing to work closely with the FDA as we endeavor to bring cosibelimab to patients in need as quickly as possible. I would like to thank the patients and physicians who participated in the cosibelimab clinical studies, as well as our team for their hard work and dedication in achieving this important milestone

Mr. Oliviero continued, "According to U.S. prescription claims data, in 2021, approximately 11,000 cSCC patients were treated with systemic therapies. As PD-1 inhibitors comprised less than half of patient prescriptions, cSCC remains a disease with a high need for more effective and tolerable treatment options, particularly for the significant number of cSCC patients with immunosuppressive conditions or autoimmune diseases. With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients that are currently underserved by available therapies

The BLA submission is supported by the positive results from Checkpoint’s registration-enabling clinical trial evaluating cosibelimab in patients with metastatic and locally advanced cSCC. In January 2022, Checkpoint announced that the metastatic cSCC cohort met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate ("ORR") of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the cohort using Response Evaluation Criteria in Solid Tumors version 1.1 ("RECIST 1.1") criteria. The pivotal results were subsequently presented at the June 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting. Also in June 2022, Checkpoint announced positive interim results from its locally advanced cSCC cohort, with cosibelimab demonstrating a confirmed ORR of 54.8% (95% CI: 36.0, 72.7) based on independent central review of 31 patients enrolled in the cohort. Based upon subsequent interactions with the FDA, the BLA under review includes both the metastatic and locally advanced cSCC indications

About Cutaneous Squamous Cell Carcinoma (cSCC)

cSCC is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from this disease each year. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. The immune-suppressed population represents a challenging target in the treatment of advanced cSCC, as they present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment

About Cosibelimab

Cosibelimab is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

Cancer Advances, Inc. Announces Issuance of New U.S. Patent

On March 2, 2023 Cancer Advances, Inc., a clinical stage biopharmaceutical company developing therapeutics for gastrointestinal (GI) cancers, reported that the U.S. Patent and Trademark Office has issued new patent No. 11,583,576, enhancing the Company’s intellectual property position for lead asset Polyclonal Antibody Stimulator (PAS) vaccine (Press release, Cancer Advances, MAR 2, 2023, View Source [SID1234628053]). The new patent titled "Compositions and Methods for Inducing Humoral and Cellular Immunities against Tumors and Cancer" covers a method for treating and/or preventing and/or inhibiting development of a tumor and/or a cancer associated with gastrin signaling in a subject. Gastrin mediated tumors include, but are not limited to, gastrointestinal cancers.

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The novel IP further covers methods for treatment of GI cancer by administering PAS followed by an immune checkpoint inhibitor. A related claim covers reduction in fibrosis associated with pancreatic cancer via the administration of this combination.

"After more than six years of research, we are excited to have this patent issued. We have known that PAS can induce the development of antibodies to Gastrin, bringing Gastrin levels down and increasing survival times by 50% in GI clinical trials. With our research now demonstrating that PAS is able to alter the tumor microenvironment, it opens the door to many new opportunities to improve current treatment for GI cancer patients," commented Lynda Sutton, President of Cancer Advances.

The issued patent adds to the over one hundred granted global patents for PAS. Cancer Advances plans to seek approval for PAS in the treatment of gastric and pancreatic cancers.

Biomea Fusion To Participate In Upcoming Investor Events

On March 2, 2023 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, reported that Biomea’s management is scheduled to host investor meetings and participate in the following upcoming events (Press release, Biomea Fusion, MAR 2, 2023, View Source [SID1234628051]).

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A virtual fireside chat with Oppenheimer & Co.: Type 2 Diabetes and New Treatment Options with Biomea Fusion (BMEA) Mgmt. & Key Opinion Leaders on Thursday, March 2nd at 12:00 PM (EST)
Barclays Global Healthcare Conference in Miami:
A fireside chat on Tuesday, March 14th at 4:35 PM (EST)
1×1 Meetings: Tuesday, March 14th, 2023
Oppenheimer’s 33rd Annual Healthcare Conference:
A virtual fireside chat on Wednesday, March 15th at 11:20 AM (EST)
1×1 Virtual Meetings: Monday, March 13th, 2023
A webcast of the fireside chats will be available on the investor page of Biomea’s website at View Source, with archived replays available following the events.

ARCA biopharma Announces 2022 Financial Results and Provides Corporate Update

On March 2, 2023 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported 2022 financial results and provided a corporate update (Press release, Arca biopharma, MAR 2, 2023, View Source [SID1234628050]).

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In May 2022, the Company retained Ladenburg Thalmann & Co. Inc. to act as its financial advisor to explore and evaluate strategic options for maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.
Full Year 2022 Summary Financial Results
Cash and cash equivalents were $42.4 million as of December 31, 2022, compared to $53.4 million as of December 31, 2021. ARCA believes that its current cash and cash equivalents, consisting primarily of money market funds, will be sufficient to fund its operations through the middle of 2024.
Research and development (R&D) expenses were $4.7 million for the year ended December 31, 2022, compared to $13.8 million for 2021. In the third quarter of 2022, ARCA implemented a strategic reduction of the workforce and recorded total restructuring charges of approximately $0.8 million, of which $0.5 million and $0.3 million were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. The $9.1 million decrease in R&D expenses in 2022 as compared to 2021 was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021, partially offset by the restructuring charges discussed above. R&D expenses in 2023 are expected to be lower than 2022.
General and administrative (G&A) expenses were $5.8 million for the year ended December 31, 2022, compared to $5.5 million for 2021, an increase of approximately $0.3 million. The increase in expenses during 2022 was primarily a result of increases in professional fees and consulting costs and one-time termination benefits discussed above in 2022. G&A expenses in
2023 are expected to be consistent with those in 2022 as the Company maintains administrative activities to support our ongoing operations.
Total operating expenses for the year ended December 31, 2022 were $10.6 million compared to $19.3 million in 2021.
Net loss for the year ended December 31, 2022 was $9.9 million, or $0.69 per basic and diluted share, compared to $19.3 million, or $1.39 per basic and diluted share in 2021.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically and other targeted therapies for cardiovascular diseases through a precision medicine approach to drug development. At present, ARCA is evaluating options for development of its assets, including partnering and other strategic options. For more information, please visit www.arcabio.com or follow the Company on LinkedIn.

Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding potential future development plans for Gencaro and rNAPc2, if any, the Company’s review of strategic options. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: ARCA’s financial resources and whether they will be sufficient to meet its business objectives and operational requirements; ARCA may not be able to raise sufficient capital on acceptable terms, or at all, to continue development of Gencaro or rNAPc2 or to otherwise continue operations in the future; results of earlier clinical trials may not be confirmed in future clinical trials; the protection and market exclusivity provided by ARCA’s intellectual property; risks related to the drug discovery and the regulatory approval processes; the Company’s ability to complete a strategic transaction, and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the Securities and Exchange Commission, including without limitation ARCA’s annual report on Form 10-K for the year ended December 31, 2022, and subsequent filings. ARCA disclaims any intent or obligation to update these forward-looking statements.

Investor & Media Contact:
Jeff Dekker 720.940.2122 [email protected]
(Tables follow)
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ARCA BIOPHARMA, INC.
BALANCE SHEET DATA
(in thousands)
(unaudited)
December 31, 2022 December 31, 2021
Cash and cash equivalents $42,445 $53,359
Working capital $41,567 $50,923Total assets $43,085 $54,924Total stockholders’ equity $41,673 $51,043

ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS

Years Ended December 31,

(in thousands, except share
and per share amounts)
Costs and expenses: Research and development $4,749 $13,832General and administrative 5,847 5,503 Total costs and expenses 10,596 19,335
Loss from operations (10,596) (19,335)
Interest and other income 675 13Other loss (5) —Net loss $(9,926) $(19,322)
Net loss per share:
Basic and diluted $(0.69) $(1.39)Weighted average shares outstanding: Basic and diluted 14,410,143 13,903,871