UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2024, Cullinan Therapeutics, Inc. (the "Company") announced its financial results for the quarter ended June 30, 2024. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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Press release issued by Cullinan Therapeutics, Inc. on August 8, 2024, furnished herewith |
104 |
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Cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CULLINAN THERAPEUTICS, INC. |
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Date: |
August 8, 2024 |
By: |
/s/ Mary Kay Fenton |
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Mary Kay Fenton |
Exhibit 99.1
Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results
Investigational New Drug (IND) application for CLN-978 in systemic lupus erythematosus (SLE) remains on track to be filed in third quarter of 2024
Company to pursue rheumatoid arthritis (RA) as second autoimmune indication for CLN-978 development
CLN-619 combination therapy data presented at ASCO demonstrated objective responses in oncogenic driver mutation NSCLC, which is typically unresponsive to checkpoint inhibition
Company appoints Mary Thistle to its Board of Directors
CAMBRIDGE, Mass. August 8, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2024.
“We are keenly focused on executing on the strategic plans we made during the first half of 2024, including our expansion into autoimmune diseases and continued advancement of our oncology pipeline, each facilitated by our recent oversubscribed financing,” said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. “During the second half of 2024, we will advance CLN-978 toward a first global clinical study in systemic lupus erythematosus (SLE) and remain on track to file an investigational new drug (IND) application in the third quarter of this year. We are committed to exploring the broad potential of CLN-978 across autoimmune diseases and will pursue rheumatoid arthritis (RA) as our next indication, where there is both significant unmet patient need and clinical validation for CD19 T cell engagers. We are excited to collaborate with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome to conduct a clinical trial of CLN-978 in patients with RA. Both are pioneering centers of excellence in the field of T cell redirecting therapies for autoimmune diseases and the first to demonstrate the potential of a CD19 T cell engager in RA. Finally, to focus our resources on our most promising programs, we will discontinue development of CLN-418 based on initial clinical observations.”
“At FAU, we are excited about the prospect of a clinical trial of a new T cell engager in RA,” said Dr. Ricardo Grieshaber-Bouyer, M.D., Ph.D., Professor of Clinical Systems Immunology and Head of the Clinical Trials Unit at FAU Erlangen-Nuremberg, “There is a significant unmet need in treating patients with RA who are refractory to currently available treatments. Our team at Erlangen has already demonstrated that a T cell engager targeting CD19 has potential to dramatically alter the course of disease in these patients, and we look forward to furthering our initial groundbreaking work in this area with CLN-978, which could potentially offer significant benefit to patients with convenient, off-the-shelf subcutaneous administration and a favorable safety profile.”
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Portfolio Highlights
Immunology
Oncology
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Corporate Updates
Second Quarter 2024 Financial Results
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R&D expenses were $66.9 million for the first six months of 2024, compared to $79.5 million for the first six months of 2023. R&D expenses for the first six months of 2024 and 2023 included $7.0 million and $6.3 million, respectively, of equity-based compensation expenses. The decrease in R&D expenses, excluding equity-based compensation, was primarily due to the one-time upfront in-licensing fee for CLN-418 in 2023, partially offset by increases in clinical and preclinical costs, and increased personnel costs relating to additional headcount.
G&A expenses were $26.1 million for the first six months of 2024, compared to $20.9 million for the first six months of 2023. G&A expenses in the first six months of 2024 and 2023 included $11.8 million and $8.9 million, respectively, of equity-based compensation expenses. The increase in G&A expenses, excluding equity-based compensation, was primarily driven by increased personnel costs relating to additional headcount.
Net loss (before items attributable to noncontrolling interest) for the first six months of 2024 was $79.4 million, compared with net loss of $90.4 million for the six months of 2023. Net losses resulted from the expenses described above, partially offset by interest income of $13.8 million and $9.8 million in the first six months of 2024 and 2023, respectively.
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About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about our Company at www.cullinantherapeutics.com, and follow us on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities and our cash runway. The words “believe,” “continue,” “expect,” “plan,” “potential,” “pursue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions, including the IND that we intend to file for CLN-978; the risk that any INDs we may file are not cleared by the United States Food and Drug Administration or are not cleared on our expected timelines, or at all; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person
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assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.
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Cullinan Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
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June 30, 2024 |
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December 31, 2023 |
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Cash, cash equivalents, investments, and interest receivable |
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$ |
664,943 |
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$ |
468,264 |
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Total assets |
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$ |
681,216 |
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$ |
484,182 |
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Total current liabilities |
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$ |
23,476 |
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$ |
28,137 |
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Total liabilities |
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$ |
24,995 |
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$ |
30,287 |
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Total stockholders’ equity |
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$ |
656,221 |
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$ |
453,895 |
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Cullinan Therapeutics, Inc.
Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
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Three Months Ended |
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Six Months Ended |
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June 30, 2024 |
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June 30, 2023 |
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June 30, 2024 |
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June 30, 2023 |
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Operating expenses: |
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Research and development |
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$ |
36,259 |
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$ |
27,391 |
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$ |
66,905 |
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$ |
79,487 |
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General and administrative |
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13,768 |
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10,214 |
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26,111 |
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20,874 |
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Total operating expenses |
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50,027 |
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37,605 |
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93,016 |
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100,361 |
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Loss from operations |
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(50,027 |
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(37,605 |
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(93,016 |
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(100,361 |
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Other income (expense): |
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Interest income |
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8,071 |
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5,322 |
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13,764 |
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9,830 |
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Other income (expense), net |
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(72 |
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69 |
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(116 |
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176 |
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Net loss |
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(42,028 |
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(32,214 |
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(79,368 |
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(90,355 |
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Net loss attributable to noncontrolling interests |
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— |
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— |
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(192 |
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(179 |
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Net loss attributable to common stockholders of Cullinan |
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$ |
(42,028 |
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$ |
(32,214 |
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$ |
(79,176 |
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$ |
(90,176 |
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Net loss per share attributable to common stockholders of Cullinan: |
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Basic and diluted |
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$ |
(0.75 |
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$ |
(0.82 |
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$ |
(1.61 |
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$ |
(2.24 |
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Weighted-average shares used in computing net loss per share attributable to common stockholders of Cullinan: |
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Basic and diluted |
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55,052 |
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39,952 |
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49,031 |
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40,315 |
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Contacts:
Investors
Chad Messer
+1 203.464.8900
cmesser@cullinantx.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com
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