UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01. | Entry into a Material Definitive Agreement. |
Share Purchase Agreement
On May 11, 2022, Cullinan Oncology, Inc. (the “Company”), Taiho Pharmaceutical Co., Ltd. (“Taiho”) and Cullinan Pearl Corp. (“Pearl”), a subsidiary of the Company, entered into a Share Purchase Agreement (the “Purchase Agreement”) pursuant to which Taiho will acquire all of the Company’s equity interest in Pearl, and Pearl will become a wholly-owned subsidiary of Taiho (the “Acquisition”). In connection with the Acquisition, Taiho will make an upfront payment to the Company of $275 million and the Company may receive up to an additional $130 million upon the achievement of certain regulatory milestones related to Pearl’s lead program known as CLN-081 or TAS6417, an Epidermal Growth Factor Receptor inhibitor (the “Lead Program”).
The parties to the Purchase Agreement have each made customary representations, warranties and covenants. The parties have also agreed to cooperate with each other and use reasonable best efforts to make all filings and obtain all consents, approvals and authorizations of all governmental entities to the extent required by law in connection with the execution, delivery and performance of the Purchase Agreement and the consummation of the transactions contemplated thereby, subject to specified limitations. The Purchase Agreement also contains indemnification obligations of the Company, on the one hand, and Taiho, on the other hand, subject to certain limitations. Consummation of the Acquisition is subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and execution and delivery of the Co-Development Agreement (as defined below), as well as other customary closing conditions and deliverables. The Purchase Agreement may be terminated by either party under certain circumstances, including if the Acquisition is not consummated by June 30, 2022.
Co-Development Agreement
In connection with the consummation of the Acquisition, the Company will enter into a Co-Development Agreement (the “Co-Development Agreement”) with Taiho Oncology, Inc., an affiliate of Taiho (“Taiho Oncology”). Under the Co-Development Agreement, the Company and Taiho Oncology will co-develop the Lead Program and the Company will retain the option to co-promote the Lead Program in the U.S. together with Taiho Oncology. Taiho will commercialize the Lead Program in territories outside of the U.S. Taiho and the Company will share the future clinical development costs of the Lead Program for the U.S. and U.S. commercialization costs equally, and each will receive 50% of the profits from potential U.S. sales.
Either party can terminate the Co-Development Agreement in the event of material breach of the other party and the Company can terminate the Co-Development Agreement for convenience upon six months’ prior notice after completion of certain development activities, provided that the Company would continue to share development costs related to any clinical study that had been initiated prior to termination.
The foregoing descriptions of the Purchase Agreement and the Co-Development Agreement are only summaries of the material terms thereof, and do not purport to be complete. The descriptions are qualified in their entirety by reference to the Purchase Agreement and the Co-Development Agreement, which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022.
| Item 2.02. | Results of Operations and Financial Condition. |
As of March 31, 2022, the Company had approximately $410 million of cash, cash equivalents, investments, and interest receivable (“cash and investments”). Including the $275 million expected upfront payment from the Acquisition, cash and investments would have been $685 million as of March 31, 2022. As a result of the Acquisition, and based on current operating plans, the Company expects to have cash runway through 2026, compared to its previous guidance of through 2024.
The information contained in Item 2.02 is unaudited and preliminary and does not present all information necessary for an understanding of the Company’s financial condition as of March 31, 2022 and its results of operations for the three months ended March 31, 2022. The information in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 7.01. | Regulation FD Disclosure. |
On May 12, 2022, the Company and Taiho issued a joint press release regarding the Acquisition and the Co-Development Agreement. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
In addition, the Company has made available on its website the Company’s investor presentation regarding the Acquisition and the Company’s partnership with Taiho to jointly develop and commercialize the Lead Program. The presentation has been added to the “Events” section of the Company’s website at https://investors.cullinanoncology.com. A copy of the presentation is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K.
The information furnished in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, or otherwise subject to liabilities under that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or incorporates it by reference into a filing under the Exchange Act or the Securities Act.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including express or implied statements regarding the Company’s beliefs and expectations regarding the consummation of the Acquisition; the milestone payments the Company may receive from Taiho; the anticipated development and commercialization of the Lead Program; and the Company’s cash runway. Any forward-looking statements in this Current Report on Form 8-K 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 the Company’s actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the risks and uncertainties discussed in the Company’s filings with the Securities and Exchange Commission (“SEC”), including under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and subsequent filings with the SEC. While the Company may elect to update such forward-looking statements in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Current Report on Form 8-K. Moreover, except as required by law, neither the Company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this Current Report on Form 8-K. Any forward-looking statement included in this Current Report on Form 8-K speaks only as of the date on which it was made.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release, dated May 12, 2022. | |
| 99.2 | Investor Presentation | |
| 104 | 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.
| CULLINAN ONCOLOGY, INC. | ||||||
| Date: May 12, 2022 | By: | /s/ Jeffrey Trigilio | ||||
| Jeffrey Trigilio | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Cullinan Oncology and Taiho Pharmaceutical Announce Strategic
Collaboration to Jointly Develop and Commercialize CLN-081/TAS6417 and
Taiho’s Acquisition of Cullinan Pearl
Taiho obtains exclusive global rights to CLN-081/TAS6417 outside the U.S.; in the U.S.,
Taiho and Cullinan Oncology to jointly develop and co-commercialize CLN-081/TAS6417
Cullinan Oncology will receive an upfront cash payment of $275 million, with potential
to receive up to an additional $130 million in regulatory-based milestone payments
Cullinan Oncology and Taiho will equally share future profits in the U.S.
CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) — Cullinan Oncology, Inc. (Cullinan Oncology) (Nasdaq: CGEM) and Taiho Pharmaceutical Co., Ltd. (Taiho) today announced an agreement through which Taiho will acquire Cullinan Pearl Corp. (Cullinan Pearl) and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417 (development code in Cullinan Oncology: CLN-081, development code in Taiho: TAS6417), an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR. Subject to customary closing conditions, including expiration or termination of the waiting period under U.S. antitrust laws, the acquisition is expected to close in the second quarter of 2022.
Under the agreement, Taiho will acquire Cullinan Oncology’s subsidiary, Cullinan Pearl, which has worldwide rights outside of Japan* to CLN-081/TAS6417, for an upfront payment to Cullinan Oncology of $275 million and up to an additional $130 million tied to EGFR exon20 non-small cell lung cancer (NSCLC) regulatory milestones.
Cullinan Oncology will co-develop CLN-081/TAS6417 and will retain the option to co-commercialize CLN-081/TAS6417 in the United States together with Taiho Pharmaceutical through its U.S. subsidiary, Taiho Oncology, Inc. Taiho will commercialize CLN-081/TAS6417 in territories outside U.S. and China. Taiho and Cullinan Oncology will equally contribute to the future clinical development of CLN-081/TAS6417 in the U.S., with each receiving 50% of the profits from potential U.S. sales. As a result of the upfront cash payment and reduction in development and pre-commercialization costs, Cullinan Oncology anticipates its cash runway to extend through 2026 based on current operating plans. This guidance does not include the potential regulatory milestone cash payments or future U.S. profit share post-launch.
It is estimated that approximately 85%1 of all newly diagnosed patients with lung cancer, or approximately 1.9 million people worldwide have NSCLC. Among those patients with NSCLC, approximately 2%2-3 or 38,000 patients have exon 20 insertions. In the U.S., approximately 16% of NSCLC cases harbor EGFR mutations, with insertions at exon 20 accounting for 12%(4) of those mutations. Patients with EGFR exon 20 insertions are known to have poorer outcomes than those with more common EGFR mutations, such as exon 19 deletion. CLN-081/TAS6417 is currently in Phase I/IIa development for treatment of patients with NSCLC having an exon 20 insertion mutation.
“We are pleased to bring CLN-081/TAS6417 back into our pipeline and move it towards commercialization with Cullinan Oncology,” said Masayuki Kobayashi, President and Representative Director of Taiho Pharmaceutical Co., Ltd. “Cullinan Oncology has carried CLN-081/TAS6417 from pre-IND to planned pivotal study in approximately three years. Meanwhile the Food and Drug Administration (FDA) has granted Breakthrough Designation status for this novel molecule. Utilizing Cullinan Oncology’s unique business model through this strategic collaboration, we aim to hasten and maximize the development of CLN-081/TAS6417. Together with Cullinan Oncology, the Taiho group will work to expeditiously deliver this agent to patients as soon as possible.”
“We are excited to embark on this collaboration with Taiho. Taiho is an ideal partner with whom to advance CLN-081/TAS6417 into later stage development and commercialization, given their deep understanding of the molecule and strategic focus on targeted therapies, existing stake in Cullinan Pearl, and strong oncology-focused commercial capabilities in the U.S.,” said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. “Importantly, the structure of the agreement provides the opportunity to efficiently establish our own commercial infrastructure, which will also be leveraged for our future programs. The transaction payments, reduced development expense, and potential ongoing revenue stream upon future commercialization will help us to devote greater resources to advance our robust pipeline of assets across a wide range of modalities, each with the potential to be the first or best in their class, to deliver on our promise to bring new therapeutic solutions to patients with cancer.”
Cullinan Oncology Conference Call Information
Cullinan Oncology will host a conference call today, May 12, at 8 a.m. EDT during which company executives will provide an overview of the collaboration. Investors and the general public are invited to listen to a live webcast of the call. A link to join the call and to find related materials will be available at: https://investors.cullinanoncology.com/news-events/events
About CLN-081/TAS6417
CLN-081/TAS6417 is an orally available tyrosine kinase inhibitor designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. CLN-081/TAS6417 is a clinical candidate for NSCLC driven by EGFR exon 20 insertion mutations and is expected to be a novel therapeutic option for patients with highly unmet medical needs. In 2019, Taiho granted Cullinan Pearl, a company that Taiho and its subsidiaries and Cullinan Oncology had established together, an exclusive global license, excluding Japan, for the development and commercialization of CLN-081/TAS6417. Following this agreement, Cullinan Pearl rapidly advanced CLN-081/TAS6417, opening an Investigational New Drug application and initiating a global Phase I/IIa study in NSCLC patients harboring EGFR exon 20 mutations, which is currently ongoing. Cullinan Oncology announced that the FDA granted Breakthrough Therapy Designation for CLN-081/TAS6417 in early 2022. Cullinan Oncology and Taiho expect to initiate a pivotal study in the second half of 2022.
About Cullinan Oncology
Cullinan Oncology, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications. Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization. As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. Learn more about our Company at www.cullinanoncology.com, and follow us on LinkedIn and Twitter.
About Taiho
Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma company with a focus on oncology. Taiho Pharmaceutical also has development programs in allergy and immunology, urology and consumer healthcare products. Our corporate philosophy is simple: “We strive to improve human health and contribute to a society enriched by smiles.” For more information about Taiho Pharmaceutical Co., Ltd., please visit: https://www.taiho.co.jp/en/
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 Cullinan’s beliefs and expectations regarding the milestone payments we may receive from Taiho; the anticipated development and commercialization of CLN-081/TAS6417; the development of our commercial infrastructure; potential investments in our pipeline and the potential for such product candidates; and our cash runway. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” 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 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; 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; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; 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 performance and results 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 (SEC), 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 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 Cullinan nor any other person 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.
Contacts:
Investor Relations
Chad Messer
+1 203.464.8900
cmesser@cullinanoncology.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinanoncology.com
| 1 | American Cancer Society. What Is Non-Small Cell Cancer?. https://www.cancer.org/cancer/lung-cancer/about/what-is.html |
| 2 | Konduri et al. (Cancer Discov 2016 6 601) |
| 3 | Riess et al. (WCLC2016) |
| 4 | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6764748/ |
| * | Cullinan Pearl previously licensed the rights to CLN-081/TAS6417 in Greater China to Zai Lab in 2020. |
Exhibit 99.2 Mining for Tomorrow’s Cures Strategic Partnership With Taiho to Jointly Develop and Commercialize CLN-081 in the U.S. May 12, 2022
Important Notice and Disclaimers This presentation 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 Cullinan’s beliefs and expectations regarding the milestone payments we may receive from Taiho; the anticipated development and commercialization of CLN-081/TAS6417; the development of our commercial infrastructure; potential investments in our pipeline and the potential for such product candidates; and our cash runway. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” 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 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; 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; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; 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 performance and results 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 (SEC), 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 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 Cullinan nor any other person 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. Certain information contained in this Presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this Presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this Presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. 2
Webcast Agenda AGENDA PRESENTERS Nadim Ahmed 1. Introduction Chief Executive Officer Corinne Savill, Ph.D. 2. Collaboration Overview Chief Business Officer 3. Financial Context Jeff Trigilio Chief Financial Officer 4. Strategic Perspective JOINING US FOR Q&A Jeffrey Jones, M.D., MPH, MBA 5. Q&A Promise of Chief Medical Officer single agent activity 3
CLN-081: Selective EGFR Inhibitor With Best-in-Class Potential for NSCLC Patients with Exon 20 Mutations CLN -081: UNIQUE DESIGN PROPERTIES Distinct chemical scaffold HER2-sparing High selectivity to mutant vs WT EGFR DATA FROM ONGOING PHASE 1 / 2A STUDY (100 mg BID) 41% 15-month 12-month Favorable confirmed overall rate median duration median progression- safety and tolerability profile of response (16/39) of response free survival 4
Cullinan has Advanced CLN-081 Rapidly, Generating POC and a Strategic Collaboration within ~3 Years Cullinan Oncology enters Taiho discovery of 1st patient dosed in Initial data reported collaboration with Taiho CLN-081 phase 1/2a study at ASCO START DEC 2019 JUN 2021 APR/MAY 2022 2019 2021 2020 2022 FEB 2019 DEC 2020 JAN 2022 JUN 2022 Cullinan Pearl licenses License agreement with Announced Breakthrough Updated data to be CLN-081 from Taiho Zai Lab for Greater China Therapy Designation presented at ASCO 5
Taiho Oncology is the Ideal Partner for CLN-081 • Discovered CLN-081 Unique insight into CLN- • Involved in CLN-081 development through Cullinan Pearl 081’s potential • Molecule well-aligned with Taiho’s strategic focus Robust oncology clinical • Focused on small molecule, molecularly targeted development engine therapeutics enables accelerated • Actively advancing 7 molecules in approximately 20 solid- advancement of CLN-081 tumor clinical trials Strong US oncology • Currently marketing two oncology products, LONSURF commercial and regulatory and INQOVI infrastructure to maximize • Futibatinib (FGFR1-4 inhibitor) NDA under review BTD value of CLN-081 status for cholangiocarcinoma • Comprehensive U.S. oncology commercial infrastructure in place, including salesforce, marketing, market access, and medical affairs capabilities 6
Summary of Terms Upfront Payment Milestone Payments $275 million Up to $130 million regulatory-based milestones st nd to Cullinan Oncology on 1 /2 line EGFR exon20 NSCLC Collaboration Profit Sharing U.S. co-development and co- 50/50 share of potential commercialization agreement U.S. profits 7
Transaction Provides Compelling Return on Investment Today and Commercial Participation in Future Upside PEARL RETURN $425 million in aggregate $295 million to date $42m $20m $275m $130m + 50% of future U.S. development costs and profits Pearl R&D expense Zai Lab upfront Taiho upfront Taiho milestones inception to March 31, 2022 (Q1 2021)* (Q2 2022) (Timing TBD)** *Excludes withholding taxes and sub-license fees, resulting in ~$16 million net proceeds to Cullinan Oncology ** Potential payments based on NSCLC EGFR exon 20 regulatory events 8 PEARL INVESTMENT
Maximizing Shareholder and Patient Value, Commercialization Potential, and Investment Taiho’s unique insight into CLN-081’s Maximizes value of CLN-081 and supports commercial success potential Retains strategic value to CLN-081 in the most valuable oncology territory and provides potential US 50/50 profit share ongoing revenue stream Opportunity for Cullinan to establish a commercial infrastructure, which will be US co-commercialization leveraged for future programs Extends Cullinan’s cash runway through 2026 and Up to $405m in near term deal proceeds will accelerate development of diverse pipeline of + downstream economics existing and new oncology assets 9
Q & A Nadim Ahmed Corinne Savill, Ph.D. Chief Executive Officer Chief Business Officer Jeffrey Jones, M.D., MPH, MBA Jeff Trigilio Chief Medical Officer Chief Financial Officer 10