UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 27, 2022
Elevation Oncology, Inc.
(Exact name of Registrant as Specified in its Charter)
Delaware | 001-40523 | 84-1771427 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
888 Seventh Ave., 12th Floor New York, New York | 10106 | |
(Address of Principal Executive Offices) | (Zip Code) |
(716) 371-1125
Registrant’s Telephone Number, Including Area Code
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 (see General Instructions A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common stock, par value $0.0001 per share | ELEV | The Nasdaq Stock Market LLC |
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 1.01. Entry into a Material Definitive Agreement.
CSPC License Agreement
On July 27, 2022, Elevation Oncology (the “Company”) entered into a license agreement (the “License Agreement”) with CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited (the “Licensor”), with an effective date of July 27, 2022 (the “Effective Date”), pursuant to which the Licensor granted to the Company a worldwide exclusive right and license (outside of the People’s Republic of China, Hong Kong, Taiwan, and Macau (such worldwide territory excluding the foregoing, the “Territory”)) under certain patents identified in the License Agreement (the “Licensed Patents”) and know-how (collectively, the “Licensed IP”) to develop and commercialize products (“Licensed Products”) containing EO-3021 (SYSA1801) (the “Licensed Compound”) in the treatment of cancer (the “Field”).
Subject to certain conditions set forth in the License Agreement, the Company may grant sublicenses (including the right to grant further sublicenses) to its rights under the License Agreement to any of its affiliates or any third party. Either party to the License Agreement may assign its rights under the License Agreement (i) in connection with the sale or transfer of all or substantially all of its assets to a third party, (ii) in the event of a merger or consolidation with a third party or (iii) to an affiliate; in each case contingent upon the assignee assuming in writing all of the obligations of its assignor under the License Agreement.
Under the terms of License Agreement, the Company is required to pay to the Licensor a one-time upfront license fee of $27 million, milestone payments of up to $148 million following the achievement of certain development and regulatory milestones, and additional milestone payments of up to approximately $1.0 billion following the achievement of certain commercial milestones.
During the Term (as defined below), the Company is also required to pay to the Licensor (i) royalties ranging from mid-single digits through low double digits on net sales of each Licensed Product and (ii) a percentage of non-royalty sublicense income received by the Company of up to an aggregate of $50 million.
Under the terms of the License Agreement, the development of the Licensed Compound and the first Licensed Product for the Territory will be governed by a clinical development plan, including anticipated timeline goals in connection with the clinical trials for the first Licensed Product (the “Development Plan”). The Development Plan may be amended by a joint steering committee established by the Company and the Licensor.
The Company will purchase Licensed Products for any clinical or commercial supply from the Licensor under the terms of a supply agreement. Until the Company has completed the first Phase 2 clinical trial for the first Licensed Product in the United States, the Licensor shall supply the Licensed Compound to the Company for clinical purposes as the Company requests, but only to the extent necessary for the Company to conduct such clinical trial, at no cost to the Company.
The License Agreement will expire automatically upon the expiration of the last royalty term of the last Licensed Product (the “Term”), with each royalty term expiring on a country-by-country basis upon the later of: (i) the expiration or abandonment of the last-to-expire Licensed Patent covering a Licensed Product; (ii) 10 years after the date of first commercial sale in the applicable country; and (iii) expiration of regulatory exclusivity for the Licensed Product in the applicable country. Following the expiration of the Term, the License will become non-exclusive and fully-paid.
The License Agreement may be terminated by the Company for any reason upon 180 days prior written notice to the Licensor. The Licensor may terminate the License Agreement if the Company or any sublicensee commences an action challenging the Licensed Patents or following the occurrence of certain change of control transactions. Either party may terminate the License Agreement (i) for an uncured material breach of the License Agreement by the other party or (ii) if, at any time, the other party undergoes certain bankruptcy, insolvency or dissolution proceedings.
The above description of the License Agreement is only a summary of the material terms of the License Agreement, which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2022.
K2 Loan Agreement
On July 27, 2022, the Company entered into a loan and security agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”, together with any other lender from time to time party thereto, the “Lenders”), as administrative agent for the Lenders, and Ankura Trust Company, LLC, as collateral agent for the Lenders. The Loan Agreement provides up to $50.0 million principal in term loans (the “Term Loan”) consisting of a first tranche of $30.0 million funded at closing and a subsequent second tranche of up to $20.0 million upon the Company’s request, subject to review by the Lenders of certain information from the Company and discretionary approval by the Lenders.
The Term Loan will mature on August 1, 2026, with interest only payments for 30 months, and bears a variable interest rate equal to the greater of (i) 7.95% and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate, as determined by the Lenders, if The Wall Street Journal ceases to quote such rate) and (B) 3.20%. Upon the final payment under the Loan Agreement, the Lenders are entitled to an end of term charge equal to 6.45% of the aggregate original principal amount of the term loans made pursuant to the Loan Agreement. The Company may prepay, at its option, all, but not less than all, of the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being prepaid of the term loans, subject to a prepayment premium to which the Lenders are entitled and certain notice requirements.
The Lenders may elect at any time following the closing and prior to the full repayment of the term loans to convert any portion of the principal amount of the term loans then outstanding, up to an aggregate of $3.25 million in principal amount, into shares of the Company's common stock, $0.0001 par value per share (“Common Stock”), at a conversion price of $2.6493, subject to customary 19.99% Nasdaq beneficial ownership limitations. The Company also granted registration rights to the Lenders with respect to shares received upon such conversion.
Further, the Lenders may elect to invest up to $5.0 million in future equity financings of the Company, provided such investment is limited to no more than 10% of the total amount raised in such equity financing.
The Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, dispose of assets, make changes to the Company’s business, management, ownership or business locations, merge or consolidate, incur additional indebtedness, pay dividends or other distributions or repurchase equity, make investments, and enter into certain transactions with affiliates, in each case subject to certain exceptions. The Loan Agreement also contains covenants requiring that that the Company maintain cash, cash equivalents and marketable securities balance of at least $25 million so long as the Company’s total market capitalization is less than $250 million.
As security for its obligations under the Loan Agreement, the Company granted the Lenders a first priority security interest on substantially all of the Company’s assets (other than intellectual property), subject to certain exceptions.
In connection with entering into the Loan Agreement, the Company also issued to K2HV a warrant to purchase 339,725 shares of Common Stock (the “Warrant”), with an exercise price per warrant of $1.3246. The Warrant expires on July 27, 2032.
The Loan Agreement and the Warrant each provide the Lenders with certain piggyback registration rights with respect to the shares issuable upon conversion under the Loan Agreement or upon exercise of the Warrant.
The above descriptions of the Loan Agreement and the Warrant are only a summary of the material terms of the Loan Agreement and the Warrant, which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2022.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The information set forth under Item 1.01 above that relates to the Loan Agreement is hereby incorporated by reference into Item 2.03.
Item 3.02. Unregistered Sales of Equity Securities.
The information set forth under Item 1.01 above that relates to the issuance of the Warrants is hereby incorporated by reference into Item 3.02.
The Warrants described in Item 1.01 above were offered and sold in reliance upon the exemption from registration provided by Section 4(a)(2) under the Securities Act of 1933, as amended (the “Securities Act”), in that the issuance of the Warrants did not involve a public offering.
Item 7.01. Regulation FD Disclosure.
On July 28, 2022, the Company issued a press release and held a conference call presenting the License Agreement referred to in Item 1.01, and the Company issued a press release announcing the closing of the term loan facility and the execution of the Loan Agreement referred to in Item 1.01.
A copy of each press release and the In-Licensing Presentation are attached as Exhibits 99.1, 99.2 and 99.3, respectively, to this Current Report on Form 8-K.
The information in this Item 7.01, including Exhibits 99.1, 99.2 and 99.3 to this report, shall not be deemed to be “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 or Sections 11 and 12(a)(2) of the Securities Act. The information contained in this Item 7.01 and in the accompanying Exhibits 99.1, 99.2 and 99.3 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
Exhibit |
| Description of Document |
99.1 | Press release dated July 28, 2022 relating to the License Agreement. | |
99.2 | Press release dated July 28, 2022 relating to the Loan Agreement | |
99.3 | ||
104 | Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) |
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 thereunto duly authorized.
Elevation Oncology, Inc. | |||
Date: July 28, 2022 | By: | /s/ Shawn M. Leland | |
Shawn M. Leland, Pharm.D., RPh | |||
President, Chief Executive Officer and Director |
Exhibit 99.1
Elevation Oncology Expands Pipeline through Exclusive Licensing of EO-3021 (SYSA1801), a Clinical Stage Anti-Claudin18.2 Antibody Drug Conjugate, From CSPC Pharmaceutical Group
· | Obtains exclusive worldwide rights (outside Greater China) to develop and commercialize EO-3021 (SYSA1801) |
· | Expands pipeline to now include two clinical stage precision oncology candidates for patients with genomically defined solid tumors, including those with Claudin18.2 overexpression |
· | Company expects to initiate a Phase 1 clinical trial in the U.S. evaluating EO-3021 (SYSA1801) in 2023 |
· | Management to host an investor conference call and webcast today at 5:00 p.m. ET |
NEW YORK, NY July 28, 2022 – Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, today announced that it has entered into an exclusive license agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) to develop and commercialize EO-3021 (SYSA1801), a differentiated, clinical stage antibody drug conjugate (ADC) targeting Claudin18.2, in all global territories outside Greater China (mainland China, Hong Kong, Macau and Taiwan). SYSA1801 is currently being evaluated by CSPC in a Phase 1, dose-escalation clinical trial in China. Elevation Oncology expects to initiate a Phase 1 clinical trial evaluating EO-3021 in the U.S. in 2023.
“This licensing transaction represents successful, continued execution of our business development strategy and expands our clinical-stage pipeline,” said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. “We look forward to unlocking the potential of EO-3021 alongside our partner CSPC as we continue to build an industry-leading precision oncology company. EO-3021 is an exciting, differentiated ADC that has significant potential for the treatment of patients with solid tumors that express Claudin18.2, including those with genomically defined cancers. This transaction is a significant milestone for Elevation Oncology which further diversifies our company, expands our commercial potential and allows us to leverage our existing expertise in genomically defined cancers.”
Claudin18.2 is a protein expressed across several types of solid tumors including many gastrointestinal cancers such as gastric, gastroesophageal junction (GEJ), and pancreatic cancer. EO-3021 is an ADC containing monomethyl auristatin E (MMAE) payload, a potent anti-mitotic agent. MMAE has been clinically validated as an effective anti-tumor payload and is the cytotoxic component of four U.S. Food and Drug Administration-approved ADCs.
“Claudin18.2 is a clinically validated oncology target that has significant potential in multiple gastrointestinal cancers and several other solid tumors, and could be best addressed by utilizing a weaponized antibody like EO-3021,” said David Dornan, PhD, Chief Scientific Officer of Elevation Oncology. “High Claudin18.2 expression is associated particularly with gastrointestinal cancers, but can also frequently be found in lung, breast and liver cancer, representing an attractive commercial market opportunity. The targeting of Claudin18.2 with EO-3021 could have a transformative role in addressing the unmet medical need in patients whose tumors express Claudin18.2.”
Under the terms of the agreement, Elevation Oncology will develop and commercialize EO-3021 in all global territories outside of Greater China. In exchange, CSPC will receive a one-time, upfront payment of $27 million. CSPC will also be eligible to receive up to $148 million in potential development and regulatory milestone payments and up to $1.0 billion in potential commercial milestone payments plus royalties on net sales.
“This agreement with Elevation Oncology brings our innovative pipeline overseas with the potential to help patients battling cancer. We are delighted to partner with Elevation Oncology to realize the full global potential for SYSA1801 (EO-3021) in meeting the unmet medical needs in pancreatic and gastric cancer, as well as other types of cancers,” said Zhang Cuilong, Chief Executive Officer of CSPC. “Recognizing the value that Elevation Oncology has created in building an
industry-leading operational platform for enrolling clinical trials in genomically defined patient populations, this partnership gives us confidence in the potential worldwide development of this program targeting Claudin18.2.”
Conference Call and Webcast Information
Elevation Oncology will host an investor conference call and webcast today, Thursday, July 28, 2022, at 5:00 p.m. ET to discuss the licensing transaction with CSPC. To access the live call, please dial 1-877-870-4263 (local) or 1-412-317-0790 (international) at least 10 minutes prior to the start time of the call and ask to be joined into the Elevation Oncology investor call. The live, listen-only webcast of the conference call can be accessed by visiting the "Events" page within the "Investors" section of Elevation Oncology’s website at www.elevationoncology.com. An archived replay of the webcast will be available on Elevation Oncology’s website approximately two hours after the event.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated, clinical stage antibody drug conjugate that targets Claudin18.2. Claudins are a family of proteins acting to maintain the tight junction that controls the interchange of molecules between cells and are mainly found in gastric, pancreatic, and lung tissues.1 Claudin18.2 is a specific subtype that is expressed in only cancer cells of the gastric epithelia.1 When the gastric epithelial cells become malignant, the tight junctions become disrupted, exposing the Claudin18.2 epitopes and allowing them to be targeted by anti-cancer agents.1 An Investigational New Drug application for EO-3021 has been cleared with the U.S. Food and Drug Administration.
About Elevation Oncology, Inc.
Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our most advanced candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on CRESTONE are available at www.NRG1fusion.com. The Company’s other product candidate, EO-3021, is a differentiated, clinical stage antibody drug conjugate that targets Claudin18.2 and is currently being developed for the treatment of genomically defined solid tumors. For more information, visit www.ElevationOncology.com.
About CSPC Pharmaceutical Group Limited
CSPC is a leading pharmaceutical conglomerate in China with strong capabilities in research and development, manufacturing, and marketing of innovative drugs. The Company was listed on the Hong Kong Stock Exchange (stock code: HK1093) in 1994 and became a constituent stock of the Hang Sang Index in 2018. Currently, it is also a constituent stock of Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Mainland Healthcare Index, Hang Seng Stock Connect Index, Hang Seng (Hong Kong-listed) 100 Index and Hang Seng China Enterprise Index. CPSC has more than 24,000 employees. CSPC has a national top research and development team with research and development bases in Shijiazhuang, Shanghai, Beijing, and the United States, focusing on the discovery, research and development of small molecule targeted drugs, nanodrugs, monoclonal antibody drugs, bispecific antibody drugs, antibody-drug conjugates, mRNA vaccines, small nucleic acid drugs and biological drugs in the immune field. For more information, please visit its website at http://www.e-cspc.com
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, expectations relating to Elevation Oncology’s licensing transaction with CSPC, Elevation Oncology’s anticipated preclinical and clinical development activities, potential benefits of Elevation Oncology’s product candidates, potential market opportunities for Elevation Oncology’s product
candidates and the ability of Elevation Oncology’s product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology’s ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on Elevation Oncology’s business, Elevation Oncology’s ability to fund development activities and achieve development goals, Elevation Oncology’s ability to protect intellectual property, Elevation Oncology’s ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the U.S. Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
References
1 | Zhang, et al. Evaluation and reflection on claudin 18.2 targeting therapy in advanced gastric cancer. Chin J Cancer Res. 2020 Apr; 32(2): 263–270. |
Elevation Oncology Investor and Media Contact
Candice Masse, 978-879-7273
Senior Director, Corporate Communications & Investor Relations
cmasse@elevationoncology.com
Exhibit 99.2
Elevation Oncology Secures $50 Million Loan Facility with K2 HealthVentures
· | Initial tranche supports the exclusive license of EO-3021 (SYSA1801) outside of Greater China from CSPC Pharmaceutical Group and execution of Company’s pipeline |
NEW YORK, JULY 28, 2022 -- Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, today announced that it has secured a $50 million senior secured loan facility from funds managed by K2 HealthVentures, a leading healthcare-focused investment firm. The initial proceeds from the facility will primarily support the exclusive license of EO-3021 (SYSA1801) outside of Greater China from CSPC Pharmaceutical Group and the execution of the Company’s pipeline.
“This financing supports the expansion of our clinical oncology pipeline with an exciting new opportunity in precision oncology, furthering our mission to bring important new medicines to patients in need,” said Joseph Ferra, Chief Financial Officer of Elevation Oncology. “We are pleased to partner with K2 HealthVentures, a premier partner known for its strategic investments in promising healthcare companies and assets, and we believe this transaction speaks to the significant potential of both seribantumab and EO-3021.”
Austin Sherwindt, Managing Director at K2 HealthVentures, stated: “We are excited to partner with Elevation Oncology, and provide the company with enhanced financial flexibility to expand and diversify its portfolio, expand its commercial potential and address significant unmet needs in oncology. We believe in the power of precision oncology and the long-term potential of Elevation Oncology’s pipeline development approach, and we look forward to continuing to partner with the company as it advances its clinical stage assets and further expands its precision-based portfolio of medicines.”
The facility provides Elevation Oncology with up to $50 million in borrowing capacity in two tranches, with an initial tranche of $30 million available immediately. A second tranche, consisting of up to $20 million, will be available to Elevation Oncology in the future, subject to mutual agreement by Elevation Oncology and K2 HealthVentures.
Elevation Oncology plans to use the initial proceeds from the facility primarily to fund a one-time, upfront payment of $27 million to license EO-3021 (SYSA1801) from CSPC Pharmaceutical Group. Elevation Oncology expects to use any future proceeds from the facility to support the continued development of EO-3021 and seribantumab, for additional pipeline expansion, and for general corporate purposes. Following the licensing of EO-3021 and the initial tranche of the loan facility, Elevation Oncology expects its cash, cash equivalents and marketable securities to fund current operations into 2024.
About Elevation Oncology, Inc.
Elevation Oncology is founded on the belief that every patient living with cancer deserves to know what is driving the growth of their disease and have access to therapeutics that can stop it. We aim to make genomic tests actionable by selectively developing drugs to inhibit the specific alterations that have been identified as drivers of tumor growth. Together with our peers, we work towards a future in which each tumor's unique genomic test result can be matched with a purpose-built precision medicine to enable an individualized treatment plan for each patient. Our most advanced candidate, seribantumab, is intended to inhibit tumor growth driven by NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 gene fusion. Details on CRESTONE are available at www.NRG1fusion.com. Our other product candidate, EO-3021, is a differentiated, clinical stage antibody drug conjugate that targets Claudin18.2 and is currently being developed for the treatment of genomically defined solid tumors. For more information, visit www.ElevationOncology.com.
About K2 HealthVentures
K2 HealthVentures is an alternative investment firm focused on providing flexible, long-term financing solutions to innovative private and public companies in the life sciences and healthcare industries. The investment team comprises collaborative, experienced professionals with diverse backgrounds in finance and operations, as well as deep domain knowledge across various healthcare sectors. A uniquely flexible, permanent capital structure enables the firm to provide creative, adaptive financing solutions and meet the evolving capital needs of its portfolio companies as they grow. K2HV is driven by dual goals of Profit and Purpose—aiming to fuel the growth of innovative companies that will ultimately improve the lives of patients and giving a percentage of investment profits back to underserved areas in healthcare. For more information, visit www.k2hv.com.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, expectations relating to Elevation Oncology’s use of proceeds from the loan facility, Elevation Oncology’s anticipated preclinical and clinical development activities, potential benefits of Elevation Oncology’s product candidates, and Elevation Oncology’s expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, the impact of the COVID-19 pandemic on Elevation Oncology's business, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Elevation Oncology Investor and Media Contact
Candice Masse, 978-879-7273
Senior Director, Corporate Communications & Investor Relations
cmasse@elevationoncology.com
2
Expanding Pipeline with EO - 3021 Investor Conference Call JULY 28, 2022 |
Forward Looking Statements These slides contain forward - looking statements and information relating to Elevation Oncology, Inc. within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. You should not place undue reliance on f orw ard - looking statements, as these statements are based upon our current expectations, forecasts, and assumptions and are subject to signif ica nt risks and uncertainties. Any statements contained herein or provided orally that are not statements of historical fact may be deemed to be forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” “predict,” “potential” and similar express ion s that convey uncertainty of future events or outcomes, although not all forward - looking statements contain these words. Forward - looking statements include a ll statements other than statements of historical fact contained in this presentation, including information concerning our future financia l p erformance, business plans and objectives, timing and success of our planned development activities, our ability to obtain regulatory approval, th e p otential therapeutic benefits and economic value of our product candidates, potential growth opportunities, competitive position, industry environ men t and potential market opportunities, and the impact of the COVID - 19 pandemic on our business and operations. Forward - looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors. It is not possi ble for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any facto r, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statements we may make. These factors, together with those that are described in under the heading “Risk Factors” contained in documents we file with the Securities and Exch ang e Commission (“SEC”) from time to time, may cause our actual results, performance or achievements to differ materially and adversely from tho se anticipated or implied by our forward - looking statements. Statements, including forward - looking statements, speak only to the date they are pro vided (unless an earlier date is indicated). We undertake no obligation to update publicly any forward - looking statements for any reason after t he date of this prospectus to conform these statements to actual results or to changes in our expectations, except as required by law. Althou gh we believe the expectations reflected in such forward - looking statements are reasonable, we can give no assurance that such expectations will p rove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward - looking statements. 2 |
Overview of the Deal Role of Claudin18.2 in Cancer Opportunity for EO - 3021 Closing Remarks 3 Today’s Agenda Shawn M. Leland, PharmD RPh FOUNDER AND CHIEF EXECUTIVE OFFICER David Dornan, PhD CHIEF SCIENTIFIC OFFICER Valerie M. Jansen, MD PhD CHIEF MEDICAL OFFICER Shawn M. Leland, PharmD RPh FOUNDER AND CEO All Q&A |
4 Shawn M. Leland , PharmD RPh OVERVIEW OF THE DEAL FOUNDER AND CHIEF EXECUTIVE OFFICER |
5 Building a Leading Precision Oncology Pipeline Strategy for Pipeline Expansion 1 The CRESTONE study is designed as a potential registrational trial following an accelerated approval pathway contingent upon con tinued discussions with the FDA 2 Report additional clinical data from Cohort 1 of the CRESTONE study treated with seribantumab at 3 grams weekly in the first half of 2023 3 CSPC Pharmaceutical Group has rights to develop and commercialize EO - 3021 (SYSA1801) in Greater China 1 Worldwide Worldwide (Outside Greater China) MAXIMIZE THE VALUE OF SERIBANTUMAB AND EO - 3021 ONCOGENIC FUSION DRUG DISCOVERY COLLABORATION WITH CARIS EXPAND PARTNERSHIPS THROUGH BD GENOMIC ALTERATION DRUG CANDIDATE PRE - IND PHASE 1 PHASE 2/ PIVOTAL PHASE 3 or CONFIRMATORY MILESTONE RIGHTS 3 NRG1 Fusions Seribantumab (anti - HER3 mAb ) Additional Interim Clinical Data Readout 1H 2023 2 Claudin18.2 EO - 3021 (anti - Claudin18.2 ADC ) US Phase 1 Clinical Trial Expected to Initiate in 2023 |
6 EO - 3021 Expanding Pipeline with a Differentiated ADC Candidate Targeting an Attractive Market Opportunity in Claudin18.2 Claudin18.2 expressed across several solid tumor types including many GI cancers Clinically validated oncology target Potential for EO - 3021 to play a transformative role in addressing unmet medical needs across solid tumors Adding a Potential First - in - Class and Best - in - Class ADC Candidate Exclusive rights to develop and commercialize EO - 3021 outside Greater China Currently being evaluated by CSPC in Phase 1 dose - escalation trial in China Expect to initiate US Phase 1 study of EO - 3021 in 2023 Favorable Economic Structure and Facility to Support Execution of Strategy Favorable licensing terms consist of an upfront payment of $27 million and up to $148 million in development and regulatory milestones Secured $50M loan facility to potentially support continued development of EO - 3021 and seribantumab , and additional pipeline expansion |
7 David Dornan, PhD ROLE OF CLAUDIN18.2 IN CANCER CHIEF SCIENTIFIC OFFICER |
Claudin18.2 is a Unique and Highly Selective Target 8 ● Claudin18.2 is a highly selective cell surface target often overexpressed in several types of cancers ● Claudin18.2 is largely inaccessible to antibodies in normal tissue, but is exposed on epithelial surface during tumorigenesis ● Overexpressed across multiple solid tumors including gastric, esophageal, pancreatic, ovarian and lung cancer ● No approved therapies targeting Claudin18.2 Cao, W., Xing, H., Li, Y. et al. Claudin18.2 is a novel molecular biomarker for tumor - targeted immunotherapy. Biomark Res 10, 38 (2022). https://doi.org/10.1186/s40364 - 022 - 00385 - 1 |
EO - 3021 – A Differentiated ADC Targeting Claudin18.2 9 Linker Anti - Claudin18.2 Antibody MMAE Payload |
10 Valerie M. Jansen, MD PhD OPPORTUNITY FOR EO - 3021 CHIEF MEDICAL OFFICER |
● O verexpressed in several high unmet need cancers, including gastric, esophageal, pancreatic, ovarian, and NSCLC, among others ● Expression is highest in GC/GEJ and pancreatic tumors (≥70%) ● Elevation Oncology’s license to EO - 3021 is for all global territories outside Greater China Significant Global Opportunity for the Treatment of Patients with Tumors Expressing Claudin18.2 11 CANCER TYPE TOTAL US INCIDENCE 1 TOTAL WW INCIDENCE 2 CLAUDIN18.2 EXPRESSION Gastric & Esophogeal 3 ~47,000 ~1,700,000 77% 4 Pancreatic 5 ~62,000 ~496,000 70 - 80% 6,4 Ovarian ~20,000 ~314,000 24% 4 NSCLC ~237,000 ~2,200,000 6% 7 1 https://www.cancer.gov/types 2 https://gco.iarc.fr/ 3 Unresectable advanced HER2 - gastric cancer and esophageal adenocarcinoma. 4 Sahin, et al . Claudin - 18 splice variant 2 is a pan - cancer target suitable for therapeutic antibody development. Clin Cancer Res . 2008 Dec 1;14(23):7624 - 34. doi : 10.1158/1078 - 0432.CCR - 08 - 1. 5 Metastatic pancreatic adenocarcinoma. 6 Tanaka, et al. Claudin - 18 Is an Early - Stage Marker of Pancreatic Carcinogenesis. J Histochem Cytochem . 2011 Oct; 59(10): 942 – 952. doi : 10.1369/0022155411420569. 7 Micke, et al. Aberrantly activated claudin 6 and 18.2 as potential therapy targets in non - small - cell lung cancer. Int J Cancer. 2014 Nov 1;135(9):2206 - 14. doi : 10.1002/ijc.28857. |
12 EO - 3021 Expected to Enter US Clinical Trials in 2023 Ongoing Phase 1 dose - escalation and dose - expansion study of EO - 3021 (SYSA1801) being conducted in China by CSPC IND cleared for EO - 3021 in US US Phase 1 clinical trial of EO - 3021 expected to be initiated by Elevation Oncology in 2023 |
13 Shawn M. Leland , PharmD RPh CLOSING REMARKS FOUNDER AND CHIEF EXECUTIVE OFFICER |
14 Obtained exclusive worldwide rights (outside Greater China) to develop and commercialize EO - 3021 EO - 3021 is a potential first - in - class, best - in - class, clinical - stage ADC targeting Claudin18.2 and currently in Phase 1 dose - escalation trial in China Claudin18.2 is clinically validated target that is overexpressed across many solid tumor types, and presents an attractive market opportunity Expands precision oncology pipeline to include two clinical - stage assets, including EO - 3021 and seribantumab Building an Industry - Leading Precision Oncology Company |
15 KEY UPCOMING MILESTONES *As of March 31, 2022 ~$132.1M cash and cash equivalents* Cash runway into 2024 Mid - 2022 Report initial data from CRESTONE Cohort 1 SERIBANTUMAB First Half 2023 Report additional interim data from CRESTONE Cohort 1 Mid - 2022 Complete enrollment of the first 20 patients in CRESTONE Cohort 1 2024 Report topline data from CRESTONE Cohort 1 2023 Initiate Phase 1 study in the US EO - 3021 FINANCIAL |
Q&A Shawn M. Leland, PharmD RPh Founder and CEO David Dornan, PhD Chief Scientific Officer Valerie M. Jansen, MD PhD Chief Medical Officer Joseph Ferra Chief Financial Officer |