8-K
Century Therapeutics, Inc. (IPSC)
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):August 12, 2021
Century Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40498 | 84-2040295 |
|---|---|---|
| (State or other jurisdiction of<br><br>incorporation or organization) | (Primary Standard Industrial<br><br>Classification Code Number) | (I.R.S. Employer<br><br>Identification No.) |
| 3675 Market Street<br><br> <br>Philadelphia, Pennsylvania | 19104 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:
(267) 817-5790
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 Instruction 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 | Name of Exchange on Which Registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | IPSC | Nasdaq Global Select Market |
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 12, 2021, Century Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02 (including Exhibit 99.1) is being 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 and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 7.01 | Regulation FD Disclosure |
|---|
On August 12, 2021, the Company updated information reflected in a slide presentation, which is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. Representatives of the Company will use the updated presentation in various meetings with investors from time to time.
The information contained in this Item 7.01 (including Exhibit 99.2) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
|---|
(d) Exhibits
| ExhibitNo. | Document |
|---|---|
| 99.1 | Press Release of Century Therapeutics, Inc., dated August 12, 2021 |
| 99.2 | Investor Presentation of Century Therapeutics, Inc., dated August 12, 2021 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| CENTURY THERAPEUTICS, INC. | |
|---|---|
| By: | /s/ Osvaldo Flores, Ph.D. |
| Name: | Osvaldo Flores, Ph.D. |
| Title: | President and Chief Executive Officer |
Date: August 12, 2021
Exhibit 99.1
CenturyTherapeutics Reports Second Quarter 2021 Financial Results and Business Updates
Continued Company investmentacross our iPSC platforms, programs and manufacturing
Lead program, CNTY-101,remains on track for IND filing in mid-2022
Recent IPO with net proceedsof approximately $221M
June 30, 2021 cash,cash equivalents, and marketable securities of $440M
PHILADELPHIA, August 12, 2021 - Century Therapeutics, (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, today reported financial results and business highlights for the second quarter ended June 30, 2021.
“With the proceeds raised from our IPO in June, we are well positioned to advance our lead candidate CNTY-101 toward clinical development, targeting IND filing in mid-2022,” said Lalo Flores, Chief Executive Officer, Century Therapeutics. “We continue our investment in our iPSC platforms and are pleased with the progress achieved in developing iPSC-derived cell product candidates for the treatment of cancers with high unmet clinical need. We look forward to providing scientific updates on our programs and platform in the second half of 2021.”
Recent Highlights
| · | Raised $221 million<br> in public offering of common stock: In June 2021, the company announced a public offering<br> of 10,550,000 shares of its common stock at a price of $20 per share. The underwriters also<br> exercised their option to purchase an additional 1,582,500 shares of common stock for total<br> offering net proceeds of $221 million. |
|---|---|
| · | Expanded our Board<br> of Directors: The Company appointed pharmaceutical industry veterans Alessandro Riva, M.D.<br> and Kimberly Blackwell, M.D., as new Independent Directors. |
| --- | --- |
| · | Continued manufacturing<br> and technical operations investment: Our US manufacturing facility is expected to be operational<br> by end of 2021. |
| --- | --- |
Second Quarter 2021 Financial Results
| · | Cash Position: Cash,<br> cash equivalents and marketable securities were $440.0 million as of June 30, 2021,<br> as compared to $246.1 million as of March 31, 2021. This includes $221.2 million in<br> net proceeds from the company’s public offering in June 2021. |
|---|---|
| · | Research and Development (R&D) expenses: R&D expenses were $18.9 million for the three<br> months ended June 30, 2021, compared to $8.5 million for the same period in 2020. |
| --- | --- |
| · | General and Administrative (G&A) expenses: G&A<br>expenses were $4.1 million for the three months ended June 30, 2021, compared to $2.3 million for the same period in 2020. |
| --- | --- |
| · | Net loss: Net loss was $23.3 million for the three months ended June 30, 2021, compared<br> to $15.3 million for the same period in 2020. |
| --- | --- |
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is harnessing the power of adult stem cells to develop curative cell therapy products for cancer that we believe will allow us to overcome the limitations of first-generation cell therapies. Our genetically engineered, iPSC-derived iNK and iT cell product candidates are designed to specifically target hematologic and solid tumor cancers. We are leveraging our expertise in cellular reprogramming, genetic engineering, and manufacturing to develop therapies with the potential to overcome many of the challenges inherent to cell therapy and provide a significant advantage over existing cell therapy technologies. We believe our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care. For more information on Century Therapeutics please visit https://www.centurytx.com/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our cash and financial resources, our clinical development plans, and the development of our U.S. manufacturing facility are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors 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. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this presentation are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our ability to successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our reliance on the maintenance of certain key collaborative relationships for the manufacturing and development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of the COVID-19 pandemic on our business and operations; the performance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third-party suppliers and manufacturers; our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Investor.relations@centurytx.com
267.857.1080
Media Contact:
media@centurytx.com
CENTURY THERAPEUTICS, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(In thousands,except share amounts)
| December 31, | |||||
|---|---|---|---|---|---|
| 2020 | |||||
| Assets | |||||
| Current assets | |||||
| Cash and cash equivalents | 272,277 | $ | 27,211 | ||
| Short-term investments | 125,290 | 48,542 | |||
| Escrow deposits, current | 419 | 783 | |||
| Prepaid expenses and<br> other current assets | 4,625 | 2,261 | |||
| Total current assets | 402,611 | 78,797 | |||
| Property and equipment, net | 34,462 | 15,385 | |||
| Operating lease right-of-use assets | 12,251 | 9,392 | |||
| Restricted cash | 2,235 | 517 | |||
| Escrow deposits, non-current | 555 | 723 | |||
| Long-term investments | 42,474 | 1,053 | |||
| Security deposits | 1,042 | 909 | |||
| Total assets | 495,630 | $ | 106,776 | ||
| Liabilities, convertible preferred stock, and stockholders’<br> equity (deficit) | |||||
| Current liabilities | |||||
| Accounts payable | 13,427 | $ | 8,082 | ||
| Accrued expenses and other liabilities | 6,832 | 4,030 | |||
| Deposit liability | 966 | — | |||
| Total current liabilities | 21,225 | 12,112 | |||
| Operating lease liability, long term | 14,752 | 11,679 | |||
| Deposit liability, non-current | 2,268 | — | |||
| Long-term debt, net | 9,788 | 9,636 | |||
| Total liabilities | 48,033 | 33,427 | |||
| Commitments and contingencies | |||||
| Non-cumulative convertible preferred stock, Series A,<br> 0.0001 par value, 0 and 35,000,000 shares authorized, issued and outstanding at June 30, 2021 and December 31, 2020,<br> respectively | — | 34,922 | |||
| Non-cumulative convertible preferred stock, Series B,<br> 0.0001 par value, 0 and 26,143,790 shares authorized, issued and outstanding at June 30, 2021 and December 31, 2020,<br> respectively | — | 144,839 | |||
| Stockholders' equity (deficit): | |||||
| Preferred stock, 0.0001 par value, 10,000,000 and 0 shares<br> authorized at June 30, 2021 and December 31, 2020, respectively, and 0 shares issued and outstanding | — | — | |||
| Common stock, 0.0001 par value, 300,000,000 and 125,236,190<br> shares authorized; 54,404,091 and 7,481,861 shares issued and outstanding at June 30, 2021 and December 31, 2020,<br> respectively | 5 | 1 | |||
| Additional paid-in capital | 781,558 | 217,832 | |||
| Subscription receivable | — | (31,900 | ) | ||
| Accumulated deficit | (333,963 | ) | (292,342 | ) | |
| Accumulated other comprehensive loss | (3 | ) | (3 | ) | |
| Total stockholders’ equity<br> (deficit) | 447,597 | (106,412 | ) | ||
| Total liabilities and stockholders’<br> equity (deficit) | 495,630 | $ | 106,776 |
All values are in US Dollars.
CENTURY THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVELOSS
(Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended | Three Months Ended | Six Months Ended | Six Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| June 30, 2021 | June 30, 2020 | June 30, 2021 | June 30, 2020 | |||||||||
| Operating expenses | ||||||||||||
| Research and development | $ | 18,933 | $ | 8,484 | $ | 34,307 | $ | 16,427 | ||||
| General and administrative | 4,088 | 2,310 | 6,776 | 4,360 | ||||||||
| Write off of in-process research and<br> development asset | - | 4,722 | - | 4,722 | ||||||||
| Total operating<br> expenses | 23,021 | 15,516 | 41,083 | 25,509 | ||||||||
| Loss from operations | (23,021 | ) | (15,516 | ) | (41,083 | ) | (25,509 | ) | ||||
| Interest expense | (318 | ) | — | (632 | ) | — | ||||||
| Other income, net | 66 | 215 | 94 | 535 | ||||||||
| Net loss | $ | (23,273 | ) | $ | (15,301 | ) | $ | (41,621 | ) | $ | (24,974 | ) |
| Net loss per common share Basic and Diluted | (1.93 | ) | (2.05 | ) | (4.26 | ) | (3.34 | ) | ||||
| Weighted average common shares outstanding Basic and Diluted | 12,044,610 | 7,481,861 | 9,775,840 | 7,481,861 | ||||||||
| Other comprehensive loss | ||||||||||||
| Net loss | $ | (23,273 | ) | $ | (15,301 | ) | $ | (41,621 | ) | $ | (24,974 | ) |
| Unrealized gain on short-term investments | 32 | 97 | 5 | 124 | ||||||||
| Foreign currency translation<br> adjustment | (9 | ) | — | (5 | ) | — | ||||||
| Comprehensive loss | $ | (23,250 | ) | $ | (15,204 | ) | $ | (41,621 | ) | $ | (24,850 | ) |
Exhibit 99.2
CORPORATE OVERVIEW August 2021
2 2 FORWARD - LOOKING STATEMENTS This presentation contains forward - looking statements within the meaning of, and made pursuant to the safe harbour provisions of , The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to , s tatements regarding possible or assumed future results of operations, business strategies, research and development plans, regulatory activities, market opportunity, competitive position and potential growth opportunities are forward - looking statement s. These statements involve known and unknown risks, uncertainties and other important factors that may cause the our actual results, performance or achievements to be materially different from any future results, performance or achievemen ts expressed or implied by the forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target, ” “ project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward - looking statements in this presentation are only predictions. We have based thes e forward - looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect the our business, financial condition and results of operations. These forward - looking stateme nts speak only as of the date of this presentation and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among others: our abilit y t o successfully advance our current and future product candidates through development activities, preclinical studies, and clinical trials; our reliance on the maintenance on certain key collaborative relationships for the manufacturin g a nd development of our product candidates; the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates; the impact of the COVID - 19 pandemic on our business and operations; the per formance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third - party suppliers and manufacturers; our ability to successfully commercial ize our product candidates and develop sales and marketing capabilities, if our product candidates are approved; and our ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainti es are described more fully in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward - looking statements as predictions of future events . The events and circumstances reflected in the our forward - looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward - looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not pl an to publicly update or revise any forward - looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
3 3 CENTURY THERAPEUTICS - EMERGING LEADER IN i PSC CELL THERAPIES EMPLOYEES INCLUDING EXPERIENCED LEADERS AND ENTREPRENEURS ~120 COMPREHENSIVE iPSC CELL PLATFORM FOR IMMUNE EFFECTOR CELLS LEAD PROGRAM EXPECTED TO FILE IND IN MID 2022 STATE - OF - THE ART GMP MANUFACTURING FACILITY EXPECTED TO BE OPERATION BY YEAR - END 2021 IN CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES AS OF 6/30/2021 $440M GENETIC & PROTEIN ENGINEERING, PROCESS DEVELOPMENT, AND IMMUNO - ONCOLOGY EXPERTISE WITH CENTERS OF EXCELLENCE IN SEATTLE AND ONTARIO HEADQUARTERED IN PHILADELPHIA PRODUCT CANDIDATE ENGINE WITH PIPELINE IN SOLID AND HEMATOLOGIC MALIGNANCIES
4 4 Osvaldo (Lalo) Flores, CEO Hy Levitsky , President R&D Adrienne Farid, COO Greg Russotti , CTO Luis Borges, CSO Michael Diem, CBO PROVEN LEADERSHIP TEAM
5 5 Allogeneic, donor - derived Multiple donors Fewer doses per batch • Complex manufacturing, heterogeneous product, limited scale • Limited genetic engineering options Allogeneic, i PSC - derived Greater doses per batch • Efficient manufacturing, homogeneous product, greater scale • Likely unlimited genetic engineering options Single Donor iPSC TECHNOLOGY CAN OVERCOME LIMITATIONS OF DONOR DERIVED PLATFORMS
6 6 FOUNDATIONAL INVESTMENTS IN iPSC KNOW - HOW AND MANUFACTURING 6 In - House Manufacturing accelerates learnings and enables faster product iteration • Century facility expected to be operational by the end of 2021 • 53,000 ft 2 facility • Designed to produce multiple immune cell types • Two sites provides optionality and maximizes flexibility Significant acceleration of platform and product development iPSC License and collaboration agreement established in 2018 • Access to clinical grade iPSC lines • Exclusive IP and know - how to generate immune effector cells using feeder - free methods (NK, T, Mac, DC) • Dedicated FCDI GMP manufacturing capacity for Century’s product candidates • Leveraging two decades of research & investment at University of Wisconsin and FCDI
7 7 Sequential gene edits Engineered iPSC iNK cell iT cell iPSC bank Cell Engineering Manufacturing INTEGRATED CELL ENGINEERING AND MANUFACTURING ENABLES RAPID PROD UCT ITERATION ITERATIVE ENHANCEMENT OF PRODUCT FITNESS AND FUNCTIONALITY Engineered iPSC MCB Differentiation
8 8 ALLO - EVASION TM TECHNOLOGY b 2M KO (HLA - I) HLA - E CIITA KO (HLA - II) CD8 + T Cell CD4 + T Cell NK cell Evading the dominant mediators of allo - rejection
9 9 Not for further distribution ILLUSTRATIVE POTENTIAL OF ALLO - EVASION TM ON CELLULAR PHARMACOKINETICS Repeat doses With Allo - Evasion TM engineering Without Allo - Evasion TM engineering Time Cell count Initial dose
10 10 CENTURY’S APPROACH TO OPTIMIZING ANTI - TUMORAL RESPONSE Potentially maximizing durability of clinical responses and efficacy Genetic Engineering (To improve fitness) Manufacturing Optimization (To improve product quality) Engineered CAR - iNK or CAR - iT cells Allo - Evasion TM To avoid rejection Repeat Dosing To replenish cell product
11 11 iNK CELL PLATFORM IS OUR MOST ADVANCED PLATFORM CNTY - 101, our first product candidate is a CAR - iNK cell engineered with multiple features Allo - Evasion Persistence Safety switch CD19 - CAR 0 5 10 15 20 0 2.0×10 8 4.0×10 8 6.0×10 8 8.0×10 8 1.0×10 9 1.2×10 9 Day Post-tumor Implantation A v e r a g e R a d i a n c e ( p / s / c m ² / s r ) S E M C A R - i N K C A R - i N K C A R - i N K Tumor only CAR - iNK NALM - 6 tumor xenograft model CNTY - 101 iNK cell CAR - iNK Cells Have Significant* Anti - Tumor Activity In Vivo *Statistically significant (p=0.0027)
12 12 OUR i T CELL PLATFORM IS CLOSELY BEHIND AND MAKING DEMONSTRABLE PROGRESS Developing ab and gd iT platforms with Trusted TCRs that are not expected to cause GvHD CAR TCR 0 5 10 15 20 0 5.0×10 8 1.0×10 9 1.5×10 9 2.0×10 9 2.5×10 9 Day Post-tumor Implantation A v e r a g e R a d i a n c e ( p / s / c m ² / s r ) S E M C A R - i T Tumor only CAR - iT Century CAR - iT with Trusted TCR iT cell NALM - 6 tumor xenograft model CAR - iT Cells Have Significant* Anti - Tumor Activity In Vivo *Statistically significant (p<0.0001)
13 13 Product iPSC Platform Targets Indications Ownership Expected IND Submission Discovery Preclinical Phase 1 Phase 2 Phase 3 CNTY - 101 iNK CD19 Lymphoma Mid 2022 CNTY - 103 iNK CD133 + EGFR Glioblastoma 1H 2023 CNTY - 102 iT or iNK CD19 + CD79b Lymphoma 2H 2023 CNTY - 104 iT or iNK Multi - specific Acute Myeloid Leukemia 1H 2024 Hematologic Tumors Solid Tumors Product candidate pipeline across cell platforms and targets in solid and hematologic cancers PIPELINE
14 14 CENTURY’S NEXT GENERATION i PSC TECHNOLOGY PLATFORM Broad product pipeline with first 1 st IND submission targeting M id - 2022 Precision gene editing Advanced manufacturing Allo - Evasion Ρ Protein engineering iPSC - derived NK cells iPSC - derived T cells Comprehensive allogeneic iPSC - based cell platform
THANK YOU