UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): November 12, 2019
SPRINGWORKS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39044 | 83-4066827 | ||
|
(State or other jurisdiction of incorporation)
|
(Commission File Number) |
(I.R.S. Employer Identification No.) |
100 Washington Blvd
Stamford, CT 06902
(Address of principal executive offices, including zip code)
(203) 883-9490
(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:
| ¨ | 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 | SWTX | The 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 x
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 November 12, 2019 SpringWorks Therapeutics, Inc. announced its financial results for the quarter ended September 30, 2019. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release issued by SpringWorks Therapeutics, Inc. on November 12, 2019, furnished herewith. |
SIGNATURE
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.
| SpringWorks Therapeutics, Inc. | |||
| Date: November 12, 2019 | By: | /s/ Francis I. Perier, Jr. | |
| Francis I. Perier, Jr. | |||
| Chief Financial Officer | |||
Exhibit 99.1
SpringWorks Therapeutics Reports Third Quarter 2019 Financial Results and Recent Business Highlights
- Commenced Phase 2b ReNeu Clinical Trial for Patients with Neurofibromatosis Type 1-Associated Plexiform Neurofibromas (NF1-PN) –
- Received Important Regulatory Designations for Nirogacestat and Mirdametinib –
- Completed $186 Million Initial Public Offering–
STAMFORD, Conn – November 12, 2019 – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced financial results for the third quarter ended September 30, 2019, and provided an update on recent company developments.
“The third quarter of 2019 was a productive period for SpringWorks as we completed a successful initial public offering while simultaneously achieving important regulatory and clinical development milestones, including dosing the first patient in our Phase 2b ReNeu trial of mirdametinib for patients with plexiform neurofibromas,” said Saqib Islam, Chief Executive Officer of SpringWorks. “Our team is focused on enrolling patients in our two potentially registrational trials in rare oncology indications and our Phase 1b trial in patients with RAS and RAF mutated solid tumors, and collaborating with our partners to initiate two additional Phase 1 studies in genetically defined cancers by early next year. We also continue to evaluate new business development opportunities to expand our pipeline and maximize the value of our portfolio.”
Third Quarter 2019 Business Highlights
| · | Initiated Potentially Registrational ReNeu Clinical Trial: In October 2019, SpringWorks announced the initiation of the Phase 2b ReNeu clinical trial evaluating mirdametinib in children and adults with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). |
| · | Completed Successful Initial Public Offering: In September 2019, SpringWorks completed its initial public offering of 10,350,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,350,000 additional shares of its common stock, at the public offering price of $18.00 per share. The Company raised $186.3 million in aggregate gross proceeds. |
| · | Received EU Orphan Drug Designation for Nirogacestat: In September 2019, the European Commission granted Orphan Drug Designation for nirogacestat for the treatment of soft tissue sarcoma. |
| · | Received Breakthrough Therapy Designation for Nirogacestat: In August 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. |
| · | Strengthened Leadership Team and Board of Directors: In August 2019, SpringWorks appointed Francis (Frank) I. Perier, Jr. as Chief Financial Officer and Alan Fuhrman to its Board of Directors and as Audit Committee Chair. |
| · | Received EU Orphan Drug Designation for Mirdametinib: In July 2019, the European Commission granted Orphan Drug Designation for mirdametinib for the treatment of neurofibromatosis type 1 (NF1). |
Third Quarter and Year to Date 2019 Financial Results
| · | Research and Development (R&D) Expenses: R&D expenses as of September 30, 2019 were $10.7 million and $30.4 million for the third quarter and year-to-date periods, respectively, compared to $3.4 million and $6.2 million for the comparable periods of 2018, respectively. The increases in R&D expenses in 2019 are primarily attributable to increased clinical study and drug supply costs related to the ongoing Phase 3 DeFi and Phase 2b ReNeu trials, as well as growth in employee costs, including non-cash share-based compensation associated with increases in the number of R&D personnel. |
| · | General and Administrative (G&A) Expenses: G&A expenses as of September 30, 2019 were $4.6 million and $11.5 million for the third quarter and year-to-date periods, respectively, compared to $1.8 million and $5.9 million for the comparable periods of 2018, respectively. The increases in G&A expenses in 2019 are primarily attributable to growth in employee costs, including non-cash share-based compensation associated with increases in the number of G&A personnel, and increases in consulting and professional services related to the expansion of our business activities. |
| · | Net Loss Attributable to Common Stockholders: As of September 30, 2019, SpringWorks reported net losses of $16.8 million, or $1.77 loss per share, and $34.4 million, or $9.24 loss per share, for the third quarter and year-to-date periods respectively. This compares to net losses of $5.0 million, or $11.55 loss per share, and $11.6 million, or $44.20 loss per share, for the comparable periods of 2018, respectively. |
| · | Cash Position: Cash and cash equivalents were $343.8 million as of September 30, 2019. This includes net proceeds of $169.7 million from SpringWorks’ initial public offering completed in September 2019. |
About SpringWorks Therapeutics
SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio. For more information, please visit www.springworkstx.com.
Follow SpringWorks Therapeutics on social media: @SpringWorksTx and LinkedIn.
SpringWorks uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company’s website in the ‘Investors & Media’ section. Accordingly, investors should monitor such portions of the SpringWorks website, in addition to following press releases, SEC filings and public conference calls and webcasts.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding SpringWorks’ clinical trials and its strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” 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 and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the timing for completion of SpringWorks’ clinical trials of its product candidates, whether and when, if at all, SpringWorks’ product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in SpringWorks’ SEC filings, including its final prospectus for its initial public offering filed on September 13, 2019 and subsequent filings with the SEC. SpringWorks cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. SpringWorks disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent SpringWorks’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
SpringWorks Therapeutics, Inc.
Consolidated Balance Sheet
(in thousands, except share, unit per-share and per-unit amounts)
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 343,825 | $ | 45,648 | ||||
| Prepaid expenses and other current assets | 689 | 1,382 | ||||||
| Total current assets | 344,514 | 47,030 | ||||||
| Property and equipment, net | 820 | 317 | ||||||
| Investment in VIE (MapKure) | 999 | - | ||||||
| Other assets | 2,062 | 1,043 | ||||||
| Total Assets | $ | 348,395 | $ | 48,390 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders’ (Deficit) Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,157 | $ | 774 | ||||
| Accrued expenses | 7,682 | 2,568 | ||||||
| Deferred rent | 356 | 335 | ||||||
| Total current liabilities | 10,195 | 3,677 | ||||||
| Long-term portion of deferred rent | 881 | 1,152 | ||||||
| Total liabilities | 11,076 | 4,829 | ||||||
| Commitments and contingencies | ||||||||
| Convertible Preferred Stock: | ||||||||
| Series A convertible preferred stock, $0.0001 par value; no shares authorized, | ||||||||
| issued or outstanding at September 30, 2019 and December 31, 2018, | ||||||||
| respectively. | - | - | ||||||
| Series A convertible preferred units, no par value, net of issuance costs; | ||||||||
| no units authorized, issued and outstanding at September 30, 2019; | ||||||||
| 103,000,000 units authorized; 63,600,000 units issued and outstanding | ||||||||
| at December 31, 2018. | - | 62,930 | ||||||
| Stockholders' (deficit) equity: | ||||||||
| Junior Series A convertible preferred stock, no par value; no shares authorized, | ||||||||
| issued or outstanding at September 30, 2019 and December 31, 2018, respectively. | - | - | ||||||
| Junior Series A convertible preferred units, no par value; | ||||||||
| no units authorized, issued or outstanding at September 30, 2019; | ||||||||
| 6,437,500 units authorized, issued and outstanding at December 31, 2018. | - | 2,014 | ||||||
| Common stock, $0.0001 par value, 150,000,000 shares authorized, | ||||||||
| 43,233,387 shares issued and outstanding, at September 30, 2019; | ||||||||
| no shares authorized, issued or outstanding at December 31, 2018. | 4 | - | ||||||
| Common units, no par value; no units authorized, issued or outstanding | ||||||||
| at September 30, 2019; 195,638 units authorized, issued and outstanding at | ||||||||
| December 31, 2018. | - | - | ||||||
| Additional paid-in capital | 394,127 | 1,069 | ||||||
| Accumulated deficit | (56,812 | ) | (22,452 | ) | ||||
| Total stockholders’ (deficit) equity | 337,319 | (19,369 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders’ (deficit) equity | $ | 348,395 | $ | 48,390 | ||||
SpringWorks Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share, unit per-share and per-unit amounts)
| Three Months ending September 30, 2019 | Three Months ending September 30, 2018 | Nine Months ending September 30, 2019 | Nine Months ending September 30, 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 10,745 | $ | 3,406 | $ | 30,373 | $ | 6,192 | ||||||||
| General and administrative | 4,584 | 1,824 | 11,495 | 5,852 | ||||||||||||
| Total operating expenses | 15,329 | 5,230 | 41,868 | 12,044 | ||||||||||||
| Loss from operations | (15,329 | ) | (5,230 | ) | (41,868 | ) | (12,044 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income, net | 997 | 226 | 2,280 | 450 | ||||||||||||
| Total other Income. | 997 | 226 | 2,280 | 450 | ||||||||||||
| Equity investment loss | (2,501 | ) | - | (2,501 | ) | - | ||||||||||
| Net loss | $ | (16,833 | ) | $ | (5,004 | ) | $ | (42,089 | ) | $ | (11,594 | ) | ||||
| Reconciliation of net loss to net loss attributable to common stockholders: | ||||||||||||||||
| Net loss | $ | (16,833 | ) | $ | (5,004 | ) | $ | (42,089 | ) | $ | (11,594 | ) | ||||
| Net gain attributable to extinguishment of Series A convertible preferred and Junior Series A convertible preferred shares | - | - | 7,729 | - | ||||||||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (16,833 | ) | $ | (5,004 | ) | $ | (34,360 | ) | $ | (11,594 | ) | ||||
| Net loss per unit, basic and diluted | - | $ | (11.55 | ) | - | $ | (44.20 | ) | ||||||||
| Net loss per share, basic and diluted | $ | (1.77 | ) | - | $ | (9.24 | ) | - | ||||||||
| Weighted average common units outstanding, basic and diluted | - | 433,401 | - | 262,273 | ||||||||||||
| Weighted average common shares outstanding, basic and diluted | 9,487,329 | - | 3,716,877 | - | ||||||||||||
Contact:
Kim Diamond
Phone: 646-661-1255
Email: kdiamond@springworkstx.com