UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| |
||
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
(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 |
Name of each exchange | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Sec.230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Sec.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 November 7, 2022, eFFECTOR Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, 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, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Press Release issued on November 7, 2022 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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.
| eFFECTOR Therapeutics, Inc. | ||||||
| Date: November 7, 2022 | By: | /s/ Michael Byrnes | ||||
| Name: | Michael Byrnes | |||||
| Title: | Chief Financial Officer | |||||
Exhibit 99.1
eFFECTOR Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update
- Key executive appointments: Douglas Warner, M.D., as CMO & Mayank Gandhi, M.D., as CBO –
- Cohort treating ER+ breast cancer with combination of zotatifin, fulvestrant and abemaciclib has been
expanded from 7 patients to 18 patients -
- Initiated dosing and completed enrollment in second cohort of Phase 1b clinical trial of zotatifin for
the treatment of COVID-19 -
SOLANA BEACH and REDWOOD CITY, Calif., November 7, 2022 – eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today reported financial results for the third quarter ended September 30, 2022 and provided a corporate update.
“We continue to make progress on all fronts, most visibly this quarter with the expansion of a second zotatifin cohort in patients with ER+ breast cancer and completion of the second cohort testing zotatifin in patients with COVID-19,” remarked Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. “We also continue to build out our executive team with key strategic additions including the previously announced appointment of Doug Warner, M.D., as CMO and the recent addition of Mayank Gandhi, M.D., as CBO. With momentum from positive interim data, we are confident we have the operational team necessary to effectively execute on our clinical development and strategic plans.”
Pipeline Highlights
Tomivosertib (eFT508): eFFECTOR’s wholly-owned, highly selective MNK inhibitor designed to enhance anti-tumor immune activity by activating T cells, delaying their exhaustion, and expanding the pool of central memory T cells.
| • | Enrollment continues in Phase 2b KICKSTART trial in NSCLC. KICKSTART trial includes patients in two cohorts: (1) “PD-L1 ≥50% cohort” for patients with PD-L1 expression ≥50% who will receive tomivosertib or placebo in combination with pembrolizumab as their initial therapy; and (2) “PD-L1 ≥1% cohort” for patients with PD-L1 expression ≥1% who will receive tomivosertib or placebo in combination with pembrolizumab as maintenance therapy immediately after completing the platinum-based chemotherapy doublet phase of their frontline treatment without disease progression. The company plans to enroll approximately 60 patients in each cohort. Topline data readouts from both cohorts are anticipated in the first half of 2023. |
Zotatifin (eFT226): eFFECTOR’s wholly-owned potent and selective inhibitor of mRNA helicase eIF4A, designed to downregulate expression of key oncoproteins and cell cycle proteins that drive tumor growth and resistance.
| • | Further expansion in Part 2 of ongoing trial in ER+ breast cancer. The cohort evaluating zotatifin in combination with fulvestrant and abemaciclib (ECBF+A) has been expanded from the previously disclosed 7 patients to 18 patients. This builds on the previously announced expansion of the cohort evaluating zotatifin plus fulvestrant (ECBF) from 7 to 18 patients, and the planning for a new cohort evaluating zotatifin in combination with fulvestrant in ER+ breast cancer patients with Cyclin D1 amplification. |
| • | On track to report topline data by end of 2022. Topline data from the expanded ECBF cohort (n=18) and from the initially planned 7 patients in the ECBF+A cohort are anticipated by the end of 2022. Initial overall response rate data from the Cyclin D1 amplified ER+ breast cancer cohort is expected in the first half of 2023. |
| • | COVID-19 program progresses with topline data from Phase 1b clinical trial expected in the first half of 2023. Enrollment completed in the first two cohorts of a three cohort Phase 1b clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. The study is a double-blind, randomized, placebo-controlled trial evaluating the safety and antiviral activity of a single dose of zotatifin. The company anticipates opening enrollment in the third cohort by the end of 2022, and expects to report topline data for all three cohorts in the first half of 2023. |
Business Highlights:
| • | Appointment of Mayank Gandhi, M.D., as chief business officer: In addition to the previously announced appointment of Doug Warner, M.D., as chief medical officer, in this last fiscal quarter eFFECTOR also welcomed Mayank Gandhi, M.D., as chief business officer. Dr. Gandhi brings over 15 years of experience in biopharmaceutical corporate development, partnering, product development and commercialization. Dr. Gandhi most recently served as vice president of corporate development & strategy of Jiya Acquisition Group, where he helped raise over $100 million towards an IPO, prior to which he held several senior business development, commercial operations and medical affairs roles at Genentech. Earlier in his career, he was an equity research analyst at Citigroup, Cowen and Avet Capital. Dr. Gandhi received his medical degree from the University of Mumbai and an M.B.A., with a concentration in healthcare management and finance, from Case Western Reserve University. |
Third Quarter 2022 Financial Results
Cash Position and Guidance: The company had cash and cash equivalents, and short-term investments totaling $33.0 million as of September 30, 2022, compared to $41.0 million in cash and cash equivalents, and short-term investments as of June 30, 2022. Current cash is anticipated to be sufficient to fund readouts of topline data from Phase 2b KICKSTART trial evaluating tomivosertib in combination with pembrolizumab in patients with NSCLC in the first half of 2023, topline data from Phase 2a dose expansion cohorts evaluating zotatifin in patients with certain biomarker-positive solid tumors, including ER+ breast cancer, in the second half of 2022, initial overall response rate data from the Cyclin D1 amplified ER+ cohort in the first half of 2023 and topline data from Phase 1b clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infections in the first half of 2023.
Research and Development (R&D) Expenses: R&D expenses were $6.6 million for the quarter ended September 30, 2022, compared to $5.0 million for the same quarter of 2021. This increase for the quarter was due to higher external development expenses primarily associated with clinical trial costs for both the tomivosertib and zotatifin programs, partially offset by a decrease in license fees due to a one-time license payment made in the third quarter of 2021 as a result of the consummation of the business combination with Locust Walk Acquisition Corporation. R&D expenses included approximately $0.8 million and $0.9 million of non-cash stock compensation expense in the quarters ended September 30, 2022 and 2021, respectively.
General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the quarter ended September 30, 2022, compared to $4.1 million for the same quarter of 2021. This decrease for the quarter was primarily due to a decrease in non-cash stock compensation expense, partially offset by an increase in amortization related to D&O insurance. G&A expenses included approximately $0.8 million and $1.5 million of non-cash stock compensation expense in the quarters ended September 30, 2022 and 2021, respectively.
Other Income (Expense): Other expense was $0.3 million for the quarter ended September 30, 2022 and other income for the quarter ended September 30, 2021 was $17.6 million. Other expense in the quarter ended September 30, 2022 consisted primarily of interest expense associated with the company’s term loan. Other income for the quarter ended September 30, 2021 primarily consisted of income related to the change in fair value of the company’s earn-out liability for the period. The fair value of the share earn-out liability of $61.0 million at the closing date of the business combination, was remeasured at $43.3 million as of September 30, 2021.
Net Income (Loss): Net loss was $9.6 million, or $0.23 per basic and diluted share, for the quarter ended September 30, 2022, as compared to net income of $8.9 million, or a net income of $0.53 and $0.42 per basic and diluted share, respectively, for the same quarter of 2021.
About eFFECTOR Therapeutics
eFFECTOR is a clinical-stage biopharmaceutical company pioneering the development of a new class of oncology drugs referred to as STRIs. eFFECTOR’s STRI product candidates target the eIF4F complex and its activating kinase, mitogen-activated protein kinase interacting kinase (MNK). The eIF4F complex is a central node where two of the most frequently mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK pathways, converge to activate the translation of select mRNA into proteins that are frequent culprits in key disease-driving processes. Each of eFFECTOR’s product candidates is designed to act on a single protein that drives the expression of a network of functionally related proteins, including oncoproteins and immunosuppressive proteins in T cells, that together control tumor growth, survival and immune evasion. eFFECTOR’s lead product candidate, tomivosertib, is a MNK inhibitor currently being evaluated in KICKSTART, a randomized, double-blind, placebo-controlled Phase 2b trial of tomivosertib in combination with pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC). Zotatifin, eFFECTOR’s inhibitor of eIF4A, is currently being evaluated in Phase 2a expansion cohorts in certain biomarker-positive solid tumors, including ER+ breast cancer and KRAS-mutant NSCLC. eFFECTOR has a global collaboration with Pfizer to develop inhibitors of a third target, eIF4E. In addition to the company’s oncology focus, zotatifin is being evaluated as a potential host-directed anti-viral therapy in patients with mild to moderate COVID-19 in collaboration with the University of California, San Francisco, which holds a $5 million cooperative agreement sponsored by the Defense Advanced Research Projects Agency.
Forward-Looking Statements
eFFECTOR cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the future clinical development of our product candidates, including expectations on enrollment and the timing of reporting data from ongoing clinical trials; the planned expanded development of zotatifin and the timing thereof; the potential therapeutic benefits of our product candidates; and the sufficiency of our capital resources to allow clinical data readouts and the expansion of our clinical development programs. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more
comprehensive reviews of the data and more patient data become available; potential delays in the commencement, enrollment and completion of clinical trials; additional disruptions to our operations from the COVID-19 pandemic, including clinical trial and manufacturing delays; our dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of our clinical trials and preclinical studies for our product candidates is uncertain; we may use our capital resources sooner than expected and they may be insufficient to allow clinical trial readouts; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for our product candidates; any future impacts to our business resulting from inflation or the conflict between Russia and Ukraine or other geopolitical developments outside our control; and other risks described in our prior filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
eFFECTOR Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 11,903 | $ | 49,702 | ||||
| Short-term investments |
21,053 | — | ||||||
| Prepaid expenses and other current assets |
2,565 | 3,194 | ||||||
|
|
|
|
|
|||||
| Total current assets |
35,521 | 52,896 | ||||||
|
|
|
|
|
|||||
| Property and equipment, net |
246 | 91 | ||||||
| Operating lease right-of-use assets |
125 | 166 | ||||||
| Other assets |
759 | 903 | ||||||
|
|
|
|
|
|||||
| Total assets |
$ | 36,651 | $ | 54,056 | ||||
|
|
|
|
|
|||||
| Liabilities and stockholders’ equity |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 1,214 | $ | 516 | ||||
| Accrued expenses |
3,615 | 3,418 | ||||||
| Current term loans, net |
18,985 | — | ||||||
| Accrued final payment on term loans, current |
1,100 | — | ||||||
| Lease liabilities, current portion |
54 | 44 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
24,968 | 3,978 | ||||||
|
|
|
|
|
|||||
| Earn-out liability, non-current |
6 | 12,130 | ||||||
| Non-current term loans, net |
— | 18,760 | ||||||
| Accrued final payment on term loans |
— | 1,100 | ||||||
| Non-current warrant liability |
40 | 678 | ||||||
| Non-current lease liabilities |
77 | 126 | ||||||
|
|
|
|
|
|||||
| Total liabilities |
25,091 | 36,772 | ||||||
|
|
|
|
|
|||||
| Stockholders’ equity: |
||||||||
| Common stock |
4 | 4 | ||||||
| Additional paid-in capital |
145,931 | 138,181 | ||||||
| Accumulated other comprehensive loss |
(69 | ) | — | |||||
| Accumulated deficit |
(134,306 | ) | (120,901 | ) | ||||
|
|
|
|
|
|||||
| Total stockholders’ equity |
11,560 | 17,284 | ||||||
|
|
|
|
|
|||||
| Total liabilities and stockholders’ equity |
$ | 36,651 | $ | 54,056 | ||||
|
|
|
|
|
|||||
eFFECTOR Therapeutics, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Income (Loss)
(Unaudited)
(in thousands, except share and per share data)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Grant revenue |
$ | 867 | $ | 427 | $ | 2,878 | $ | 1,119 | ||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
6,632 | 5,022 | 16,663 | 13,562 | ||||||||||||
| General and administrative |
3,486 | 4,119 | 9,895 | 7,052 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Total operating expenses |
10,118 | 9,141 | 26,558 | 20,614 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Operating loss |
(9,251 | ) | (8,714 | ) | (23,680 | ) | (19,495 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Other income (expense) |
(308 | ) | 17,593 | 10,275 | 16,244 | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net income (loss) |
(9,559 | ) | 8,879 | (13,405 | ) | (3,251 | ) | |||||||||
| Other comprehensive income (loss) |
13 | — | (69 | ) | — | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Comprehensive income (loss) |
$ | (9,546 | ) | $ | 8,879 | $ | (13,474 | ) | $ | (3,251 | ) | |||||
| Net income (loss) per share, basic |
$ | (0.23 | ) | $ | 0.53 | $ | (0.33 | ) | $ | (0.49 | ) | |||||
|
|
|
|
|
|
|
|
|
|||||||||
| Net income (loss) per share, diluted |
$ | (0.23 | ) | $ | 0.42 | $ | (0.33 | ) | $ | (0.49 | ) | |||||
|
|
|
|
|
|
|
|
|
|||||||||
| Weighted-average common shares outstanding, basic |
41,171,990 | 16,701,967 | 41,047,533 | 6,588,282 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Weighted-average common shares outstanding, diluted |
41,171,990 | 20,067,715 | 41,047,533 | 6,588,282 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Contacts:
| Investors: | Media: | |||
| Christopher M. Calabrese Managing Director LifeSci Advisors 917-680-5608 ccalabrese@lifesciadvisors.com |
Kevin Gardner Managing Director LifeSci Advisors 617-283-2856 kgardner@lifesciadvisors.com |
Heidi Chokeir, Ph.D. Managing Director Evoke Canale 619-203-5391 Heidi.chokeir@evokegroup.com |
# # #