Item 1.01 Entry Into a Material Definitive Agreement.
On
Additionally, on
Upon entering into the Purchase Agreement, the Company issued 142,939 shares of
common stock to Lincoln Park as consideration for Lincoln Park's commitment to
purchase up to
On the Commencement Date, the Company shall sell to Lincoln Park and Lincoln
Park shall purchase
In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases on the terms and subject to the conditions set forth in the Purchase Agreement. Lincoln Park has no right to require the Company to sell any common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to conditions and limitations set forth in the Purchase Agreement.
The Purchase Agreement also prohibits the Company from directing Lincoln Park to
purchase any shares of common stock if those shares, when aggregated with all
other shares of common stock then beneficially owned by Lincoln Park and its
affiliates, would result in
Under applicable rules of The Nasdaq Capital Market, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more than 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement (or 8,133,926 shares, based on 40,689,975 shares outstanding immediately prior to the execution of the Purchase Agreement), unless (i) stockholder approval is obtained or (ii) the issuances and sales of common stock pursuant to the Purchase Agreement are not deemed to be "below market" in accordance with the applicable rules of Nasdaq.
The Company may elect to terminate the Purchase Agreement at any time, without any cost or penalty. The Purchase Agreement does not include any of the following: limitations on the Company's use of amounts it receives
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as the purchase price for shares of common stock sold to Lincoln Park; financial or business covenants; restrictions on future financings (other than restrictions on its ability to enter into a "Variable Rate Transaction" as defined in the Purchase Agreement); rights of first refusal; participation rights or penalties.
The Company's net proceeds under the Purchase Agreement will depend on the frequency of sales and the number of shares sold to Lincoln Park and the prices at which the Company sells shares to Lincoln Park. The Company expects that any net proceeds it receives from such sales to Lincoln Park will be used for general corporate purposes, including working capital. . . .
Item 3.02 Unregistered Sale of
The information contained above in Item 1.01 is incorporated by reference into
this Item 3.02. Based in part upon the representations of Lincoln Park in the
Purchase Agreement, the offering and sale of the issuance of the securities to
Lincoln Park under the Purchase Agreement is exempt from registration under
Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506(b) of
Regulation D thereunder. Lincoln Park represented that it is an accredited
investor, as such term is defined in Rule 501(a)(3) of Regulation D under the
Securities Act of 1933, as amended, and that it is acquiring the shares for its
own account and not with a view to any resale, distribution or other disposition
of such securities in violation of the
Item 7.01 Regulation FD Disclosure.
On
The information in Item 7.01 of this Current Report on Form 8-K, including the slides incorporated herein by reference, 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 it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Item 7.01 of this Current Report on Form 8-K.
Item 8.01 Other Events.
On
The new cohort in the Phase 2b KICKSTART trial of tomivosertib in NSCLC will enroll approximately 60 patients with PD-L1 ³1% NSCLC immediately after they complete the platinum chemotherapy phase (4-6 cycles) of their frontline treatment without disease progression. Patients in this cohort will be randomized 1:1 to standard-of-care maintenance therapy plus tomivosertib in the treatment group versus standard-of-care maintenance plus placebo in the control group. Standard-of-care maintenance therapy is defined as pembrolizumab + pemetrexed in non-squamous NSCLC and pembrolizumab in squamous NSCLC.
Enrollment continues in the frontline PD-L1 ³50% cohort in the KICKSTART trial, which will evaluate approximately 60 patients, but has been slower than originally anticipated. Reasons for slow enrollment include the impact of COVID-19 on site operations and an evolving treatment landscape with greater than anticipated use of chemotherapy + pembrolizumab as frontline therapy. The Company has taken multiple steps to drive enrollment, including increasing the number of trial sites and continuing emphasis on the importance of PD-L1 testing to select optimal frontline therapy, especially for patients with PD-L1 ³50% who may be managed using a chemotherapy-free regimen. The Company believes these mitigation efforts, combined with patient and physician outreach activities, will enhance enrollment.
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These two trial cohorts represent the large majority of advanced NSCLC patients
and a significant market opportunity, estimated at
The Company discontinued enrollment in the frontline extension cohort of the KICKSTART trial, which was evaluating tomivosertib as an add-on to treatment in NSCLC patients who had progressed on pembrolizumab, representing the smallest NSCLC population of ~9,000 patients. Enrollment in this cohort had been slower than anticipated, in part due to reluctance of patients to continue pembrolizumab monotherapy treatment after progression in the control group. In addition, the treatment landscape is rapidly evolving for frontline NSCLC such that pembrolizumab monotherapy use may diminish in the future.
Across the two active cohorts, the company plans to enroll approximately 120 patients randomized equally to receive standard-of-care plus tomivosertib versus standard-of-care plus placebo. Primary endpoints of the trial are progression free survival ("PFS") in each cohort separately, with key secondary endpoints being safety, objective response rate ("ORR") and overall survival ("OS"). Topline data readouts from both cohorts are now anticipated to occur in the first half of 2023.
Pending positive results from the KICKSTART Phase 2b clinical trial, the Company plans to advance tomivosertib into Phase 3 registration trials. If results from the KICKSTART trial are clinically and statistically significant, the Company plans to explore the potential for accelerated approval with the FDA.
In the ongoing Phase 1/2 dose escalation and expansion trial of zotatifin in multiple solid tumors, patients have been dosed in two recently opened combination cohorts: KRAS G12C-mutant NSCLC in combination with sotorasib; and ER+/Her2- breast cancer in combination with fulvestrant and abemaciclib. Two additional breast cancer cohorts, ER+/FGFR+ evaluating zotatifin as monotherapy and ER+ evaluating zotatifin in combination with fulvestrant, continue to enroll.
The primary objective of this trial is to assess the safety, tolerability and activity of zotatifin as a monotherapy treatment and in combination with targeted agents in biomarker-specific patient populations. If positive activity is observed in one or more Phase 2a expansion cohorts, the Company plans to evaluate zotatifin, potentially as a combination in a randomized trial against a relevant comparator control group, or potentially in a single-arm monotherapy trial following demonstration of an appropriate ORR in the Phase 2a monotherapy expansion cohort.
The Company anticipates reporting initial response data from one or more of the expansion cohorts, as well as additional data from the Phase 1 dose escalation portion of the trial, in the first half of 2022. The Company anticipates reporting topline results from the trial in the second half of 2022.
The Company expects that its existing cash resources will allow it to read out initial response and topline results from the ongoing Phase 2a dose-expansion cohorts in the zotatifin program as well as topline data from both of the active cohorts in the ongoing Phase 2b KICKSTART trial.
Cautionary Note Regarding Forward-Looking Statements
The Company cautions readers that statements contained in this report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the future clinical development of the Company's product candidates, including potential future registrational trials and plans to potentially seek accelerated approval ; the expected timing of reporting data from the Company's clinical trials;
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the potential therapeutic benefits of the Company's product candidates; the
potential market opportunity for the Company's product candidates; the
sufficiency of the Company's capital resources to allow clinical trial data
readouts; and the timing and amount of any capital raised under the LPC facility
and the use of proceeds from any capital raised. The inclusion of
forward-looking statements should not be regarded as a representation by the
Company that any of its plans will be achieved. Actual results may differ from
those set forth in this report due to the risks and uncertainties inherent in
the Company's business, including, without limitation: potential delays in the
commencement, enrollment and completion of clinical trials; additional
disruptions to the Company's operations from the COVID-19 pandemic, including
clinical trial and manufacturing delays; the Company's ability to access the LPC
facility is subject to certain conditions, including the
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 10.1 Purchase Agreement, datedJanuary 24, 2022 , between eFFECTOR andLincoln Park Capital Fund, LLC 10.2 Registration Rights Agreement, datedJanuary 24, 2022 , between eFFECTOR andLincoln Park Capital Fund, LLC 99.1 Slide Presentation 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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