Entry into a Material Definitive Agreement

On October 30, 2023, Athersys, Inc. (the "Company") reported to have entered into an offer letter (the "Letter Agreement") with a holder ("Holder") of the Company’s common stock purchase warrants issued on October 16, 2023 (the "Existing Warrants") to (1) reduce the exercise price of the Existing Warrants from $0.1395 to $0.01 per share (the "Reduced Exercise Price"), (2) issue to the Holder new common stock purchase warrants (the "New Warrants") to purchase up to 20,000,000 shares of the Company’s common stock at an exercise price of $0.01 per share; and (3) make the Existing Warrants immediately exercisable (Filing, 8-K, Athersys, OCT 30, 2023, View Source [SID1234636429]).

Pursuant to the Letter Agreement, the Holder agreed to (A) reduce the period of the subsequent equity sale restrictions contained in Section h)(i) of Annex A to the warrant exercise inducement offer letter dated October 11, 2023 between the Holder and the Company (the "October 11, 2023 Letter") from 60 days to 30 days; (B) reduce the applicable period in each and all of the provisions relating to restrictions on the Company (or any of its subsidiaries) involving a "Variable Rate Transaction" (as such term, or a term of similar meaning, is defined in the applicable document) so that each such period terminates on March 1, 2024 in all stock purchase agreements, related letter agreements, and all other related agreements with the Holder; and (C) vote as set forth below in connection with a Fundamental Transaction.

The Holder agreed that upon the occurrence of a Fundamental Transaction (as defined in the New Warrants), if the Holder holds any shares of the Company’s common stock and a stockholder vote is required for such Fundamental Transaction, then the Holder agrees to vote all shares of its common stock that it holds as of any such record date that may be taken the vote of stockholders that are entitled to vote on such Fundamental Transaction in accordance with the recommendations of the Company’s board of directors.

We also agreed to file a registration statement (the "Registration Statement") on Form S-1 (or other appropriate form) providing for the resale of the shares of common stock issuable upon exercise of the New Warrants (the "New Warrant Shares"), on or before November 12, 2023, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective by the U.S. Securities and Exchange Commission (the "SEC") within 90 days following the date of filing with the SEC and to keep the Resale Registration Statement effective at all times until no holder of the New Warrants owns any New Warrants or New Warrant Shares.

In addition, on October 30, 2023, the Company and the Holder entered into an Amendment to Series A Common Stock Purchase Warrants (the "Warrant Amendment") which amended the Existing Warrants to reflect (i) the Reduced Exercise Price, (ii) that the Existing Warrants are now immediately exercisable, and (iii) that the Existing Warrants will terminate on October 30, 2028. The Warrant Amendment is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference. The foregoing description of the Warrant Amendment is qualified in its entirety by reference to such exhibit.

New Warrant Terms

The following summary of certain terms and provisions of the New Warrants is not complete and is subject to, and qualified in its entirety by, the provisions of the New Warrants, the form of which is filed as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated herein by reference. The following description of the New Warrants is qualified in its entirety by reference to such exhibit.

Exercise Period and Dilution

Each New Warrant will have an exercise price equal to its applicable Reduced Exercise Price. The New Warrants are immediately exercisable on the date of issuance and may be exercised for a period of five years therefrom. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate proportional adjustment in the event of share dividends, share splits, reorganizations or similar events affecting our common stock and the exercise price.

Exercisability

The New Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice and, within the earlier of (i) two trading days and (ii) the number of trading days comprising the standard settlement period with respect to the common stock as in effect on the date of delivery of the notice of exercise thereafter, payment in full for the number of shares of common stock purchased upon such exercise (except in the case of a cashless exercise as discussed below). A holder may not exercise any portion of the New Warrant to the extent that the holder, together with its affiliates and any other persons acting as a group together with any such persons, would own more than 4.99% (or, at the election of the purchaser, 9.99%) of the number of shares of common stock outstanding immediately after exercise (the "Beneficial Ownership Limitation"); provided that a holder with a Beneficial Ownership Limitation of 4.99%, upon notice to us and effective  61 days after the date such notice is delivered to us, may increase the Beneficial Ownership Limitation so long as it in no event exceeds 9.99% of the number of shares of common stock outstanding immediately after exercise.

Cashless Exercise

If, at the time a holder exercises its New Warrants, a registration statement registering the issuance of the shares of common stock underlying the New Warrants under the Securities Act is not then effective or available for the issuance of such shares, then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, the holder may only exercise its New Warrants (either in whole or in part), at such time by means of a cashless exercise in which the holder shall be entitled to receive upon such exercise the net number of shares of common stock determined according to a formula set forth in the New Warrants, which generally provides for a number of shares of common stock equal to (A) (1) the volume weighted average price on (x) the trading day preceding the notice of exercise, if the notice of exercise is executed and delivered on a day that is not a trading day or prior to the opening of "regular trading hours" on a trading day or (y) the trading day of the notice of exercise, if the notice of exercise is executed and delivered after the close of "regular trading hours" on such trading day, or (2) the bid price on the day of the notice of exercise, if the notice of exercise is executed during "regular trading hours" on a trading day and is delivered within two hours thereafter, less (B) the exercise price, multiplied by (C) the number of shares of common stock the New Warrant was exercisable into, with such product then divided by the number determined under clause (A) in this sentence.

Fractional Shares

No fractional shares of common stock will be issued upon the exercise of the New Warrants. Rather, we will, at our election, and in lieu of the issuance of such fractional share, either (i) pay cash in an amount equal to such fraction multiplied by the exercise price or (ii) round up to the next whole share issuable upon exercise of the New Warrant.

Transferability

Subject to applicable laws, a New Warrant may be transferred at the option of the holder upon surrender of the New Warrant to us together with the appropriate instruments of transfer and funds sufficient to pay any transfer taxes payable upon such transfer.

Market

There is no trading market available for the New Warrants on any securities exchange or nationally recognized trading system. We do not intend to list the New Warrants on any securities exchange or nationally recognized trading system. The shares of common stock issuable upon exercise of the New Warrants are currently quoted on the Pink Open Market tier operated by OTC Markets Group, Inc. (the "OTC Pink") under the symbol "ATHX."

Rights as a Stockholder

Except as otherwise provided in the New Warrants or by virtue of such holder’s ownership of shares of the Company’s common stock, the holders of the New Warrants do not have the rights or privileges of holders of the Company’s common stock, including any voting rights, until they exercise their New Warrants.

Fundamental Transaction

In the event of a fundamental transaction, as described in the New Warrants and generally including any reorganization, recapitalization or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding shares of common stock, the holders of the New Warrants will be entitled to receive upon exercise of the New Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the New Warrants immediately prior to such fundamental transaction. Additionally, in the event of a fundamental transaction, we or any successor entity will, at the option of the holder of a New Warrant exercisable at any time concurrently with or within 30 days after the consummation of the fundamental transaction (or, if later, the date of the public announcement thereof), purchase the New Warrant from the holder by paying to the holder an amount of consideration equal to the value of the remaining unexercised portion of such New Warrant on the date of consummation of the fundamental transaction based on the Black-Scholes option pricing model, determined pursuant to a formula set forth in the New Warrants. The consideration paid to the holder will be the same type or form of consideration that was offered and paid to the holders of shares of common stock in connection with the fundamental transaction; provided that if no such consideration was offered or paid, the holders of common stock will be deemed to have received common stock of the successor entity in such fundamental transaction for purposes of this provision of the New Warrants.

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ArriVent Receives FDA Breakthrough Therapy Designation for Furmonertinib for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

On October 30, 2023 ArriVent Biopharma, Inc., a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (Press release, ArriVent Biopharma, OCT 30, 2023, https://arrivent.com/arrivent-receives-fda-breakthrough-therapy-designation-for-furmonertinib-for-first-line-treatment-of-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations/?utm_source=rss&utm_medium=rss&utm_campaign=arrivent-receives-fda-breakthrough-therapy-designation-for-furmonertinib-for-first-line-treatment-of-advanced-or-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations [SID1234636428]).

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"Breakthrough Therapy designation is an important step forward in our development of furmonertinib and highlights its exciting potential as a first-line therapy for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations," said Bing Yao, Chairman, Co-founder and Chief Executive Officer of ArriVent.

Stuart Lutzker, Co-founder and President of R&D added: "This FDA designation underscores the encouraging clinical activity we have seen with furmonertinib in the FAVOUR study and reflects the critical need for effective and tolerable therapeutic options for these patients. We look forward to continuing our work with the agency as we progress our furmonertinib clinical development program in NSCLC, including our ongoing pivotal, global Phase 3 FURVENT trial evaluating furmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations."

The Breakthrough Therapy designation was granted based on interim results from FAVOUR trial (NCT04858958), a Phase 1b, randomized, open-label, multi-center clinical trial evaluating the efficacy and safety of furmonertinib in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. FDA’s Breakthrough Therapy designation is designed to expedite development and review of drugs intended to treat a serious or life-threatening condition for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies. Interim results from the trial demonstrated furmonertinib has promising anti-tumor activity as a single agent with a well-tolerated safety profile in the first-line and previously treated patients. The pivotal Phase 3 FURVENT trial (NCT05607550) of furmonertinib for the treatment of first-line NSCLC with EGFR exon 20 insertion mutations is currently enrolling patients globally.

Aptose Presents Highlights from Clinical Update Webcast Featuring Latest Available Data on AML Drug Tuspetinib

On October 30, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported highlights from a clinical update event held today, October 30, 2023, in conjunction with the European School of Haematology (ESH) 6th International Conference: Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, being held in Estoril, Portugal (the "ESH 2023 Conference") (Press release, Aptose Biosciences, OCT 30, 2023, View Source [SID1234636427]).

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The webcast event featured a comprehensive review of up-to-date clinical data for Aptose’s lead compound tuspetinib (TUS) by Rafael Bejar, MD, PhD, Aptose’s Chief Medical Officer, and featured Naval G. Daver, MD, Professor, Director Leukemia Research Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX. Dr. Daver is the lead investigator on Aptose’s APTIVATE trial of tuspetinib and is recognized for significant achievements in the development of novel acute myeloid leukemia (AML) treatments, including several combination therapies.

Tuspetinib (TUS) is a once-daily, oral, precision targeted kinase inhibitor that suppresses select kinases that drive the proliferation of AML. These key kinase targets include the SYK, FLT3, JAK1/2, mutant forms of KIT, RSK2, and the TAK1-TAB1 kinases operative in AML, while other kinases are avoided to promote safety.

AML care has shifted toward venetoclax (VEN) containing combination regimens and a new population of difficult-to-treat VEN relapsed patients ("VEN failures") is emerging. Tuspetinib’s safety, activity, mechanism of action, and convenient dosing make it ideal for combination therapy. Importantly, TUS directly targets VEN resistance mechanisms (suppresses mutated FLT3, mutated KIT, SYK and mutated JAK1/2 of the JAK/STAT pathway, RSK2 of the RAS/MAPK pathway, key oncogenic growth and proliferation signals, and MCL-1 expression). This means that TUS targets pathways and may lead to re-sensitizing VEN-resistant cells to VEN when given in combination. TUS/VEN may safely and successfully treat these VEN failures, as we already have observed clinically, and an accelerated approval path may be available for VEN failure relapsed or refractory (R/R) AML patients treated with TUS/VEN.

"We are really pleased by our growing safety and efficacy data on tuspetinib in very difficult-to-treat AML patient populations," said Dr. Bejar. "This includes activity in FLT3-unmutated patients, a population that accounts for more than 70% of AML and has few effective treatment options. Additionally, tuspetinib’s significant activity in patients who have failed venetoclax treatment – a rapidly-emerging population of particularly high unmet medical need – provides a clear development pathway for tuspetinib with the potential for accelerated approval."

"The safety and efficacy data we’ve seen with the tuspetinib/venetoclax combination is very encouraging, suggesting that tuspetinib may effectively treat the large number of VEN failures we are seeing frequently in our clinics," said Dr. Daver. "Data from the TUS/VEN doublet gives us confidence to move tuspetinib forward into a TUS/VEN/HMA triplet for the treatment of frontline newly-diagnosed AML patients. Tuspetinib is an exciting agent, and I am happy to be part of the clinical development team."

Clinical Findings

Aptose provided updated clinical findings from the ongoing APTIVATE study of tuspetinib:

Patient Enrollment

More than 140 patients have been treated with tuspetinib to date
91 patients have received TUS as a single agent
Aptose anticipated dosing up to 30 patients with TUS/VEN by the ESH 2023 Conference; however, investigator enthusiasm resulted in dosing of 49 patients (as of October 23, 2023), and patients continue being enrolled
Safety Profile

In the most recent data cut (October 23, 2023), the favorable safety profile remained consistent for TUS and TUS/VEN treated R/R AML patients:

No TUS related adverse events (AEs) of QTc prolongation
No observed differentiation syndrome
No TUS related non-hematologic serious AEs
No TUS related deaths
No rhabdomyolysis or AEs of elevated creatine phosphokinase (CPK)
No TUS related dose-limiting toxicities (DLT) from 20 mg level through 160 mg level
One DLT of muscle weakness at 200 mg
Occurred in patient with high exposure
Not rhabdomyolysis │ No muscle destruction
Avoids many typical toxicities observed with other FLT3, IDH1/2, and menin inhibitors
In TUS/VEN doublet, no unexpected or new safety signals were observed
Tuspetinib Single Agent

Tuspetinib as a single agent was well-tolerated and highly active among relapsed or refractory (R/R) AML patients with a diversity of adverse genotypes. TUS single agent delivered 42% and 60% CR/CRh response rates across all patients and across FLT3-mutated patients, respectively, among evaluable VEN-naïve patients at the 80mg daily recommended phase 2 dose (RP2D)
Tuspetinib demonstrated a 29% CR/CRh rate in VEN-naïve FLT3 unmutated (wildtype) AML at 80 mg daily RP2D, unlocking the potential for TUS to treat the additional 70-75% of the AML population without FLT3-mutation not currently addressed by any approved tyrosine kinase inhibitors
Responses were achieved across four dose levels
Responses were shown to mature over time with sustained blood count recovery during continuous dosing
Several responders were bridged to potentially lifesaving transplant (HSCT)
Durability was observed when HSCT was unavailable
Tuspetinib single agent response rates compare favorably to gilteritinib FLT3 inhibitor
TUS/VEN Doublet (TUS 80mg/VEN 400mg)

Patients who have failed venetoclax treatment represent an increasing AML population in need of improved salvage therapies
Over 90% of recent U.S. patients enrolled in the APTIVATE trial were VEN failures
VEN resistance involves mutations in multiple pathways to evade BCL-2 blockade
Tuspetinib directly targets pathways involved in VEN resistance
By shutting down these pathways, tuspetinib appears to re-sensitize prior-VEN failures to venetoclax (see poster presented at the ESH 2023 Conference here)
Overall Response Rates (ORR) with TUS/VEN Doublet (see Table below, includes recent preliminary responses)

31 evaluable patients showed an ORR 48% (15 of 31)
81% (25 of 31) of patients were VEN failures
44% ORR (11 of 25) in VEN failures
60% ORR (6 of 10) in FLT3-mutant
43% ORR (9 of 21) in FLT3-wildtype
Most patients are very early in treatment, having initiated dosing in the past 2-6 weeks, and responses are expected to mature over time
Overall Response Rates

Patient Population Aug 1, 2023
10 patients evaluable
of 15 dosed Sep 1, 2023
15 patients evaluable
of 26 dosed Oct 23, 2023
31 patients evaluable
of 49 dosed
Prior-VEN Failures 44% (4 of 9) 38% (5 of 13) 44% (11 of 25)
FLT3-Mutant 67% (2 of 3) 67% (4 of 6) 60% (6 of 10)
FLT3-Wildtype 43% (3 of 7) 33% (3 of 9) 43% (9 of 21)
Overall 50% (5 of 10) 47% (7 of 15) 48% (15 of 31)
Response Types 1CR│3CRi│1CRp 1CR│6CRi 2CR│7CRi│6PR

Multiple Planned Value-creating Milestones Ahead

TUS/VEN incremental data readout in R/R AML planned: ASH (Free ASH Whitepaper) 2023
TUS/VEN further data on duration of response in R/R AML planned: 1Q & 2Q2024
TUS/VEN/HMA planned initiation of pilot triplet study in 1L AML: 1H2024
Extension into HR-MDS and CMML planned: 4Q2023
The associated slides from the presentation are available on Aptose’s website here. The webcast of the presentation will be archived here.

Allogene Therapeutics Announces Participation in November Investor Conferences

On October 30, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will participate in two upcoming investor conferences in November (Press release, Allogene, OCT 30, 2023, View Source [SID1234636426]).

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TD Cowen’s 7th Annual Fall Oncology Innovation Summit
Friday, November 3, 2023
8:30AM PT/11:30AM ET

Jefferies London Healthcare Conference
November 15, 2023
4:30AM PT/7:30AM ET/1:30PM GMT

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

AIM ImmunoTech Announces Abstract Accepted for Poster Presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting

On October 30, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that an abstract from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine ("UPMC") has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting being held November 1 – 5, 2023 in San Diego, CA and virtually (Press release, AIM ImmunoTech, OCT 30, 2023, View Source [SID1234636425]).

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The abstract concerns a Phase 2 single arm efficacy/safety trial to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with AIM’s drug Ampligen and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer. The abstract authors include Robert Edwards, MD, Chief Medical Officer of the UPMC Community and Ambulatory Services Division and Co-Director of the Women’s Cancer Research Center at the UPMC Hillman Cancer Center.

Details for the presentation are as follows:

Abstract Number: 799
Title: Combination intraperitoneal chemoimmunotherapy triggers a T-cell chemotactic locoregional response in patients with recurrent platinum-sensitive ovarian cancer

For more information, please visit the SITC (Free SITC Whitepaper) website.