PULM Pulmatrix Inc

 

 

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): January 6, 2024

 

 

PULMATRIX, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-36199		46-1821392
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

36 Crosby Drive, Suite 100

Bedford, MA 01730

(Address of principal executive offices) (Zip Code)

 

(781) 357-2333

(Registrant’s telephone number, including area code)

 

N/A

(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 exchange on which registered
Common Stock, par value $0.0001 per share		PULM		The NASDAQ Stock Market LLC

 

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 1.01 Entry into a Material Definitive Agreement.

 

As previously disclosed, on April 15, 2019, Pulmatrix, Inc. (the “Company”) and Pulmatrix Operating Company, Inc. entered into a Development and Commercialization Agreement (as amended on May 3, 2019 and November 8, 2021, the “Cipla Agreement”) with Cipla Technologies LLC (“Cipla” and together with the Company and Pulmatrix Operating Company, Inc., the “Parties”), for the co-development and commercialization, on a worldwide exclusive basis, of Pulmazole (PUR1900), the Company’s inhaled iSPERSE drug delivery system (the “Product”) enabled formulation of the antifungal drug, itraconazole, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis in patients with asthma.

 

On January 6, 2024 (the “Effective Date”), the Parties entered into the third amendment to the Cipla Agreement (the “Third Amendment”), which terminates the Phase 2b clinical study (the “Phase 2b Clinical Study”) of the Product and makes certain related modifications to the Cipla Agreement. The Third Amendment, among other things, provides that all development and commercialization activities with respect to the Product in all countries outside the United States (such countries, the “Cipla Territory”) will be conducted exclusively by Cipla, with all such development and commercialization expenses of the Product in the Cipla Territory incurred after the Effective Date to be borne at Cipla’s sole cost and expense.

 

Additionally, during the period commencing on the Effective Date and ending on July 30, 2024, the Company has agreed to use commercially reasonable efforts to immediately close enrollment for the Phase 2b Clinical Study and to terminate the Phase 2b Clinical Study as soon as reasonably possible. In connection with the termination of the Phase 2b Clinical Study (the “Development Wind Down Plan”), the Company and Cipla will each be responsible for (i) 60% and 40%, respectively, of the Company’s overhead costs and the time spent by the Company’s employees and consultants on development of the Product (the “Direct Costs”) associated with the Development Wind Down Plan, and (ii) 50% each for all of the other development costs that are not Direct Costs (the “Non-Direct Costs”) associated with the Development Wind Down Plan. The Company has agreed to work to immediately reduce all Non-Direct Costs to the minimum amount necessary to terminate the Phase 2b Clinical Study, including through the termination of contract research organization sites and other agreements, and to assign and/or transfer to Cipla all relevant contracts, regulatory documents, product data and other similar documents required for the continued development of the Product, among others.

 

The foregoing is only a summary of the material terms of the Third Amendment and does not purport to be complete. The foregoing summary is qualified in its entirety by reference to the complete text of the Third Amendment, which is attached hereto as Exhibit 10.1 and incorporated herein by reference.

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On January 8, 2024, the Company issued a press release (the “Press Release”) regarding its entry into the Third Amendment and the termination of the Phase 2b Clinical Study, which is attached hereto as Exhibit 99.1. The Press Release additionally contains certain preliminary selected financial information for the year ended December 31, 2023.

 

The preliminary selected financial results reported by the Company are unaudited, subject to adjustment, and in accordance with General Instruction B.2 of Form 8-K, being furnished pursuant to Item 2.02 and thus shall not be deemed to be “filed” for the 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 incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

On January 6, 2024, the Company and Teofilo Raad entered into a letter agreement (the “Letter Agreement”), pursuant to which Mr. Raad shall be granted a retention bonus of $170,000 per quarter, for each of the full calendar quarters ending March 31, 2024 and June 30, 2024, respectively, less applicable payroll and other tax withholdings (such bonus, the “Retention Bonus”). Pursuant to the Letter Agreement, Mr. Raad must be employed by the Company on the last day of such applicable calendar quarter unless Mr. Raad’s employment is terminated on the closing date of a potential acquisition of the Company by an unrelated third party, merger by the Company with or into an unrelated third party or other liquidation event (such closing date, the “Retention Date”), in which case, Mr. Raad shall receive the full Retention Bonus for the calendar quarter in which the Retention Date occurs.

 

Notwithstanding the foregoing, if Mr. Raad’s employment with the Company is terminated by the Company without Cause (as defined in the Amended and Restated Executive Employment Agreement by and between Mr. Raad and the Company dated June 28, 2019, as amended) prior to the Retention Date, or due to death or disability, then the Company shall pay to Mr. Raad the full Retention Bonus with respect to the calendar quarter of such termination, subject to the receipt of a release of claims by the Company (the “Release”). The Company shall not be obligated to pay the Retention Bonus if (i) Mr. Raad terminates his employment with the Company prior to the Retention Date, (ii) the Company terminates Mr. Raad’s employment prior to the Retention Date for Cause, or (iii) Mr. Raad’s employment is terminated due to his death, disability or by the Company without Cause, and a Release has not been received.

 

The foregoing is only a summary of the material terms of the Letter Agreement and does not purport to be complete. The foregoing summary is qualified in its entirety by reference to the complete text of the Letter Agreement, which is attached hereto as Exhibit 10.2 and incorporated herein by reference.

 

Item 7.01 Regulation FD Disclosure.

 

The Company also intends, from time to time, to present and/or distribute to the investment community and utilize at various industry and other conferences a slide presentation, which is attached hereto as Exhibit 99.2. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.2, being furnished pursuant to Item 7.01, shall not be deemed to be “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 8.01 Other Events

 

On January 8, 2024, the Company issued the Press Release, which is attached hereto as Exhibit 99.1 and incorporated herein by reference (excluding the portions of Exhibit 99.1 that are furnished and not deemed “filed” pursuant to Item 2.02 of this Current Report on Form 8-K).

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
10.1*		Third Amendment to Development and Commercialization Agreement, dated January 6, 2024, by and between the Company, Pulmatrix Operating Company, Inc., and Cipla Technologies LLC
10.2		Letter Agreement, dated January 6, 2024, by and between Teofilo Raad and the Company
99.1**		Press Release, dated January 8, 2024
99.2		Investor Presentation (furnished herewith pursuant to Item 7.01)
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Certain of the schedules (and similar attachments) to this exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K under the Securities Act because they do not contain information material to an investment or voting decision and that information is not otherwise disclosed in the exhibit or the disclosure document. The registrant hereby agrees to furnish a copy of all omitted schedules (or similar attachments) to the Securities and Exchange Commission upon its request.

 

** Certain information within this exhibit is furnished pursuant to Item 2.02 and shall not be deemed to be “filed.”

 

 

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.

 

	PULMATRIX, INC.
Date: January 8, 2024	By:	/s/ Teofilo Raad
		Teofilo Raad
		Chief Executive Officer

 

 

 

Exhibit 10.1

 

THIRD AMENDMENT TO THE DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

This Third amendment to the Development and Commercialization Agreement (“Third Amendment”) is entered into as of 6 January, 2024 (the “Effective Date”) and to the extent applicable amends the Development and Commercialization Agreement entered into on April 15, 2019 (as amended by the parties on May 3, 2019 (the “First Amendment”) and as further amended by the parties on November 8, 2021 (the “Second Amendment”) collectively (the “Agreement”) between, PULMATRIX, INC. a company incorporated under the laws of the State of Delaware, and PULMATRIX OPERATING COMPANY, INC., a company incorporated under the laws of the State of Delaware (together the “Company”), and each having a principal place of business at 36 Crosby Drive, Suite 100, Bedford, Massachusetts 01730, and CIPLA TECHNOLOGIES, LLC, a limited liability company organized under the laws of Delaware and having a principal place of business at 7 Oser Avenue, Hauppauge, NY 11788 (“Cipla”). Company and Cipla may be referred to herein as a “Party” and collectively as the “Parties.” Capitalized terms used herein but not otherwise defined herein shall have the respective meanings given such terms in the Agreement.

 

RECITALS

 

Whereas:

 

A.	Prior to the date of this Third Amendment, the Parties initiated a new Phase 2b Clinical Study of the Product (“Phase 2b Clinical Study.”)

 

B.	The Parties agree to terminate the Phase 2b Clinical Study and consequently intend to suspend further enrollment of patients in the Phase 2b Clinical Study and make certain related modifications to the terms of the Agreement; and

 

Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows.

 

1.1

Recitals & Modifications. (a) The above preamble shall be an integral part of this Third Amendment; (b) provisions of the Agreement not expressly modified or amended by this Third Amendment shall continue to apply without any change thereto and (c) in the event of inconsistency in the provisions of this Third Amendment and those of the Agreement, the provisions of this Third Amendment shall prevail.

 

1.2	Amendments to Article 1 of the Agreement. Article 1 of the Agreement is hereby amended by adding the following definitions thereto in appropriate alphabetical order:

 

“Third Amendment” means the Third Amendment to the Agreement dated 6 January, 2024, by and between the Parties.

 

1.3	Amendments to Section 1.2 of the Second Amendment.

 

1.3.1

Section 1.2(a) of the Second Amendment is hereby amended and restated as follows with effect from and after the Effective Date:

 

“(a) Subject to the terms of this Second Amendment, all Development and Commercialization activities with respect to the Product in all countries outside of the United States (such countries outside of the United States, the “Cipla Territory”) will be conducted exclusively by Cipla and all expenses associated with the development and commercialization of the Product in the Cipla Territory incurred after the Effective Date, shall be at Cipla’s sole cost and expense. Accordingly, each reference to the Territory in the Agreement is by reference amended to exclude the Cipla Territory, as the term has been defined in this Third Amendment. For the avoidance of doubt, from the Effective date Cipla Territory shall mean and include all countries except the United States. ”

 

 

1.3.2

Section 1.2(b) of the Second Amendment is hereby amended and restated as follows with effect from and after the Effective Date:

 

“(b) All of Cipla’s Development activities for the Product in the Cipla Territory shall be conducted pursuant exclusively to one or more plans (such plans, a “Cipla Territory Development Plan(s)”) prepared by Cipla.”

 

1.3.3

Section 1.2(f) of the Second Amendment is hereby amended and restated as follows with effect from and after the Effective Date:

 

“(f) All Product used in the Development or Commercialization in the Cipla Territory may at Cipla’s decision and sole cost be supplied utilizing the Company’s existing global supply chain for manufacturing of the Product (it being understood that Cipla will need to enter new agreements with the Company’s existing vendors and suppliers in order to utilize such supply chain). Cipla, may, at its option and at its sole cost and expense, transfer the manufacturing of the Product for Development or Commercialization activities in the Cipla Territory to a manufacturing site designated by Cipla. Any such manufacturing site shall be qualified under applicable laws and such site transfer shall be conducted in accordance with applicable laws and regulations, good manufacturing practices (as defined by the International Council on Harmonization). The Company shall cooperate with Cipla in such site transfer and all actual costs and expenses, including cost of time spent by the Company’s employees and consultants, incurred by the Company in connection with such site transfer to the extent that such cost is solely incurred with respect to the Cipla Territory shall be paid by Cipla in the Wind Down Phase Funding contributed by Cipla.”

 

1.3.4

Section 1.2(g) of the Second Amendment is hereby amended and restated as follows with effect from and after the Effective Date:

 

“(g) Section 6.5 of the Agreement shall not apply with respect to any sublicense or other transfer of Cipla’s rights under the Agreement and this Second Amendment with respect to the Cipla Territory. For clarity, (i) nothing herein impacts Cipla’s ownership of the Assigned Assets as detailed under Section 6.1 of the Agreement; and (ii) Cipla will solely and exclusively own all of the Intellectual Property Rights generated with respect to the Cipla Territory, provided, that, without limiting Cipla’s absolute ownership of Assigned Assets and the Cipla Territory Intellectual Property Rights as stated in the foregoing sentence.”

 

1.4	Amended Phase 2b Development Plan.

 

1.4.1

The Parties previously adopted a Development Plan, including a budget of all Development Costs, for a Phase 2b Clinical Study of the Product for the treatment of ABPA (the “Phase 2b Development Plan”).

 

 

1.4.2

During the period commencing on the Effective Date and ending July 30, 2024 (the “Wind Down Period”); the Parties agree to do the following, at no extra cost to Cipla, except as otherwise approved in a JSC approved Budget and subject to appropriate proportion of expenses sharing between the Company and Cipla as stated below:

 

1.4.2.1.1 the Company will use Commercially Reasonable Efforts to immediately close enrollment for the Phase 2b Clinical Study and terminate the Phase 2b Clinical Study as soon as reasonably possible;

 

1.4.2.1.2 Exhibit C sets forth the patents related to the Product and Cipla’s rights therein as previously licensed and assigned pursuant to Article 6 of the Agreement. The Company will reasonably cooperate with Cipla in perfecting such assignment or license of all Patents (as in Exhibit C) to Cipla and their registration with the appropriate authorities in the Cipla Territory;

 

1.4.2.1.3 reserved;

 

1.4.2.1.4 the Company will to the extent not yet completed, complete a physical and demonstrable Company assisted technology transfer (“Tech Transfer”) and assignment of all Development, Intellectual Property Rights, proprietary data and technology (“Proprietary Data and Technology”) and technology to Cipla, an indicative and non-exhaustive list of which activity items is attached as EXHIBIT A; this list being subject to further changes and supplementation by Cipla and the Company;

 

1.4.2.1.5 during the Wind Down Period, each Party will use Commercially Reasonable Efforts to secure all data from the Phase 2b Clinical Study for inclusion in the safety database for the Cipla Territory program;

 

1.4.2.1.6 a development wind down plan is attached hereto as Exhibit B (“the Development Wind Down Plan”) for implementation and closure within the Wind Down Period, for approval by the JSC, the Development Wind Down Plan being effective immediately upon such approval;

 

1.4.2.1.7 all Direct Costs to terminate the Phase 2b Clinical Study shall be within the budget approved in Development Wind Down Plan and the Company and Cipla will each be responsible for sixty percent (60%) and forty percent (40%), respectively of Wind Down Period Direct Costs;

 

1.4.2.1.8 the Company will work to immediately reduce all Non-Direct Costs to the minimum amount necessary to terminate the Phase 2b Clinical Study, including the termination of CRO or contract research organization, sites and other agreements and within the budget approved in Development Wind Down Plan (allowing for possible eight percent (8%) overage from the budget), the Company and Cipla then being responsible for the Wind Down Period Non-Direct Costs in the manner set out in Clause 3.5 of the Agreement as amended by Clause 1.5.1 of this Amendment;

 

1.4.2.1.9 Cipla shall pay Company for the period up to the Effective Date, all accrued Direct and Non-Direct Costs computed according to the Second Amendment;

 

 

1.4.2.2 Exhibit B is the Company expected timeline for Phase 2b clinical study wind down;

 

1.4.2.2.1 all relevant contracts, regulatory documents, product data and other similar documents required for the continued development of the Product shall be assigned and transferred to Cipla during the Wind Down Period; and

 

1.4.2.2.2 the Parties’ shall use Commercially Reasonable Efforts to monetize the Parties’ rights in the Product within the United States.

 

	1.4.2.3	The Parties understand that expenses incurred during the Wind Down Period may not be invoiced by third party vendors until after the expiration of the Wind Down Period and the Parties shall remain liable for the respective share of any expenses appropriately incurred during the Wind Down Period regardless of when invoiced.
	1.4.2.4	In addition to the requirements stated in this Amendment, Cipla and the Company representatives may add other reasonable items to the list of requirements including but not limted to intellectual property, iSPERSETM for Product, data and technology transfer.

 

1.5	Amendment to Section 3.5.

 

1.5.1

Section 3.5 of the Agreement is hereby amended and restated as follows with effect from and after the date hereof:

 

“ 3.5 Winding Down Period Contributions.

 

Winding Down Phase. After the Initial Development Funding is depleted, Company shall, within ten (10) days after the end of each calendar month, deliver an invoice to Cipla for the Winding Down Period costs incurred by the Company, including a breakdown of Direct Costs and Non-Direct Costs, for such calendar month and for which Cipla is responsible pursuant to Section 3.5(a). By not later than the last Business Day of the calendar month in which such invoice was delivered to Cipla, Cipla shall deliver to the Company, by wire transfer of immediately available funds, the invoiced amount. Attached as EXHIBIT-D is the proposed Wind Down Budget provided by the Company to Cipla, to be discussed, negotiatited, finalized and approved by the JSC. The parties agree that Cipla shall not be responsible for any Non-Direct Cost that is in excess of the budgeted amount therefor set forth on EXHIBIT-D by more than 8%. Furthermore, the parties agree that that Cipla shall not be responsible for any Direct Cost that is in excess of the budgeted amount therefor set forth on EXHIBIT-D.

 

1.6	Amendment to Section 12.4.

 

Section 12.4 of the Agreement is hereby amended and restated as follows with effect from and after the date hereof:

 

1.6.1

Company Termination. Upon written notice to Cipla, the Company shall be entitled to terminate the Agreement upon a sale of all or substantially all assets of the Company or a merger or consolidation involving the Company. For clarity, any Intellectual Property licenses contained in the Agreement that are necessary or Cipla to continue the Development and Commercialization of the Product in the Cipla Territory shall survive any termination of this Agreement pursuant to this Section 12.4.

 

 

1.6.2

In the event that Company desires to abandon or cease prosecution or maintenance of any licensed patents, and trade secrets in any country or in the event of the Company’s bankruptcy is unable to so prosecute or maintain, the Company (or its successor or as applicable its bankruptcy administrator or trustee) shall provide reasonable prior written notice to Cipla of such intention to abandon or cease prosecution (which notice shall, to the extent possible, be given no later than 60 days prior to the next deadline for any action that must be taken with respect to any such patents in the relevant patent office). In such case, at Cipla’s sole discretion, upon written notice to the Company (or its successor or as applicable its bankruptcy administrator or trustee)), Cipla may elect to assume responsibility for prosecution and maintenance of such patents, at Cipla’s sole cost and expense and by counsel of its own choice, in which event the Company (or its successor or as applicable its bankruptcy administrator or trustee) shall at no cost assign the respective patents to Cipla.

 

1.6.3

Intellectual Property Rights Protection. The Agreement is the intellectual property licensing agreement for the applicable Intellectual Property Rights and licensed technology, including for the purposes of the United States Bankruptcy Code §365(n) protection of Cipla’s continued use of the licensed Intellectual Property Rights and licensed technology, in the event of the Company’s bankruptcy.

 

1.6.4

For clarity, the provisions of clauses 1.6.2 and 1.6.3 above shall apply to the iSPERSETM technology.

 

1.6.5

Entire Agreement. This Third Amendment, as part of the Agreement, constitutes the entire agreement between the Parties with respect to the subject matter herein, and supersedes all prior agreements, proposals, negotiations, representations or communications relating to such subject matter. The Parties acknowledge that they have not been induced to enter into this Agreement by any representations or promises not specifically stated herein.

 

1.6.6

Execution; Counterparts. This Third Amendment may be executed in multiple counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile signatures, including signatures in a fixed electronic format such as PDF, shall have the same effect as originals.

 

(Signature Page Follows) 

 

 

IN WITNESS WHEREOF, THE PARTIES HAVE EXECUTED THIS THIRD AMENDMENT AS OF THE EFFECTIVE DATE.

 

PULMATRIX, INC.			PULMATRIX OPERATING COMPANY, INC.
By:	/s/ Teofilo Raad		By:	/s/ Teofilo Raad
Name:	Teofilo Raad		Name:	Teofilo Raad
Title:	Chief Executive Officer		Title:	Chief Executive Officer
Date:	January 6, 2023		Date:	January 6, 2023
Cipla Technologies LLC
By:	/s/ Dr. Jaideep Gogtay
Name:	Dr. Jaideep Gogtay
Title:	EVP and Chief Medical Officer
Date:	January 5, 2024

 

 

 

Exhibit 10.2

 

To:	Teofilo Raad
From:	Pulmatrix, Inc.
Date:	January 6, 2024
Subject:	Retention Bonus Opportunity

 

Pulmatrix, Inc. (the “Company”) is in a period of transition. You are a valued member of our team, and we need you to help the Company meet the challenges ahead. To recognize your service to the Company, and to retain your ongoing and future employment with the Company, we are pleased to present you with a retention bonus opportunity, subject to the terms and conditions set forth below. Terms capitalized but not otherwise defined herein shall have the meaning given to such terms in that certain Amended and Restated Executive Employment Agreement by and between you and the Company dated June 28, 2019, as amended (the “Employment Agreement”).

 

We appreciate your commitment to the Company. To accept this retention bonus opportunity, please sign, date and return this letter.

 

TERMS AND CONDITIONS

 

1.	Retention Bonus.

 

a.

You agree to remain employed with the Company through the closing date of a potential acquisition of the Company by an unrelated third party, merger by the Company with or into an unrelated third party or other liquidation event (the “Retention Date”). As consideration for your agreement, the Company agrees to pay you a retention bonus for the full calendar quarters ending March 31, 2024 and June 30, 2024, respectively, provided you remain employed during such quarters, equal to $170,000 each quarter (each “Retention Bonus”), less all applicable payroll and other tax withholdings, payable on the first payroll period of the month following the calendar quarter to which the Retention Bonus relates (for example, the Retention Bonus for the quarter ending March 31, 2024 will be paid in April of 2024). Except as otherwise provided by Section 1.b. below, you must be employed on the last day of the applicable calendar quarter to receive the Retention Bonus for such calendar quarter unless your employment is terminated on the Retention Date, in which case, you shall receive the full Retention Bonus for the calendar quarter in which the Retention Date occurs.

 

b.

Notwithstanding the foregoing, if your employment with the Company is terminated prior to the Retention Date by the Company without Cause (as defined in the Employment Agreement) or due to your death or Disability (as defined in the Employment Agreement), then the Company shall pay the full Retention Bonus with respect to the calendar quarter of your termination of employment to you (or to your estate) on the Company’s next regularly scheduled payroll date following the date you (or your estate or legal representative) return a validly executed, irrevocable release of claims in the form provided by the Company at the time of your termination (the “Release”) and such Release becomes effective; provided, however, that in the event the time period for signing the Release, plus the expiration of any applicable revocation period, begins in one taxable year and ends in a second taxable year, payment of the Retention Bonus will not be made until the second taxable year.

 

 

c.

The Company shall have no obligation to pay you the Retention Bonus for the month of your termination of employment if (i) you terminate your employment with the Company prior to the Retention Date, (ii) the Company terminates your employment with Cause prior to the Retention Date, or (iii) your employment terminates prior to the Retention Date due to your death or Disability or the Company’s termination of your employment without Cause and you (or your estate or legal representative) refuse to sign the Release (or revoke the Release).

 

2.	Right to Continued Employment. Please note that your eligibility for the Retention Bonus does not in any way alter, modify, or amend your relationship with the Company, nor does it guarantee you the right to continue in the employ or service of the Company.

 

3.

Other Benefits. The Retention Bonus is a special incentive payment to you and will not be taken into account in computing the amount of salary or compensation for purposes of determining any bonus, incentive, severance, pension, retirement, death or other benefit under any other bonus, incentive, pension, retirement, insurance, or other employee benefit plan of the Company, unless such plan or agreement expressly provides otherwise.

 

4.	Governing Law. All questions concerning the construction, validity, and interpretation of this letter will be governed by the laws of the State of Massachusetts, without giving effect to conflict of laws principles thereof.

 

5.

Entire Agreement. This letter constitutes the entire agreement between you and the Company with respect to the Retention Bonus and supersedes any and all prior agreements or understandings between you and the Company with respect to the Retention Bonus, whether written or oral. This letter may be amended or modified only by a written instrument executed by you and the Company.

 

We ask that you acknowledge your receipt of this letter and your acceptance of its terms and conditions by signing and dating the Acknowledgement and Acceptance section below and returning it to me for the Company’s records by the Acceptance Date.

 

Very truly yours,

 

/s/ Michael J. Higgins
Michael J. Higgins, Chairman

 

ACKNOWLEDGEMENT AND ACCEPTANCE

 

I hereby acknowledge receipt of this letter setting forth the terms and conditions governing the opportunity to receive the Retention Bonuses. I have carefully read the letter and hereby agree to and accept all those terms and conditions, and agree that my entitlement to any Retention Bonus described in the letter shall be determined solely by the terms and conditions described herein.

 

/s/ Teofilo Raad
Signature
Printed Name: Teofilo Raad
Dated: January 6, 2024

 

 

 

Exhibit 99.1

 

 

Pulmatrix Announces Stopping the PUR1900 Phase 2B Study Patient Enrollment and Closing the Study, in Agreement With Partner Cipla, to Preserve Cash and Facilitate Pursuit of Strategic Alternatives

 

Cipla to take sole responsibility for development of PUR1900, refocused on markets with greatest unmet need and faster path to approval, in exchange for 2% royalty on net sales payable to Pulmatrix

 

Pulmatrix to significantly reduce cash burn and focus on strategic alternatives that leverage the company’s promising pipeline, iSPERSE™ technology and approximately $19 million cash on hand as of 12/31/23

 

BEDFORD, Mass., January 8^th, 2024 – Pulmatrix, Inc. (“Pulmatrix” or the “Company”) (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system diseases, today announced that it has entered into a further amendment to its agreement with Cipla for the development of PUR1900 in the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA). Under the terms of the amendment Cipla and Pulmatrix agreed, among other things, to stop patient enrollment of the Ph2b study of PUR1900 at 8 subjects and close the study.

 

Ted Raad, Chief Executive Officer of Pulmatrix, commented, “Stopping the Ph2b study, along with other cost-savings measures, is expected to extend Pulmatrix’s cash runway into Q1 2026. As of December 31, 2023, Pulmatrix cash on hand was approximately nineteen million dollars. Pulmatrix focus will be on maximizing shareholder value by pursuing strategic alternatives for the company while it winds down the Ph2b study for PUR1900. We are confident in Cipla’s ability to develop PUR1900 for the benefit of patients in markets where there is significant unmet need and a faster path to commercialization.”

 

Pursuant to the amended agreement with Cipla, Pulmatrix has granted Cipla exclusive rights to the development and commercialization of PUR1900 in the “Cipla Territory”, which has been expanded to include all markets other than the United States. In the United States, both parties will seek to monetize PUR1900 which has potential for development in areas other than ABPA in Asthma. After the study winddown, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive 2% royalties on net sales of Pulmazole in the Cipla Territory. For more information about the amendment please refer to Pulmatrix’s Current Report on Form 8-K to be filed with U.S. Securities and Exchange Commission on or around the date of this press release.

 

Pulmatrix has retained MTS Health Partners, L.P. (MTS) as its financial advisor to support the company’s Board of Directors and management team to review and evaluate strategic alternatives intended to maximize long-term value for all stockholders.

 

About PUR3100

 

PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. The Phase 1 PUR3100 trial results were presented at the 65th Annual Meeting of the American Headache society in June 2023. The PUR3100 IND for a Phase 2 trial was accepted by the FDA in September 2023.

 

 

 

About PUR1800

 

PUR1800 is an orally inhaled formulation of RV1162, a narrow-spectrum kinase inhibitor with p38, Syc and Src kinase activity. PUR1800 is being developed for the treatment of acute exacerbations in Chronic Obstructive Pulmonary Disease. The Phase 1 PUR1800 trial results were presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology in February 2023.

 

About iSPERSE™ Technology

 

Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.

 

About Pulmatrix, Inc.

 

Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system (“CNS”) disorders using its patented iSPERSE™ technology. The Company’s proprietary product pipeline includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis (“ABPA”), Chronic Obstructive Pulmonary Disease (“COPD”) and CNS disorders such as acute migraine. Pulmatrix’s product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

 

For more on our inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html.

 

Forward-Looking Statements

 

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that”, “may,” “plans,” “seeks,” “projects,” “targets,” and “would,” and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by, and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the impact of the novel coronavirus (COVID-19) on the Company’s ongoing and planned clinical trials; realizing the expected cost savings from closing the Ph2b study of PUR1900, the ability to identify and consummate strategic alternatives for the Company, our ability to preserve and allocate our cash on-hand most efficiently, the geographic, social and economic impact of COVID-19 on the Company’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Investor Contact:

Timothy McCarthy, CFA

917-679-9282

tim@lifesciadvisors.com

 

 

 

Exhibit 99.2

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

v3.23.4

Cover	Jan. 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 06, 2024
Entity File Number	001-36199
Entity Registrant Name	PULMATRIX, INC.
Entity Central Index Key	0001574235
Entity Tax Identification Number	46-1821392
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	36 Crosby Drive
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Bedford
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01730
City Area Code	(781)
Local Phone Number	357-2333
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	PULM
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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