8-K

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): April 15, 2019

PULMATRIX, INC.

(Exact name of registrant as specified in its charter)

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

99 Hayden Avenue, Suite 390

Lexington, MA 02421

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (781) 357-2333

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ 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))

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

counsel

On April 15, 2019, Pulmatrix, Inc. (the “Company”), entered into a Development and Commercialization Agreement (the “Agreement”) with Cipla Technologies LLC (“Cipla”) for the co-development and commercialization, on a worldwide exclusive basis, of Pulmazole (PUR1900), the Company’s inhaled iSPERSE drug delivery system enabled formulation of the antifungal drug, itraconazole, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis in patients with asthma.

Pursuant to the Agreement, within 30 days following April 15, 2019, Cipla will make an initial upfront payment of $22 million to the Company (the “Upfront Payment”) in exchange for an irrevocable assignment of all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets with respect to Pulmazole, specifically in relation to Pulmonary Indications (“Assigned Assets”), which Cipla will then irrevocably license back to the Company only for non-pulmonary application. In addition, Cipla will be granted a non-exclusive, perpetual, irrevocable, royalty-free and sub-licensable license with respect to the Company’s iSPERSE technology, any current or future right affiliated with the Product with respect to non- pulmonary indications, and any patent or patent application that would otherwise be an Assigned Asset, but which is subject to a terminal disclaimer, in each, case for use with respect to Pulmazole for the Pulmonary Indications. As a condition precedent to signing Agreement, the Company demonstrated to Cipla that is has at least $15 million of unencumbered cash available for the development of Pulmazole. Within 30 days following the signing of the Agreement, the Company will make available at least $24 million of cash dedicated to the development of Pulmazole. After such $24 million is exhausted, each of the Company and Cipla will bear 50% of any costs incurred with respect to the development, regulatory and commercialization costs of Pulmazole. The parties will share equally the total free cash flow in relation to commercialization of Pulmazole.

The parties have agreed to create a joint steering committee (the “JSC”) to have an overview of the development and commercialization activities (including all budgetary activities) in relation to the development and commercialization of Pulmazole. The JSC will be comprised of eight (8) members, with four (4) members representing Cipla and four (4) members representing the Company. The JSC will generally be responsible for approving development and commercialization plans, development budgets, and reviewing and monitoring the progress of the parties’ collaborative efforts under the Agreement.

Under the Agreement, the Company will be primarily responsible for the development of Pulmazole and Cipla will primarily be responsible for the commercialization of Pulmazole, in each case, in accordance with a JSC-approved plan. Each of the Company and Cipla may delegate its development or commercialization activities, as applicable, to an affiliate or other third-party consultant or subcontractor with the prior approval of the JSC, provided that such delegate complies with certain conditions. Under the Agreement, the Company will be responsible for all worldwide regulatory filings until Pulmazole shall have been approved by a regulatory authority in a certain jurisdiction. Cipla will own all regulatory filings, materials and approvals with respect to Pulmazole in relation to pulmonary indications regardless of whether such filing was made by the Company or Cipla.

Under the Agreement, the Company and Cipla have each granted the other party a right of first offer with respect to the rights and assets related to Pulmazole under the Agreement. If either party proposes to sell or in any way alienate such rights or assets, such other party will have the right, following its receipt of written notice, to purchase the rights and/or assets, as applicable, on the same terms. Cipla also has a right of first refusal with respect to any license, sale, assignment, transfer or other disposition or co-development agreement with a third party for non-pulmonary indications of Pulmazole. In addition, if either party develops Pulmazole in respect of indications other that those related to pulmonary applications or develops any other inhaled anti-fungal product, then the other party shall have a right of first offer with respect to such other indications and/or products.

The Agreement will continue in perpetuity unless terminated in accordance with its terms. The Agreement will automatically terminate upon a bankruptcy or insolvency event of the Company or Cipla. The Agreement may be terminated by a party (i) upon material breach of the other party which remains uncured for (30) days following

written notice of breach (ii) if the other party is engaged in willful misconduct or gross negligence or (iii) if the other party is engaged in fraud in connection with the negotiation, execution or performance of the Agreement (collectively, (i)-(iii), “Fundamental Breaches”) by delivering written notice to the other party within 90 days after the later occurrence of the Fundamental Breach or the expiration of any cure period. If a party experiences a force majeure event that continues for 120 days, then the party experiencing such event may terminate the Agreement. In addition, either party may terminate the Agreement on country-by-country basis upon 30 days written notice under certain circumstances.

In the event of a Fundamental Breach by the Company, then Cipla shall have the right to acquire the Company’s interest in Pulmazole for an amount equal to 25% of the fair market value of Pulmazole as determined by an independent third-party appraiser. If Cipla shall cause a Fundamental Breach, then the Company shall the right to acquire Cipla’s interest in Pulmazole for the same amount. If the Agreement is terminated for any reason other than a Fundamental Breach, then Cipla shall continue to own absolute and exclusive ownership of Pulmazole and the intellectual property rights and other associated rights and assets with respect to Pulmazole and all licenses and sublicenses shall cease on the effective date of the termination.

The Agreement contains a mutual exclusivity obligation whereby each party agreed not to develop or commercialize another inhaled anti-fungal product containing itraconazole for pulmonary indications.

The Agreement also contains mutual indemnification obligations of the Company and Cipla.

Item 8.01 Other Events.

On April 15, 2019, the Company issued a press release regarding its entry into the Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit   No.	Description
99.1	Press release, dated April 15, 2019

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: April 15, 2019	By:	/s/ William Duke, Jr.
		William Duke, Jr.
		Chief Financial Officer

EX-99.1

Exhibit 99.1

Pulmatrix and Cipla Technologies LLC enter into Definitive Agreement for the Development and Commercialization of Pulmazole^TM

• Transaction marks Cipla’s entry into specialty respiratory segment, building on inroads made into the specialty business in the recent past

• iSPERSE^™ formulation of the anti-fungal drug itraconazole will enable inhaled drug delivery and on-label treatment of ABPA, a condition that affects over 2 million worldwide

• Definitive Agreement lays ground for Phase 2 study, and partnership between the two companies for future development and commercialization costs as well as revenues from worldwide sales

Lexington, Mass.; April 15, 2019: Pulmatrix, Inc. (NASDAQ: PULM; hereafter referred to as “Pulmatrix”), a clinical stage biopharmaceutical company focused on developing novel inhaled therapeutics to serve unmet needs in respiratory disease, and Cipla Technologies LLC (“Cip Tec”), a subsidiary of Cipla Limited (BSE: 500087; NSE: CIPLA EQ; along with its subsidiaries, affiliates and joint ventures, hereafter together referred to as “Cipla”) today announced their entry into a Definitive Agreement for the co-development and commercialization of Pulmazole^TM (PUR1900) – an inhaled iSPERSE^TM formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.

Following the Definitive Agreement, Cip Tec will make an upfront payment of $22 million to Pulmatrix in exchange for assignment of all rights for Pulmazole in relation to pulmonary indications to Cip Tec. Thereafter, both parties will equally share costs related to the future development and commercialization of Pulmazole, and equally share worldwide free cash flow from future sales of Pulmazole. Pulmatrix will remain primarily responsible for the execution of the clinical development of Pulmazole, and Cip Tec will be responsible for the commercialization of the product. The partnership will be overseen by a Joint Steering Committee with equal representation from both companies.

With the signing of the Definitive Agreement, Pulmatrix is in a strong position to complete the Phase 2 study entitled: ‘A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA)’. Pulmatrix plans to initiate this study in April 2019.

Robert W. Clarke, Ph.D., Chief Executive Officer of Pulmatrix, said: “Cipla’s expertise in respiratory drug development and manufacturing strengthens our development program while its global commercialization experience and footprint will enable us to bring this novel therapeutic option to patients suffering from ABPA. This is also an important financial milestone for the company, securing adequate funds to complete the Pulmazole Phase 2 study, along with 50% commitment from Cip Tec for future Pulmazole development and commercialization costs while retaining worldwide rights to 50% of the free-cash-flow from future revenues.”

Umang Vohra, Managing Director and Global Chief Executive Officer of Cipla, said: “Pulmazole will be Cipla’s entry into the branded respiratory space and will serve a vital unmet medical need for the treatment of ABPA, a condition that possibly impacts over 2 million patients worldwide but has no labelled drug. Pulmatrix has a capable development team and a strong intellectual property (IP) estate through its iSPERSE delivery platform. This creates potential to expand the scope of this collaboration and extract synergies from Cipla’s long-established in-house capability in the development of inhalation therapy solutions.”

About ABPA and inhaled itraconazole

ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of the immune system to the fungus Aspergillus colonizing and growing in the airways. Oral itraconazole (Sporanox^®) is currently used as an adjunctive treatment to corticosteroids in ABPA patients. However, its use is limited by poor bioavailability, variable pharmacokinetics, and toxicity concerns related primarily to the risk of gastrointestinal and cardiac side effects, as well as extensive drug-drug interactions. The Pulmatrix Pulmazole program is the first inhaled dry

powder version of itraconazole known to the company to be advanced into clinical development, with the goal of improving upon the known safety and efficacy profile associated with oral Sporanox^® by delivering the drug directly to the lung.

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE^™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole^TM, inhaled anti-fungal itraconazole for patients with ABPA, and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and chronic obstructive pulmonary disease (“COPD”). Pulmatrix’s product candidates are based on iSPERSE^™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

Investor Contacts
Robert Clarke, Chief Executive Officer	William Duke, Chief Financial Officer
Phone: (781) 357-2333	Phone: (781) 357-2333
E-mail: rclarke@pulmatrix.com	E-mail: wduke@pulmatrix.com

About Cipla Limited

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. Cipla’s strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Cipla’s 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Dec’18), 3rd largest in the pharma private market in South Africa (IQVIA YTD Dec’18), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Its paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement. A responsible

corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com, or click on Twitter, Facebook, LinkedIn.

Corporate Communications	Investor Relations
Heena Kanal	Naveen Bansal
E-mail: CorpComm@cipla.com	E-mail: Investor.Relations@cipla.com

About Cipla Technologies LLC

Cipla has a three-decade history in USA through its long-standing partnerships and through the acquisition of Invagen and Exelan, that marked its entry in the generic space under its own label. Cipla Technologies LLC (“Cip Tec”), a wholly-owned subsidiary of Cipla Ltd, is based in San Diego and was incorporated for the realization of Cipla’s long-term aspiration of becoming a global specialty pharmaceutical company and creating the next growth engine for Cipla. Its focus is to provide effective, innovative and clinically relevant solutions to unmet needs of patients in the CNS & respiratory therapies by creating a pipeline of branded products in the USA specialty market. The Cip Tec pipeline includes CPN 101, a transdermal system for the delivery of Tizanidine, that aims to address the poor tolerability profile and its inconvenient dosing in spasticity patients. The pipeline also includes CPN 103 (formerly CTP 354), an oral Deuterated selective GABA-A agonist for spasticity, pain and anxiety that is expected to have a superior safety profile and a possibly improved efficacy through absence of dose limiting side effects. Cip Tec has created strong capability in scientific, clinical and commercial assessment of innovative assets across the identified focus areas of CNS and Respiratory.

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 safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s

results of operations. 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 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; and 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 filed by the Company with the Securities and Exchange Commission, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. 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.