Form 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): July 23, 2019

 

 

Chiasma, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

DELAWARE   001-37500   76-0722250

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

460 Totten Pond Road, Suite 530

Waltham, Massachusetts

  02451
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code (617) 928-5300

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:

 

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 or to be registered pursuant to Section 12(b) of the Act.

 

Title of each class

 

Trading

symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.01 par value   CHMA   Nasdaq Global Select Market

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 2.02

Results of Operations and Financial Condition.

On July 23, 2019, Chiasma, Inc. (the “Company”) issued a press release announcing top-line results from its pivotal Phase 3 CHIASMA OPTIMAL clinical trial (“CHIASMA OPTIMAL”) evaluating its octreotide capsules product candidate, conditionally trade-named Mycapssa®, for the maintenance treatment of adults with acromegaly (the “Press Release”). The Press Release includes an estimate of the Company’s unaudited cash balance as of June 30, 2019 (the “Financial Information”), which Financial Information is incorporated herein by reference. A copy of the Press Release is furnished herewith as Exhibit 99.1.

The Financial Information set forth in Item 2.02 and in Exhibit 99.1 is intended to be 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, nor shall it be deemed incorporated by reference in any filing 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 7.01

Regulation FD Disclosure.

The Company’s management will host a conference call and webcast to discuss the CHIASMA OPTIMAL results on Tuesday, July 23, 2019 at 8:30 a.m. ET. A copy of the slide deck accompanying such presentation is being furnished as Exhibit 99.2, which is incorporated herein by reference.

The information set forth in Item 7.01 and Exhibit 99.2 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 8.01

Other Events.

On July 23, 2019, the Company issued the Press Release. 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 by Chiasma, Inc. dated July 23, 2019
99.2    Investor Presentation furnished by Chiasma, Inc.


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.

 

Date: July 23, 2019     Chiasma, Inc.
    By:  

/s/ Mark J. Fitzpatrick

      Mark J. Fitzpatrick
      President
EX-99.1

Exhibit 99.1

 

LOGO

Chiasma Announces Positive Phase 3 Top-Line Results from CHIASMA OPTIMAL Clinical Trial of Mycapssa® for the Maintenance Treatment of Adults with Acromegaly

SPA-agreed trial met primary and all secondary endpoints

No new or unexpected safety signals in the Mycapssa treated patients

90% of the patients treated with Mycapssa who completed the 36-week study opted to continue into the Open Label Extension

Company to host conference call today at 8:30 a.m. EDT

Waltham, MA – July 23, 2019 – Chiasma, Inc. (NASDAQ: CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today announced positive top-line data from the company’s pivotal Phase 3 CHIASMA OPTIMAL clinical trial evaluating its octreotide capsules product candidate, conditionally trade-named Mycapssa®, for the maintenance treatment of adults with acromegaly.

In the CHIASMA OPTIMAL trial, a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules conducted under special protocol assessment, or SPA, agreement with the U.S. Food and Drug Administration, or FDA:

 

   

The primary endpoint was met: 58% of the patients on octreotide capsules maintained their IGF-1 response compared to 19% of the patients on placebo (p = 0.008).

 

   

All secondary endpoints were met.

“We are pleased with the positive results from the CHIASMA OPTIMAL trial and we believe this brings us one step closer to making the first oral somatostatin analog (SSA) product candidate available to adults suffering from acromegaly,” said Raj Kannan, Chief Executive Officer of Chiasma. “We plan to submit an NDA by the end of the year with an expected six-month PDUFA review time period.”

“I am excited that the CHIASMA OPTIMAL study met the primary and all secondary endpoints,” commented Susan Samson, MD, PhD, Medical Director of the Pituitary Center at Baylor St. Luke’s Medical Center, and lead investigator of the CHIASMA OPTIMAL study. “I consistently observe the burdens posed by SSA injections, including injection site pain and reactions. I believe octreotide capsules, if approved, would be a welcome treatment option to patients and physicians.”


Mycapssa® Secondary Efficacy Data:

 

   

78% of patients treated with octreotide capsules maintained their growth hormone (GH) levels below 2.5 ng/mL at the end of the core study vs. 30% of patients treated with placebo (p = 0.001)

 

   

Median time to loss of response (IGF-1 >1.0 × ULN) was not reached (>36 weeks) for patients treated with octreotide capsules vs. 16 weeks for patients treated with placebo (p <0.001)

 

   

Median time to loss of response (IGF-1 ³ 1.3 × ULN) was not reached (>36 weeks) for patients treated with octreotide capsules vs. 16 weeks for patients treated with placebo (p <0.001)

 

   

25% of patients treated with octreotide capsules required rescue medication with injectable SSAs (octreotide LAR or lanreotide depot) anytime throughout the study vs. 68% of patients treated with placebo (p =0.003)

Additionally, in a pre-specified exploratory endpoint, mean IGF-1 values across all patients treated with octreotide capsules (including primary endpoint non-responders per protocol), remained within normal limits (£ 1.0 x ULN) up to the end of oral treatment. For purposes of this analysis, the end of oral treatment value was the average of week 34 and week 36 values for all patients who completed the study on octreotide capsules and for those patients that required rescue medication, it was their last observed value prior to the use of rescue medication.

Mycapssa® Safety and Tolerability:

In the CHIASMA OPTIMAL trial, octreotide capsules appeared safe and well tolerated. No new or unexpected safety signals were observed. The overall number of treatment emergent adverse events (TEAEs) was comparable between the octreotide capsules and placebo treatment groups. Two patients on octreotide capsules and one patient on placebo discontinued treatment due to TEAEs. Two patients on octreotide capsules and one patient on placebo had serious adverse events, or SAEs, assessed as not related to study drug. Severe TEAEs as well as TEAEs of special interest (acromegaly symptoms) were more common in placebo treated patients than in patients treated with octreotide capsules.

“We are pleased to have successfully completed the CHIASMA OPTIMAL trial under a SPA agreement with the FDA. The FDA previously indicated that this trial is adequately designed to address the clinical deficiency listed in their Complete Response Letter, subject to their review. We look forward to working with the FDA to bring this important treatment option to patients,” said Gary Patou, MD, Head of Clinical. “It is noteworthy that 90% of patients completing the trial on Mycapssa treatment elected to participate in the optional open-label extension.”

CHIASMA OPTIMAL Trial Design

The CHIASMA OPTIMAL trial was a randomized, double-blind, placebo-controlled, nine-month clinical trial of octreotide capsules that was conducted under a special protocol assessment, or SPA, agreement with the FDA. The trial enrolled 56 adult acromegaly patients whose disease was biochemically controlled by injectable somatostatin analogs (average IGF-1 £ 1.0 × upper limit of normal (ULN)). The patients also had confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ³ 1.3 × ULN. Patients were randomized on a 1:1 basis, to octreotide capsules or placebo. Patients were dose titrated from 40 mg per day to up to a maximum of 80 mg per day, equaling two capsules in the morning and two capsules in the evening. Patients who met the predefined withdrawal criteria, or discontinued from oral treatment for any reason, in either treatment arm during the course of the trial were considered treatment failures and reverted to their original treatment of injections and monitored for the remainder of the trial. The primary endpoint of the trial


was the proportion of patients who maintained their biochemical response at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels £ 1.0 × ULN (assessed at weeks 34 and 36). Hierarchical secondary endpoints that are expected to be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment include: proportion of patients who maintain GH response at week 36 compared to screening; time to loss of response: IGF-1 of 2 consecutive visits is > 1.0 × ULN; time to loss of response: IGF-1 of 2 consecutive visits is ³ 1.3 × ULN; and proportion of patients requiring rescue treatment.

Regulatory and Financial Update

Chiasma plans to submit a New Drug Application (NDA) by the end of the year for octreotide capsules for the maintenance treatment of adults with acromegaly. The CHIASMA OPTIMAL trial was conducted under a SPA agreement with the FDA, which indicates that the FDA agreed the design and planned analysis of the CHIASMA OPTIMAL results adequately address the objectives necessary to support a regulatory submission. However, a SPA is not a guarantee of regulatory approval. Chiasma anticipates that the FDA will review the totality of the data collected from the CHIASMA OPTIMAL trial, including both primary and secondary endpoints, together with certain data from Chiasma’s other clinical trials of octreotide capsules, including but not limited to data related to the loss of biochemical response when switching from injectable somatostatin analogs to octreotide capsules, in evaluating any NDA.

The Company ended June 30, 2019 with approximately $58.1 million in cash and investments as compared to $41.7 million at December 31, 2018.

Conference Call and Webcast Information:

Chiasma management will host a conference call and webcast to discuss the CHIASMA OPTIMAL results in more detail today, July 23, 2019, at 8:30 am EDT.

The dial-in number in the U.S./Canada is 877-407-4018; for international participants, the number is 201-689-8471. For all callers, please refer to Conference ID 13692819.

To access the live webcast, please use the following link: http://public.viavid.com/index.php?id=135476

About Acromegaly

Acromegaly typically develops when a benign tumor of the pituitary gland produces too much GH, ultimately leading to significant health problems. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs. Serious health conditions associated with the progression of acromegaly include type 2 diabetes, hypertension, respiratory disorders and cardiac and cerebrovascular disease. We believe that approximately 8,000 adult acromegaly patients are chronically treated with SSAs in the United States.

About Chiasma

Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as


injections. In July 2019, the Company reported statistically significant data from CHIASMA OPTIMAL, its third Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named Mycapssa®, for the maintenance therapy of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. Prior to trial initiation, the Company reached agreement with the FDA on the design of the trial through a Special Protocol Assessment. Chiasma is headquartered in Waltham, MA with a wholly-owned subsidiary in Israel. Mycapssa, TPE and CHIASMA are registered trademarks of Chiasma. For more information, please visit the Company’s website at www.chiasma.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the data from the CHIASMA OPTIMAL trial and whether the data will support the submission of an NDA for octreotide capsules and ultimately regulatory approval, statements regarding the timing of NDA submission and regulatory review, including the company’s anticipated eligibility for a six-month PDUFA review cycle, statements concerning the nature of the FDA’s review of any such NDA submission and whether the data submission will be sufficient to support regulatory approval, and statements regarding the number of adult acromegaly patients chronically treated with SSAs in the United States. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Annual Report on Form 10-K for the year ended December 31, 2018, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

Contact:

Ashley R. Robinson

LifeSci Advisors, LLC

617-535-7742

arr@lifesciadvisors.com

EX-99.2

Slide 0

Chiasma OPTIMAL Top-line Results JULY 23, 2019 NASDAQ: CHMA Exhibit 99.2


Slide 1

Forward-Looking Statements These slides and the accompanying presentation contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. All forward-looking statements are based on estimates and assumptions by our management that, although we believe them to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expect, including those material risks and uncertainties that are described under the heading “Risk Factors” in our Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Chiasma’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.


Slide 2

Acromegaly: A Rare and Debilitating Hormonal Disorder Caused by excessive secretion of growth hormone (GH) stemming from a benign pituitary tumor ~69,000* patients worldwide Features include enlarged hands, feet and internal organs, and altered facial features Significant comorbidities lead to premature death if untreated Patients not cured by surgery typically receive chronic somatostatin analog (SSA) injection therapy to suppress GH and IGF-1 Prior trials showed 51-67% IGF-1 response rate on injectable octreotide LAR** * Acromegaly Epidemiology abstracts and publications 1980-2016. **Sandostatin LAR prescribing information 2019 Cardiomegaly Headache Frontal bossing Increased perspiration Hypertension Enlarged hands (breadth) Nephromegaly Hepatomegaly Thyroid gland hypertrophy Prognathism (malocclusion) Coarse features Vision defect Supraorbital bulging Enlarged nose Enlarged tongue and lips Skin tags Galactorrhea Splenomegaly Polyps Enlarged colon Carpal tunnel syndrome Deformed sella turcica (pituitary adenoma) being developed as a much needed alternative in the treatment of acromegaly


Slide 3

Orphan, Addressable U.S. Acromegaly Market Opportunity 1.Endocrinology market studies. 2.Company estimates Sizing the Acromegaly Market Addressing the Market Cured through surgery Not treated with SSAs Chronically treated with SSA injections ~14,0001 ~8,0002 ~2,0002 # of U.S. Patients Diagnosed Acromegaly Patients ~24,0001 Fewer than 1,000 accounts manage ~90% of target acromegaly patients2 Pituitary Centers Regional Referral Centers High Volume Community Endocrinologists All Other Community Endocrinologists


Slide 4

Current Injection Therapies Carry Significant Treatment Burdens* Emotional Impact 36% feel loss of independence due to chronic injections Injection Site Reactions Hardness (48%), nodules (38%), swelling (28%), bruising (16%) and inflammation (7%) Lost Work Days 16% regularly miss work for injections (averages 11 days/year) Suboptimal Symptom Control 52% report symptoms worsen toward the end of the monthly dosing interval 32% controlled patients still complain about symptoms Pain 70% experienced pain during injection; half of these experienced continuing pain days later intramuscular Novartis’ Octreotide LAR: 19 or 20 Gauge Ipsen’s Lanreotide Depot: 18 or 19 Gauge deep subcutaneous cm Reference: insulin needle: 30 Gauge *Strasburger et al. Patient reported outcomes of parenteral somatostatin analogue injections in 195 patients with acromegaly. Eur J Endocrinol. 2016 Mar;174(3):355-62. An effective and painless oral therapy has the potential to disrupt the acromegaly market


Slide 5

CHIASMA OPTIMAL TRIAL* MET ITS ENDPOINTS Study met its primary endpoint and all secondary endpoints in acromegaly patients Positive top-line data brings us a step closer to advancing Mycapssa to registration with the FDA NDA resubmission planned by year end 2019 with an anticipated mid-2020 PDUFA date *This Special Protocol Assessment (SPA) agreed-upon Phase 3 clinical trial was designed to address FDA’s clinical concerns raised in the Complete Response Letter from April 2016


Slide 6

CHIASMA OPTIMAL – Study Design Open Label Extension Double-blind placebo-controlled (DPC) (36 weeks) Eligibility criteria: Average IGF-1 ≤ 1.0 ´ ULN Confirm active disease (IGF-1 ≥ 1.3 x ULN post last surgery) Pre-defined withdrawal criteria (both arms) IGF-1 ≥1.3 x ULN for 2 consecutive visits on the highest dose and exacerbation of clinical signs / symptoms Early terminated patients followed up to 36 weeks on injections, per protocol Baseline Placebo N=28 N=28 36 weeks 34 Last Injection Screening IGF-1s 2x IGF-1s 50% 50% Withdrawal Octreotide Capsules Versus Placebo Treatment In MultinationAL Centers Primary Endpoint Proportion of patients who maintain biochemical response (average of week 34 and 36 IGF-1 ≤ 1.0 x ULN)


Slide 7

Subject Disposition and Demographics 56 patients, 28 per group (octreotide capsules or placebo) 38% from the U.S. All patients completed trial No missing primary endpoint data Baseline characteristics well balanced between the groups


Slide 8

58% Maintained IGF-1 Response on Octreotide Capsules vs. 19% on Placebo (p = 0.008) Primary Endpoint: Proportion of patients who maintain biochemical response at end of 36 weeks p = 0.008


Slide 9

78% Maintained GH Response on Octreotide Capsules vs. 30% on Placebo (p = 0.001) 1st Secondary Endpoint: Proportion of patients who maintain GH response at week 36 (of GH responders at screening) p = 0.001


Slide 10

Median Time to Loss of Response Not Reached (>36 Weeks) for Patients on Octreotide Capsules (p < 0.001) Median time to loss of response Octreotide Capsules Placebo p Value 2nd Secondary Endpoint: IGF-1 >1.0×ULN Not reached 16 weeks < 0.001 3rd Secondary Endpoint: IGF-1 ≥1.3×ULN Not reached 16 weeks < 0.001


Slide 11

25% of Patients on Octreotide Capsules Began Rescue with SSA Injections vs. 68% on Placebo (p = 0.003) Confidential 4th Secondary Endpoint: Proportion of patients who began rescue treatment p = 0.003


Slide 12

90% Who Completed Trial with Octreotide Capsules Opted to Continue into the Open Label Extension 90% continued to OLE Patients completed 36-weeks on Mycapssa Patients elected to continue on Mycapssa


Slide 13

Octreotide Capsules Appeared Safe and Well Tolerated   Octreotide Capsules Placebo Subjects with: n % n % At least one TEAE 28 100% 27 96.4 Treatment-Related TEAE 18 64.3 15 53.6 SAEs 2 7.1 1 3.6 Treatment-Related SAEs 0 0.0 0 0.0 Severe TEAEs 3 10.7 7 25.0 TEAE Leading to Study Drug Discontinuation 2 7.1 1 3.6 TEAEs of Special Interest (acromegaly symptoms) 15 53.6 26 92.9 TEAE - Treatment-Emergent Adverse Events; SAEs – Serious Adverse Events; TEAEs of special interest: e.g. headache, perspiration, joint pain, fatigue, soft tissue swelling


Slide 14

CHMA Investment Highlights Rare and Orphan Disease Focus Registration-Ready Lead Asset Lead asset targeting adults with acromegaly Octreotide capsules (Mycapssa®), if approved, positioned to become the first oral somatostatin analog in an injectable-only market Positive top-line safety and efficacy results for CHIASMA OPTIMAL Phase 3 trial NDA submission planned by year end 2019 Ongoing EMA-accepted MPOWERED™ Phase 3 trial data anticipated in 2H 2020 Stable Financial Position Approximately $58.1 million of cash and investments as of June 30, 2019 Cash expected to be sufficient to fund operations into late 2020 Positive CHIASMA OPTIMAL data; NDA submission planned by year end 2019 Significant Market Opportunity SSAs in acromegaly represent approximately $0.8 billion annual global market opportunity Patent protection for Mycapssa through early 2036